B. Braun Medical Inc. received an FDA warning letter citing repeat problems at its Irvine, Calif., plant with resolving complaints about leaky intravenous (I.V.) bags of parenteral drugs. The plant has been cited for the problem following annual FDA inspections beginning in 2013 and received an untitled letter in 2014. Read More

Biohaven Pharmaceutical Holding Co. Ltd., of New Haven, Conn., said it completed enrollment in its 180-patient, randomized, double-blind, placebo-controlled, multicenter study designed to compare the safety and efficacy of once-daily oral therapy with tripeptide prodrug trigriluzole (BHV-4157) 140 mg vs. placebo in patients with spinocerebellar ataxia (SCA). Read More

Taigen Biotechnology Co. Ltd., of Taipei, Taiwan, submitted an FDA new drug application (NDA) for the intravenous formulation of Taigexyn (nemonoxacin) to the CFDA The application was supported by a pivotal phase III trial comparing intravenous formulations of Taigexyn 500 mg to levofloxacin 500 mg in 518 patients with moderate to severe community-acquired pneumonia. Read More

TEL AVIV, Israel – One of the most visible contingents of investors and industry people during the recent MIXiii Biomed conference came from China. Two large delegations brought in more than 170 participants, a Chinese researcher gave one of the keynotes on aging, and for some delegates, there was simultaneous translation in Mandarin. Read More

Japanese researchers have screened existing drugs for potential to treat amyotrophic lateral sclerosis (ALS) using neurons developed from induced pluripotent stem (iPS) cells of a patient with an ALS gene mutation, thereby identifying a potential new target pathway for drugs against the currently incurable disease. Read More

An FDA complete response letter (CRL) for the chronic obstructive pulmonary disease (COPD) therapy SUN-101 (glycopyrrolate) and the Eflow nebulizer used to deliver it is sending Sunovion Pharmaceuticals Inc. back into talks with the agency and pushing out the potential realization of up to $210 million in commercial milestones for former backers of Elevation Pharmaceuticals Inc., from which Sunovion acquired the program in 2012. Read More

HONG KONG – South Korea’s Celltrion Inc. will be the first foreign company in China to initiate clinical trials of an antibody biosimilar. The company recently received the go-ahead from the CFDA for a trial testing Remsima (infliximab), based on an application submitted two years ago under the agency’s IND program. Read More

In what CEO Dinesh Patel called a “front-end-loaded deal that is significant from now through successful completion of phase II trials,” Protagonist Therapeutics Inc. sealed a deal potentially worth $990 million with Janssen Biotech Inc., one of the Janssen Pharmaceutical companies of New Brunswick, N.J.-based Johnson & Johnson (J&J), for the co-development and commercialization of PTG-200. Read More