FDA drug reviewers indicate they are split on the safety of Avandia in GlaxoSmithKline’s RECORD study. Their views are included in briefing documents made available prior to the advisory committee meeting on July 13.
FDA advisory committee to review Avandia data to determine whether the diabetes drug has real safety signals in the cardiovascular area.
Accreditation Council for Continuing Medical Education issues its 2009 annual report on CME activities. The number of CME activities has declined over the past two years and income has dropped from $2.54 billion in 2007 to $2.18 billion in 2009.
A decision against AstraZeneca by the European Court of Justice suggests a hardening line against manipulating patent and regulatory systems to discourage competition. AZ’s fine is minor, but the ruling may empower the European Commission to act more swiftly and more punatively.
