United Kingdom
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.
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.
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.
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.
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.
Ohtuvayre is off to a great start in the US but Verona's new owner MSD has pulled the EU marketing application from the European Medicines Agency for the closely-watched chronic obstructive pulmonary disease drug.
The UK’s early access to medicines scheme could be due a rethink, a senior figure from the Medicines and Healthcare products Regulatory Agency has suggested, after feedback indicated “discontent” with how the program functions.
The deadline by which pharma companies must decide whether they want to leave the UK’s voluntary pricing scheme for branded medicines has been extended to mid-December – meaning that for the first time, companies can find out the terms of the scheme before opting in or out.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.
A senior AstraZeneca executive says the UK MHRA must develop specialist expertise and create incentives for companies to file marketing authorizations nationally if it wants to stand out to strategic decision-makers.
Pharmaceutical companies will be expected to phase out certain animal tests in the drug development process under a UK roadmap aimed at pivoting towards using alternative models, such as organ-on-a-chip systems and artificial intelligence.
Horizon scanning is a tool used by regulators to prepare for forthcoming medicines that might challenge existing processes. Senior figures from the European Medicines Agency, Swissmedic and the UK MHRA explain how they conduct horizon scanning activities in their respective jurisdictions.
As more medicines come off patent in the coming years, the UK generics and biosimilars industry association is hoping to see more generic products evaluated for reimbursement by the health technology assessment institute, NICE.
Sam Roberts, chief executive of England’s NICE, has defended the health technology assessment institute’s cost-effectiveness thresholds and the country’s ranking against other nations when it comes to market access, while acknowledging that the UK’s pharma ecosystem is “really tough.”
The UK drug regulator is planning to introduce a “flexible, proportionate” licensing and registration model for rare diseases, which could see drugs granted provisional approvals based on “appropriate, albeit limited” evidence.
Recipients of the public-private funding are also expected to receive wraparound support, including strategic guidance to identify the right progression pathway for their antimicrobial resistance asset and access to key resources and sector connections.