This week's edition of Life Sciences weekly highlights includes an MLex analysis of the European Data Protection Board (EDPB) and European Data Protection Supervisor (EDPS) issuing a joint opinion on the proposed EU Biotech Act, supporting harmonisation of clinical trials rules under the proposal, but calling for specific safeguards for sensitive health data. Also included, is news that the Council of the EU has agreed its position on the Digital Omnibus on AI proposal, and that the European Parliament’s Internal Market and Consumer Protection and Civil Liberties committees have adopted their joint position, supporting proposals to simplify AI rules, including amendments to revise timelines for high-risk systems, MedTech Europe has published a joint industry statement on packaging and sustainability requirements affecting medical devices, as well as news that the House of Lords has opened an inquiry into innovation in the NHS, focusing on personalised medicine and AI, EFPIA has published research on EU competitiveness for pharmaceutical investment and updates on Innovative Health Initiative (IHI) projects tackling health challenges ranging from antimicrobial resistance and AI to big data and regulatory innovation. Further news included is that the EMA has published an implementation strategy for the revised International Council for Harmonisation (ICH) E2D(R1) pharmacovigilance guideline, and has also opened a consultation on paediatric oncology development, the EMA and the Heads of Medicines Agency (HMA) have approved a 2026–28 workplan on using AI and big data in medicines regulation, the MHRA has highlighted the potential of medicines reclassification, involving switches from prescription-only (POM) to pharmacy, general sales list and over-the-counter (OTC) status, and a key Patents Court decision in Nador Cott Protection SAS v Asda Stores Ltd confirming that a mandarin variety was not essentially derived for Plant Breeders’ Rights purposes, among other stories.

This week's edition of Life Sciences weekly highlights includes a Law360 reporting on the European Patent Office’s decision to uphold the validity of Bayer AG’s European MRI patent. Also included, is news that the data protection authority in The Netherlands has fined Uber €290m for transferring personal data of Uber drivers, including medical data, from the EU to Uber’s headquarters in the US without appropriate safeguards, the European Notified Bodies association (Team-NB) released an agreement for the transfer of surveillance activities of legacy devices to comply with the MDR, the MHRA issued guidance on implementing the Windsor Framework for wholesalers and manufacturers producing human medicines, the Innovative Health Initiative has launched a project to deliver reliable synthetic datasets for medical research, the US FDA released final guidance on decentralised clinical trials and also news that the Advertising Standards Authority (ASA) found two companies misleadingly implied that CBD gummies were suitable for consumption by children and incorrectly stated the recommended maximum consumption of CBD per day for adults.

This week's edition of Life Sciences weekly highlights includes news that the European Parliament adopted its position on the Digital Omnibus amendments to the EU AI Act, including revised timelines for high-risk systems and the European Consumer Organisation (BEUC) expressed concerns regarding the impact on consumer protection of many consumer-facing AI systems being removed from the high-risk classification under the AI Act, the DHSC published an explanatory memorandum on proposed reforms of the EU MDR and IVDR, the MHRA published a collection of guidance on clinical investigations for medical devices and the Commission updated its Q&A on the obligation to inform of interruptions in the supply of medical devices, together with a decision tree diagram. Further news included is that the MHRA published draft guidance on ICH E6 good clinical practice compliance and new guidance on phasing out animal testing in medicines development, with the EMA also consulting on a draft opinion on virtual control groups to reduce animal use in medicines testing, the UK government published a new pandemic preparedness strategy, the Human Medicines (Amendment) Regulations 2026, SI 2026/381 came into force on 31 March 2026, amending the Human Medicines Regulations 2012 (HMR 2012) to allow pharmacist preparation without a manufacturer’s licence and extend vaccine flexibilities, as well as news that the UK confirmed a Technology Transfer Block Exemption Order under the Competition Act 1998, replacing the assimilated TTBER from 1 May 2026 with a UK regime, the EMA published the data quality framework for EU medicines regulation, to support regulatory decision-making, the Commission updated its FAQ guidance on EHDS regulation implementation and opened a consultation on draft Guidance on EU Cyber Resilience Act, among other stories.

