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EU Accelerated Assessment Tracker

It's Not Been A Great Year For Companies Seeking Speedy Review In The EU

Executive Summary

In the first half of 2021, just six requests from companies seeking accelerated assessment of their planned EU marketing authorization applications were granted; 11 were rejected. The outcomes of five decided on in July and August are still unknown.

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Tab-Cel Gets EU Fast-Track Nod; Nefecon Reverts To Standard Review

The outcomes of a handful of requests for accelerated assessment at the European Medicines Agency appear not yet to be in the public domain. In the meantime, there's been good for news for Atara's tab-cel and a switch to standard review for Nefecon from Calliditas.

Immunocore's Tebentafusp Sole Winner In EU Fast-Track Stakes In June

If Immuncore's tebentafusp is fast-tracked all the way through the centralized procedure at the EMA, it could be approved a few months earlier than it otherwise would be.

EU Accelerated Assessment Tracker

The EU marketing authorization application for Takeda's dengue vaccine candidate is no longer being fast-tracked. Also, four requests for accelerated assessment were decided on at the latest meeting of the European Medicines Agency's drug evaluation committee, the CHMP.

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