CHMP backs Seebri
EMA's CHMP on Friday recommended approval of Seebri/Enurev/ Tovanor Breezhaler glycopyrronium bromide from Novartis AG (NYSE:NVS; SIX:NOVN) to treat chronic obstructive pulmonary disease (COPD). Novartis has worldwide rights to the inhaled long-acting muscarinic receptor antagonist (LAMA) from Vectura Group plc (LSE:VEC) and Sosei Group Corp. (Tokyo:4565). Vectura was up 8p (11%) to 79.50p on Friday. Sosei was up Y2,600 to Y114,500.
The committee also issued positive opinions for Zinforo ceftaroline from AstraZeneca plc (LSE:AZN; NYSE:AZN) to treat complicated skin and soft tissue infections (cSSTI) and community-acquired bacterial pneumonia (CABP); and Revestive teduglutide from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) to treat short bowel syndrome (SBS). Forest Laboratories Inc. (NYSE:FRX), which markets ceftaroline in the U.S. as Teflaro, was up $0.25 to $34.09 on Friday. An NDA for Revestive is under FDA review with a name of Gattex. Takeda has ex-North American rights to the product from NPS Pharmaceuticals Inc. (NASDAQ:NPSP), which gained $1.01 (14%) to $8.21. ...