The US Food and Drug Administration issued a refuse-to-file letter for the BCMA-targeting CAR-T therapy idecabtagene vicleucel (ide-cel) for relapsed/refractory multiple myeloma, partners Bristol Myers Squibb Co. and bluebird bio Inc. announced on 13 May. But while this threatens the timeline for a contingent value right payment to Celgene Corp. investors, it still leaves the door open to meet the deadline.
The companies said the FDA cited problems with the chemistry, manufacturing and controls section of the biologics license application and they see a
Read the full article – start your free trial today!
Join thousands of industry professionals who rely on Scrip for daily insights
- Start your 7-day free trial
- Explore trusted news, analysis, and insights
- Access comprehensive global coverage
- Enjoy instant access – no credit card required
Already a subscriber?