Will Dynavax’ HBV Vaccine Resubmission Make The Safety Grade?
This article was originally published in The Pink Sheet Daily
Executive Summary
Company says it now has enough safety data to support a new FDA filing in the first quarter of 2016, and that it expects a superiority claim for diabetics.
You may also be interested in...
Keeping Track: New Drugs For Glaucoma, Sickle Cell Submitted; IDegLira, Brineura Reviews Extended; Keytruda Advances In First-Line NSCLC
The latest drug development news and highlights from our FDA Performance Tracker.
Heplisav-B Review Still On Track Even After Cancelled Advisory Cmte., Dynavax Says
FDA calls off November meeting to give 'more time to review and resolve several outstanding issues' with adjuvanted hepatitis B vaccine; Dynavax says agency determined meeting was not necessary to ensure regulatory decision by Dec. 15 goal date.
Dynavax Hep B Vaccine Gets Second Panel Review; Scrutiny On Safety, Superiority
After clinical hold, lost partnership and rejection by an advisory committee four years ago, Dynavax will again make its case for approval of Heplisav-B.