Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Antengene, Ascletis, Biontech, Bioxytran, Brim, Cerecin, Curadev, Delta-Fly, Hexaell, Liscure, Moderna, Novavax, Pfizer, Recce, Takeda.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Beigene, Clear Creek, Daiichi Sankyo, Equillium, Gilead Sciences, Hitgen, Kite, Kyowa Kirin, MEI, Merck, Nitrase, Ono, Pfizer, Phanes, Pharmabcine, Sosei, Spikimm, Tevogen.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Aim Immunotech, Createrna Science and Technology, Daiichi Sankyo, Immuneoncia, Innovent Biologics, Kinarus, Lynk, Qilu, Union.
Sotyktu (deucravacitinib), the tyrosine kinase 2 (TYK2) inhibitor for psoriasis from Bristol Myers Squibb Co., is “a good first-in-class” drug, said Nimbus Therapeutics LLC CEO Jeb Keiper, but his firm may have the best in class, ready for phase III trials. Takeda Pharmaceutical Co. Ltd. apparently believes so. The company has agreed to pay $4 billion up front and pledge as much as $2 billion more in potential milestone payments to acquire Nimbus’s wholly owned subsidiary, Nimbus Lakshmi Inc., thereby bringing aboard the TYK2 prospect called NDI-034858.
Full-Life Technologies Ltd. reported that it will acquire Focus-X Therapeutics Inc. to expand its radiopharmaceutical oncology therapy pipeline in a deal worth up to $245 million.
Researchers have identified a link between amyloid plaques and dysfunctional neuronal conduction in animal models of Alzheimer’s disease (AD). Their study, which was published in the Dec. 1, 2022, issue of Nature, suggests new ways to think about AD, as well as badly needed potential alternatives to plaque removal to fight the disease.
Ironically, one of the casualties of the COVID-19 pandemic is an overdue review and revision of U.S. dual use research of concern (DURC) policies, as well as the Department of Health and Human Services’ Potential Pandemic Pathogen Care and Oversight guidance. Consequently, several senators are asking the White House to halt all ongoing and new viral gain-of-function and DURC studies in the life sciences that involve enhanced pathogens of pandemic potential.
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