This week's edition of Life Sciences weekly highlights includes news that the Commission launched a new strategy to make Europe a global leader in life sciences by 2030, the government has published its 10 Year Health Plan for England, with ambitions to accelerate clinical trials, increase research access, and improve NHS sustainability, and key life sciences bodies have responded to the plan, including the Health Research Authority, which has also launched a new three-year strategy to support the government’s 10 Year Health Plan for England. Also included, is news that the EMA published its third annual report on its Real-World Evidence framework, covering February 2024–February 2025, the MHRA launched a consultation on the International Council for Harmonisation (ICH) E21 guideline regarding the inclusion of pregnant and breastfeeding individuals in clinical trials, the Commission adopted Implementing Decision (EU) 2025/1324, amending the 2019 framework regarding medical device expert panel rules and establishing a new expert panel for paediatrics and rare diseases, as well as news that the EFPIA published a position paper responding to the EU Critical Medicines Act, the DHSC announced plans for new legislation requiring healthcare providers to contribute to a single patient record system, and the ASA has found an Instagram post promoting weight loss medication in breach of the CAP Code for promoting prescription-only medicines (POMs) to the public, in a ruling that forms part of a wider body of work on POMs used for weight loss, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis by Pinsent Masons LLP on the finding that the Pfizer/BioNTech coronavirus (COVID-19) vaccine infringed a valid Moderna mRNA patent, and by Debevoise & Plimpton LLP on the Court of Justice ruling in Illumina v Grail regarding below-threshold referrals under Article 22 of the EU Merger Regulation. Also included is news that the EMA and HMA published their draft joint EU network strategy to 2028 for consultation, the MHRA published its business plan for 2024–25, the European Commission launched a consultation on the draft implementing regulation for joint scientific consultations on medicinal products under the new Health Technology Assessment Regulation, the British pharmaceutical industry expressed concerns in a report about the effect of the Windsor Agreement for drug approval from 1 January 2025, the EU pharmaceutical industry voiced criticisms and recommendations regarding Regulation (EU) 2020/852 (the EU Taxonomy Regulation) and its Technical Screening Criteria (TSC), the British health tech industry body (ABHI) welcomed the UK government’s launch of a Regulatory Innovation Office (RIO) dedicated to speed up public access to new technologies, the Office for Life Sciences published its report on the potential of UK HealthTech and news that the MDCG published EU guidance for the qualification of in vitro diagnostic medical devices as well as guidance and templates on corrective and preventive action (CAPA) plans, among other stories.

This week's edition of Life Sciences weekly highlights includes an analysis of the request for a preliminary ruling in Case C-371/26 in the context of proceedings between Janssen Biotech and Samsung Bioepis concerning the interpretation of the scope and requirements of the supplementary protection certificate (SPC) manufacturing waiver by Grau & Angulo. Also included is news that Advocate General Kokott has recommended annulment of certain extended producer responsibility (EPR) provisions in the Urban Wastewater Treatment Directive, with EFPIA and Medicines for Europe calling for implementation to be paused, and the EMA has launched a pilot of a revised pre-submission interactions model for initial marketing authorisation applications. Further news includes joint industry guidance on single-unit barcoding for medicines, a Commission consultation on technical requirements for HealthData@EU under the European Health Data Space (EHDS) Regulation, and updates to the MHRA–NICE real-world evidence dialogue programme, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the European Federation of Pharmaceutical Industries and Associations (EFPIA) responded to the consultation on the draft implementing act (IA) on Joint Clinical Assessment (JCA) of medicinal products as part of the implementation of the new Health Technology Assessment Regulation, expressing concerns and suggesting reforms to the draft IA. Also included is news that the DHSC published a one-year update to its first medical technology strategy for the NHS alongside an accompanying medical technology innovation classification framework, the UK government has responded in a joint letter to the Regulatory Horizons Council (RHC) agreeing to review guidance and considering generating specific novel regulation of neurotechnology that would also introduce equivalence standards, the MHRA released two guidance on UK Parallel Import Licences following the Windsor Framework and the disapplication of the Falsified Medicines Directive (FMD) safety features, and news that the Chancery Division considered a preliminary issue in a claim for trade mark infringement against Viovet Ltd, among other news.

