This week's edition of Life Sciences weekly highlights includes news that the Council of the EU adopted a Directive updating the EU’s civil liability law to reflect technological advancements and circular economy practices, the UK government announced a move to reduce waste in the NHS using a new ‘Design for Life Roadmap’ strategy to minimise the number of single-use medical devices, the Association of British HealthTech Industries (ABHI) released a report on the economic impact of the HealthTech policies, the UK government announced a major collaboration with industry resulting in the launch of the first Lilly Gateway Lab in Europe, and news that the European Medicines Agency (EMA) opened a consultation on its draft revised policy regarding the handling of competing interests among scientific committee members and experts (Policy 0044) and also published a concept paper on the clinical evaluation of therapeutic radiopharmaceuticals in oncology, among other news.

This week's edition of Life Sciences weekly highlights includes news that the MHRA published recommendations for a future regulatory framework for artificial intelligence in healthcare and the DHSC has published impact assessments on the recently proposed reforms to the MHRA’s medicines and medical-device regulatory frameworks. Further news includes guidance from the EMA on the submission of electronic product information for centrally authorised medicines and revised guidance from the EMA and HMA on pharmacovigilance inspections, clarifying inspection powers in relation to subcontracted pharmacovigilance activities and reflecting experience gained from remote inspections. Also included is news that the MDCG has updated its guidance on the classification of in vitro diagnostic medical devices, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the European Parliament has adopted its position on the EU pharmaceutical reform package and the UK Tobacco and Vapes Bill has reached its second reading in Parliament, as well as, a Law360 analysis of the US FDA Commissioner urging Congress to create a regulatory framework for CBD and a Law360 analysis of General Counsels’ increasing reliance on external counsel in the life sciences for deal structuring, such as with Sofinnova’s investment in a UK company. Also included is news that the High Court has allowed an application for interim relief in a patent dispute about the sale of a generic blood thinner (Bayer v Aspire), the Heads of Medicines Agencies (HMA) and the EMA have published a guidance document on personal data and commercially confidential information within a marketing authorisation application (MAA) dossier, the ICO has published new and updated guidances, the European pharmaceutical industry has published key recommendations to improve the content and accessibility of Patient Information Leaflet (PIL), and the Commission has approved Illumina’s plan to divest GRAIL under the EU Merger Regulation, among other stories.

This week's edition of Life Sciences weekly highlights includes consideration of the arguments put forward against DeepMind, Google’s subsidiary, for misuse of medical data brought in a class action and news of the UK launching dispute proceedings under the Trade and Cooperation Agreement (TCA) over access to EU scientific research programmes, NICE issuing its first recommendation under the Early Value Assessment pilot project for a mobile phone cardiac rhythm monitoring device in people taking antipsychotic medication and other stories.

This week's edition of Life Sciences weekly highlights includes news that the Council of the EU and the European Parliament have reached a provisional agreement on the proposed pharmaceutical legislation reform package, the European Commission has published proposed amendments to the medical device regulations, and it also has published the long-awaited draft Biotech Act along with a draft directive for genetically modified micro-organisms, together with announcing €10bn investment into the sector, which aim to boost EU biotech competitiveness, accelerate EU clinical trials and strengthen biosecurity. Further news included is that the European Parliament adopted an amended draft Critical Medicines Act, the MHRA has established a Regulatory Innovation Corridor with Singapore that allows companies to engage with both nation’s regulators simultaneously to obtain early joint advice and streamline clinical trial design for breakthrough health technologies, the Commission has published a draft implementing regulation establishing the operational framework for the European Health Data Space (EHDS) Board, the Commission has released the three-year working plan agendas for five working groups (Biosimilars, Biologics, joint CHMP/CVMP Quality, Non-clinical domain and Synthetic Peptides) and the ASA continues to sanction companies for advertisements of weight-loss medicines that are prescription-only medicines (POMs) and for claims that go beyond the medicine’s authorised indication, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis on the Merck v Comptroller-General case by AA Thornton IP LLP and news that the Information Commissioner’s Office has opened a consultation series on generative artificial intelligence, which will close on 1 March 2024. This week’s edition also includes news that the University of Portsmouth has been held liable for £1m in damages resulting from a research agreement dispute involving a retraction in an academic journal and the Human Medicines (Amendments Relating to Coronavirus and Influenza) (England and Wales and Scotland) Regulations 2024 will come into force on 31 March 2024 to extend coronavirus (COVID-19)-related transitional provisions until 1 April 2026, among other news.

