Amylyx Pharmaceuticals Inc.’s amyotrophic lateral sclerosis candidate, AMX-0035, will get a rare second bite at the adcom apple Sept. 7. This time around, the Cambridge, Mass.-based company is looking to improve on its first performance by stressing the survival benefit of its drug. Read More
Questioners probed the fine points during Iveric Bio Inc.’s conference call, but news proved unmistakably good with Zimura (avacincaptad pegol) in geographic atrophy (GA), and shares of the firm (NASDAQ:ISEE) closed Sept. 6 at $15.70, up $6.26, or 66%, on positive top-line data from Gather 2, the firm’s second phase III study. Read More
China’s NMPA has granted emergency use authorization for two COVID-19 vaccines as boosters, Cansino Biologics Inc.’s inhaled vaccine Convidecia Air and Livzon Pharmaceutical Group Inc.’s recombinant protein vaccine. Convidecia Air is an aerosolized adenovirus type 5 vector-based vaccine. It is the first inhaled COVID-19 vaccine to be approved globally, according to Cansino. Read More
Pleco Therapeutics BV has raised €17.3 million (US$17.1 million) in equity, loan and grant financing to move its lead program into a phase I trial next year. The company, based in Nijmegen, the Netherlands, is bringing a fresh perspective to bear on a longstanding therapeutic concept – that cancer can be tackled by metal chelation. Quite a number of agents have entered the clinic over the years, but none as yet has delivered any useful outcome. Read More
After raising AU$2.2 million in its series A round, University of Western Australia spinout Lixa Pty Ltd. has emerged from stealth mode and is gearing up for clinical trials of its anti-biofilm platform technology that could preserve antibiotics in the fight against antimicrobial resistance. Read More
China has upheld a recent ruling on a dispute between Chugai Pharmaceutical Co. Ltd. and Wenzhou Haihe Pharmaceutical Co. Ltd. over a generic form of an osteoporosis treatment. The move is seen as an indicator that patent protection for drugs has improved in China. Read More
With a diminishing number of deals in the last month, the gap between deal values this year compared with each of the last two years has shrunk. In August, 2022 deal values were ahead of 2021 by 7% and of 2020 by 2%. Now, in early September, they are ahead of last year by 0.6% and behind 2020 by 3.5%. Volumes, which were down by 23% last month, are now down by 26%. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Beactica, Cellorigin, Clarus, Dong-A, Emergence, Qilu, Synaffix. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Azurity, Bayer, Boehringer, Immuneering, Intellia, Moderna, Novavax, Y-mabs. Read More
