Opthea Ltd. is considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD). The global Coast phase III trial evaluated the efficacy and safety of intravitreally administered 2-mg sozinibercept every four or eight weeks in combination with 2-mg aflibercept every eight weeks after a loading phase for the treatment of wet AMD. The trial did not meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
Building upon its already impressive obesity drug portfolio, Novo Nordisk A/S has licensed a triple agonist of the receptors for GLP-1, GIP and glucagon from United Biotechnology Co. Ltd. China-based United is getting $200 million up front and the chance to earn up to $1.8 billion in milestone payments. United Biotechnology retains the rights to subcutaneously administered UBT-251, which is in the early stages of development for treating obesity, type 2 diabetes and other diseases, in China, Hong Kong, Macau and Taiwan while Bagsværd, Denmark-headquartered Novo get exclusive rights to develop, manufacture and commercialize the triple agonist receptor across the rest of the world.
The U.S. FDA rejected, for the second time, Elevar Therapeutics Inc.’s NDA of a novel combination therapy for advanced liver cancer, which comprised Jiangsu Hengrui Pharmaceutical Co. Ltd.’s PD-1 inhibitor camrelizumab and HLB Co. Ltd.’s small-molecule tyrosine kinase inhibitor, rivoceranib.
Histoindex Pte Ltd. launched its laboratory-developed test for metabolic dysfunction-associated steatohepatitis (MASH), Fibrosight, in the U.S. as the company’s first in a suite of next-generation digital pathology solutions.
Taimed Biologics Inc.’s TMB-365/TMB-380 long-acting combination of broadly neutralizing antibodies regimen for HIV maintenance could reshape HIV treatment management, offering a viable alternative to daily combination antiretroviral therapy (cART), the Taipei-based company said after reporting on phase IIa results.
Seung-min Park, professor at Nanyang Technological University and cofounder of Kanaria Health, is working to manufacture smart bidets that can capture biomarker data from urine and stool automatically and enable continuous monitoring.
New Zealand med-tech startup Avasa Ltd. has developed an arterial coupler that could save surgeons 30 minutes in the operating room to better connect arteries.
Ono Pharmaceutical Co. Ltd. struck a licensing deal with Ionis Pharmaceuticals Inc. for sapablursen, which is in phase II trials for polycythemia vera. Under terms, Osaka, Japan-based Ono gains an exclusive license to develop and commercialize sapablursen worldwide. Carlsbad, Calif.-based Ionis will be responsible for completing the ongoing phase II Imprssion study, while Ono will be responsible for subsequent development, regulatory filings and commercialization.
Celltrion Inc. is on a biosimilar roll with the U.S. FDA this month, having gained clearance of Stoboclo and Osenvelt as products referencing Amgen Inc.’s biologic, denosumab (Prolia, Xgeva), along with Omlyclo becoming the first and only interchangeable biosimilar to omalizumab (Xolair, Genentech Inc. and Novartis AG).
Aim Vaccine Co. Ltd. may become the first company to gain regulatory clearance of a prophylactic iterative serum-free human rabies vaccine. Beijing-based Aim said it is preparing a regulatory submission of its independently developed rabies vaccine based on positive phase III results that showed good safety, immunogenicity and immune persistence.
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