Dynavax to resubmit marketing application for Heplisav-B
US biopharmaceutical company Dynavax Technologies (Nasdaq: DVAX) has confirmed it will resubmit its marketing application for experimental hepatitis B vaccine Heplisav-B following positive Phase III trials.
A previous marketing application was rejected by the US Food and Drug Administration in February 2013, when the agency said more safety information was required.
But the latest trial, HBV-23, shows the vaccine was safe and more effective than GlaxoSmithKline’s (LSE: GSK) Engerix-B.
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