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. Read More
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. Read More
Vivace Therapeutics Inc. closed a $35 million series D round led by RA Capital Management, an existing investor, and including other backers already on board: Canaan Partners and Cenova Capital. Proceeds will support the continued development of what the company describes as its first-in-class and best-in-class transcriptional enhanced associate domain autopalmitoylation (TEAD) inhibitor, VT-3989, with an initial focus on mesothelioma. Read More
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). Read More
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. Read More
Looking to shave $65 million from its annual expenditures while streamlining the first stage of its two-level grant review process, the U.S. NIH is proposing to centralize the peer review of all applications for grants, cooperative agreements and R&D contracts within its Center for Scientific Review. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Arvinas, Cervomed, Immunocore, Kaerus, Longeveron, Pfizer. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Coeptis, Coherus, Genmab, Daiichi, Harrow, Merck, Nosis, Reparris, Vygen, Vycellix. Read More
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. Read More
