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Rare EU Fast-Track Nod For Sanofi Genzyme's Olipudase Alfa

Product Is One Of Few To Secure Accelerated Assessment In Recent Months

Executive Summary

Only three planned marketing authorization applications are known to have been granted accelerated assessment status by the European Medicines Agency between July and October this year. 

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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. 

EU Accelerated Assessment Tracker

The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to investigational products from, among others, Janssen, Sanofi, Boehringer Ingelheim and Mirum.

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