The BioSlice Blog, published by Arnold & Porter Kaye Scholer LLP, focuses on regulatory, legal, and policy developments in the life sciences sector. It covers topics such as medical device regulations, pharmaceutical legislation reforms, intellectual property frameworks in healthcare, and digital health innovations. The blog provides analysis on EU and UK regulatory changes, compliance challenges, and industry impacts, including discussions on breakthrough and orphan device pathways, notified body regulations, NHS IP guidance updates, and antimicrobial resistance measures. It also addresses litigation, transactional, and public policy issues relevant to biotech, medtech, and pharmaceutical companies operating in regulated markets.
Introduction
Assays used in clinical trials vary widely in complexity and regulatory status.. They may be fully developed and marketed as in vitro diagnostic medical devices (IVDs), including companion diagnostics (CDx), that clearly fall within the scope of the EU…
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during February and early March 2026 from the the United Kingdom, and European…
On 19 March 2026, the Court of Justice of the European Union (CJEU or Court) issued its judgment in Case C-526/24, Brillen Rottler GmbH & Co. KG v TC. The case concerned a data subject who subscribed to a…
On 16 December 2025, the European Commission published its Proposal for a Regulation establishing a framework of measures for strengthening the EU’s biotechnology and biomanufacturing sectors, particularly in the area of health (the “European Biotech Act” or the “Proposal”). The…
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2025 and early January 2026 from the the United Kingdom, and…
On 19 November 2025, the European Commission published two legislative proposals – the Digital Omnibus on AI Regulation Proposal and the broader Digital Omnibus Regulation Proposal (“Proposals”) – as part of a wider initiative to simplify and streamline the EU’s…
The Prescription Medicines Code of Practice Authority (PMCPA) has published revised guidance on social media.
Social media has remained a significant focus for the PMCPA in recent years, with numerous companies found in breach of the ABPI Code (the…
Today, 16 February 2026, the UK Medicines and Healthcare products Regulatory Agency (MHRA) opened an important consultation seeking views on proposed changes to the recognition of CE‑marked medical devices in Great Britain (GB). The initiative forms part of the UK’s…
The UK Department of Health and Social Care (DHSC) has proposed to set the repayment percentage on sales of branded “newer” prescription-only medicines to the NHS at 16.5% for 2026, a significant reduction on the current rate of 24.3%. The…
