This week's edition of Life Sciences weekly highlights includes a Law360 news analysis on the opening of the Unified Patent Court’s life sciences division in Milan and analysis of the European Court of Justice upending a lower court decision while issuing nine rulings rejecting appeals from Servier SAS and the generics companies accused of illegally paying off to avoid generic competition to its perindopril. Further Law360 analysis discusses how the UK Competition Appeal Tribunal refused a more restrictive statute of limitations to allow pay-for-delay proceedings against Lundbeck Ltd and generic drug manufacturers to continue, as well as, details of a High Court patent infringement dispute between Samsung and Alexion Pharmaceuticals over sales of a biosimilar of patented Soliris which is anticipated to go to trial in 2025. Also included, the European Federation of Pharmaceutical Industries and Associations (EFPIA) recommended the creation of a new Office of European Life Sciences and Competitiveness strategy and released its Call for a Competitiveness Strategy for European Life Sciences and the Medical Device Coordination Group (MDCG) released a guidance on the clinical evaluation of orphan medical devices, among other news.

This week's edition of Life Sciences weekly highlights includes news that EFPIA has set out industry priorities for a proposed EU Action Plan on Rare Diseases, the European Commission has published a roadmap to phase out animal testing in chemical safety assessments, the HRA has published its 2026–28 plan to support the safe use of AI in health and social care research, and the EMA, Commission and Heads of Medicines Agencies (HMA) have published a revised ACT EU workplan for 2026–27 to strengthen the EU clinical research environment. Also included is news that the Commission has announced that four EUDAMED modules become mandatory under the MDR and IVDR, MedTech Europe has responded to the Commission’s consultation on the revision of the EU Cybersecurity Act, and the MHRA has launched a consultation on a proposed standard for digital mental health technologies, as well as news that the European Commission has launched a stakeholder survey on the use of artificial intelligence in healthcare and pharmaceuticals, among other stories.

This week’s edition of Life Sciences weekly highlights includes a Law360 news analysis on the Patents Court striking out Sandoz’s claim for an account of profits made from selling blood-thinning treatment Xarelto during an interim sales ban against Bayer and news that the Patents Court addressed cost and interim payments following patent litigation in a complex dispute involving diabetes treatment dapagliflozin. Also included is news that the European Economic and Social Committee (EESC) published its opinion on the proposed EU Critical Medicines Act and Medicines for Europe responded to the European Parliament’s draft report on the Act, highlighting areas of concern, the Commission opened a consultation on revised Good Manufacturing Practice (GMP) quality system guidelines, the MHRA published an update to its March 2025 government response on statutory fees following post-market surveillance legislation for medical devices and published revised guidance on clinical investigations for medical devices, MedTech Europe published a position paper on aligning EU digital legislation with sector-specific frameworks and responded to the Commission’s consultation on extending the Carbon Border Adjustment Mechanism (CBAM). Further news included is that the ABPI announced that the Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) scheme review negotiations with the UK government have ended without agreement, the EESC issued its opinion on the EU’s cybersecurity action plan for healthcare, the HRA published a report on the legal and ethical use of patient information in research, the Prescription Medicines Code of Practice Authority (PMCPA) updated guidance on Clauses 3.1 and 11 of the ABPI Code of Practice, which prohibit the promotion of medicines prior to marketing authorisation, among other stories.

This week's edition of Life Sciences weekly highlights includes a Law360 analysis on the US FDA’s final guidance on decentralised clinical trials. Also included, is news that the HRA proposed changes to simplify the informed consent process for low-risk clinical trials in the UK, the MHRA announced the selection of five innovative AI technologies for its AI Airlock regulatory sandbox pilot scheme and it issued a final call for marketing authorisation holders to comply with the incoming Windsor Framework arrangements for medicines by 31 December 2024, the ICH launched a consultation on a global multi-regulatory technology platform for the joint assessment of variations to drug licences, MedTech Europe urgently called for reforms to the EU’s medical devices regulatory frameworks, the Association of British HealthTech Industries (ABHI) submitted a comprehensive response to the UK government’s Industrial Strategy Green Paper and news that the EMA revised its Q&A guidance on good manufacturing and distribution practices (GMP/GDP), among other stories.

