Sanofi Pasteur/Merck Expect Hexavac Market Return Following Suspension
Executive Summary
Merck is working with European regulatory authorities to address immunogenicity concerns involving the hepatitis B component of its Hexavac pediatric vaccine
You may also be interested in...
Hexavalent vaccine surveillance
Aventis and GlaxoSmithKline's hexavalent vaccines under surveillance by European regulatory authorities following report of four deaths in two-year-olds within 48 hours of vaccination with Aventis' Hexavac. Hexavalent vaccines are not licensed in the U.S.; Aventis has said it will file Hexavac with FDA in 2005-2006...
Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials