BioWatch Stock Alert: Somanetics Jumps on Volume Spike

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
______________________

Tested on the young, used on the old

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
_________________

McCain is the FrontRunner - The Tea Leaves for Pharma

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
_______________

Thursday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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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

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
_____________

Schering-Plough Relief on Partner Earnings

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
________________

Wednesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

ONCOTHYREON [ONTY] +48.06%
METABASIS THERAPEUTI [MBRX] +30.86%
IMMUNOSYN CORPORATIN [IMYN.OB] +16.67%
PLURISTEM THERAPEUTC [PSTI] +14.17%
HESKA CORPORATION [HSKA] +10.53%



Diagnostic Substances

IMMUCELL CP [ICCC] +9.48%
SCOLR PHARMA INC [DDD] +7.14%
AVALON PHARMACEUTIC [AVRX] +7.05%
EPICEPT CORPORATION [EPCT] +6.77%
GENELABS TECH INC [GNLB] +4.58%



Drug Delivery

ELAN CP PLC ADR [ELN] +2.88%
BENTLEY PHARMACEUTIC [BNT] +2.17%
GENEREX BIOTECH CORP [GNBT] +0.01%



Drug Manufacturers

AVANIR PHARMACEUTICL [AVNR] +16.07%
DUSA PHARM INC [DUSA] +10.50%
NEUROCHEM INC [NRMX] +9.74%
AMARIN CORP ADS NEW [AMRND] +6.40%
NEUROGEN CP [NRGN] +5.76%



Drug Related Products

CURATECH INDUSTRIES [CUTC.OB] +6.06%
TIENS BIOTECH GR USA [TBV] +4.83%
MANNATECH INC [MTEX] +3.55%
AUXILIUM PHARMACEUT [AUXL] +2.77%
SALIX PHARM DEL [SLXP] +1.71%



Generic Drugs

CATALYST PHARMACEUTI [CPRX] +1.21%
MYLAN INC [MYL] +1.08%
CARACO PHARMA LABS [CPD] +0.78%



Medical Appliances & Equipment

IRIDEX CP [IRIX] +36.96%
SYNERGETICS USA INC [SURG] +13.86%
THERMOGENESIS CORP [KOOL] +11.24%
IVIVI TECHNOLOGIES, [IVVI] +9.62%
ZYNEX MEDICAL HLDGS [ZYNX.OB] +8.70%



Medical Instruments & Supplies

BIOLASE TECH INCS3 [BLTI] +12.23%
CAS MEDICAL SYS INC [CASM] +7.87%
RETRACTABLE TECH INC [RVP] +5.71%
INFUSYSTEMS HOLDINGS [INHI.OB] +5.26%
CONCEPTUS INC [CPTS] +5.18%



Medical Laboratories & Research

SPHERIX INC [SPEX] +5.22%
GENOPTIX, INC. [GXDX] +2.26%
PSYCHEMEDICS NEW [PMD] +2.08%
BIO-REFERENCE LAB [BRLI] +1.00%
BIO-IMAGING TECH [BITI] +0.26%




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

WuXi PharmaTech Puts Squeeze on Suppliers

by Richard Daverman, PhD
ChinaBio Today




WuXi PharmaTech (WX) held a conference yesterday with its suppliers. Following a classic good-news/bad-news theme, the Shanghai-based CRO told its suppliers that it expected to increase spending between 50% and 100%, but at the same time, the company asked suppliers for better terms: longer payment periods, quality guarantees and lower prices. WuXi projects its 2008 spending on equipment and materials will total between 300 million RMB ($45.5 million) and 400 million RMB ($54 million).

The theme of the half-day supplier conference, which was attended by 120 representatives of 70 companies, was “Support Partner Success.” The suppliers provide WuXi with equipment and instruments, raw materials, reagents, consumables, etc. According to Li Ge, Chairman and CEO of WuXi, the goal of the conference was to foster “a win-win cooperation for us and our suppliers."

WuXi awarded Preferred Supplier Awards to Sigma-Aldrich and Alfa Aesar, based on their quality of management systems, the quality of products, on-time delivery, customer service and cost.

In addition, WuXi announced it has centralized supplier buying for its various facilities and for its soon-to-be acquired US division, AppTec Laboratory Services. In early January 2008, WuXi signed a letter of intent to purchase CRO AppTec for $151 million (including debt). Part of the supplier purchases will be to upgrade AppTec so that it can perform the tasks WuXi envisions for it.

In its 2007 fiscal year, AppTec produced $70 million of revenue, while WuXi is on record as expecting its 2007 revenues to be in the $130 million to $135 million range, which would mean the 2007 pro forma revenues of the combined company equal $200 million plus. So far, WuXi has not predicted its 2008 results, but Wall Street analysts have called for the existing WuXi operations by themselves to generate $205 million, an increase of 52%.

WuXi has been growing fast, doubling revenues in the first nine months of 2007 over 2006. It will have difficulty maintaining this level of growth as it gets bigger, and AppTec, though its revenues are also on the upswing, may bring the rate of growth lower as well. WuXi has promised that the acquisition will be accretive from the start, although closing the transaction will cause one-time writedowns.

