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BMS/bluebird’s Ide-Cel: EU Decision Time On First CAR-T For Multiple Myeloma

 
• By Vibha Sharma

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. 

Open Book Of prostate multiple myeloma, Conceptual Image - Image
Multiple myeloma is a cancer of the plasma cells • Source: Shutterstock

Bristol Myers Squibb Company and bluebird bio could learn this week whether the European Medicines Agency will recommend pan-EU marketing approval for idecabtagene vicleucel (ide-cel), the cell-based gene therapy they have co-developed to treat multiple myeloma.

Ide-cel, which was approved in the US in March under the brand name Abecma, is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T-cell therapy. Each...

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More from Europe

EMA: ‘Sad To See’ Member States Against Patient Engagement Under EU Pharma Reform

 
• By Eliza Slawther

The European Medicines Agency’s chief medical officer Steffen Thistrup argued that patients are able to understand the “complex regulatory and scientific issues” that the EMA committees discuss when they assess drugs.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.

More from Geography

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Why Hympavzi Secured English Funding For Hemophilia B But Not Hemophilia A

 
• By Neena Brizmohun

Pfizer told the Pink Sheet it would work with the health technology assessment institute, NICE, with the hope of making Hympavzi available to patients with hemophilia A via the National Health Service.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

The verdict by the Unified Patent Court in the dispute between Sanofi/Regeneron Pharmaceuticals and Amgen explains what companies should look out for when deciding whether infringement has taken place when it comes to second medical use patents.