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.
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?
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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.
An analyst wrote that it is unlikely bluebird would provide full data from its registration-directed study of the CAR-T bb2121 by year end, which is more likely to come early next year.
Celgene plans to file for approval of bb2121 (idecabtagene vicleucel) in myeloma in the first half of 2020, and lisocabtagene maraleucel in lymphoma in the fourth quarter of this year.
In a statement, the agency said that a decision on whether to have Medicare cover the cell therapies would not be issued Friday, but would be forthcoming.
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The data for AMG 420 are early, an Amgen executive said, but where to place the drug relative to CAR-Ts is a "million-dollar question."
A company analysis deemed the patient's myelodysplastic syndrome was unrelated to LentiGlobin, but a news report indicated it may have stemmed from the conditioning regimen used in the trial.
Bispecific antibodies like Amgen's AMG 420 could present some competition to CAR-Ts. But could sequential use of the therapies - which target the same antigen - be possible?
Keeping manufacturing close to home allows for greater flexibility, lower long-term costs and building up native manufacturing capability, panelists said at the B. Riley Health Conference Tuesday.
Scheduling software is helpful for wellness business owners in numerous ways. They get everything they need to create appointments, reschedule clients and track cancellations in one platform.
Non-binding vote by MEDCAC supports use of PROs in CAR-T clinical trials, drawing opposition from industry and oncology groups.
The company plans to open its upcoming trial of a Chinese-developed CAR-T at four initial sites later this year.