Roche Pegasys sBLA Filing For Hepatitis B Could Receive Priority Review
This article was originally published in The Pink Sheet Daily
Executive Summary
Roche announced simultaneous U.S. and European submissions July 21; six-month review would set user fee date at mid-January. Roche is likely to highlight superiority to GlaxoSmithKline’s Epivir-HBV and efficacy in HBeAg-negative patients in promotions.