Japan has issued positive approval recommendations for 10 new drugs, including Catalyst’s Firdapse and Idorsia/Nxera’s Quviviq, as well as a global-first nod for mecobalamin in ALS. 

Plus transactions involving Nissan Chemical/Sanwa Kagaku, Memel/Therabest, Chugai/Alnylam, Takeda/Kumquat, Nxera/Handok, 3SBio/CStone and deals in brief.

The lower benefit in the olmesartan arm of KARDIA-2 could draw scrutiny, but the company said it was expected and noted polypharmacy is common in hypertension.

Seven novel agents approved in March include one accelerated approval, two rare pediatric disease priority review vouchers, two breakthrough therapy designations and one regenerative medicine advance therapy designation.