controversy

In Austin, VC is booming for biotechs

Fri, 28 Mar 2008 07:59:55 -0400

Further evidence of Texas' growing power in the biotech industry: the Austin Business Journal reports that in recent months, central Texas-based life science outfits have attracted about $500 million in VC. "The 'we can't do bio in Austin' attitude is no longer true," said Isaac Barchas, director of the University of Texas' IC2 Institute. "Taken together, it feels like this is the moment when things are happening in bio. I think in two years we'd point to this moment and say, 'that was when things started to happen.'" Texas' biotech efforts--particularly its $3 billion bond program for cancer research--propelled it to first place on FierceBiotech's annual list of the top five regions attracting biotech business.

- see the Austin Business Journal piece
- read FierceBiotech's special report on Texas. Report

Related Articles:
Texas' $3B cancer program draws controversy. Report
Texas touts $3B plan for cancer research. Report
Venture group targets tech transfer deals in Texas. Report

Cepheid cashes in on MRSA trends--for now

Fri, 07 Mar 2008 06:59:56 -0500

With cases of antibiotic-resistant MRSA multiplying and fear of the superbug rising, Cepheid was perfectly positioned when it came out with a rapid genetic screening test. Sales have soared as Cepheid has reaped the benefits of new programs that use the screening test to identify MRSA and isolate patients. But as a profile of the company in The New York Times makes clear, the test has spurred controversy over the best way to combat MRSA. Rather than test and isolate patients, critics contend hospitals would be better off if they stuck with hospital-wide campaigns to ward off the bug with regular hand washing campaigns and other such tactics. Meanwhile, as Times scribe Andrew Pollack points out, companies such as Gen-Probe, Roche and Qiagen are advancing their own tests. Cepheid may not have this market to itself very much longer.

- read the article from the New York Times

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Study finds alarming spread of MRSA. Report

Experts debate FDA signals on cancer drug approval

Tue, 04 Mar 2008 06:59:55 -0500

When is a cancer therapy good enough? The Boston Globe examines answers to that question following the recent controversy over the FDA's decisions in the field. Most recently, Avastin gained a new approval after it demonstrated an ability to delay the development of breast cancer tumors. But researchers never demonstrated an improvement in symptoms or the drug's ability to extend patients' lives.

"If the goal of any new therapy is to cure metastatic breast cancer, it is going to be a very long time--if ever--before we see it," Dr. Maurie Markman, vice president for clinical research at M.D. Anderson Cancer Center in Houston, tells the Globe.

But where's the real benefit for patients? A number of experts say that research should set out to prove if a therapy actually improves their quality of life. But others are quick to add that that can be a very ambiguous standard.

- read the report in The Boston Globe

Related Articles:
Does Avastin nod lower approvals bar? Report
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Will FDA care about new Avastin study? Report

Financial conflicts raise questions over trial results

Wed, 30 Jan 2008 06:59:55 -0500

A bubbling controversy over a clinical trial for a new device to cure back pain is being used to highlight how conflicts arise when researchers stand to gain financially from an experimental product's success. The case in point focuses on Prodisc, an artificial disk that has compared favorably to spinal fusion in clinical trials. Doctors in about half of the trial centers stood to earn money from its success. And now the FDA is investigating the case while the manufacturer--Synthes--is ducking questions from The New York Times. The study results eliminated a large number of people, including some who say they had a poor response to the device.

"The surgeons themselves are guilty of being insufficiently critical of products and techniques they are developing," Dr. Richard A. Deyo, a medical professor at Oregon Health and Science University, told The Times. "More people are interested in getting on the gravy train than on stopping the gravy train."

- check out the article from The New York Times

ALSO NOTED: Cardiome awaits FDA decision; Congress to investigate Vytorin scandal; and much more...