This week’s edition of Life Sciences weekly highlights includes news analysis by Law 360 of arguments made in an appeal by drugmakers sanctioned for antitrust breaches that are challenging the court rulings in relation to their pricing and supply of hydrocortisone tablets. A further news analysis by MLex discusses the Court of Appeal’s finding that the CAT had made errors in its 2024 ruling, invalidating the verdict and permitting Pfizer, Flynn Pharma and the UK’s CMA appeals in their long-running epilepsy drug pricing case. Also included is news that the European Commission has published delegated regulations expanding the list of well-established technologies under the Medical Devices Regulation to reduce regulatory burdens on manufacturers and it has launched phase 2 of the COMBINE pilot for combined medicine-device clinical studies, expanding the co-ordinated assessment procedure for multinational studies involving drug-device combinations including diagnostics and advanced therapies.

This week's edition of Life Sciences weekly highlights includes news that the MHRA has released its strategic approach to AI following the UK government’s white paper, the European pharmaceutical industry published a white paper on the circular economy and pharmaceutical regulation, the Competition Appeals Tribunal (CAT) has upheld the CMA’s £2.8bn fine on Accord-UK, the European Parliament adopted an amending Regulation to the In Vitro Diagnostic Medical Devices Regulation (IVDR) to improve the availability of IVDs and, also, news that the EMA released guidance on the anonymisation of personal data and commercially confidential information in risk management plans. Also included this week is analysis by CMS Cameron Nabarro Olswang LLP on the High Court’s preliminary ruling on what product features were being compared in comparative advertisements for veterinary nutraceutical products in Gibraltar v Viovet and news that the ASA found a press ad indirectly promoted unlicensed e-cigarettes, among other news.

This week's edition of Life Sciences weekly highlights includes news that MedTech Europe urged the European Commission to promptly address regulatory issues impacting medical device and diagnostics, the National Institute for Health and Care Excellence (NICE) announced the expansion of its HealthTech evaluation programme to include medical devices, diagnostics and digital tools, MHRA established the UK National Commission to develop a new regulatory framework for AI in healthcare and updated its guidance on clinical trials to accompany the new clinical trial reform in the UK, the Council of the EU adopted conclusions on EU life sciences competitiveness strategy, EMA published a draft reflection paper encouraging the systematic inclusion of patient experience data (PED) in medicines development and regulatory submissions, the Department for Science, Innovation and Technology (DSIT) launched £50m fund to support large-scale life sciences R&D projects and opened Moderna facility to facilitate the production of mRNA vaccines. Also included, is news that the International Council on Harmonisation (ICH) adopted E2D(R1) guideline to standardise adverse event terminology and streamline post-approval safety reporting, the Competition and Markets Authority (CMA) published final recommendation to replace Assimilated Technology Transfer Block Exemption Regulation (Assimilated TTBER), the Patents Court ruled on costs from multiple interim applications in AstraZeneca diabetes drug patent litigation, the European Directorate for the Quality of Medicines and Healthcare (EDQM) published guidance on classification of active substances for their supply, as well as news that industry groups called for an EU Critical Medicines Act to address supply chain vulnerabilities and the MHRA, together with the Advertising Standards Authority (ASA) and the General Pharmaceutical Council (GPhC), issued an updated enforcement notice on advertising prescription-only medicines (POMs) for weight management to the public, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis of the timetable for the implementation of the Tobacco and Vapes Act 2026 and the delay to the retail licensing consultation by Irwin Mitchell LLP. Also included is news that the MHRA has published its position on the licensing pathway for microbiome-based medicinal products (MBMPs) as biological medicinal products or advanced therapy medicinal products. Also included is news that the MHRA has published guidance on its Phase 1, 14-Day Pilot Programme for qualifying low-risk phase 1 clinical trials involving healthy adult volunteers, with assessment timelines reducing in stages to 14 calendar days from 28 December 2026. Further news includes the Patents Court dismissing Accord Healthcare’s challenge to Novartis’ patent and supplementary protection certificate protecting the valsartan and sacubitril combination used in Entresto, with the court finding both the Patent and SPC valid and that Accord’s intended product would infringe the SPC.

