Immunocore and Argenx Among Fast-Track Hopefuls At EMA
Five Accelerated Assessment Decisions Due, Including On Tebentafusp And Efgartigimod
Executive Summary
EU reviewers will decide this week whether to grant accelerated assessment to a handful of new dug candidates that will soon be filed for approval.
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EU Accelerated Assessment Tracker
EU marketing authorization applications from Bayer for copanlisib and from Takeda for maribavir will be reviewed under standard timelines at the European Medicines Agency.
BMS/bluebird’s Ide-Cel: EU Decision Time On First CAR-T For Multiple Myeloma
The European Medicines Agency will decide this week whether BMS and bluebird bio’s cell-based gene therapy for multiple myeloma should be approved for use in the EU.
Dismay For Argenx As J&J Pulls Out Of Lucrative Blood Cancer Pact
The launch of efgartigimod at the end of 2021 is very much Argenx's focus now that J&J is terminating their alliance for the anti-CD70 antibody cusatuzumab for acute myeloid leukemia "in consideration of the evolving standard of care" for the disease.