Fri, 18 Jan 2008 06:59:50 -0500

> Cardiome is awaiting a critical FDA decision on its drug vernakalant. Report

> It seems that many black U.S. residents are less likely to participate in clinical studies, possibly due to distrust of physicians and fears that they might be harmed by participation, according to a study published in the journal Medicine. Report

> Amgen, you're being served. The New Jersey Attorney General has sent out a subpoena to the California company, asking for "a comprehensive array of documents and information" related to Enbrel sales and marketing. Report

> The deadline bell has rung. At final count, more than 50,000 Vioxx plaintiffs have registered for the $4.85 billion settlement. Report

> Congress is promising hearings on the Vytorin controversy. Report

And Finally... What's in a name? Drug-naming experts are charging hundreds of thousands for just the right combinations of vowels and consonants. Report

Human embryo clones unveiled by CA scientists

Thu, 17 Jan 2008 06:59:54 -0500

Scientists in California made embryo clones of two men, a step toward developing new stem cells for therapeutic purposes. But a number of experts quickly noted that cloned embryos of humans have been made before. The next key advance would be developing new stem cell lines from the clones. "It's only a mater of time before some group succeeds," notes one expert.

- see this release
- check out the report in the International Herald Tribune

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Foundation draws charges of industry influence

Mon, 07 Jan 2008 06:59:56 -0500

The Reagan-Udall Foundation was created by Congress to ramp up innovation in drug science, help the FDA sort through complex new technologies and improve drug safety. But before it even begins operations, lawmakers are charging that it's vulnerable to manipulation by a widely mistrusted pharma industry and includes one board member charged with muting claims that a diabetes drug raised heart risks. For some observers, the controversy surrounding the foundation underscores the awful reputation of the pharma industry and threatens the utility of the new group. For now, the Foundation appears to be ready to proceed using mostly private funds--which won't do anything to improve its reputation among Congressional critics.

- read the report from the Star-Ledger

Related Article:
FDA, Big Pharma team up on drug research center. Report

Mass. Bio members distraught over new controversy

Wed, 05 Sep 2007 06:59:56 -0400

With a fresh controversy swirling around newly appointed Executive Director Robert Coughlin, the Massachusetts Biotechnology Council is being hit with criticism from its own members concerned that the group is constantly finding itself mired in one political scrap after the next. Coughlin has been hit with allegations that he had a conflict when he worked as an aide to the governor, developing biotech initiatives while he was being considered for the top post on the council. His predecessor, former House Speaker Thomas Finneran, was forced to resign after he pleaded guilty to obstruction charges.

"It's a real shame," Alison Taunton-Rigby, chief executive of RiboNovix, told The Boston Globe. "We are an industry that is very clean and very pure and it hurts to have things like this happen."

- here's the article from The Boston Globe

Texas'$3B cancer program draws controversy

Tue, 04 Sep 2007 06:59:56 -0400

Texas voters will have the final say on a proposed $3 billion effort to support cancer research over 10 years inside the Lone Star state. This is the brainchild of the governor, who's clearly anxious to match the $3 billion stem cell program underway in California. And even though it emphatically has no connection to embryonic stem cell work, Texas' proposed program is already generating controversy.

Some researchers are uncomfortable with the way an 18-member panel is supposed to be selected to manage the money. Some say that with half of the committee made up of non-voting representatives of schools and the other half drawn from cancer groups, physicians and treatment centers, a majority may not have a very solid understanding of what they should be evaluating. Others want a significant number of non-Texans to be involved in peer review to help eliminate any conflicts that could arise.

- read the report from the Wall Street Journal

Related Articles:
Texas touts $3B plan for cancer research. Report
Mass. governor files $1B biotech bill. Report
California stem-cell institute open for business. Report

Gilead touts Phase III Hep B results

Mon, 25 Jun 2007 00:01:36 -0400

Gilead is reporting that a Phase III trial of its HIV drug Viread was more effective at reducing amounts of the hepatitis B virus than the company's other antiviral drug, Hepsera. At 48 weeks, 66.5 percent receiving Viread had a complete response compared to 12.2 percent in the Hepsera arm. "The preliminary data observed in both Phase III trials evaluating Viread as a potential treatment option for chronic hepatitis B are very encouraging," said Franck Rousseau, MD, Vice President, Clinical Research, Gilead Sciences. "We look forward to reviewing these data with regulatory authorities and are working quickly to file a New Drug Application in the United States and Marketing Authorization Application in Europe in the fourth quarter of this year."

