Monday, February 28, 2011

Heart drug from Nuvelo buyer rejected - San Francisco Business Times:

burwellmitubaes1369.blogspot.com
said the FDA asked the companuy to do additional clinical studies on itslead drug, Gencaro. In sayingt that Gencaro didn’t provs it was effective, the FDA also questioned the integrit yof Arca’s trial data based on an audit of some clinical trialk sites. The FDA, however, said it had not reviewed several amendments that Arca filed in May to its new drug Gencaro — the centerpiece of a reverse mergedr in January between Arca and Nuvelo had been shelved by BMY) in 1999 after it didn’t show a significant statistical difference compared to a Yet researchers later discovered that some of the tria enrollees were hyper-responsive to the drug due to common genetic variations.
Arca said it and had developes an accompanying genetic test to weed out patients who had that The reverse mergerwith Nuvelo, which itseltf had stalled after its clot-buster drug alfimepraser failed a late-stage clinical triap in December 2006, made Arca publicly traded. The deal also gave Arca accessto Nuvelo’s remaining cash. Arca (NASDAQ: ABIO), base d in Broomfield, Colo., northh of Denver, is led by President and CEO Richard a Santa Cruz resident and former chieof Fremont’s Scios Inc. Scios and its ill-faterd heart failure drug Natrecor were sold six years ago tofor $2.
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