WuXi has been a rollercoaster of a stock since its August IPO. The company priced slightly above the range at $14, opened at $19, and subsequently traded as high as $45 per share. The shares have backed off from those levels as the speculative fever for stocks has cooled around the globe. Today, WuXi is trading up $1.01 at $24.50.






ChinaBio Today is a regular contributor to BioHealth Investor
_________________

Tuesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

OPEXA THERAPEUTICS [OPXA] +27.39%
STEMCELLS INC [STEM] +19.09%
CARDIOVASCULAR BIOTH [CVBT.OB] +13.91%
COMPUGEN LTD [CGEN] +13.87%
GTC BIOTHERAP INC [GTCB] +11.65%



Diagnostic Substances

INTERLEUKIN GENETICS [ILI] +9.08%
ABAXIS INC [ABAX] +4.31%
IDEXX LABS [IDXX] +3.72%
SYNTA PHARMACEUTICAL [SNTA] +3.67%
AMAG PHARMACEUTICALS [AMAG] +2.88%



Drug Delivery

PENWEST PHARM CO [PPCO] +26.17%
ELAN CP PLC ADR [ELN] +4.88%
ACURA PHARMACEUTICAL [ACPH.OB] +4.00%
COLUMBIA LABS INC [CBRX] +3.33%
NOVEN PHARMACEUTIC [NOVN] +3.09%



Drug Manufacturers

PROTALEX INC [PRTX.OB] +14.04%
CHATTEM INC [CHTT] +12.50%
GERON CORP [GERN] +10.99%
ARDEA BIOSCIENCES [RDEA] +9.33%
SUCAMPO PHARMA. INC. [SCMP] +8.92%



Drug Related Products

LABOPHARM INC. [DDSS] +20.67%
PRESTIGE BRAND HLGS [PBH] +7.28%
SALIX PHARM DEL [SLXP] +5.71%
MANNATECH INC [MTEX] +4.78%
AUXILIUM PHARMACEUT [AUXL] +4.70%



Generic Drugs

CATALYST PHARMACEUTI [CPRX] +12.24%
HELICOS BIOSCIENCES [HLCS] +5.24%
CARACO PHARMA LABS [CPD] +1.31%
MYLAN INC [MYL] +0.82%
BARR PHARMA INC [BRL] +0.31%



Medical Appliances & Equipment

LANGER INC [GAIT] +20.40%
MEDICALCV INC [MCVI.OB] +19.51%
ZIMMER HOLDINGS INC [ZMH] +13.15%
NORTHSTAR NEUROSCI [NSTR] +11.03%
CANDELA CP [CLZR] +9.81%



Medical Instruments & Supplies

MILESTONE SCIENTIFIC [MLSS.OB] +13.04%
HOME DIAGNOSTICS, IN [HDIX] +8.66%
BIOSPHERE MEDICAL [BSMD] +8.37%
MEMRY CORPORATION [MRY] +7.83%
CRYOCOR, INC. [CRYO] +7.54%



Medical Laboratories & Research

ERESEARCHTECHNOLOG [ERES] +3.63%
PSYCHEMEDICS NEW [PMD] +2.83%
NATL DENTEX CP [NADX] +1.31%
QUEST DIAGNOSTC [DGX] +0.54%
LABORATORY CORP NEW [LH] +0.52%




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

Breast Cancer Screening Co-Pay Could Hurt Insurers’ Bottom Line

by Doug Cress
Med Tech Sentinel



A new study in The New England Journal of Medicine found that a modest insurance co-pay was enough to deter many older women from getting potentially life-saving mammograms.

The study examined 366,475 women between the ages of 65 to 69 enrolled at 174 Medicare managed-care plans. Screening rates were 8.3% lower for women whose plans required a co-payment (versus women whose plans covered the entire cost). Co-pays averaged $20, but ranged from $12.50 to $35. During the four-year study, the number of plans requiring co-pays rose 10%, from three plans in 2001 to 21 in 2004.

Mammography has been shown to reduce the rate of mortality by as much as 20 – 40%. Because it is cheaper to treat breast cancer when caught early, it may be cost-effective for insurers to exempt elderly patients from mammogram co-pays. The American Cancer Society estimates that there were 40,060 breast cancer fatalities in 2007. Approximately 80% of breast cancers occur in women over the age of 50; in women over 65 the cancer kills one out of two.

The study supports the idea of value-based insurance, in which insurers lower co-pays and other costs to patients as a way of increasing compliance and standards of care. While such strategies may increase short term expenditures, savings can be accrued over the long term by improving the patient’s health.

With technologies on the horizon that could detect cancer in its earliest stages, insurers may begin to selectively target treatments that are best for the patient, and best for their bottom line.

