The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants. Vivani said it plans to create two focused companies dedicated to driving current and future value in their respective therapeutic areas.
After scrapping plans for an IPO in 2022, Hinge Health Inc. is taking a more favorable view of going public given the increased support seen for health care and med-tech stocks in recent months. The San Francisco-based company, a digital provider of physical therapy services, filed a form S-1 with the U.S. SEC stating it plans to offer an unspecified number of shares of class A common stock on the New York Stock Exchange this year.
The U.S. FDA’s January 2025 draft guidance for test validation in public health emergencies drew only six responses, but pointed responses they were, indeed. As an example, the Association for Molecular Pathology (AMP) said the draft’s recommendation for the use of 30 positive and 30 negative (30/30) samples for validation of lab-developed tests is likely to hamper test availability in an emergent situation, a time when samples are likely to be difficult to obtain.
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.
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).
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.
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.
The Vivani Medical Inc. combination appears to be over less than three years since its inception after the company reported plans to spin off Cortigent, the division that develops brain implants.
Neuromod Devices Ltd. raised €10 million (US$10.9 million) in financing to expand the reach of Lenire, which treats tinnitus. The fundraise, which was an expansion of its series B financing round, was led by existing investors Fountain Healthcare Partners and Panakès Partners.
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