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

Atara Plans November Filing As Calliditas Expects Three-Month Approval Decision Delay

 
• By Maureen Kenny

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.

Innovation letters
Fast-Track Review Is Available Only For The Most Innovative Products • Source: Alamy

Atara Biotherapeutics' lead product tabelecleucel (tab-cel), in development for the treatment of Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD), will be fast-tracked when the company files for approval in the EU.

The company plans to file a marketing authorization application (MAA) with the European Medicines Agency for the experimental immunotherapy in...

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