A BCMA Setback For Bristol And Bluebird With FDA Refuse-To-File Letter
Executive Summary
The US FDA took issue with the CMC portion of the BLA for the BCMA-targeted therapy idecabtagene vicleucel for multiple myeloma. An approval is tied to a $9 CVR for Celgene shareholders.
You may also be interested in...
Nearly One Year Post-Celgene: BMS CMO On Pipeline Progress, Clinical Trial Diversity
Chief medical officer Samit Hirawat outlines R&D successes – though there have been some setbacks since it bought Celgene for $74bn last year – and the company’s commitment to clinical trial diversity.
Approval Of BMS/Bluebird’s Ide-Cel May Come Just In Time
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.
Biotechs Face Daunting Launch Environment Going It Alone
Several small biotechs are launching new drugs independently in a launch environment that now presents unexpected challenges caused by COVID-19.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports