Tulyp Medical Inc. has emerged from stealth mode with a pressure-driven perfusion system designed to improve vascular procedures. The company, born out of Sofinnova Partners' medical device accelerator, has submitted the technology to the U.S. FDA for 510(k) clearance following initial clinical results that demonstrated safety and functionality.
Qyuns Therapeutics Co. Ltd. signed a potential $1.07 billion license deal with Roche Holding AG, granting the latter exclusive rights to QX-031N – a human thymic stromal lymphopoietin and interleukin-33)-targeting bispecific antibody.
In 2025, the biopharma industry has undergone a wave of workforce reductions that surpasses previous years’ trends. Multiple major pharma companies have announced sizeable job cuts, driven by a convergence of shifting regulatory terrain, vaccine slowdowns and cost-structure rationalization.
Pfizer Inc. upped its original $7.3 billion September offer to buy Metsera Inc., but the obesity specialist maintained that a now-improved unsolicited bid by semaglutide developer Novo Nordisk A/S is superior.
Five-year follow-up data for Santhera Pharmaceuticals AG’s Duchenne muscular dystrophy (DMD) drug, Agamree (vamorolone), confirm that its efficacy in preserving muscle function is comparable to standard-of-care corticosteroids, but that the overall side-effect profile is more benign. There was less positive DMD news from Sarepta Therapeutics Inc.
Oversonic Robotics Srl believes that its humanoid robot Robee could transform health care in Europe as it helps address the challenges of an aging population, rising chronic conditions and the shortage of health care workers. Robee has already received CE mark certification as a class I medical device, and plans are underway to achieve class II certification next year as the company looks to make a significant social impact with its humanoid robot.
The U.K. Medicines and Healthcare products Agency (MHRA) has committed to major reforms of how it regulates drugs for rare diseases, making it easier to run clinical trials and get approvals. The new rules will be published in full early in 2026 and come into effect later in the year, but following consultation with industry, academics and patients’ groups, the agency has released a position paper setting out its plans.
Pfizer Inc. has delivered on its threat of legal action against the attempt by Novo Nordisk A/S to scupper its acquisition of Metsera Inc., and has filed two lawsuits, one alleging breach of contract, and a second claiming that a merger of Novo Nordisk and Metsera would violate antitrust regulations.
Uniqure NV is regrouping after a surprise switcheroo by the havoc-beset U.S. FDA regarding phase I/II studies with AMT-130 vs. external control in Huntington’s disease (HD) – news of which pushed down the Lexington, Mass.-based firm’s shares (NASDAQ:QURE) Nov. 3 by $33.40, a loss of 49%, at the closing price of $34.29.
Scientists in the U.K. are developing glucose-powered bioelectronics to advance the use and capabilities of implantable medical devices. A research team, led by the University of Bath, received £2.1 million (US$3.3 million) in funding from the government to develop miniature, lightweight and long-lasting glucose fuel cells to help address the invasiveness and limitations of current battery-powered implants.
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