Dynavax's Hep B Vaccine Doesn't Pass Muster With FDA

Law360, New York (February 25, 2013, 4:23 PM EST) -- Dynavax Technologies Corp. disclosed Monday that the U.S. Food and Drug Administration has balked at approving its Heplisav vaccine for hepatitis B because of safety concerns, but said it's optimistic about winning the agency's blessing for narrower uses.

Dino Dina, chief executive at California-based Dynavax, said it's not yet clear what sort of additional studies will be required to win FDA endorsement of Heplisav in patients ages 18 to 70, but that existing data could be sufficient to allow sales to Americans older than 40 as...
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