[Breast Cancer Mortality Rates: Surveillance, Epidemiology, and End Results (SEER) Program, April 2004]

























Med Tech Sentinel is a regular contributor to BioHealth Investor
________________

Monday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

ACORDA THERAPEUTICS [ACOR] +25.25%
TRANSDEL PHARMACTL [TDLP.OB] +17.47%
BIODELIVERY SCI INTL [BDSI] +14.52%
MEDIVATION INC [MDVN] +12.46%
I G I INC [IG] +8.97%



Diagnostic Substances

IMMUCELL CP [ICCC] +9.66%
ICAGEN, INC. [ICGN] +7.80%
IMMUNOMEDICS INC [IMMU] +7.58%
ISTA PHARMACTLS [ISTA] +7.20%
INTERLEUKIN GENETICS [ILI] +6.80%



Drug Delivery

EMISPHERE TECH [EMIS] +19.00%
DELCATH SYSTEMS INC [DCTH] +13.50%
PENWEST PHARM CO [PPCO] +11.88%
NEKTAR THERAPEUTIC [NKTR] +2.88%
BENTLEY PHARMACEUTIC [BNT] +2.84%



Drug Manufacturers

GAMMA PHARMACEUTICAL [GMPM.OB] +20.45%
AMARIN CORP ADS NEW [AMRND] +14.16%
MIDDLEBROOK PHARMACL [MBRK] +12.73%
SOMAXON PHARMACEUTIC [SOMX] +9.93%
ARYX THERAPEUTICS, I [ARYX] +9.86%



Drug Related Products

LABOPHARM INC. [DDSS] +33.58%
N B T Y INC [NTY] +8.17%
AUXILIUM PHARMACEUT [AUXL] +3.26%
MANNATECH INC [MTEX] +2.73%
SCHIFF NUTRIT INTL [WNI] +0.92%



Generic Drugs

HI-TECH PHARMACAL [HITK] +2.13%
BARR PHARMA INC [BRL] +1.30%
PHARMACUTICAL CO [PRX] +1.12%
MYLAN INC [MYL] +0.55%
WATSON PHARMACEUTCLS [WPI] +0.11%



Medical Appliances & Equipment

ARRHYTHMIA RES TECH [HRT] +18.29%
IVIVI TECHNOLOGIES, [IVVI] +7.54%
CUTERA, INC. [CUTR] +6.10%
SOMANETICS CORP [SMTS] +5.72%
IRIDEX CP [IRIX] +5.25%



Medical Instruments & Supplies

STEN CORPORATION [STEN] +33.61%
VICOR TECHNOLOGIES [VCRT.OB] +28.57%
ELECTRO-OPTICAL SCIE [MELA] +12.56%
TRANS1 INC. [TSON] +11.72%
VELCERA, INC. [VLCR.OB] +10.00%



Medical Laboratories & Research

BIO-IMAGING TECH [BITI] +7.12%
PHARM PROD DEV [PPDI] +1.97%
GENOPTIX, INC. [GXDX] +1.83%
ALLIANCE IMAGING INC [AIQ] +1.67%
MEDTOX SCIENTFIC INC [MTOX] +1.43%




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

The Tragedy of Nitromed

by Michael Shulman
BiotechBlitz




Skip this today if you are looking for investment ideas – I am venting today.

Two days ago I sat on a set of Fox Business Channel in Washington and was to be part of a discussion that never happened – and before I was to be on I listened to bumped as Magic Johnson and the president of Aetna (AET), Ronald Williams. It was a puff piece about some community health initiative targeting African Americans and as I listened to it I longed to be able to cut into this discussion – and cut these two frauds into pieces.

What does this have to do with disintegrating Nitromed (NTMD) -- the company is laying off most of its employees and throwing in the toweltrying to market its drug BiDil. In 2005 the company got FDA approval for the first ever drug targeted at an ethnic group – African Americans with heart disease. The drug, BiDil, was no me too drug – it was a resounding success in clinical trials. Called the A-HeFT trial, this was a typical double-blind, placebo-controlled trial. The trial was co-sponsored by the Association of Black Cardiologists -- the right … no, the perfect group of influencers for this drug. More than a thousand patients were in the trial, which was abruptly halted in July 2004 on the recommendation of the independent Data and Safety Monitoring Board and the steering committee for the trial. 

Why? Were there problems? Did the molecules get stuck somewhere? 

No -- long before the trial was scheduled to end, there were 43% fewer deaths and 39% fewer hospitalizations in the group receiving BiDil than the group taking a placebo. It was considered unethical to keep the placebo group on trial, so they were immediately switched to the real thing.

A hit you say? The drug has failed in the marketplace for a variety of reasons, one being the incompetence of the company in getting the right copayments from companies like Aetna and Medicare. And the lack of political support and pressure from public figures such as Magic Johnson, a man kept alive the last 16 years by HIV drugs – he, more than most, should understand the value of access to life saving drugs.

I asked a former CEO of Nitromed why they did not explicitly take the political route to get better co pays form Medicare and other payors – these are important because 80% of the target population has insurance. He shrugged as if embarrassed – remember, even morons get to be CEOs occasionally. And where are the members of the Congressional Black Caucus? Or the professional race baiters like Al Sharpton?

