biotech stocks, news, & commentary - BioHealth Investor

Unusual Biotech Movers (ASTM, BTRX, BCRX, CELG, NSTK, TRMS)

2008-05-09T12:44:00.006-04:00

If you are a stem cell watcher, you may want to watch Aastrom Biosciences Inc. (NASDAQ: ASTM) as it reports earnings on Monday. Shares are down 3% at $0.40 today. With a $53 million market cap, this isn't the most influential stock tied to stem cells.

Barrier Therapeutics Inc. (NASDAQ: BTRX) saw some highly unusual movement with a 15% rise to $2.31 (52-week trading range $1.63 to $7.60).

BioCryst Pharmaceuticals Inc. (NASDAQ: BCRX) saw a continues drop of almost 7% to $2.73 today, and that is after a similar drop yesterday after the company's earnings report.

Celgene Corporation (NASDAQ: CELG) saw a 1% drop to $61.80. We saw a duel in analyst calls today, and generally speaking downgrades take away more 'ooomph' than upgrades can add on the same day, particularly when the downgrade is from a bulge bracket firm and the upgrade is by a boutique. Pacific Growth Equities raised its rating to Buy, but Credit Suisse lowered its rating to Neutral from outperform.

Nastech Pharmaceutical Company, Inc. (NASDAQ: NSTK) saw a drop of more than 8% to $1.19 after its earnings report yesterday. 52-week trading had been $1.25 to $17.05. Count that as a 52-week low.

Shares of Trimeras Inc. (NASDAQ: TRMS) are down 9% at $6.35 today after the company has unveiled its plans to return most of its cash to shareholders now that it is down to a whopping 10 employees. At $50, 5-years ago, this stock has gone from potential boom to bust. Why does the term biotech zombie ring a bell here????

Rachel Lopez
May 9, 2008

Novo Nordisk Donates Compound Library to China Center

2008-05-01T07:46:00.005-04:00

by Richard Daverman, PhD
ChinBio Today

Novo Nordisk (NYSE: NVO) donated a license for its very extensive small-molecule compound library to the National Center for Drug Screening (NCDS), which is affiliated with the Shanghai Institute of Materia Medica, Chinese Academy of Sciences. The compound library contains an estimated 325,000 chemical structures. Because Novo Nordisk is turning its attention from small-molecule drugs to protein-based compounds, the company wanted the library, accumulated over decades of research, to be put to good use. It feels that NCDS will be able to accomplish that by using the library to find drugs for unmet needs.

The NCDS will screen the library’s compounds and its database for drug candidates that can treat and prevent the infectious tropical diseases that afflict people in poor countries. In this endeavor, the NCDS will be aided by the World Health Organization-based Special Program for Research and Training in Tropical Diseases (TDR).

The TDR will select targets and screens to support the identification of new drug candidates or leads for infectious tropical diseases, including malaria, tuberculosis, African sleeping sickness, dengue, Chagas disease, leishmaniasis, schistosomiasis, filariasis, onchocerciasis and soil-transmitted helminths. It will also bring in young scientists from developing countries, especially Africa, to be trained at the institute, combining scientists from developing and developed countries.

Novo Nordisk was the first international pharmaceutical company to establish an R&D center in China, building a Center of Excellence in Beijing in 2002. Previously, the company constructed a manufacturing facility to make insulin in Tianjin in 1996. Novo Nordisk has been selling diabetes-related products in China since the 1960s.

ChinaBio Today is a regular contributor to BioHealth Investor
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SMS makes its way into US health care

2008-04-17T08:32:00.037-04:00

by David E. Williams
Health Business Blog

Text messaging isn’t exactly big news. Most people have heard about it, even if they associate it only with teens who’ve given up talking on the phone or even meeting in person in order to spend their time texting. But text messaging has actually been slower to catch on with the general population in the US than has been the case overseas. And of course health care isn’t usually the rapid adopter of new communications tools.

Clickatell, which provides SMS text messaging solutions in various industries around the world thanks to its relationships with over 700 mobile carriers, is making a push into the health care space. I spoke yesterday with the company’s EVP of marketing, Chuck Drake in advance of today’s announcement that Clickatell is partnering with three health care organizations. (Although you wouldn’t know it from his Clickatell profile, Chuck actually has experience in the pharmaceutical world, where he worked on Rx to OTC switches for GSK.)

Clickatell has an interesting initial list of health care partners:

A branch of the UK’s National Health Service, “which will raise awareness around health issues such as diet, drugs and safe sex among the general public, with a specific focus on teen health.” Teens can send simple messages like “stop smoking” and get info in return. (You can bet that some of the requests will be a little more titillating than the one chosen for the press release.)

ComplyRx, a Georgia-based health care compliance company. According to ComplyRx’s president, “Text messaging provides and inexpensive and convenient way for doctors to communicate with patients or caregivers to remind them of important medical treatments, and Clickatell… ensure[s] that… messages don’t get lost…”

Cell-Life, a non-profit that uses SMS to send HIV/AIDS management information to South Africans.

I told Chuck I was somewhat skeptical about the ability of older Americans, who are the principal users of health care, to use text messaging. He told me I should put aside my thoughts of how teens text on a peer-to-peer basis and think instead about the receipt of messages from an entity like ComplyRx or a bank. That’s a much lower hurdle to clear and is good for applications such as appointment and medication reminders as well as basic educational information.

I also wonder about whether consumers will object to seeing text messaging charges on their cell phone bills, but according to Chuck the days of carriers charging for individual messaging are coming to an end. (I hope someone tells my carrier about that.)

What I like about SMS for health care is its low cost and ease of use. I’m hopeful that it will catch on.

Health Business Blog is a regular contributor to BioHealth Investor
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NatusConsolidates Newborn Hearing Loss Screening with Acquisition

2008-04-17T08:25:00.005-04:00

by Doug Cress
Med Tech Sentinel

Natus Medical (BABY) announced yesterday that it will acquire SonaMed, a privately held company based in Waltham, MA.

SonaMed manufactures and markets the Clarity Screener for the screening of hearing loss in newborns. The company reported revenues of $3.5 million in 2007.

According to Jim Hawkins, Natus’ President and CEO, “SonaMed has successfully created a distinct presence in the domestic newborn hearing screening market. We believe SonaMed is a very well run company that has been consistently profitable for many years.”

Earlier this month, Natus priced an offering to sell 770,000 shares of common stock at $18.27 per share, in all likelihood meant to offset SonaMed’s purchase price. Net proceeds were approximately $13.4 million. The acquisition will be accretive to Natus’ earnings in the first full quarter of ownership. Natus raked in $118 million last year and expects revenues of $160 million in 2008.

Natus already enjoys an 80% market share in the U.S. newborn hearing screening market. Approximately 95% of the children born in the U.S. are currently being tested for hearing impairment prior to discharge from the hospital. As such, the U.S. market is mature. Growth in the company’s newborn hearing loss screening segment will come mostly from abroad where less than one-in-four newborns are being tested.

Like Natus, most of Sonamed’s revenues (two-thirds) are recurring and generated from the sale of disposables. These supplies sell at very a high gross profit margin. Natus may face increasing competition from independent suppliers offering lower prices, according to its most recent annual report.

Sources estimate that 1 – 6 out of 1000 newborns will have congenital hearing loss. The first three years of life, and especially the first six months, are critical for normal speech and language development; if left unidentified, a child is at a significant disadvantage for the remainder of their life.

Med Tech Sentinel is a regular contributor to BioHealth Investor
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BioHealth Investor.com is for sale!

2008-04-14T15:56:00.003-04:00

I was dreading this announcement, but its time has come. My career as a dentist is finally taking off and keeping me too busy to maintain this blog's full potential.

Therefore, after a year and a half of surprising success I have no choice but to place BioHealth Investor(BHI) up for sale.

BHI is syndicated on SeekingAlpha.com, BioSpace.com, TheMoneyBlogs.com, Newstex.com and is regularly featured on Yahoo! Finance, Google Finance, TheStreet.com. Those were just the big boys, BHI is also syndicated all over the net, through hundreds of sites, blogs, networks, and directories.

BHI has also been approved for the soon to be launched Forbes financial blog network, and is currently a member of the Business of Biotech Network and Investors Blog Network (IBN)

BHI usually places on the first page of Google Search for keywords Biotechnology Stocks, Medical Stocks, and Biotech Stocks. This search placement can be very valuable.

BHI is syndicated to various educational and media outlets through Newstex.com
http://www.newstex.com/products/story_blog.php?blog_id=1514

BHI currently collects revenue through various advertising and syndication channels, including Google AdSense, Yahoo Ads, CommissionJunction (www.cj.com), BHI company directory (yearly subscription), newstex.com, and will soon start collecting ad revenue from the soon to be launched Forbes financial blog network.

you can learn more about BioHealth Investor by visiting biohealthinvestor.com and clicking on About Us.

Here are the links to BioHealth Investor as shown by Google
http://www.google.com/search?hl=en&q=link%3Abiohealthinvestor.com

value of BioHealthInvestor.com on dnscoop.com:
go to http://www.dnscoop.com/, enter biohealthinvestor.com into field and click on CheckIt!

All the above was achieved in less than 18 months.

currently, I am the only administrator and editor of the blog. on a daily basis I update the top stocks in the industry through Yahoo Finance, that takes me about 10 to 15 minutes 5 days a week. I also write my own exclusive articles once every 2 weeks or so. I also syndicate posts from various contributors of other blogs and sites, that takes another 10 to 15 minutes daily.

Who coule be interested in taking over BHI?

PR Firms - BHI could be a great tool in promoting medical and health related clients. The blogosphere is fast becoming a valuable resource for companies to reach out to investors in an informal way.

financial brokers - who would be interested in promoting their services to new investors and clients, including their newsletters and stock picks.

bloggers - interested in writing and keeping up with finance and stocks, and in making revenue through various advertising channels.

If you are interested in finding out more about BHI or details such as revenue numbers and asking price please contact me at:

hsayoub @ biohealth investor . com (ignore spacing)

Sincerely,
Hisham

Dr.Hisham S. Ayoub, DMD
www.biohealthinvestor.com

Friday's Top Medical & Biotech Stocks

2008-04-11T18:03:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PDL BIOPHARMA INC [PDLI] +16.91%
SENESCO TECH [SNT] +10.40%
TRANSDEL PHARMACTL [TDLP.OB] +8.53%
METABASIS THERAPEUTI [MBRX] +8.14%
MICROMET INC [MITI] +7.94%

Diagnostic Substances

ORCHID CELLMARK INC [ORCH] +5.36%
PRESSURE BIOSCIENC [PBIO] +3.42%
REMOTEMDX INC [RMDX.OB] +3.25%
LEXICON PHARMACEUTCL [LXRX] +1.53%
IMMUCELL CP [ICCC] +1.36%

Drug Delivery

ACURA PHARMACEUTICAL [ACUR] +2.79%
COLUMBIA LABS INC [CBRX] +2.27%
ARADIGM CORP [ARDM.OB] +1.96%

Drug Manufacturers

MARSHALL EDWARDS [MSHL] +16.88%
NOVOGEN LTD ADS [NVGN] +7.83%
PROVECTUS PHARMA [PVCT.OB] +6.67%
ARDEA BIOSCIENCES [RDEA] +4.17%
MIDDLEBROOK PHARMACL [MBRK] +4.01%

Drug Related Products

INTEGRATED BIOPHARMA [INBP] +8.50%
NUTRACEUTICAL INTL [NUTR] +1.35%
CURATECH INDUSTRIES [CUTC.OB] +0.77%
DRAXIS HEALTH INC [DRAX] +0.51%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +4.27%
MYLAN INC [MYL] +0.08%

Medical Appliances & Equipment

SIGNALIFE INC. [SGN] +30.10%
NEWCARDIO, INC. [NWCI.OB] +5.41%
IVIVI TECHNOLOGIES, [IVVI] +5.00%
SRI/SURGICAL EXPRE [STRC] +4.78%
LECTEC CORP [LECT.OB] +4.55%

Medical Instruments & Supplies

INSULET CORPORATION [PODD] +4.51%
PRO-DEX INC NEW [PDEX] +3.29%
INFUSYSTEMS HOLDINGS [INHI.OB] +2.92%
CAS MEDICAL SYS INC [CASM] +2.10%
OCULUS INNOVATIVE SC [OCLS] +1.80%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +2.96%
MEDTOX SCIENTFIC INC [MTOX] +0.54%

- Thursday's Top Medical & Biotech Stocks
- Wednesday's Top Medical & Biotech Stocks
__________________

To Antigenics or Not to Antigenics?

2008-04-10T16:25:00.002-04:00

by Michael Shulman
BiotechBlitz

Antigenics (AGEN) got a Russian approval for its cancer immunotherapy -- a cancer "vaccine" is the sexy, headline grabbing term. This also created a few seconds of buzz around two other immunotherapy companies, Dendreon (DNDN) and Cell Genesys (CEGE). I mention these two other companies because (for purposes of full disclosure) I own CEGE stock and recommend it in my newsletter service. I also own a full hedged position of DNDN that I can't wait to liquidate when my hedge expires.

In the United States, AGEN has failed to get approvals from the FDA for good reason: Its treatment, Oncophage, didn't work in Phase III trials and didn't even come close -- which is at least a sort of argument DNDN could and did make.

Oncophage targets kidney cancer and was shown to work within a sub-group of patients with "lower-stage tumors," and therefore a better shot at survival. 45% of these patients responded to Oncophage, hence the approval in a Russia looking to build new industries.

A couple of things are going on that are of critical interest to dying patients and some interest to investors:

• I started my career as a biotech wise-guy and sage, and I was a fan of the FDA under Dr. Mark McClellan. I now believe the agency kills far more people in a month than Rumsfeld and successors have done in Iraq. How? The FDA, despite what it says, does not really change its view of trial results for drugs for dying patients who have no hope.

Its statisticians hide behind numbers, insisting trial data be used only based on the original protocol for the trial -- subset analyses not in the original plan are verboten. And this is true even for patients with absolutely no alternative other than a very painful death.

• Medicine is moving worldwide and if Antigenics can treat a cancer patient in Russia, people with money in the United States and Europe will go there for treatment -- treatment that will be a lot cheaper than in the United States, even if Oncophage is approved in the U.S.

Immunotherapies from Antigenics and Dendreon are capital and labor intensive -- treatments are literally customized and prepared in a factory for each patient -- and Russia is a lot cheaper place to do that than other places.

• Professional investors are so disgusted with the FDA and so aware of the vibrant new international medicine market that they are willing to financially support the Antigenics business model. The proof is a new private offering by Antigenics to the tune of $21 million.

Where does this leave investors?

• AGEN is now an interesting play because it may now be able to generate revenue AND prove out its therapy in a distinctive sub-group of patients without needing huge additional infusions of capital.

• DNDN now has a fallback. I believe their interim trial results will not get them an approval due to the way the trial is structured and their final results may not be strong enough under the current regime of statistical fascism at the FDA. So, Dendreon could go to Russia, but probably would go the China or India route if necessary.

• Cell Genesys has by far the best-structured trials -- it provide for patients with and without the current standard of late-stage care, have embedded metrics using immune system biomarkers and are huge. In my opinion CEGE stands the best chance of an FDA approval, but the Russia, India, China option helps CEGE too, as it now has a fallback if needed.

The bottom line here is that this was not a minor announcement by Antigenics. It has far-reaching ramifications and you can expect other companies with good sub-group analysis and life-saving treatments -- but no FDA approval -- to look to Russia, China and India for quick trials, drug approvals and an international base to build out their product.

And this reduces the risk in many companies.

BiotechBlitz is a regular contributor to BioHealth Investor
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Thursday's Top Medical & Biotech Stocks

2008-04-10T16:18:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

GENETIC TECH SPON [GENE] +18.21%
TRUBION PHARMACEUTIC [TRBN] +15.83%
XENACARE HOLDINGS [XCHO.OB] +15.38%
VION PHARMACEUTICALS [VION] +14.97%
NORTHFIELD LABS IN [NFLD] +13.86%

Diagnostic Substances

AVIGEN INC [AVGN] +14.58%
ISTA PHARMACTLS [ISTA] +9.41%
HUMAN GENOME SCI [HGSI] +8.33%
INFINITY PHARMACEUTI [INFI] +6.24%
LEXICON PHARMACEUTCL [LXRX] +5.38%

Drug Delivery

PENWEST PHARM CO [PPCO] +7.89%
GENEREX BIOTECH CORP [GNBT] +4.17%
ALKERMES INC [ALKS] +3.47%
ELAN CP PLC ADR [ELN] +3.17%
NOVEN PHARMACEUTIC [NOVN] +2.24%

Drug Manufacturers

MILLENNIUM PHARM [MLNM] +48.87%
GERON CORP [GERN] +12.73%
NEUROCHEM INC [NRMX] +9.82%
SIGA TECH INC [SIGA] +8.39%
GEOPHARMA INC [GORX] +7.20%

Drug Related Products

USANA HEALTH SCIEN [USNA] +4.82%
PRESTIGE BRAND HLGS [PBH] +3.13%
SALIX PHARM DEL [SLXP] +1.52%
AUXILIUM PHARMACEUT [AUXL] +1.28%
SCHIFF NUTRIT INTL [WNI] +0.71%

Generic Drugs

HI-TECH PHARMACAL [HITK] +13.08%
PHARMACUTICAL CO [PRX] +6.17%
CATALYST PHARMACEUTI [CPRX] +1.74%
CARACO PHARMA LABS [CPD] +1.47%
WATSON PHARMACEUTCLS [WPI] +0.71%

Medical Appliances & Equipment

IRIDEX CP [IRIX] +20.00%
PATIENT SAFETY TECH [PSTX.OB] +12.07%
BIOFORM MEDICAL, INC [BFRM] +9.47%
LECTEC CORP [LECT.OB] +8.91%
EDAP TMS SA ADR [EDAP] +8.45%

Medical Instruments & Supplies

OSTEOTECH INC [OSTE] +5.93%
NEUROMETRIX, INC. [NURO] +5.00%
SENORX, INC. [SENO] +4.97%
CANTEL MEDICAL CORP [CMN] +4.91%
NUCRYST PHARMACEUTIC [NCST] +4.55%

Medical Laboratories & Research

GENOPTIX, INC. [GXDX] +7.33%
ARRAY BIOPHARMA IN [ARRY] +5.60%
GENOMIC HEALTH, INC. [GHDX] +3.44%
ALLIANCE IMAGING INC [AIQ] +1.16%
PSYCHEMEDICS NEW [PMD] +0.53%

- Wednesday's Top Medical & Biotech Stocks
- Tuesday's Top Medical & Biotech Stocks
__________________

Aida Pharma Affiliate Developing New Antibiotic

2008-04-09T17:30:00.002-04:00

by Richard Daverman, PhD
ChinaBio Today

Aida Pharmaceuticals, Inc. (OTCBB: AIDA) is working on a new wide-spectrum antibiotic that was discovered by its recently acquired affiliate, the Jiangsu Institute of Microbiology Co., Ltd (JSIM). Wetimicin, which belongs to a new generation of amino-glycoside antibiotics, is in Phase I trials. Aida believes the product will have a wider market than its current antibiotic, Etimicin Sulphate. In its various forms, Etimicin Sulphate produced the majority of Aida’s $29 million of revenues in 2007. Etimicin Sulphate belongs to the same family of antibiotics as Wetimicin.

Wetimicin is being tested as a treatment for inflammations (including respiratory infection, urinogenital infection, soft skin tissue infection) and also for infections from trauma and operations. JSIM expects that Wetimicin will prove to be safer and more reliable for children and elderly patients than current antibiotics.

Aida has a controlling interest in JSIM, but does not own it outright. It has a right of first refusal on any drugs that are granted marketing approval by the SFDA.

JSIM began working on the compound in 2000. Aida expects JSIM to begin a Phase II trial of Wetimicin later in 2008.

ChinaBio Today is a regular contributor to BioHealth Investor
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Wednesday's Top Medical & Biotech Stocks

2008-04-09T17:23:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PROTEO INC [PTEO.OB] +31.19%
CHAMPIONS BIOTECHNLG [CSBR.OB] +9.52%
IOMAI CORPORATION [IOMI] +9.43%
LPATH INC [LPTN.OB] +9.03%
GENAERA CORP [GENR] +8.21%

Diagnostic Substances

ISTA PHARMACTLS [ISTA] +13.48%
TORREYPINES THERAPEU [TPTX] +6.37%
REMOTEMDX INC [RMDX.OB] +3.40%
AVALON PHARMACEUTIC [AVRX] +1.85%
AVIGEN INC [AVGN] +1.27%

Drug Delivery

GENEREX BIOTECH CORP [GNBT] +12.15%
ARADIGM CORP [ARDM.OB] +2.86%
ACURA PHARMACEUTICAL [ACUR] +2.55%
DELCATH SYSTEMS INC [DCTH] +0.41%
QUIGLEY CORP THE [QGLY] +0.39%

Drug Manufacturers

GENEREX BIOTECH CORP [GNBT] +12.15%
AMARIN CORP ADS [AMRN] +9.56%
DUSA PHARM INC [DUSA] +4.48%
MARSHALL EDWARDS [MSHL] +3.98%
AVANIR PHARMACEUTICL [AVNR] +3.88%

Drug Related Products

TIENS BIOTECH GR USA [TBV] +1.47%
PERRIGO COMPANY [PRGO] +0.82%
LABOPHARM INC. [DDSS] +0.45%

Generic Drugs

MYLAN INC [MYL] +3.02%
CATALYST PHARMACEUTI [CPRX] +2.47%
WATSON PHARMACEUTCLS [WPI] +0.73%

Medical Appliances & Equipment

LANGER INC [GAIT] +11.51%
ARRHYTHMIA RES TECH [HRT] +6.54%
EDAP TMS SA ADR [EDAP] +6.29%
ARTHROCARE CP [ARTC] +6.13%
BSD MEDICAL CORP [BSM] +3.98%

Medical Instruments & Supplies

EP MEDSYSTEMS INC [EPMD] +102.84%
THORATEC CORP [THOR] +7.78%
LEMAITRE VASCULAR [LMAT] +7.73%
INSULET CORPORATION [PODD] +5.58%
MEMRY CORPORATION [MRY] +5.26%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +3.36%
LABORATORY CORP NEW [LH] +2.79%
QUEST DIAGNOSTC [DGX] +2.46%
PSYCHEMEDICS NEW [PMD] +0.53%
PHARM PROD DEV [PPDI] +0.09%

- Tuesday's Top Medical & Biotech Stocks
- Monday's Top Medical & Biotech Stocks
__________________

Drug Recycling: Not Much of a Solution

2008-04-08T19:12:00.002-04:00

by David E. Williams
Health Business Blog

The Associated Press reports that most US states have implemented “drug recycling” programs or are considering doing so. The basic idea is to accept donations of unused drugs and re-dispense them to people in need. It sounds like a good idea on the surface. After all, why should the drugs go to waste when there are people who can’t afford their prescriptions?
I’m sure that some people are helped by such programs and that the people running them have the best of intentions. Still, I have some concerns:

Donations aren’t likely to be particularly steady, so I don’t see how chronically ill patients will be able to count on gaining access to a specific drug and dose over a long period of time

Although there are some restrictions on who can donate and what can be donated, there will definitely be concerns over the integrity of the supply chain. I’m worried more about drugs being stored in poor conditions (e.g., heat, humidity) than tampering

Inventory management will be hard. The donation centers want products six months or more before expiration, but will be challenged to manage stock. It’s expensive to do it well

The administrative costs of these programs will be large relative to the volume of drugs. Even the larger programs seem to be dispensing only hundreds of thousands of dollars per year worth of products (though of course that could increase)

There are better, more cost-effective ways to get products into the hands of patients who can’t afford them:

Patient Assistance Programs run by drug manufacturers. States and/or private agencies could put their resources into publicizing the existence of these programs rather than scrounging for donations of unwanted products

Increased generic utilization. Generic drugs are generally cheap. (Take $4 Wal-Mart generics for example.) I’m sure the drug recycling programs spend more than $4 per prescription even though they get the drugs for free

Health Business Blog is a regular contributor to BioHealth Investor
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Tuesday's Top Medical & Biotech Stocks

2008-04-08T19:05:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

ANTIGENICS INC [AGEN] +22.67%
ADVANCED LIFE SCIENC [ADLS] +16.68%
PLURISTEM THERAPEUTC [PSTI] +15.44%
REPLIGEN CP [RGEN] +14.10%
ARTES MEDICAL, INC. [ARTE] +11.11%

Diagnostic Substances

IMMUCELL CP [ICCC] +10.26%
ISTA PHARMACTLS [ISTA] +7.23%
ROSETTA GENOMICS LTD [ROSG] +4.82%
SCOLR PHARMA INC [DDD] +4.13%
SURMODICS INC [SRDX] +3.61%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +16.75%
FLAMEL TECH SA ADR [FLML] +2.52%
NOVEN PHARMACEUTIC [NOVN] +2.51%
MATRIXX INITIATVS [MTXX] +2.18%
BIOVAIL CORP [BVF] +0.91%

Drug Manufacturers

ACCESS PHARMACEUTICL [ACCP.OB] +41.18%
DELCATH SYSTEMS INC [DCTH] +16.75%
NEUROCHEM INC [NRMX] +12.93%
DUSA PHARM INC [DUSA] +12.06%
SUCAMPO PHARMA. INC. [SCMP] +10.80%

Drug Related Products

XELR8 HOLDINGS, INC [BZI] +8.11%
NATURAL ALTERNATIV [NAII] +5.55%
PRESTIGE BRAND HLGS [PBH] +2.63%
AUXILIUM PHARMACEUT [AUXL] +2.59%
SALIX PHARM DEL [SLXP] +2.25%

Generic Drugs

MYLAN INC [MYL] +3.02%
CATALYST PHARMACEUTI [CPRX] +2.47%
WATSON PHARMACEUTCLS [WPI] +0.73%

Medical Appliances & Equipment

SRI/SURGICAL EXPRE [STRC] +14.21%
FONAR CORP [FONR] +12.33%
BIOFORM MEDICAL, INC [BFRM] +10.37%
EDAP TMS SA ADR [EDAP] +9.15%
NXSTAGE MEDICAL, INC [NXTM] +8.86%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +13.33%
VASCULAR SOLUTIONS [VASC] +12.66%
LEMAITRE VASCULAR [LMAT] +10.40%
BOVIE MEDICAL CORP [BVX] +9.57%
EV3 INC. [EVVV] +7.47%

Medical Laboratories & Research

NEOGENOMICS INC [NGNM.OB] +1.98%
GENOPTIX, INC. [GXDX] +1.19%
BIO-REFERENCE LAB [BRLI] +0.87%
PSYCHEMEDICS NEW [PMD] +0.81%
ENZO BIOCHEM INC [ENZ] +0.56%

- Monday's Top Medical & Biotech Stocks
- Friday's Top Medical & Biotech Stocks
__________________

Nanogen Strengthens Active Partnering and Licensing Program

2008-04-07T17:35:00.002-04:00

by Doug Cress
Med Tech Sentinel

Nanogen and Thermo Fisher Scientific Partner to Provide Molecular Biology Products to the Research Market

As the biomedical industry works to gain a better understanding of the molecular basis of disease, the need for specific methods to detect genetic variation are becoming increasingly central to research.

San Diego, CA-based Nanogen (NGEN) has developed a suite of molecular genetics technologies; the company’s product line includes instruments, electronic microarrays, reagents, ELISAs and rapid tests sold directly to end-users through licenses, and through a network of distributors in North America, Europe and Asia.

In a deal announced last week, Thermo Fisher Scientific will become the exclusive provider of a variety of Nanogen products used in gene-expression experiments.

The agreement covers both custom and standard catalog products based on Nanogen’s technology for real-time PCR (polymerase chain reaction, a method of duplicating small amounts of DNA to assess its make-up) applications. This probe technology (a probe is a fragment of DNA which is used to detect in DNA or RNA samples the presence of nucleotide sequences – the DNA target – that are complementary to the sequence in the probe) will incorporate Nanogen’s proprietary Minor Groove Binder (MGB) technology.

Minor Groove Binder

The Minor Groove Binder is a crescent-shaped molecule that when coupled to an oligonucleotide (a short molecule of single-stranded DNA) probe improves efficiency and specificity compared to longer traditional probes.

According to Howard Birndorf, Nanogen’s CEO, “[MGB] provides product differentiation and superior performance for our research and clinical customers employing widely-used real-time PCR applications for molecular and gene-expression analysis.”

The company was issued two patents for the technology in May 2005.

Nanogen’s MGB technology is licensed broadly in various fields and is now an integral component in thousands of PCR probe products. Nanogen has more than 35 reagent and kit products that are sold for clinical diagnostic use under the MGB Alert and Q-PCR Alert brands.

Applied Biosystems (ABI) had licensed MGB for use in the company’s TaqMan products, a life science research product library for PCR applications. In a deal announced earlier this month, DRI Capital acquired for $10 million all future royalties to be generated by ABI’s licensing of MGB.

Strong Revenue Growth

Nanogen has managed to consistently grow revenues over the past several years: from $5.3 million in 2004 to $12.5 million in 2005 to $26 million in 2006. In 2007 revenues were $38.2 million (an increase of 43% YOY).

Total fiscal 2008 revenues are expected to increase by approximately 25% from 2007 levels with a gross margin of approximately 60%.

Nanogen stock opened at $.42 today, down from a 52-week high of $2.07.

