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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.

EU Accelerated Assessment Tracker

Marinus’s ganaxolone has lost its accelerated assessment status mid-review at the European Medicines Agency while Roche’s glofitamab will be fast-tracked once a filing has been made.

EU Accelerated Assessment Tracker

The EU filing for AstraZeneca’s nirsevimab is being reviewed under the accelerated pathway at the European Medicines Agency. Also, Janssen should know by now whether its planned filing for Zejula plus Zytiga will get the same treatment – as should SIFI for its planned Akantior filing.

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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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