Fast-Track Loss In EU For Celgene’s CAR-T Cell Therapy
Liso-cel Review Will Take Longer Than Anticipated in EU As Well As In US
The review of liso-cel, Celgene/Bristol Myers Squibb's potential new CAR T-cell therapy for R/R DLBCL, is facing regulatory setbacks in the EU as well as in the US.
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BMS Touts Breyanzi's Outpatient Administration As EU Approval Beckons
The US major won a positive opinion from the EU CHMP for Breyanzi with hopes the advantage of outpatient administration could help combat the lack of market impetus for CAR-T therapies.
BMS’ Cell Therapy For Lymphoma On Track For EU-Wide Approval
Several new drugs are now on track for an EU marketing authorization after getting the EMA’s thumbs up this week.
Immunocore Expects EU Verdict This Week On Novel TCR Immunotherapy
Pfizer’s oral COVID-19 antiviral drug and Celgene/Bristol Myers Squibb’s CAR-T for treating large B-cell lymphoma are among 11 new drugs on which the EMA is set to adopt recommendations on their possible EU-wide approval.