Med Tech Sentinel is a regular contributor to BioHealth Investor
________________

Monday's Top Medical & Biotech Stocks

2008-04-07T17:24:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PLURISTEM THERAPEUTC [PSTI] +107.90%
TRANSDEL PHARMACTL [TDLP.OB] +54.55%
METABASIS THERAPEUTI [MBRX] +21.29%
AETERNA ZENTARIS [AEZS] +17.14%
LIFECELL CP [LIFC] +16.94%

Diagnostic Substances

TORREYPINES THERAPEU [TPTX] +16.91%
MONOGRAM BIOSCIENCES [MGRM] +5.26%
ROSETTA GENOMICS LTD [ROSG] +4.85%
ISTA PHARMACTLS [ISTA] +4.40%
INFINITY PHARMACEUTI [INFI] +3.55%

Drug Delivery

GENEREX BIOTECH CORP [GNBT] +10.89%
ELAN CP PLC ADR [ELN] +6.92%
NEKTAR THERAPEUTIC [NKTR] +5.00%
COLUMBIA LABS INC [CBRX] +3.57%
DELCATH SYSTEMS INC [DCTH] +2.45%

Drug Manufacturers

SUCAMPO PHARMA. INC. [SCMP] +13.68%
SEPRACOR INC [SEPR] +9.50%
PHARMAXIS LTD ADR [PXSL] +8.87%
OSCIENT PHARMACEUT [OSCI] +6.98%
WYETH [WYE] +6.59%

Drug Related Products

ARGAN INC [AGX] +7.72%
CURATECH INDUSTRIES [CUTC.OB] +6.67%
XELR8 HOLDINGS, INC [BZI] +5.71%
CHINA SHENGHUO PHARM [KUN] +4.17%
MANNATECH INC [MTEX] +3.07%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +5.66%
CATALYST PHARMACEUTI [CPRX] +3.52%
WATSON PHARMACEUTCLS [WPI] +2.63%
MYLAN INC [MYL] +2.19%
PHARMACUTICAL CO [PRX] +1.81%

Medical Appliances & Equipment

CYTOCORE INC [CYOE.OB] +10.42%
HANSEN MEDICAL, INC. [HNSN] +6.94%
RTI BIOLOGICS INC [RTIX] +6.71%
DIGIRAD CORPORATION [DRAD] +6.11%
ARRHYTHMIA RES TECH [HRT] +5.87%

Medical Instruments & Supplies

DEXCOM [DXCM] +15.77%
BIOSPHERE MEDICAL [BSMD] +13.53%
ANGEION CORP [ANGN] +8.26%
MEMRY CORPORATION [MRY] +7.77%
PRO-DEX INC NEW [PDEX] +6.54%

Medical Laboratories & Research

MEDTOX SCIENTFIC INC [MTOX] +4.23% $0
NATL DENTEX CP [NADX] +4.16% $104.5 M
ALLIANCE IMAGING INC [AIQ] +1.27% $531.8 M
BIO-IMAGING TECH [BITI] +0.86% $33.5 M
PHARM PROD DEV [PPDI] +0.71%

- Friday's Top Medical & Biotech Stocks
- Thursday's Top Medical & Biotech Stocks
__________________

No Recession in Healthcare

2008-04-04T16:53:00.001-04:00

by David E. Williams
Health Business Blog

The housing market’s in a tailspin, gas and food prices are crazy and the “R” word is in the air. Retailers are seeing a drop in business and more people are taking public transportation.

But you wouldn’t know about any sort of slowdown if you did what I did and tried to park at the Tufts Medical Center in Boston today. I arrived at about 1:30 pm and went into the parking garage. I drove all the way to the top without spotting a single open parking place. (I even looked in the handicap section: completely full!) Plenty of other people were driving around and having the same experience. When I finally gave up and exited the cashier admitted the lot was full. Meanwhile cars kept coming through the gate, one after the other.

I then went to the valet parking lot but the valet initially refused to take me! He said I had to be a patient or visiting a patient. He finally relented when I insisted I was going to a business meeting at the medical center and would only be there an hour. But he wasn’t happy about it.

Demand for health care in Boston (and everywhere else in the US) is insatiable. Decreasing the number of uninsured as we’re doing in Massachusetts and as all the presidential candidates are talking about is going to drive demand even higher. Somehow I don’t think that’s going to help with costs.

Health Business Blog is a regular contributor to BioHealth Investor
_____________

Friday's Top Medical & Biotech Stocks

2008-04-04T16:46:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

XENACARE HOLDINGS [XCHO.OB] +28.71%
OPEXA THERAPEUTICS [OPXA] +27.83%
MEDICINOVA, INC. [MNOV] +11.11%
REPLIGEN CP [RGEN] +11.09%
SUNESIS PHARMACEUTIC [SNSS] +10.67%

Diagnostic Substances

ISTA PHARMACTLS [ISTA] +13.57%
INFINITY PHARMACEUTI [INFI] +9.49%
HUMAN GENOME SCI [HGSI] +4.41%
IMMUCOR INC [BLUD] +3.44%
LEXICON PHARMACEUTCL [LXRX] +2.40%

Drug Delivery

EMISPHERE TECH [EMIS] +8.12%
NOVEN PHARMACEUTIC [NOVN] +4.84%
MATRIXX INITIATVS [MTXX] +3.31%
PETMED EXPRESS INC [PETS] +2.46%
FLAMEL TECH SA ADR [FLML] +2.46%

Drug Manufacturers

SIGA TECH INC [SIGA] +30.45%
NITROMED, INC. [NTMD] +11.71%
MINRAD INTL INC [BUF] +11.61%
VYREX CORP DE NEW [VYXC.OB] +10.00%
LANNETT COMPANY INC [LCI] +5.96%

Drug Related Products

DRAXIS HEALTH INC [DRAX] +20.41%
SALIX PHARM DEL [SLXP] +5.11%
CHINA SHENGHUO PHARM [KUN] +3.52%
PERRIGO COMPANY [PRGO] +2.23%
PRESTIGE BRAND HLGS [PBH] +1.65%

Generic Drugs

BARR PHARMA INC [BRL] +3.66%
CARACO PHARMA LABS [CPD] +1.37%
MYLAN INC [MYL] +0.90%
WATSON PHARMACEUTCLS [WPI] +0.90%
HI-TECH PHARMACAL [HITK] +0.77%

Medical Appliances & Equipment

ESCALON MED CP [ESMC] +13.06%
NXSTAGE MEDICAL, INC [NXTM] +11.35%
LECTEC CORP [LECT.OB] +10.00%
MISONIX INC [MSON] +8.22%
SONIC INNOVATIONS [SNCI] +6.45%

Medical Instruments & Supplies

ENCISION INC [ECI] +25.68%
BIOTEL INC [BTEL.OB] +15.79%
YOUNG INNOVATIONS [YDNT] +8.71%
STRATEGIC DIAGNOST [SDIX] +8.24%
INSULET CORPORATION [PODD] +7.23%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +4.39%
ALLIANCE IMAGING INC [AIQ] +1.88%
PHARM PROD DEV [PPDI] +0.76%
RADNET INC [RDNT] +0.13%

- Thursday's Top Medical & Biotech Stocks
- Wednesday's Top Medical & Biotech Stocks
__________________

A Biotech Turnaround?

2008-04-03T17:28:00.002-04:00

by Michael Shulman
BiotechBlitz

Are biotech's turning around? They are certainly beating the market and, frankly, worrying about FDA decisions is easier now than worrying about how much toxic waste is hidden on a bank's balance sheet.

I have a good feel for the odds of whether Cell Genesys (CEGE) will get an approval in a couple of years GVAX, its prostate cancer treatment. I don't know the odds of Citigroup (C) writing down another $50 billion, rather than the $12 billion to $20 billion analysts are talking about this quarter.

Think of it this way: If Citigroup is as bad off as I believe it is (and as Meredith Whitney of Oppenheimer thinks it is -- she was the first analyst to say it would blow up and cut its dividend, and for her insightfulness received death threats), then the stock is going from $24 to $11.

If Cell Genesys doesn't get an approval in 2010, the stock is going from $3 to $1. The upside for Citigroup could be $40 in three years -- about a 60% gain. The upside for Cell Genesys is $80, a 25-fold increase.

Both stocks carry the same risk, i.e., we just don't know what is going to happen. So which one has a better risk/reward ratio -- a highly speculative biotech or Citigroup? Maybe, for the first time in the history of mankind the winner is the molecules, and not the money-center banks.

This kind of thinking may finally be occurring to speculators and traders. Why?

Many itty bitty biotech's are trading at historic lows, based on their available cash and the proximity of binary events that could catalyze the stock. The market is so down on these guys it is amazing!

A couple of weeks ago Spectrum (SPPI) got its first approval ever for a cancer drug, and the stock went essentially nowhere.

Cell Genesys cut a great deal with Takeda, eliminated the need to raise capital, got funding to finish its Phase III trials for GVAX and the stock popped a little bit, but a small move compared to what wold have happened three years ago.

Prana (PRAN) had very-strong Phase II results (my interpretation) for an Alzheimer's drug and the stock moved -- but not as much as it would have three years ago.

This indifference could be ending, and if it is there is huge upside in many smallish biotechs. So, if you have some extra cash from shorting the banks -- and you are thinking about your next speculative play, and I mean speculative -- get some coffee or some other biotech-based brewed liquids, and take a look at some very cheap smallish biotech's.

BiotechBlitz is a regular contributor to BioHealth Investor
_______________

Thursday's Top Medical & Biotech Stocks

2008-04-03T17:21:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

IDM PHARMA INC [IDMI] +15.37%
ADVANCED LIFE SCIENC [ADLS] +14.69%
ANESIVA INC [ANSV] +14.33%
IOMAI CORPORATION [IOMI] +12.82%
CYTORI THERAPEUTICS [CYTX] +11.00%

Diagnostic Substances

INTERLEUKIN GENETICS [ILI] +14.29%
IMMUCELL CP [ICCC] +11.67%
TORREYPINES THERAPEU [TPTX] +7.41%
PRESSURE BIOSCIENC [PBIO] +7.09%
ISTA PHARMACTLS [ISTA] +6.06%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +2.42%
BIOVAIL CORP [BVF] +2.37%
ACURA PHARMACEUTICAL [ACUR] +1.60%
ARADIGM CORP [ARDM.OB] +0.96%
COLUMBIA LABS INC [CBRX] +0.90%

Drug Manufacturers

ANGIOTECH PHARMA I [ANPI] +25.66%
ACCESS PHARMACEUTICL [ACCP.OB] +16.55%
SCHERING PLOUGH CP [SGP] +10.97%
PHARMAXIS LTD ADR [PXSL] +7.45%
OSCIENT PHARMACEUT [OSCI] +7.41%

Drug Related Products

INTEGRATED BIOPHARMA [INBP] +6.23%
N B T Y INC [NTY] +5.61%
TIENS BIOTECH GR USA [TBV] +4.88%
XELR8 HOLDINGS, INC [BZI] +3.85%
CHINA SHENGHUO PHARM [KUN] +3.64%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +5.06%
MYLAN INC [MYL] +2.09%
CATALYST PHARMACEUTI [CPRX] +1.14%
BARR PHARMA INC [BRL] +1.06%

Medical Appliances & Equipment

ATS MEDICAL INC [ATSI] +15.07%
AMER MED ALERT CP [AMAC] +14.70%
FONAR CORP [FONR] +12.46%
EDAP TMS SA ADR [EDAP] +10.90%
XCORPOREAL INC [XCR] +9.21%

Medical Instruments & Supplies

XTENT INC [XTNT] +26.52%
BIOMIMETIC THERAPEUT [BMTI] +11.96%
ANGIODYNAMICS INC [ANGO] +10.82%
LEMAITRE VASCULAR [LMAT] +8.90%
ELECTRO-OPTICAL SCIE [MELA] +8.02%

Medical Laboratories & Research

ERESEARCHTECHNOLOG [ERES] +1.92%
NATL DENTEX CP [NADX] +0.82%
PSYCHEMEDICS NEW [PMD] +0.81%
BIO-IMAGING TECH [BITI] +0.14%

- Wednesday's Top Medical & Biotech Stocks
- Tuesday's Top Medical & Biotech Stocks
__________________

China Biopharma Stocks Suffer Tough First Quarter

2008-04-02T17:13:00.002-04:00

by Richard Daverman, PhD
ChinaBio Today

China biopharma stocks listed on US exchanges weathered a difficult first quarter of 2008. The ChinaBio® Stock Index fell from 1675 to 1215 during the three months, a substantial decline of 27.4%.

During the same time, the Dow Jones Industrials Average was lower by just 7.5%, though Nasdaq lived up to its reputation for volatility by dropping 14%. Still, the loss in the ChinaBio® Index was almost twice as much.

China, on the other hand, suffered an even more negative quarter. The Shanghai Composite, which had climbed from 1,000 to over 6,000 in two years, peaked in October. Since that time, it dropped below 3,500. In the first quarter of 2008, it watched 34% of its value vaporize as it slid from 5261 to 3472.

Today, on the first day of the new quarter, most markets around the world posted positive sessions, as though they were celebrating, even if it was only a celebration that the first quarter was over. Japan and Hong Kong both gained more than 1%, but the Shanghai Composite dropped another 4%. Looking into the future, investors envision a slowing economy as the government clamps down to prevent inflation.

Interestingly, the Halter Golden Dragon ETF (AMEX: PGJ) – a composite of many China companies that trade in the US, and a list that is not restricted to any industrial sector – suffered the same 27% loss in the first three months of the year as the ChinaBio® Stock Index. This suggests that the difficulty is not located in biopharma, but in investors’ perceptions of the future of China.

Last year, China could do no wrong. Now, the future does not seem so completely free of limits.

The decline in prices has made many China biopharma stocks seem like bargains in terms of the usual financial measurements – PE ratios, Price to Revenue, etc. Of course, just because the stocks are cheap, it does not mean that they can’t get cheaper, as stock markets tend to overshoot the mark that says “Good Value,” both on the upside and the down.

Many of the China biopharmas that make up the ChinaBio® Stock Index are suffering in price because they are listed on less-desirable exchanges, like the Bulletin Board, and also because they lack the transparency of their Stateside counterparts – analysts have a difficult time vetting their operations. When stocks are on an upward roll, these problems are not as glaring as they become when stocks begin to slide lower.

This is not a problem for the likes of Mindray Medical (NYSE: MR) and WuXi PharmaTech (NYSE: WX). These large companies are adept at providing analysts with data and insight to convince the investment community that these enterprises are viable beyond a doubt. Still, Mindray and WuXi have watched their stock prices decline from very high PE ratios to modest ones. But the smaller biopharmas do not have this same sense of solidity, and their prices are very low in comparison to their revenues and earnings.

Nevertheless, if these smallish companies continue to perform well, announcing higher revenues and steady growth in net income – in other words, to perform as they did in 2007 – they will build the credibility they now lack. When that happens, their stock prices will move higher until the price of their shares is in line with that of other growing and profitable biopharmas.

ChinaBio Today is a regular contributor to BioHealth Investor
___________

Wednesday's Top Medical & Biotech Stocks

2008-04-02T17:05:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PROTEO INC [PTEO.OB] +34.58%
AETERNA ZENTARIS [AEZS] +32.46%
SENESCO TECH [SNT] +17.70%
CORCEPT THERAPEUTICS [CORT] +16.98%
ATHERSYS INC [ATHX] +16.67%

Diagnostic Substances

IMMUCOR INC [BLUD] +9.75%
ICAGEN, INC. [ICGN] +9.40%
INFINITY PHARMACEUTI [INFI] +8.02%
SURMODICS INC [SRDX] +5.90%
AVANT IMMUNOTHERAPEU [AVAND] +4.67%

Drug Delivery

PENWEST PHARM CO [PPCO] +7.69%
EMISPHERE TECH [EMIS] +7.19%
BIOVAIL CORP [BVF] +3.20%
ACURA PHARMACEUTICAL [ACUR] +1.98%
NEKTAR THERAPEUTIC [NKTR] +0.73%

Drug Manufacturers

OSCIENT PHARMACEUT [OSCI] +7.39%
ALLOS THERAPEUTICS [ALTH] +6.49%
INSPIRE PHARMACEUT [ISPH] +6.41%
ACETO CP [ACET] +5.97%
ANGIOTECH PHARMA I [ANPI] +5.12%

Drug Related Products

XELR8 HOLDINGS, INC [BZI] +5.69%
AUXILIUM PHARMACEUT [AUXL] +5.69%
LABOPHARM INC. [DDSS] +5.33%
DRAXIS HEALTH INC [DRAX] +3.07%
NUTRACEUTICAL INTL [NUTR] +0.69%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +26.52%
MYLAN INC [MYL] +0.67%
PHARMACUTICAL CO [PRX] +0.50%
CARACO PHARMA LABS [CPD] +0.43%

Medical Appliances & Equipment

NXSTAGE MEDICAL, INC [NXTM] +7.93%
VISION SCIENCES IN [VSCI] +7.36%
STEREOTAXIS, INC. [STXS] +6.80%
VOLCANO CORPORATION [VOLC] +6.73%
CYBERONICS INC [CYBX] +6.00%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +11.11%
ELECTRO-OPTICAL SCIE [MELA] +10.33%
ROCHESTER MEDICAL [ROCM] +7.74%
MESA LABS INC [MLAB] +6.30%
CRYOCOR, INC. [CRYO] +5.68%

Medical Laboratories & Research

RADNET INC [RDNT] +4.50%
MEDTOX SCIENTFIC INC [MTOX] +3.07%
ARRAY BIOPHARMA IN [ARRY] +2.44%
PHARM PROD DEV [PPDI] +1.80%
GENOPTIX, INC. [GXDX] +1.74%

- Tuesday's Top Medical & Biotech Stocks
- Monday's Top Medical & Biotech Stocks
__________________

Novare Surgical Removes Appendix via Vagina

2008-04-02T10:38:00.002-04:00

by Doug Cress
Med Tech Sentinel

Sorry guys, we’re out of luck.

Novare Surgical Systems announced today the successful completion of an appendix removal performed using its RealHand HD instruments. Two surgeons from the UC San Diego Medical Center removed an inflamed appendix through a patient’s vagina, a first in the U.S.

Only one incision was made through the belly button to accommodate a two millimeter camera in the abdominal cavity. The patient reported only minor discomfort following the 50-minute procedure.

Dubbed Natural Orifice Translumenal Endoscopic Surgery or NOTES, Novare believes that by avoiding major incisions through the abdomen, patients may experience a quicker recovery with less pain while reducing the risk of post operative hernias.

Dr. Santiago Horgan, director of the UC San Diego Center for the Future of Surgery, has performed 14 of these scarless NOTES procedures in the U.S. and Argentina. The procedure received approval for a limited number of patients by UC San Diego’s Institutional Review Board which oversees clinical research.Unlike standard laparoscopic instrumentation, Novare’s RealHand HD offers a more complete range of motion. RealHand technology is designed to mirror the surgeon’s hand direction with the added benefit of tactile feedback. The instruments have received FDA 510(k) clearance.

Med Tech Sentinel is a regular contributor to BioHealth Investor
_________________

Tuesday's Top Medical & Biotech Stocks

2008-04-01T18:38:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

CELL GENESYS INC [CEGE] +31.49%
IDENIX PHARMACEUT [IDIX] +20.32%
ARTES MEDICAL, INC. [ARTE] +19.23%
KOSAN BIOSCIENCES [KOSN] +19.11%
INTERMUNE INC [ITMN] +18.59%

Diagnostic Substances

IMMUCOR INC [BLUD] +10.59%
AVANT IMMUNOTHERAPEU [AVAND] +9.18%
PRESSURE BIOSCIENC [PBIO] +8.68%
MONOGRAM BIOSCIENCES [MGRM] +8.49%
LEXICON PHARMACEUTCL [LXRX] +8.42%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +13.23%
NOVEN PHARMACEUTIC [NOVN] +6.01%
PETMED EXPRESS INC [PETS] +5.68%
PENWEST PHARM CO [PPCO] +5.00%
COLUMBIA LABS INC [CBRX] +4.23%

Drug Manufacturers

NEUROGEN CP [NRGN] +23.66%
GEOPHARMA INC [GORX] +14.00%
NOVABAY PHARMACEUTCL [NBY] +10.22%
ISIS PHARM INC [ISIS] +9.57%
ALLOS THERAPEUTICS [ALTH] +9.05%

Drug Related Products

BOND LABORATORIES [BNLB.OB] +46.67%
LABOPHARM INC. [DDSS] +27.84%
SALIX PHARM DEL [SLXP] +10.51%
N B T Y INC [NTY] +6.34%
AUXILIUM PHARMACEUT [AUXL] +5.87%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +6.83%
WATSON PHARMACEUTCLS [WPI] +4.09%
CARACO PHARMA LABS [CPD] +3.29%
PHARMACUTICAL CO [PRX] +2.99%
MYLAN INC [MYL] +2.50%

Medical Appliances & Equipment

LECTEC CORP [LECT.OB] +25.00%
ENTEROMEDICS INC. [ETRM] +24.70%
NXSTAGE MEDICAL, INC [NXTM] +13.89%
ALIGN TECHNOLOGY I [ALGN] +11.61%
NORTHSTAR NEUROSCI [NSTR] +8.86%

Medical Instruments & Supplies

POWER MED. INT. INC. [PMII] +21.70%
NEUROMETRIX, INC. [NURO] +9.34%
CANTEL MEDICAL CORP [CMN] +8.85%
ADVANCED MED OPTICS [EYE] +7.44%
PRO-DEX INC NEW [PDEX] +7.19%

Medical Laboratories & Research

RADNET INC [RDNT] +7.39%
ENZO BIOCHEM INC [ENZ] +5.39%
QUEST DIAGNOSTC [DGX] +3.93%
MEDTOX SCIENTFIC INC [MTOX] +3.87%
GENOPTIX, INC. [GXDX] +3.20%

- Monday's Top Medical & Biotech Stocks
- Friday's Top Medical & Biotech Stocks
__________________

Monday's Top Medical & Biotech Stocks

2008-03-31T17:23:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

TRANSDEL PHARMACTL [TDLP.OB] +17.45%
BIOCRYST PHARM INC [BCRX] +13.55%
GENAERA CORP [GENR] +12.67%
GENETIC TECH SPON [GENE] +10.89%
ACHILLION PHARMACEUT [ACHN] +9.38%

Diagnostic Substances

INTERLEUKIN GENETICS [ILI] +7.41%
ICAGEN, INC. [ICGN] +7.28%
AVIGEN INC [AVGN] +3.33%
AMAG PHARMACEUTICALS [AMAG] +2.77%
AVALON PHARMACEUTIC [AVRX] +2.49%

Drug Delivery

BENTLEY PHARMACEUTIC [BNT] +18.27%
EMISPHERE TECH [EMIS] +8.44%
ALKERMES INC [ALKS] +7.22%
PENWEST PHARM CO [PPCO] +4.00%
ELAN CP PLC ADR [ELN] +3.47%

Drug Manufacturers

VERTEX PHARMACEUT [VRTX] +28.03%
ARYX THERAPEUTICS, I [ARYX] +24.22%
TIANYIN PHARMACEUTCL [TYNP.OB] +12.00%
AP PHARMA INC [APPA] +10.63%
TELIK INC [TELK] +8.44%

Drug Related Products

XELR8 HOLDINGS, INC [BZI] +9.26%
CURATECH INDUSTRIES [CUTC.OB] +7.14%
ARGAN INC [AGX] +5.62%
CHINA SHENGHUO PHARM [KUN] +5.34%
USANA HEALTH SCIEN [USNA] +3.23%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +6.35%
CARACO PHARMA LABS [CPD] +2.51%
BARR PHARMA INC [BRL] +1.30%
MYLAN INC [MYL] +0.96%
HI-TECH PHARMACAL [HITK] +0.89%

Medical Appliances & Equipment

ENTEROMEDICS INC. [ETRM] +20.87%
PATIENT SAFETY TECH [PSTX.OB] +19.20%
DEL GLOBAL TECH CORP [DGTC.OB] +11.37%
SRI/SURGICAL EXPRE [STRC] +9.41%
IVIVI TECHNOLOGIES, [IVVI] +6.17%

Medical Instruments & Supplies

NUCRYST PHARMACEUTIC [NCST] +53.48%
POWER MED. INT. INC. [PMII] +24.53%
BIOMERICA INC [BMRA.OB] +12.50%
ATRICURE, INC. [ATRC] +5.81%
ARISTOTLE CP [ARTL] +5.67%

Medical Laboratories & Research

NATL DENTEX CP [NADX] +4.37%
BIO-REFERENCE LAB [BRLI] +3.32%
ARRAY BIOPHARMA IN [ARRY] +3.24%
ENZO BIOCHEM INC [ENZ] +1.34%
RADNET INC [RDNT] +1.00%

- Friday's Top Medical & Biotech Stocks
- Thursday's Top Medical & Biotech Stocks
__________________

Cephalon: New Player in Chronic Lymphocytic Leukemia

2008-03-30T15:58:00.002-04:00

by Hisham S. Ayoub, DMD
BioHealth Investor

For the first time in seven years a new therapy for Chronic Lymphocytic Leukemia (CLL) has been cleared in the U.S. by the FDA. Biotech firm Cephalon’s (CEPH) TREANDA (bendamustine hydrochloride) was given final approval by the FDA on March 20, only six months after the company submitted the NDA in September of 2007.

CLL is one of the four main types of leukemia, and is characterized by a slow progression of abnormal white blood cells (lymphocytes) in the bone marrow usually spreading to other parts of the body, including lymph nodes, liver, spleen, and the central nervous system.

A particular lymphocyte, the B cell, is affected. This pathological B cell then divides and accumulates in the bone marrow leaving little room for healthy lymphocytes. This leaves patients with a weakened immune system to fight off infections.

The condition is usually diagnosed in white males of older age, with more than 75% of those diagnosed are over 50 year old. The latest estimates peg the number of new CLL cases in the US at over 15,000 in 2007, with about 4,500 deaths.

While CLL is technically incurable, it is manageable and patients do have various options in prolonging their quality of life. Treating CLL is focused on managing symptoms rather than an outright cure.

CLL therapy has been shown to be far superior when used as a combination of agents; principally purine analogues combined with monoclonal antibodies.

Bayer Schering Pharma’s (SCH.DE) Fludara (fludarabine) and GlaxoSmithKline’s (GSK) Leukeran (chlorambucil) are purine analogues which are usually designated as primary therapy. Monoclonal antibodies used in combination with purine analogues include Roche’s (RHO.DE) MabThera (rituximab) and Bayer Schering Pharma’s MabCampath (alemtuzumab).

Enter Cephalon’s Treanda, which has been shown to be far superior to using chlorambucil in CLL patients. In an international study of over 300 patients suffering from CLL, and who have never been treated for the disease, Treanda showed a longer progression-free survival rate of 18 months versus 6 months for those taking chlorambucil, and the response to Treanda lasted on average 19 months, much longer than that seen in patients taking chlorambucil (7 months).

Treanda is expected to be available to U.S. doctors in April of 2008, and gives CLL sufferers a new treatment option for the first time since 2001. It also received Orphan Drug Designation by the FDA, which gives Cephalon market exclusivity in the U.S. until 2015.

New competition is on the horizon however as two clinical stage agents are clearing hurdles, Oral Fludarabine by Xanthus Pharmaceuticals and Acadra (acadesine) by Protherics and Advancell.

Xanthus Pharmaceuticals, a privately held company in the U.S., announced on January 3rd of 2008 that it has received FDA orphan drug designation for its fludarabine phosphate oral tablets for the treatment of CLL, and on January 22 the FDA accepted the company’s New Drug Application (NDA) for review. While IV administration of fluradabine, which is currently the favored choice for first-line treatment of CLL, has been used for some time now, the option for a patient-friendly oral version could give Xanthus substantial market share quickly. Xanthus licensed the exclusive rights to develop and market oral fludarabine in the U.S. from Schering in October of 2006.

A little further down the road is the potential approval of Acadra co-developed by Prostherics (PTIL) of the U.K. and the Spanish based nanomedical firm Advancell. Acadra has great potential as yet another new form of nucleoside analogue for the treatment of CLL. The excitement behind Acadra is that it has been shown ex-vivo to target B-cells while exhibiting only a minimal effect on T-cells in the bone marrow, much less than current chemotherapeutic agents, according to the two firms. This means patients will suffer from less complicated and severe infections associated with CLL treatment, which can be a significant cause of death. Phase I/II trials were initiated on January 11 of 2008.

Cephalon’s Treanda still has plenty of time ahead of Acadra (that is if Acadra gets approved at all), and would still be an attractive new alternative to oral fludarabine. Cephalon is also not a small development biotech firm. It was founded in 1987, is a Fortune 1000 company, and employs 3,000 people internationally.

The company has an extensive U.S. marketing and sales network already in force promoting the company’s other big drugs, including Provigil (modafinil) and Fentora (fentanyl buccal tablet), among others. Cephalon should see minimal strategic and cost barriers to ensuring the success of Treanda in the U.S. over the next few years.

With the company’s shares trading at an attractive level (near 52-week low), and strong support just under $60 (high volume surge in mid-February), it behooves investors to take a good long look at initiating a long position in Cephalon stock.

The author does not currently have any investment position in any of the companies mentioned in this article.

BioHealth Investor.com
___________________

The FDA and Overseas Drug Approvals

2008-03-28T22:03:00.002-04:00

by Mark Senak
Eye On FDA

Where is the Most Promising Pipeline?

For a while now, I've been thinking about the growing number of drugs that are being approved overseas and going on the market overseas, but are not getting approved or are getting approvable letters in the U.S. It is a list that is growing.

Then today, the Wall Street Journal carried an article entitled Overseas Drugs Hit Regulatory Snags and details some of the drugs that are on the market elsewhere, but not in the U.S. The article mentions several large companies such as GlaxoSmithKline (GSK), Novartis (NVS) and Sanofi-Aventis (SNY) for Cervarix, Galvus and Rimonabant, respectively. Not mentioned are also some smaller companies, such as the Canadian firm Labopharm (DDSS) which has not gotten approval for once daily Tramadol even though it is approved in Canada. The article accounts for the post-Vioxx jitters on drug safety and a lack of FDA funding.

However, as pointed out here many times, there is more at work than a lack of funding or the current risk-averse environment. In fact, there have been budget increases and PDUFA increases - so money is flowing from both the public and private side, yet product approvals and enforcement continue a downward path. A more cautious approach might account for a slowdown in approvals and a rise in approvables, but not a lack of funding where money is up and the number of new compounds submitted is down. And neither a lack of funding or a risk-averse environment explains a lower enforcement rate.

The issues at stake are more comprehensive than money or safety issues and it is going to take a comprehensive strategy to pull the agency and the industry out of the current situation. Right now, as Congress launches multiple investigations, there is no sign of that happening and it will likely be Congress that re-writes the FDA page.

