FDA has historically rejected about a third of proprietary names proposed by drug sponsors. But that rate is on the rise as the agency implements changes to the review process based on post-marketing drug safety experience. For drug sponsors, that could really muck up launch plans.
It’s getting harder to get a preferred brand name for a new drug or biologic through the Food & Drug Administration. About two in five proprietary names proposed by drug sponsors are now turned down by FDA prior to the approval of a new product.
That’s a jump from FDA’s historical rejection rates. At the beginning of the decade, the agency tossed out about 33%...
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.
