This week's edition of Life Sciences weekly highlights includes news that the MHRA plans to overhaul rare disease regulation, the EFPIA and eight other healthcare associations raised concerns that the European Chemicals Agency (ECHA) will not conduct individual sector assessments for medicines as part of its proposed universal restriction on PFAS chemicals, the EMA launches a new Combination Products Operational Group (COMBO), MedTech Europe submitted a critical response to the EU consultation on Regulation (EU) 2024/1157 harmonising the classification of certain waste types for cross-border shipment, and MedTech Europe and other trade bodies called on the European Commission and EU legislators to permit non-essential information about medical devices to be provided by digital label. Also included, is news that the Commission published a comprehensive package of updated clinical trials guidance, the Notified Body trade group unanimously adopted a comprehensive position paper to identify significant changes affecting companion diagnostic devices, and the EU Pharma industry calls for greater HTA clarification in supporting guidance to implement Joint Clinical Assessments of medicines, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the NICE and the MHRA announced a joint information-sharing agreement intended to accelerate access to new medicines for patients in the NHS, the European Parliament’s Committee on the Environment, Climate and Food Safety proposed key amendments to the draft Critical Medicines Act to mitigate impact of overlapping environmental and chemical regulations on medicine supply, the European Commission launched a public consultation regarding its proposed Biotech Act. Also included is news that DHSC published a report on the progress made to implement the Lord O'Shaughnessy review of commercial clinical trials, the Health Research Authority updated its suite of model commercial agreements used in clinical research and published results from a survey on simplified arrangements for consents in clinical trials as part of its work to support updated clinical trial regulations, and the MHRA published a statement of policy intent outlining plans to establish an Early Access service for innovative medical devices. Further stories included are news that the Court of Appeal dismissed the appeal of Pfizer/BioNTech and uphold the High Court’s ruling finding Moderna’s patent concerning mRNA technology valid and novel, the EMA, in collaboration with the Heads of Medicines Agencies issued an addendum to its good pharmacovigilance practices guidelines and the Advertising Standards Authority issued a ruling clarifying medical device advertising evidence requirements, among other stories.

This week's edition of Life Sciences weekly highlights includes the Spring Budget 2024 and its key life sciences and R&D announcements, analysis of the Newron v Comptroller case by Hogarth Chambers, and news of the European Commission consultation on draft Health Technology Assessment (HTA)-related implementing regulation, the publication of the England Rare Diseases Action Plan 2024. Also included is news that the EMA is developing an Artificial Intelligence (AI)/Knowledge tool for data mining of scientific information, the MHRA has granted its first approval for a product through the new International Recognition Procedure (IRP), the DHSC has published the 2024 report on the Medicines and Medical Devices Act 2021 (MMDA 2021) as well as its response to antimicrobial potential of bacteriophages report, among other stories.

This week’s edition of Life Sciences weekly highlights includes news that the Health Research Authority (HRA) implemented updated operational guidance following the entry into force of the new UK clinical trials framework, the MHRA reported results from its route B substantial modifications pilot for low-risk clinical trials modifications, the EMA launched a pilot programme to support breakthrough medical devices, the Commission adopted a new implementing regulation on Notified Body conformity assessment procedures, and MedTech Europe responded to proposed reforms to the MDR and IVDR regime. Further developments include the Council of Europe adopting recommendation on the remote and online provision of medicines, the MHRA reporting that it met performance targets and announcing the appointment of a new Chief Digital and Technology Officer, as well as news that the CMA launched a consultation on draft guidance for technology transfer agreements under the new UK block exemption regime, the HRA has responded to concerns regarding UK Biobank data advertised for sale online, the Tobacco and Vapes Act 2026 partly came into force, and the Committee of Advertising Practice (CAP) reported on related CAP Code guidance on advertising restrictions concerning tobacco products, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the European Commission has fined Teva €462.6m for abusing its dominant position to delay competing products to its treatment for multiple sclerosis, Copaxone, entering the market and the UK Supreme Court has refused to hear Sandoz v Bayer appeal of the revocation of the rivaroxaban patent based on prior art. Also included is news that the Windsor Framework for supplementary protection certificates for medicinal products will come into force on 1 January 2025 amending a piece of assimilated direct legislation in relation to patents, the EMA has published guidance on how to comply with the amended Variations Regulation, the Council of the EU has adopted a revision to Council Directive 91/271/EEC (the Urban Waste Water Treatment Directive) and the European pharma industry has expressed concern about its Extended Producer Responsibility imposing a disproportionate financial burden on human pharmaceuticals and cosmetics in a joint statement. Furthermore, the Association of British HealthTech Industries has criticised MHRA’s proposals to increase the statutory fees as anti-competitive with other jurisdictions and the DSIT has confirmed its R&D projects resulting from the Autumn Budget, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the EMA launched a pilot programme for the development of orphan medical devices in the EU, published a concept paper for a guideline on therapeutic equivalence for nasal products, published revised guidelines on good pharmacovigilance practices and complied a list of enforcement procedures and templates to support the exchange of inspection-related information and enhance co-operation between Member States. Also included, is news that the Patents Court has ruled in Samsung’s favour finding Janssen’s patent for an antibody (ustekinumab) used in the treatment of ulcerative colitis is invalid due to obviousness because of a presentation of the clinical trial results at a conference (Samsung Bioepis v Janssen Biotech), the the HRA published a report and issued recommendations on how to improve clinical research for participants, the ICH published a reflection paper on the EMA’s efforts to establish a sustainable framework enabling better integration of real-world data and real-world evidence into regulatory decisions, the US FDA for the first time used AI/ML for a regulatory decision to identify a population who will likely benefit from a drug therapy, the UK DSIT provided funding for semiconductor start-ups working on chips that make AI more efficient and create new lifesaving healthcare tech through a pilot incubator (ChipStart), and an influencer was found in breach of the advertising code for posting about her positive personal experience with a device to treat depression, among other news.