This week's edition of Life Sciences weekly highlights includes news analysis of the European Commission’s withdrawal of the AI Liability Directive withdrawal as part of last week’s 2025 Work Programme. Also included, is news that NICE announced proposals to transform its HealthTech programme, the European medical devices industry published a joint reflection paper calling for the EU to become a full member of the Medical Device Single Audit Program, NICE has teamed up with the US and Canada to establish the Health Economics Methods Advisory (HEMA) international initiative to evaluate health technology assessment (HTA) methods and the British pharmaceutical industry remains concerned about the ‘at or below’ principle in NHS England’s updated commercial framework for new medicines that include indication-specific pricing as an alternative to uniform pricing and sharing data for combination therapies. Other stories included are that the EMA has initiated the development of a new guideline on the assessment and reporting of mechanistic models used in model-informed drug development, the EMA published a revised draft reflection paper outlining non-animal replacement tests for pharmaceutical testing and updated its guidance on biosimilar medicines; among other stories.

This week's edition of Life Sciences weekly highlights includes news that the Commission Delegated Regulation (EU) 2024/1701 of 11 March 2024 amending Regulation (EC) 1234/2008, the Variations Regulation, regarding the examination of variations of marketing authorisations for medicinal products for human use will come into force on 7 July 2024 and will start applying from 1 January 2025. Also included is news that the MHRA, US FDA and Health Canada released a guidance on their guiding principles on the transparency of machine learning medical devices, the Council of the EU approved conclusions to ensure the supply of medical radioisotopes to meet demand for therapeutic radiopharmaceuticals, the European Commission sent a Statement of Objections to Alchem for suspected participation in a long-term cartel in relation to the active ingredient of the anti-cramp medicine Buscopan® and its generic versions and news that the ASA found that an ad for a food supplement was misleading and made unauthorised health claims.

This week's edition of Life Sciences weekly highlights includes news that the MHRA and NICE outlined new regulatory processes that MHRA will permit point-of-care manufacturing of personalised medicines and NICE will complete 60% of technology appraisals within 240 working days beginning from July 2025, the EMA and HMA released a joint warning about unregulated advanced therapy medicinal products (ATMPs) in the EU market, the Notified Body (NB) industry group encouraged its NBs to more widely use conditional certificates for medical devices, the UK CMA launched a consultation whether to replace the Assimilated Technology Transfer Block Exemption Regulation with a new UK block exemption order, the DHSC launched a consultation proposing changes to the statutory scheme for branded medicines pricing and the High Court upheld the Human Givens Institute decision to sanction Ms Emmerson for breaching confidentiality, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis on the decision of the UK Court of Appeal decision clarifying the approach of UK courts to confidentiality in patent litigation. Also included, is news that the European Commission proposed a new Digital Package aimed at simplifying EU technology and data rules across Member States, the IP guidance for the NHS has been revised to streamline processes and encourage innovation, the DSIT announced a significant funding package to support a series of pioneering life sciences initiatives, the EFPIA and Vaccines Europe (VE) set out several priorities for the EU Biotech Act in its response to the public consultation, the MHRA announced its pilot programme offering clinical investigation application fee waivers to micro and small UK enterprises developing innovative medical devices, the MHRA also launched a consultation on adopting draft ICH guideline Q3E for Extractables and Leachables to establish a holistic framework for the assessment and control of leachable impurities, and European Notified Bodies (Team-NB) adopted a position paper and template agreement governing the transfer of a Medical Devices Regulation (MDR) formal application, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by Browne Jacobson of the Court of Appeal’s decision in Accord v Astellas that a patent for prostrate cancer was not invalidated by prior art due to the expert’s reasoning being tainted by hindsight, analysis by Pinsent Masons of the High Court decision invalidating Alexion’s patent for eculizumab and not infringed by biosimilars that matched the therapeutic amino acid sequence but not the leader sequence specified in the patent (Samsung v Alexion), analysis by Lewis Silkin of the key changes to data protection and ePrivacy law introduced by the Data (Use and Access) Act 2025 and a Law360 analysis of a £2.1m fine levied against an investment firm for ‘unashamedly misappropriating’ a software developer’s application designed to help the elderly care industry, among other stories.