1. Pink Sheet

Second Time Lucky For Dynavax’s Hep B Vaccine In EU?

 
• By Neena Brizmohun

The European Medicines Agency is set to decide whether Dynavax’s “fewer dose” Heplisav-B vaccine should be authorized for use across the EU – years after the company experienced a setback with its first attempt to get the vaccine approved.

Vaccination healthcare concept. Hands of doctor or nurse in medical gloves injecting a shot of vaccine to a man patient
Dynavax's two-dose hepatitis B vaccine is up for a CHMP opinion • Source: Shutterstock

Dynavax Technologies should find out this week whether its EU marketing application for its hepatitis B vaccine is likely to fare better than its previous attempt to secure European approval for what appears to be the same product years ago.

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