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Europe Drug Review Regulation

Seventeen And Counting – Bumper Crop Of New EU Filings

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Executive Summary

Orphan drugs and COVID-19 products are among the latest filings under review by the European Medicines Agency for potential pan-EU approval.

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New EU Filings

Tabelecleucel, Atara Biotherapeutics’ advanced therapy for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease, is among the latest new medicines that have been submitted for review for potential pan-EU approval.

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from Roche and CSL Behring/UniQure.

Accelerated Assessment Success In EU For CSL Behring And Roche

There have been some recent successes on the accelerated assessment front in the EU but more requests are rejected than granted. 

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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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