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 GLP-1/GIP receptor dual agonist. “We are extremely happy with the agreement, and not least, the opportunity to collaborate with Roche, to bring petrelintide forwards as a future foundational therapy – we could not be more excited,” Adam Steensberg, president and CEO of Zealand Pharma told BioWorld. Money apart, the attractions include Roche’s global manufacturing network and commercial reach, and a complementary portfolio of clinical programs in obesity. “We consider Roche the ideal partner,” Steensberg said.

Ono scoops Ionis' hematology candidate sapablursen for up to $940M

Ono Pharmaceutical Co. Ltd. struck a licensing deal with Ionis Pharmaceuticals Inc. for sapablursen, which is in phase II trials for polycythemia vera (PV). 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 exchange, Ionis will receive an up-front payment of $280 million, plus up to $660 million in development, regulatory and sales-based milestones. Ono will also pay Ionis sales-based royalties. The FDA granted sapablursen fast track designation in January 2024 and orphan drug designation in August 2024.

Vivace secures $35M series D, boosting mesothelioma prospect

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 inhibitor, VT-3989, with an initial focus on mesothelioma. San Mateo, Calif.-based Vivace is working on cancer therapies that target the Hippo pathway.

Celltrion wins FDA approval of denosumab, omalizumab biosimilars

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). The FDA cleared Celltrion’s Omlyclo (omalizumab-igec, CT-P39) on March 9 for all four of Xolair’s indications, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, immunoglobulin E-mediated food allergy and chronic spontaneous urticaria. The agency on March 3 cleared Stoboclo (CT-P41, denosumab-bmwo) as a reference product to Prolia for osteoporosis and Onsenvelt (CT-P41, denosumab-bmwo) as a biosimilar to Xgeva to treat bone metastases from breast, prostate and other solid cancers, along with multiple myeloma. As of January 2025, the FDA has approved a total of 63 biosimilars to date, including 18 new approvals that came in 2024.

Aim seeks approval of first serum-free human rabies vaccine

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. Disclosed March 12 by Aim chairman, executive director and CEO Yan Zhou on the Hong Kong stock exchange, the company expects to swiftly move the product to launch post-approval, considering its wholly owned subsidiary, Aim Rongyu (Ningbo) Biopharmaceutical Co. Ltd., already secured a production license.

US NIH plans to centralize peer review of grant applications

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 (CSR). As it is, the CSR manages the peer review process for more than 78% of NIH grants. The other 22% are reviewed by study sections within the agency’s 23 institutes and centers. If the plan is finalized, the NIH said those study sections would be eliminated.

Also in the news

Apnimed, Arvinas, Capricor, Cervomed, Coeptis, Coherus, Daiichi, Fondazione Telethon, Genmab, Harrow, Hemogenyx, Immunocore, Ipsen, Kaerus, Longeveron, Lupin, Merck, Nosis, NS Pharma, Pfizer, Pharmather, Purespring, Reparris, Shift, Shuttle, Sydnexis, Taro, Tuhura, Vygen, Vycellix