Manufacturing Issues Delay Half Of Pending BLAs, CBER’s Yetter Says
• By The Pink Sheet
Half of the active pending BLAs at the Office of Therapeutics Research & Review as of Jan. 1 have manufacturing concerns, Center for Biologics Evaluation & Research Associate Director-Review Management Robert Yetter, PhD, said
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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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While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
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