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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Aspen Neurosciences and BlueRock Therapeutics see hope for artificial intelligence to improve the quality of cell therapies to replace dopaminergic neurons in Parkinson's disease.
While Japan tries to balance its healthcare costs, the major US industry group is concerned reimbursement pricing practices in the country could influence US levels under Trump's MFN policy.