Provisions included in a Plavix patent infringement settlement agreement between Sanofi-Aventis/Bristol-Myers Squibb and Apotex "foresaw the possibility that Apotex would launch a generic product and prohibited Sanofi from seeking injunctive relief for a specific period of time after the launch occurred," Manhattan Federal Judge Sidney Stein said in an Aug. 31 ruling, refusing to grant a recall of generic clopidogrel
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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.’
Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.
Agency staff once again have access to the Lexis-Nexis legal and news database, but are still waiting for access to journals, and laid off librarians have not been reinstated.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
