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.

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