Does the approval slowdown downgrade the desirability of the American marketplace? Probably not. It may be inconvenient for patients, treaters, companies and investors, but the reality remains that the U.S. is by far the largest market for pharmaceutical products and the current situation isn't likely to change that. According to the European Federation of Pharmaceutical Industries and Associations, North America represented 47.7% of sales of the world pharmaceutical market, while Europe represented 29.9%. EFPIA also has compiled other relevant statistics on the European market compared to the U.S. Market in The Pharmaceutical Industry in Figures. One of the facts is that between 1990 and 2006 investment in new research in the U.S. grew 5 times while in Europe it grew 2.9 times. If the U.S. regulatory market does not straighten out, that investment may find reason to ebb away.

Eye On FDA is a regular contributor to BioHealth Investor
_________________

Friday's Top Medical & Biotech Stocks

2008-03-28T17:29:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PROTEO INC [PTEO.OB] +93.07%
BIOSANTE PHARMA INC [BPAX] +19.39%
TRANSDEL PHARMACTL [TDLP.OB] +19.20%
HESKA CORPORATION [HSKA] +18.52%
HEMOBIOTECH INC [HMBT.OB] +18.18%

Diagnostic Substances

REMOTEMDX INC [RMDX.OB] +13.42%
RESPONSE GENETICS, I [RGDX] +8.11%
INFINITY PHARMACEUTI [INFI] +6.82%
SYNTA PHARMACEUTICAL [SNTA] +4.49%
AVALON PHARMACEUTIC [AVRX] +4.33%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +16.00%
QUIGLEY CORP THE [QGLY] +6.25%
ACURA PHARMACEUTICAL [ACUR] +5.80%
FLAMEL TECH SA ADR [FLML] +2.05%
ARADIGM CORP [ARDM.OB] +1.79%

Drug Manufacturers

VYREX CORP DE NEW [VYXC.OB] +17.65%
GAMMA PHARMACEUTICAL [GMPM.OB] +12.50%
ACCESS PHARMACEUTICL [ACCP.OB] +10.37%
SEPRACOR INC [SEPR] +5.02%
PROVECTUS PHARMA [PVCT.OB] +5.00%

Drug Related Products

XELR8 HOLDINGS, INC [BZI] +4.85%
NUTRACEUTICAL INTL [NUTR] +3.54%
ARGAN INC [AGX] +1.96%
INTEGRATED BIOPHARMA [INBP] +1.02%
AUXILIUM PHARMACEUT [AUXL] +0.88%

Generic Drugs

WATSON PHARMACEUTCLS [WPI] +0.82%
HI-TECH PHARMACAL [HITK] +0.22%

Medical Appliances & Equipment

NEWCARDIO, INC. [NWCI.OB] +23.53%
XCORPOREAL INC [XCR] +14.00%
THERAGENICS CORP [TGX] +13.90%
MB SOFTWARE CORP [MBSB.OB] +13.33%
SONIC INNOVATIONS [SNCI] +12.86%

Medical Instruments & Supplies

BIOMIMETIC THERAPEUT [BMTI] +30.00%
MEDPRO SAFETY PD [MPSP.OB] +27.72%
CPC OF AMERICA INC [CPCF.OB] +11.72%
STEN CORPORATION [STEN] +10.91%
BIOSPHERE MEDICAL [BSMD] +7.80%

Medical Laboratories & Research

RADNET INC [RDNT] +1.75%
MEDTOX SCIENTFIC INC [MTOX] +1.63%
BIO-IMAGING TECH [BITI] +0.85%
GENOPTIX, INC. [GXDX] +0.56%
QUEST DIAGNOSTC [DGX] +0.53%

- Thursday's Top Medical & Biotech Stocks
__________________

Drugs: Penny Wise, But a Pound Foolish

2008-03-27T22:17:00.002-04:00

by Michael Shulman
BiotechBlitz

I typically write about stocks of interest to investors, but today I am just hacked off. Bear with me and pardon the pun.

Not all drugs and biotech companies are created equal -- and the belief that a drug may cost too much because of its price, is representative of the simplicity and shallowness of the current debate in politics and in press about healthcare costs in the United States.

We live and, for the most part, benefit from a capitalist healthcare system built into a capitalist economy -- with all the commensurate risks and rewards. High-priced drugs with large profit margins are part of this system, and the numbers kicked around by politicians and the press obscure the central reality of our system: A high price for a drug is not necessarily a high cost to society when a drug saves or extends a life and when profits spur the development of treatments that (over time) reduce costs by saving or improving the lives of patients.

Two recent editorials complained about the price of cancer treatment Avastin, made by biotech giant Genentech (DNA), and Genzyme's (GENZ) treatment, Cerezyme, for Gaucher disease.

Avastin fights various forms of cancer and costs upward of $110,000 per annum or more, while Genzeyme's product can top more than $400,000 per annum. The Times's editorialists believe this is way too expensive. Tell that to a patient with Gaucher's disease or a cancer patient who lived, on average, the five and a half months predicted by the median survival of patients in the Avastin clinical trial that led to the drug's approval. In a country that rewards creativity and success, don't you want to reward companies for saving patients so they can reinvest the money to save more patients in the future?

I am no apologist for an industry holding many companies that currently make far too much money for what they return in improvements in public health -- Amgen and its anemia drugs come to mind -- but this specific complaint is misplaced and depressingly similar to the hollow campaign rhetoric dominating the air waves.

While the editorial reflected public frustration with medical costs it also is a mirror of the poverty of the healthcare debate which is increasingly dominated by the inability of patients and the general media to separate prices from costs. In reality, a seemingly high-priced drug may actually save money in the short or long run, not to mention the life of a patient.

I do not deny that patient, public and political frustration is well grounded - too many things cost too much, from allergy shots to fifteen dollar boxes of sterile tissues -- but price should and cannot be confused with cost. In this instance, the clarity of the target (a $100,000 a year drug) and the vast size of the company led the debate.

If the company were a start up that had never made a penny, tried for 10 years to develop the drug and finally succeeded, would there have been criticism? Of course not, and the focus would have been on the happiness felt by surviving patients and the money saved when they left the hospital and went home to live, and not to die in a hospice.

A new report that came out today made this point all too well.

Genentech's cancer drug Rituxan, in combination with chemotherapy, has helped younger patients with non-Hodgkin's lymphoma live two-thirds of the time for five years or more, compared to 50% of the time in the early 1990s. Call it longer living through high-profit chemistry. Genzyme has a robust pipeline paid for with profits from Cerezyme.

This does not seem to faze politicians, patients and pundits who fail to discriminate among the products and the companies that supply them. Avastin is not a "me-too" product; it is not the umpteenth variation of the same pain killer; it is not a treatment for a brand new disease like restless toe syndrome. Avastin, along with many other high-priced drugs, extend and, sometimes, save lives. That is Genentech's mission. Reducing the price of Avastin, and the flow of dollars available to develop new products at a company like Genentech will materially affect the development of new products and eventually lead to the premature death of many patients.

Do I exaggerate?

The drugs in question took more than a decade to develop and are (or were) unique when approved. Avastin is a first and best-in-class anti-angiogenesis cancer drug that reflects billions of dollars in past, current and future development costs. I follow many companies in the life sciences industry and can say without hesitation the drug's parent and creator is considered by many (including me) to be the world's finest cancer company. Genentech has more than 100 clinical trials underway, and is always pushing the envelope and looking for new ways to save lives. The funds for the trials and "envelope pushing" come from high-priced drugs already on the market.

Some surveys also find Genentech to be the finest place to work in the United States -- and it would be difficult to find a company with a better track record for working with, and listening to, the FDA. You won't see pictures of Genentech scientists on yachts with Congressional lobbyists and call girls -- instead they spent their money on R&D last year -- more than they declared as a net profit.

The laws of economics are simple -- a reduction in price of current drugs will reduce Genentech's ability to improve Avastin, develop new treatments and serve patients. Ultimately, a lower price for Avastin may actually mean a higher cost to society.

Genentech and Avastin are easy targets for politicians, the media and complaining patients. The harder (and real) targets are avoided by too many people.

What are the real drivers of runaway costs? People, not patients.

According to Dr. Mark McClellan -- former FDA and Medicare chief now at the Brookings Institution -- the key to cost control is keeping people healthy. The current system rewards the treatment for illness and its reimbursement and often does not pay for routine physicals and other measures to improve health, like managed exercise and diet programs.

Of course, no one ever sold a newspaper or got a vote by saying "Hey, fatso, you may need help, but the first place to start is by getting the potato chips out of your mouth."

But sticking it to a company that has improved or saved 10s of thousands of lives (but is an easy target because of a $100,000-a-year drug) is sexy.

It would be better if the politicos, the public and the media took a look at the real cost and value of a drug, not the price -- and that's something we currently don't do.

A good example is the recent demise of drug BiDil and NitroMed.

BiDil was the first drug ever approved by the FDA for one ethnic group: African Americans. This heart medication was so successful in trial that the patients on placebo were put on BiDil midway through the trial for ethical reasons -- the patients receiving the drug saw a 43% reduction in deaths from heart attacks.

No matter -- BiDil failed in the marketplace because payers (insurers and Medicare) would not pay. Medicare and private insurers asked for too high of a co-payment from patients who could not afford the drug. These payers did not, and would not, factor in a 43% reduction in deaths, and all the costs associated with a sick and dying patient, when demanding these co-payments. And this narrow view of the costs won the day! Since the drug has been approved it is probable that more patients have died unnecessarily of heart problems who could have been managed with BiDil, than the number of soldiers who have died in Iraq.

Narrow-but-headline-grabbing analyses of high-priced drugs undermine the truth: It is the value of a drug relative to its price that matters. Narrow, artificial price limits on life-saving, unique drugs can kill -- and, are likely, already doing so.

BiotechBlitz is a regular contributor to BioHealth Investor
_____________

Thursday's Top Medical & Biotech Stocks

2008-03-27T20:42:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

IMMUNOSYN CORPORATIN [IMYN.OB] +19.90%
BIOSANTE PHARMA INC [BPAX] +19.88%
TITAN PHARMA INC [TTP] +14.17%
REXAHN PHARMACEUTICL [RXHN.OB] +13.64%
ANESIVA INC [ANSV] +10.00%

Diagnostic Substances

IMMUCELL CP [ICCC] +25.02%
TORREYPINES THERAPEU [TPTX] +18.32%
REMOTEMDX INC [RMDX.OB] +10.37%
AVANT IMMUNOTHERAPEU [AVAND] +9.92%
ISTA PHARMACTLS [ISTA] +8.50%

Drug Delivery

COLUMBIA LABS INC [CBRX] +3.77%
FLAMEL TECH SA ADR [FLML] +2.99%
BIOVAIL CORP [BVF] +1.49%
PENWEST PHARM CO [PPCO] +1.15%
NEKTAR THERAPEUTIC [NKTR] +1.00%

Drug Manufacturers

GEOPHARMA INC [GORX] +12.77%
NEUROGESX, INC. [NGSX] +11.21%
MAP PHARMACEUTICALS, [MAPP] +9.65%
SIGA TECH INC [SIGA] +9.50%
PROVECTUS PHARMA [PVCT.OB] +9.09%

Drug Related Products

ARGAN INC [AGX] +5.37%
DRAXIS HEALTH INC [DRAX] +3.39%
PERRIGO COMPANY [PRGO] +2.56%
AUXILIUM PHARMACEUT [AUXL] +2.40%
SCHIFF NUTRIT INTL [WNI] +2.05%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +1.00%
CATALYST PHARMACEUTI [CPRX] +0.79%

Medical Appliances & Equipment

FONAR CORP [FONR] +19.75%
SOMANETICS CORP [SMTS] +8.45%
ENDOCARE INC [ENDO] +8.33%
ESCALON MED CP [ESMC] +6.91%
LANGER INC [GAIT] +5.15%

Medical Instruments & Supplies

OCULUS INNOVATIVE SC [OCLS] +30.53%
NANOSPHERE, INC. [NSPH] +27.39%
RETRACTABLE TECH INC [RVP] +22.54%
ORTHOVITA INC [VITA] +13.30%
SAFESTITCH MEDICAL, [SFES.OB] +9.09%

Medical Laboratories & Research

SPHERIX INC [SPEX] +13.89%
PSYCHEMEDICS NEW [PMD] +2.44%
ERESEARCHTECHNOLOG [ERES] +1.97%
RADNET INC [RDNT] +1.33%
BIO-REFERENCE LAB [BRLI] +1.14%

BioHealth Investor.com
__________________

Painting the Colon: Early Stage Cancer Detection without Biopsy

2008-03-20T19:32:00.001-04:00

by Doug Cress
Med Tech Sentinel

Most cases of colon cancer begin as small noncancerous polyps. Over time these polyps may become colon cancers. Regular screening helps identify polyps before they become cancerous, allowing for prophylactic treatment.

According to the American Cancer Society, 112,000 people are diagnosed with colon cancer annually.

The most common and effective diagnostic procedures is the oft-dreaded colonoscopy. It is recommended that individuals 50 and up get one – some 90% of colon cancers occur in this age group.

During the exam, a colonoscope, a long, slender, flexible tube attached to a video camera is used to view the colon and rectum. Polyps found during the procedure are typically biospied and analyzed.

A new technique being developed at the Stanford University School of Medicine may one day detect colon cancer without a biopsy – including early stage cancers that have not yet become polyps.

The study, led by Dr. Christopher Contag, used a unique protein that sticks to colon cells in the early stages of cancer. The protein was attached to a “fluorescent beacon”.

When sprayed into the colon, and viewed with a Mauna Kea Technologies’ miniaturized microscope, CellVizio, researchers were able to see fluorescent patches where the protein had attached to cancerous cells.

The fine resolution afforded by the technique (researchers could spot individual cancer cells) will allow for the detection of even early stage cancers.

In the initial trial with 15 patients, the Contag detected 82% of cancerous polyps. Contag believes that by working with additional proteins, the technique will become even more accurate.

Med Tech Sentinel is a regular contributor to BioHealth Investor
_______________

Thursday's Top Medical & Biotech Stocks

2008-03-20T19:26:00.002-04:00

by H.S. Ayoub
BioHealth Investor

Subscribe now to keep up to date on the latest news, articles and daily top stocks:

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Biotechnology

IOMAI CORPORATION [IOMI] +27.62%
TRUBION PHARMACEUTIC [TRBN] +22.18%
SEQUENOM INC [SQNM] +17.59%
BIOSPECIFICS TECH CP [BSTC.OB] +14.85%
3SBIO INC [SSRX] +13.82%

Diagnostic Substances

ISTA PHARMACTLS [ISTA] +12.56%
TRINITY BIO ADR [TRIB] +10.84%
IMMUNOMEDICS INC [IMMU] +9.72%
INFINITY PHARMACEUTI [INFI] +8.30%
SYNTA PHARMACEUTICAL [SNTA] +8.02%

Drug Delivery

ACURA PHARMACEUTICAL [ACUR] +15.41%
EMISPHERE TECH [EMIS] +11.66%
ELAN CP PLC ADR [ELN] +7.85%
DELCATH SYSTEMS INC [DCTH] +6.59%
NOVEN PHARMACEUTIC [NOVN] +5.14%

Drug Manufacturers

NEUROGEN CP [NRGN] +57.95%
MAP PHARMACEUTICALS, [MAPP] +15.24%
OSCIENT PHARMACEUT [OSCI] +10.00%
GAMMA PHARMACEUTICAL [GMPM.OB] +8.89%
RELIV INTL INC [RELV] +6.29%

Drug Related Products

CHINA SHENGHUO PHARM [KUN] +9.29%
MANNATECH INC [MTEX] +6.28%
PRESTIGE BRAND HLGS [PBH] +5.54%
INTEGRATED BIOPHARMA [INBP] +4.55%
SALIX PHARM DEL [SLXP] +4.26%

Generic Drugs

CARACO PHARMA LABS [CPD] +4.68%
BARR PHARMA INC [BRL] +1.20%
HELICOS BIOSCIENCES [HLCS] +0.85%
MYLAN INC [MYL] +0.73%
WATSON PHARMACEUTCLS [WPI] +0.24%

Medical Appliances & Equipment

MB SOFTWARE CORP [MBSB.OB] +21.43%
CYTOCORE INC [CYOE.OB] +12.24%
ARRHYTHMIA RES TECH [HRT] +7.97%
CYBERONICS INC [CYBX] +6.58%
VISION SCIENCES IN [VSCI] +6.25%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +22.67%
ARISTOTLE CP [ARTL] +20.17%
XTENT INC [XTNT] +17.41%
UROPLASTY INC [UPI] +13.33%
SAFESTITCH MEDICAL, [SFES.OB] +13.21%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +6.74%
ALLIANCE IMAGING INC [AIQ] +5.30%
GENOMIC HEALTH, INC. [GHDX] +4.55%
SPHERIX INC [SPEX] +3.70%
ERESEARCHTECHNOLOG [ERES] +3.02%

- Wednesday's Top Medical & Biotech Stocks
- Tuesday's Top Medical & Biotech Stocks
__________________

Amgen: Whither Thou Goest?

2008-03-20T08:59:00.002-04:00

by Michael Shulman
BiotechBlitz

I have disliked Amgen (AMGN) for a very long time and have the good fortune of having two publishing platforms to discuss the company: my ChangeWave Biotech Investor service and my short service, ChangeWave Shorts.

I write about it whenever I hear "value" investors who know nothing about biotech or life sciences telling investors to buy the stock because it "must come back" or it's "cheap."

My background is the computer industry -- when it had 49 personal computer companies, eight major mini-computer makes and the "bunch" of mainframe companies -- the five major competitors to IBM.

All but one of those original 49 are gone, all eight minicomputer makers are gone, all of the IBM mainframe competitors are gone from that business and just three are in business, at all, doing something else.

And over and over I heard and read analysts and pundits telling people to buy these dying companies because they were "cheap" and "must come back." Don't you believe it!

Amgen has not created an original blockbuster drug since the breakup of the Soviet Union and has a terrible pipeline. Two-thirds of the company's profits are from anemia drugs getting slammed by the FDA, Medicare and private insurers -- with falling sales due to safety concerns revealed during the runup to a recent FDA panel meeting. The company now seems to rely more on lobbyists than scientists for its success.

I know, this sounds like a non-quantitative polemic. So let's talk numbers.

At least $1.35-$1.55 of their anticipated $4 in 2008 profits are from anemia drugs for dialysis patients with declining sales due to declining reimbursement rates, new dosage guidelines, anticipated competition from Micera from Roche (which I believe will eventually be allowed in the U.S. by the courts and/or the ITC) and an eventual crackdown on rebates.

Some serious percentage of this is going away - and the best case for Amgen is 40 cents to 60 cents per share in profits. I see another 40 cents to 50 cents at risk in the cancer market due to an FDA panel ruling (and, eventually, an agency ruling) that will restrict the use of these drugs for an annoying reason -- data shows they may accelerate death in some patients.

Oh, and cut out the rebates, someone is gong to say. Shocking! Rebates! Shocking!

So, the best case is $3 a share in profits, and at current multiples that means a $30 stock price -- and this dog is being valued on profits, not growth, since there ain't no growth.

Oh, and AMGN has announced the stock buyback.

And did I mention Moody's may knock Amgen's credit rating down depending on the final FDA decision on anemia drugs?

My subscribers have saved a lot of money by avoiding Amgen and some have made a lot of money buying puts on the company. Whatever you do, anytime you give consideration to this company, hear a little voice in your head saying: "value trap, value trap."

If you don't believe me, think Digital Equipment Corporation; or Burroughs; or how about the Osborne computer? Remember them?

BiotechBlitz is a regular contributor to BioHealth Investor
_______________

Wednesday Recap: Biotech Restructuring Day!

2008-03-19T17:18:00.005-04:00

by H.S. Ayoub, DMD
BioHealth Investor

Nasdaq Biotechnology Index (^NBI) -2.92%
Amex Pharmaceutical Index (^DRG) -2.69%
iShares Dow Jones Medical Devices (IHI) -1.25%

Kosan Biosciences (KOSN) up 24.34%... investors were cheering the company's appointment of a new CEO, and its announcement that it will cut 37% of its workforce and refocus its clinical efforts to only a couple of late stage developments, as the new CEO puts it; "This represents an important step in Kosan's evolution to a product-oriented company". So I guess before this step the company was not interested in developing products but just to spend money on research! Joking aside, in these trying times in our economy smaller companies, especially little biotechs, need to do what Kosan just did in order to survive the next couple of years.

Alkermes (ALKS) down 0.28%... after Eli Lilly (LLY) pulled the plug on the AIR® Insulin joint program back on March 7th, Alkermes stock took a big dive, and forced its current decision to cut 18% of its workforce. I love the CEO's comment in the press release, "The flexibility of our business model allows us to adapt our cost structure while maintaining our ability to develop innovative products of our own." What does he mean exactly by Flexibility, firing employees?

Wednesday's Top Medical & Biotech Stocks
__________________________________________

Wednesday's Top Medical & Biotech Stocks

2008-03-19T16:54:00.003-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

KOSAN BIOSCIENCES [KOSN] +24.34%
HALOZYME THERAPEUTIC [HALO] +23.17%
METABASIS THERAPEUTI [MBRX] +17.68%
BARRIER THERAPEUTICS [BTRX] +10.83%
DISCOVERY LABS INC [DSCO] +10.70%

Diagnostic Substances

LEXICON PHARMACEUTCL [LXRX] +10.31%
RESPONSE GENETICS, I [RGDX] +8.00%
ISTA PHARMACTLS [ISTA] +7.57%
HUMAN GENOME SCI [HGSI] +4.88%
TORREYPINES THERAPEU [TPTX] +3.03%

Drug Delivery

ACURA PHARMACEUTICAL [ACUR] +17.08%
EMISPHERE TECH [EMIS] +9.40%
MATRIXX INITIATVS [MTXX] +6.24%
NOVEN PHARMACEUTIC [NOVN] +3.08%
FLAMEL TECH SA ADR [FLML] +2.98%

Drug Manufacturers

NEUROGEN CP [NRGN] +14.04%
NOVABAY PHARMACEUTCL [NBY] +9.38%
NEXMED INC [NEXM] +6.93%
DEPOMED INC [DEPO] +5.84%
SCICLONE PHARMA [SCLN] +4.97%

Drug Related Products

DRAXIS HEALTH INC [DRAX] +3.32%
NUTRACEUTICAL INTL [NUTR] +1.70%
USANA HEALTH SCIEN [USNA] +1.66%
LABOPHARM INC. [DDSS] +1.28% $0
PERRIGO COMPANY [PRGO] +0.49%

Generic Drugs

PHARMACUTICAL CO [PRX] +5.20%
BARR PHARMA INC [BRL] +0.26%

Medical Appliances & Equipment

STEREOTAXIS, INC. [STXS] +17.17%
PATIENT SAFETY TECH [PSTX.OB] +8.91%
CELSION CORP [CLN] +7.71%
EDAP TMS SA ADR [EDAP] +7.65%
ENDOCARE INC [ENDO] +6.60%

Medical Instruments & Supplies

NUCRYST PHARMACEUTIC [NCST] +8.98%
ELECTRO-OPTICAL SCIE [MELA] +8.46%
ANGIODYNAMICS INC [ANGO] +4.56%
BIOMIMETIC THERAPEUT [BMTI] +3.86%
ATRICURE, INC. [ATRC] +3.78%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +11.43%
BIO-IMAGING TECH [BITI] +3.14%
SPHERIX INC [SPEX] +2.85%
PSYCHEMEDICS NEW [PMD] +1.10%
RADNET INC [RDNT] +0.94%

- Tuesday's Top Medical & Biotech Stocks
- Monday's Top Medical & Biotech Stocks
__________________

Another Silly Bio-Generics Bill

2008-03-18T23:32:00.003-04:00

by David E. Williams
Health Business Blog

Two Congressional Reps have introduced a bill to create a pathway for generic biopharmaceuticals. It seems to me like a big waste of time.

The bill has the following key provisions, according to Kaiser Daily Health Policy Report:

12-14.5 years of market exclusivity for the original product before generics can appear

Clinical trial requirements for follow-on products, which could be waived by FDA (I don’t have more details on this yet)

Exempting “select agents and toxins” like Botox from competition, for “national security” reasons. (Maybe it will keep the enemy wrinkly-faced?)

Granting the FDA the authority to declare medications as interchangeable

I can’t imagine how this bill would have any significant impact on drug costs. It seems likely to severely limit the number of biotech drugs facing serious competition, which will keep prices up. The only beneficiaries will be brand name biotech companies and a few generic biotech companies who get drugs approved and enter into an oligopolistic market environment.

As I’ve said before, a better idea would be to simply regulate the prices of biotech drugs once they’re off patent (or have been on the market for a certain number of years). Advantages of this approach include:

Guaranteed, predictable savings

Elimination of risky and expensive clinical trials of follow-on products, with their potential to harm patients

Limitation on the breadth of FDA oversight. Fewer new manufacturing facilities makes it easier for FDA to keep up

Higher manufacturing capacity utilization for brand name companies, who will retain 100 percent of the market

The only losers will be generic biotech companies. Since that industry doesn’t really exist yet, I don’t think it’s such a problem.

Health Business Blog is a regular contributor to BioHealth Investor
__________________

Tuesday Recap: Medical & Biotech Stocks

2008-03-18T18:42:00.004-04:00

by H.S. Ayoub, DMD
BioHealth Investor

Nasdaq Biotechnology Index (^NBI) +2.85%
Amex Pharmaceutical Index (^DRG) +2.30%
iShares Dow Jones Medical Devices (IHI) +3.03%

Ista Therapeutics (ISTA) up 39.10%... Well, I guess the company's presentation at the Cowen & Company 28th Annual Health Care Conference in Irvine, California went well today. The company's President and CEO was slated to update the investment community on commercial and clinical progress around 4pm Eastern Standrad Time. At around 3pm volume spiked sending shares from around $1.60 to a day high of $1.95. Ista is a biotech firm focused on eye disease.

Nuvelo (NUVO) down 46.32%... Like I mentioned in Monday's recap, Nuvello is headed to a long stay in Pennyland! After announcing further poor study results, 40 jobs being cut, and further cost and program cutting measures Pacific Growth Equities had the astonishing foresight to downgrade the stock. Amazing!

Dynavax (DVAX) down 58.62%... the FDA halted an experimental Hepatitis B vaccine being co-developed by Dynavax and Merck (MRK), absolutely destroying shares of the little biotech. The vaccine, Helisav, was in phase 3 trials in Europe and Canada, and had shown great progress so far until one patient was diagnosed with Wegener's granulomatosis, a disease in which the blood vessels become inflamed. The trial is on hold until the FDA investigates the cause of that patient's condition and removes the halt. Unlike Nuvello's predicament (See above) Dynavax traders could still make substantial gains on today's price action since that one patient's condition could very well be a statistical outlier.

Tuesday's Top Medical & Biotech Stocks
__________________________________________

China a Priority for AstraZeneca

2008-03-18T17:55:00.002-04:00

by Richad Daverman, PhD
ChinaBio Today

Expanding the presence of AstraZeneca (NYSE: AZN) in the Asia-Pacific region in general and China specifically is a priority for AstraZeneca, according to John Ramsey, AstraZeneca’s Vice President for Global Development. Ramsey made the remarks in an interview with EView Week.

Ramsey stressed that AstraZeneca is interested in developing drugs that address the needs of China’s population. Toward that end, AstraZeneca has established its Innovation Center China (ICC), which began operations in 2007 and establishes relationships with China’s universities and medical centers. Because of the company’s emphasis on China’s needs, Ramsey can boast that AstraZeneca’s $100 million investment in China (spread over two to three years) is the largest of any biopharma that is focused on China’s diseases.

The ICC will concentrate on cancer, seeking to learn more about liver cancer, gastric cancer, lung cancer and pre-menopausal breast cancer. It will study the causes of the disease, define biomarkers and identify new targets for innovative drugs.

The growing China market for drugs is one reason that AstraZeneca chose to concentrate in China. But just as important was its pool of scientific talent and unique medical needs.

Although AstraZeneca China’s motto is “In China, For China,” the staff at ICC has the ability to work with AstraZeneca scientists from around the world. So far, the ICC has put on its staff 40 researchers, 40% of them with PhDs. The target is to hire 60 scientists.

AstraZeneca China currently has a total workforce of 2,500.

Worldwide, AstraZeneca has 65,000 employees, and about 12,000 of them are involved in drug discovery/development.

ChinaBio Today is a regular contributor to BioHealth Investor
_________________

Tuesday's Top Medical & Biotech Stocks

2008-03-18T17:42:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

SUNESIS PHARMACEUTIC [SNSS] +31.58%
DARA BIOSCIENCES [DARA] +24.56%
RXI PHARMACEUTICALS [RXII] +22.16%
TERCICA INC [TRCA] +19.11%
BIONOVO INC [BNVI] +15.25%

Diagnostic Substances

ISTA PHARMACTLS [ISTA] +39.10%
QUIDEL CP [QDEL] +6.62%
MERIDIAN BIOSCIENC [VIVO] +6.34%
ABAXIS INC [ABAX] +5.97%
AMAG PHARMACEUTICALS [AMAG] +5.68%

Drug Delivery

NEKTAR THERAPEUTIC [NKTR] +7.45%
PENWEST PHARM CO [PPCO] +6.90%
DELCATH SYSTEMS INC [DCTH] +4.40%
K V PHARMA CL A [KV-A] +4.04%
ELAN CP PLC ADR [ELN] +3.91%

Drug Manufacturers

MINRAD INTL INC [BUF] +17.16%
TELIK INC [TELK] +11.87%
MIDDLEBROOK PHARMACL [MBRK] +10.81%
SEPRACOR INC [SEPR] +9.91%
MARSHALL EDWARDS [MSHL] +9.71%

Drug Related Products

AMEXDRUG CP [AXRX.OB] +9.09%
SALIX PHARM DEL [SLXP] +7.37%
PERRIGO COMPANY [PRGO] +6.54%
TIENS BIOTECH GR USA [TBV] +5.80%
USANA HEALTH SCIEN [USNA] +5.61%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +5.39%
MYLAN INC [MYL] +3.81%
WATSON PHARMACEUTCLS [WPI] +2.96%
PHARMACUTICAL CO [PRX] +2.74%
CARACO PHARMA LABS [CPD] +1.61%

Medical Appliances & Equipment

BIOFORM MEDICAL, INC [BFRM] +17.83%
ALIGN TECHNOLOGY I [ALGN] +11.51%
BSD MEDICAL CORP [BSM] +11.34%
IRIDEX CP [IRIX] +10.10%
CUTERA, INC. [CUTR] +8.82%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +23.33%
TRANS1 INC. [TSON] +14.99%
NANOSPHERE, INC. [NSPH] +12.15%
AMDL, INC [ADL] +8.49%
CONCEPTUS INC [CPTS] +8.22%

Medical Laboratories & Research

ENZO BIOCHEM INC [ENZ] +11.11%
ERESEARCHTECHNOLOG [ERES] +6.84%
ARRAY BIOPHARMA IN [ARRY] +5.78%
BIO-REFERENCE LAB [BRLI] +5.54%
QUEST DIAGNOSTC [DGX] +4.47%

- Monday's Top Medical & Biotech Stocks
- Friday's Top Medical & Biotech Stocks
__________________

Despite Media Carping, Americans Largely Trust Drug Companies

2008-03-17T21:02:00.002-04:00

by Nathan Burchfiel
Business & Media Institute

Media attacks on pharmaceutical companies don't resonate with the public, which overwhelmingly believes drug makers improve quality of life.

