"The Next Best Way To Block Generics" May Be Novo's Patent Use Code Switch
The generic industry has lined up against Novo Nordisk's maneuver to keep Caraco Pharmaceuticals from getting approval of a generic version of its diabetes drug Prandin
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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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A new pilot aims to take Brazil closer to ‘digital transformation.’
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Six deaths early in treatment inspired a new safety requirement for Biogen/Eisai’s Leqembi to promote early identification of patients affected by the well-known risk of amyloid-related imaging abnormalities with edema (ARIA-E).
The CBER director rejected Pfizer’s assertions that pediatric dosing gaps, supply constraints and comparative mRNA content justify keeping the vaccine under emergency use authorization for younger children.
The agency is creating two new AI councils to facilitate its role in responsible AI adoption and regulation.