Large Language Models (LLMs) are transforming back-office quality management processes in European healthcare systems through automation of compliance monitoring, quality assurance, and process optimization without direct patient interaction. This narrative review synthesizes evidence from recent systematic reviews and implementation studies (2023-2025) examining LLM deployment within the European regulatory framework encompassing the Medical Device Regulation (MDR), […]
Prediction of maturity-onset diabetes of the young subtypes using machine learning
IntroductionMaturity-onset diabetes of the young (MODY) is a monogenic type of diabetes caused by different pathogenic genetic variants in glucose metabolism-related genes, with GCK-MODY and HFN1A-MODY subtypes being the most frequent. Diagnosing the specific MODY subtype is essential for correct treatment and follow-up, but it requires gene sequencing, a time-consuming and costly process that depends […]
EMA seeks input on virtual alternative to animal test
EMA delivers a milestone in the replacement of animals in drug testing with the qualification of a virtual model for repeat-dose toxicity studies.
FDA delays decision on Orca Bio cell therapy after filing more manufacturing data
The FDA has postponed its deadline on whether to approve Orca Bio’s T cell therapy by three months to July 6. The agency was expected to reach a verdict by April 6, but pushed back …
Oric to advance prostate cancer drug to Phase 3, but combo choice raises doubts
Oric Pharmaceuticals on Tuesday detailed its plans to advance a PRC2 inhibitor into a registrational program for prostate cancer after sharing results from a Phase 1b trial. But the company’s shares $ORIC dropped by as …
Agios mulls early FDA filing for sickle cell therapy
Agios is planning to file its sickle cell disease candidate mitapivat with the FDA under the accelerated pathway within the next few months.
The gig workers who are training humanoid robots at home
When Zeus, a medical student living in a hilltop city in central Nigeria, returns to his studio apartment from a long day at the hospital, he turns on his ring light, straps his iPhone to his forehead, and starts recording himself. He raises his hands in front of him like a sleepwalker and puts a […]
Are We Training AI Too Late?
Ask the Expert: Cybersecurity teams need to expand their field of view to include new, unique threat sources, rather than relying on past, proven threat actors.
FDA points to liver injury with Amgen’s Tavneos
The FDA has raised the pressure on Amgen to withdraw vascultitis drug Tavneos from the market with a report linking serious side effects to the drug.
NHS to offer Wegovy to a million more people in England
The NHS in England will make Novo Nordisk’s Wegovy available to around 1.2m people in order to reduce their risk of heart attacks and strokes.
Evotec hires exec with AI experience to lead rebooted commercial team
Evotec has appointed Ashiq Khan, Ph.D., as chief commercial officer, putting an executive with robotics and artificial intelligence experience in charge of a unit that is central to the company’s recently unveiled transformation plan.
Negotiating privacy and responsibility in digital public health: a qualitative study of the social and ethical implications of peer-to-peer health data sharing
IntroductionPeer-to-peer sharing of personal health data on social media is increasingly used as a strategy to support public health goals. Such sharing is often assumed to motivate individuals to adopt or maintain healthy behaviors. However, the social and ethical implications of sharing-based interventions remain insufficiently examined. This paper offers an empirical and theoretical contribution by […]