Seven out of ten Americans believe prescription drugs developed over the past 20 years have made life better for their fellow Americans – in spite of journalists’ incessant attacks on pharmaceutical companies – a new survey by USA TODAY, the Kaiser Family Foundation and the Harvard School of Public Health shows.

A majority of Americans (59 percent) believe prescription drugs, costly as they may be, help reduce the need for more expensive medical procedures. A majority (55 percent) also believe drugs are tested and monitored vigorously enough to ensure safety.

An overwhelming majority of Americans trust drug companies to develop new and effective drugs (80 percent trust the companies “somewhat” or “a lot”), offer reliable information about the side effects and safety of the drugs (72 percent), inform the public quickly of a safety concern (55 percent) and offer reliable information about how well the drugs work (71 percent).

The only negative views of the drug companies came from profits and advertising. Sixty percent of respondents said companies spend too much money advertising their drugs. Nearly three-quarters (74 percent) said drug companies make “too much” profit. Seventy-nine percent said the costs of prescription drugs are “unreasonable.”

Yet those “overpriced” drugs contribute to a better life for most Americans, according to the same survey. They could also help prevent further spending on expensive medical procedures. So why do Americans think drugs are overpriced, or that companies make “too much” profit?

Could it be caused in any way by the consistently negative coverage of pharmaceutical companies by the media?

The Business & Media Institute Special Report “Prescription for Bias” found that network news shows focused on the cost of drugs to consumers 11 times more than they mentioned the costs associated with developing those drugs. Only 2 percent of stories examined in the study dealt with the costs of research and development.

The Tufts Center for the Study of Drug Development estimated the cost of developing one new drug is more than $800 million before it is even approved by the Food and Drug Administration. And with other countries – such as Canada – setting price ceilings for prescriptions, American patients bear a bigger share of the research and development costs.

Business & Media Institute is a regular contributor to BioHealth Investor
_________________

Monday Recap: Medical & Biotech Stocks

2008-03-17T16:44:00.004-04:00

by H.S. Ayoub, DMD
BioHealth Investor

QLT Inc. (QLTI) up 41.63%... The FDA has completed its review the company's labeling supplement (sNDA) for Aczone(TM) and has removed certain requirements imposed earlier. Aczone is the only acne treatment to use the potential of dapsone in a topical formulation.

Nuvelo (NUVO) down 26.47% aftermarket 4:40pm... the biotech company released more failed phase 2 results of its blood thinner alfimeprase, following two failed studies in 2006. The company will restructure and lay off 40 employees to redirect resources for other programs. Nuvelo is headed to a long stay in pennyland!

Cardiome Pharma (CRME) up 30.61%... the Canadian drug maker released positive phase 2b results of an oral version of its atrial fibrillation drug Vernakalant. The 500mg dose was found to be statistically safer and more efficient than a placebo. An Oppenheimer analyst suggested that the market for such a drug is worth at least $500 million. The company hired Merril Lynch to conduct review of partnership offers from various pharmaceutical companies.

RXi Pharmaceuticals (RXII) down 28.49%... the RNAi technology company continues its erratic Wall Street debut. On March 12 the company IPO opened at $6, quickly jumped to a high of almost $24, before declining to Monday's closing price of $7.58.

Monday's Top Medical & Biotech Stocks
__________________________________________

Monday's Top Medical & Biotech Stocks

2008-03-17T16:24:00.003-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

QLT INC [QLTI] +41.63%
TRUBION PHARMACEUTIC [TRBN] +18.55%
GENVEC INC [GNVC] +10.17%
CADENCE PHARM. INC. [CADX] +9.57%
CV THERAPEUTICS I [CVTX] +7.78%

Diagnostic Substances

SCOLR PHARMA INC [DDD] +5.69%
IMMUCELL CP [ICCC] +4.56%
INTERLEUKIN GENETICS [ILI] +2.76%
ASPENBIO PHARMA INC [APPY] +1.85%
AVALON PHARMACEUTIC [AVRX] +1.01%

Drug Delivery

NOVEN PHARMACEUTIC [NOVN] +11.31%
ARADIGM CORP [ARDM.OB] +2.56%
PENWEST PHARM CO [PPCO] +2.35%
K V PHARMA CL A [KV-A] +0.91%

Drug Manufacturers

CARDIOME PHARMA NEW [CRME] +30.61%
NEUROGESX, INC. [NGSX] +13.01%
OSCIENT PHARMACEUT [OSCI] +8.87%
NEUROGEN CP [NRGN] +8.81%
GAMMA PHARMACEUTICAL [GMPM.OB] +7.41%

Drug Related Products

TIENS BIOTECH GR USA [TBV] +2.99%
PRESTIGE BRAND HLGS [PBH] +1.87%
DRAXIS HEALTH INC [DRAX] +1.79%
MEDICAL NUTRITN USA [MDNU] +1.43%
INTEGRATED BIOPHARMA [INBP] +1.29%

Generic Drugs

WATSON PHARMACEUTCLS [WPI] +1.60%

Medical Appliances & Equipment

CYTOCORE INC [CYOE.OB] +14.58%
ASPECT MEDICAL SYS [ASPM] +8.01%
MICRUS ENDOVASCULAR [MEND] +1.20%
VNUS MEDICAL TECHNOL [VNUS] +0.90%
MASIMO CORPORATION [MASI] +0.74%

Medical Instruments & Supplies

ISORAY INC [ISR] +13.21%
ARISTOTLE CP [ARTL] +9.44%
SAFESTITCH MEDICAL, [SFES.OB] +7.94%
CRYOCOR, INC. [CRYO] +5.91%
BIOSPHERE MEDICAL [BSMD] +5.36%

Medical Laboratories & Research

GENOPTIX, INC. [GXDX] +4.49%
ERESEARCHTECHNOLOG [ERES] +1.04%
PSYCHEMEDICS NEW [PMD] +0.91%

- Friday's Top Medical & Biotech Stocks
- Thursday's Top Medical & Biotech Stocks
__________________

JP Morgan Grabs Bear Stearns for $2; Long Recession Ahead

2008-03-16T22:59:00.004-04:00

by H.S. Ayoub, DMD
BioHealth Investor

I know this is supposed to be a blog covering the biotechnology and medical industry, but in an unprecedented move for this blog, a major non-health related event will have to be commented on.

Bear Steans (BSC) was forced to sell itself to JP Morgan (JPM) for a whopping $2 a share, equal to $236 million in total! The company was worth over $20 billion just a couple of months ago, representing a drop of over 90%.

This was following the horrible day of trading on Friday after JP Morgan, with the help of the Federal Government, gave Bear Stearns a month long loan after investment firms and banks pulled their holdings from the troubled firm amid liquidity concerns.

Asian markets dropped big as soon as the acquisition was announced on Sunday, and Wall Street is bracing for another crash on Monday.

Firms around the world will be forced to re-analyze their investment assets in other financial firms, especially those based in the US, in order to stay ahead of a similar illiquidity problem that brought down Bear Stearns, and will be less motivated to invest new capital any time soon.

The dwindling economy, coupled with rising energy costs due to high demand from China and India, places the US in a situation never seen before; at the sidelines and not the epicenter of the financial world.

For those that think we are not in a recession, or at least the recession we are already in will not last too long, think again. We might very well be at the start of a long and gloomy couple of years.

BioHealth Investor.com
_______________

Hacking the Heart

2008-03-16T22:52:00.002-04:00

by Doug Cress
Med Tech Sentinel

A team of computer security researchers have remotely hacked Medtronic’s (MDT) Maximo – a stopwatch-sized implantable cardiac defibrillator.

Armed with an antenna, radio hardware and a PC, the team was able to shut down and manipulate the device – and even deliver potentially lethal jolts of electricity.

The investigation was led by The Medical Device Security Center, a cross-disciplinary partnership between researchers at Harvard Medical School, UMass, and the University of Washington.

The study (available here in .pdf) evaluated the security and privacy properties of wireless implantable devices used in hundreds of thousands of patients worldwide.

The Wireless Age

Using wireless technology, physicians are better able to monitor patients and adjust devices without the need for additional surgeries. Many pacemakers, implantable defibrillators and drug pumps now incorporate computers and radios.

Researchers found that the security of these devices may be lacking, opening the door to potentially murderous attacks, “Our investigation shows that an implantable cardioverter defibrillator (1) is potentially susceptible to malicious attacks that violate the privacy of patient information and medical telemetry, and (2) may experience malicious alteration to the integrity of information or state, including patient data and therapy settings for when and how shocks are administered.”

While I have difficulty imagining a scenario where the techniques would be used to harm or kill, I also have difficulty imagining why a hacker would create a computer virus for no other reason than to annoy or impact economic hardship.

“No Cause for Concern”

A Medtronic spokesperson, Robert Clark, quickly dismissed any fears in a statement released yesterday, “To our knowledge there has not been a single reported incident of [ICD hacking] in more than 30 years of device telemetry use, which includes millions of implants worldwide.”

The researchers also said there is no need for public concern: the experiment required some $30,000 worth of gear and a sustained effort by a team of specialists; the ICD was placed within two inches of the team’s equipment.

Med Tech Sentinel is a regular contributor to BioHealth Investor
____________________

Friday's Top Medical & Biotech Stocks

2008-03-14T17:25:00.003-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

SGX PHARMACEUTICALS [SGXP] +16.28%
REXAHN PHARMACEUTICL [RXHN.OB] +14.29%
BARRIER THERAPEUTICS [BTRX] +13.56%
ZIOPHARM ONCOLOGY IN [ZIOP] +12.35%
OSIRIS THERAPEUTICS [OSIR] +8.74%

Diagnostic Substances

LEXICON PHARMACEUTCL [LXRX] +31.18%
IMMUNOMEDICS INC [IMMU] +9.82%
MONOGRAM BIOSCIENCES [MGRM] +4.35%
SCOLR PHARMA INC [DDD] +3.36%
PRESSURE BIOSCIENC [PBIO] +3.29%

Drug Delivery

EMISPHERE TECH [EMIS] +17.48%
PETMED EXPRESS INC [PETS] +2.66%

Drug Manufacturers

WUXI PHARMATECH ADS [WX] +13.37%

Drug Related Products

DRAXIS HEALTH INC [DRAX] +18.12%
LABOPHARM INC. [DDSS] +9.01%
SALIX PHARM DEL [SLXP] +0.33%

Generic Drugs

MYLAN INC [MYL] +3.65%

Medical Appliances & Equipment

LECTEC CORP [LECT.OB] +17.95%
DEL GLOBAL TECH CORP [DGTC.OB] +11.36%
ENDOCARE INC [ENDO] +6.38%
ARRHYTHMIA RES TECH [HRT] +4.89%
NATUS MEDICAL INC [BABY] +3.86%

Medical Instruments & Supplies

CPC OF AMERICA INC [CPCF.OB] +5.60%
NEUROMETRIX, INC. [NURO] +5.26%
DEXCOM [DXCM] +4.46%
NUCRYST PHARMACEUTIC [NCST] +3.89%
NMT MEDICAL INC [NMTI] +3.86%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +6.62%
NATL DENTEX CP [NADX] +4.02%

- Thursday's Top Medical & Biotech Stocks
- Wednesday's Top Medical & Biotech Stocks
__________________

Pharma Sales Slowdown

2008-03-13T18:37:00.002-04:00

by Mark S. Senak
Eye On FDA

IMS, the world’s leading provider of market intelligence to the pharmaceutical and healthcare industries released the annual "U.S. Pharmaceutical Market Performance Review" which found that pharmaceutical market growth slowed from 8% in 2006 to 3.8% in 2007. According to the release, this was the slowest growth seen since 1961.

The company attributes the slowdown to:

- loss of exclusivity of branded medicines;
- fewer new product approvals
- the leveling of year-over year growth from the Medicare Part D program
- the impact of safety issues.

The categories leading in sales were anti-depressants, lipid control agents, pain medications and blood pressure medications such as ace inhibitors and beta blockers.

Also of note, with respect to the second reason listed for the slowdown - fewer product approvals - one can truly see one of the many impacts of the fact that the agency has issued more approvable letters in 2007, to a degree shutting down the pipeline, impacting the market, patients and stockholders. This of course, leads to the question whether or not this is a product of (i) a risk averse environment, or (ii) products have suddenly gotten bad, or (iii) the FDA has purposely slowed things down so that it can catch up.

And, perhaps most importantly, why is the pipeline so slow and enforcement expressed through warning letters so lax when the FDA is getting more budget and increased PDUFA fees?

Eye On FDA is a regular contributor to BioHealth Investor
______________

Thursday's Top Medical & Biotech Stocks

2008-03-13T17:11:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

DARA BIOSCIENCES [DARA] +23.75%
SUNESIS PHARMACEUTIC [SNSS] +11.35%
TERCICA INC [TRCA] +11.27%
AFFYMAX, INC. [AFFY] +10.13%
EURAND N.V. [EURX] +8.51%

Diagnostic Substances

IMMUCELL CP [ICCC] +10.29%
IMMUCOR INC [BLUD] +7.68%
HUMAN GENOME SCI [HGSI] +7.00%
MONOGRAM BIOSCIENCES [MGRM] +6.48%
SCOLR PHARMA INC [DDD] +6.25%

Drug Delivery

ACURA PHARMACEUTICAL [ACUR] +6.90%
BENTLEY PHARMACEUTIC [BNT] +6.82%
NEKTAR THERAPEUTIC [NKTR] +6.09%
FLAMEL TECH SA ADR [FLML] +4.11%
PETMED EXPRESS INC [PETS] +3.09%

Drug Manufacturers

NOVABAY PHARMACEUTCL [NBY] +18.10%
PHARMASSET INC. [VRUS] +13.06%
NEUROGESX, INC. [NGSX] +12.00%
AP PHARMA INC [APPA] +11.02%
UNIGENE LABS INC [UGNE.OB] +10.40%

Drug Related Products

SALIX PHARM DEL [SLXP] +7.04%
AUXILIUM PHARMACEUT [AUXL] +6.63%
MANNATECH INC [MTEX] +4.56%
XELR8 HOLDINGS, INC [BZI] +3.64%
PERRIGO COMPANY [PRGO] +3.59%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +6.61%
MYLAN INC [MYL] +1.81%
WATSON PHARMACEUTCLS [WPI] +1.53%
CARACO PHARMA LABS [CPD] +0.98%
PHARMACUTICAL CO [PRX] +0.49%

Medical Appliances & Equipment

ECHO THERAPEUTICS [ECTE.OB] +40.74%
XCORPOREAL INC [XCR] +33.22%
WORLD HEART CORP [WHRT] +15.94%
EMERGENT GROUP INC [EMGP.OB] +15.89%
IRIDEX CP [IRIX] +10.86%

Medical Instruments & Supplies

LEMAITRE VASCULAR [LMAT] +14.06%
ROCHESTER MEDICAL [ROCM] +10.90%
STEN CORPORATION [STEN] +9.51%
IMPLANT SCIENCES CP [IMX] +7.44%
MEDPRO SAFETY PD [MPSP.OB] +7.14%

Medical Laboratories & Research

ENZO BIOCHEM INC [ENZ] +5.68%
ARRAY BIOPHARMA IN [ARRY] +5.64%
MEDTOX SCIENTFIC INC [MTOX] +1.39%
GENOPTIX, INC. [GXDX] +1.18%
SPHERIX INC [SPEX] +0.90%

- Wednesday's Top Medical & Biotech Stocks
- Tuesday's Top Medical & Biotech Stocks
__________________

Wednesday's Top Medical & Biotech Stocks

2008-03-12T16:25:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

THIRD WAVE TECH IN [TWTI] +31.27%
IMMUNOGEN INC [IMGN] +19.29%
NASTECH PHARM CO [NSTK] +14.29%
CV THERAPEUTICS I [CVTX] +13.31%
CADENCE PHARM. INC. [CADX] +13.10%

Diagnostic Substances

RESPONSE GENETICS, I [RGDX] +18.80%
LEXICON PHARMACEUTCL [LXRX] +14.29%
SYNTA PHARMACEUTICAL [SNTA] +6.96%
ROSETTA GENOMICS LTD [ROSG] +6.17%
AMAG PHARMACEUTICALS [AMAG] +4.04%

Drug Delivery

ULURU Inc [ULU] +11.61%
MATRIXX INITIATVS [MTXX] +3.13%
ARADIGM CORP [ARDM.OB] +2.50%
ELAN CP PLC ADR [ELN] +1.61%
PENWEST PHARM CO [PPCO] +1.43%

Drug Manufacturers

UNIGENE LABS INC [UGNE.OB] +14.57%
OSCIENT PHARMACEUT [OSCI] +13.65%
ADOLOR CORP [ADLR] +9.09%
ACCESS PHARMACEUTICL [ACCP.OB] +7.89%
Elite Pharmaceuticals, Inc [ELI] +7.62%

Drug Related Products

CURATECH INDUSTRIES [CUTC.OB] +7.33%
N B T Y INC [NTY] +6.64%
AUXILIUM PHARMACEUT [AUXL] +6.33%
LABOPHARM INC. [DDSS] +6.28%
USANA HEALTH SCIEN [USNA] +3.52%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +4.91%
MYLAN INC [MYL] +0.29%

Medical Appliances & Equipment

MB SOFTWARE CORP [MBSB.OB] +68.32%
ALLIED HEALTHCARE [AHPI] +9.47%
STEREOTAXIS, INC. [STXS] +8.62%
Arrhythmia Research Technology, [HRT] +8.44%
CRYOLIFE INC [CRY] +6.71%

Medical Instruments & Supplies

IsoRay, Inc. [ISR] +32.08%
Encision, Inc [ECI] +17.44%
XTENT INC [XTNT] +12.63%
IMPLANT SCIENCES CORPORATION [IMX] +11.61%
MINDRAY MEDICAL INTL [MR] +7.61%

Medical Laboratories & Research

RADNET INC [RDNT] +3.73%
GENOMIC HEALTH, INC. [GHDX] +1.44%
MEDTOX SCIENTFIC INC [MTOX] +1.28%
PHARM PROD DEV [PPDI] +0.39%
ALLIANCE IMAGING INC [AIQ] +0.34%

- Tuesday's Top Medical & Biotech Stocks
- Monday's Top Medical & Biotech Stocks
__________________

Cepheid: A False Hit From A False Claim

2008-03-12T08:27:00.002-04:00

by Michael Shulman
BiotechBlitz

Before you read this, please know I do not own this stock. I do recommend it in my service. I am writing this because a hatchet job has been done on a product category that can save tens of thousands of lives and because a company's stock took a hit for no reason.

That company, Cepheid (CPHD), took a major hit yesterday after the close due to an article in the Journal of the American Medical Association -- an article that should never have been published and if it was vetted, the people who agreed to its publication, next time they are not feeling well, should check into a hospital that does not do any MRSA testing.

The article claimed that MRSA testing did not help reduce MRSA infections - which of course is not only illogical but utter nonsense if you live in the real world. The study at the core of the article was based in Switzerland (University of Geneva) and I have been told by sources used this hospital used home brewed, home built tests -- not a standard test from Cepheid or competitor Becton Dickinson. A more detailed criticism was published by Betsy McCaughey, founder and chairman of the Committee to Reduce Infection Deaths, a not for profit with an obvious goal. Her critique is found below, verbatim. The organization's website is www.hospitalinfection.org.

Let's cut to the chase -- this article is quasi-science that is a short seller's dream. For those of you more interested in the truth and the potential for MRSA testing to save lives (and help companies succeed) look at the the Veterans Administration. The VA has arguably has one of the the toughest potential MRSA problems in the country due to the nature of their patient population, reduced MRSA infections by more than 70% with a pilot program with testing at its core and is now pushing that program nationwide. Cepheid has captured the vast majority of the testing business at the VA. Enough said, read the letter from MS. McCaughey.

Last note: some unsolicited, non-stock advice -- do get any procedure done in a hospital that does not do comprehensive MRSA testing -- no one in my family will. Am I paranoid? A teacher in the school situated next door to my son's high school died a few months back for she was diagnosed with a malady other than MRSA and was sent home. She died of MRSA.

The rebuttal letter -- verbatim -- hope you don't mind Ms. McCaughey. If you do, contact me and I will pull it down.

March 11, 2008
New York, New York

JAMA Article Provides False Support for CDC's Do-Nothing Position on MRSA

A new study in the Journal of the American Medical Association (JAMA) purports to show that screening for MRSA (methicillin-resistant Staphylococus aureus), a simple skin or nasal swab, is not effective in reducing MRSA hospital infections ("Universal Screening for Methicillin-Resistant Staphylococcus aureus at Hospital Admission and Nosocomial Infection in Surgical Patients," JAMA vol. 299, no. 10, March 12, 2008).

The findings of the authors will be seized upon by the Centers for Disease Control and Prevention (CDC) and advocates of the do-nothing status quo. But the study is seriously flawed - rendering is findings meaningless.

1. Researchers used a 'rapid test,' but many patients were not tested until they had already been in the hospital for twelve hours. Furthermore, the results of the MRSA tests were not acted upon for another 22½ hours on average. Most patients had completed more than half of their hospital stay before their results were known. Therefore, the precautions they needed - isolation, proper antibiotics, chlorhexidine baths - were taken late or not at all.

2. Unbelievably, almost a third of surgical patients (31%) who tested positive didn't get their test results until after their surgery. Therefore they too didn't receive any of the precautions they needed. Some people carry MRSA germs in their noses or on their skin without realizing it. The bacteria do not cause infection unless they get inside the body - usually via a catheter, a ventilator, or an incision or other open wound.

3. No weekly MRSA testing was conducted, which is de rigour when conducting universal screening to prevent patients colonized with MRSA from passing it on to other patients in the hospital.

4. A previous study by the same lead author at the same location, The University of Geneva Hospital, found that universal screening on admission with preemptive contact precautions (the way it's supposed to be done) decreased MRSA infections in the medical intensive care unit.

The study released today, says Betsy McCaughey, Chairman of the Committee to Reduce Infection Deaths, "doesn't prove that MRSA screening is ineffective. The study omits the precautions that are supposed to follow a MRSA positive test result. It's like testing a recipe, but omitting half the ingredients or test-driving a car without the tires."

Today's JAMA article provides false support for the CDC's persistent do-nothing position on the dire problem of M.R.S.A. The CDC's lax guidelines continue to give hospitals an excuse to do too little.

Chairman and founder of the Committee to Reduce Infection Deaths and former Lieutenant Governor of New York State, Betsy McCaughey is available for interview immediately at:
917-748-0227 or 212-534-3047
www.hospitalinfection.org

BiotechBlitz is a regular contributor to BioHealth Investor
______________

Tuesday's Top Medical & Biotech Stocks

2008-03-11T16:41:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

REXAHN PHARMACEUTICL [RXHN.OB] +25.00%
TRUBION PHARMACEUTIC [TRBN] +21.87%
CYTRX CP [CYTR] +16.87%
TERCICA INC [TRCA] +15.41%
GENETIC TECH SPON [GENE] +14.58%

Diagnostic Substances

IMMUNOMEDICS INC [IMMU] +8.37%
ASPENBIO PHARMA INC [APPY] +6.94%
Interleukin Genetics, Inc [ILI] +6.43%
LEXICON PHARMACEUTCL [LXRX] +6.06%
AKORN INC [AKRX] +4.42%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +10.26%
BENTLEY PHARMACEUTIC [BNT] +5.95%
ELAN CP PLC ADR [ELN] +4.73%
NEKTAR THERAPEUTIC [NKTR] +3.73%
ALKERMES INC [ALKS] +3.71%

Drug Manufacturers

NEUROGEN CP [NRGN] +21.23%
Opko Health Inc [OPK] +17.86%
DURECT CORP [DRRX] +16.46%
ALEXZA PHARMACEUTICA [ALXA] +15.71%
SANTARUS, INC. [SNTS] +12.70%

Drug Related Products

PERRIGO COMPANY [PRGO] +8.19%
PRESTIGE BRAND HLGS [PBH] +7.27%
Tiens Biotech Group (USA), Inc [TBV] +7.00%
China Shenghuo Pharmaceutical H [KUN] +6.93%
N B T Y INC [NTY] +5.37%

Generic Drugs

BARR PHARMA INC [BRL] +3.92% $5.2 B
HI-TECH PHARMACAL [HITK] +3.33% $231.1 M
Caraco Pharmaceutical Labortori [CPD] +2.05% $188.2 M
MYLAN INC [MYL] +1.36% $4.5 B
WATSON PHARMACEUTCLS [WPI] +0.98%

Medical Appliances & Equipment

XCORPOREAL INC [XCR] +15.83%
DATASCOPE CP [DSCP] +14.17%
THERMOGENESIS CORP [KOOL] +12.77%
CYNOSURE, INC. [CYNO] +10.94%
SONIC INNOVATIONS [SNCI] +8.91%

Medical Instruments & Supplies

CARDICA, INC. [CRDC] +17.36%
STEN CORPORATION [STEN] +14.80%
MEDPRO SAFETY PD [MPSP.OB] +11.43%
LUMINEX CORP [LMNX] +10.92%
Retractable Technologies, Inc [RVP] +10.34%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +6.46%
ENZO BIOCHEM INC [ENZ] +6.14%
ERESEARCHTECHNOLOG [ERES] +5.70%
BIO-IMAGING TECH [BITI] +3.70%
SPHERIX INC [SPEX] +3.64%

Monday's Top Medical & Biotech Stocks
__________________

Anavex Life Sciences takes innovative approach to targeting major diseases

2008-03-11T13:13:00.004-04:00

Anavex Life Sciences (AVXL.OB)
BHI Company Directory

Biopharmaceutical company takes its cues from new FDA standards

When it comes to creating drugs to combat the world’s most devastating diseases, established pharmaceutical companies sometimes prefer extending the lifecycle of existing drugs to developing truly new and groundbreaking treatments.

But as the US Food and Drug Administration’s most recent standards emphasize, it is crucial that pharmaceutical companies stay focused on their core mission – bringing genuinely new medicines and treatments, ones with revolutionary, disease-modifying potential, to the pharmaceutical market.

Enter Anavex Life Sciences Corp. The company’s proprietary SIGMACEPTORTM Discovery Platform makes use of a new class of molecules known as sigma ligands, which show strong promise in treating a range of diseases, including Alzheimer’s, epilepsy, depression and several types of cancer – combating the diseases themselves rather than merely the symptoms.

Anavex is currently focused on two key drug development programs. Its SIGMACEPTORTM-N program targets neurological diseases, and currently has three compounds in development – one for Alzheimer’s, another for epilepsy, and a third for depression. The SIGMACEPTORTM-C program, meanwhile, is made up of candidate drugs for prostate, colorectal, breast and lung cancers as well as other types of solid tumors.

So far, indicators have been very promising. Pre-clinical data on the company’s SIGMACEPTORTM-N compounds has revealed, among other things, the anticonvulsant, anti-amnesic, neuroprotective (i.e. protects nerve cells from degeneration or death) and anti-depressant properties of its lead epilepsy candidate. Meanwhile, scientific publications are emphasizing the promise of sigma ligands and highlighting the fact that they stop tumor growth and induce selective cell death in various tumor cell lines, including leukemia, melanoma and cancers of the lung, colon, brain, ovary, breast, prostate, and kidney – underscoring the enormous potential of SIGMACEPTORTM-C.

The potential of these programs, say company officials, is enormous. According to Anavex’s estimate, the market size for cancer drugs will reach $83 billion annually by the year 2015 in the world’s seven major pharmaceutical markets alone ( France , Germany , Italy , Spain , UK , USA and Japan ). The company estimates that markets for drugs that combat Alzheimer’s disease, epilepsy and depression will reach an annual $8.25 billion, $12.7 billion, and $14.0 billion respectively by that same year.

Companies that can help to meet this enormous need stand to realize enormous success – particularly companies whose work is in tune with the FDA’s most recent drug development priorities. Anavex’s drug candidates have shown effectiveness at very low doses and high safety profiles, even in large doses, qualities singled out alongside novelty for emphasis by the FDA’s new standards.

While its head offices are in Geneva , Switzerland , Anavex’s core research facility is an 11,000-square-foot laboratory in Athens , Greece – home base to a core team of 15 researchers with expertise in medicinal chemistry, molecular biology and pharmacology.

The company also maintains a network of scientific collaborations with renowned European research and academic institutions such as Montpellier University , Louis Pasteur University and the Academy of Athens ’ Institute of Biomedical Research . These partnerships have been a great source of strength to Anavex, allowing the company to keep its research and development costs at comfortable levels while maintaining full control over its research and intellectual property rights.

