News

IDM Pharma gets new CEO as founder departs

IDM Pharma said founder, president and CEO Jean-Loup Romet-Lemonne is leaving to "pursue other opportunities." The board named Timothy Walbert, the former EVP of commercial operations at NeoPharm, to the CEO's job.

"Our immediate priority will be continuing to work with the regulatory authorities in the U.S. and Europe to complete the review process of Junovan," says Walbert. "Based on the Phase III results of the trial with Junovan, we are committed to an ongoing dialogue with the …

Docs shunning Avandia in wake of safety study

In another blow to GlaxoSmithKline, researchers say that Avandia's share of the market for newly prescribed oral anti-diabetics dropped from 10 percent to 0 percent in the two days after an NEJM study highlighting the drug's previously undisclosed safety risks. Most of those prescribers have evidently been shifting to …

SPOTLIGHT: Shareholders blast Dendreon


Angry shareholders have sued Dendreon, claiming that the company misrepresented its clinical data for Provenge and failed to provide clear guidance on when the FDA would make its decision on the prostate cancer drug. Several weeks ago the agency demanded more data on Provenge before it could be approved. Report

ALSO NOTED: FDA delays FluMist decision; Experts to meet on Tysabri for Crohn's; New biotech campus planned; and much more...

> The FDA says that it will delay a decision on extending the age range allowed for FluMist until MedImmune brings its UK facility into compliance. Regulators cited the facility last March. Regulators also say that their warning shouldn't disrupt the delivery of MedImmune's nasal flu vaccine. Report

> An FDA advisory panel will meet on July 31 to review the case for using Tysabri against Crohn's disease. …

Going global


I'd like to thank everyone who tuned in to yesterday's live webinar on animal-based therapeutics in New Zealand. The call connected experts in New Zealand with a truly global audience. In case you missed it, you'll find the …

AtheroGenics halves payroll as it scrambles to restructure

Faced with the April departure of a key development partner, AtheroGenics revealed that it has cut its work force in half, leaving 67 people on the payroll. This is just the first step in the company's restructuring plans, which revealed the cuts in documents filed with the SEC. More cuts are expected as the company circles its wagons around its lead candidate: AGI-1067. AstraZeneca pulled out of its partnership with AtheroGenics after a trial failed to show a significant difference from …

VaxGen shutters program, axes staff in second retrenchment

Troubled VaxGen has taken the axe to its budget for the second time in five months, chopping out a quarter of its workforce - 20 people - following the cancellation of a government contract for its anthrax vaccine. VaxGen is also halting any further development work on its recombinant anthrax vaccine and is actively searching for a partner. The South San Francisco-based developer handed pink slips to more than half of its staff at the beginning of the year after the company lost the …

Senator attacks FDA over its handling of Avandia

Influential U.S. Senator Charles Grassley ripped into the FDA yesterday, saying the agency's own data analysis demonstrated that the diabetes drug Avandia raised the risk of cardiovascular incidents and that up to 100,000 heart attacks could be linked to the drug since it was approved eight years ago. But agency officials held off putting a "black box" warning on the drug, which earned $2.2 billion last year, as it waited for new data from an ongoing study that won't be available for two …

Amgen prepares to appeal European rejection of Vectibix

Amgen is planning to appeal a decision by the European Committee for Medicinal Products for Human Use to reject Vectibix for use against colorectal cancer that has spread to other parts of the body and not responded to chemotherapy. The FDA approved Vectibix last September and the biotech giant believes that its data on progression-free survival will ultimately win over the Europeans.

- here's the AP's …

European regulators green-light a host of new drugs

There was a lineup of important European drug decisions released today. At the top of the list:

European regulators have given a green light to Glaxosmithkline's OTC version of the obesity drug Xenical.

