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.
Companies across biotech and pharma are scrambling to find ways of reducing their energy consumption and overall dependence on fossil fuels, following the sudden and stark increase in prices sparked by Russia’s invasion of Ukraine.
Three months after agreeing to an intellectual property waiver for COVID-19 vaccines, World Trade Organization (WTO) members are discussing expanding it to therapies, diagnostics and devices used in preventing, diagnosing and treating COVID-19 infections.
Simcere Pharmaceutical Group has out-licensed its autoimmune drug candidate SIM-0278 for all indications to Almirall SA in a deal worth up to $507 million. Simcere granted exclusive global rights to the candidate to Almirall for development and commercialization excluding mainland China, Hong Kong, Macau, and Taiwan. In return, Almirall will pay Simcere $15 million up front.
Zai Lab Ltd. has agreed to pay $30 million up front to in-license from Seagen Inc. exclusive rights to the antibody-drug conjugate (ADC) Tivdak (tisotumab vedotin) in mainland China, Hong Kong, Macau and Taiwan.
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