The company has a busy calendar of activities planned for the near future. It is planning to file Investigational New Drug (IND) applications for three of lead drug candidates in 2008, with the goal of proceeding rapidly into Phase 1 clinical trials. Meanwhile, it is continuing to advance numerous other compounds, currently in the discovery or lead optimization stage, for insertion into both the SIGMACEPTORTM-N and SIGMACEPTORTM-C pipelines.

Given the strength of its groundwork and the urgent need for new medications in its areas of focus, Anavex seems poised for growth in the near term.

Anavex Life Sciences is listed in the BHI Company Directory
_________________

Monday's Top Medical & Biotech Stocks

2008-03-10T17:06:00.002-04:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

TONGJITANG CH MD ADR [TCM] +31.37%
TRANSDEL PHARMACTL [TDLP.OB] +20.13%
IMMUNOSYN CORPORATIN [IMYN.OB] +19.12%
MEDICINOVA, INC. [MNOV] +8.96%
ALSERES PHARMACEUTCL [ALSE] +8.43%

Diagnostic Substances

TORREYPINES THERAPEU [TPTX] +4.32%
INTERLEUKIN GENETICS [ILI] +2.94%
SCOLR PHARMA INC [DDD] +2.40%
INFINITY PHARMACEUTI [INFI] +1.29%

Drug Delivery

EMISPHERE TECH [EMIS] +4.02%

Drug Manufacturers

SPECTRUM PHARMA INC [SPPI] +20.08%
GAMMA PHARMACEUTICAL [GMPM.OB] +9.43%
AVI BIOPHARMA INC [AVII] +8.80%
ACCESS PHARMACEUTICL [ACCP.OB] +5.21%
SIMCERE PHARMA ADS [SCR] +1.00%

Drug Related Products

MANNATECH INC [MTEX] +5.51%
N B T Y INC [NTY] +1.88%
MEDICAL NUTRITN USA [MDNU] +1.47%
INTEGRATED BIOPHARMA [INBP] +0.95%
PERRIGO COMPANY [PRGO] +0.50%

Generic Drugs

N/A

Medical Appliances & Equipment

ALLIED HEALTHCARE [AHPI] +8.95%
CRITICARE SYS INC [CMD] +4.54%
DEL GLOBAL TECH CORP [DGTC.OB] +3.73%
VISION SCIENCES IN [VSCI] +3.21%
DYNATRONICS CP [DYNT] +1.96%

Medical Instruments & Supplies

RETRACTABLE TECH INC [RVP] +7.41%
CRYOCOR, INC. [CRYO] +5.99%
VIVUS INC [VVUS] +4.04%
BIOSPHERE MEDICAL [BSMD] +3.68%
AMDL, INC [ADL] +3.68%

Medical Laboratories & Research

SPHERIX INC [SPEX] +3.77%
PSYCHEMEDICS NEW [PMD] +2.32%
QUEST DIAGNOSTC [DGX] +0.26%

BioHealth Investor.com
___________________

Airborne Justice

2008-03-07T08:56:00.002-05:00

by Doug Cress
Med Tech Sentinel

Airborne is a dietary supplement and health formula which is said to help ward off harmful bacteria and germs, and help prevent the flu and the common cold. The formula contains herbal extracts, amino acids, antioxidants, electrolytes, vitamins and other nutrients, and can be purchased in many U.S. retail stores over-the-counter.

It has been ranked the #1 cold and flu remedy at Drugstore.com, and is considered one of the fastest selling health products in retail history.

Intrigued?

At this point I’m sure you are wondering what team of scientists came up with this proprietary formulation…how many hours were spent perfecting this natural formula containing 17 herbs and nutrients, and of course, what type of carefully controlled clinical testing was undertaken to establish Airborne’s efficacy.

Well, who needs scientists?

Airborne was developed by, “a school teacher who was sick of getting sick in the classroom.”

Victoria Knight-McDowell, an elementary school teacher from Carmel, CA developed the product to “ward off” the germs spread by her 2nd grade students.

The marketing masterminds (or perhaps the cartoonists who devised the packaging) chose to disclose this fact prominently on all Airborne advertising – but it seems they went too far when touting the product’s benefits.

Because Airborne is classified as a food supplement, it does not fall under FDA jurisdiction. Even so, companies aren’t allowed to make grandiose unsubstantiated claims concerning effectiveness.

The maker of Airborne has removed some of its more idiotic claims and has agreed to pay $23.3 million to settle a false advertising class-action suit.

The company will refund money to consumers who bought Airborne product between May 2001 and November 2007. It will also pay for advertisements in major publications instructing consumers on how to get refunds.

Med Tech Sentinel is a regular contributor to BioHealth Investor
_______________

Monday's Top Medical & Biotech Stocks

2008-03-03T16:40:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

HESKA CORPORATION [HSKA] +22.30%
EURAND N.V. [EURX] +14.18%
GENAERA CORP [GENR] +13.53%
EXACT SCIENCES COR [EXAS] +10.82%
CYTRX CP [CYTR] +8.33%

Diagnostic Substances

REMOTEMDX INC [RMDX.OB] +10.18%
AVIGEN INC [AVGN] +8.16%
TRINITY BIO ADR [TRIB] +3.71%
GENELABS TECH INC [GNLB] +3.64%
CNS RESPONSE, INC. [CNSO.OB] +3.57%

Drug Delivery

PENWEST PHARM CO [PPCO] +14.94%
ARADIGM CORP [ARDM.OB] +9.92%
BIOVAIL CORP [BVF] +1.76%
K V PHARMA CL A [KV-A] +1.59%
DELCATH SYSTEMS INC [DCTH] +1.32%

Drug Manufacturers

DUSA PHARM INC [DUSA] +9.84%
LIGAND PHARM CMN STK [LGND] +8.55%
NITROMED, INC. [NTMD] +6.31%
DYNAVAX TECHNOLOGIES [DVAX] +5.31%
AP PHARMA INC [APPA] +5.07%

Drug Related Products

CURATECH INDUSTRIES [CUTC.OB] +42.86%
TIENS BIOTECH GR USA [TBV] +9.27%
PRESTIGE BRAND HLGS [PBH] +4.41%
SCHIFF NUTRIT INTL [WNI] +3.29%
ARGAN INC [AGX] +2.09%

Generic Drugs

PHARMACUTICAL CO [PRX] +8.71%
CARACO PHARMA LABS [CPD] +8.64%
CATALYST PHARMACEUTI [CPRX] +0.53%

Medical Appliances & Equipment

RTI BIOLOGICS INC [RTIX] +13.49%
SYNERGETICS USA INC [SURG] +12.81%
ARTHROCARE CP [ARTC] +7.10%
VISION SCIENCES IN [VSCI] +6.75%
EDAP TMS SA ADR [EDAP] +5.85%

Medical Instruments & Supplies

STEN CORPORATION [STEN] +125.06%
CPC OF AMERICA INC [CPCF.OB] +8.01%
BIOLASE TECH INCS3 [BLTI] +5.13%
NANOSPHERE, INC. [NSPH] +4.76%
ENDOLOGIX INC [ELGX] +4.75%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +17.14%
GENOMIC HEALTH, INC. [GHDX] +3.25%
ERESEARCHTECHNOLOG [ERES] +1.25%
RADNET INC [RDNT] +1.23%
GENOPTIX, INC. [GXDX] +1.21%

- Friday's Top Biotech & Medical Stocks
- Thursday's Top Biotech & Medical Stocks
___________________

Behind the Great Wall of China Biotech

2008-03-03T09:09:00.004-05:00

by Greg Scott
ChinaBio Today

Editor's note: The following is an edited excerpt combining questions from interviews with our Executive Editor, Greg Scott, who is also President of ChinaBio® LLC, conducted by CCTV in Beijing, and Windhover Information in the U.S.

Q. With all of your activities at ChinaBio®, you’re obviously well positioned to understand the pharma industry here in China. Tell us about the market size and potential growth of the industry.

Scott: The global pharma market is approaching $700 billion a year now, and growing at 8% to 10% per year. China is only about 5% of the market, but it’s growing at over 20% per year. That means that over 1/10th of the total global growth is coming from China, making it a market that can no longer be ignored.

What are some of the changes you've witnessed in the marketplace and how has China played a role in those changes?

The world has suddenly become aware of the China biotech industry because of WuXi PharmaTech’s (NYSE: WX) IPO last August. Every big pharma is now investing in China and VC investment in biotech here has grown four-fold in just the last year.

What is the most highly anticipated policy for the next year and why?

While it hasn’t been announced yet [at the time of this interview], China is committing an additional $1.5 billion to biotech innovation over the next five years. This doubles the current rate of investment. You can literally see the level of excitement increasing in the major life science parks here.

Given the growing trend to outsourcing using CROs and CMOs in China, what benefits does this provide to big pharma and what can we expect in the future?

You can reach human proof-of-concept in China much more cheaply and quickly than almost anywhere in the world, and the quality of the data is rapidly becoming world class. This is one of the reasons we founded ChinaBio® Therapeutics: to quickly build value in highly promising molecules that would be ignored in the U.S.

Outsourcing will likely continue to grow significantly for the next 5-10 years in China. But there will be fewer players. Charles River’s (NYSE: CRL) acquisition of BioExplorer is just the first of many we expect to see over the next 2-3 years as the industry consolidates.

Where do you see the industry in the short-, medium-, and long-term?

The short-term focus is still on services, as evidenced at our ChinaBio® Investor Forum last December in Shanghai. And there will certainly be several more CRO IPOs – watch for ChemPartner, Pharmaron, and maybe Shanghai Genomics to come out in the next 12 to 24 months. But we’re also seeing a trend toward more VC funding of early and mid-stage biotechs.

Medium-term, we’ll start to see more novel, China-developed drugs reaching the clinic, and eventually the global market.

Long-term, China will become the #1 player in the pharma industry in 15-20 years.

ChinaBio Today is a regular contributor to BioHealth Investor
_________________

Expanded Indications for Immunicon’s CellSearch

2008-03-03T09:04:00.002-05:00

by Doug Cress
Med Tech Sentinel

Immunicon’s (IMMC) CellSearch Circulating Tumor Cell (CTC) Kit has received FDA clearance as an aid in the monitoring of patients with metastatic prostate cancer.

The kit is now cleared for three of the four most prevalent cancers; a combined ≈$1 billion market, according to the company.

The CellSearch CTC kit was originally cleared in January 2004 to predict progression-free and overall survival in patients with metastatic breast cancer and later expanded to include monitoring. In November 2007, the kit was cleared by the FDA for monitoring metastatic colorectal cancer.

The American Cancer Society estimates that in 2006 there were 1.4 million new cancer cases diagnosed and 564,000 deaths. Close to 90% of all cancers are solid tumors or carcinomas. Computed tomography (CT) scans are standard for tracking the progression of carcinomas by assessing changes in tumor size, but CT scans are highly subjective and for best results measurement takes place over long intervals of time, potentially allowing the carcinoma to metastasize.

Immunicon’s CellSearch addresses these inadequacies using blood samples to counts and characterizes the number of tumor cells present in a blood sample.

The CTC Kit has better predictive power than serum tumor markers and CT scans and is performed more regularly – every 3-4 weeks versus every 3-6 months. The Kit is able to predict survival time in patients undergoing chemo and hormonal therapy. It helps oncologists determine if a therapy is working, allowing them to manipulate a course of treatment with much greater speed.

In August 2000, Immunicon entered into an exclusive partnership with Veridex, a J&J subsidiary. Under the terms of the agreement Veridex is responsible for all marketing, sales and distribution. The revenues are shared, except for reagents for which Immunicon receives 30%. Reimbursements are also the responsibility of Veridex —CPT codes exist for most products.

Med Tech Sentinel is a regular contributor to BioHealth Investor
__________________

Friday's Top Medical & Biotech Stocks

2008-02-29T16:53:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

MOMENTA PHARMA [MNTA] +28.61%
TRANSDEL PHARMACTL [TDLP.OB] +23.33%
CHAMPIONS BIOTECHNLG [CSBR.OB] +13.45%
CARDIUM THERAPEUTICS [CXM] +13.33%
ATHERSYS INC [ATHX] +11.25%

Diagnostic Substances

IMMUCELL CP [ICCC] +10.20%
PRESSURE BIOSCIENC [PBIO] +3.26%
SYNTA PHARMACEUTICAL [SNTA] +2.90%
ICAGEN, INC. [ICGN] +2.34%
TRINITY BIO ADR [TRIB] +1.33%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +2.70%
COLUMBIA LABS INC [CBRX] +1.24%
FLAMEL TECH SA ADR [FLML] +1.20%
ULURU INC [ULU] +1.19%
ARADIGM CORP [ARDM.OB] +0.77%

Drug Manufacturers

ELITE PHARMA INC [ELI] +19.23%
YM BIOSCIENCES INC [YMI] +9.09%
NEUROGESX, INC. [NGSX] +5.24%
GENTIUM SPA ADS [GENT] +3.92%
NEUROCHEM INC [NRMX] +3.92%

Drug Related Products

INTEGRATED BIOPHARMA [INBP] +2.30%
SCHIFF NUTRIT INTL [WNI] +1.85%
NATURAL ALTERNATIV [NAII] +1.00%

Generic Drugs

HI-TECH PHARMACAL [HITK] +0.91%

Medical Appliances & Equipment

PATIENT SAFETY TECH [PSTX.OB] +18.18%
ALLIED HEALTHCARE [AHPI] +17.25%
SRI/SURGICAL EXPRE [STRC] +7.69%
CANDELA CP [CLZR] +7.11%
VISION SCIENCES IN [VSCI] +6.87%

Medical Instruments & Supplies

CPC OF AMERICA INC [CPCF.OB] +43.09%
MEDPRO SAFETY PD [MPSP.OB] +42.18%
BIOMERICA INC [BMRA.OB] +21.74%
POWER MED. INT. INC. [PMII] +8.89%
EP MEDSYSTEMS INC [EPMD] +8.72%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +9.57%
MEDTOX SCIENTFIC INC [MTOX] +1.52%
NATL DENTEX CP [NADX] +0.85%
GENOPTIX, INC. [GXDX] +0.47%

- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
___________________

Replidyne Announces Year-end Results

2008-02-29T07:54:00.001-05:00

by Adam Rubenstein
CLSDF

IMHO I remain incredibly optimistic about Replidyne’s (NASDAQ: RDYN), a leader in next-generation anti-infective products, direction (note: this in no why should be interpreted as investment advice). After being dealt a bum deal by the FDA re: a change in protocol for antibiotic trials, management at Replidyne has retrenched. With $90.3M in cash on the books as-of 31 December 2007 and a quarterly burn of approximately $18M it is full steam ahead with the Faropenem asset as Phase III enrollment continues for treatment of acute exacerbation of chronic bronchitis and preparation for three additional Phase III trials is likewise underway, one for treatment of acute bacterial sinusitis and two for treatment of community acquired pneumonia.

The search continues for a partner on the Faropenem asset and when and if one is identified and announced I would have to venture to guess that there will be a significant step up in value from today’s ~$53M market cap, which by the way indicates that the entity is trading below the sum of its parts.

Finally, great progress is being made in the pipeline with an expected IND filing this year for REP3123 in the Clostridium difficile program, and there is too an expectation for the identification of an IND candidate in the DNA replication inhibition program as an additional 2008 milestone.

CLSDF is a regular contributor to BioHealth Investor
______________

Thursday's Top Medical & Biotech Stocks

2008-02-28T16:26:00.008-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

TRANSDEL PHARMACTL [TDLP.OB] +25.00%
OCTILLION CORP NEW [OCTL.OB] +21.09%
EXACT SCIENCES COR [EXAS] +20.32%
BARRIER THERAPEUTICS [BTRX] +9.88%
GPC BIOTECH AG [GPCB] +8.87%

Diagnostic Substances

HUMAN GENOME SCI [HGSI] +8.85%
IMMUNOMEDICS INC [IMMU] +4.18%
SCOLR PHARMA INC [DDD] +3.85%
AVALON PHARMACEUTIC [AVRX] +3.60%
ASPENBIO PHARMA INC [APPY] +2.44%

Drug Delivery

NEKTAR THERAPEUTIC [NKTR] +10.37%
HOSPIRA INC [HSP] +7.57%
BIOVAIL CORP [BVF] +5.75%
ELAN CP PLC ADR [ELN] +3.29%
ULURU INC [ULU] +2.42%

Drug Manufacturers

KERYX BIOPHARM INC [KERX] +19.92%
SPECTRUM PHARMA INC [SPPI] +13.92%
MARSHALL EDWARDS [MSHL] +12.08%
MIDDLEBROOK PHARMACL [MBRK] +10.26%
ARYX THERAPEUTICS, I [ARYX] +9.46%

Drug Related Products

MANNATECH INC [MTEX] +8.38%
INTEGRATED BIOPHARMA [INBP] +4.11%
ARGAN INC [AGX] +0.86%
TIENS BIOTECH GR USA [TBV] +0.48%
USANA HEALTH SCIEN [USNA] +0.31%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +8.70%

Medical Appliances & Equipment

RESTORE MEDICAL INC [REST] +12.87%
CONSORTIUM SVC MGT [CTUM.OB] +12.75%
ATS MEDICAL INC [ATSI] +10.65%
UROLOGIX INC [ULGX] +6.86%
[MAKO] +6.66%

Medical Instruments & Supplies

EP MEDSYSTEMS INC [EPMD] +6.43%
CARDIAC SCIENCE CORP [CSCX] +5.74%
ENCISION INC [ECI] +5.00%
CPC OF AMERICA INC [CPCF.OB] +4.76%
IMPLANT SCIENCES CP [IMX] +2.21%

Medical Laboratories & Research

ERESEARCHTECHNOLOG [ERES] +4.99%
PHARM PROD DEV [PPDI] +0.97%
ENZO BIOCHEM INC [ENZ] +0.94%
ARRAY BIOPHARMA IN [ARRY] +0.36%

- Wednesday's Top Biotech & Medical Stocks
- Tuesday's Top Biotech & Medical Stocks
___________________

20 Surprising Ways Wal-Mart Clinics Will Affect US Healthcare

2008-02-28T09:36:00.002-05:00

By Jessica Hupp
RNCentral

Big-box behemoth Wal-Mart has ventured into the healthcare realm, offering low-cost, walk-in clinics in more and more of its stores every day. Although Wal-Mart medicine may not sound like a great idea at first, these clinics can bring good changes to the health care industry, like insurance-free care, eased emergency rooms, and more widespread treatments. Of course, the plan is not without its drawbacks, creating a "Wal-Mart effect" on small practitioners, as well as a race to the bottom. Here, we'll take a good look at some of the implications you might not have thought about.

1. More immunizations: With immunizations available at Wal-Mart, they're much more convenient for those that may not have time to go to the doctor. As a result, more people will be immunized, and the risk of contagious disease will be lowered.

2. Flat fee visits: Most Wal-Marts charge a flat $45 for a "Get Well" visit, which is painstakingly simple when compared with health care's typical insurance, co-pay, and deductible scheme. As Wal-Mart clinics become more popular, other health practitioners may be forced to adopt a similar pay structure in order to compete.

3. Faster care: Wal-Mart offers walk-in visits, offering a refreshing alternative to appointment-based health care. As Wal-Mart's clinics and others like them become more popular, we'll see patients getting care right when they need it.

4. Automated health: At Wal-Mart clinics, practitioners check out patients with the aid of a proprietary computer program that diagnoses illnesses. This sort of automation can help make diagnosis more accurate and efficient, while still allowing for human expert guidance when needed.

5. No insurance necessary: Perhaps the biggest thing to come out of Wal-Mart clinics is that they don't require insurance. Paired with flat-fee service, this simple pricing structure is likely to bring in patients that otherwise would just go without medical care.

6. Race to the bottom: Wal-Mart tends to have this effect on local businesses, creating a situation where quality must be sacrificed for price. In the healthcare world, cheaper isn't always better, and competing with Wal-Mart clinics could result in decreased quality of care.

7. One-stop shopping: Retail clinics like Wal-Mart's open up an opportunity for a place to take care of basic medical needs, combining the clinic with optometry, pharmacy, and over the counter supplies.

8. Primary care providers can narrow their focus: As Wal-Mart takes on all of the sniffles and scratches, doctors can spend more time working with patients who need more professional help. They'll be able to use their time more effectively and appropriately.

9. Automated health care could be problematic: Although automation increases efficiency and reduces human error, that doesn't mean that a computer program is the best way to diagnose a patient. Critics are worried that this type of diagnosis will cause important intricacies to be missed.

10. Eased emergency room crunches: As health care becomes more accessible, the patients that generally clog up emergency rooms unnecessarily will be able to take care of problems before they become worse. Additionally, clinics like Wal-Mart's can take care of ailments that for some without insurance would require a trip to the hospital.

11. More retail pricing information: To compete with Wal-Mart, physicians will start sharing information about how much specific visits and procedures will cost. This can make health care more competitive and consumer-friendly.

12. Better rural medical access: In many rural areas, the nearest health care practitioner isn't so near. However, you can often find a Wal-Mart even in remote parts of the country. This would make it much more convenient for rural citizens to get hassle-free care.

13. Increased medical awareness: With health care right where people shop, it's a lot harder to ignore aches and pains. Plus, as stores run campaigns for prevention services and screening, they'll be able to catch and stop ailments earlier than before.

14. Increased office hours: Wal-Mart's clinics offer evening and weekend hours, while many primary care physicians do not. To compete, these doctors will need to offer extended hours to patients.

15. Mall health clinics: Wal-Mart isn't the only one in the neighborhood clinic game. As their clinics become more successful, we can expect to see this sort of health care facility popping up in more places, like malls and strip centers.

16. Traditional medical offices will feel the crunch: As Wal-Mart's clinics tackle the easy patients, regular health practitioners will be left with more complicated patients that take more time and money. These patients are generally less profitable, and could cause monetary problems for these offices.

17. More referrals: Primary care physicans and specialists will see more referrals as Wal-Mart and others like it determine that some cases are too difficult to be handled by the clinic. This would include finding doctors and sharing medical records.

18. Increased utilization of nurse practitioners: For the most part, Wal-Mart clinics are and will be staffed by nurse practitioners. This is part of a growing trend to use highly skilled and trained nurses instead of doctors.

19. Less red tape for known illnesses: For patients who have recurring or easily-diagnosed illnesses, Wal-Mart clinics will make getting treatment easier. This will help patients avoid the high cost of taking the time to visit a primary care physician.

20. Decreased continuity of care: With traditional doctors, patients have charts and medical records, but at in-store clinics, diagnosis is a one-off deal. Problems that could be caught over multiple visits and diagnosis could go unearthed unless the patient works to inform practitioners

This article first published by RNCentral.com
_____________________

Wednesday's Top Medical & Biotech Stocks

2008-02-27T16:22:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

VION PHARM INC [VIOND] +17.33%
SEQUENOM INC [SQNM] +9.14%
CORCEPT THERAPEUTICS [CORT] +7.91%
MEDAREX INC [MEDX] +7.48%
IMMUNOSYN CORPORATIN [IMYN.OB] +5.61%

Diagnostic Substances

IMMUNOMEDICS INC [IMMU] +5.29%
AVIGEN INC [AVGN] +5.12%
MONOGRAM BIOSCIENCES [MGRM] +3.42%
TORREYPINES THERAPEU [TPTX] +3.06%
SURMODICS INC [SRDX] +2.26%

Drug Delivery

ULURU INC [ULU] +2.06%
DELCATH SYSTEMS INC [DCTH] +1.96%
PETMED EXPRESS INC [PETS] +1.87%
FLAMEL TECH SA ADR [FLML] +1.53%
K V PHARMA CL A [KV-A] +1.08%

Drug Manufacturers

ELITE PHARMA INC [ELI] +11.57%
SOMAXON PHARMACEUTIC [SOMX] +10.94%
PROVECTUS PHARMA [PVCT.OB] +10.19%
MIDDLEBROOK PHARMACL [MBRK] +7.95%
SUPERGEN INC [SUPG] +7.04%

Drug Related Products

CHINA SHENGHUO PHARM [KUN] +8.17%
MANNATECH INC [MTEX] +1.39%
INTEGRATED BIOPHARMA [INBP] +1.39%
N B T Y INC [NTY] +0.54%
SALIX PHARM DEL [SLXP] +0.44%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +5.89%
CATALYST PHARMACEUTI [CPRX] +5.18%
BARR PHARMA INC [BRL] +1.03%
CARACO PHARMA LABS [CPD] +0.18%

Medical Appliances & Equipment

ZYNEX MEDICAL HLDGS [ZYNX.OB] +13.64%
BIOFORM MEDICAL, INC [BFRM] +10.50%
CANDELA CP [CLZR] +10.03%
[MAKO] +8.82%
SYNOVIS LIFE TECH [SYNO] +7.54%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +7.84%
CARDIAC SCIENCE CORP [CSCX] +5.96%
WEST PHARMA SVCS INC [WST] +5.56%
MINDRAY MEDICAL INTL [MR] +4.33%
ISORAY INC [ISR] +0.97%

Medical Laboratories & Research

ERESEARCHTECHNOLOG [ERES] +12.06%
BIO-IMAGING TECH [BITI] +2.12%
MEDTOX SCIENTFIC INC [MTOX] +1.58%
ALLIANCE IMAGING INC [AIQ] +1.01%
RADNET INC [RDNT] +0.47%

- Tuesday's Top Biotech & Medical Stocks
- Monday's Top Biotech & Medical Stocks
___________________

FDA Strategy When Under Attack - Drift

2008-02-27T12:19:00.002-05:00

by Mark S. Senak
Eye On FDA

In recent weeks, policymakers have turned up the heat on the FDA. First, Congressman Bart Stupak (D-MI) sent Dr. Andrew C. von Eschenbach a Valentine by demanding his resignation on February 14. Less than a week later, Congresswoman Rosa DeLauro (D-Conn) likened the management of the FDA to the Keystone Cops. Congressman John Dingell (D-MI) was one of the members to raise concerns and demand answers about the Pfizer Jarvick ads for Lipitor, notable at a time and after a year when FDA's DDMAC sent out fewer warning letters than ever. And also this month, hearings were scheduled by the House Subcommittee on Oversight and Investigations hearing titled “Ketek Clinical Study Fraud: What Did Aventis Know?”

And that is just February! All in all, not a good month for the agency or for the industry it regulates. Each of these issues reflects on the FDA's judgment, leadership, character, abilities and direction. In short, the FDA is in the stew. The response from the FDA?

Silence.

If you go to the FDA Web site, and look at the compilation of speeches by its leaders, you will see only two from 2007, none in 2008. Only one of those two speeches was by Dr. von Eschenbach.

I've stated many times on this page, the need for the FDA to exercise at least some basic crisis communications efforts and for Dr. von Eschenbach to lay out some strategy and vision, but sadly, no such effort has been forthcoming. The result is that foes of the FDA and political opportunists, to be fair, are able to shape the debate almost exclusively.

Imagine if either Senator Barack Obama or Senator Hillary Clinton sat silently by while their opponent characterized their record, accomplishments, character and competence. The public would not vote for that silent candidate. FDA leadership may not believe that they are running for office. They are mistaken. They are running for an office called public confidence. And right now, as for the past few years, the agency is losing that essential race.

The FDA is drifting. That drift has set the stage, at least in part, for a massive overhaul and reform of the FDA by Congress. Perhaps that is a good thing, perhaps not.

Presumably there is not much time left to the tenure of Dr. von Eschenbach and one can easily imagine that whatever happens in November, his days as Commissioner are few. His legacy should be focused on getting the agency as far out of drift as possible to leave some hope of restoring the FDA's once golden image, rather than letting Congress do the job for him.

Eye On FDA is a regular contributor to BioHealth Investor
_______________

Prana Biotechnology: A Challenge for the FDA

2008-02-27T12:15:00.002-05:00

by Michael Shulman
BiotechBlitz

Prana Biotechnology (PRAN), a tiny Australian company working for many years on a treatment for Alzheimer's disease (AD), announced Phase II trial results yesterday that the company characterized as successful -- and the stock popped 40%-50% today.

The trial results, for those who care about these things, raise many future questions that will have to be answered by the FDA and about the future of AD drug development. That may happen when the company approaches the agency to move forward into Phase III trials.

What this company does withthe FDA has enormous implications way beyond its own drug efforts.

Prana has a different approach towards Alzheimer's which is how I found them five years ago. A good deal of big pharma has aimed at reducing the secretion of amyloid proteins and failed.

Simply put, humans need these proteins and to limit their presence in the brain would require a drug that could cross the brain barrier -- and that's a non-starter. Instead, Prana aims to reduce the plaque, not the protein, by stopping the reaction between these proteins and the naturally occurring copper and zinc in the brain.

The heart of Prana's research is to commercialize what are called Metal Protein Attenuating Compounds (MPACs) to reduce or eliminate the interaction of naturally occurring metals in the body (such as copper) with amyloid proteins -- and in the process reduce or eliminate beta-amyloid creation and plaque buildup.

MPACs may also be a technology useful for the treatment of other brain disorders (i.e., Parkinson's) that could also be occurring, in part, due to the interaction of metals and amyloid proteins. Prana's research approach believes oxidation releases the key proteins, these proteins interact with a metal (naturally occurring copper in the brain being the main culprit), and this then leads to both the buildup of plaques and the release of hydrogen peroxide causing brain-cell death and reduced brain function.

In the Phase II trials, the drug (PBT-2) was safe and, as measured by two of four standard measurements (by the FDA and the industry) for the progression of Alzheimer's disease, it showed statistically significant results. The drug did not have any impact as measured by the most important test, the ADAS-cog for overall cognitive impairment. The company also reported its own measurement result showing significant reductions in a biomarker for certain amyloid beta proteins (Abeta 42) associated with AD.

It is this result that could attract a partner of some sort.

These markers are not accepted by everyone and have never been used to get a drug approval from the FDA. And that is the rub. There are vocal minority of researchers who believe these proteins and their plaques are a symptom and not a cause of AD.

If and when the company puts forward a request to go to a Phase III trial, I can only assume it will include these markers as a secondary endpoint, perhaps a primary endpoint, of the trial.

