Regulatory activity is underway to bring a new treatment for patients with thymidine kinase 2 deficiency (TK2d) to the European market, an ultra-rare disease that is characterised by progressive and severe muscle weakness. On 30 January, the European Medicines Agency issued a positive opinion for the treatment, Kygevvi (doxecitine and doxribtimine). It is expected to be reviewed by the European Commission in the second quarter for a marketing authorisation decision.
France-based Abivax SA has disclosed evidence that obefazimod, its small molecule drug candidate for inflammatory bowel disease and the subsets Crohn’s disease and ulcerative colitis, has shown evidence of anti-fibrotic activity. This has been illustrated in both preclinical human fibroblast and in vivo animal models of the disease. The data were presented at the European Crohn’s and Colitis Organization’s 21st Annual Congress in Stockholm on 21 February.
A non-invasive device using electrical fields to disrupt cancer cell division was approved by the US Food and Drug Administration on 12 February. Developed by Novocure Ltd, the therapy is designed to treat locally advanced pancreatic cancer and can be used in a home care setting. It is administered through electrically insulated adhesive patches that are placed on a patient’s skin and connected to an electric field generator.
A vaccine developed by GSK Plc and approved for the prevention of lower respiratory tract disease caused by the respiratory syncytial virus (RSV) appears to have a wider benefit, according to a retrospective study of patients who have received the drug. The study results were presented at a conference in Italy on 17 February. The vaccine, Arexvy, protects against respiratory syncytial virus which causes infections in the lungs and respiratory tract. The virus is common but the effects are most serious for young children and older adults.
After initially refusing to review a candidate mRNA vaccine developed by Moderna Inc for influenza, the US Food and Drug Administration has reversed itself and agreed to consider the product for a marketing authorisation. The decision was announced by Moderna on 18 February and follows a meeting between the agency and the company during which a compromise was reached.
Moderna Inc has asked for a meeting with the US Food and Drug Administration to query the agency’s decision to refuse to review its candidate mRNA vaccine for influenza. Effective 16 February, the agency hadn’t disclosed whether or not it would consider a follow-up discussion known as a Type-A meeting. This follows an event in early February when the director of the FDA’s biologics evaluation and research division at the agency, Vinayak Prasad, issued a refusal-to-file letter to Moderna overruling the advice of career staff at the agency.
AstraZeneca Plc is looking to expand its presence in emerging markets outside China as the size and diversity of its portfolio offer new opportunities for the years ahead. This was one of the messages delivered to journalists by Pascal Soriot, the chief executive, on 10 February following the publication of the company’s 2025 results. After a year of product launches and higher demand for key medicines, the company delivered revenue of $58.7 billion in 2025, up by 9% in actual exchange rates and by 8% at constant rates.
The Board of Directors of Sanofi SA has decided not to renew Paul Hudson’s mandate as chief executive after six years of leadership and to appoint Belén Garijo to the role effective 29 April. This is the date of the company’s annual general meeting. Dr Garijo was an executive at Sanofi for 15 years before moving to Merck KGaA in 2011 as chief operating officer and then progressing to the position of CEO in 2021. At the Sanofi AGM, she will be nominated as a group director in addition to her upcoming role as CEO.
Britain’s decision to quit the European Union in 2016 upended many formal commercial links. But it didn’t stop scientists on both sides of the English Channel from meeting on a regular basis to map out collaborations. On 9 February, a group of scientists involved in translational research met in Ghent, Belgium to discuss opportunities for partnerships in immunology and immunotherapy. The meeting was organised by the Flanders Institute for Biotechnology (VIP), Biovia, a health cluster in Flanders, and the UK membership group One Nucleus.
Net sales at Novartis took a hit in the fourth quarter of 2025 as generic versions of some of its iconic drugs faced competition from new producers. Group sales for the period were $13.3 billion, down by 1% at constant exchange rates and up by just 1% as measured in dollars. For the year as a whole, the company reported sales of $54.5 billion, up by 8% in constant and actual exchange rates.