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Sanofi, Regeneron Seek Fast-Track Reviews From EMA

Speedy Evaluations Requested For Avalglucosidase Alfa And Evinacumab

Executive Summary

EU sponsors of two investigational drugs – one to treat the rare genetic Pompe disease and the other for patients with severe inherited form of high cholesterol – have requested a speedy review of their respective marketing applications.

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EU Accelerated Assessment Tracker

Two products that were under fast-track review at the European Medicines Agency have reverted to standard review timelines – Eiger's lonafarnib and GSK's dostarlimab. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

EU Accelerated Assessment Tracker

At least another four investigational therapies will join the few that are already being fast-tracked at the European Medicines Agency.

EU Accelerated Assessment Tracker

Alnylam and Eiger join the select group of companies whose products have been granted fast-track status at the European Medicines Agency

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