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.
In what it says is the biggest obesity deal to date, Zealand Pharma A/S has signed up Roche AG to a potential $5.3 billion global collaboration and license agreement to develop petrelintide, an amylin analog that is currently in phase IIb development. The two companies will co-develop and co-commercialize petrelintide and combination products, including a fixed-dose combination of petrelintide and CT-388, Roche’s dual GLP-1/GIP receptor agonist.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Capricor, Fondazione Telethon, Lupin, Pharmather, NS Pharma, Sydnexis, Taro.
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coeptis, Coherus, Genmab, Daiichi, Harrow, Merck, Nosis, Reparris, Vygen, Vycellix.
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arvinas, Cervomed, Immunocore, Kaerus, Longeveron, Pfizer.
Leyden Laboratories BV added a fresh $70 million in financing to advance Panflu, its phase II-ready intranasal pan-influenza prophylactic medicine, while acquiring Cov Biotechnology Pte. Ltd. (Covbio) and its zoonotic virus-targeting portfolio to prepare for the next pandemic.
In another real-life episode of “sponsor beware,” the owners of a clinical research facility pleaded guilty March 10 in U.S. district court to fraud charges resulting from their conduct of two clinical trials for potential asthma drugs.