Apr 28, 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...
Apr 20, 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...
Apr 03, 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...
Nov 15, 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...
Jul 14, 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...
May 24, 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...
Apr 04, 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...
Mar 16, 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...
Feb 18, 2022 Clinical Trial Regulations in the EU – how will the UK follow? By Kate Burgess The European Medicines Agency has confirmed that the new Clinical Trials Regulation is now in effect as of 31 January 2022. Please see...
Dec 13, 2021 Do medical devices have systematic bias? By Kate Burgess 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...
Nov 17, 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...
Sep 21, 2021 Open consultation on the future regulation of medical devices in the United Kingdom By Richard Taylor Elinor Cavil BackgroundThe Medicines & Healthcare products Regulatory Agency (MHRA) is holding an open consultation to gather views on possible...
Mar 22, 2021 The future regulation of medical devices in the UK under the Medicines and Medical Devices Act 2021 By Kate Burgess 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...
Mar 09, 2021 Brexit and the MRDCRP - update on 5-digit company number By Veronika Appl On 23 February 2021, an update was published to the British Medicines and Healthcare products Regulatory Agency's (MHRA) Guidance on the...
Mar 02, 2021 Telehealth - a white hot M&A market? By Moritz von Hesberg The global outlook for M&A in the digital health and particularly the telehealth sector has never been brighter than today. Telehealth’s...
Feb 28, 2021 UK investment in life sciences By Victoria Rhodes At a time when the importance of the life sciences industry to our daily lives has never been clearer, the UK Government has been...