This week's edition of Life Sciences weekly highlights includes a case analysis by Pinsent Masons of the Patents Court’s invalidation of Abbott’s continuous glucose monitor patent for obviousness finding that Dexcom would not have infringed it anyway (Abbott Diabetes Care v Dexcom) and an MLex commentary on whether the Cyber Security and Resilience Bill represents a stricter regulatory shift for UK cybersecurity enforcement. Also included, is news that the WHO is consulting on collaborative registration procedures for marketing authorisations of new medicinal products to expand access in low- and middle-income countries, the British pharmaceutical industry in a blog has called on NICE to take a different approach in applying the ‘severity modifier’ for patient access to medicines and the Innovation Medicines Fund pathway has led to the world’s first CRISPR-based gene therapy for a blood disorder, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the Court of Appeal allowed an appeal by the defendant from a decision of the High Court in the Astrazeneca UK Ltd v Tesaro on the scope of royalties under licence, where the licensed patents were for a second medical use, the Department for Science, Innovation and Technology (DSIT) released its response to the 2021 Independent Review of Research Bureaucracy call for evidence and provided an update on the progress on the Science and Technology Framework, as well as news that the European Parliament approved new rules which lay down the conditions for the EU compulsory licence and to help prepare the EU for possible cross-border crises, and the Advertising Standards Authority (ASA) upheld complaints about CBD products claiming to help anxiety and insomnia, and prevent, treat or cure disease, among other news.

This week's edition of Life Sciences weekly highlights includes news analysis by Lexis+ that discusses what the key developments were for life sciences lawyers in 2025 and looks ahead to what is coming in 2026. Also included, is news that data shows ‘a sharp rise’ in UK clinical trial applications and activity in 2025 in anticipation of the new clinical trial regulations and reforms to take effect from 28 April 2026, Dr Melanie Ivarsson has been appointed as the first CEO of the recently established Health Data Research Service (HDRS) to improve access to health data in preparation to be operational by December 2026, the MHRA also announced that certain commonly prescribed medicines will now be required to include a warning on their packaging against risks of dependence and addiction. It also includes news that techUK is seeking evidence to inform its response to the MHRA consultation on AI regulation, a judgment in the longstanding Abbott v Dexcom dispute has been handed down and Regulation (EU) 2026/78 amending Regulation (EC) 1223/2009 (the EU Cosmetic Products Regulation) to address the use of substances classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) has been published in the Official Journal.

This week's edition of Life Sciences weekly highlights includes two analyses by Gill Jennings & Every LLP: one regarding the EU landscape of patent-eligible subject matter in AI healthcare and another on a judgment (Generics, Teva & Glenmark v AstraZeneca) that again demonstrates how UK patent law is diverging from the European Patent Office’s approach. Also included, are Law360 news reports on the call for the UK-US trade deal to address better pharma and IP and analysis of the Court of Appeal’s unanimous decision upholding the CMA’s initial fine against Advanz for breaking competition law through excessive pricing of liothyronine tablets to the NHS overruling the CAT’s reduction of the fines. Further stories included are news that international draft guidance establishing regulatory principles for AI’s use in pharmacovigilance was published, the ABPI warned in its response to the DHSC’s March 2025 consultation on increasing the statutory scheme payment rates for branded medicines that these rates along with VPAG payments could undermine UK pharmaceutical investment, the EMA and the HMA published a joint workplan on data and AI in medicines regulation through 2028, the EMA launched a consultation on revised ATMP manufacturing guidelines, and the European Commission opened a consultation on its EU Biotech Act proposal, among other stories.

