Speedy EU Review For AZ/DS's Enhertu; Cheer Too For BMS/bluebird, Celgene And Rhythm
US And Japanese Approvals For Enhertu Are Already In The Bag
Executive Summary
The European Medicines Agency has agreed to fast track the review of four marketing applications in recent months.The products include AstraZeneca's advanced breast cancer treatment, Enhertu, two investigational CAR-T therapies, and a potential treatment for rare genetic disorders of obesity.
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EU Accelerated Assessment Tracker
Sanofi failed in its attempt to have its EU marketing authorization application for avalglucosidase alfa fast-tracked through the centralized review process at the European Medicines Agency. This and other developments relating to the agency's accelerated assessment mechanism are logged in this latest update to the Pink Sheet's EU accelerated assessment tracker.
EU Accelerated Assessment Tracker
Another three marketing authorization applications will be fast-tracked through the centralized review process at the European Medicines Agency. The Pink Sheet tracker logs these and other developments relating to the agency's accelerated assessment mechanism.
Review Of BMS's CAR-T Therapy Liso-Cel Gets Under Way At EMA
Bristol Myers Squibb's lisocabtagene maraleucel, UCB's bimekizumab and Rhythm Pharmaceuticals' setmelanotide are among the six latest additions to the list of products under review at the European Medicines Agency.