There has been no let-up in the number of clinical trials conducted in the UK since the country left the EU and the Medicines and Healthcare products Regulatory Agency is taking steps to make sure the country continues to be attractive to clinical research, says June Raine, the head of the agency.
UK Clinical Trial Numbers Still ‘Buoyant’ After Brexit
MHRA Transformation Will 'Reshape And Reskill' Workforce
In this second article on the post-Brexit fortunes of the UK medicines regulator, the MHRA, Pink Sheet looks at the emergence of a new UK clinical trials environment, how the agency is facing up to resource pressures, and when the new fee structure might be ready.
More from Europe
• By
The weight management drug, Mysimba, continues to demonstrate a positive benefit-risk balance but the data available are not sufficient to fully determine the cardiovascular safety beyond 12 months. Meanwhile, Currax this month announced the publication of a peer-reviewed study of Mysimba that followed patients for over 4.7 years and found no evidence of excess cardiovascular risk.
• By
Health technology assessment body NICE said it has taken on feedback about the implications of allowing higher cost-effectiveness thresholds for some medicines after senior health economists offered diverging views on its methods.
• By
The European Medicines Agency has recommended five drugs for EU-wide approval , including Averoa’s Xoanacyl for concomitant hyperphosphatemia. Two companies have withdrawn their marketing authorization applications.
• By
Eli Lilly’ will request a re-examination after the European Medicines Agency declined to recommend its Alzheimer’s disease drug Kisunla for EU approval.
More from Geography
• By
A former CMS manager worries casework and other necessary functions could suffer as a result of the 300 staff cuts at the agency that are part of a massive HHS restructuring.
• By
The April departures of Paul Kluetz and Marc Theoret follow resignations by other senior agency scientific staff and come on top of HHS’ plans to lay off 3,500 FDA employees.
• By
Pink Sheet reporter and editors discuss how staff may not be the only thing the FDA could lose with the latest layoffs announced by the Health and Human Services Department.