This week's edition of Life Sciences weekly highlights includes news that the European Commission released a Communication, which proposed a series of actions to tackle challenges and barriers in the EU biotechnology and biomanufacturing sectors, the MEPs adopted their proposals on the reform of the EU pharmaceutical legislation, and the UK government introduced the Tobacco and Vapes Bill to ensure a smokefree generation. Also included is news that the Accelerating Clinical Trials in the EU (ACT EU) initiative established a multi-stakeholder platform to enhance clinical trials in the EU, the Health Research Authority (HRA) has published a list of clinical trials which received a favourable opinion from a Research Ethics Committee (REC) in 2022 to improve research transparency and news that the European Parliament and Council of the EU reached a provisional agreement on the European Health Data Space (EHDS), among other stories.

This week's edition of Life Sciences weekly highlights includes news that the European Commission and the Member State Coordination Group on Health Technology Assessment (HTA CG) have published new and updated guidance on the EU Health Technology Assessment Regulation, and that EFPIA has published its annual WAIT Indicator report highlighting continuing disparities in patient access to innovative medicines across Europe. Also included is news that the Commission has launched calls for evidence on industrial biotechnology and biomanufacturing, to inform the proposed Biotech Act II, and on revisions to the Tobacco Products Directive and Tobacco Advertising Directive, as well as the first quarterly report from the Commission, Heads of Medicines Agencies (HMA) and EMA tracking progress against EU clinical trial targets. Further news includes the MHRA announcing increased life sciences engagement in Wales, as well as two High Court judgments: Novo Nordisk A/S v British Telecommunications Plc concerning website blocking injunctions against sites supplying counterfeit and unlicensed prescription-only medicines (POMs), and a Merck judgment concerning confidentiality restrictions in trade mark and breach of contract litigation, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by Taylor Wessing of the new UK post-market surveillance statutory instrument to amend the Medical Devices Regulation 2002 as the first major piece of UK medical devices legislation post-Brexit and Law360 analysis of the General Court’s ruling that Boehringer Ingelheim cannot keep its three-dimensional trade mark over a lung disease inhaler because its shape is functional rather than decorative. Also included, is news that the MHRA has launched a consultation on proposed changes to the medical device regulation focusing on UKCA marking, international reliance, in vitro diagnostic devices, and assimilated EU law; news that the MHRA is consulting on ICH E6(R3) Good Clinical Practice Guideline; the MHRA is relaunching a revised Innovative Licensing and Access Pathway (ILAP) in March 2025; the EMA issued guidance for marketing authorisation holders regarding the submission of variations for 2024; NICE offered guidance to pharmaceutical companies considering the International Recognition Procedure (IRP) for UK market entry; MedTech Europe and industry bodies have called for EU regulatory oversight of Third-Party Litigation Funding; and an HMA/EMA report focuses on the use of social media data to generate real-world evidence in support of regulatory submissions, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the Court of Appeal dismissed an appeal upholding the finding that the marketing authorisation of a Parkinson’s disease treatment was for a single active ingredient and not for a combination of active ingredients (Newron Pharmaceuticals v Comptroller), as well as, news that the British pharmaceutical industry recommended measures to be implemented in the Spring Budget on 6 March 2024, the DHSC announced £10m funding for eight innovative medtech companies and the HRA published its response to proposed revisions to the Declaration of Helsinki. Also included is news that the UK, Australia and Canada are collaborating to pilot a Good Manufacturing Practice (GMP) Single Inspection Program and the industry body representing EU Notified Bodies recommended lowering the device risk classification of coronavirus (COVID-19) diagnostic tests post-pandemic, among other news about EMA updated guidance and an ASA ruling finding breach for an ADHD product’s FaceBook ad.

