Changes to the procurement of critical medicines and their active ingredients are among the amendments the Council of the EU has made to the draft Critical Medicines Act.
The Association of the British Pharmaceutical Industry said 2024 marks the fourth consecutive year of declining patient recruitment in UK industry trials, calling it the most concerning trend despite a surge in trial initiations.
New approach methodologies are increasingly shaping the future of medicine development by making drug testing less reliant on animals.
Portugal has made permanent a pilot aimed at cutting review timelines for certain clinical trial applications.
International reliance mechanisms for approving drugs have an important place, but the UK regulator should increase focus on becoming a first approver of medicines, according to the British pharmaceutical industry.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Lynkuet, Bayer's treatment for moderate to severe vasomotor symptoms associated with menopause or endocrine therapy for breast cancer.
Under the newly-announced UK-US trade deal, the UK will increase the thresholds used to evaluate the cost-effectiveness of new medicines, which should allow higher prices for innovative therapies.
Postmarket optimization studies for cancer drugs can strengthen clinical trust in cancer medicines, which in turn results in therapies being used more often, a researcher says.
Integrating patient choice in clinical trials is a compelling vision, but achieving it at scale requires balancing flexibility with regulatory compliance, operational feasibility, and data integrity.
The UK’s autumn budget failed to introduce any widespread changes for pharma, but scale-ups and innovators could benefit from changes to enterprise and investment schemes. Some industry voices warn of underinvestment in the MHRA and innovative medicines.
Decentralizing clinical research demands rethinking accountability and logistics to prevent gaps that could compromise safety and trial integrity.
The European Commission says it will soon publish an updated study on the impact of the Urban Waste Water Treatment Directive on the pharmaceutical and cosmetics industry and that it would support member states in avoiding “unintended consequences.”
While there is a general shift towards alignment and collaboration in health technology assessments in the EU under the new HTA Regulation, member states still have “their own recipe” when it comes to making reimbursement decisions.
The pharmaceutical industry has been pushing back on a deeply unpopular rebate on products deemed to be “free combination” medicines in Germany.
France is set to pilot a new fast-track process that could more than halve the timeline for authorizing certain clinical trial applications.
Europe’s RADIAL study comparing fully decentralized, hybrid and conventional trial approaches reveals why online recruitment is not simple.
While the volume of questions that companies have received from the EU member states under the Health Technology Assessment Regulation has been lower than expected, some firms are struggling with the comparator analysis required to answer some questions, an expert says.
With UK chancellor Rachel Reeves set to deliver the country’s budget on Wednesday, Medicines UK has set out five “focus areas” where the off-patent industry believes that action is needed.
England is set to become the first market outside of the US where Autolus’ CAR-T therapy Aucatzyl is reimbursed for acute lymphoblastic leukemia, after the country’s health technology assessment institution, NICE, recommended its use for certain patients.
Sponsors and CROs planning commercial trials in the UK can now use a standardized template to confirm NHS site selection and start study setup activities in parallel with formal contracting and regulatory approvals.