The FDA will have to decide if this is an appropriate surrogate for efficacy. This is important because it is hard to measure the mild-to-moderate patient group that is typical in many AD, trials and everyone agrees a biological marker and measurement would be of great value to drug development and for early, pre-symptomatic diagnosis.

If Prana can get a partner, then the question is whether that partner will endorse these biomarkers as a valid endpoint and use their big pharma skills to get the FDA to accept this point of view.

There is a lot riding on the FDA in this process -- many companies are working on AD treatments and FDA acceptance of this kind of biomarker as a primary endpoint would be revolutionary! Even acceptance as a secondary endpoint for a Phase III trial would be ground breaking.

Stay tuned. This is very interesting. I have recommended PRAN in my service for many years and I own the stock.

BiotechBlitz is a regular contributor to BioHealth Investor
______________

Tuesday's Top Medical & Biotech Stocks

2008-02-26T16:58:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

IMMUNOSYN CORPORATIN [IMYN.OB] +23.91%
BARRIER THERAPEUTICS [BTRX] +18.28%
THIRD WAVE TECH IN [TWTI] +13.28%
TRANSDEL PHARMACTL [TDLP.OB] +13.04%
ALFACELL CORP [ACEL] +12.80%

Diagnostic Substances

REMOTEMDX INC [RMDX.OB] +17.28%
INTERLEUKIN GENETICS [ILI] +8.82%
PRESSURE BIOSCIENC [PBIO] +7.18%
IMMUNOMEDICS INC [IMMU] +6.57%
AVIGEN INC [AVGN] +6.07%

Drug Delivery

COLUMBIA LABS INC [CBRX] +6.41%
FLAMEL TECH SA ADR [FLML] +4.94%
NOVEN PHARMACEUTIC [NOVN] +4.93%
NEKTAR THERAPEUTIC [NKTR] +4.02%
EMISPHERE TECH [EMIS] +2.63%

Drug Manufacturers

PRANA BIO LTD ADS S1 [PRAN] +36.34%
COLLAGENEX PHARM I [CGPI] +27.58%
NEUROCHEM INC [NRMX] +14.60%
LIGAND PHARM CMN STK [LGND] +14.04%
SUPERGEN INC [SUPG] +12.03%

Drug Related Products

MANNATECH INC [MTEX] +11.66%
SALIX PHARM DEL [SLXP] +5.92%
DRAXIS HEALTH INC [DRAX] +4.64%
LABOPHARM INC. [DDSS] +4.42%
AUXILIUM PHARMACEUT [AUXL] +3.48%

Generic Drugs

WATSON PHARMACEUTCLS [WPI] +1.84%
MYLAN INC [MYL] +1.69%
HI-TECH PHARMACAL [HITK] +1.26%
CARACO PHARMA LABS [CPD] +1.26%

Medical Appliances & Equipment

ECHO THERAPEUTICS [ECTE.OB] +11.76%
WORLD HEART CORP [WHRT] +10.29%
SRI/SURGICAL EXPRE [STRC] +10.11%
ATS MEDICAL INC [ATSI] +10.00%
THERMOGENESIS CORP [KOOL] +9.32%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +25.62%
RETRACTABLE TECH INC [RVP] +7.59%
EP MEDSYSTEMS INC [EPMD] +6.03%
BIOMIMETIC THERAPEUT [BMTI] +5.93%
BIOLASE TECH INCS3 [BLTI] +5.08%

Medical Laboratories & Research

RADNET INC [RDNT] +10.30%
ENZO BIOCHEM INC [ENZ] +5.70%
PSYCHEMEDICS NEW [PMD] +3.95%
ERESEARCHTECHNOLOG [ERES] +3.76%
SPHERIX INC [SPEX] +3.48%

- Monday's Top Biotech & Medical Stocks
- Friday's Top Biotech & Medical Stocks
___________________

Monday's Top Medical & Biotech Stocks

2008-02-25T17:36:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

GTX, INC. [GTXI] +36.46%
NASTECH PHARM CO [NSTK] +35.64%
GENAERA CORP [GENR] +12.72%
ZIOPHARM ONCOLOGY IN [ZIOP] +10.00%
PIPEX PHARMACEUTALS [PP] +9.80%

Diagnostic Substances

REMOTEMDX INC [RMDX.OB] +19.12%
QUIDEL CP [QDEL] +9.55%
ICAGEN, INC. [ICGN] +7.10%
MERIDIAN BIOSCIENC [VIVO] +5.90%
ABAXIS INC [ABAX] +5.56%

Drug Delivery

PENWEST PHARM CO [PPCO] +11.70%
ULURU INC [ULU] +4.64%
GENEREX BIOTECH CORP [GNBT] +3.88%
COLUMBIA LABS INC [CBRX] +3.54%
ELAN CP PLC ADR [ELN] +3.31%

Drug Manufacturers

CARDIOME PHARMA NEW [CRME] +26.44%
DYNAVAX TECHNOLOGIES [DVAX] +11.79%
DURECT CORP [DRRX] +7.72%
MAP PHARMACEUTICALS, [MAPP] +7.07%
OSCIENT PHARMACEUT [OSCI] +6.80%

Drug Related Products

LABOPHARM INC. [DDSS] +11.66%
DRAXIS HEALTH INC [DRAX] +5.72%
PERRIGO COMPANY [PRGO] +3.93%
N B T Y INC [NTY] +2.09%
AUXILIUM PHARMACEUT [AUXL] +2.02%

Generic Drugs

HI-TECH PHARMACAL [HITK] +4.31%
PHARMACUTICAL CO [PRX] +3.25%
WATSON PHARMACEUTCLS [WPI] +2.21%
CARACO PHARMA LABS [CPD] +1.39%
MYLAN INC [MYL] +0.85%

Medical Appliances & Equipment

ECHO THERAPEUTICS [ECTE.OB] +13.33%
CRITICARE SYS INC [CMD] +11.67%
CANDELA CP [CLZR] +10.37%
ORTHOFIX INTL NV [OFIX] +8.07%
FONAR CORP [FONR] +7.88%

Medical Instruments & Supplies

STEN CORPORATION [STEN] +14.48%
TRANS1 INC. [TSON] +12.44%
NUCRYST PHARMACEUTIC [NCST] +10.80%
BIOMERICA INC [BMRA.OB] +9.52%
IMPLANT SCIENCES CP [IMX] +6.66%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +6.13%
ENZO BIOCHEM INC [ENZ] +4.41%
RADNET INC [RDNT] +3.79%
GENOMIC HEALTH, INC. [GHDX] +3.10%
QUEST DIAGNOSTC [DGX] +2.69%

- Friday's Top Biotech & Medical Stocks
- Thursday's Top Biotech & Medical Stocks
___________________

Friday's Top Medical & Biotech Stocks

2008-02-22T16:22:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

ONCOTHYREON [ONTY] +14.46%
NOVAVAX INC [NVAX] +9.75%
BARRIER THERAPEUTICS [BTRX] +8.61%
FAVRILLE, INC. [FVRL] +7.23%
ATHERSYS INC [ATHX] +7.14%

Diagnostic Substances

MONOGRAM BIOSCIENCES [MGRM] +4.29%
ABAXIS INC [ABAX] +3.63%
NYMOX PHARM CORP [NYMX] +3.14%
NEOGEN CP [NEOG] +1.87%
AVALON PHARMACEUTIC [AVRX] +1.71%

Drug Delivery

MATRIXX INITIATVS [MTXX] +4.77%
ARADIGM CORP [ARDM.OB] +3.13%
NEKTAR THERAPEUTIC [NKTR] +2.45%
BIOVAIL CORP [BVF] +1.33%
BENTLEY PHARMACEUTIC [BNT] +1.15%

Drug Manufacturers

GEOPHARMA INC [GORX] +12.17%
SOMAXON PHARMACEUTIC [SOMX] +6.09%
ENDO PHARM HLDGS I [ENDP] +5.92%
DYNAVAX TECHNOLOGIES [DVAX] +4.99%
SHIRE PLC ADS [SHPGY] +3.61%

Drug Related Products

CURATECH INDUSTRIES [CUTC.OB] +42.86%
AUXILIUM PHARMACEUT [AUXL] +5.28%
PRESTIGE BRAND HLGS [PBH] +4.12%
INTEGRATED BIOPHARMA [INBP] +1.70%
TIENS BIOTECH GR USA [TBV] +1.45%

Generic Drugs

PHARMACUTICAL CO [PRX] +3.41%
HELICOS BIOSCIENCES [HLCS] +3.17%
WATSON PHARMACEUTCLS [WPI] +1.17%
MYLAN INC [MYL] +0.78%
CATALYST PHARMACEUTI [CPRX] +0.61%

Medical Appliances & Equipment

LANGER INC [GAIT] +17.28%
ESCALON MED CP [ESMC] +8.81%
ACCURAY INCORPORATED [ARAY] +3.75%
ECHO THERAPEUTICS [ECTE.OB] +3.45%
SYNERGETICS USA INC [SURG] +3.37%

Medical Instruments & Supplies

TRANS1 INC. [TSON] +24.31%
XTENT INC [XTNT] +7.53%
BIOTEL INC [BTEL.OB] +7.46%
CHINA MEDICAL TECH [CMED] +6.10%
INSULET CORPORATION [PODD] +5.21%

Medical Laboratories & Research

ARRAY BIOPHARMA IN [ARRY] +4.13%
ERESEARCHTECHNOLOG [ERES] +3.88%
PSYCHEMEDICS NEW [PMD] +2.80%
BIO-IMAGING TECH [BITI] +0.39%
MEDTOX SCIENTFIC INC [MTOX] +0.19%

- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
___________________

Is off-label promotion off the mark?

2008-02-22T07:04:00.002-05:00

by Karen Donovan
Health Business Blog

Most people know that off-label use of drugs is rampant, but not everyone may know its extent or history. In the WSJ article U.S. FDA gives boost to off-label drug use, the authors discuss the proposed FDA guidance which would allow drug and device companies to disseminate articles that discuss unapproved uses.

“The regulator is stepping into a high-stakes business issue, because off-label uses of prescription drugs are a mainstay of the industry — an estimated 21% of drug use overall, according to a 2006 analysis published in the Archives of Internal Medicine. Drug makers are generally expected to welcome the proposal because it clarifies a blurry legal area. At least under certain conditions, it promises a haven for a controversial promotional practice. It also contains an argument from the agency that may help the companies in court cases about marketing practices.”

Interestingly, the authors failed to mention that this really isn’t a new guideline at all. In fact, in the FDA press release and draft guidance, they gave the history and context for this proposed guideline which was enacted in 1997 and expired in 2006:

“Previously, Section 401 of the Food and Drug Administration Modernization Act set out guidelines that allowed the dissemination of information on unapproved uses of FDA-approved products. As long as the guidelines were met by the manufacturers, the dissemination of such materials was not viewed by the FDA as evidence of an intent to promote the product for an “off-label” use. However, Section 401 expired on Sept. 30, 2006.”

Furthermore, it gives very specific conditions that must be met, including detailed descriptions of the “types of reprints/articles/reference publications and the manner in which to disseminate scientific and medical information.” For example,

“Some of the principles include ensuring that the article or reference be published by an organization that has an editorial board. The organization also should fully disclose any conflicts of interest or biases for all authors, contributors or editors associated with the journal article. Articles should be peer-reviewed and published in accordance with specific procedures.”

However, the new guidelines omit some previously outlined safeguards. According to a Modern Healthcare article,

“[The previous FDA guidance] had required companies to submit medical journal articles in advance to the FDA and agree to file within three years a supplemental new drug application for the off-label use it wanted to promote. Yet, these important safeguards are nowhere to be found in the new proposed guidance, said Sidney Wolfe, director of Public Citizen’s Health Research Group, in a written statement.”

I believe that this is an important guideline that should be closely examined. The intent is to provide physicians with “truthful and non-misleading” information that can be used for evidence-based decision making. I would support this guideline with the appropriate safeguards in place to ensure patient safety and promote public health.

Feel free to send your own comments and suggestions to the FDA by April 15, 2008 to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Health Business Blog is a regular contributor to BioHealth Investor
__________________

Thursday's Top Medical & Biotech Stocks

2008-02-21T19:50:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PLURISTEM THERAPEUTC [PSTI] +19.83%
GTX, INC. [GTXI] +13.90%
BIONOVO INC [BNVI] +13.39%
NUVELO INC NEW [NUVO] +11.39%
EPIX PHARMACEUTICALS [EPIX] +7.95%

Diagnostic Substances

RESPONSE GENETICS, I [RGDX] +6.43%
NEOGEN CP [NEOG] +5.31%
TORREYPINES THERAPEU [TPTX] +4.15%
ICAGEN, INC. [ICGN] +3.97%
INTERLEUKIN GENETICS [ILI] +3.82%

Drug Delivery

ULURU INC [ULU] +5.22%
MATRIXX INITIATVS [MTXX] +4.12%
COLUMBIA LABS INC [CBRX] +1.78%
EMISPHERE TECH [EMIS] +1.06%
QUIGLEY CORP THE [QGLY] +0.37%

Drug Manufacturers

ELITE PHARMA INC [ELI] +6.09%
PHARMACYCLICS INC [PCYC] +4.27%
DEPOMED INC [DEPO] +3.98%
ANGIOTECH PHARMA I [ANPI] +3.88%
ALEXION PHARM INC [ALXN] +3.07%

Drug Related Products

SCHIFF NUTRIT INTL [WNI] +5.31%
DRAXIS HEALTH INC [DRAX] +4.46%
SALIX PHARM DEL [SLXP] +1.55%
NUTRACEUTICAL INTL [NUTR] +0.89%
NATURAL ALTERNATIV [NAII] +0.33%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +2.18%

Medical Appliances & Equipment

GIVEN IMAGING LTD [GIVN] +12.54%
CRYOLIFE INC [CRY] +11.82%
LECTEC CORP [LECT.OB] +9.52%
CYBERONICS INC [CYBX] +8.33%
PATIENT SAFETY TECH [PSTX.OB] +5.83%

Medical Instruments & Supplies

MILESTONE SCIENTIFIC [MLSS.OB] +8.91%
WEST PHARMA SVCS INC [WST] +7.96%
MESA LABS INC [MLAB] +5.63%
RETRACTABLE TECH INC [RVP] +5.59%
PROTHERICS PLC ADR [PTIL] +3.70%

Medical Laboratories & Research

MEDTOX SCIENTFIC INC [MTOX] +3.20%
PHARM PROD DEV [PPDI] +3.17%
RADNET INC [RDNT] +1.32%
PSYCHEMEDICS NEW [PMD] +1.22%
BIO-REFERENCE LAB [BRLI] +1.10%

- Wednesday's Top Biotech & Medical Stocks
- Tuesday's Top Biotech & Medical Stocks
___________________

BioMS Medical: Time to Take a Look?

2008-02-20T22:27:00.002-05:00

by Michael Shulman
BiotechBlitz

A couple of weeks back Eli Lilly (LLY) cut what seemed to be a very good deal with a Canadian company, BioMS (MS.TO) for rights to its multiple sclerosis (MS) drug in trial, MBP8298. Catchy name, eh? The stock did a Rodney Dangerfield and did not react. Should you?

On Dec. 17 LLY and BioMS announced a partnership where BioMS would complete development of an MS drug in two Phase III, late-stage trials, and one mid-stage, Phase II trial.

Lilly would get exclusive worldwide rights in return for an upfront payment of $87 million and milestones of $410 million, plus escalating royalties. The stock ran up a buck -- more than a third -- from $2.70 to $3.72, but the cash added to the company was worth a buck, so the enterprise value of the stock did not move. I know markets act strangely when stressed (as they are now) but it was still a weird market reaction.

The stock has begun to creep up -- it is trading around $4 -- but the validation provided by this sort of agreement and the late stage of the drug did not seem to affect investors. The agreement was approved by the Federal Trade Commission in late January

Should it have an affect you? I do not recommend or own the stock, but I thought it was worth a look -- and if the drug gets approved, the stock is a five-bagger, right out of the gate.

BiotechBlitz is a regular contributor to BioHealth Investor
________________

Wednesday's Top Medical & Biotech Stocks

2008-02-20T16:24:00.003-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

ENCYSIVE PHARMA [ENCY] +110.19%
NORTHWEST BIOTH NEW [NWBO.OB] +16.28%
INTROGEN THERAPEU [INGN] +12.88%
NUVELO INC NEW [NUVO] +7.48%
TRUBION PHARMACEUTIC [TRBN] +5.91%

Diagnostic Substances

REMOTEMDX INC [RMDX.OB] +15.00%
AVIGEN INC [AVGN] +7.43%
NEOGEN CP [NEOG] +4.35%
EPICEPT CORPORATION [EPCT] +4.03%
ASPENBIO PHARMA INC [APPY] +2.69%

Drug Delivery

EMISPHERE TECH [EMIS] +6.78%
FLAMEL TECH SA ADR [FLML] +1.94%
GENEREX BIOTECH CORP [GNBT] +1.49%
BIOVAIL CORP [BVF] +1.16%
ALKERMES INC [ALKS] +1.07%

Drug Manufacturers

OSCIENT PHARMACEUT [OSCI] +30.18%
CHINA YCT INTL GROUP [CYIG.OB] +22.22%
MIDDLEBROOK PHARMACL [MBRK] +15.54%
PHARMACYCLICS INC [PCYC] +11.43%
MINRAD INTL INC [BUF] +8.48%

Drug Related Products

TIENS BIOTECH GR USA [TBV] +6.34%
INTEGRATED BIOPHARMA [INBP] +5.30%
DRAXIS HEALTH INC [DRAX] +2.28%
NUTRACEUTICAL INTL [NUTR] +0.97%
PRESTIGE BRAND HLGS [PBH] +0.82%

Generic Drugs

PHARMACUTICAL CO [PRX] +4.44%
CARACO PHARMA LABS [CPD] +1.41%
MYLAN INC [MYL] +0.54%

Medical Appliances & Equipment

CYBERONICS INC [CYBX] +17.27%
ECHO THERAPEUTICS [ECTE.OB] +16.80%
ESCALON MED CP [ESMC] +10.53%
THERMOGENESIS CORP [KOOL] +7.59%
CYTOCORE INC [CYOE.OB] +6.06%

Medical Instruments & Supplies

EP MEDSYSTEMS INC [EPMD] +8.97%
CPC OF AMERICA INC [CPCF.OB] +6.09%
NUVASIVE, INC. [NUVA] +5.93%
MEDPRO SAFETY PD [MPSP.OB] +3.33%
NANOSPHERE, INC. [NSPH] +3.21%

Medical Laboratories & Research

NATL DENTEX CP [NADX] +6.68%
QUEST DIAGNOSTC [DGX] +3.04%
MEDTOX SCIENTFIC INC [MTOX] +2.94%
ALLIANCE IMAGING INC [AIQ] +2.31%
GENOPTIX, INC. [GXDX] +2.29%

- Tuesday's Top Biotech & Medical Stocks
- Friday's Top Biotech & Medical Stocks
___________________

New Public Relations and Public Affairs Challenge for FDA

2008-02-19T23:27:00.001-05:00

by Mark S. Senak
Eye On FDA

Last evening, CBS 60 Minutes ran an investigative report rather dramatically entitled "One Thousand Lives a Month" about the drug Trasylol, manufactured by Bayer for the control of bleeding in patients undergoing surgery. The title of the piece is derived from the estimation that the drug may have contributed to the death of 22,000 people, or 1,000 people a month, since the time when it was uncovered through a study that there was a signal that the drug might cause renal impairment or failure in patients. I say it was dramatically named because, in a piece about evidence-based decision making, CBS named the story by using a figure someone guessed at. But that is beside the point.

The investigation by CBS News alleges several damning aspects as to how the drug was approved, stayed on the market and how the FDA investigates safety. If you did not see the piece, don't worry, you will probably hear a lot about it in weeks and months to come and I would imagine that some you will be hearing talk about it will be members of Congress.

The allegations of the piece are far too complicated to detail here, as are the implications. However, part of the story involves an FDA Advisory Committee meeting in which the drug was reviewed for safety and that safety was supported by the Committee apparently because, the report says, the Committee did not know all that it needed to know about the studies done on the drug.

There were many aspects of the report that call into question FDA practices - that there is inadequate review for safety at the time of approval; that once a safety signal is detected, the agency takes too long to react; the level of regard to observational studies that raise the possibility of a safety signal; and that once it does react, it moves glacially and does not have the authority to ensure full disclosure and transparency.

The agency saw some action aimed at Congressional reform last year with the Food and Drug Administration Amendment Act (FDAAA). Surely a story such as this, is going to fuel a greater passion for much more radical reform of FDA, particularly as we head into this election cycle, and out of it. From the looks of it now, I'd say the chances are very high that some further significant reforms will be proposed, if not enacted and that will re-shape the way FDA investigates safety in the coming years in the same way that FDA was reshaped with FDAMA and PDUFA in the 1990's by the public outcry for increased access and swifter approvals. It is quite possible that the entire advisory committee structure might be reformed and new weight given to observational data, or at least to its regular collection and analysis.

Last night, FDA chose not to participate in the story and did not have a spokesperson to explain the agency's workings. That allowed the story to be formed in spite of them, without their input. I'm not questioning the judgment of the agency with regard to that, but in the coming months, the agency needs to think long and hard about how it is going to shape the debate to come, or be willing to allow the debate to re-shape the agency.

Sorry about the lack of posting last week, by the way. I have been under the weather of late.

Eye On FDA is a regular contributor to BioHealth Investor
_____________

Tuesday's Top Biotech & Medical Stocks

2008-02-19T18:09:00.003-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

CELL GENESYS INC [CEGE] +19.92%
ARTES MEDICAL, INC. [ARTE] +11.44%
ANTIGENICS INC [AGEN] +10.43%
FAVRILLE, INC. [FVRL] +7.14%
REXAHN PHARMACEUTICL [RXHN.OB] +6.71%

Diagnostic Substances

QUIDEL CP [QDEL] +12.65%
LEXICON PHARMACEUTCL [LXRX] +6.77%
TORREYPINES THERAPEU [TPTX] +4.74%
ROSETTA GENOMICS LTD [ROSG] +3.96%
INTERLEUKIN GENETICS [ILI] +3.57%

Drug Delivery

ACURA PHARMACEUTICAL [ACUR] +5.81%
QUIGLEY CORP THE [QGLY] +2.99%
ARADIGM CORP [ARDM.OB] +2.27%
DELCATH SYSTEMS INC [DCTH] +1.76%
NOVEN PHARMACEUTIC [NOVN] +1.64%

Drug Manufacturers

PROTALEX INC [PRTX.OB] +9.09%
MAP PHARMACEUTICALS, [MAPP] +8.76%
APP PHARMACEUT [APPX] +8.37%
ADOLOR CORP [ADLR] +8.00%
INSPIRE PHARMACEUT [ISPH] +6.23%

Drug Related Products

INTEGRATED BIOPHARMA [INBP] +5.60%
SALIX PHARM DEL [SLXP] +2.89%
MANNATECH INC [MTEX] +2.16%
NUTRACEUTICAL INTL [NUTR] +2.14%
PRESTIGE BRAND HLGS [PBH] +0.68%

Generic Drugs

WATSON PHARMACEUTCLS [WPI] +1.36%
BARR PHARMA INC [BRL] +0.86%
CATALYST PHARMACEUTI [CPRX] +0.62%

Medical Appliances & Equipment

LECTEC CORP [LECT.OB] +31.43%
CONSORTIUM SVC MGT [CTUM.OB] +14.29%
WORLD HEART CORP [WHRT] +13.42%
VISION SCIENCES IN [VSCI] +7.05%
CRITICARE SYS INC [CMD] +6.89%

Medical Instruments & Supplies

IMPLANT SCIENCES CP [IMX] +13.63%
NUCRYST PHARMACEUTIC [NCST] +9.47%
STRATEGIC DIAGNOST [SDIX] +7.17%
OCULUS INNOVATIVE SC [OCLS] +6.77%
DEXCOM [DXCM] +6.12%

Medical Laboratories & Research

SPHERIX INC [SPEX] +5.36%
ARRAY BIOPHARMA IN [ARRY] +3.39%
NATL DENTEX CP [NADX] +2.95%
PHARM PROD DEV [PPDI] +2.35%
ALLIANCE IMAGING INC [AIQ] +0.87%

- Friday's Top Biotech & Medical Stocks
- Thursday's Top Biotech & Medical Stocks
___________________

Friday's Top Biotech & Medical Stocks

2008-02-15T16:29:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

CELL GENESYS INC [CEGE] +19.80%
ONCOTHYREON [ONTY] +12.65%
OSTEOLOGIX INC [OLGX.OB] +7.69%
PDL BIOPHARMA INC [PDLI] +7.50%
REXAHN PHARMACEUTICL [RXHN.OB] +7.10%

Diagnostic Substances

HUMAN GENOME SCI [HGSI] +4.79%
GENELABS TECH INC [GNLB] +3.36%
SCOLR PHARMA INC [DDD] +1.59%
ORCHID CELLMARK INC [ORCH] +1.40%
ISTA PHARMACTLS [ISTA] +0.89%

Drug Delivery

DELCATH SYSTEMS INC [DCTH] +3.03%
HOSPIRA INC [HSP] +0.78%
ARADIGM CORP [ARDM.OB] +0.76%
BIOVAIL CORP [BVF] +0.36%
QUIGLEY CORP THE [QGLY] +0.19%

Drug Manufacturers

SOMAXON PHARMACEUTIC [SOMX] +18.63%
GAMMA PHARMACEUTICAL [GMPM.OB] +14.29%
VYREX CORP DE NEW [VYXC.OB] +12.50%
OSCIENT PHARMACEUT [OSCI] +7.69%
PHARMACYCLICS INC [PCYC] +6.80%

Drug Related Products

N B T Y INC [NTY] +3.86%
PRESTIGE BRAND HLGS [PBH] +2.52%
MEDICAL NUTRITN USA [MDNU] +1.80%
NATURAL ALTERNATIV [NAII] +0.66%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +3.20%
HELICOS BIOSCIENCES [HLCS] +0.65%
MYLAN INC [MYL] +0.15%
BARR PHARMA INC [BRL] +0.12%

Medical Appliances & Equipment

CAMBRIDGE HEART INC [CAMH.OB] +28.04%
MB SOFTWARE CORP [MBSB.OB] +26.67%
PATIENT SAFETY TECH [PSTX.OB] +18.81%
AMER MED SYS HLDG [AMMD] +13.41%
CRITICARE SYS INC [CMD] +7.98%

Medical Instruments & Supplies

NUCRYST PHARMACEUTIC [NCST] +18.74%
IMPLANT SCIENCES CP [IMX] +8.82%
ISORAY INC [ISR] +8.34%
PRO-DEX INC NEW [PDEX] +8.23%
RETRACTABLE TECH INC [RVP] +2.86%

Medical Laboratories & Research

ALLIANCE IMAGING INC [AIQ] +1.98%
QUEST DIAGNOSTC [DGX] +1.71%
BIO-IMAGING TECH [BITI] +1.44%
ERESEARCHTECHNOLOG [ERES] +1.24%
GENOPTIX, INC. [GXDX] +1.23%

- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
___________________

Baxter’s Heparin Problems May Have China Connection

2008-02-14T22:53:00.001-05:00

by Richard Daverman, PhD
ChinaBio Today

Baxter’s (NYSE: BAX) heparin product, lately in the news because of recent side-effect problems, sourced its active pharmaceutical ingredient from a US supplier who, in turn, manufactured the drug in a China subsidiary. Even worse, the FDA was supposed to inspect the subsidiary, but some snafu prevented the inspection from ever taking place.

It’s not surprising that the manufacturing plant hasn’t received an FDA visit: only 7% of overseas pharma manufacturing plants whose products end up in the US will see an FDA inspector in any given year. It would take about 14 years for each plant to be inspected – if there were no additions to the roster of overseas facilities. Given the number of additions and deletions to the list, it would take considerably longer.

So far in 2008, the FDA has received 350 reports of problems that may have been caused by Baxter’s heparin, a blood thinner that has been in use since the 1930s. Of the 350 incidents, 40% were termed serious, such as septic shock, and there are four deaths associated with the drug, though the causal link has not been definitively established.

In response to the side-effect outbreak, Baxter several weeks ago recalled nine lots of multi-dose injected heparin, but that remedy did not contain the problem. On Tuesday, the company suspended use of all its vials of multi-dose injected heparin, though the single-dose injected forms of the drug remain on the market. Baxter supplies about 50% of the heparin used in the US, making shortages a possibility.

At the moment, neither Baxter nor the FDA knows for certain that the China facility caused the problem. Baxter says it made an inspection of the plant within the last six months and found nothing amiss.

Baxter did not release the name of the owner of the facility, which was located near Shanghai.

The side effects of pharmaceuticals and active pharmaceutical ingredients imported from China was a big story in 2007. Lately, the news flow has included more items about treaties between the US and China and stationing inspectors in China (and other countries) to prevent similar problems from occurring, putting a more positive spin on the ongoing story. However, with this incident, the fears move back to the forefront.

