In the first blemish for Gilead’s previously spotless hepatitis C candidate, GS-7977, the company unveiled data showing that six of eight “null responders” experience viral relapse four weeks after ending treatment with the drug. The news sent Gilead’s share price tumbling. The compound had a 100% cure rare in a small Phase II trial last year, leading Gilead to pay almost $11 billion to buy out its developer, Pharmasset.
On Feb. 17, FDA said a long-term cardiovascular outcome trial is necessary to determine the risk for major CV adverse events in patients taking Vivus’ weight-loss drug Qnexa. The agency will ask an advisory panel whether the trial must be conducted prior to approval.
