A BCMA Setback For Bristol And Bluebird With FDA Refuse-To-File Letter
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.
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Approval Delayed, But Janssen/Legend’s Cilta-Cel May Hit Market Just In Time
The US FDA has extended the user fee date by three months for the partners’ BCMA-targeting CAR-T therapy but its first-to-market rival is facing manufacturing challenges that limit access to treatment.
Bluebird Spins Off Oncology Business As Cell, Gene Therapy Segments Grow Apart
Nick Leschly will become CEO of oncology-focused spinoff, while Andrew Obenshain will help gene therapy-focused bluebird
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.