6/30/2011 8:16:35 AM
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.
comments powered by