The FDA requested supplemental documentation related to chemistry, manufacturing and controls rather than new clinical or preclinical data. The companies plan to resubmit the application and request a priority review by the end of July.
BMS bought out its milestone and royalty obligations for ex-U.S. markets for idecabtagene vicleucel, or ide-cel, which is currently undergoing FDA review. The companies will continue to share profits and losses in the U.S.
The home care industry is booming. As Baby Boomers age and more families seek in-home solutions for loved ones, demand for home care services is at an all-time high.
A Cannacord Genuity analyst pointed to BMS' large pipeline of BCMA-targeting therapies and advanced data, particularly for its CAR-T. However, GlaxoSmithKline has also asserted its anti-BCMA drug could be first past the FDA finish line. But does it matter?
In data from several clinical trials released Friday and during the weekend, cell and other therapies for multiple myeloma targeting the antigen BCMA showed strong response rates.