The European Medicines Agency is set to adopt opinions on whether marketing approval should be granted to five new products, including three orphans. A decision is also due on a previously-rejected Alzheimer’s drug that was under re-examination.
Sponsors making “big statements” with “no evidence” to back them up is one of the biggest issues faced by the UK drug regulator when it is assessing the regulatory dossiers for advanced therapy medicinal products, a quality assessor from the Medicines and Healthcare products Regulatory Agency says.
Weight loss drugs have likely proven to be the most challenging medicines to introduce to the National Health Service in England, and lessons should be learned in preparation for other game changing products.
The European Medicines Agency wants to develop a structured framework for non-clinical proof-of-concept studies in pediatric oncology.
While regulators are “catching up” to the use of artificial intelligence in clinical development, some skepticism remains around the use of AI to generate synthetic patient data, says Alexion’s Nick France.
Lawyers from Sidley Austin tell the Pink Sheet how European drug manufacturers and marketing authorization holders should proactively deal with warning letters from the US Food and Drug Administration.
According to the health technology assessment institute, NICE, new cost-effectiveness thresholds – which are higher than those that applied when the original decisions were made – will apply when its committee reconsiders the appraisals for Eisai and Eli Lilly’s Alzheimer’s disease drugs.
The first multinational clinical trial approval under the EU’s 70‑day fast-track pilot pathway is expected by the end of April 2026.
A regulatory roadmap and product development tracker, expedited scientific advice, and submission readiness meetings are being integrated into the European Medicines Agency’s decade-old priority medicines scheme.
Artificial intelligence in pharmaceutical manufacturing is increasing in prevalence, offering a unique opportunity for global regulators to align on expectations, industry group IFPMA says.
Smaller biotech companies without the regulatory resources of big pharma should approach the UK medicines regulator and health technology appraisal body for early, informal discussions on how to generate the right evidence.
The draft report lays out a unified EU framework to reduce disparities and modernize rare disease diagnosis, treatment, care and research.
Asieris Pharmaceuticals' hexaminolevulinate, for treating high-grade squamous intraepithelial lesions, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
The European Medicines Agency has requested updated safety warnings for Ixchiq’s product information after a case of aseptic meningitis was reported in a healthy young adult.
Novartis’s ianalumab, for treating Sjögren’s disease, is also among the new drugs that the European Medicines Agency has started reviewing for potential pan-EU marketing approval.
EU data protection bodies back clinical trial harmonization under the draft Biotech Act, but insist on strong safeguards for sensitive health data.
A new survey of French healthcare professionals reveals concerns that France is increasingly being excluded from major international clinical studies.
Strengthening the European Medicines Agency’s capacity to analyze clinical and non‑clinical raw data, expanding real-world evidence infrastructure, and boosting AI literacy across the EU regulatory network all feature prominently in a new 2026–2028 workplan.
So far this year, four drug candidates have secured a place on the European Medicines Agency’s priority medicines scheme for promising treatments for unmet medical needs.
England’s health technology institute, NICE, said that Astellas’ non-hormonal drug for menopausal hot flushes, Veoza, should be funded for use via the National Health Service and that the drug addresses a “real and important” need for people who cannot take hormone replacement therapy.