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November 15, 2012
13:44 EDTDVAXFDA panel votes against backing Dynavax's Heplisav, Bloomberg reports
An FDA panel voted against recommending approval of Dynavax's hepatitis B vaccine Heplisav, saying the company provided inadequate safety data, Bloomberg reports.
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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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