This week's edition of Life Sciences weekly highlights includes news that the European Parliament held a plenary vote to approve the proposed Critical Medicines Act which has received a critical reception from industry, several industry bodies published a joint statement on policy for safeguarding IP and trade secrets when implementing the EHDS framework, the EMA and the US FDA have jointly published ten guiding principles for good AI practice in medicines development, the DHSC issued a response to a public consultation supporting its proposal to amend the Human Medicines Regulations 2012 to support the ongoing supply and access to vaccines, Chancellor Reeves secured £500 million R&D investment from UCB at Davos, and the EFPIA expressed concern that the EU–Mercosur Free Trade Agreement fell short of supporting innovation by not including key provisions on IP, SPCs and regulatory data protection despite welcoming partial tariff reductions, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis of the new UK Clinical Trials Regulation which is a major overhaul of the UK regulatory framework and news that the MHRA celebrated the steps it has taken for clinical trial reform in the UK in an International Clinical Trials Day press release and further announced the launch of a six-week consultation on the use of real-world data (RWD) for external control arms of clinical trials following its two related guidance documents on the use of RWD and real-world evidence for regulatory decisions. Also included, is news that the UK Patents Court has handed down a judgment in relation to the rare blood disease biosimilar patent dispute between Samsung Bioepis and Alexion Pharmaceuticals, the EMA updated guidance on the implementation of Policy 0070 for the publication of clinical data, the EMA also updated FAQ guidance and several documents concerning the European Shortages Monitoring Platform, the EFPIA has criticised the proposal requiring pharmaceutical companies to launch and continuously supply products in all Member States and NICE published a modular update to its health technology evaluations manual for assessing health inequalities, among other stories.

This week’s edition of Life Sciences weekly highlights includes an MLex analysis of the EU age-verification app and its implications for data protection enforcement and policy direction, alongside news that the European Data Protection Board (EDPB) launched a consultation on guidelines on the processing of personal data for scientific research purposes, the EMA announced a pilot programme to support breakthrough medical devices and in vitro diagnostics, the European Commission updated its manual on borderline and classification under the MDR and IVDR, the Medical Device Coordination Group (MDCG) published revised guidance on medical device classification, and the MHRA extended its clinical investigation fee waiver programme for small and micro enterprises. Further developments include the DHSC reporting improved clinical trial set-up times under the UK Clinical Research Delivery programme, the EMA publishing sponsor guidance on the Clinical Trials Information System (CTIS), and the MHRA issuing updated guidance on clinical trials for medicines, outlining roles and responsibilities, as well as news that EMA and Heads of Medicines Agencies (HMA) published a joint horizon scanning report on radiopharmaceuticals, and NICE launched a consultation on the adoption of a new UK EQ-5D-5L value set to update how quality of life is measured in cost-effectiveness assessments, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the European Health Data Space Regulation, aimed at enhancing cross-border access to health data within the EU, has been adopted after lengthy negotiations. Also included, is analysis by Simmons & Simmons of the Court of Justice’s decision extending product liability to suppliers with the same distinguishing name or mark as the producer under by the Product Liability Directive which could have significant impact for life science companies. Further news included is that the World Health Organization released a draft guideline to support paediatric medicine development, NICE and international agencies published guidance on the use of surrogate endpoints in cost-effectiveness analyses for health technology assessments, Regulation (EU) 2025/40 on packaging and packaging waste was published impacting certain medicines and medical device packaging obligations, the MHRA has launched a real-world evidence scientific dialogue pilot programme to inform regulatory decisions as part of its announced Data Strategy for 2024–27, and MedTech Europe released findings from its latest survey, indicating that while access to Notified Bodies has improved for medical device manufacturers, significant challenges remain under EU regulations.

This week's edition of Life Sciences weekly highlights includes an analysis of the High Court’s decision in Merck Sharp & Dohme (UK) Ltd v Halozyme, Inc, in which the court considered the scope of waiver of privilege in relation to the disclosure of experimental evidence in patent proceedings. Also included is news that the Member State Coordination Group on Health Technology Assessment (HTA CG) has adopted general principles governing the use of artificial intelligence in the preparation of Joint Clinical Assessment (JCA) dossiers, setting out expectations for transparency, human oversight and compliance with the applicable EU regulatory framework.

