European Regulatory Round-Up: New Faces; Revised Guidances; More Cost Controls
A new chairman will take the helm of Germany's G-BA panel at a pivotal time for AMNOG implementation; the European Medicines Agency issues guidances in oncology drug development and genotoxicity; more regulatory updates.
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Decisions by Germany’s drug benefit assessor, IQWiG, to recommend novel prostate cancer treatment Zytiga and reject me-too diabetes treatment Trajenta may allay confusion over just how well the country’s new added value assessment process is working
Price cuts and austerity measures made 2011 a bleak year for European pharma. These dynamics are more severe but not new, and likely will accelerate firms’ existing geographic expansion and market access strategies.