The European Commission has outlined a strategy for building capacity in artificial intelligence across the 27-nation union alongside the first grants to execute it. Announced on 9 April, the strategy envisions the construction of new AI data centres and laboratories, the use of new algorithms, and the recruitment of skilled labour.
A new drug for haemophilia that targets antithrombin, a protein that inhibits blood clotting, has been approved by the US Food and Drug Administration. Discovered by Alnylam Pharmaceuticals Inc and licensed to Sanofi SA, Qfitlia (fitusiran) will be used to treat patients with both haemophilia A and haemophilia B with or without inhibitors. The standard treatment for patients with haemophilia are clotting factor replacement therapies where patients with haemophilia A receive replacement for factor VIII and those with haemophilia B, replacement for factor IX.
Effective 7 April, the US Food and Drug Administration had lost 28 senior leaders who left the agency voluntarily or were fired following the Trump Administration’ decision to reduce the workforce by 3,500 people. The figures, compiled by the STAT news agency, show that departures included deputy directors and commissioners across all departments from the centres for devices and radiological health, to the centres for small molecule and biologic evaluation, and for tobacco regulation.
The US Food and Drug Administration announced plans on 10 April to phase out animal testing for monoclonal antibodies and other drugs – a safety requirement for the development of human medicines that was first introduced in 1938. The reason is to adopt new methods for evaluating safety that could harness technologies such as artificial intelligence while reducing research and development costs.
Only hours before announcing countermeasures against prospective US tariffs on steel and aluminium, the European Commission has pulled back in response to a pause from the Trump Administration. The US announced a 90-day pause on its tariff measures on 9 April. The pause affects a second tier of tariffs that would have driven the tax on exports by the US’ trading partners up by double-digit figures. The pause does not affect China.
The European Union member states have agreed to enact countermeasures against US tariffs on steel and aluminium from 15 April should negotiations over trade fail to reach a fair and balanced outcome by that time, the European Commission announced on 9 April. The vote by member states gave support to a proposal from the Commission in response to a US decision in March to impose import duties on the two products.
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.
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.