This week's edition of Life Sciences weekly highlights includes news that the European Commission opened a public consultation on high-risk AI classification and obligations under the EU AI Act, the DHSC responded to the consultation on the proposed review of the statutory scheme for branded medicines pricing and the Branded Health Service Medicines (Costs) (Amendment) Regulations 2025 amended the statutory payment rates, the EFPIA and Medicines for Europe expressed diverging views on the Council of the EU’s position on the EU pharma reform package, the MHRA published several new guidance documents on decentralised manufacture as well as the UK’s first official guidance on the regulatory framework for the development of bacteriophage therapies, and the Patents Court granted an interim injunction to restrain multiple respondents from marketing generic dapagliflozin products pending the resolution of an appeal by AstraZeneca. Further news included is that the EMA opened a consultation on draft ICH guideline to promote the inclusion and retention of pregnant and breastfeeding individuals in clinical trials, the Innovative Health Initiative launched and supported a range of projects aimed at reducing the environmental impact of the health sector, and the Council of the EU adopted a new cyber crisis management blueprint to guide the EU’s collective response to large-scale cybersecurity incidents or crises, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the EMA has published draft guidance from the Accelerating Clinical Trials in the EU (ACT EU) initiative on the conduct of clinical trials during public health emergencies, the MHRA has published and updated several key guidance documents ahead of amendments to the new UK clinical trials regulations and has announced the publication of a new analysis on the global impact of UK health data resource. Also included, is news that MedTech Europe has commented on the EU–US trade framework and the development on US tariff measures, and has also joined an industry statement calling for harmonised rules under the Circular Economy Act, the European Commission and Switzerland have signed a broad package of agreements to simplify trade in goods such as medical devices, Medicines for Europe has urged stronger supply security measures in Critical Medicines Act trilogues, the Commission has identified safety and labelling non-compliance in dermal fillers, the Association of the British Pharmaceutical Industry (ABPI) has outlined outcomes of the December 2025 VPAG review, the Department of Health and Social Care (DHSC) has completed its review of the genetic testing and insurance code, and the UK Space Agency, the MHRA, the Regulatory Innovation Office (RIO) and the Civil Aviation Authority (CAA) have announced a collaborative effort to develop a regulatory framework for in-orbit pharmaceutical manufacturing, among other stories.

This week's edition of Life Sciences weekly highlights includes Law360 news of the Court of Appeal decision in the hydrocortisone tablet alleged price-fixing cartel investigation that overturned the Competition Appeal Tribunal’s decision and upheld £100m in fines against the group of pharmaceutical companies. An MLex news analysis provides commentary on the wider impact of last week’s Illumina/GRAIL victory on the EU’s system of merger control. Another major development this week is that Mario Draghi’s report on ‘The future of European competitiveness’ has been published, alongside an in-depth analysis with recommendations to enhance the EU's competitiveness including focus on incentives for life sciences R&D innovation, including an emphasis on AI, and regulatory reforms which the European pharmaceutical and medical devices industry bodies welcomed. Other important news includes that the EMA and the Heads of Medicines Agencies (HMA) have published guiding principles for using large language models (LLMs) across the European medicines regulatory network (EMRN) as part of the 2023–28 AI workplan, the MHRA released guidance on the implementation of changes to pharmacovigilance for medicines to take effect from 1 January 2025 following the Windsor Framework and the requirement for testing for pyrogens in rabbits for vaccines will be removed, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the International Medical Device Regulators Forum (IMDRF) has published final guidance setting out essential principles and content for predetermined change control plans (PCCPs) for medical device software, allowing manufacturers to obtain advance authorisation for agreed changes without requiring separate regulatory submissions for each change. Also included is news that the MHRA has advised healthcare organisations and distributors to stop using or supplying six medical devices without valid UKCA or CE markings or certification and to quarantine existing stock, as well as news that the DHSC has published guidance on restrictions affecting the sale, promotion and enforcement of tobacco, vaping and nicotine products under the Tobacco and Vapes Act 2026. Further news includes the EMA publishing guidance on shortage prevention plans for marketing authorisation holders, setting out the information required to establish and maintain plans for medicines at risk of shortages.

