In a massive deal that is one of the year’s biggest, Akeso Inc. signed a collaboration and license deal with Summit Therapeutics Inc. to out-license its bispecific antibody, ivonescimab (AK-112), for development and commercialization in the U.S., Canada, Europe and Japan.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Ascletis, Aum, Bluejay, Buchang, CSL Vifor, Eli Lilly, Everest Medicines, Gilead Sciences, Junshi, Mabwell, Novavax, Remd, Revive, Takeda.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aclaris, Astellas, Biocon, CMS Aesthetics, Cosmo, ERS Genomics, Focus-X, Full-Life Technologies, Immutep, Incyte, Legochem, Merck KGaA, Pediatrix, Pfizer, Sirona, Sotio, Viatris, Wanbang.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Ascletis, Atea, Biogen, Clover, Eisai, H. Lundbeck, Henlius, Intravacc, Kintor, Kira, Otsuka, Providence, Qilu, Qurient, Sorrento, Vaxxinity.
The shadow of two reported patients’ deaths hovers over Eisai Co Ltd. and Biogen Inc.’s Alzheimer’s disease treatment, lecanemab, as the companies prepare to present phase III study data on the drug later today at the 15th Clinical Trials on Alzheimer's Disease conference.
With only a year to go before 100% compliance with the U.S. Drug Supply Chain Security Act’s serialization provisions will be required from the beginning to the end of the drug supply chain, most biopharma manufacturers are pretty confident they’re ready for the Nov. 27, 2023, deadline. But distributors? Not so much. And they lay the blame at the manufacturers’ feet.
A combination of radiation therapy and CD47 blockade induced an abscopal effect in animal studies even in animals that lacked T cells, researchers reported in the Nov. 21, 2022, online issue of Nature Cancer.
Nearing the end of 2022, the COVID-19 pandemic clearly no longer dominates the clinical activity reported by biopharma companies. Overall clinical data tracked by BioWorld is down significantly, as is the proportion focused on the SARS-Cov-2 virus. Therapeutics and vaccines targeting cancer, infectious diseases and neurological disorders, however, remain a stronghold.
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