Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Apellis, Akeso, Astrazeneca, Biogen, Clearside, CSL Behring, GSK, Iaso, Impact, Innovent, Junshi, Kalvista, Telix, Vyluma, Zai Lab.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Adagene, Alerity, Ascletis, Merck, Recce, Taiho.
A global commission has proposed a fundamental change to the way obesity is defined and diagnosed. If the change is implemented, obesity would be considered a health risk in some contexts, and a disease in others. “The commission is reframing obesity... in a way that allows for the nuanced reality of obesity,” Robert Eckel told reporters at a press briefing announcing the proposal, which was published online in The Lancet Diabetes & Endocrinology on Jan. 14, 2025.
It’s one thing for the scientific community to propose a fundamental change to the way obesity is defined and diagnosed. But it’s another for that proposal to be adopted by regulators, especially when the current definition that relies primarily on the body mass index is entrenched in guidance and obesity drug development and approval.
Shionogi & Co. Ltd. won a $375 million project agreement from the Rapid Response Partnership Vehicle to develop its 3CL protease inhibitor, S-892216, as a long-acting injectable for COVID-19 pre-exposure prophylaxis. The project was awarded to New Jersey-based Shionogi Inc., a subsidiary of the Osaka, Japan-based pharmaceutical company. S-892216 is an investigational second-generation 3CL protease inhibitor in development as a long-acting injectable for prophylaxis treatment of SARS-CoV-2.
As more Asia biotechs turn to regenerative medicine to address disorders without a cure, Medipost Inc. is continuing global expansion with Cartistem, its allogeneic human umbilical cord blood-derived mesenchymal stem cell product that gained clearance in South Korea in 2012 to treat knee osteoarthritis.
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