BioCentury
ARTICLE | Product Development

Feb. 10 Product Development Quick Takes: Priority Review for Gilead CAR T cell therapy; plus Zai, Aquestive, Biohaven, Oculis, Blue Water, GlycoMimetics, Fluidi

February 11, 2020 1:00 AM UTC
Updated on Feb 11, 2020 at 3:38 AM UTC

Gilead’s second CAR T under Priority Review
Gilead Sciences Inc. (NASDAQ:GILD) said FDA accepted and granted Priority Review to a BLA for KTE-X19 to treat adults with relapse or refractory mantle cell lymphoma. The anti-CD19 CAR T therapy, which uses the same construct as Yescarta axicabtagene ciloleucel but is manufactured using the XLP T cell selection and lymphocyte enrichment process, has a PDUFA date of Aug, 10; it is also under review in Europe.

China reviewing antibiotic from Zai, Paratek
Zai Lab Ltd. (NASDAQ:ZLAB) said China’s National Medical Products Administration (NMPA) has accepted an NDA for omadacycline to treat community-acquired bacterial skin pneumonia and acute bacterial skin and skin structure infections. Zai gained rights from Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) in 2017 to the antibiotic in China, Hong Kong, Macau and Taiwan. FDA approved omadacycline in 2018 to treat both infections...