March 2 Quick Takes: FDA Priority Review for MorphoSys-Incyte lymphoma therapy; plus Pfizer-Lilly, Merck, AbbVie, Novartis, Cerovene

Priority Review for MorphoSys follows Incyte deal
FDA accepted and granted Priority Review to a BLA for tafasitamab from MorphoSys AG (NASDAQ:MOR; Xetra:MOR) to treat relapsed or refractory diffuse large B cell lymphoma in combination with Revlimid lenalidomide. The anti-CD19 mAb has a PDUFA date of Aug. 30. In January, Incyte Corp. (NASDAQ:INCY) paid $900 million up front to co-commercialize tafasitamab with MorphoSys in the U.S., and receive exclusive rights elsewhere (see “Global Deal with Incyte for Anti-CD19 mAb”).

OA therapy from Pfizer, Lilly under FDA review
Pfizer Inc. (NYSE:PFE) and Eli Lilly and Co. (NYSE:LLY) said FDA accepted a BLA for tanezumab to treat chronic pain due to moderate to severe osteoarthritis. FDA will hold an advisory committee meeting for the anti-NGF mAb, which has a PDUFA date in December. In April, tanezumab hit a major stumbling block in Phase III after exceptionally good Phase II efficacy data (see “New Targets in Osteoarthritis are About More Than Just Pain”). ...