Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.
Kyorin Pharmaceutical Co. Ltd. has out-licensed its preclinical candidate, KRP-M223, and its back-up compounds to Novartis Pharma AG in a deal worth up to $777.5 million. Under the terms, Novartis gains an exclusive worldwide license to develop, manufacture and commercialize Kyorin-discovered KRP-M223.
The executive orders (EOs) pouring out of the Trump White House, and the resulting court challenges, continue to pile up, deepening the uncertainty hanging over the life sciences sector and the U.S. economy in general.
The U.K. has released a huge repository of children’s genomic data after sequencing blood samples from three large cohorts recruited at birth and followed across three decades. The power of the data is amplified by the large volume of longitudinal health information, biological samples and responses to surveys and questionnaires that has been provided by participating families.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bavarian, Bioarctic, Carsgen, Celltrion, Eisai, GSK, Latigo, Moderna, Ocugen, Pharmather, Valneva.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Arbutus, Ipsen, Genevant, Marengo, Mitocarex, Nkgen, Oqory, Scisparc, Vincerx, Vivasor.
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