Dynavax Initiates Phase 3 Study of HEPLISAV-B

April 15, 2014 Dynavax Technologies Corporation today announced initiation of a new phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine. This large safety and immunogenicity study (known as HBV-23) was designed to address the Complete Response Letter regarding the HEPLISAV-B Biologics License Application that was issued to Dynavax by the U.S. Food and Drug Administration in …

Dynavax Withdraws European Marketing Authorisation Application for Hep B Vaccine

Yesterday, the 18th of February 2014, Dynavax announced that it would be withdrawing it’s European Marketing Authorisation Application for it’s investigationalĀ hepatitis B vaccine Heplisav. The decision comes after the the European Medicines Agency indicated that the current safety data is too small to rule out the risk of less common but serious adverse events. Dynavax state that the time frame …