The European Union’s struggles with regulations for devices and in vitro diagnostics seem virtually endless, but the European Commission floated a series of changes that would present a significant reset of both regulations. One of the more sweeping changes would be to exempt medical technologies from much of the text of the Artificial Intelligence Act, a move that would ease the drag on AI-based technologies in the EU.

Siemens Healthineers AG became the latest company to sign a licensing agreement with Alzpath Inc. to use its pTau217 antibody in the development of a blood-based diagnostic assay for Alzheimer's disease. Alzpath previously signed deals with the likes of Roche AG and Beckman Coulter Diagnostics Inc. to use its pTau217 antibody to create diagnostic tests based for early detection and monitoring of Alzheimer's.

ADEL Inc. closed a year-end licensing deal worth up to $1.04 billion with Sanofi SA for ADEL-Y01, a specific tau-targeting Alzheimer’s disease drug candidate in a U.S. phase I study.

Two large deals and an acquisition, totaling about $4.64 billion in all, are helping wrap up what’s turning out to be a strong year. Through the first 11 months of 2025, biopharma dealmaking was robust with a collective value of $261.14 billion, the highest January through November total of the past seven years and well above 2024’s $201.35 billion. These three December deals helped revive the surge in dealmaking that had cooled in November.

The EU finally reached agreement on an update of the 20-year-old pharmaceutical legislation, more than five years after the EU Commission first put forward the case for reform and following two and a half years of negotiations on the new rules.

Sanofi SA reported more hitches in the development of Bruton’s tyrosine kinase inhibitor tolebrutinib, saying the phase III Perseus study failed to meet its primary endpoint in primary progressive multiple sclerosis (MS) and that the ongoing U.S. regulatory review in non-relapsing secondary progressive MS likely will extend beyond the targeted PDUFA date of Dec. 28.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) is joining the U.S. FDA and the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) in approving Anktiva (nogapendekin alfa inbakicept-pmin) in patients with non-muscle invasive bladder cancer (NMIBC) who have not responded to immune stimulation treatment with Bacillus Calmette-Guérin (BCG) vaccine and would otherwise require surgical removal of the bladder.

Ebenbuild GmbH is hoping that its digital twin technology platform that combines AI and physics-based computational models tailored to individual patients will transform respiratory care. From drug development to optimizing mechanical ventilation in critical care, the company’s software-based solutions aim to reveal what is happening in the ‘black box’ of the lungs, helping clinicians to improve outcomes and reduce mortality.

Disco Pharmaceuticals GmbH announced the final close of its seed round at €36 million (US$42 million), as it shapes up novel targets it has discovered with its surfaceome platform technology for formal preclinical development.

Disco Pharmaceuticals GmbH announced the final close of its seed round at €36 million (US$42 million), as it shapes up novel targets it has discovered with its surfaceome platform technology for formal preclinical development.