Tab-Cel Gets EU Fast-Track Nod; Nefecon Reverts To Standard Review
Atara Plans November Filing As Calliditas Expects Three-Month Approval Decision Delay
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.
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Amryt Pharmaceuticals is set to appear before the European Medicines Agency to explain why its treatment for patients with epidermolysis bullosa merits EU-wide approval. The drug was recently rejected in the US.
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.
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.