- read the release

Related Articles:
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Viread program mired in controversy. Report

SPOTLIGHT: Finneran resigns from council

Tue, 09 Jan 2007 19:01:33 -0500

The controversy over Thomas Finneran's agreement to plead guilty to a felony on Friday proved fatal to his attempt to remain as head of the Massachusetts Biotechnology Council. Finneran, the former House speaker and prominent Democrat, turned in his resignation yesterday. Report

Northfield shares hammered on late-stage results

Tue, 19 Dec 2006 19:01:38 -0500

Shares of Northfield Labs were halved after the company announced that a higher number of patients receiving its blood substitute died in a late-stage study compared to the number of deaths among patients getting standard care. Altogether, 46 of 349 patients receiving PolyHeme died compared to the deaths of 35 people among 365 receiving standard care. Northfield maintains that part of the data supports PolyHeme and added that mistakes were made in the trial. But investors bailed, sending its shares down 51 percent, which followed a 20 percent dive that occurred Tuesday after the company announced its plans to discuss the data.

Northfield insists that once you exclude the people who were inappropriately enrolled or improperly treated, Polyheme demonstrated that it was not inferior to standard therapy. More safety data will be available in four to six weeks, researchers added, as the company plans to proceed with an application for FDA approval. A number of analysts weren't buying it, though, saying that any application from Northfield would be subject to intense scrutiny.

- check out Northfield's press release on the data
- here's the article from The Chicago Sun-Times

Related Articles:
Northfield controversy grows over trial data. Report
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Senator claims FDA ignored Polyheme charge. Report

FDA puts hold on Phase II anthrax vaccine trial

Thu, 02 Nov 2006 19:01:35 -0500

The FDA has put a clinical hold on VaxGen's next Phase II trial for its troubled anthrax vaccine, "because data submitted to date by the company are insufficient to determine that the product is stable enough to resume clinical testing." In the notification, VaxGen added, the agency expressed concerns that the vaccine's potency could decline during the immunization phase of the trial, potentially resulting in an uninterpretable outcome.

VaxGen has run into repeated trouble with the FDA over its anthrax vaccine. The agency has accused VaxGen of making exaggerated claims about the vaccine and threatened court action this year in an effort to make the company shape up. And the Washington Post reported last spring that trouble in developing the vaccine was delaying delivery past an agreed November deadline.

- here's the release on VaxGen

Related Article:
VaxGen's vaccine program in doubt. Report

NIH group accuses Lilly of manipulating guidelines

Wed, 18 Oct 2006 20:01:37 -0400

A group of top scientists at the NIH have accused Eli Lilly of orchestrating the creation of medical guidelines in order to push sales of its sepsis drug Xigris. And they add that the company is now lobbying to make the use of Xigris for sepsis a quality standard that would earn physicians who use the drug additional bonus funds. Senior NIH investigator Dr. Peter Q. Eichacker says that people deserve to see medical guidelines developed without the undue influence of the drug industry. And they warn that drug companies instead are using the guidelines as a powerful method for promoting products. A statement from Lilly said that the company did not believe that Lilly had played a role in creating the guidelines and that it had always been open about its funding of the initiative.

- check out the report on Lilly from The Boston Globe

Report: Project BioShield fails to deliver

Sun, 17 Sep 2006 20:01:35 -0400

The New York Times concludes that the country's $5.6 billion Project BioShield is largely a bust so far. Big pharma never did like the low upside or liability risks associated with developing new therapies for anthrax and other potential bioterror weapons. But perhaps the government's biggest problem was being forced to deal with small biotech companies that made large promises they couldn't keep. VaxGen comes in for star treatment, of course, with its troubled $900 million effort to develop a new vaccine for anthrax. And with the program mired in controversy over hardball lobbying efforts, other drug developers say they're even less likely to jump in now.

