EU Accelerated Assessment Tracker
The Pink Sheet's EU accelerated assessment tracker has been updated to include developments relating to experimental products from Atara, Calliditas, and Roche.
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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.
Two companies are set to learn whether the European Medicines Agency will agree that their planned EU marketing applications merit an accelerated assessment.
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.