Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time
Manufacturing Inspection Delays Could Impact Decision Due 27 March
In last year’s acquisition, Bristol Myers Squibb agreed to pay Celgene investors another $9 per share based on three approvals, including idecabtagene vicleucel (bb2121) by 30 March 2021.
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Keeping Track: New Nucala Indication; BMS’ Ide-Cel Clears Filing Hurdle; First Applications From Telix And ADC Therapeutics
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Agency may share outcomes of remote record reviews in lieu of inspections at US and foreign facilities.
US FDA-approved belantamab mafodotin is indicated for heavily pre-treated multiple myeloma and has a list price of $23,900 per month. Its REMS could limit initial uptake, but response rates have been encouraging.