Minneapolis-based Smiths Medical Inc., recalled two entries in the company’s CADD-Solis line of ambulatory infusion pumps due to problems with the preloaded software.
Nevro Corp. retained advisors to explore strategic alternatives, including a possible sale of the business or acquisitions that could shift its focus to earlier points in the pain management process. The spinal cord stimulator company faces increased competition in its core market.
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
Novo Nordisk A/S presented a mixed bag of R&D results for its cardiometabolic assets in the first half of 2024 as it axed three drug candidates but advanced one to a late-stage study. In the search for greener pastures beyond a crowding obesity market, Novo announced Aug. 7 that it advanced ziltivekimab into a phase III study to assess the subcutaneous therapy’s cardiovascular outcomes in acute myocardial infarction patients.
The U.S. CMS announced the release of the Transitional Coverage for Emerging Technologies policy, which is less than clear on the definition of a key term.
Twelve-month results from Fractyl Health Inc.’s real-world registry show sustained, significant weight loss following treatment with its Revita procedure, which uses ablation to resurface the mucosal lining of the duodenum.
Croívalve Ltd. raised $16 million in a series B financing round that will be used to fund a clinical trial in the U.S. looking at the safety and performance of its Duo system to treat patients with severe or greater symptomatic tricuspid regurgitation.
Just ahead of the Aug. 13 PDUFA date, Citius Pharmaceuticals Inc. won the U.S. FDA’s go-ahead for Lymphir (denileukin diftitox-cxdl), a new immunotherapy for relapsed/refractory (r/r) cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The drug is Cranford, N.J.-based Citius’ first approved therapy and the only CTCL treatment that targets the interleukin-2 receptor found on malignant T cells and regulatory T cells. It’s also the first green light given by the FDA for r/r CTCL since 2018.
China’s Genor Biopharma Co. Ltd. agreed to out-license GB-261, its bispecific antibody candidate primarily targeting B-cell lymphomas, to TRC 2004 Inc., a U.S.-based newco co-founded by Third Rock Ventures LLC and Two River Group Holdings LLC.
Sangamo Therapeutics Inc. put pen to paper on a would-be $1.9 billion-plus deal with Genentech, a unit of Roche AG, to develop intravenously administered genomic drugs for neurodegenerative conditions.
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