Researchers at the Walter and Eliza Hall Institute of Medical Research (WEHI) in Melbourne, Australia, have developed a new genome editing technique than can activate any gene, including those that have been silenced, allowing new drug targets and causes of drug resistance to be explored.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Angel, Astrazeneca, Atai Life Sciences, Azura Ophthalmics, Biontech, Biosyngen, Corvus, Everest Medicines, Legend, Lepu, Maruishi, Merck, Pfizer.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Contera, Hitgen, Novavax, Ocugen, Olipass, Resverlogix, Sciwind, Seagen, Synerk, Vanda, Zai Lab.
Paradigm Biopharmaceuticals Ltd. reported top-line data from its phase II trial of Zilosul (pentosan polysulfate/PPS) that suggest the non-opioid treatment for knee osteoarthritis is effective in navigating pain management but also has the potential to be disease modifying.
In what may just be the takeover effort’s first volley, Sumitovant Biopharma Ltd., a subsidiary of Sumitomo Pharma Co. Ltd., made a hefty offer for Myovant Sciences Ltd. – which said no. Shares of Myovant (NASDAQ:MYOV) closed at $24.44, up $6.48, or 36.1% on word of the unsolicited buyout proposal.
The U.S. FDA has approved Taiho Oncology Inc.’s Lytgobi (futibatinib) for adults with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR-2) gene fusions or other rearrangements. The approval arrived on its Sept. 30 PDUFA date.
Japan’s Ministry of Health, Labor and Welfare (MHLW) approved a slew of new drugs in the last week of September, including Japan’s first sustained release GIP/GLP-1 receptor agonist for type 2 diabetes from Eli Lilly and Co. and Mitsubishi Tanabe Pharma Corp.; a self-administered injectable drug for rheumatoid arthritis from Eisai Co. Ltd. and Nippon Medac Co. Ltd.; a CAR T from Legend Biotech Corp. and Janssen Pharmaceutical KK; and two drugs from Astrazeneca plc, one in asthma and the other in pediatric plexiform neurofibromas in neurofibromatosis type 1.
RSS
