Generic biologics was not a priority for Andrew von Eschenbach when he accepted the job as acting commissioner of FDA. But two events -- a federal court ruling requiring a decision on Sandoz' Omnitrope NDA and the European Union approval of the follow-on biologic -- mean FDA may be pressed to take action on a regulatory pathway. The Omnitrope ruling makes it more important than ever that FDA have a fully confirmed leader in place, but it will also make it harder to get one.
By Kate Rawson
Andrew von Eschenbach really didn’t want to deal with follow-on biologics when he accepted the job as acting commissioner of...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
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.