This week's edition of Life Sciences weekly highlights includes analysis of the EU Cybersecurity Package 2026 by Hogan Lovells International LLP and analysis by Lexis+ that discusses key developments in the field of Information Law in England & Wales and at supranational EU level in 2025 and looks ahead to what is coming up in 2026. Also included is news that the Department for Science, Innovation and Technology (DSIT) has announced a package of UK–Japan science and technology collaborations, the Health Research Authority (HRA) has announced plans to introduce changes for non-clinical trials of investigational medicinal products (CTIMPs) studies to align with the new clinical trials regulations, the Secretary of State launched the National Cancer Plan for England with a strong emphasis on digital, data and innovation, alongside a House of Lords report calling for stronger leadership on medicines supply security, the European Commission has published two new Implementing Decisions updating the references of harmonised standards under the EU medical devices framework, as well as news that the Prescription Medicines Code of Practice Authority (PMCPA) has updated its guidance on pharmaceutical companies’ use of social media, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by D Young & Co of the first UPC infringement decision for second medical use claims, and two Mlex analyses: one on the European Commission considering postponing the entry into application of the EU AI Act following controversy around a code of practice for AI models, and another on EU governments approving a proposal to enforce procurement restrictions on Chinese medical devices manufacturers. Also included, is news that the European Commission launched a public consultation on the draft implementing regulation concerning joint clinical assessments of medical devices and in vitro diagnostic medical devices, the Council of the EU agreed its position on the European Commission’s proposed pharmaceutical legislation, known as the ‘pharma package’, Medicines for Europe issued an open letter to the European Commission, Ministers of Health, Industry and Environment across the EU, urging co-ordinated legislative action to protect patient access and strengthen the supply of critical medicines. Further news included is that the Department for Environment, Food & Rural Affairs announced the commencement of the single-use vape ban, effective from 1 June 2025, NICE published a blog post outlining efforts to accelerate the adoption of digital health technologies within the NHS, the ABPI expressed concerns about the very high and unpredictable medicines payment rates, and the ASA has found an ad is in breach of the CAP Code for promoting prescription-only medicine oral minoxidil for hair loss, a drug licensed in the UK for certain types of hypertension, among other stories.

This week's edition of Life Sciences weekly highlights includes: the DHSC published its response to proposed amendments to the NICE cost-effectiveness threshold regulations which will come into force 24 March 2026, in advance of the increased thresholds anticipated for April, and it has issued the England Rare Diseases Action Plan 2026 extending the UK Rare Diseases Framework to January 2027. At EU level, the Commission launched a consultation on draft guidance under the Cyber Resilience Act, EFPIA and Medicines for Europe called for a pause to the extended producer responsibility scheme under the revised Urban Wastewater Treatment Directive and Team-NB and the International Medical Device Regulators Forum (IMDRF) published updates concerning the MDR/IVDR and regulatory reliance for medical devices. In addition, the European pharmaceutical industry highlighted progress in rare disease research under IMI and IHI projects, the Health Research Authority (HRA) launched a pilot information governance guide for research approvals and the Commission adopted a recommendation on diagnostic reference levels for medical radiation procedures.

This week's edition of Life Sciences weekly highlights is a relatively light news cycle that includes Law360 news reporting on the Court of Justice’s landmark decision overturning the General Court’s decision and finding that the European Commission did not have the authority to investigate Illumina’s US$8bn acquisition of the cancer detection company Grail further to Member State referrals under Article 22 of the EU Merger Regulation (‘killer acquisition’ rule) when it both did not have an EU nexus and did not meet any national laws on merger thresholds. Also included, is news that MedTech Europe published its response to the EU AI Act’s entry into force, highlighting the importance of the medical device regulations aligning with the Act, news that the Innovative Health Initiative (IHI) opened a two-stage call for proposals on diseases, regulatory sandboxes, and the best ways to measure the impact of a therapy on patients’ lives which will soon close in October; and news that the UK government will be providing £5m funding to the University of Dundee cell biology unit over five years in advance of announcing its funding plans and vision to support UK university translational research.