So, thousands of African Americans – oh, to hell with their heritage – thousands of my fellow citizens die needlessly every year because a drug that would help or save them is either unavailable to too expensive. Probably more needless deaths from heart disease since the drug was approved than have died in Iraq.

OK, I have vented. By the way, Ronald Williams of Aetna (AET) is African American. Ron, go home and explain to your kids how your company reimburses for BiDil.




BiotechBlitz is a regular contributor to BioHealth Investor
_______________

Friday's Top Biotech & Medical Stocks

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

GENETIC TECH SPON [GENE] +21.21%
COMBINATORX [CRXX] +17.31%
METABASIS THERAPEUTI [MBRX] +15.15%
TARGANTA THERAPEUTIC [TARG] +14.91%
TRUBION PHARMACEUTIC [TRBN] +13.30%



Diagnostic Substances

IMARX THERAPEUTICS [IMRX] +7.10%
ISTA PHARMACTLS [ISTA] +4.60%
AVIGEN INC [AVGN] +4.00%
IMMUCOR INC [BLUD] +2.71%
SCOLR PHARMA INC [DDD] +2.59%



Drug Delivery

DELCATH SYSTEMS INC [DCTH] +31.46%
QUIGLEY CORP THE [QGLY] +11.83%
ULURU INC [ULU] +5.70%
FLAMEL TECH SA ADR [FLML] +2.63%
COLUMBIA LABS INC [CBRX] +1.47%



Drug Manufacturers

LANNETT COMPANY INC [LCI] +16.13%
AMARIN CORP ADS NEW [AMRND] +15.90%
MARSHALL EDWARDS [MSHL] +9.69%
PRANA BIO LTD ADS S1 [PRAN] +5.96%
PHARMAXIS LTD ADR [PXSL] +5.63%



Drug Related Products

LABOPHARM INC. [DDSS] +14.53%
USANA HEALTH SCIEN [USNA] +3.41%
N B T Y INC [NTY] +2.42%
NUTRACEUTICAL INTL [NUTR] +2.03%
AUXILIUM PHARMACEUT [AUXL] +1.39%



Generic Drugs

CATALYST PHARMACEUTI [CPRX] +4.59%
CARACO PHARMA LABS [CPD] +1.70%



Medical Appliances & Equipment

MB SOFTWARE CORP [MBSB.OB] +32.00%
ARRHYTHMIA RES TECH [HRT] +16.96%
LANGER INC [GAIT] +15.79%
LECTEC CORP [LECT.OB] +14.29%
CELSION CORP [CLN] +12.12%



Medical Instruments & Supplies

PERKIN ELMER INC [PKI] +17.53%
NMT MEDICAL INC [NMTI] +12.73%
PROTHERICS PLC ADR [PTIL] +12.09%
ROCHESTER MEDICAL [ROCM] +9.13%
DEXCOM [DXCM] +9.08%



Medical Laboratories & Research

ERESEARCHTECHNOLOG [ERES] +3.48%
GENOPTIX, INC. [GXDX] +2.79%
BIO-IMAGING TECH [BITI] +2.38%
INSIGHT HLTH SVC HLD [ISGT.OB] +1.64%
PSYCHEMEDICS NEW [PMD] +0.51%




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

Image gently, or when the diagnostic is worse than the disease

by David E. Williams
Health business blog



From the time I was little I had an awareness of the potential dangers of medical X-rays. My mom was always careful to limit the number and frequency of dental x-rays she let us have, and luckily we rarely needed X-rays for anything else. Her concern was probably based on scientific awareness coupled with regret from playing with fluoroscopes in shoe-stores in the 1950s. I’m sure it also had something to do with the fact that a relative whom we saw a couple of times a year had a developmentally disabled daughter, most likely having something to do with working as an x-ray technician in the 1950s while pregnant.
So with the rise of imaging, especially high-radiation CT scanners, I’ve written about the possible dangers (see Saying no to CT). It’s shocking to me the number of CT scans that individuals receive, in some cases approaching or exceeding the radiation exposure from survivors of Nagasaki and Hiroshima.

I’m glad to see that the Alliance for Radiation Safety in Pediatric Imaging has announced an “image gently” campaign, designed to educate radiologists, technologists, medical physicists and parents to minimize radiation dose in children. They have an excellent website, which I recommend. See for example, the section for parents, which advises on how to be an advocate for your child. Even if you are shy about taking an active role in your own care, I urge you to do so when it comes to your kids.
The site lists five steps that radiologists should take to improve care:

1. Increase awareness for the need to decrease radiation dose to children during CT scanning. Protocol development recommendations are offered under What can I do? or directly here.

2. Be committed to make a change in your daily practice by working as a team with your technologists, physicist, referring doctors and parents to decrease the radiation dose! Sign the pledge! Click on the link on the home page to join the image gently campaign today.

3. Contact your physicist to review your adult CT protocols and then use the simple CT protocols on this website to “down-size” the protocols for kids. More is not better….adult size KV and mAs are not necessary for small bodies.