This week's edition of Life Sciences weekly highlights includes news that the EU AI Act has received its final approval by the Council of the EU and the UK Department for Science, Innovation and Technology (DSIT) has released the interim International Scientific Report on the Safety of Advanced Artificial Intelligence (AI) amidst nations meeting in Seoul at the AI Summit. Also included, is medical device news that the MHRA proposed a new regulatory certification pathway for medical devices via UK reliance on authorisations by certain international regulators and it launched a consultation on whether to introduce proposed common specification requirements for high-risk in vitro diagnostic (IVD) devices into the Medical Devices Regulations 2002 in alignment with the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) while the EMA updated guidance on drug-device combination products. Further included is news that a UK report was released highlighting the effects of the current economic instability on life sciences companies, the UK government has provided £85m to help tackle global antimicrobial resistance (AMR) including £1.8m to establish a dedicated regulatory support team for AMR innovators, Moderna has successfully defended a key patent underpinning its coronavirus (COVID-19) vaccine to the European Patent Office (EPO) and the UK Court of Appeal allowed an appeal against a judge’s decision to suspend a medical device’s certification for sale in British Standards v RRR Manufacturing, among other news.

This week's edition of Life Sciences weekly highlights includes news on the UK Administrative Court’s decision to dismiss a judicial review challenging a refusal to be included in the pharmaceutical list for distance selling premises (R (Medis Pharma) v NHS Resolution), the European Commission adopted its sixth and final implementing regulation for joint clinical assessments of medical devices under the Health Technology Assessment Regulation, and the MHRA selected seven AI healthcare technologies for the second phase of its AI Airlock regulatory sandbox programme. Also included, is news that the European Parliament’s Environment, Public Health and Food Safety (ENVI) Committee will vote on its draft opinion regarding environmental aspects of the Commission’s Critical Medicines Act following 119 tabled amendments, the EMA updated its FAQ guidance document on parallel distribution, the European Commission adopted its 2026 Work Programme, the DHSC and NHS England published positive time-saving findings from the world’s largest healthcare AI trial and the UK government announced a funding boost for regional science and technology sectors, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the UK government has published its final response to a consultation on new medical device legislation that would improve routes to market and it released its Life Sciences Sector Plan, outlining significant regulatory changes through 2035. Also included is an analysis by Freshfields LLP that considers the three chapters of the final General-Purpose AI Code of Practice, an MLex analysis of the European Commission’s guidelines on the EU AI Act’s rules for general-purpose AI models and a Law360 story on the Court of Appeal’s refusal to revive AstraZeneca’s patent for its billion-dollar diabetes drug enabling generic competition. Further stories this week include that the EU pharmaceutical industry (EFPIA) expressed concerns and a proposal  in response to the Commission’s release of its Multiannual Financial Framework package for 2028–34 that totalled nearly €2trn, the EFPIA also submitted its General Data Protection Regulation Code of Conduct on Clinical Trials and Pharmacovigilance for final assessment, groundbreaking new UK legislation applies from 23 July 2025 providing the world's first regulatory framework that transforms the decentralised manufacture of innovative medicines at the point of patient care, the Home Office and DHSC published a joint response to a report on barriers to Schedule 1 controlled drugs research, Commission Implementing Regulation (EU) 2025/1467 which establishes the EU SoHO Platform to register and exchange information concerning the donation and supply of substances of human origin (ie blood, tissues and cells) published in the Official Journal,  and the Human Medicines (Authorisation by Pharmacists and Supervision by Pharmacy Technicians) Order 2025 introduces flexibilities concerning how medicines are prepared, assembled, dispensed, sold, and supplied within pharmacy services, among other stories.