Wegovy (semaglutide) has passed the notoriously strict cost-effectiveness scrutiny of the U.K. health technology assessment body and will now be reimbursed for the prevention of further serious cardiovascular events in people who have had a heart attack or stroke, or are diagnosed with peripheral arterial disease.
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) is to offer an early review of nonanimal data to give companies more confidence that evidence generated with new approach methodologies, such as organoids and microphysiological systems, will be accepted as part of marketing authorization applications.
U.K. biopharma is working with the country’s space agency and Civil Aviation Authority (CAA) to plot a route for manufacturing biologic drugs in low earth orbit.
With CE-marked products accounting for about 90% of medical devices currently used in Great Britain, the Medicines and Healthcare products Regulatory Agency (MHRA) is considering proposals for a path forward that would help the U.K. achieve its goal of becoming a leading country for med-tech access by 2030.
Four years after they were first mooted, the finishing line is in sight for new U.K. clinical regulations, which will come into force on April 28. In the first major update since 2004, about 20% of lower-risk studies are expected to be approved by a fast track, and the Medicines and Healthcare products Regulatory Agency will introduce a 14-day assessment route for phase I healthy volunteer trials, amongst other measures to streamline approvals.
The U.K. Medicines and Healthcare products Agency (MHRA) has committed to major reforms of how it regulates drugs for rare diseases, making it easier to run clinical trials and get approvals. The new rules will be published in full early in 2026 and come into effect later in the year, but following consultation with industry, academics and patients’ groups, the agency has released a position paper setting out its plans.
The U.K. Medicines and Healthcare products Agency (MHRA) is calling for more research into the vaginal microbiome as a way to redress the historic under-representation of women in clinical studies, which it said has contributed to “critical shortcomings” in understanding of female-specific conditions.
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
Representatives of patients’ groups, industry bodies and venture philanthropy funders are calling for a renewal of the U.K. Rare Diseases Framework, to put fresh momentum behind translational research and clinical trials, streamline regulatory oversight and improve access to therapies.
The increased use of GLP-1 receptor agonists has led on to an increase in reports of acute pancreatitis in people taking these weight loss drugs in the U.K. That has prompted the launch of a pharmacogenomics project to investigate if there are any genetic links underlying the occurrence of this adverse event.
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