19 Dec, 2024 Déjà VPAG – 2025 repayment percentage announced By Hugo Kent-Egan Anna Hall On 16 December, the DHSC announced that the 2025 headline VPAG repayment percentage for sales of “newer medicines” will be 22.9%. This...
25 Nov, 2024 UK MDR consultation – proposals for International Reliance on medical device approvals By Jamie Hatzel The consultation on the future of the UK’s Medical Devices Regulations 2002 (UK MDR), initiated by the MHRA on 14 November 2024,...
25 Nov, 2024 Shaping the future of medical devices: MHRA proposes four key changes to regulations By Alex Denoon Anna Hall Background The MHRA has launched a Consultation on future changes to the UK Medical Devices Regulations. The consultation addresses four...
19 Nov, 2024 Reasons to be cheerful: 4 takeaways from the BIA UK Life Sciences Regulatory Conference 2024 By Hugo Kent-Egan We had an insightful day hearing about the future of UK life sciences regulation at the BIA’s flagship annual Life Sciences Regulatory...
05 Nov, 2024 Early Christmas present: MHRA consultation on international recognition of devices By Hugo Kent-Egan The MHRA has provided more information on its plans for rolling-out its new medical device framework. It aims to publish its additional...
28 Oct, 2024 Split poly(A) tail mRNA patents invalid for insufficiency and obviousness By Kate O'Sullivan This article was first published in Kluwer Patent Blog [October 2024]. On 8 October 2024, Mr Justice Meade handed down judgment in...
28 Oct, 2024 GDPR and scientific research in the UK: what does the Data (Use and Access) Bill have to say? By Mac Macmillan Back in July I speculated, based on the King's Speech, that the new government's proposals for scientific research were likely to be a...
07 Oct, 2024 Incoming: MHRA consultation on UK Medical Devices Regulations By Hugo Kent-Egan Alex Denoon On 25 September 2024, the MHRA updated its roll-out of the new medical device regulatory framework for Great Britain. The MHRA aims to...
02 Oct, 2024 TEAM-NB’s interpretation of “Structured Dialogue” between Manufacturer and Notified Body, clarifies little By Alex Denoon Anna Hall TEAM-NB has published a new version (v5.0) of its Code of Conduct for Notified Bodies. While we don’t normally comment on this Code,...
02 Sep, 2024 Abbott Diabetes Care Inc. v Sibio Technology Limited – an update By Gregory Bacon Aida Tohala This article was first published in Kluwer Blog [August, 2024]. Background In June 2024, we reported that in an application for...
19 Aug, 2024 CASGEVY: CRISPR/Cas9 gene therapy now available in England following NICE recommendation By Claire Smith Luca Cericola Vertex Pharmaceuticals announced a reimbursement agreement with NHS England for individuals 12 years or older with transfusion-dependent...
13 Aug, 2024 UK – Samsung Bioepis v. Janssen Biotech / ustekinumab By Sophie Britton This article was first published in EPLAW blog [August, 2024]. Patents Court finds Janssen Biotech’s patent, for the antibody ustekinumab...