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News Breaks
February 18, 2014
09:18 EDTDVAXDynavax withdraws EU marketing application for HEPLISAV
Dynavax Technologies announced that it has withdrawn the European Marketing Authorization Application for HEPLISAV, its investigational hepatitis B vaccine. The Day 180 List of Outstanding Issues provided by the European Medicines Agency indicated that the current HEPLISAV safety database is considered to be too small to rule out a risk of less common serious adverse events. Dynavax has chosen to withdraw the application because the required timeframe for response under the MAA procedure is not long enough to permit the collection of the necessary clinical data. Dynavax expects to begin shortly an additional HEPLISAV clinical trial, HBV-23, that is intended to provide a safety database sufficient to support licensure.
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September 22, 2014
06:02 EDTDVAXDynavax completes enrollment of HEPLISAV-B Phase 3 study
Dynavax Technologies announced completion of planned enrollment in the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. More than 8,250 adults, including over 1,100 diabetic subjects, have been enrolled at 40 sites in the U.S. This large safety and immunogenicity study is intended to provide an adequately-sized database of vaccinated subjects to enable the FDA to complete its review of the pending HEPLISAV-B Biologics License Application. The study is also designed to assess the immunogenicity of HEPLISAV-B in adults for whom approved hepatitis B vaccines are less effective, including those with type-2 diabetes mellitus.

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