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With EU MDR/IVDR review proposals out, UK MHRA progress on a premarket regulation and, up ahead, a prospective consultation on accepting the CE marking indefinitely, now is a good time to assess EU-UK regulatory positions for the benefit of UK industry, says ABHI director Steve Lee.
External reference pricing is one of several drug pricing control measures used by a number of countries to contain drugs prices.
The UK-US trade deal offers the “the most encouraging signs the industry has seen for many years,” but UK companies had little influence over it and details are still scarce, according to one industry expert.
A key UK database of new medicines in drug company pipelines is being updated to future-proof horizon scanning in the UK and include vaccines.
Just a few days after Alvotech announced global settlements for its Eylea rival, Samsung Bioepis has followed up with its own agreements with the originators.
The UK MHRA says it is ready to deliver the new Clinical Trials Regulation, which aims to balance faster review of trial applications with greater flexibility to deliver a competitive, innovation-friendly clinical research ecosystem.
Alvotech has ticked off all of the remaining patent-related matters for its aflibercept biosimilar, with multiple market entries expected in 2026.
Fund IV exclusively targets company creation and early-stage investing across the UK and the US.
Healthtech companies seek to optimize the opportunity of AI while navigating a thicket of requirements from providers as well as regulations like the EU MDR. Andrew Davies, digital health lead at the Association of British HealthTech Industries, explained the importance of streamlining AI processes.
In a busy month for triple-digit percentage average price rises for generics in the UK, repaglinide led the pack in December.
The UK MHRA will soon consult on allowing CE-marked devices indefinite access to the Great Britain market. Meanwhile, the EU has at last moved to make the MDR/IVDR more user friendly. Taylor Wessing partner Alison Dennis reflects on how these events could influence evolving UK medtech legislation.
Oxford-based Allos is scaling up its AI platform, which aims to revive investments into reformulating complex generics.