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Drug Review Europe Regulation

Latest EU Filings Include A First For BeiGene

AZ's Enhertu Has Also Been Filed

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Executive Summary

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

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Plenty Of Action On EU Accelerated Assessment Front

A number of companies have sought to convince the European Medicine Agency that their drug merits a fast-track regulatory review.

Early EU Approval Wins In Line For Daiichi/AZ & Lilly

Advanced breast cancer treatment Enhertu and non-small cell lung cancer and thyroid cancer therapy Retsevmo are set to win conditional marketing authorizations in the EU shortly. The two drugs are among a number of new products that the European Medicines Agency has just recommended for approval.

Moment Of Truth For Daiichi/AstraZeneca’s Enhertu In EU

The EU marketing application for the HER2-targeted antibody drug conjugate has been fast-tracked and is now up for an opinion from the European Medicines Agency.

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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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