July 23 Company Quick Takes: FDA approves Pfizer’s Rituxan biosimilar; plus Intra-Cellular, OTC Tamiflu, Cimzia and more
Pfizer’s Rituxan biosimilar approved in U.S.
FDA approved Ruxience rituximab-pvvr from Pfizer Inc. (NYSE:PFE) for non-Hodgkin lymphoma, chronic lymphocytic leukemia and granulomatosis with polyangitis and microscopic polyangitis. Ruxience is the second biosimilar of Rituxan, an anti-CD20 mAb, the agency has approved. The first was Truxima rituximab-abbs from Celltrion Inc. (KRX:068270) and Teva Pharmaceutical Industries Ltd. in November 2018 (NYSE:TEVA; Tel Aviv:TEVA) (see "FDA Approves First Biosimilar for NHL").
FDA cancels Intra-Cellular panel meeting
Intra-Cellular Therapies Inc. (NASDAQ:ITCI) fell $3.79 (32%) to $8.19 on Tuesday after FDA canceled a July 31 meeting of the Psychopharmacologic Drugs Advisory Committee to discuss the NDA for lumateperone to treat schizophrenia, citing “new information regarding the application.” Lumateperone is a 5-HT2A antagonist and dopamine receptor phosphoprotein modulator. ...