This week's edition of Life Sciences weekly highlights includes news that the European Commission adopted its 2025 Work Programme confirming the objectives for life sciences introduced in the recent Commission Competitiveness Compass, and withdrawing the AI Liability Directive in the absence of foreseeable agreement on the proposal, the MHRA released a tool to guide researchers and developers to navigate the regulatory framework for nanomedicines products, the Commission published guidelines on AI system definition under the EU AI Act and announced a pilot programme for co-ordinated assessment of clinical investigations and performance studies under the MDR and IVDR. Also included, is news that the EMA established a procedure for manufacturers of certain high-risk medical devices to request scientific advice on clinical development strategies, and adopted a guideline on requirements for investigational advanced therapy medicinal products (ATMPs) in clinical trials, the European Forum for Good Clinical Practice (EFGCP) and the EFPIA announced that their EU-X-CT initiative opened a public consultation on draft recommendations for cross-border clinical trials, and the High Court ruled against Abbott in a trade mark infringement case by dismissing its claims on a tridimensional trade mark over a glucose monitoring device, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis by Freshfields Bruckhaus Deringer of the UK government’s MedTech strategy one year onward and the innovation classification framework introduced in April 2024. Also included, is news that the European Commission has proposed amendments to Regulation (EU) 2022/123 (the EEA Agreement) to strengthen the EMA’s role for crisis preparedness and maintenance, the European pharma industry body, EFPIA, published three reports on unequal access to new medicines across Europe and released an environmental sustainability statement outlining its initiatives to reduce its environmental impacts and build a resilient health system, two advice pilots were launched via the Accelerating Clinical Trials (ACT EU) initiative to improve the quality of applications for clinical trials, and the FDA launched an AI and emerging technology pharmacovigilance programme, among other news.

This week's edition of Life Sciences weekly highlights includes an MLex analysis on the European Commission’s adoption of the Implementing Act setting out the establishment and operation of scientific panel of independent experts that will advise the general-purpose artificial intelligence (AI) models under the EU AI Act. Also included, is news that the European Commission released the updated model contractual clauses for AI procurement, the DHSC published its response to the recommendations made by the Regulatory Horizons Council on the regulation of AI as a medical device (AlaMD), MedTech Europe released Article 10a MDR/IVDR implementation guidance and calls for life sciences priority in the EU Competitiveness Compass, the MHRA published government response to consultation on changes to its fees, as well as news that the European Commission proposed a Critical Medicines Act to strengthen EU pharmaceutical supply chains, the EMA released data access policy and updated guidance for new medicines shortage platform, the EFPIA filed an application before the General Court against the extended producer responsibility obligations of Directive 91/271/EEC (Urban Wastewater Treatment Directive (UWWTD)) and ABPI analyses revealed record £3.5bn VPAG payments expected for 2025, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis on the UK High Court’s decision arising from a tax scheme dispute linked to an early-stage pharmaceutical business (Nemaura Pharma) and involving a claim for misuse of confidential information brought against a company and three of its directors. Also included is news that the European Commission has launched a pilot programme for the co-ordinated assessment of medical device clinical investigations, enabling a single application process for multinational studies to streamline regulatory processes, MedTech Europe has published a position paper calling for a more pragmatic, risk-based approach to post-market clinical follow-up requirements under the Medical Devices Regulation (MDR), the MHRA has announced the closure of its RegulatoryConnect programme to develop a central portal for tracking regulatory assessments, and has published an international study revealing significant variability in global microbiome research methods, as well as news that the NHS Health Research Authority (HRA) has launched a consultation on proposed changes to the model Clinical Trial Agreement (mCTA) and the Association of the British Pharmaceutical Industry (ABPI) has published its pre-Budget submission urging the government to reform NICE’s cost-effectiveness thresholds and the Voluntary Scheme for Branded Medicines Pricing, Access, and Growth (VPAG) rebate system to address declining life sciences investment.

