An international team of researchers has successfully used Onward Medical N.V.’s ARC-IM therapy to develop a neurostimulation system that improves blood pressure stability in patients with spinal cord injuries. According to data from two studies published in Nature and Nature Medicine, the implanted system also led to durable reduction of hypotensive symptoms, resulting in an improvement in the quality of life of patients.
The dash for MASH is gaining momentum, with Roche AG acquiring 89bio Inc. and its phase III FGF21 analogue, pegozafermin, for treating metabolic dysfunction-associated steatohepatitis, in a deal worth up to $3.5 billion. The Swiss pharma is to pay $14.50 per share, valuing San Francisco-based 89Bio at $2.4 billion, a premium of approximately 52% to 89bio’s 60-day average price on Sept. 17, 2025. Shares of 89bio (NASDAQ:ETNB) gained $6.88, or 85%, to close Sept. 18 at $14.96.
Roche Holdings AG received CE mark approval for the integration of its AI-enabled continuous glucose monitoring system, Accu-Chek Smartguide, with the Mysugr diabetes management app. The integrated solution, which combines predictive CGM technology with therapy data in one place, will simplify the daily decision-making for users managing their diabetes.
With positive phase III results in hand, Roivant Sciences Ltd. and Priovant Therapeutics Inc. anticipate an NDA filing in the first half of 2026, seeking approval for brepocitinib, a dual inhibitor of tyrosine kinase 2 and JAK1, in dermatomyositis, a rare autoimmune disease with limited treatment options.
A new generative AI model trained on UK Biobank data can simultaneously forecast the risks and timing of developing over 1,000 different diseases a decade into the future. The developers applied similar algorithmic concepts to those used to develop large language models like ChatGPT and Gemini to build the model, using medical records from 402,799 participants in UK Biobank.
On the heels of the announcement of German bionics developer Ottobock SE KGaA's pending IPO and more than 20 med-tech IPOs completed to date in 2025, four other med-tech companies spanning three continents queued up to go public on four exchanges, potentially signaling an active fall for med techs worldwide.
Biocartis Group NV received premarket approval from the U.S. FDA for its Idylla Cdx MSI test, developed in partnership with Bristol Myers Squibb Co., to help in the diagnosis and treatment of colorectal cancer. The cartridge-based, fully automated, sample-to-result test enables faster identification of patients with the disease who may benefit from therapeutic treatment.
The U.K.’s failure to join the dots from discovery research to patient access to innovative drugs was cited repeatedly by pharma leaders, who were called to an emergency hearing in parliament on Tuesday to explain decisions to pull out of promised capital investments.
CSL Ltd. inked a potential $2.1 billion deal with Dutch biotech company Varmx BV to develop VMX-C001 as a new treatment to restore blood coagulation in patients taking a factor Xa inhibitor.
Although cagrilintide from Novo Nordisk A/S proved less than impressive when paired with GLP-1 agonist semaglutide in a single drug known as Cagrisema, the dual long-acting amylin analogue and calcitonin receptor agonist is looking good as a monotherapy in a subanalysis of the phase III Redefine-1 trial.
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