This week's edition of Life Sciences weekly highlights includes a key administrative court judgment in R (Bayswater Support Group) v Health Research Authority (HRA) refusing permission to judicially review HRA and MHRA decisions approving the PATHWAYS Trial, and emphasising the court’s caution in reviewing specialist regulators’ scientific and technical assessment. Also included is news that the HRA has published its response to the High Court’s decision, confirming that the trial may proceed following amendments to the study protocol and favourable regulatory review, as well as news that the PMCPA has launched a consultation on proposed amendments to its Constitution and Procedure, including changes to complaint limitation periods and the expanded use of the abridged complaints procedure.

This week's edition of Life Sciences weekly highlights includes news that EU industry, including MedTech Europe and EFPIA, published a joint statement calling for the withdrawal of the proposed AI Liability Directive, the European Commission has announced plans for a Critical Medicines Act to address essential medicines supply chain vulnerabilities which follows the EFPIA proposed action plan to address medicine shortages in Europe, the ABPI has strongly criticised the high Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) payment rate of 22.9% for 2025, the Commission has initiated a comprehensive review of Regulation (EU) 316/2014, the Technology Transfer Block Exemption Regulation (TTBER) and accompanying Guidelines, and a European industry joint statement raises concerns about draft guidelines on Article 102 TFEU. Also included, is news that the IMDRF has released final guidelines on good machine learning practices in medical device development and another on risk characterisation for medical device software and software-specific risks, the UK government issued its response and a final Code of Practice for AI in Cyber Security, the MHRA launched a revised and expanded ILAP pathway for innovative medicines from March 2025, a new regulatory framework for medicines manufactured at the ‘point of care’ (POC) and modular manufacturing came into force on 24 January 2025 and the MHRA has launched a consultation on regulatory guidance for individualised mRNA cancer immunotherapies, among other stories.

This week's edition of Life Sciences weekly highlights covers a relatively light news cycle including news of a summary from the European Patent Office (EPO) analysing the progress of the unitary patent system which filings for the medtech sector currently leads, the European Commission released its annual report and monitoring of the Horizon programme, the European Medicines Agency (EMA) released its annual 2023 report on its contribution to science, medicines and health, the EMA has also created a website collating updated and new guidance regarding paediatric medicine applications and procedures for IRIS platform submissions which are mandatory from 4 June 2024 and news that the Competition and Markets Authority (CMA) closed its inquiry into the acquisition of Demant by Cochlear Limited after a phase 2 clearance with remedies, among other news.

This week's edition of Life Sciences weekly highlights includes an MLex analysis of the interplay between the EU AI Act and medical device regulations and an analysis by Herbert Smith Freehills of two recent judgments that demonstrate the difficulties in determining ownership of innovation and the need for careful drafting of collaboration and service agreements. Also included, is news that Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space was published in the Official Journal and will take effect on 25 March 2025, the European pharmaceutical industry has raised a legal challenge to Directive 91/271/EEC (Urban Wastewater Treatment Directive (UWWTD)) in the EU General Court for singling out the pharma and cosmetic industries for wastewater treatment costs and it has issued a response voicing concerns about the implementation of the Critical Medicines Act, Medicines for Europe has issued a press release calling for substantial reforms in EU pharmaceutical regulation, NICE launched a new Medicines and Medical Devices Access Initiative to streamline Health Technology Assessment, MedTech Europe urged the Commission to permit pre-submission clinical strategy discussions for medical devices and ABPI called for improved access to rare disease medicines in the UK, among other stories.