This week's edition of Life Sciences weekly highlights includes an analysis by Freshfields LLP on the UK Law Commission’s review of the product liability regime, with a focus on AI technologies and recent EU developments, an analysis by Pinsent Masons of the High Court’s ruling in Samsung Bioepis v Alexion, which invalidated Alexion’s eculizumab patent and found no infringement, underscoring the importance of precise drafting in biologic patents and a Law360 story on the Court of Appeal’s ruling in a long-running patent infringement dispute between coronavirus (COVID-19) vaccine developers, upholding Moderna’s mRNA patent against Pfizer/BioNTech. Also included is news that the MHRA has been designated as a WHO-Listed Authority, launched a consultation seeking UK stakeholder feedback on the revised ICH M4Q(R2) and announced that UK licence holders must now independently monitor US FDA Warning Letters, the EMA updated its guidance on paediatric submissions, as well as news that the European Commission published a study on legal and regulatory challenges to AI deployment in healthcare across the EU, the MHRA launched a stakeholder survey on the health institution exemption for medical devices and updated guidance on adverse event reporting requirements for digital mental health technologies, following the implementation of the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024, and the DHSC dispute resolution panel ruled that Haleon must remain in the voluntary branded medicines pricing scheme (VPAG) for 2024, despite its claim of administrative error in joining, among other stories.

This week's edition of Life Sciences weekly highlights includes news and a Law 360 analysis of the CAT’s handing down of two further appeal decisions in Allergan PLC v CMA upholding the CMA’s findings in the first instance but permitting the ‘due process’ appeals because it felt the CMA did not fully present its case under cross-examination of key witnesses in regards to the unlawful agreements it entered to keep 10 mg hydrocortisone tablets off the market and charge the NHS higher prices. This week’s edition also includes a Law360 analysis of a US ruling that Pfizer does not need to provide access to documents to a French non-profit about its coronavirus (COVID-19) vaccine development agreement with the French government in which Pfizer was granted indemnity. Also included, is news that the European Commission adopted the new legislation amending Regulation (EU) 712/2012 (Variations Regulation) to streamline the procedure for varying marketing authorisations of medicinal products as part of its pharmaceutical reform package and issued three factsheets about key areas of regulatory reform (ie access to medicines, preventing medicines shortages and rare disease innovation), the DHSC has announced new action to tackle ethnic and other biases in medical devices and news that the Commission adopted two implementing decisions on harmonised standards for medical devices, among other news stories.

This week’s edition of Life Sciences weekly highlights includes several important legislative news stories: the MHRA has published its much-anticipated draft Medical Devices (Amendment) Regulations 2026 overhauling the Medical Devices Regulations 2002 to introduce new pre-market requirements for placing medical devices on the GB market, the European Parliament and the Council of the EU have reached a provisional agreement on the proposed Critical Medicines Act, MLex provides analysis of the political agreement reached on the EU AI omnibus package reducing regulatory burden under the AI Act for businesses, King Charles III discussed the proposed Regulating for Growth Bill during his speech for the State Opening of Parliament which will support innovation in medicines and medical technologies through regulatory sandbox powers and deregulation efforts, and the UK Government announced in a letter its intention to proceed with the ACMD legislative recommendations for the control of semi-synthetic cannabinoids (SSCs) and THC precursors (THCAs). Also included is news that the MHRA has launched a consultation on proposed changes to the legal definition of gene therapy medicinal products in UK legislation; MedTech Europe welcomes Commission Implementing Regulation (EU) 2026/977, introducing harmonised procedural requirements for Notified Body conformity assessments; the ABPI is calling for measures to strengthen UK medicines supply chain resilience; and Nuffield Council on Bioethics published a report proposing measures to address governance gaps in neural organoid research, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by Gill Jennings & Every LLP of the impact of the UK Intellectual Property Office’s (UK IPO) statutory guidance on changes to marketing authorisations and SPCs for medicines from 1 January 2025 and case analysis by Penningtons Manches Cooper LLP of the BioNTech & Pfizer v CureVac patent dispute that revoked CureVac’s patents on ‘split poly(A) tails’ mRNA technology used to develop coronavirus (COVID-19) vaccines. Also included, is news that the MHRA published guidance on implementing changes to the advertising and promotion of medicines authorised in the UK after 1 January 2025 further to the Windsor Framework, the European Commission has issued guidance on implementing the mandatory notification system for medical device shortages and it substantively revised its vigilance guidance for medical devices, the World Medical Association adopted the 2024 revision of the Declaration of Helsinki for medical research ethics, the UK HRA welcomed the Sudlow Report reviewing the UK health data landscape and released a draft model Commercial Chief Investigator Agreement for consultation, among other stories.