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Regulation Drug Review Europe

New Filings At The EMA

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Executive Summary

New medicines under evaluation at the European Medicines Agency.

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Latest EU Filings Include A First For BeiGene

Potential treatments from BeiGene, AstraZeneca, Bayer and Cancer Prevention Pharmaceuticals are under review at the European Medicines Agency.

Sanofi Seeks Double Vaccine Approval Nod In EU

The sponsors of up to seven new drugs or vaccines will find out this week whether their products will soon be approved in the EU. The products include two vaccines from Sanofi and what is possibly the first generic rival to Bayer's Xarelto to be assessed by the European Medicines Agency.

EU Fast-Track Review In Store For Takeda’s Dengue Vaccine

Takeda will soon seek EU approval of its dengue vaccine candidate. The marketing application will be fast-tracked, as will the applications for Regeneron's evinacumab and bluebird bio's eli-cel Lenti-D gene therapy.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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