This week's edition of Life Sciences weekly highlights includes news that the EU AI Act has been published in the Official Journal on 12 July 2024 meaning its impact on digital health regulation will begin as a gradual roll-out of application of certain sections from the date of its entry into force on 2 August 2024 until full application on 2 August 2027. Also, His Majesty King Charles III included among the government’s priorities and proposed policies that he set out in his first State Opening of Parliament speech, the Tobacco and Vapes Bill and the Digital Information and Smart Data Bill impacting e-cigarette/vaping and digital health and data regulation. Further news included is that the European Commission issued a statement in response to the General Court’s ‘access to documents’ decisions in relation to public access to the coronavirus (COVID-19) vaccine agreements it negotiated, the UK Office for Life Sciences (OLS) published its Life sciences competitiveness indicators reports for 2024 drawing a critical response from the British pharmaceutical industry and the European Economic and Social Committee (EESC) urged the European Commission to prioritise nuclear medicine and reduce barriers to the cross-border supply of radioisotopes, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by Venner Shipley LLP of the Advocate General’s opinion that a substance expressly classified as an excipient in the marketing authorisation cannot constitute a protected active ingredient under the SPC regime in Halozyme v Czech IPO. Further analysis included by MLex examines a UK Court granting Novo Nordisk a blocking order against more than 130 websites selling counterfeit drugs and devices. Also included is news that the Council of the EU has agreed its negotiating mandate on a draft directive under the European Biotech Act I package updating rules on genetically modified micro-organisms (GMMs) and organ transplantation, the DHSC published its response to its consultation on changes to the statutory scheme controlling the cost of branded medicines that it will reduce headline payment to 16.5% from 1 July 2026 to be commercially equivalent with the voluntary scheme, and the MHRA has published findings on the regulation of AI in healthcare, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis by Shoosmiths LLP of the Court of Appeal’s ruling in a closely watched dispute over mRNA vaccine technology, upholding Moderna’s patent against Pfizer/BioNTech. Also included is news that the Advisory Council on the Misuse of Drugs (ACMD) launched a consultation to review the impact of 2018 changes to the Misuse of Drugs Regulations 2001 regarding cannabis-based products for medicinal use, the Court of Justice delivered its judgment on a second reference for a preliminary ruling in Kwizda Pharma II concerning a borderline case between a medicinal product and a food for special medical purposes, the ICH adopted guidelines on the use of real-world data for observational studies, the Association of the British Pharmaceutical Industry (ABPI) published a report that assesses the UK’s attractiveness in global pharmaceutical investment, the Medical Device Coordination Group (MDCG) updated its manual on borderline and classification for medical devices, the Department for Science, Innovation and Technology (DSIT) announced £3.6m funding for regulated mental health tech devices and the MHRA published a blog outlining the implementation of the new Decentralised Manufacturing (DM) legislation, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis on emerging trends in the Unified Patent Court. Also included, is news that long-awaited legislation was introduced by MHRA which will overhaul the UK’s clinical trials regulatory framework, the MHRA also revised its roadmap outlining the implementation timeline for the future medical devices regulatory framework in the UK, the European Commission has initiated a public consultation to evaluate the EU medical devices regulatory framework and whether further urgent reform is required, MedTech Europe has voiced concerns regarding the Health Technology Assessment Regulation and its implementation which begins 12 January 2025, the US FDA has established the CDER Center for Real-World Evidence Innovation to streamline the use of real-world data and real-world evidence in regulatory decision-making and the ASA has sanctioned several companies for misleading medical or health claims in breach of the advertising code, among other stories.

This week's edition of Life Sciences weekly highlights includes the analysis of the High Court’s decision in AA v Human Fertilisation and Embryology Authority, in which the High Court (Family Division) granted declaratory relief in 14 of 15 applications to renew consent for the storage of gametes and embryos outside statutory time limits, holding that section 3 of the Human Rights Act 1998 could be used to avoid a breach of Article 8 ECHR rights where applicants were denied a fair opportunity to renew consent due to clinic error. Also included, is MLex analysis of the European Commission’s 2026 priorities for implementing the EU AI Act and news that the MHRA launched a consultation on indefinite recognition of CE-marked medical devices in Great Britain and it has updated guidance on transitional arrangements under the amended Clinical Trials Regulations, as well as updated its guidance on the reporting procedure for defective medicinal products. Further news includes the Commission launching, BE READY, a €120m Horizon Europe partnership to strengthen pandemic preparedness research and the MHRA has reported seizing approximately 4.4 million doses of unlicensed erectile dysfunction pills in 2025 as one of the most frequently seized illegally traded medicines.

This week's edition of Life Sciences weekly highlights includes a Law360 news analysis that the Unified Patent Court ruled that Curio Bioscience's Seeker Spatial Mapping Kits infringed patents by 10x Genomics, upholding an injunction against the U.S. biotech company's rival in Germany, France and Sweden, and an MLex analysis that the European Commission is pressing ahead for August 2025 with finalising the Code of Practice for general-purpose AI (GPAI) model developers despite possible AI Act delays as well as news that the Commission has published its timeline for the implementation of the EU AI Act. Also, this week includes several important news stories in the medical devices sector: the MHRA brought into force the Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2024 from 16 June marking the first major reform to post-market surveillance (PMS) legislation for medical devices in Great Britain, the UK MedTech Forum called on the MHRA for the indefinite recognition of EU CE-marked medical devices and advocated for the introduction of internationally aligned reliance pathways for pre-market approvals, the EU’s MDCG has published guidance clarifying the regulatory responsibilities of providers facilitating the availability of medical device software apps on the EU market, and the MedTech Europe commissioned a report on how the MedTech industry can contribute to healthcare decarbonisation efforts while improving competitiveness. Further news included, is that Parliament passed the Data (Use and Access) Bill (DUA Bill) on 11 June 2025, the MHRA has published new guidances to support the implementation of the world’s first decentralised manufacture regulatory framework (encompasses both point of care (POC) and modular manufacturing), the DHSC unveiled the government’s 10 Year Health Plan to overhaul the UK’s clinical trial system, the EU pharma industry called for reforms in its response to the Commission’s call for evidence on the proposed EU Biotech Act and the EMA launched the COMBINE programme to streamline drug-diagnostic study approvals, among other stories.