- read the article on Project BioShield from The New York Times

Gene therapy makes a big comeback

Sun, 27 Aug 2006 20:01:36 -0400

After running into a buzzsaw of controversy over the safety of gene therapy studies, the Los Angeles Times notes that the field has made a big comeback. There are currently more than 300 gene therapy trials underway and solid evidence that the approach can help patients with Parkinson's and other lethal immune disorders. Gene therapy works by replacing the faulty genes that cause the disorders with healthy ones.

- read the The Los Angeles Times report on gene therapy

FDA clears Plan B, ending FDA confirmation fight

Wed, 23 Aug 2006 20:01:38 -0400

After three years of regulatory limbo, Barr Laboratories has won the right to market the Plan B contraceptive without a prescription. Women over 18 will be required to show proof of their age to buy the drug while under age girls will still need a prescription. Plan B has been a favorite cause on both sides of the political divide. Opponents say that OTC access of what it calls an "abortion pill" would encourage promiscuity and further spread sexually transmitted diseases while backers have insisted that the FDA had to approve the drug before they would allow Bush's nominee to run the agency gain official title to his office. In the end, the shift happened swiftly as Andrew von Eschenbach signaled a desire to deal with the controversy and move on. Resolving the impasse over Plan B is likely to swiftly lead to a Senate confirmation of his nomination.

- check out the article on Plan B from The Washington Post

Hedge fund blasts Nabi management, demands sale

Wed, 16 Aug 2006 20:01:39 -0400

A hedge fund with a big stake in Nabi Biopharmaceuticals is stepping up its campaign to force a sale of the company. Third Point's Daniel Lobe, no stranger to confrontational tactics, has accused top management of burning through cash and failing to meet expectations on Wall Street. CEO Thomas McLain came in for some particularly harsh comments. "Mr. McLain has made one blunder after another, making him, in our opinion, one of the most disliked and least-respected executives in the biotechnology industry," said Loeb in a statement. Nabi endured the attack--and unsolicited advice--in silence.

- here's the report on Nabi from The Wall Street Journal (sub. req.)

Biovail trading halted on generic court decision

Tue, 01 Aug 2006 20:01:38 -0400

Canada's Biovail got some more unwelcome news today when a judge ruled that Anchen Pharmaceuticals did not violate its patent on Wellbutrin XL with its generic version of the drug. Trading of Biovail shares was halted as the news hit the wires. Biovail makes most of its money from Wellbutrin XL. While analysts had been looking for a mid-2007 entry of generic competitors, this ruling could well open the way to a much faster rollout. Meanwhile, Biovail's chairman has been accused of violating Canada's insider trading regulations, and the SEC is investigating the company's accounting practices. Shares of GlaxoSmithKline, the marketing partner for Wellbutrin XL, had slipped 2 percent on the announcement.

- check out the Globe and Mail report on the decision

ALSO: A number of experts say the case against Biovail founder Eugene Melnyk will be hard to prove. Report

Biovail chairman charged with securities violations

Mon, 31 Jul 2006 20:01:36 -0400

Canadian officials have accused Biovail chairman Eugene Melnyk of violating securities laws by failing to disclose that offshore family trusts controlled 12 million shares of the drug developer. Canada's top securities regulator says that Melnyk is required to disclose the trust's control of the shares under insider trading rules. Melnyk, however, denied that conclusion, saying he didn't own the shares after the trusts were created. Biovail wasn't charged with Melnyk and a former board member who acted as the stockbroker in the transaction. The SEC, though, is investigating Biovail's accounting practices.

- read the article on Biovail from The Wall Street Journal (sub. req.)