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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The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to experimental products from Atara, Calliditas, and Roche.
Shares in Sweden's Calliditas have taken a tumble on the news that the US FDA has pushed back the action date for its immunoglobulin A nephropathy Nefecon. However, the company, and certain analysts, are less worried, believing the delay is just a blip.
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.