Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Eli Lilly, Eva, Everest, Eyedna, Gilead, Jaguar, Lipocine, Merck, Merz, Tonix, Viiv.
Researchers at the University of Leipzig and ETH Zurich have used single-cell sequencing to identify differences between fat tissue of obese individuals who are metabolically unhealthy, and those who were in good metabolic health. The findings, which were published online Dec. 17, 2024, in Cell Metabolism, identify measurements that can be used to decouple obesity from metabolic disease.
The Danish Medicines Agency is to ask the EMA’s pharmacovigilance committee to investigate a potential increased risk of an acute eye condition in diabetic patients being treated with the glucagon-like peptide-1 receptor agonist Ozempic (semaglutide).
Released from a clinical hold by the U.S. FDA in late September, Biomea Fusion Inc.’s menin inhibitor, icovamenib, has charged ahead to produce positive top-line data from a phase II study in type 2 diabetes (T2D). The data, however, didn’t stop the stock from dropping to near its lowest level of the past 12 months.
Caliway Biopharmaceuticals’ lipolysis candidate, CBL-514, met all the primary and secondary efficacy endpoints in a phase IIb study for subcutaneous fat reduction, paving the way for the company to begin a global pivotal phase III study in 2025.
SK Biopharmaceuticals Co. Ltd. and Proen Therapeutics Co. Ltd. joined hands in a research collaboration to advance up to two preclinical small protein-based radiopharmaceuticals by 2027 – the year SK Biopharmaceuticals aims to “become a leading radiopharma player” worldwide.
Candid Therapeutics Inc. and Epimab Biotherapeutics Inc. have entered a $1 billion research collaboration to discover and develop novel T-cell engager candidates for autoimmune indications.
Kyorin Pharmaceutical Co. Ltd. has acquired Bayer AG’s phase II obstructive sleep apnea candidate, BAY-2925976, in a deal worth €85M (US$89.3 million) plus sales-based royalties and commercial milestones.
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