News

The 2025 Nobel Prize in Physiology or Medicine has been awarded jointly to Mary E. Brunkow, Fred Ramsdell, and Shimon Sakaguchi for their discoveries concerning peripheral immune tolerance, a breakthrough that has transformed understanding of how the immune system avoids attacking the body’s own tissues.

Their pioneering research uncovered the identity and genetic control of regulatory T cells, the so-called “security guards” of the immune system that prevent autoimmune attack.

Restructuring across the biotech industry has resulted in decisions by three companies to end programmes in cell therapy after investing heavily in the sector for several years. On 30 September, Heartseed Inc of Japan announced that partner Novo Nordisk A/S, was ending a collaboration to create a stem cell-based therapy for heart failure. In separate announcements on 1 October, Takeda Pharmaceutical Co Ltd of Japan and Galapagos NV of the Netherlands announced plans to discontinue or divest cell therapy progammes in cancer.

An Italian university, hospital, and biotech and diagnostic companies, have joined forces to develop new treatments for lung cancer patients targeting the human epidermal growth factor receptor 3 (HER3). The collaboration is expected to identify HER3-positive circulating tumour cells with the goal of developing targeted therapies for the disease. It includes the Sant’Andrea Hospital in Rome, the Department of Clinical and Molecular Medicine at Sapienza University, also in Rome, the biotech company Takis Srl, and the diagnostics company Tethis SpA.

GSK Plc has appointed Luke Miels as chief executive officer designate, as well as a member of the company’s board of directors, from 1 January 2026. Emma Walmsley, the current CEO who has led the company since 2017, will step down from her position. However she will remain with the business until her notice period ends on 30 September 2026.

A gene therapy intended as a one-time treatment for Huntington’s disease significantly slowed progression of the disorder in a pivotal Phase 1/2 trial, paving the way for a regulatory submission in the first quarter of 2026. The developer, uniQure NV, showed that it is possible to safely impact the disease by targeting both the disease-causing huntingtin protein and the normal protein using a vector-based gene therapy and a gene encoding a microRNA (miRNA).

Pfizer Inc is to pay $4.9 billion to acquire a three-year old company, Metsera Inc, which is developing drugs for weight management giving it a selection of candidate products that can be delivered orally and by injection and which include both amylin and incretin mimetics. The amylin-based treatments restore sensitivity to leptin, a satiety hormone that enables people to feel naturally full after eating. The incretins, which include the glucagon-like peptide-1 (GLP-1) drugs, mimic hormones in the gut that help regulate blood sugar and appetite.

The European Medicines Agency has issued a positive opinion for a new indication of an antibody therapeutic that targets B cells in order to treat immunoglobulin G4 related diseases. These are autoimmune disorders caused when the body’s own defence system attacks normal tissues. This can lead to fibrosis and inflammation in one or multiple organs of the body. The therapy, Uplizna (inebilizumab), has already been approved for the treatment of neuromyelitis optica spectrum disorder, an inflammatory disorder of the central nervous system.

Netherlands’s- based VectorY Therapeutics BV has negotiated an option and licensing agreement with a US manufacturer of adeno-associated viral (AAV) capsids ahead of making its first regulatory filings for clinical trials of a new drug for amyotrophic lateral sclerosis. The supplier of the tool is Shape Therapeutics Inc of Seattle, Washington which is developing capsids for genetic medicines for difficult-to-reach tissues. Capsids are the protein shells of AAV viruses that can be used to carry a working copy of a gene into the nucleus of a target cell. 

Roche is to acquire 89bio Inc of San Francisco, US, to expand its cardiovascular, renal and metabolic disease portfolio with a drug that is being developed for metabolic dysfunction-associated steatohepatitis (MASH). MASH (previously called non-alcoholic steatohepatitis) is a liver disease that develops when fat builds up and causes inflammation. Without treatment, it can lead to cirrhosis and liver cancer.

Novo Nordisk A/S has announced plans to cut its workforce by 9,000 as part of a restructuring measure that will enable it to concentrate more resources on its diabetes and obesities medicines. The Danish company is a market leader in both sectors, alongside Eli Lilly and Co, but has experienced setbacks on the US market owing to product shortages and competition. This led to the resignation of its chief executive Lars Fruergaard Jørgensen in May. His successor, Mike Doustdar, is a long-time employee of the company and assumed the position of CEO in August.