Prostate Cancer Risk Reduction sNDAs Go Before ODAC, Pitting Statistical Versus Clinical Significance
• By The Pink Sheet Daily
GlaxoSmithKline's Avodart and Merck's Proscar reduce the risk of low-grade prostate cancers in trials, but FDA's Oncologic Drugs Advisory Committee will hear the agency argue on Dec. 1 that the actual benefit of this is questionable.
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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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Final guidelines explaining how staff at Canada’s Patented Medicine Prices Review Board should go about identifying drugs that could be considered for an excessive price hearing will come into force soon.
Denmark is shaking up clinical trial timelines with a new process for reviewing applications for early-phase mono-national trials that is twice as fast as the standard timelines in the EU and the UK.
The legislation expected to be signed by President Trump is a mixed bag for pharmaceutical manufacturers depending on their product mix and manufacturing situation.