The European Medicines Agency has begun reviewing a number of new medicines for potential pan-EU marketing authorization, including three investigational orphan drugs –Nefecon (budesonide), maribavir and copanlisib, from Calliditas Therapeutics, Takeda Pharmaceutical and Bayer respectively.
Orphan Drugs Nefecon, Maribavir & Copanlisib Among New EU Filings
US Filings For The Orphan Drugs Are Under Review
Marketing applications for two generic versions of the multiple sclerosis blockbuster, Tecfidera, are also under review by the European Medicines Agency.

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Faced with Trump’s hostile tariff moves, the UK aims to speed up clinical trial start times to support its pharma sector and invest £600m in a new health data research service.