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...
12 Dec, 2024 SynbiTECH 2024: Engineering biology’s promise for the future By Ellen Lambrix In London last week, over 400 attendees and speakers gathered together for the fifth annual SynbiTECH conference in London. The event...
27 Nov, 2024 The UK Assisted Dying Bill and its implications for pharmaceutical companies By Jamie Hatzel The Terminally Ill Adults (End of Life) Bill, introduced as a private members’ bill by Kim Leadbeater MP on 11 November 2024 (Leadbeater...
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...
22 Nov, 2024 Gene therapies and regulatory milestone triggers: Licensors and Licensees beware By Ellen Lambrix Luca Cericola As briefly mentioned in our article last week on Priority Review Vouchers, the financial terms of a biopharma patent licence agreement...
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...
11 Nov, 2024 Priority Review Vouchers: another high value sale generates a significant return for licensor By Ellen Lambrix Luca Cericola On 5 November 2024, Acadia Pharmaceuticals Inc. ("Acadia") announced that it sold its rare paediatric disease priority review voucher...
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...
30 Oct, 2024 Further revisions to the MDR and IVDR By Alex Denoon Last week, the European Parliament (EP) passed a resolution calling on the European Commission (EC) to further revise the Medica Devices...
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,...