4. Single phase scans are usually adequate. Pre- and post contrast, and delayed CT scans rarely add additional information in children yet can double or triple the dose! Consider removing multi-phase scans from your daily protocols.

5. Scan only the indicated area. If a patient has a possible dermoid on ultrasound, there is rarely need to scan the entire abdomen and pelvis. “Child-size” the scan and only scan the area required to obtain the necessary information.

Imaging is expensive and growing rapidly. My guess is that CT utilization could be better controlled if patients had a better awareness of what’s involved.




Health Business Blog is a regular contributor to BioHealth Investor
________________

PPD Opens Central Lab Services Unit in Beijing

by Richard Daverman, PhD
ChinaBio Today




PPD, Inc. (PPDI), a $5.3 billion CRO headquartered in Wilmington, NC, will expand its presence in China, opening a global central lab services unit in Beijing in conjunction with Peking Union Lawke Biomedical Development Limited (PUL).

Presently, PPD has central labs in Brussels, Belgium, and Highland Heights, KY. The Beijing lab is closely coordinated with these two facilities and will offer the same services.

The goal of the Beijing lab is to serve clients in China, rather than to provide low-cost outsourcing to Western biopharmas. This point was implied by Agostino L. Fede, Ph.D., senior vice president of PPD and head of PPD's global central labs in a statement: "Chinese law makes it extremely difficult to export lab samples to other countries for testing," he said.

To facilitate setup of the lab, PPD established a relationship with PUL, investing in laboratory equipment that is installed in PUL’s facility in the Beijing Zhong Guan Cun Life Sciences Park in Beijing. Because the equipment in Beijing has been cross validated and calibrated with PPD’s existing equipment, all lab data is combinable, no matter which lab produced it. When not being used for PPD work, PUL has the option to use the equipment for its own experiments.

The lab will be led by Jian Ho, M.D., Ph.D., medical director at PUL. PPD will lead project management and investigator services and help clients with study setup. PUL will conduct chemistry, hematology, urinalysis and hemoglobin A1c tests to support PPD's clinical trials business in China.

In October 2007, PPD realigned the organization of its CRO services, establishing for the first time a vice president of clinical operation for Asia. Simon J. Britton was named as the first person to the post. Previous to the new central lab, PPD had opened facilities in Beijing and Hong Kong, plus India, Korea, Singapore, Taiwan and Indonesia.

PPD has offices in 30 countries and more than 10,000 professionals worldwide. In the last 12 months, PPD reported earnings of $163 million on revenues of $1.3 billion.




ChinaBio Today is a regular contributor to BioHealth Investor
______________

Thursday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

METABASIS THERAPEUTI [MBRX] +17.86%
CYTRX CP [CYTR] +17.49%
ALFACELL CORP [ACEL] +15.45%
ATHERSYS INC [ATHX] +15.29%
GTC BIOTHERAP INC [GTCB] +12.87%



Diagnostic Substances

SCOLR PHARMA INC [DDD] +8.41%
HUMAN GENOME SCI [HGSI] +7.29%
MONOGRAM BIOSCIENCES [MGRM] +5.74%
RESPONSE GENETICS, I [RGDX] +5.43%
EPICEPT CORPORATION [EPCT] +3.25%



Drug Delivery

MATRIXX INITIATVS [MTXX] +9.78%
ACURA PHARMACEUTICAL [ACPH.OB] +3.20%
NEKTAR THERAPEUTIC [NKTR] +2.54%
BIOVAIL CORP [BVF] +2.22%
PENWEST PHARM CO [PPCO] +1.89%



Drug Manufacturers

MIDDLEBROOK PHARMACL [MBRK] +139.20%
GENTIUM SPA ADS [GENT] +15.08%
AMARIN CORP ADS NEW [AMRND] +7.73%
SOMAXON PHARMACEUTIC [SOMX] +5.48%
PRANA BIO LTD ADS S1 [PRAN] +5.18%



Drug Related Products

CHINA SHENGHUO PHARM [KUN] +10.25%
MANNATECH INC [MTEX] +5.20%
USANA HEALTH SCIEN [USNA] +4.86%
INTEGRATED BIOPHARMA [INBP] +4.20%
TIENS BIOTECH GR USA [TBV] +2.70%



Generic Drugs

WATSON PHARMACEUTCLS [WPI] +4.20%
CARACO PHARMA LABS [CPD] +0.06%



Medical Appliances & Equipment

MEDICALCV INC [MCVI.OB] +21.95%
PATIENT SAFETY TECH [PSTX.OB] +14.29%
IVIVI TECHNOLOGIES, [IVVI] +10.43%
VARIAN MED SYS INC [VAR] +9.10%
CANDELA CP [CLZR] +9.03%



Medical Instruments & Supplies

ABIOMED INC [ABMD] +12.89%
ROCHESTER MEDICAL [ROCM] +11.70%
CPC OF AMERICA INC [CPCF.OB] +10.00%
ELECTRO-OPTICAL SCIE [MELA] +8.86%
BIOLASE TECH INCS3 [BLTI] +8.74%



