Getting overwhelmed by the news is an everyday struggle for those wishing to stay in touch with the latest news. Our newsletter should make it easier for those interested in pharmacovigilance regulations, advancement in the relevant use of artificial intelligence, and personal growth. Approaching with care, the same as we provide PV services, we thoughtfully pick articles every month to keep you updated.
Leaders from Fortune 1000 and leading global brands are bullish about their AI investments—but face common problems around adoption and change management.
While the FDA came out on top over the EMA in terms of approvals, both agencies greenlighted fewer new drugs than in 2024.
In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before.
And much more...
In 2025, EMA recommended 104 medicines for marketing authorisation. Of these, 38 had a new active substance which had never been authorised in the European Union (EU) before.
Questions and answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by marketing authorisation holders
EMA and the U.S. Food and Drug Administration (FDA) have jointly identified ten principles for good artificial intelligence (AI) practice in the medicines lifecycle.The…, "The guiding principles of good AI practice in drug development are a first step of a renewed EU-US cooperation in the field of novel medical technologies.
Mark Sullivan explains why trust, data discipline and human oversight will determine who wins in an agent-driven future.
Leaders from Fortune 1000 and leading global brands are bullish about their AI investments—but face common problems around adoption and change management.
Startups raised $14.2 billion last year, the highest funding total since 2022. Health AI companies collected 54% of total funding, according to Rock Health.
While the FDA came out on top over the EMA in terms of approvals, both agencies greenlighted fewer new drugs than in 2024.
Paracetamol should be taken as directed in the patient information leaflet.
A focus group organised by the Drug Safety Research Unit (DSRU) International Working Group (IWG) on New Developments in Pharmacovigilance discussed current challenges and opportunities in pharmacovigilance (PV), emphasising the need for a multimodal approach in data analysis and accessibility of diverse data sources for drug safety surveillance.
Pictures used in this newsletter were generated by AI.