FDA staffers question Q-Med data; BioSante shares shoot up on adjuvant efficacy;

> Two days ahead of a scheduled expert panel meeting, FDA staffers have released their concerns about the data filed by Q-Med AB for Durolane, an injection for arthritis knee pain. Two studies for the therapy were done outside the U.S. without FDA review and one of the studies found no statistical difference between the drug and a placebo. Report

> BioSante shares shot up this morning after it said that its adjuvant increased the efficacy of vaccines designed to guard against various flu strains, including swine flu. Story

> After years of difficulties gaining FDA approval for its lead drug candidate, Discovery Labs announced Thursday the resignation of Robert Capetola, its CEO since the company's founding 13 years ago. Board Chairman Thomas Amick, a Johnson & Johnson alum, has been appointed as interim CEO and remain in the position until Discovery secures much-needed cash or partnerships. Report

> India's Aurobindo Pharma got the green light from its board to acquire Hyderabad-based Trident Life Sciences for about $28 million. Aurobindo says the buyout gives the company a chance to enter the injectables business. Story

> The FDA has approved Extavia (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis medicines from Novartis. Release / Report

> Shares of Immunomedics jumped on Friday after the FDA gave it the go-ahead to start early-stage trials of a new therapy for multiple myeloma. Report

Pharma News

> Gardasil will have another chance at broader use next month. The FDA's vaccines advisory committee will meet to consider data on use of the human papillomavirus vaccine in boys and young men. Meanwhile, Gardasil faces a threat at the same committee meeting next month. Report

> Pharma's heavyweight status in the healthcare reform fight has claimed a high-profile victim: former House Republican leader Dick Armey. The Congressman-turned-lobbyist quit his job at the DLA Piper firm, apparently because some drug company clients complained about his extracurricular opposition to healthcare reform. Report

> If patients just took their meds as directed, pharma sales would grow significantly. That's why drugmakers have been trying all sorts of ways to remind folks to take their pills: mailings from the pharmacy, emails, you name it. Maybe the government should join in on the compliance push. Report

> Vaccines are one of the healthiest segments of the pharma market these days. So it's no surprise that two Big Pharma firms are locked in an intense squabble over vaccine-related patents. The question is, how will the battle shake out--and will it throw a kink into anybody's shot production? Report

Biotech IT News

> WuXi AppTec has purchased the Provantis preclinical software from Instem for use in a newly constructed, 314,000-square-foot toxicology facility in Suzhou, China. Report

> Comedian Bob Monkhouse is tweeting "from beyond the grave" to solicit contributions for the Prostate Cancer Research Foundation. Monkhouse died in 2003 of the disease. Report

> Publishers are exploring methods to make supporting data and software more readily available with scholarly papers, reports Genomeweb. The idea is to help users finding and share research results in online literature. Report

> The cancer center at Massachusetts General Hospital now has a genetic analysis system from Helicos Biosciences. Report

And Finally... Scientists said a profile of the chemicals released from decomposing bodies could also lead to a valuable new addition to the forensic toolkit: An electronic device that could determine the time elapsed since death quickly, accurately and onsite. Release