The House Energy and Commerce Committee is considering the need for legislation to set new parameters for organizations involved in drug development. Their concern is prompted by the failure of individuals overseeing safety study 3014 for Sanofi-Aventis' Ketek (telithromycin) to report investigator misconduct to FDA
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While treatments for scleroderma are in development, none are approved for the condition that is associated with high morbidity and mortality. The European Medicines Agency says guidance on how to design development programs for the disorder is needed.
Madrigal Pharmaceuticals’ Rezdiffra is on track to become the first medicine approved in the EU for non-cirrhotic metabolic dysfunction-associated steatohepatitis after the European Medicines Agency recommended that it be granted conditional marketing authorization.
Highlights from Day Four of the BIO International Convention include policy concerns helping constrain dealmaking, Novartis discussing its approach to partnering, and Generate looking for funding to move into Phase III.