This week's edition of Life Sciences weekly highlights includes analysis of the English court’s jurisdiction to decide COVID-related business interruption matters as upheld in AI Mana Lifestyle Trading v United Fidelity Insurance, as well as, news of a crackdown prohibiting hayfever treatment advertisements for Kenalog injections, launch of a new complex generic drugs webpage by the US FDA, the issuance of further EU medical devices guidance and a demand from the MedTech Europe trade association to address concerns regarding the over-regulation of medical devices that fall under multiple regimes, such as AI health apps.

This week's edition of Life Sciences weekly highlights includes analyses of the European Commission’s published Digital Omnibus on AI Regulation Proposal and an MLex analysis of Member States criticisms of planned delays for key EU AI Act duties. Also included, is news that the UK government has reduced the 2026 Voluntary Scheme for Branded Medicines Pricing and Access (VPAG) rebate rate for newer medicines to 14.5% (from 22.9% in 2025) with a total 2026 rebate for newer medicines at 15.5%, the UK and EU welcome the establishment of the world’s first global carbon footprint standards framework for assessing the environmental impact of pharmaceutical products, an EFPIA report highlights governance challenges and the policy actions needed to implement AI regulation across medicines’ lifecycles and the DHSC launched a consultation on proposed changes to give ministers limited powers to set NICE cost-effectiveness thresholds for health technology assessments. Further news included is that Medicines for Europe has called for urgent drug pricing reform to address antibiotic shortages caused by low national price caps of off-patent antibiotics despite increasing production costs, the BIA has called for a new pathway to improve UK patient access to rare disease medicines, the EMA updated its guidance on stepwise paediatric investigation plans (sPIPs), MedTech Europe supports the Commission’s proposal for a European Competitiveness Fund to support scaling up innovative digital health tech and the ASA has upheld a series of complaints in its crackdown on online advertising for food supplements claiming to alleviate medical conditions or diseases, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by DLA Piper of the EMA’s five-year AI Workplan and also analysis by Covington & Burling LLP of the Association of the British Pharmaceutical Industry (ABPI) proposals to update the 2021 ABPI Code and the Prescription Medicines Code of Practice Authority (PMCPA) Constitution and Procedure. Also included is news that the MHRA has announced that its International Recognition Procedure (IRP) is live from 1 January 2024 and has updated its guidance on the labelling and packaging of medicinal products for human use, and that the MHRA has also released a roadmap for delivering the future core regulatory framework for medical devices, as well as news that the Advisory Council for the Misuse of Drugs (ACMD) issued advice to reduce research barriers for Schedule 1 controlled drugs, among other stories.

This week's edition of Life Sciences weekly highlights includes a Law360 analysis of Pfizer and BioNTech patent infringement of Moderna’s mRNA vaccines following the High Court’s finding a key patent to be valid and another Law360 story about the CMA’s decision to clear unconditionally Thermo Fisher Scientific Inc’s USD$3.1bn acquisition bid for Olink Holding AB’s proteomics technology. Also included, is news that a consultation has launched aiming to establish international guiding principles for artificial intelligence/good machine learning (AI/ML) practices in medical device development that reflect the proposals by the US, UK and Canadian regulators, the MDCG revised guidance to help classify in vitro diagnostic (IVD) devices, the WHO published the world’s first global repository of medical device data called the MeDevIS (Medical Devices Information System), the European pharma industry jointly issued a statement urging the EU to increase the budget for the next European Framework Programme for Research and Innovation (FP10) and news that the European Commission’s Health Emergency Preparedness and Response Authority (HERA) released the main findings of a technical report on the supply chain vulnerabilities for 11 critical medicines, among other news.

