PHARMACY DIRECT NETWORK PBM UNDER NACDS GUIDANCE is in the start-up phase, with application materials for membership in the for-profit, non-stock membership firm scheduled to be sent to all community retail pharmacies by the end of April. The prescription drug benefits management company, set up with guidance from the National Association of Chain Drug Stores, will be based in Alexandria, Va., where NACDS is headquartered.
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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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Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.
The UK’s medicines regulator wants to ensure that guidance on the use of artificial intelligence in pharmacovigilance processes remains fit for the future.