BMS ‘Slow-Rolled’ Approval of Liso-Cel, Investors Claim, Citing Timeline Of Other CAR-T Therapies
Two complaints allege BMS deliberately delayed approval of non-Hodgkins lymphoma treatment to avoid $6.4bn contingency payment. Former FDA reviewer is expert for plaintiffs in securities class action arguing that similar cell therapies Yescarta and Kymriah were approved twice as fast.
You may also be interested in...
Breyanzi Is Third To Market, But BMS’s First CAR-T Therapy Priced Above Competitors
Breyanzi’s list price is $410,300. The CD19-targeting CAR-T therapy previously known as liso-cel has a lot of ground to make up following competitors Yescarta and Kymriah.
It Was Inevitable: FDA Inspection Delay Postpones BMS’s Liso-Cel Approval
Bristol Myers Squibb confirmed that approval for lisocabtagene maraleucel (liso-cel) will be delayed by the US FDA’s COVID-19-related restrictions on travel for manufacturing facility inspectors.
Top US FDA Official Says New 'Playbook' Needed For CMC Reviews Of Gene Therapy Products
CBER director says lack of a clear regulatory structure is holding back the development and acceleration of gene therapy products, while industry says regulations should be flexible to keep up with changing technology for these products.