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Vertex's Triple CF Combo Gets EU Approval Nod; Rejection For Daiichi Sankyo

Executive Summary

EU approval is likely for the eight medicines that got the thumbs up this week from the European Medicines Agency's drug evaluation committee, the CHMP. The panel held fire on one product it had been considering and also issued its first rejection of 2020.

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EU Accelerated Assessment Tracker

Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.

EU Accelerated Assessment Tracker

Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.

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.

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