This week's edition of Life Sciences weekly highlights includes an MLex analysis of UK reforms to the regulation of AI-enabled medical devices, including forthcoming guidance on managing device changes and a planned consultation on classification, as well as news that the MHRA has published its Strategy 2030, setting out plans to modernise medicines and medical devices regulation, the European Commission has accepted legally binding commitments from Sanofi addressing concerns about possible anticompetitive disparagement of a competing flu vaccine. Also included is news that the European pharmaceutical industry has called for suspension of implementation of extended producer responsibility provisions under the revised Urban Wastewater Treatment Directive, the EMA has announced that the ACT EU clinical trial applications advice pilot will become permanent from January 2027, and published a concept paper revising its good pharmacogenomic practice guideline. Further news includes the Law Commission’s consultation on reforms to product liability law for digital technologies, including software and AI systems, and EU–China trade and investment consultations covering market access for medical devices, pharmaceuticals and cosmetics.

This week's edition of Life Sciences weekly highlights includes analysis by Venner Shipley of the UK High Court decision to follow Medeva’s precedent and uphold the IPO’s decision on appeal that an uncombined medicinal product is not entitled to an SPC where an earlier marketing authorisation existed for the same active ingredient in a combination product. Also included is a helpful blog by the HRA discussing the incoming application of the clinical trial regulation’s transparency and transitional provisions from 28 April 2026 and news that the European Commission has launched two consultations on proposed implementing regulations under the European Health Data Space (EHDS) for cross-border exchange of personal health data under MyHealth@EU and the required descriptions of health datasets for inclusion in dataset catalogues. In the medical devices space, international regulators opened consultation on a technical framework for the lifecycle management of AI medical devices, MedTech Europe flagged potential implications for European manufacturers arising from US section 301 trade investigations, Team-NB submitted feedback on proposed revisions to EU medical device legislation and the MHRA secured additional funding to expand its AI Airlock regulatory sandbox. Further stories report on MHRA enforcement activity with eBay leading to the removal of unauthorised medicines from online marketplaces and the government evaluation of UK life sciences manufacturing funding schemes, among other developments.

This week's edition of Life Sciences weekly highlights includes news analysis on the Court of Justice’s decision to introduce an invention test for combination products to be eligible for supplementary protection certificates. Also included, is news that the MHRA published a collection of post-market surveillance guidance to support the new PMS regulation adopted 16 December 2024, EMA announced its readiness to support the implementation of the new regulation on health technology assessment effective on 12 January 2025, the ICH has adopted a new version of its Guideline for Good Clinical Practice E6(R3), the European pharmaceutical industry proposed a phased implementation of electronic product information for medicinal products, the European Commission has unveiled an action plan aimed at strengthening cybersecurity measures in the healthcare sector and it launched the COMBINE programme aimed at harmonising drug-device studies, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the MHRA has updated its International Recognition Procedure (IRP) guidance, introducing changes to validation requirements, approval timelines, and eligibility criteria, including for advanced therapy medicinal products (ATMPs). Also included is news that the International Council for Harmonisation (ICH) has completed the revision of its Good Clinical Practice (GCP) guideline with the publication of Annex 2 covering decentralised and pragmatic clinical trials and the use of real-world data, and that the DHSC has launched a UK-wide consultation on restrictions for tobacco and vaping product packaging, appearance and retail display. Further news includes the MHRA has announced the sentencing of four members of an organised criminal group following an investigation into the illegal online supply of medicines, prescription-only medicines (POMs) and unauthorised medicinal products, as well as news that the UK Covid-19 Inquiry has published its Module 5 report identifying procurement failures in the supply of healthcare equipment during the coronavirus (COVID-19) pandemic.

This week's edition of Life Sciences weekly highlights includes news analysis by Bird & Bird LLP of the Patents Court decision to grant Bayer an interim injunction restraining sales of generics of a once-daily blockbuster blood-thinner drug, rivaroxaban, in Bayer v Aspire pending appeal of a judgment invalidating its patent due to disclosure through scientific conference materials. Also included is news that the EU pharma industry feels that despite some improvements there are key problematic provisions that the proposed EU compulsory licensing for crisis management regulation still must address, the MHRA launched its new regulatory sandbox for AI as a Medical Device, the European Commission considered regulatory reforms for drug-device clinical studies in a report, the Association of British HealthTech Industries (ABHI) published its ‘The Plan for Health Tech’ manifesto and news that the Council for Science and Technology (CST) set out recommendations to improve global AMR in a letter to the UK Prime Minister, among other news.

