BMS gets the ball rolling on liso-cel in Europe; BeiGene files China NDA for in-house PARP drug
→ The EMA has validated Bristol Myers Squibb’s marketing application for liso-cel, its CAR-T that’s been held up at the FDA. The move marks the beginning of the regulatory group’s drug review process. Bristol Myers reported back in May that the FDA had notified the company that US regulators needed an extra 3 months for their review, putting it in line for a mid-November PDUFA deadline. If the drug isn’t approved by the FDA before the end of the year, Celgene investors will lose their CVR picked up in the buyout. The drug had been developed by Juno before Celgene bought out the biotech.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.