ChinaBio Today is a regular contributor to BioHealth Investor
_____________

Thursday's Top Biotech & Medical Stocks

2008-02-14T16:31:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

IDM PHARMA INC [IDMI] +37.67%
ONCOTHYREON [ONTY] +18.68%
IMMUNOSYN CORPORATIN [IMYN.OB] +11.11%
GENETIC TECH SPON [GENE] +10.22%
PLURISTEM THERAPEUTC [PSTI] +9.20%

Diagnostic Substances

INTERLEUKIN GENETICS [ILI] +13.49%
IMARX THERAPEUTICS [IMRX] +9.57%
ASPENBIO PHARMA INC [APPY] +9.23%
NEOGEN CP [NEOG] +3.82%
IMMUNOMEDICS INC [IMMU] +2.97%

Drug Delivery

ULURU INC [ULU] +9.27%
ARADIGM CORP [ARDM.OB] +6.50%
GENEREX BIOTECH CORP [GNBT] +0.74%
DELCATH SYSTEMS INC [DCTH] +0.61%
NOVEN PHARMACEUTIC [NOVN] +0.15%

Drug Manufacturers

VYREX CORP DE NEW [VYXC.OB] +53.85%
MARSHALL EDWARDS [MSHL] +10.87%
CEPHALON INC [CEPH] +6.93%
NOVOGEN LTD ADS [NVGN] +4.77%
MIDDLEBROOK PHARMACL [MBRK] +3.31%

Drug Related Products

INTEGRATED BIOPHARMA [INBP] +1.87%
DRAXIS HEALTH INC [DRAX] +1.72%

Generic Drugs

WATSON PHARMACEUTCLS [WPI] +6.12%

Medical Appliances & Equipment

MEDICALCV INC [MCVI.OB] +6.82%
THERAGENICS CORP [TGX] +6.22%
SHAMIR OPTICAL INDUS [SHMR] +6.09%
NEWCARDIO, INC. [NWCI.OB] +4.95%
CAMBRIDGE HEART INC [CAMH.OB] +4.90%

Medical Instruments & Supplies

ADVANCED MED OPTICS [EYE] +9.55%
EP MEDSYSTEMS INC [EPMD] +4.87%
NMT MEDICAL INC [NMTI] +4.62%
MESA LABS INC [MLAB] +3.87%
OCULUS INNOVATIVE SC [OCLS] +3.60%

Medical Laboratories & Research

NATL DENTEX CP [NADX] +6.58%
BIO-IMAGING TECH [BITI] +6.40%
SPHERIX INC [SPEX] +2.78%
PHARM PROD DEV [PPDI] +1.38%
PSYCHEMEDICS NEW [PMD] +1.17%

- Wednesday's Top Biotech & Medical Stocks
- Tuesday's Top Biotech & Medical Stocks
___________________

Find and Treat Coronary Artery Disease with Bayer’s Medrad-Possis Posse

2008-02-13T22:46:00.002-05:00

by Doug Cress
Med Tech Sentinel

Bayer Healthcare (BAY.DE) affiliate Medrad and Minneapolis, MN-based Possis Medical (POSS) have entered into a definitive merger agreement whereby Medrad will acquire Possis for $19.50 a share, or $361 million.

The merger will capitalize on each company’s strengths to create a synergistic cardiovascular portfolio and sales force.

The offer represents a premium of approximately 39% over Possis’ recent share price.

Medrad develops contrast injection systems used to diagnose cardiovascular and other diseases. The company’s diagnostic imaging product line includes vascular injection systems, magnetic resonance surface coils and patient care products. Revenues are also generated through the sale of disposables; primarily, high pressure, large volume syringes used with Medrad and third party injection systems. Medrad revenues totaled $478 million in 2006.

Possis develops mechanical thrombectomy devices that use waterjet technology to remove blood clots from arteries and veins, as well as from synthetic and saphenous vein grafts. The company’s primary product, AngioJet, is the only mechanical thrombectomy device approved for the coronary vasculature. Over 300,000 patients worldwide have been treated with AngioJet therapy. The recently launched the AngioJet Ultra, an easier-to-use system, has been a key growth driver over the last four quarters.

The proposed combination will join two “highly compatible” sales organizations that can target the same customers, potentially expanding the reach of both companies. Medrad’s international distribution infrastructure will allow Possis’ thrombectomy portfolio to gain marketshare in - what the company describes as - largely underpenetrated international markets. International sales accounted for only 3% percent of Possis’ $66.7 million in revenues last year.

The complimentary focus on high pressure intravascular fluid management will create a broadened base for the development of new products.

“This merger will capitalize on both companies’ strengths to deliver growth in our current markets, and create a formidable cardiovascular portfolio in the future. It is a truly compatible partnership in terms of product performance, company growth and employee culture.” said John P. Friel, Medrad President and CEO.

Med Tech Sentinel is a regular contributor to BioHealth Investor
________________

Wendesday's Top Biotech & Medical Stocks

2008-02-13T16:21:00.002-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

RENOVIS INC [RNVS] +18.18%
CHAMPIONS BIOTECHNLG [CSBR.OB] +16.36%
TRUBION PHARMACEUTIC [TRBN] +15.42%
ACORDA THERAPEUTICS [ACOR] +14.62%
AMICUS THERAPEUTICS, [FOLD] +13.87%

Diagnostic Substances

ABAXIS INC [ABAX] +5.50%
AVALON PHARMACEUTIC [AVRX] +4.84%
AKORN INC [AKRX] +4.79%
ISTA PHARMACTLS [ISTA] +4.50%
EPICEPT CORPORATION [EPCT] +4.32%

Drug Delivery

ULURU INC [ULU] +7.36%
DELCATH SYSTEMS INC [DCTH] +6.49%
COLUMBIA LABS INC [CBRX] +3.69%
NOVEN PHARMACEUTIC [NOVN] +3.52%
MATRIXX INITIATVS [MTXX] +3.18%

Drug Manufacturers

SIGA TECH INC [SIGA] +23.35%
MINRAD INTL INC [BUF] +19.83%
NEUROGEN CP [NRGN] +12.87%
VERTEX PHARMACEUT [VRTX] +11.67%
GAMMA PHARMACEUTICAL [GMPM.OB] +9.09%

Drug Related Products

LABOPHARM INC. [DDSS] +14.67%
TIENS BIOTECH GR USA [TBV] +5.45%
SALIX PHARM DEL [SLXP] +4.75%
XELR8 HOLDINGS, INC [BZI] +1.90%
NUTRACEUTICAL INTL [NUTR] +1.45%

Generic Drugs

PHARMACUTICAL CO [PRX] +2.05%
WATSON PHARMACEUTCLS [WPI] +1.94%
BARR PHARMA INC [BRL] +1.56%
CARACO PHARMA LABS [CPD] +1.32%
MYLAN INC [MYL] +0.54%

Medical Appliances & Equipment

MB SOFTWARE CORP [MBSB.OB] +27.59%
VOLCANO CORPORATION [VOLC] +17.38%
ECHO THERAPEUTICS [ECTE.OB] +12.07%
SONIC INNOVATIONS [SNCI] +9.95%
SYNERON MEDICAL LTD. [ELOS] +9.48%

Medical Instruments & Supplies

ENDOLOGIX INC [ELGX] +10.07%
CHINA MEDICAL TECH [CMED] +8.06%
DEXCOM [DXCM] +6.42%
ANGIODYNAMICS INC [ANGO] +6.38%
VITAL SIGNS INC [VITL] +6.17%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +6.26% $33.5 M
ALLIANCE IMAGING INC [AIQ] +4.83% $531.8 M
GENOPTIX, INC. [GXDX] +4.20% $0
RADNET INC [RDNT] +3.41% $0
ENZO BIOCHEM INC [ENZ] +3.04%

- Tuesday's Top Biotech & Medical Stocks
- Monday's Top Biotech & Medical Stocks
___________________

Fourth Quarter 2007 FDA Warning Letters

2008-02-12T22:40:00.003-05:00

by Mark S. Senak
Eye On FDA

The pathetic rate of enforcement by CDER continues. I am so stymied why some smart reporter hasn't posed the question - what is happening when the amount of PDUFA dollars and money in the federal budget for FDA goes up, and the rates of enforcement continue to go down?

During the last quarter of 2007, CDER's DDMAC issued a total of 4 - count 'em 4 letters that were focused on promotion and not a result of inspections. This results in a total for the year 19 - a record low by my count and anemic when compared to a decade ago.

# OF DDMAC WARNING LETTERS

2007: 19

2006: 22

2005: 29

2004: 23

2003: 25

2002: 28

2001: 64

2000: 75

1999: 108

1998: 156

1997: 139

Looking briefly at the letters:

Two large companies and two not-so-large companies received letters.

- In November GlaxoSmithKline (GSK) received a Warning Letter regarding promotional materials for Tykerb - a treatment for patients with advanced or metastatic breast cancer that has not responded to other treatments and that overexpresses HER2. The material in question involved three Dear Healthcare Practitioner letters issued on connection with the launch campaign for the drug. DDMAC found that they were misleading and minimized important risk information. The FDA found that the letters actually omitted important risk information. The agency also found an overstatement of efficacy because the description of efficacy did not include the range described in the package insert.

- Scios Inc., the maker of Natrecor, received an untitled letter in November where the focus was an attempt at "reminder labeling" which is exempt from risk information requirements. Natrecor treats congestive heart failure. The agency found that the attempt at reminder labeling failed and therefore the communications vehicles in question (a mouse pad and pen) did violate regulations by not containing indication and risk information. Here, the interesting basis for the letter is the fact that the mousepad displayed a patient deep in water and even though the indication was not stated, the agency felt that "the image evokes the concept of a sedentary hospital patient drowning...suggests that Natrecor is indicated for seriously ill patients who have difficulty breathing while at rest because of fluid accumulation in the lungs, a suggestion that is consistent with Natrecor's indication..." Combined with the logo, FDA felt that this was promoting an indication beyond the boundaries of a "reminder" promotion. The lesson here is to look closely at what is being conveyed by the images used to ensure the reminder at is merely reminder and not suggesting indication.

- Morton Grove Pharmaceuticals received a Warning Letter in December for promotional pieces for Lindane Shampoo, indicated as a second line treatment for head lice, on web sites. The package insert contains a boxed warning. The Warning Letter stated that the web sites minimized, and in some cases failed to state risk information, which according to the boxed warning, was considerable. The lesson here is that products with boxed warnings should go to extra lengths to state them in promotional materials.

- Lastly, Wyeth (WYE) received a Warning Letter in December for a professional journal advertisement for Effexor XR. There were several problems here, involving an overstatement of efficacy for using studies that the agency did not feel substantiated claims made in the ad, and in addition, the ad had language that said over 20 million patients had been treated with Effexor XR, which the agency felt was misleading since the data was based on estimates of daily average consumption and did not reflect "unique patients" which could infer greater efficacy and safety.

All in all, an interesting batch of letters, especially respecting the reminder ad.

Eye On FDA is a regular contributor to BioHealth Investor
________________

Tuesday's Top Biotech & Medical Stocks

2008-02-12T16:35:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

DYAX CORP [DYAX] +20.79%
ONCOTHYREON [ONTY] +12.12%
ZIOPHARM ONCOLOGY IN [ZIOP] +9.44%
VANDA PHARMACEUTICAL [VNDA] +9.11%
EPIX PHARMACEUTICALS [EPIX] +7.72%

Diagnostic Substances

HUMAN GENOME SCI [HGSI] +5.40%
AVALON PHARMACEUTIC [AVRX] +4.20%
MONOGRAM BIOSCIENCES [MGRM] +4.14%
IMMUCOR INC [BLUD] +3.78%
REMOTEMDX INC [RMDX.OB] +3.33%

Drug Delivery

PENWEST PHARM CO [PPCO] +3.83%
FLAMEL TECH SA ADR [FLML] +3.74%
GENEREX BIOTECH CORP [GNBT] +2.98%
NOVEN PHARMACEUTIC [NOVN] +2.91%
COLUMBIA LABS INC [CBRX] +2.84%

Drug Manufacturers

DEPOMED INC [DEPO] +14.07%
VALEANT PHARMA INTL [VRX] +13.93%
AVANIR PHARMACEUTICL [AVNR] +10.71%
PANTERA PETROLEUM [PTPE.OB] +9.35%
AVI BIOPHARMA INC [AVII] +8.46%

Drug Related Products

AUXILIUM PHARMACEUT [AUXL] +5.77%
PRESTIGE BRAND HLGS [PBH] +3.92%
CHINA SHENGHUO PHARM [KUN] +2.81%
N B T Y INC [NTY] +2.21%
SALIX PHARM DEL [SLXP] +2.03%

Generic Drugs

PHARMACUTICAL CO [PRX] +3.15%
WATSON PHARMACEUTCLS [WPI] +2.06%
CARACO PHARMA LABS [CPD] +0.79%
HELICOS BIOSCIENCES [HLCS] +0.38%
MYLAN INC [MYL] +0.08%

Medical Appliances & Equipment

CONSORTIUM SVC MGT [CTUM.OB] +16.25%
SYNERON MEDICAL LTD. [ELOS] +10.78%
NATUS MEDICAL INC [BABY] +7.80%
CUTERA, INC. [CUTR] +2.74%
SYNOVIS LIFE TECH [SYNO] +2.55%

Medical Instruments & Supplies

ENCISION INC [ECI] +11.65%
ANGEION CORP [ANGN] +9.97%
BIOMERICA INC [BMRA.OB] +7.27%
CONCEPTUS INC [CPTS] +5.47%
OCULUS INNOVATIVE SC [OCLS] +4.59%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +7.81%
ARRAY BIOPHARMA IN [ARRY] +6.04%
BIO-REFERENCE LAB [BRLI] +5.06%
ALLIANCE IMAGING INC [AIQ] +3.50%
ERESEARCHTECHNOLOG [ERES] +3.34%

- Monday's Top Biotech & Medical Stocks
- Friday's Top Biotech & Medical Stocks
____________________

A Closer Look at Accuray

2008-02-11T21:39:00.000-05:00

by Michael Shulman
BiotechBlitz

If enough people ask you a question, you should go out and find the answer.
A few days ago I finished giving seminars at the Money Show in Orlando and four people asked me about a company I do not follow or recommend, Accuray (ARAY). After reading some and talking to others, I am still not recommending it in my service but thought you might want to take a look, in part because it was recently crushed when it reduced revenue estimates for 2008.

Accuray makes several products but its leader and growth engine is CyberKnife Robotic Radiosurgery System, used to directly target cancer tumors with narrow and powerful doses of radiation. Sales doubled in Q4, year over year, for the company but a few days ago the company reduced sales estimates for 2008 to $210 million -$230 million from $250 million-$270 million. ARAY blamed tightened credit conditions, specifically as they apply to cancer and radiation treatment centers, for slowing growth. It also earned about four cents a share.

There are two ways to look at this explanation:

First, if true, then these centers are overextended, which means there are too many of them and sales were going to slow to this segment sooner rather than later.

Reimbursement rates are too low -- probably driven by traditional radiation treatment, creating margins too low to generate the profits needed to keep credit ratings up. This situation, however, can be fixed with new reimbursement rates based on clinical data showing the treatments are more effective -- which they are for many.

The stock was crushed on the pullback in forecasts, lemming analysts reduced their ratings, and the stock, although it sports a very high P/E, (more than 50) has a modest P/S (less than 3) given the sector -- medical devices.

Bottom line: at a minimum, this is a company to watch -- despite competition from industry heavyweight Varian Medical Systems (VAR), a terrific outfit. I am waiting -- I am going to ask the ChangeWave survey group to put together a survey on what is going on inside treatment and surgical centers and we may find out more about Accuray. I do not currently own any stock in this company.

A quick note: I have been unusually busy and the market unusually ugly, prompting me to reduce the frequency of articles. They will pick up again this week. Send me an e-mail at mshulman@changewave.com if something interests you.

BioHealthInvestor.com
____________________

Monday's Top Biotech & Medical Stocks

2008-02-11T17:33:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

IDM PHARMA INC [IDMI] +19.05%
NORTHWEST BIOTH NEW [NWBO.OB] +16.84%
CARDIOVASCULAR BIOTH [CVBT.OB] +14.05%
DISCOVERY LABS INC [DSCO] +13.78%
KOSAN BIOSCIENCES [KOSN] +11.50%

Diagnostic Substances

SYNTA PHARMACEUTICAL [SNTA] +13.25%
INTERLEUKIN GENETICS [ILI] +11.01%
IMMUCELL CP [ICCC] +6.08%
QUIDEL CP [QDEL] +4.99%
ISTA PHARMACTLS [ISTA] +4.48%

Drug Delivery

PENWEST PHARM CO [PPCO] +2.62% $264.2 M
FLAMEL TECH SA ADR [FLML] +2.48% $403.4 M
PETMED EXPRESS INC [PETS] +2.14% $165.1 M
ARADIGM CORP [ARDM.OB] +0.82% $80.3 M
GENEREX BIOTECH CORP [GNBT] +0.75%

Drug Manufacturers

OSCIENT PHARMACEUT [OSCI] +20.00%
AVI BIOPHARMA INC [AVII] +19.27%
ELITE PHARMA INC [ELI] +18.26%
ACCESS PHARMACEUTICL [ACCP.OB] +5.00%
KERYX BIOPHARM INC [KERX] +4.55%

Drug Related Products

LABOPHARM INC. [DDSS] +15.52%
XELR8 HOLDINGS, INC [BZI] +3.88%
CHINA SHENGHUO PHARM [KUN] +3.49%
NUTRACEUTICAL INTL [NUTR] +2.90%
SALIX PHARM DEL [SLXP] +2.73%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +1.47%
PHARMACUTICAL CO [PRX] +1.04%

Medical Appliances & Equipment

POSSIS MEDICAL INC [POSS] +34.91%
VISION SCIENCES IN [VSCI] +17.35%
CRITICARE SYS INC [CMD] +12.57%
ARTHROCARE CP [ARTC] +11.37%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +10.28%

Medical Instruments & Supplies

ENDOLOGIX INC [ELGX] +6.69%
VASOGEN INC [VSGN] +5.91%
ENCISION INC [ECI] +5.64%
ARISTOTLE CP [ARTL] +5.48%
MESA LABS INC [MLAB] +4.90%

Medical Laboratories & Research

MEDTOX SCIENTFIC INC [MTOX] +0.92%
ENZO BIOCHEM INC [ENZ] +0.74%
LABORATORY CORP NEW [LH] +0.14%

- Friday's Top Biotech & Medical Stocks
- Thursday's Top Biotech & Medical Stocks
____________________

Allergan Plunge on FDA BOTOX Review Unwarranted

2008-02-10T18:45:00.000-05:00

by H.S. Ayoub, DMD
BioHealth Investor

Shares of Allergan (AGN) plunged almost 6% on Friday following an announcement by the FDA that the agency launched a safety review of the company's flagship product, BOTOX, and Solstice Neuroscience's competing product Myobloc. Shares of Medicis (MRX), which is investigating a potential competing product through clinical trials, also dropped on Friday in sympathy.

As usual, Wall Street traders, whose majority do not know what chromosomes are, let alone the actual link between botulinism toxin and BOTOX, have over-reacted to mundane news; a common event with biotech stocks. What is even more common is the incident that spurred on the over-reaction; the FDA continues to monitor drugs long after approval, especially off-label use.

BOTOX has been used since 1995 in children suffering from cerebral palsy as a muscle relaxer, since these children tend to suffer from debilitating muscle spasms. For cosmetic reasons in adults about 20 to 50 units of BOTOX are used, while in children with cerebral palsy 700 units is not unusual.

What the FDA found was a slightly elevated risk of death in children receiving the BOTOX for such an indication. So what the agency wanted to do was force Allergan to use a warning label to describe these risks to doctors performing the procedure. That is it. The FDA does not have an issue with BOTOX as a cosmetic product, which is the bulk of Allergan's revenue. BOTOX has been cleared in many countries, including the EU and Canada for in children with cerebral palsy. It is only the FDA, which is usually the case with pharmaceuticals, that has not cleared the way.

I would take that 6% discount on Allergan stock all the way to the bank. The company reported last week that sales of Botox rose 24% to $339.8 million in the fourth quarter, and estimated 2008 sales will reach $1.37 billion to $1.42 billion.

If those numbers don't sway you, then this might; I am a dentist and was certified just 3 months ago in cosmetic treatment using BOTOX. Dentists, and other medical professionals, are increasingly adopting BOTOX programs in their practices, a sign that Allergan, and traders alike, have nothing to worry about.

BioHealthInvestor.com
_______________________

Friday's Top Biotech & Medical Stocks

2008-02-08T16:22:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

ARTES MEDICAL, INC. [ARTE] +17.26%
IMMUNOSYN CORPORATIN [IMYN.OB] +12.50%
MICROMET INC [MITI] +10.19%
OPEXA THERAPEUTICS [OPXA] +9.89%
CORCEPT THERAPEUTICS [CORT] +9.89%

Diagnostic Substances

CNS RESPONSE, INC. [CNSO.OB] +51.72%
MONOGRAM BIOSCIENCES [MGRM] +9.45%
TORREYPINES THERAPEU [TPTX] +9.22%
EPICEPT CORPORATION [EPCT] +6.02%
GENELABS TECH INC [GNLB] +4.62%

Drug Delivery

BIOVAIL CORP [BVF] +2.69%
ELAN CP PLC ADR [ELN] +2.19%
COLUMBIA LABS INC [CBRX] +1.91%
ARADIGM CORP [ARDM.OB] +1.67%
QUIGLEY CORP THE [QGLY] +1.50%

Drug Manufacturers

OSCIENT PHARMACEUT [OSCI] +13.64%
UNIGENE LABS INC [UGNE.OB] +9.04%
MIDDLEBROOK PHARMACL [MBRK] +9.00%
ARYX THERAPEUTICS, I [ARYX] +8.71%
SUPERGEN INC [SUPG] +6.62%

Drug Related Products

LABOPHARM INC. [DDSS] +17.17%
MEDICAL NUTRITN USA [MDNU] +6.06%
PERRIGO COMPANY [PRGO] +3.14%
NATURAL ALTERNATIV [NAII] +1.80%
SALIX PHARM DEL [SLXP] +1.14%

Generic Drugs

HELICOS BIOSCIENCES [HLCS] +12.07%
HI-TECH PHARMACAL [HITK] +1.56%
CATALYST PHARMACEUTI [CPRX] +0.60%

Medical Appliances & Equipment

VNUS MEDICAL TECHNOL [VNUS] +25.70%
VISION SCIENCES IN [VSCI] +9.33%
DIGIRAD CORPORATION [DRAD] +7.69%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +6.62%
ESCALON MED CP [ESMC] +6.41%

Medical Instruments & Supplies

KENSEY NASH CP [KNSY] +5.07%
VITAL SIGNS INC [VITL] +4.72%
BIOMERICA INC [BMRA.OB] +4.55%
ALPHATEC HOLDINGS [ATEC] +4.45%
BOVIE MEDICAL CORP [BVX] +4.35%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +2.91%
SPHERIX INC [SPEX] +2.70%
LABORATORY CORP NEW [LH] +1.74%
MEDTOX SCIENTFIC INC [MTOX] +0.31%
PSYCHEMEDICS NEW [PMD] +0.29%

- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
____________________

Juvaris BioTherapeutics: Colorado Roots

2008-02-08T07:17:00.000-05:00

by Adam Rubenstein
CLSDF

For those of you who do not know…Steven Dow, DVM, Ph.D., is the Founder and Chief Scientific Advisor of Juvaris Biotherapeutics. Dr. Dow currently serves as Associate Professor in the Departments of Clinical Sciences and Pathology in the College of Veterinary Medicine at Colorado State University and prior to that was an instructor and research scientist at the National Jewish Medical and Research Center.

Juvaris BioTherapeutics was created in 2003 to develop an immunotherapeutic product platform for the treatment of infectious diseases and cancers using lipid-DNA complexes. Cationic lipids are formulated with non-coding DNA (plasmid) to create the JuvImmune Immunostimulant, a lipid-DNA complex, which as a single product may have utility in multiple infectious disease and cancer applications. When combined with disease-specific antigens, the technology creates JuvaVax vaccines capable of activating substantial antibody- and cell-mediated immune responses, particularly induction of cytotoxic T lymphocytes. Immunological responses elicited by the lipid-DNA complexes have been successfully demonstrated in both prophylactic and therapeutic settings in a variety of mammals including rodents, rabbits, cats, dogs and non-human primates. Moreover, substantial immune responses have been induced following oral and intranasal administration.

The lead vaccine products are for influenza and pneumonia and the company is also pursuing immunotherapy products for Hepatitis B and Biodefense applications. Approximately 12 months ago Juvaris closed a $6M Series A financing with Kleiner Perkins Caufield & Byers out of their Pandemic & Biodefense fund.

So I put it to you, sophisticated readers of CLSDF, as Juvaris has subsequently set up shop with their headquarters and manufacturing facilities in Pleasanton, CA should CLSDF continue to cover and report on their progress? Or is Juvaris beyond the scope of CLSDF? Please leave your thoughts on the comments link below. Thank you!

CLSDF is a regular contributor to BioHealth Investor
_________________

China Shenghuo to Bring TCM-based Cosmetics to US

2008-02-07T18:51:00.000-05:00

by Richard Daverman, PhD
ChinaBio Today

China Shenghuo Pharmaceutical Holdings, Inc. (KUN) will begin marketing its new 12Ways® Skin Care products in the US during Q1 of 2008 on the Home Shopping TV Network. China Shenghuo introduced the cosmetics line in September 2007 in China.

Home Shopping Network will feature a kit of five of the thirty-four 12Ways products as a way of introducing the cosmetics line to the US. The 12Ways line is based on a traditional Chinese medicine called Sanchi. Sanchi, a root that resembles Ginseng, is grown only in a very few places in China in the Yunnan and Guangxi provinces.

Sanchi is also the main ingredient for Xuesaitong Soft Capsules, China Shenghuo’s chief product. Xuesaitong Soft Capsules is used to promote blood circulation and is indicated for cardiovascular, cerebrovascular and peptic ulcer disease. It provided 80% of China Shenghuo’s revenues in 2006.

China Shenghuo owns the rights to thirty-one SFDA approved products. Xuesaitong Soft Capsules, which are listed in the state insurance catalogue, are also exported to other Asian countries.

The shares of China Shenghuo have been very volatile since their June 2007 IPO. As we mentioned at the time, the size of the IPO – 400,000 shares – was very small. Priced at $3.50 initially, the shares zoomed to a high of $15 in September 2007. They have since given up most of their gains, and the stock is now trading at $5.26, a gain of 22 cents on the session. At this price, the company has a market capitalization of $103.5 million.

ChinaBio Today is a regular contributor to BioHealth Investor
______________

Thursday's Top Biotech & Medical Stocks

2008-02-07T18:38:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

OCTILLION CORP NEW [OCTL.OB] +15.11%
MEDICINOVA, INC. [MNOV] +10.15%
REPROS THERAPEUTICS [RPRX] +9.91%
EURAND N.V. [EURX] +8.89%
KOSAN BIOSCIENCES [KOSN] +8.52%

Diagnostic Substances

IMMUCELL CP [ICCC] +9.97%
INTERLEUKIN GENETICS [ILI] +8.85%
NYMOX PHARM CORP [NYMX] +6.07%
ABAXIS INC [ABAX] +5.93%
SYNTA PHARMACEUTICAL [SNTA] +4.80%

Drug Delivery

FLAMEL TECH SA ADR [FLML] +7.52%
PETMED EXPRESS INC [PETS] +4.48%
BENTLEY PHARMACEUTIC [BNT] +3.29%
ALKERMES INC [ALKS] +2.55%
NOVEN PHARMACEUTIC [NOVN] +2.26%

Drug Manufacturers

GAMMA PHARMACEUTICAL [GMPM.OB] +33.33%
NEUROCHEM INC [NRMX] +10.78%
PHARMASSET INC. [VRUS] +9.80%
ACCESS PHARMACEUTICL [ACCP.OB] +8.70%
MARSHALL EDWARDS [MSHL] +7.98%

Drug Related Products

MANNATECH INC [MTEX] +9.02%
PRESTIGE BRAND HLGS [PBH] +5.53%
USANA HEALTH SCIEN [USNA] +4.50%
INTEGRATED BIOPHARMA [INBP] +4.49%
CHINA SHENGHUO PHARM [KUN] +3.19%

Generic Drugs

CARACO PHARMA LABS [CPD] +5.33%
HI-TECH PHARMACAL [HITK] +3.31%
PHARMACUTICAL CO [PRX] +1.97%

Medical Appliances & Equipment

CRYOLIFE INC [CRY] +20.44%
VISION SCIENCES IN [VSCI] +18.25%
SRI/SURGICAL EXPRE [STRC] +11.97%
CONMED CP [CNMD] +11.92%
BIOFORM MEDICAL, INC [BFRM] +8.29%

Medical Instruments & Supplies

ALCON INC [ACL] +10.04%
MEMRY CORPORATION [MRY] +7.14%
ALPHATEC HOLDINGS [ATEC] +5.64%
ABIOMED INC [ABMD] +4.60%
HILLENBRAND IND [HB] +4.49%

Medical Laboratories & Research

LABORATORY CORP NEW [LH] +5.93%
NATL DENTEX CP [NADX] +4.13%
BIO-REFERENCE LAB [BRLI] +4.01%
PHARM PROD DEV [PPDI] +3.99%
GENOMIC HEALTH, INC. [GHDX] +3.77%

- Wednesday's Top Biotech & Medical Stocks
- Tuesday's Top Biotech & Medical Stocks
____________________

FDA Needs Help

2008-02-06T20:50:00.000-05:00

by Mark S. Senak
Eye On FDA

Yesterday, February 3, 2007, the New York Times ran an editorial regarding the FDA. It was a decent piece that referred to the fact that is apparently just dawning on some that agency is woefully understaffed and under-equipped to do its job. Duh.

The editorial rightfully points out that at a time when the mandate for the FDA is expanding nearly exponentially considering the rate of foreign imports and other factors, that the person-power and computer support in the agency also needs to expand.

Lump onto that a few other factors, however. Right now, all three front runners for the presidency (Clinton, McCain and Obama) favor importation of drugs. That also will increase the scope of the FDA's duties. The growth of Internet sales also challenges the agency. The increased scrutiny and oversight be Congress also sucks up resources. And staff morale has suffered greatly during the tenure of this Administration.

Amazingly, today the Administration hands to Congress a budget that makes permanent the tax cuts previously enacted for the short term and cuts just about all areas in healthcare domestic spending, including Medicare and Medicaid to name a few.

But what the FDA needs is not only cash, it needs strong leadership that is dedicated to calling attention to the needs of the agency and is willing to advocate for them. It requires leadership that is willing to say - these are the problems, these are what we're going to do about them and this is what we need to accomplish the job. Without that, and with increasingly competitive interests, the agency is likely to continue in the same vein it has for the past six years, to no one's benefit.

