News

A retrospective, observational study of semaglutide 2.4 mg (Wegovy) has shown that adults who are overweight with an established cardiovascular disease, but no diabetes, were able to reduce their risk of a major cardiovascular event over a period of years. Called SCORE, the trial compared outcomes for semaglutide users with non-users and established benefit for the drug taken as an adjunct to diet and exercise. The study started in 2018, enrolled 17,604 adults, and was conducted in 41 countries at more than 800 sites.

The European Medicines Agency issued a negative opinion on 28 March to Eli Lilly and Co which applied to market its Alzheimer’s treatment Kisunla (donanemab) in the EU for patients with amyloid beta plaques in the brain and mild cognitive impairment. Lilly said that it will appeal against the decision.

Peter Marks, MD, PhD, and director of the US Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER), announced his resignation on 28 March. His departure, which is scheduled for 5 April, coincides with a decision by the Trump Administration to downsize the Department of Health and Human Services (HHS), the FDA’s governing body, by reducing the department’s workforce by 20,000 people. The FDA is expected to lose 3,500 full-time employees. This follows the swearing in on 13 February of Robert F Kennedy Jr as the HHS secretary.

MaaT Pharma SA of France expects to make its first regulatory submission to the European Medicines Agency in June following a successful Phase 3 trial of its microbiome therapy and a capital increase of €13 million from a private share placement. The capital increase was announced on 27 March, not long after the company reported the latest clinical data for its therapy. The therapy, MaaT013, is being developed for patients with acute graft-versus-host disease with gastrointestinal involvement. 

Owlstone Medical Ltd is to receive an equity investment of up to $2.3 million from the US Cystic Fibrosis Foundation to develop a new breath test to detect a bacterial infection in patients with cystic fibrosis. The UK company has developed technology that can detect biological information from volatile organic compounds and respiratory droplets in breath. The newest project will involve developing a test for Pseudomonas aeruginosa, a Gram negative bacterial infection that can be particularly dangerous for people with compromised immune systems.

Novo Holdings A/S and Jeito Capital have co-led a new financing for Augustine Therapeutics NV of Belgium to support clinical development of the company’s candidate treatment for Charcot-Marie-Tooth disease, an inherited disorder that can cause nerve damage. The oversubscribed Series A financing raised a total of €78 million which includes an earlier sum of €17.5 million generated in 2024. Altogether 11 investors supported the company, including the US-based Charcot-Marie-Tooth Research Foundation. The closing of the Series A round was announced on 24 March.

The European Commission launched a new proposal on 19 March to stimulate private investment in industry and harmonise rules for trading in securities. The plan would essentially try to encourage citizens with large cash savings in banks in the EU to invest a portion of these assets in industry, including in small and medium size companies, to stimulate innovation and boost growth. The plan, called the savings and investment union, is a new version of an earlier capital markets union proposal that was introduced in 2014 but failed to gain traction.

Francis Collins, a geneticist and director of the US National Institutes of Health for 12 years, retired from his position on 28 February, with a tribute to his colleagues and the institution that they support. “The National Institutes of Health is the world’s foremost medical research institution. It has been rightfully called the ‘crown jewel’ of the federal government for decades. It has been the greatest honour of my life to be part of this institution in various roles over the last four decades,” he said in a statement.

A new biotech company has been launched in Seattle, US, and Singapore, with the goal of advancing the technology for antibody-drug conjugates - treatments for cancer that use an antibody and linker to deliver a cytotoxic agent to cancer cells. The company, Callio Therapeutics Inc, is developing ADCs that would be equipped with more than one cytotoxic payload. The company says this structure could increase the efficacy of ADCs, a drug class which is attracting developers across the industry.

Valneva SE, developer of the world’s first vaccine against chikungunya virus, is forecasting higher sales this year and more investment in R&D as it advances new products in the clinic against infectious diseases. Product sales this year are expected to reach €170 to €180 million, up from €163.3 million in 2024. This will drive positive cash flow for the business enabling an increase in R&D spending to between €90 to €100 million, up from €74.1 million in 2024.