This week's edition of Life Sciences weekly highlights is a relatively light news cycle that includes news of the publication of the European Economic and Social Committee’s (EESC) opinion on the proposal for a revision of the European Pharmaceutical Framework in the Official Journal of the EU, the Competition and Markets Authority’s (CMA) investigation of the anticipated acquisition by Thermo Fisher Scientific Inc of Olink Holding AB and the publication of the Medical Device Coordination Group (MDCG) guidance on vigilance reporting for Specific Devices.

This week's edition of Life Sciences weekly highlights includes several key analyses: an analysis of the Commission’s Digital Omnibus on AI Regulation Proposal and key considerations for life sciences companies by Hogan Lovells and an MLex analysis of the Commission’s proposal to ease application of the EU AI Act’s high-risk regime for medical devices. Also included are an analysis of the UK Law Commission’s published Terms of Reference for its product liability law review by Freshfields LLP, analysis of the UK government’s announcement of a landmark UK–US pharmaceutical deal by Covington & Burling LLP, an MLex analysis of the Unified Patent Court’s revocation of GXD-Bio’s breast cancer testing patent, an analysis on how to avoid misleading claims in the beauty industry by Mishcon de Reya and analysis of the ASA final guidance on less healthy food and drink advertising by Lewis Silkin. Other stories include news that the Commission has opened a feedback period on its proposal for a regulation to revise EU rules for medical devices and in vitro diagnostics, the Commission has published new MDCG guidance on post-market surveillance and breakthrough devices, the MHRA has opened a call for evidence on the regulation of AI in healthcare, and has updated its guidance on the Health Institution Exemption for medical devices, the International Medical Device Regulators Forum (IMDRF) published its strategic plan for 2026–30, and news that the EU regulation on compulsory licensing for crisis management will enter into force on 19 January 2026, among other stories.

This week's edition of Life Sciences weekly highlights includes an MLex analysis of AI model providers receiving confirmation of delays to the EU Code of Practice intended to help them comply with the EU AI Act. Also included is news that MedTech Europe developed a series of concise one-pagers designed to support the effective implementation of the MDR and the IVDR, the European Commission published an updated mandatory manufacturer incident report (MIR) under the MDR/IVDR, the Medicines for Human Use (Clinical Trials) Regulations 2004, SI 2004/1031 will reform the UK legislation for clinical trials, responding to the needs of the sector to deliver a more streamlined and flexible regulatory regime, and the EMA revised its policy on access to EudraVigilance data for medicinal products for human use.

This week's edition of Life Sciences weekly highlights includes news that the government has published its response to the National Commission into the Regulation of AI in Healthcare, accepting all 44 recommendations and setting out a UK-wide approach to implementation, alongside the European Commission’s first decision selecting medical devices for joint clinical assessment under the EU Health Technology Assessment (HTA) Regulation, and European Association of Medical Devices Notified Bodies’ (Team-NB) updated guidance on the IVDR certification process. Also included is news that the EMA has endorsed a joint statement by the International Coalition of Medicines Regulatory Authorities (ICMRA), led by several global regulators, including the UK Medicines and Healthcare products Regulatory Agency (MHRA), promoting alternatives to animal in medicines development. Further news includes two Patents Court judgments, one in AstraZeneca v Hansoh addressing proposed amendments on the doctrine of equivalents and related case management, and another in Dr. Reddy's v Boehringer Ingelheim concerning the treatment of evidence relating to plausibility.

This week's edition of Life Sciences weekly highlights includes news that the text of the groundbreaking US–UK agreement for tariff-free exports of pharmaceuticals was published while announcing the deal will extend to medical devices as well further to medicine pricing and access reforms that include NICE implementing revised cost-effectiveness thresholds increasing technology appraisals to £25,000–£35,000 per quality-adjusted life year (QALY) gained in its manual, news that MHRA and NICE published guidance on an aligned pathway to shorten medicines time to market by co-ordinating regulatory and appraisal timelines and international regulators agreed a 2026 Action Plan for the Access Consortium to develop a digital platform to support joint regulatory activity, a network for batch testing and a mutual regulatory reliance approach for clinical trials. Also included is news that MHRA expanded the AI Airlock programme with more funding, MedTech Europe submitted feedback on the proposed reforms to medical device legislation, DHSC issued guidance on systems and processes to manage medicine shortages and ensure continuity of supply and the ASA reported on enforcement action relating to the advertising of prescription-only weight-loss medicines, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis by Freshfields on MHRA’s plans for reforming the medical devices regulatory framework post-Brexit with a summary of recent developments in the form of a new Post Market Surveillance Regulation made on 16 December 2024 and coming into force on 16 June 2025, a new consultation on four key policy reforms and a revised MHRA roadmap. Two further news analyses by HGF included this week on whether diverging inventive step frameworks adopted by the EPO and Unified Patent Court (UPC) in patent disputes will lead to potential conflicting decisions and on the UPC’s First Panel of the Court of Appeal remittal of Meril’s application to stay infringement proceedings involving a patent for a transcatheter heart valve. Also included, is news that the MDCG has released revised vigilance guidance and further guidance for IVD medical device verification and the US FDA released much anticipated draft guidance on AI-enabled medical device software.