The Food and Drug Administration, often the center of attention for the U.S. biotech and medical device industries, came under the spotlight a bit more this week amid talk of changing the agency’s mission statement. There also was news from Amylin that should address at least some concerns FDA regulators have raised about its once-a-week treatment for diabetes.
—Shares of San Diego’s Amylin Pharmaceuticals (NASDAQ: AMLN) have gained more than 13 percent since Friday, when the company said its analysis of an earlier trial found no connection between its once-weekly injectable version of exenatide (Bydureon) and prolonged heart rhythms in 148 patients. At the American Diabetes Association’s annual conference in San Diego, Amylin also said another study showed that an earlier version of the drug, the twice-daily injectable version of exenatide (Byetta), was associated with a lower risk of heart failure. At the FDA’s request, the company is conducting another trial to specifically measure the drug’s effect on the QT interval, the time the heart’s electrical system takes to recharge after each beat. Amylin shares closed yesterday at $13.37, gaining $1.54 since closing last week at $11.83.
—San Diego-based Vital Therapies recently raised $22.6 million toward a possible $56.8 million Series D financing that combines equity, warrants and securities, according to a regulatory filing. The company has developed technology to stabilize liver function in patients with life-threatening, acute liver failure, through a process akin to dialysis that uses a proprietary filter to help regenerate healthy liver cells. Since the company was founded in 2003, Vital Therapies has raised about $40 million through three financing rounds. Versant Ventures is the lead investor.
—Independa, a wireless health startup founded in San Diego two years ago, said it’s making its integrated telecare app available for beta testing. The tablet-based system enables friends, relatives, and other caregivers to monitor an elderly loved one. The technology also uses … Next Page »