Medical Laboratories & Research

SPHERIX INC [SPEX] +16.22%
RADNET INC [RDNT] +4.79%
NEOGENOMICS INC [NGNM.OB] +4.55%
MEDTOX SCIENTFIC INC [MTOX] +2.14%
PSYCHEMEDICS NEW [PMD] +1.17%





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

Hep C Developments Lead Biotechs Down

by H.S. Ayoub, DMD
BioHealth Investor



The Dow Jones was down by 450 points early Wednesday before finishing the day up by almost 300 points in a second wild trading session in a row since the Fed cut rates by 75 points early Monday. Nasdaq also gained big rising more than 1%.

But the major biotech indices did not follow along as the Amex Biotech Index (BTK), heavy with large cap biotechs, lossed more than 2%, while the Nasdaq Biotech Index (NBI) slipped 0.30%.

Leading biotechs downward was Human Genome Sciences (HGSI), whose stock lossed more than 40% on the day following a press release by the company announcing that it will have to lower the dosing of its experimental hepatitis C drug Albuferon currently in phase 3 clinical trials, due to serious lung-related adverse events. The stock closed the regular session at $5.62, down $4.40.

Coincindentally, Vertex Pharma (VRTX) finished the day down more than 10% as the company's own hepatitis C experimental drug will be tested in further trials, as the previously announced clinical data in November had mixed results. This 10% drop added to the stock's decline since November leading to a 2-year low of under $20 a share as analysts were expecting the initiation of new trials. New FDA filings for the drug are now expected by 2010. Shares closed at $20.02.




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BioHealth Investor.com
___________________

Wednesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

OPEXA THERAPEUTICS [OPXA] +63.03%
HEMOBIOTECH INC [HMBT.OB] +16.36%
IMMTECH PHARM INC [IMM] +14.69%
KOSAN BIOSCIENCES [KOSN] +14.64%
CYTRX CP [CYTR] +14.38%



Diagnostic Substances

ASPENBIO PHARMA INC [APPY] +7.92%
IMARX THERAPEUTICS [IMRX] +6.21%
IMMUNOMEDICS INC [IMMU] +4.37%
MONOGRAM BIOSCIENCES [MGRM] +4.27%
SCOLR PHARMA INC [DDD] +3.88%



Drug Delivery

MATRIXX INITIATVS [MTXX] +5.23%
NEKTAR THERAPEUTIC [NKTR] +2.90%
BIOVAIL CORP [BVF] +2.36%
GENEREX BIOTECH CORP [GNBT] +0.73%
PETMED EXPRESS INC [PETS] +0.30%



Drug Manufacturers

ACCESS PHARMACEUTICL [ACCP.OB] +26.09%
NEUROGEN CP [NRGN] +18.01%
NOVOGEN LTD ADS [NVGN] +12.60%
TELIK INC [TELK] +8.36%
DURECT CORP [DRRX] +8.25%



Drug Related Products

CURATECH INDUSTRIES [CUTC.OB] +17.86%
MANNATECH INC [MTEX] +5.70%
PRESTIGE BRAND HLGS [PBH] +4.87%
TIENS BIOTECH GR USA [TBV] +4.72%
INTEGRATED BIOPHARMA [INBP] +3.62%



Generic Drugs

CARACO PHARMA LABS [CPD] +0.44%



Medical Appliances & Equipment

CYTOCORE INC [CYOE.OB] +26.94%
MB SOFTWARE CORP [MBSB.OB] +16.67%
IRIDEX CP [IRIX] +15.47%
SOMANETICS CORP [SMTS] +12.88%
SONIC INNOVATIONS [SNCI] +8.92%



Medical Instruments & Supplies

ISORAY INC [ISR] +17.09%
EP MEDSYSTEMS INC [EPMD] +12.99%
MEDPRO SAFETY PD [MPSP.OB] +10.00%
ENCISION INC [ECI] +8.79%
SENORX, INC. [SENO] +7.68%



Medical Laboratories & Research

ENZO BIOCHEM INC [ENZ] +5.02%
AETERNA ZENTARIS [AEZS] +4.49%
NEOGENOMICS INC [NGNM.OB] +3.77%
ALLIANCE IMAGING INC [AIQ] +2.25%
BIO-REFERENCE LAB [BRLI] +1.91%





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

Nanomaterial Coatings Help Drugs Bypass Bodily Defenses

by Doug Cress
Med Tech Sentinel




A new study published in the January issue of ACS Nano offers insight into cutting edge world of drug delivery research. In the study, UCLA and Northwestern University researchers used nanoscale polymer film coatings to circumvent typical bodily defenses while delivering a drug payload.

An inert nanoscale polymer film (‘orders of magnitude thinner’ than conventional drug deliver coatings, say researchers) was used to coat sandwich-like chips which held the anti-inflammatory drug Dexamethasone.

The film was designed to ‘hide’ the chips from the body’s natural defenses.

