BeiGene CEO John Oyler at BIIS18 (Endpoints News, PharmCube)

No­var­tis hands back PD-1 in­hibitor to BeiGene af­ter reg­u­la­to­ry hur­dles

BeiGene will re­gain the full glob­al rights to its an­ti-PD-1 an­ti­body tislelizum­ab from No­var­tis af­ter the com­pa­nies ran in­to reg­u­la­to­ry hur­dles in the US, it said Tues­day morn­ing.

Min­utes lat­er, BeiGene said the Eu­ro­pean Com­mis­sion ap­proved the check­point in­hibitor, to be sold as Tevim­bra, as a monother­a­py for adults with un­re­sectable, lo­cal­ly ad­vanced or metasta­t­ic esophageal squa­mous cell car­ci­no­ma (ES­CC) af­ter pri­or plat­inum-based chemother­a­py. The FDA al­so ac­cept­ed the bi­o­log­ics li­cense ap­pli­ca­tion for the first-line ad­vanced ES­CC treat­ment can­di­date, and will make a de­ci­sion in the sec­ond half of next year, BeiGene said.

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