This week's edition of Life Sciences weekly highlights includes analysis by Bird & Bird of draft Article 6 Guidelines indicating how high-risk AI systems are likely to be assessed under the EU AI Act. Also included is news that the MHRA has launched two regulatory sandboxes to test AI tools for the development and safety assessment of medicines and for innovative AI-driven medical devices while releasing its report on the AI Airlock identifying regulatory challenges and recommendations. Further news includes that the European Commission has announced the launch of the EU Innovation Platform to support startups and innovators with market access, MedTech Europe has published recommendations on the proposed revision of the In Vitro Diagnostic Medical Devices Regulation (IVDR), the EMA has added a section on the use of real-world data in medicines to regulatory guidance, and claimants have succeeded in a judicial review challenge to the Genetic Technology (Precision Breeding) Regulations 2025 as an irrational and erroneous understanding of the Genetic Technology (Precision Breeding) Act 2023, among other stories.

This week's edition of Life Sciences weekly highlights includes news that MedTech Europe published a position paper supporting proposed revisions to the Corporate Sustainability Due Diligence Directive and the Corporate Sustainability Reporting Directive and recommended further revision; a British pharmaceutical industry (ABPI) blog post criticises the Voluntary Scheme for branded Medicines Pricing, Access and Growth (VPAG) levy increases as driving disinvestment, with companies withdrawing UK investments, cutting headcounts and retreating from NHS partnerships; the European Commission published Q&A guidance on the implementation of the Health Technology Assessment Regulation (EU) 2021/2282; and the European Commission launched a consultation on proposed reforms aimed at simplifying the EU medical devices legislation (MDR/IVDR). Also included, is news that the Commission published a Staff Working Document presenting amendments to the Critical Medicines Act, the MedTech and European pharma (EFPIA) industries responded to the EU's State of the Union Address generally favourably but with further specific recommendations from MedTech Europe and the Proprietary Association of Great Britain (PAGB) has rejected a formal advertising complaint and subsequent appeal by Kenvue regarding Allevia’s ‘It’s a No-Brainer’ claim; among other stories.

This week's edition of Life Sciences weekly highlights includes news analyses by Venner Shipley LLP that the Patents Court has upheld uniQure’s patent against Pfizer’s revocation action. Also included, is news that the UK Judiciary has examined the potential impacts of artificial intelligence on the justice system and intellectual property law, the revised Product Liability Directive entered into force on 8 December 2024, the EMA/HMA have issued comprehensive guidelines on drug Shortage Mitigation Plans and Shortage Prevention Plans, a £16m joint funding boost has been dedicated to the updated UK-Swiss science and research partnership, the European pharmaceutical industry published its 2024 pipeline review and has put forward nine recommendations aimed at optimising the EU’s forthcoming Framework Programme for Research and Innovation (FP10), the ABPI released its annual report on clinical trials in the UK, and news that the CMA launched a consultation to address concerns that Vifor Pharma (Vifor) abused its dominant position by making misleading claims about a competitor’s intravenous iron treatment, among other news.

This week's edition of Life Sciences weekly highlights includes analysis of the Supreme Court’s decision in Emotional Perception AI Ltd v Comptroller-General of Patents, Designs and Trade Marks, in which the court held that an artificial neural network system is not excluded from patentability as a ‘program for a computer…as such’, aligning UK law more closely with European Patent Office jurisprudence. Also included, is news that the DHSC has opened a consultation on changes to the statutory scheme for branded medicines pricing to align with the voluntary scheme, DHSC also released its finding and recommendations on the operation of the Medicines and Medical Devices Act 2021 in its five-year report and it has also opened a consultation on proposed amendments to strengthen medicines reimbursement, supply oversight and compliance further to its 2025 annual review of the Health Service Products 2018 regulations. Further developments include NICE launching the National HealthTech Access Programme, MHRA updating its pharmacovigilance requirements for UK authorised products further to Commission Implementing Regulation (EU) 520/2012 (CIR 520/2012), the Notified Bodies industry publishing a letter addressing proposed cybersecurity amendments to the medical devices regulations, the adoption of the international standards ICH M15 guideline for model-informed drug development, the EMA launching a consultation on making Annex 15 GMP qualification and validation guidelines mandatory, and the EFPIA published proposals to strengthen EU pharmaceutical competitiveness, among other stories.