In experiments with lab mice, coated chips suppressed the expression of cytokines, proteins released by the body during an immune system response. Uncoated implants generated an inflammatory response in the tissue surrounding the implant.

The nanomaterial coating shielded the implant from bodily defenses so effectively that tissue in the mice with no implants was virtually identical to that of mice with coated implants.

Such technology might be particularly applicable to surgically implanted devices like cardiac stents or pacemakers to avoid inflammation and redundant surgeries. Said Dean Ho, the study’s senior author,

“As implantable devices continue to find widespread application in cardiovascular medicine, neural disorders and diabetes, the nano-cloaking capabilities can serve as a widely applicable approach to enhance the lifetime of these devices. The nanomaterial technology serves as a non-invasive and biocompatible platform for the delivery of a broad range of therapeutics.”

Because of their size, nanowires and other nanomaterials hold promise in future drug delivery systems. Nanomaterials can penetrate tumors more easily and could be coated with antibodies or other materials that selectively target cells while avoiding others.

An article published in a September issue of ACS Nano reported the development of a protein coating that could turn nanowires into a drug delivery system. Gregory Bohach, David McIlroy, and Carolyn Hovde used of the coating to enable silica nanowires to enter cultured human cells and deliver a lethal dose of toxin.

The researchers report nanowires coated with the protein fibronectin penetrate cells more easily than uncoated nanowires. In experiments with human and animal cells, they showed that coated nanowires can enter and deliver a toxic agent called StxA1 that killed the cells.





Med Tech Sentinel is a regular contributor to BioHealth Investor
_________________

Tuesday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

CARDIUM THERAPEUTICS [CXM] +10.61%
MICROMET INC [MITI] +10.59%
GTX, INC. [GTXI] +6.72%
GPC BIOTECH AG [GPCB] +6.09%
ARTES MEDICAL, INC. [ARTE] +4.78%



Diagnostic Substances

IMARX THERAPEUTICS [IMRX] +12.40%
MERIDIAN BIOSCIENC [VIVO] +3.94%
ROSETTA GENOMICS LTD [ROSG] +2.83%
RESPONSE GENETICS, I [RGDX] +2.71%
PRESSURE BIOSCIENC [PBIO] +1.87%



Drug Delivery

PETMED EXPRESS INC [PETS] +21.24%
COLUMBIA LABS INC [CBRX] +1.91%



Drug Manufacturers

ADOLOR CORP [ADLR] +8.00%
COLLAGENEX PHARM I [CGPI] +6.00%
NEURO-HITECH INC [NHPI] +4.00%
KING PHARMACEUTICALS [KG] +3.74%
KERYX BIOPHARM INC [KERX] +2.18%



Drug Related Products

N B T Y INC [NTY] +4.11%
USANA HEALTH SCIEN [USNA] +1.15%
ARGAN INC [AGX] +0.18%



Generic Drugs

BARR PHARMA INC [BRL] +0.97%



Medical Appliances & Equipment

BIOFORM MEDICAL, INC [BFRM] +9.64%
PATIENT SAFETY TECH [PSTX.OB] +5.22%
CYTOCORE INC [CYOE.OB] +4.26%
ARTHROCARE CP [ARTC] +4.00%
ENDOCARE INC [ENDO] +3.28%



Medical Instruments & Supplies

OCULUS INNOVATIVE SC [OCLS] +4.38%
VENTANA MED SYSTEM [VMSI] +4.35%
BIOMERICA INC [BMRA.OB] +4.17%
BIOSPHERE MEDICAL [BSMD] +3.52%
CRYOCOR, INC. [CRYO] +3.20%



Medical Laboratories & Research

MEDTOX SCIENTFIC INC [MTOX] +2.41%
BIO-IMAGING TECH [BITI] +0.52%




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

Inhaled Insulin – Alkermes/Lilly, Mannkind

by Michael Shulman
Biotech Blitz




Given market conditions, consider this an exercise in cognitive dissonance or willful denial or some other over used term. But the topic here is biotech and life sciences, where successes typically overcome all market conditions.

The demise of Novo Nordisk’s inhaled insulin program - using technology developed by Aradigm (ARDM.OB) leaves two serious inhaled programs left for investors to scrutinize.

Eli Lilly (LLY) and Alkermes (ALKS) have developed a product called AIR Insulin that is in phase III clinical trials. Lilly is a market leader in diabetes and insulin products and understands diabetics and the doctors treating them (unlike Pfizer (PFE), who blew the commercialization of Exubera, now off the market) and Alkermes is the most successful drug delivery company in the world. If inhaled insulin is to be successful in the marketplace, it will be this tandem that delivers the success. It is an easy to use disposable device (it lasts a month) and is built around the same measurements or units of insulin that is injected.

The other player in advanced stages of development is Mannkind (MNKD). They have a technology called Technosphere. The company was founded by the founder of MiniMed, Al Mann, who has reputedly put in something near a billion bucks to get the product to market. They still do not have a Big Pharma parent – a major issue – and they and many analysts counter by saying they have the best technology and delivery system for insulin.

