In Cephalon, Teva Will Get An Expanded Innovative R&D And Branded Portfolio
The giant Israeli generics firm extols Cephalon's R&D but the deal's real value may be more nuanced: a combination of cost synergies, late-stage pipeline assets, and expansion of Teva's mix of branded products in anticipation of upcoming challenges in both the branded and generics businesses.
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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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The European Medicines Agency has revised the sponsor handbook for the Clinical Trials Information System, bringing together guidance that was previously scattered across multiple platforms and documents to help sponsors navigate the trial process more efficiently.
The long-time industry executive led several drug approvals but may have a lot to learn about the intimate details of application review and the Center for Drug Evaluation and Research.
The US FDA's Psychopharmacology Advisory Committee emphasized high standards over regulatory flexibility while turning down Otsuka's brexpiprazole plus serotonin for post-traumatic stress disorder based on conflicting Phase III trials and post-hoc Phase II analyses.