- check out the report from The Scotsman

ALSO: France's Ipsen announced that the CHMP recommended marketing authorization for Increlex. A formal approval will trigger a $20 …

SPOTLIGHT: Helicos cuts IPO price


Helicos BioSciences has cut its IPO price for the second time. The company cut the price per share to $9 after originally citing a range of $13 to $15 a share. The company plans to launch the HeliScope system for genetic analysis in the fourth quarter. Report

ALSO NOTED: Integrated BioPharma looking to spin-off biotech; Eli Lilly to buy Ivy Animal Health; Novagali gains orphan status;

> Integrated BioPharma has retained Merriman Curhan Ford to act as an adviser in the divestiture of its InB:Biotechnologies subsidiary. INBP now expects that the divesture will be structured as a spin-off of Biotech, which will focus on its patented plant-based technology for the production of vaccines, antibodies and therapeutic proteins. …

Troubled CV Therapeutics uses axe on budget, jobs

Struggling to counter the effects of disappointing trial data, CV Therapeutics unveiled a restructuring effort aimed at chopping out $75 million a year in expenses. The cuts include an unspecified number of jobs and a slice of its R&D budget. The actions quickly followed the announcement that Third Point investors group has taken a 9.9 percent stake in CV. The budget axe is falling just weeks after the company announced that its experimental drug ranolazine had failed to hit a primary …

Glaxo blueprints major new Shanghai research center

GlaxoSmithKline has named Dr. Jingwu Zang to run a major new R&D center in Shanghai which will focus on developing a new generation of neurodegenerative drugs. Glaxo plans to concentrate all of its research on such diseases as Parkinson's and Alzheimer's at the center, taking its drugs from target identification through late-stage trials. The center is designed to grow into one of the largest research efforts within Glaxo's multinational operations.

"We intend to be part of a …

Diabetes expert issued harsh Avandia critique in 2000

The president-elect of the American Diabetes Association accused GlaxoSmithKline of "rampant abuse of clinical trial data" in a letter sent to the FDA seven years ago. The letter also spells out John Buse's concerns about cardiovascular deaths and adverse events experienced by patients taking Avandia to control diabetes. A new study in the NEJM has determined from long ignored trial data that Avandia raises the risk of heart attacks by 43 percent and increases the risk of death by a …

Nektar cuts $65M in costs in restructuring

Nektar Therapeutics sliced out $65 million in annual expenses and announced a series of personnel changes that includes the departure of its CFO. Nektar says that the changes will help advance the company's pipeline. Researchers plan to complete a Phase IIb clinical trial of NKTR-061 (inhaled amikacin) to treat hospital-acquired gram-negative pneumonia by year-end. Additionally, the company plans to initiate Phase II clinical trials by the end of the year in its two leading PEGylated …

Biolex pockets $30M for drug discovery work

Pittsboro, NC-based Biolex Therapeutics has raised $30 million in its third round with Investor Growth Capital of New York leading the way. Much of that money will go to advancing Locteron into Phase III clinical development in hepatitis C. Sunny Sharma, M.D., vice president with Investor Growth Capital, has joined the Biolex board.

"We are pleased to be a part of the Biolex story, which has some very interesting product and platform attributes," said Sharma. "Locteron has the …

SPOTLIGHT: Acomplia knockoffs made in India


A newspaper is reporting that three Indian drug companies have already begun making a knockoff of sanofi-aventis' obesity drug Acomplia. And at least one of the companies says it will launch the generic competitor in any countries where it would be allowed by law. Indian law protects only those drugs patented after 1995, and Acomplia's patent dates to 1994. Report

ALSO NOTED: Advanced Medical eyes Bausch & Lomb; Departing Pfizer execs pocket millions; Shire announces positive ADHD data

> Shares of Bausch & Lomb surged this morning after Advanced Medical announced that it was willing to top a $3.7 billion bid made by Warburg Pincus. Report

> Departing Pfizer CFO Alan Levin is taking a $2 million severance payment while the exiting R&D chief John LaMattina will pocket $3.3 million on the way out the door. Their successors are …