What should investors do? Inhaled or oral insulin is a breakthrough product – actually while most scientists believe it will never be possible, an oral insulin would be a revolutionary product -- in the hands of the right marketing company. Pfizer had no idea what to do with Exubera (and is clueless about a lot of other things, that is for another column) and Novo did not what to spend another half billion to get the product approved and onto the market. Lilly would if it continues to develop and otherwise back the product. No recommendations here – just keep an eye on this opportunity – and if Mannkind gets a partner, things could get very interesting.





Biotech Blitz is a regular contributor to BioHealth Investor
____________

Friday's Top Biotech & Medical Stocks

by H.S. Ayoub
BioHealth Investor



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Biotechnology

OPEXA THERAPEUTICS [OPXA] +18.14%
ALFACELL CORP [ACEL] +15.42% $
PROTALIX BIOTHERAPEU [PLX] +12.89%
NORTHFIELD LABS IN [NFLD] +8.57%
NORTHWEST BIOTH NEW [NWBO.OB] +7.32%



Diagnostic Substances

IMARX THERAPEUTICS [IMRX] +12.17%
ORCHID CELLMARK INC [ORCH] +8.71%
SYNTA PHARMACEUTICAL [SNTA] +5.23%
ISTA PHARMACTLS [ISTA] +4.09%
NYMOX PHARM CORP [NYMX] +2.76%



Drug Delivery

GENEREX BIOTECH CORP [GNBT] +1.43%
FLAMEL TECH SA ADR [FLML] +0.42%



Drug Manufacturers

GEOPHARMA INC [GORX] +24.80%
MARSHALL EDWARDS [MSHL] +18.50%
SYNVISTA THERAPEUTIC [SYI] +16.67%
AP PHARMA INC [APPA] +5.48%
ADOLOR CORP [ADLR] +5.46%



Drug Related Products

DRAXIS HEALTH INC [DRAX] +5.16%
NUTRACEUTICAL INTL [NUTR] +0.85%
INTEGRATED BIOPHARMA [INBP] +0.69%
NATURAL ALTERNATIV [NAII] +0.47%



Generic Drugs

HI-TECH PHARMACAL [HITK] +8.19%
CATALYST PHARMACEUTI [CPRX] +1.29%



Medical Appliances & Equipment

CELSION CORP [CLN] +20.48%
ECHO THERAPEUTICS [ECTE.OB] +13.64%
VISION SCIENCES IN [VSCI] +8.98%
WORLD HEART CORP [WHRT] +7.85%
IRIDEX CP [IRIX] +7.75%



Medical Instruments & Supplies

STEN CORPORATION [STEN] +11.27%
OCULUS INNOVATIVE SC [OCLS] +5.72%
NUCRYST PHARMACEUTIC [NCST] +3.64%
CPC OF AMERICA INC [CPCF.OB] +3.09%
VASCULAR SOLUTIONS [VASC] +2.54%



Medical Laboratories & Research

NEOGENOMICS INC [NGNM.OB] +3.77%
GENOPTIX, INC. [GXDX] +0.92%
SPHERIX INC [SPEX] +0.90%
NATL DENTEX CP [NADX] +0.77%
LABORATORY CORP NEW [LH] +0.39%






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

China to Commit 11 Billion RMB ($1.5 Billion) to Drug Innovation

by Richard Daverman, PhD
ChinaBio Today




According to unofficial reports, the State Government of China will spend a huge 4 billion RMB ($548 million) over the next five years to stimulate development of innovative drugs in China. Another 7 billion RMB ($966 million) will be allocated in the following 10 years. These funds are in addition to existing programs.

The State Council, China’s cabinet, is said to have approved the initiative on December 28, 2007, but as yet, it has not made a formal announcement of the program.

Still to be figured out is which government ministry will be in charge or dispensing the funds: the Ministry of Science and Technology or the Ministry of Health. This turf war could cause some delay in beginning the process of awarding grants.

Money will be distributed both for discovering and developing drugs. One of the questions still up in the air is whether the new initiative will favor academic projects or actual companies, another turf war. Companies feel as though they have been slighted in favor of academics in previous government projects that sought to bolster innovation in biopharma.

The government will establish major disease categories before dispensing grants. Inside each category, funds will be allocated to three major groups: small-molecule drugs, large-molecule drugs and traditional Chinese medicine.

Hepeng Jia of Chemistry World broke the funding story. He attributed the actual funding numbers to Lu Xianping, President of Chipscreen Biosciences of Shenzhen, who was consulted in the process.

At present, most of the government’s support for biopharma research has come from the 863 Program. It spent 400 million RMB ($55 million) in 2007. The new initiative will be in addition to any money that comes from the 863 Program.




RELATED READING:
- Multinational Pharma Wants More from China’s Drug Rules
- ChinaBio® Forum Gives “Most Promising” Award to Two China Biotechs





ChinaBio Today is a regular contributor to BioHealth Investor
_______________