This week's edition of Life Sciences weekly highlights includes analysis by Freshfields LLP of recent highlights in the UK's medical devices regulatory framework and an MLex analysis indicating that the European Commission will issue guidelines on how the EU AI Act interacts with other EU laws such as the EU GDPR. Also included is news that MedTech Europe submitted recommendations to the European Commission’s call for evidence on the forthcoming European Innovation Act, the MHRA announced an expanded partnership with the US Food and Drug Administration (FDA) to accelerate innovation in medical technologies and AI and published guidance on new medical device registration fee planned to come into effect on 1 April 2026, and the European Notified Bodies industry group (Team-NB) and the Association of British HealthTech Industries (ABHI) responded to the Commission’s call for evidence on the targeted revision of the MDR and IVDR. Also included, is news that the MHRA has awarded the first three Innovation Passports under its revised Innovative Licensing and Access Pathway (ILAP), and together with NICE have opened early access to the aligned streamlined approvals pathway six months earlier than projected, EU industry bodies have criticised the European Commission’s upcoming study on costs for implementing quaternary-level treatment upgrades under the Urban Wastewater Treatment Directive (UWWTD) and, together with Cosmetics Europe, called for a data-driven, substance-based Extended Producer Responsibility (EPR) scheme, and the European Commission opened a public consultation on its proposed European Research Area Act, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the European Commission published the second version of its guidelines on responsible use of generative AI in research that complements the EU Artificial Intelligence Act, the HRA and MHRA announced that the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024 has been enacted into UK law initiating a 12-month implementation period to become fully effective on 10 April 2026, the Charted Institute of Taxation offers insight into the application of R&D relief to going concern rules in the context of intra-group transfers of trade, an EU committee found that ‘many pharmaceuticals’ would be captured by the proposed definition of per- and polyfluorinated alkyl substances (PFAS) in the Water Framework Directive, the European Pharmacopoeia Commission adopted a new general chapter on human cell therapies providing for production and quality control preparations, the EMA has updated its Q&A guidance on GMP/GDP standards and the industry body for Notified Bodies released three position papers on AI regulation, IVDR certification and MDR documentation; among other stories.

This week's edition of Life Sciences weekly highlights includes a Law360 news analysis of Pfizer urging the Court of Appeal to revoke surplus patent protections underpinning rival Moderna’s mRNA vaccine after getting a key patent tossed. Also included, is news that in a landmark ruling, the Court of Appeal upheld the High Court’s decision that AstraZeneca’s patent for dapagliflozin was invalid for lack of inventive step and insufficiency, the government announced regulatory reforms in a new Life Sciences Sector Plan, the EMA published its first AI Observatory report and horizon scanning report on AI/ML applications in medicines lifecycle, the Commission opened a consultation on proposed AI and digital updates to EudraLex Volume 4: Good Manufacturing Practice (GMP) guidelines. Further stories included are news that the Commission fined Alchem for participating in a drug ingredient price-fixing cartel, the MHRA announced plans to align the Medical Devices Regulations 2002, SI 2002/618 with EU common specifications for high-risk in vitro diagnostic devices, the MDCG publishes position paper on Master UDI-DI implementation timeline for contact lenses and spectacle products, as well as news that the Commission launched two initiatives under its Preparedness Union Strategy: the EU stockpiling strategy and the medical countermeasures strategy and Medicines for Europe applied to intervene in legal proceedings before the EU General Court challenging the Extended Producer Responsibility (EPR) scheme in the recast Urban Wastewater Treatment Directive (UWWTD), among other stories.