Sept. 22 Quick Takes: Celgene CVR still in play; plus Dr. Reddy’s in Sputnik deal, $30M for Siolta, Amgen-Lilly, BioNTech-Novartis, Genentech-Scenic

Priority Review for bluebird-BMS program could fulfill CVR goal
FDA’s review timeline for idecabtagene vicleucel (ide-cel, bb2121) from bluebird bio Inc. (NASDAQ:BLUE) and Bristol Myers Squibb Co. (NYSE:BMY) suggests that an approval decision could come before time runs out on a contingent value right tied to BMS’s acquisition of Celgene Corp. FDA granted Priority Review to a BLA for the CAR T therapy targeting BCMA, with a PDUFA date of March 27. For Celgene shareholders to receive a payout worth up to $6.8 billion, FDA would need to approve ide-cel by March 31, 2021, as well as approve cell therapy lisocabtagene maraleucel (liso-cel) by YE20. A third criterion has already been satisfied (see “Extended Review Leaves Little Daylight”).

Russian fund, Dr. Reddy’s partner to supply 100M doses of Sputnik V to India
Through an agreement with the Russian Direct Investment Fund (RDIF), Dr. Reddy’s Laboratories Ltd. (NYSE:RDY) will supply 100 million doses of the Russian COVID-19 vaccine Sputnik V to the Indian market as early as this year depending on the timing of clinical trials and a regulatory decision. Developed by the Russian Ministry of Health’s N.F. Gamaleya Scientific Research Institute of Epidemiology and Microbiology, Sputnik V was approved in August; however, a group of international scientists has identified issues with the reliability of the Phase I/II immunogenicity data (see “Researchers Call Russian Vaccine into Question”). ...