Roche’s Hemlibra Looking For CHMP Green Light, Crunch Time for Santhera DMD Hopeful
The first meeting this year of the European Medicines Agency’s key scientific committee, the CHMP, is under way in London, with a number of new drugs up for a marketing authorization recommendation.
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An unusually large number of companies are due to appear this week before the European Medicines Agency’s key advisory panel, the CHMP, to answer questions about initial marketing authorization applications or indication extension requests. The CHMP has questions regarding nine different products.
All five of the appeals against negative opinions for new drug applications that the European Medicines Agency completed last year met with failure. On the positive side, 92 new medicines were granted positive opinions, of which 35 contained new active substances.
J&J is hoping EU regulators will follow the US in fast-tracking the company’s prostate cancer franchise-extending drug apalutamide.