3/21/2025 9:45:58 AM UK Pharma leaders: VPAG is making the UK “un-investable” By Hugo Kent-Egan Alex Denoon Krishiv Desai Various UK pharmaceutical companies yesterday co-signed a report warning that future UK investment is unlikely unless the Government...
3/17/2025 3:46:52 PM Statutory Scheme repayments: the DHSC dots the i's and crosses the t's By Hugo Kent-Egan On Friday, the DHSC published the latest consultation to update the repayment percentage under the Statutory Scheme. This consultation...
3/12/2025 3:06:22 PM Over a year on from VPAG: is there a VAT-shaped hole in the Government’s calculations? By Tabitha Reed Hugo Kent-Egan Julia Cockroft Xisca Borrás +1 more... Show less HMRC has been granted permission to appeal the First-Tier Tribunal’s VAT decision in the case of Boehringer Ingelheim Ltd v HMRC. We...
2/11/2025 3:47:37 PM A Wellcome Development for SaMD – the UK Publishes Guidance on Digital Mental Health Technologies By Ellie Handy The MHRA and NICE published guidance on “Digital mental health technology: qualification and classification” (the DMHT Guidance) last...
12/19/2024 12:27:37 PM 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...
12/12/2024 11:50:02 AM 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...
11/27/2024 1:32:08 PM 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...
11/25/2024 1:11:26 PM 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,...
11/25/2024 1:10:46 PM 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...
11/22/2024 3:51:47 PM 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...
11/19/2024 3:23:03 PM 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...
11/11/2024 10:31:26 AM 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...