Eye On FDA is a regular contributor to BioHealth Investor
_______________

Wednesday's Top Biotech & Medical Stocks

2008-02-06T17:52:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

PIPEX PHARMACEUTALS [PP] +12.50%
GENAERA CORP [GENR] +12.35%
REPLIDYNE, INC. [RDYN] +11.11%
TRUBION PHARMACEUTIC [TRBN] +10.25%
LEV PHARMACEUTICALS [LEVP.OB] +9.17%

Diagnostic Substances

CNS RESPONSE, INC. [CNSO.OB] +38.10%
AVALON PHARMACEUTIC [AVRX] +5.43%
NYMOX PHARM CORP [NYMX] +5.19%
TORREYPINES THERAPEU [TPTX] +4.95%
SCOLR PHARMA INC [DDD] +4.89%

Drug Delivery

ULURU INC [ULU] +14.16%
DELCATH SYSTEMS INC [DCTH] +6.07%
MATRIXX INITIATVS [MTXX] +4.05%
BENTLEY PHARMACEUTIC [BNT] +2.34%
ARADIGM CORP [ARDM.OB] +1.68%

Drug Manufacturers

ALPHARMA INC [ALO] +7.46%
NEUROGESX, INC. [NGSX] +5.25%
MAP PHARMACEUTICALS, [MAPP] +3.87%
PRANA BIO LTD ADS S1 [PRAN] +3.53%
ARENA PHARMACEUTIC [ARNA] +3.36%

Drug Related Products

NATURAL ALTERNATIV [NAII] +2.21%
PERRIGO COMPANY [PRGO] +2.06%
DRAXIS HEALTH INC [DRAX] +1.88%
ARGAN INC [AGX] +1.74%
N B T Y INC [NTY] +1.51%

Generic Drugs

HI-TECH PHARMACAL [HITK] +0.85%

Medical Appliances & Equipment

CAMBRIDGE HEART INC [CAMH.OB] +26.13%
CELSION CORP [CLN] +7.46%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +6.40%
NORTHSTAR NEUROSCI [NSTR] +6.25%
NEWCARDIO, INC. [NWCI.OB] +6.22%

Medical Instruments & Supplies

ENDOLOGIX INC [ELGX] +6.15%
NUCRYST PHARMACEUTIC [NCST] +5.78%
OSTEOTECH INC [OSTE] +5.36%
STEN CORPORATION [STEN] +5.00%
MEMRY CORPORATION [MRY] +5.00%

Medical Laboratories & Research

GENOMIC HEALTH, INC. [GHDX] +14.75%
NATL DENTEX CP [NADX] +5.50%
BIO-REFERENCE LAB [BRLI] +2.23%
ALLIANCE IMAGING INC [AIQ] +1.85%
RADNET INC [RDNT] +1.84%

- Tuesday's Top Biotech & Medical Stocks
- Monday's Top Biotech & Medical Stocks
____________________

IDM Pharma Jumps 234% After Big Coincidence

2008-02-05T23:39:00.000-05:00

by H.S. Ayoub, DMD
BioHealth Investor

In what might be the greatest coincidence in Wall Street history IDM Pharma (IDMI) stock skyrocketed by 234% on Tuesday as the company announced positive late stage results of its Osteosarcoma drug L-MTP-PE.

What is the coincidence you ask? On Monday the Nasdaq released a letter to the company warning that its stock has not met the $1 minimum required bid price over the last 30 days in order to keep its listing on the exchange.

What is even more interesting is that the company did not choose to issue a press release announcing the Nasdaq letter untill 7:35pm on Tuesday, after the markets were long closed.

Just read the headline of the press release, and the smaller headline:

IDM Pharma Receives Notification from NASDAQ Relating to Minimum Bid Price
Tuesday February 5, 7:35 pm ET
On February 5, 2008, the closing price of the Company's common stock was $3.81 per share

It almost seems the company is saying that "the Nasdaq must be crazy, our stock price is not even close to $1. Look, it closed at $3.81 on tuesday!"

Now don't get me wrong, I'm glad for the positive numbers from the study, as the company's press release points out;

Children's Oncology Group Report Shows the Addition of L-MTP-PE to Chemotherapy Reduced the Risk of Death by 30% in Osteosarcoma Patients

I'm just amazed at the timing that's all. Was the company anticipating the Nasdaq warning letter, and waited untill it was issued and released the positive news just in time?

How would have the stock price reacted to the release of the news of the study results prior to the Nasdaq letter? Would the stock have jumped as high?

I wonder.

BioHealth Investor.com
_____________________

Should Hospital Emergency Rooms Adopt the Managerial Techniques Found at Starbucks?

2008-02-05T20:27:00.000-05:00

by Doug Cress
Med Tech Sentinel

According to researchers at the Cambridge Health Alliance and Harvard Medical School, the median wait time in hospital emergency rooms increased 36% from 1997 to 2004, to an average of 30 minutes.

Particularly troubling, wait times more than doubled for heart attack patients. In 1997, 50% saw a doctor within eight minutes; in 2004 it took an average of 20 minutes. For 25% of heart attack patients, the wait time surpassed 50 minutes.

The study examined more than 90,000 emergency room visits. The authors believe overcrowding and patient bottlenecks are to blame. 12% of the 24-hour emergency departments closed during the seven-year study even as patient visits increased from 93 to 110 million.

A recent New York Times’ editorial was quick to point the finger at the nation’s uninsured, “Uninsured patients — and those who have no primary care doctor — flock to emergency rooms for routine coverage, clogging the system. Meanwhile, hospitals lose so much money dispensing charity care through emergency rooms that many collapse into bankruptcy or give up emergency care.”

Professor Linda Green, Faculty Director at the Columbia Business School’s Healthcare and Pharmaceutical Management Program, believes journalists tend to oversimplify the problem.

In a recent interview with Jill Stoddard of Public Offering, a new blog from the Columbia Business School, Green notes that emergency room visits for both insured and uninsured are increasing as is the incidence of diabetes, heart disease and other chronic diseases.

In some cases, hospitals could cut wait times if they adopted the management techniques found in other industries. Says Green,

“Hospitals do try to adjust the number of physicians that are on call to accommodate patient flow — for example, they realize more patients show up at noon than at two in the morning. They just don’t do it very well because they don’t know how to do it very well. Most hospitals are not run by MBAs…Banks, supermarkets, airlines and call centers all use mathematical models. Hospitals don’t use these mathematical models so it’s not surprising that they don’t operate efficiently.”

For years now, Starbucks (SBUX) has been introducing strategies to reduce customer wait time. Silvia Peterson, the director of Starbucks operations engineering, heads up a team of 10 engineers who focus exclusively on the customer experience. Thanks to her innovations (bigger ice scoops, for example) it takes 30 seconds less to complete an order at Starbucks today versus five years ago.

According to Jim Alling, President of Starbucks in the U.S., “The customer doesn’t feel like he’s waiting in line. It’s like a ballet, a well-choreographed play.”

Studer Group is one of several health care consulting firms that offer ‘evidence-based’ tools to help organizations streamline operations. They offer their services to primary care practices that seek to improve patient access. Studer examines:

- Demand (the volume of services sought by patients in the practice)
- Backlog (requests for services waiting to be provided)
- Lead-time (the length of time a patient has to wait for an appointment)
- Cycle time (the number of minutes from check-in to checkout)
and Supply (the time available for providing patient care)
- These measures form the core data around which an organization can develop improvement initiatives.

Similar data-based strategies could be adopted by emergency rooms if hospitals were to prioritize improvement. But, notes Green, this may not be likely, “It does take up a lot of time and energy from the hospital managers to keep the hospital afloat. Most hospitals are in financial straits — one third of them operate in the red, and they don’t focus on emergency rooms because it’s not where they make money.”

Med Tech Sentinel is a regular contributor to BioHealth Investor
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Tuesday's Top Biotech & Medical Stocks

2008-02-05T17:10:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

IDM PHARMA INC [IDMI] +234.21%
OSTEOLOGIX INC [OLGX.OB] +36.36%
IMMTECH PHARM INC [IMM] +14.66%
ILLUMINA INC [ILMN] +10.19%
CHAMPIONS BIOTECHNLG [CSBR.OB] +10.09%

Diagnostic Substances

ICAGEN, INC. [ICGN] +4.24%
SCOLR PHARMA INC [DDD] +4.24%
EPICEPT CORPORATION [EPCT] +3.36%
SYNTA PHARMACEUTICAL [SNTA] +2.32%
REMOTEMDX INC [RMDX.OB] +0.27%

Drug Delivery

PENWEST PHARM CO [PPCO] +0.92%
QUIGLEY CORP THE [QGLY] +0.36%

Drug Manufacturers

AMARIN CORP ADS NEW [AMRND] +7.80%
AVANIR PHARMACEUTICL [AVNR] +6.56%
NOVABAY PHARMACEUTCL [NBY] +6.25%
ALPHARMA INC [ALO] +5.07%
SCICLONE PHARMA [SCLN] +3.06%

Drug Related Products

XELR8 HOLDINGS, INC [BZI] +6.86%
PERRIGO COMPANY [PRGO] +4.49%
NATURAL ALTERNATIV [NAII] +0.58%
N B T Y INC [NTY] +0.31%
SCHIFF NUTRIT INTL [WNI] +0.17%

Generic Drugs

HI-TECH PHARMACAL [HITK] +5.12%
WATSON PHARMACEUTCLS [WPI] +0.92%
BARR PHARMA INC [BRL] +0.10%

Medical Appliances & Equipment

NEWCARDIO, INC. [NWCI.OB] +19.88%
CYTOCORE INC [CYOE.OB] +14.78%
LECTEC CORP [LECT.OB] +9.52%
CAMBRIDGE HEART INC [CAMH.OB] +8.82%
DIGIRAD CORPORATION [DRAD] +5.41%

Medical Instruments & Supplies

MEDPRO SAFETY PD [MPSP.OB] +11.11%
VASCULAR SOLUTIONS [VASC] +9.67%
YOUNG INNOVATIONS [YDNT] +8.57%
OCULUS INNOVATIVE SC [OCLS] +5.92%
ALPHATEC HOLDINGS [ATEC] +4.60%

Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +2.32%
ENZO BIOCHEM INC [ENZ] +1.32%
QUEST DIAGNOSTC [DGX] +0.62%
GENOPTIX, INC. [GXDX] +0.37%
ALLIANCE IMAGING INC [AIQ] +0.29%

- Monday's Top Biotech & Medical Stocks
- Friday's Top Biotech & Medical Stocks
____________________

BioCryst: Fugheddaboudit!

2008-02-04T22:52:00.000-05:00

by Michael Shulman
BiotechBlitz

I rarely if ever write about stocks I recommend in my service. This is a point-and-shoot blog -- I point, you shoot -- but today I want to discuss a company I had recommended and just closed, BioCryst (BCRX).

Many people may look at the stock, and its chart, and its cash position, and say maybe. I say no. BCRX is a cancer and pandemic flu company. The cancer treatment, Fodosine, and the flu drug, peramivir, have serious promise, but management is the problem.

The president of BioCryst, Jon Stonehouse, came onboard about a year ago, inherited some ridiculous problems not of his making and brought in seasoned big-pharma vets to rectify the situation -- but so far is behind the curve in running a publicly held company.

This past summer peramivir failed to reach its primary endpoint in a Phase II trial because the morons designing the trial before his arrival chose the wrong size needle. If airlines are using larger seats, using needles too small to get through the typical modern-day big butt is an absurd mistake.

After this fiasco, Stonehouse and company were cool and calm and said the there were strong enough results within the trial patients they determined actually received the drug that they would proceed to Phase III. And then a couple of weeks ago they (BCRX) said nope, not ready to go to Phase III this flu season. Instead we're going to burn investors money for another year.

That information should have been provided earlier and the comments stating the company was going forward to Phase III should never have been made.

This shows a lack of familiarity with running a publicly held company, and what is best called accidental arrogance -- a disease of many, perhaps most, big-pharma execs who are almost totally internally focused.

Do I exaggerate? A few weeks back I gave the closing keynote at a strategic planning conference for 150 big pharma execs. These were big-time, serious execs at the most senior levels of management of product development. After my remarks I was asked questions about Wall Street and shareholders my sons could have easily answered when they were first investing their own money in the market when they were 14. Letting these kind of execs loose to manage a development stage, publicly held startup such as BCRX is not a good idea.

Bottom line: BioCryst management is not a group you want to trust with your money. To date, BCRX execs have not shown enough respect for investors to earn that trust.

BiotechBlitz is a regular contributor to BioHealth Investor
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Monday's Top Biotech & Medical Stocks

2008-02-04T16:52:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

ACHILLION PHARMACEUT [ACHN] +22.68%
NASTECH PHARM CO [NSTK] +15.22%
TITAN PHARMA INC [TTP] +14.88%
STEMCELLS INC [STEM] +11.11%
NOVAVAX INC [NVAX] +10.66%

Diagnostic Substances

REMOTEMDX INC [RMDX.OB] +11.48%
ICAGEN, INC. [ICGN] +10.00%
ISTA PHARMACTLS [ISTA] +8.44%
IMMUNOMEDICS INC [IMMU] +7.66%
GENELABS TECH INC [GNLB] +7.14%

Drug Delivery

QUIGLEY CORP THE [QGLY] +10.02%
COLUMBIA LABS INC [CBRX] +4.37%
BIOVAIL CORP [BVF] +4.23%
GENEREX BIOTECH CORP [GNBT] +3.68%
ELAN CP PLC ADR [ELN] +3.21%

Drug Manufacturers

GAMMA PHARMACEUTICAL [GMPM.OB] +8.70%
BIODEL INC. [BIOD] +7.72%
ALPHARMA INC [ALO] +6.22%
OREXIGEN THERAPEUTIC [OREX] +5.46%
OPKO HEALTH INC. [OPK] +5.26%

Drug Related Products

CHINA SHENGHUO PHARM [KUN] +6.36%
USANA HEALTH SCIEN [USNA] +6.16%
DRAXIS HEALTH INC [DRAX] +3.57%
PERRIGO COMPANY [PRGO] +2.43%
NUTRACEUTICAL INTL [NUTR] +1.35%

Generic Drugs

CATALYST PHARMACEUTI [CPRX] +7.81%
HELICOS BIOSCIENCES [HLCS] +3.17%
CARACO PHARMA LABS [CPD] +3.01%
HI-TECH PHARMACAL [HITK] +2.68%
PHARMACUTICAL CO [PRX] +1.51%

Medical Appliances & Equipment

ECHO THERAPEUTICS [ECTE.OB] +20.59%
LECTEC CORP [LECT.OB] +20.00%
NORTHSTAR NEUROSCI [NSTR] +13.99%
CYTOCORE INC [CYOE.OB] +9.52%
ALIGN TECHNOLOGY I [ALGN] +5.31%

Medical Instruments & Supplies

OCULUS INNOVATIVE SC [OCLS] +18.84%
STEN CORPORATION [STEN] +17.21%
AMDL, INC [ADL] +9.79%
VIVUS INC [VVUS] +8.44%
MILESTONE SCIENTIFIC [MLSS.OB] +8.33%

Medical Laboratories & Research

INSIGHT HLTH SVC HLD [ISGT.OB] +4.84% $0
NATL DENTEX CP [NADX] +1.96% $104.5 M
ARRAY BIOPHARMA IN [ARRY] +0.77% $237.9 M
PSYCHEMEDICS NEW [PMD] +0.59% $75.0 M
GENOMIC HEALTH, INC. [GHDX] +0.42%

- Friday's Top Biotech & Medical Stocks
- Thursday's Top Biotech & Medical Stocks
____________________

Hospital Dangers

2008-02-04T07:54:00.000-05:00

by David E. Williams
Health Business Blog

Turns out installing alcohol-based handwashing gel dispensers in hospitals and encouraging staff to use them isn’t enough to prevent infections. Rings and long fingernails keep hands and dirty and other problems, such as non-sanitized treatment areas and improper handling of catheters are a problem, too. The issue was studied at a hospital in Nebraska, where gel use doubled but infection rates didn’t budge. It’s not surprising to learn that one tactic isn’t sufficient to control infections. Still, whenever I read about the poor record of hospital safety and quality it makes me mad. From the Associated Press:

More gel dispensers were put in the units, and usage rose from 37 percent to 68 percent in one unit and from 38 percent to 69 percent in the other. Compliance for hand washing of any kind in most hospitals is estimated to be about 40 percent, according to experts, although some hospitals do better.

Can you imagine a 40 percent compliance rate in any other business besides health care?

- Pilots going through their pre-flight checklists completely 40 percent of the time?
- Accountants calculating profit and loss correctly 40 percent of the time?
- Hamburger flippers putting all the ingredients on a Whopper 40 percent of the time?

No way. We shouldn’t tolerate it in health care either.

Health Business Blog is a regular contributor to BioHealth Investor
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Pharma News Briefs

2008-02-03T22:54:00.000-05:00

by Aaron Barkoff
Orange Book Blog

Earlier this week, FDA released its highly anticipated response concerning granisetron 180-day exclusivity. This marks the first time that FDA has interpreted the "failure to market" forfeiture provisions of the 2003 MMA. FDA Law Blog posted a nice summary of FDA's response.

FDA Law Blog also posted on a very interesting case recently filed by Nu-Pharm against FDA, in which Nu-Pharm seeks to force FDA to grant it final approval to market generic Depakote (divalproex sodium).

The Wall St. Journal had an interesting article yesterday on health plans that pay doctors $100 each time they switch a patient to a generic drug. The WSJ Health Blog posted this summary of the article.

A district court in New York recently held that three Purdue Pharma patents on Oxycontin are not unenforceable for inequitable conduct.

Cypress Pharmaceutical announced today that it has settled patent litigation with GSK concerning its generic version of Zantac (ranitidine) syrup.

Orange Book Blog is a regular contributor to BioHealth Investor
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Friday's Top Biotech & Medical Stocks

2008-02-01T16:32:00.000-05:00

by H.S. Ayoub
BioHealth Investor

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Biotechnology

ACHILLION PHARMACEUT [ACHN] +41.21%
STEMCELLS INC [STEM] +14.18%
HALOZYME THERAPEUTIC [HALO] +10.16%
CYTOKINETICS [CYTK] +9.91%
GPC BIOTECH AG [GPCB] +9.43%

Diagnostic Substances

ASPENBIO PHARMA INC [APPY] +6.84%
IMARX THERAPEUTICS [IMRX] +6.08%
TORREYPINES THERAPEU [TPTX] +4.95%
NEOGEN CP [NEOG] +4.79%
AVALON PHARMACEUTIC [AVRX] +4.55%

Drug Delivery

ACURA PHARMACEUTICAL [ACPH.OB] +23.85%
DELCATH SYSTEMS INC [DCTH] +5.65%
NOVEN PHARMACEUTIC [NOVN] +5.29%
PENWEST PHARM CO [PPCO] +4.13%
ALKERMES INC [ALKS] +2.85%

Drug Manufacturers

NEXMED INC [NEXM] +17.24%
AMARIN CORP ADS NEW [AMRND] +12.76%
MIDDLEBROOK PHARMACL [MBRK] +9.65%
WUXI PHARMATECH ADS [WX] +9.33%
PANTERA PETROLEUM [PTPE.OB] +9.09%

Drug Related Products

LABOPHARM INC. [DDSS] +24.60%
MANNATECH INC [MTEX] +9.48%
CHINA SHENGHUO PHARM [KUN] +8.91%
N B T Y INC [NTY] +5.24%
PRESTIGE BRAND HLGS [PBH] +3.35%

Generic Drugs

PHARMACUTICAL CO [PRX] +3.23%
CARACO PHARMA LABS [CPD] +0.97%
HELICOS BIOSCIENCES [HLCS] +0.80%
MYLAN INC [MYL] +0.54%
BARR PHARMA INC [BRL] +0.42%

Medical Appliances & Equipment

INTUITIVE SURG INC [ISRG] +20.32%
ACCURAY INCORPORATED [ARAY] +7.46%
REGENERATION TECH [RTIX] +7.00%
BSD MEDICAL CORP [BSM] +6.72%
HANSEN MEDICAL, INC. [HNSN] +6.60%

Medical Instruments & Supplies

ISORAY INC [ISR] +19.57%
ENCISION INC [ECI] +11.40%
OCULUS INNOVATIVE SC [OCLS] +11.29%
ARISTOTLE CP [ARTL] +9.17%
BIOMIMETIC THERAPEUT [BMTI] +8.74%

Medical Laboratories & Research

ENZO BIOCHEM INC [ENZ] +7.80%
ERESEARCHTECHNOLOG [ERES] +3.19%
QUEST DIAGNOSTC [DGX] +2.87%
BIO-REFERENCE LAB [BRLI] +2.85%
GENOMIC HEALTH, INC. [GHDX] +1.52%

- Thursday's Top Biotech & Medical Stocks
- Wednesday's Top Biotech & Medical Stocks
____________________

BioWatch Stock Alert: Somanetics Jumps on Volume Spike

2008-01-31T21:07:00.000-05:00

by H.S. Ayoub, DMD
BioHealth Investor

Shares of Somanetics Corp (SMTS) jumped 6.82% on Thursday as volume surged almost three times the three-month daily average!

There were no news or any significant events that could be detected.

Somanetics develops, manufacturs, and markets medical devices primarily in the United States. It offers the INVOS System, a non-invasive patient monitoring system that provides continuous information about changes in blood oxygen saturation levels in patients with or at risk for restricted blood flow.

The company has a small market cap of only $357 million. It has more than $50 million in cash and no debt according to the latest Yahoo! financial data.

The company has been experiencing great growth in revenue and net profit over the last few years with the sale of the INVOS System.

Shares of SMTS closed at $26.80 on Thursday, which is just shy of the 52-week high of $26.88 reached on the same day.

Somanetics is the first stock in 2008 to make BHI's BioWatch Alert List, and will be tracked for the next two weeks.

BioHealth Investor.com
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Tested on the young, used on the old

2008-01-31T16:40:00.000-05:00

by David E. Williams
Health business blog

Ever notice that medical devices are tested on non-Medicare populations and then paid for mostly by Medicare? Dr. Rita F. Redberg did. See (Medicare coverage decisions often based on trials in irrelevant populations)

“I was appointed to the [Medicare Evidence Development and Coverage Advisory Committee] MedCAC in 2002, and my first meeting was called because Guidant had requested expansion of defibrillator coverage in the Medicare population,” co-author Dr. Rita F. Redberg told Reuters Health. “In reviewing the technology assessment, it was obvious that the data were based on a population that was different than the population we were being asked if defibrillators would provide benefit for.”

“It was difficult to make that extrapolation, ‘how would the Medicare population do based on a study in middle-aged healthy men?’” she added. “It made me think that this was not an isolated incident.”

Sure enough, when Redberg and co-author Sanket S. Shruva looked at assessment of cardiovascular technologies between 1998 and 2006 they found that the hunch was true and their study (Variations Between Clinical Trial Participants and Medicare Beneficiaries in Evidence Used for Medicare National Coverage Decisions) was published in The Archives of Internal Medicine published on January 28, 2008.

The clinical trial participants tended to be about 10 years younger (70.8 v. 60.1) and much more likely to be male (75% v. 44%) than the Medicare population.

My understanding is that the vast majority of these devices are used in the Medicare population, so this is a legitimate point. Still, it would be a shame if the impact of this report were to require companies to do more or larger clinical trials, since it would raise development costs and keep some products off the market.

I’m sure it’s not easy, but it would be great to find a reliable way to extrapolate from typical study participants to Medicare members –or real world users of devices overall. I know that this is already done to some extent through the use of patient registries and databases such as ADHERE.

Health Business Blog is a regular contributor to BioHealth Investor
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McCain is the FrontRunner - The Tea Leaves for Pharma

2008-01-31T16:36:00.000-05:00

by Mark S. Senak
Eye On FDA

Last night, John McCain won the Florida primary, clearly putting him in the status of front runner in the Republican Party. Hillary Clinton won Florida, even though that is an empty victory as far as delegates, she is trying to make it into something, and perhaps it does count for something.

Senator McCain's speech sounded like one rallying all the troops around his nomination. Rudy Giuliani is going to endorse the Senator when he drops out of the race today. And Hillary Clinton is leading in most of the polls of states slated for the Super Tuesday primary.

As a matter of mathematics at this point, it would seem like the election is shaping up to eventually be a Clinton/McCain contest. If the polls for Super Tuesday are right - what would that mean?

As indicated in my earlier features on the candidates both Hillary Clinton and John McCain have indicated that they are in favor of importation and in favor of the ability of the government to negotiate Medicare Part D prices - two domains examined in my candidate series that could re-shape somewhat the pharmaceutical market. Rudy Giuliani opposed importation.

The difference may be that Hillary Clinton seems to have an ax to grind when it comes to the pharmaceutical industry. That does not appear in the McCain rhetoric, nor necessarily with the Obama rhetoric, though that is not clear. Nevertheless, the only difference between the two candidates may be about insurance and the way in which the uninsured are eventually covered.

In that case, it would seem that the candidate between McCain and Clinton who most wants to get the most people who are uninsured, to gain insurance as soon as possible, and therefore to have drug coverage, may be the most amenable candidate to pharma after all.

More on that later.

Eye On FDA is a regular contributor to BioHealth Investor
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Thursday's Top Biotech & Medical Stocks

2008-01-31T16:29:00.000-05:00

by H.S. Ayoub
BioHealth Investor

Subscribe now to keep up to date on the latest news, articles and daily top stocks:

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Biotechnology

ATHERSYS INC [ATHX] +14.16%
SUNESIS PHARMACEUTIC [SNSS] +14.04%
NILE THERAPEUTICS [NILT.OB] +11.76%
CRITICAL THERAPEUTIC [CRTX] +11.21%
COMBINATORX [CRXX] +11.04%

Diagnostic Substances

SYNTA PHARMACEUTICAL [SNTA] +10.06%
GENELABS TECH INC [GNLB] +8.03%
IMARX THERAPEUTICS [IMRX] +7.25%
ROSETTA GENOMICS LTD [ROSG] +6.65%
CNS RESPONSE, INC. [CNSO.OB] +3.96%

Drug Delivery

PENWEST PHARM CO [PPCO] +7.16%
BIOVAIL CORP [BVF] +4.50%
ARADIGM CORP [ARDM.OB] +4.17%
ACURA PHARMACEUTICAL [ACPH.OB] +3.17%
COLUMBIA LABS INC [CBRX] +2.78%

Drug Manufacturers

GAMMA PHARMACEUTICAL [GMPM.OB] +18.42%
CELL THERAPEUTICS [CTIC] +15.28%
AMARIN CORP ADS NEW [AMRND] +9.02%
ALPHARMA INC [ALO] +7.05%
ARDEA BIOSCIENCES [RDEA] +5.36%

Drug Related Products

CURATECH INDUSTRIES [CUTC.OB] +14.29%
INTEGRATED BIOPHARMA [INBP] +11.51%
N B T Y INC [NTY] +5.07%
PRESTIGE BRAND HLGS [PBH] +3.75%
ARGAN INC [AGX] +2.63%

Generic Drugs

HI-TECH PHARMACAL [HITK] +4.44%
BARR PHARMA INC [BRL] +1.03%
WATSON PHARMACEUTCLS [WPI] +0.77%
CATALYST PHARMACEUTI [CPRX] +0.60%

Medical Appliances & Equipment

ECHO THERAPEUTICS [ECTE.OB] +20.00%
SYNERGETICS USA INC [SURG] +12.61%
INVACARE CORP [IVC] +11.19%
CYTOCORE INC [CYOE.OB] +10.64%
ENDOCARE INC [ENDO] +9.63%

Medical Instruments & Supplies

BIOMERICA INC [BMRA.OB] +33.33%
VICOR TECHNOLOGIES [VCRT.OB] +10.37%
ANGIODYNAMICS INC [ANGO] +9.21%
HAEMONETICS CP [HAE] +8.31%
ADVANCED MED OPTICS [EYE] +6.76%

Medical Laboratories & Research

ALLIANCE IMAGING INC [AIQ] +7.08%
GENOPTIX, INC. [GXDX] +6.68%
BIO-IMAGING TECH [BITI] +5.48%
ARRAY BIOPHARMA IN [ARRY] +5.00%
INSIGHT HLTH SVC HLD [ISGT.OB] +3.33%

- Wednesday's Top Biotech & Medical Stocks
- Tuesday's Top Biotech & Medical Stocks
____________________

EU Hedge: Pharmion and Celgene

2008-01-30T16:47:00.000-05:00

by Adam Rubenstein
CLSDF

A very interesting few days for Pharmion (NASDAQ: PHRM) and Celgene (NASDAQ: CELG) and how they are faring in their product approval efforts in Europe.

The European Medicines Agency issued a positive opinion to recommend approval of Pharmion’s Thalidomide® for use in combination with melphalan and prednisone as first line treatment for patients with untreated multiple myeloma, aged 65 years or older or ineligible for high dose chemotherapy. Such an opinion often yields a final marketing approval via the European Commission, typically to occur within the window of a quarter. So let’s hope for smooth sailing over the next 12-weeks or so on Thalidomide®.

On a less positive note for Celgene, a European advisory committee recommended against approving its drug Revlimid® as a treatment for anemia patients (the drug is already approved to treat multiple myeloma). The European Medicines Agency's Committee for Medicinal Products for Human Use recommended against expanding Revlimid's approval to include treating transfusion-dependent anemia patients with blood disorders known as myelodysplastic syndrome.

Recall that the share price of CELG will effect the final terms in the Pharmion acquisition, you can read more about that in a previous post (here).

CLSDF is a regular contributor to BioHealth Investor
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Schering-Plough Relief on Partner Earnings

2008-01-30T16:42:00.000-05:00

by Jon C. Ogg
24/7 Wall St.

Schering-Plough Corp. (SGP) is probably breathing a sigh of relief this morning after Merck's earnings as it is partners with the drug giant on Vytorin and Zetia for cholesterol treatments.

The combined Vytorin & Zetia franchise was noted as having some $5.2 Billion in 2007 annual sales, with some $1.5 Billion being reported in the fourth quarter alone.

Merck (MRK) did disclose some 50 lawsuits over these sales and noted that it is complying and cooperating with investigations. But the good news is that the company's guidance wasn't sharply changed.

Continue reading article at 24/7 Wall Street...

24/7 Wall St. is a regular contributor to BioHealth Investor
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