07 Mar, 2024 Could PISCES be written in your stars or are you simply in need of a funding LIFT[S]? By Robert Newman Spring Budgets in the UK are not necessarily bookmark events in the calendar of Life Sciences lawyers. However, with a frost still on the...
23 Nov, 2023 UK CMA publishes Competition Law Guidance for Cooperations on Combination Therapies By Alexandra Kamerling Executive Summary Combination therapies involve the use of two or more separate medicines in combination to treat a disease. It can be...
17 Nov, 2023 UK Healthcare Procurement: Provider selection regime regulations overview By Sammi King Saman Anwar Mark Vipan It is currently intended that the Provider Selection Regime (PSR) will come into force on 1 January 2024. The PSR Regulations are a new...
28 Apr, 2023 The UK voluntary scheme for branded medicines pricing and access (VPAS): just what the doctor ordered, or a bitter pill to swallow? By Michael Stead Martha Pownall On the 1 April this year, amidst storm clouds gathering above the NHS in the form of staffing strikes, record waiting times and chronic...
20 Apr, 2023 Cross-border considerations for privacy in clinical trials - At the Intersection of Sciences and Law Podcast Series By James Clark Paula Gonzalez de Castejón Llano-Ponte David Kopans In this episode of At the Intersection of Sciences and Law Podcast Series, in light of the recent publication of our Cross-border Guide...
03 Apr, 2023 New Guidance from the Medicines & Healthcare products Regulatory Agency (MHRA) on the Intended Purpose Statement for Medical Device Software By Poppy Williams As part of the MHRA’s Software and AI as a Medical Device Change Programme, the MHRA has recently published guidance on crafting an...
15 Nov, 2022 Clinical Trials and Privacy Matters: A Cross-border Guide By Marco de Morpurgo This week our Life Sciences team published the first edition of its Cross-border Guide to Clinical Trials and Privacy. The Guide will...
14 Jul, 2022 UK: New National Strategy for Health Data By James Clark The UK’s Department for Health and Social Care (“DHSC”) has published a major strategy document (‘Data saves lives: reshaping health and...
24 May, 2022 Raw material shortage and its impact on the pharma industry By Sonia de Kondserovsky Marion Abecassis Marion de Galembert The COVID-19 pandemic, followed by the Ukraine war, has led to an economic crisis that has resulted in supply difficulties and a sharp...
04 Apr, 2022 MHRA announce new scheme for monitoring good manufacturing and distributions practices in IAG cases By Taryn Jones Teresa Hitchcock The Medicines & Healthcare products Regulatory Agency (MHRA) has announced a new supervisory scheme as part of its process for monitoring...
16 Mar, 2022 UK ABPI calls for standardised international approach to university-industry collaborations By Richard Taylor Anna Wrench The Association of the British Pharmaceutical Industry (ABPI, the UK’s leading association for pharmaceutical companies), has published a...
18 Feb, 2022 Clinical Trial Regulations in the EU – how will the UK follow? By Kate Black The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
13 Dec, 2021 Do medical devices have systematic bias? By Kate Black Anna Ward An investigation has been launched by the UK’s Department of Health and Social Care (“DHSC”) with the overall aim of improving healthcare...
17 Nov, 2021 Assessing the value of medicine for diverse patients: Implications of a QALY approach for health disparities By Kirsten Axelsen Momentum and debate about the application of cost-effectiveness analysis to determine the value and prices of prescription drugs in the...
21 Sep, 2021 Open consultation on the future regulation of medical devices in the United Kingdom By Richard Taylor Elinor Cavil Background The Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
22 Mar, 2021 The future regulation of medical devices in the UK under the Medicines and Medical Devices Act 2021 By Kate Black Anna Ward The Medicines and Medical Devices Act 2021 (the “MMD Act”) was granted royal assent on 11th February 2021. The MMD Act confers broad...