Guest guest Posted March 18, 2011 Report Share Posted March 18, 2011 FDA Committee Sets Review Dates for HCV Drugs Boceprevir and Telaprevir SUMMARY› The U.S. Food and Drug Administration (FDA) announced this week that the its Antiviral Drugs Advisory Committee will meet at the end of April to review data on the first eagerly awaited hepatitis C virus (HCV) protease inhibitors, Merck's boceprevir and Vertex Pharmaceuticals' telaprevir; the public is invited to attend and give their comments. The committee is expected to give a recommendation in late May, setting the stage for a full FDA approval decision this summer. New Phase 2b Study of Experimental Hepatitis C Vaccine ChronVac-C SUMMARY› Inovio Pharmaceuticals this week announced that its partner ChronTech has started a new Phase 2 clinical trial to evaluate an investigational therapeutic hepatitis C virus (HCV) vaccine candidate known as ChronVac-C. In early studies the vaccine increased T-cell responses against HCV, suppressed viral load, and appeared to be safe and well-tolerated. Quote Link to comment Share on other sites More sharing options...
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