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Nov 19, 2012
 |  BC Week In Review  |  Clinical News  |  Regulatory

Heplisav regulatory update

FDA's Vaccines and Related Biological Products Advisory Committee voted 8-5 with 1 abstention that Dynavax had not gathered enough safety data to support approval of Heplisav, an adjuvanted vaccine for HBV. The panel did vote 13-1 that the company demonstrated Heplisav's efficacy.

Heplisav is a hepatitis B surface antigen (HBsAg) given with immunostimulatory DNA sequences that target...

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