This week's edition of Life Sciences weekly highlights includes news analysis by Burges Salmon LLP on the new transparency guiding principles for machine learning medical devices published by the Medicines and Healthcare products Regulatory Agency. Also included, is news that the Council of the EU has adopted conclusions on Health Union and cancer vaccines which encouraged the incoming European Commission to keep health as a priority, set out key areas of focus for EU health policy, and also calls on Member States and the Commission to strengthen action in priority areas by improving the EU’s implementation tools and developing new ones such as an EU health investment hub, and news that the ASA found that an ad for a menopause supplement inadvertently made claims that the supplements could resolve symptoms of perimenopause and menopause breached the CAP Code.

This week's edition of Life Sciences weekly highlights includes news that the EMA, jointly with the HMA has published the EU medicines agencies’ network strategy to 2028 and has also updated guidance documents on variations regulations, the European Commission has launched a call for evidence on its proposed Life Sciences strategy, the MHRA has published information on the new regulations for decentralised manufacture, including point of care and modular manufacture. Also included, is news that MedTech Europe published a detailed report on the administrative burdens under the IVDR and the MDR, submitted its response to the EU’s consultation on the targeted evaluation of the IVDR and the MDR and outlined priorities for upcoming EHDS implementation, the EMA published an interim report covering its pilot programme for Expert Panel advice to manufacturers of high-risk medical devices, as well as news that the House of Lords Science and Technology Committee launched a call for evidence on financing and scaling UK science and technology, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis of the European Commission’s Digital Omnibus proposal. Also included are key announcements for Life Sciences and Research & Development from the 2025 Autumn Budget, news that the EMA introduced the Scientific Advice for Clinical Trial Authorisation (SA-CTA) procedure to improve processes for medicines developed in response to public health emergencies (including antimicrobial resistance), the Patents Court confirmed that the defendants could rely on the supplementary protection certificate (SPC) manufacturing waiver in Regeneron v Alvotech, MedTech Europe published a statement, responding to the Commission’s Digital Omnibus package and has also, together with other industry associations, submitted a joint letter to the Commission requesting a delay to proposed amendments on border controls for products of animal origin, as well as news that the MHRA published a report on awareness and harm reporting for digital mental health technologies (DMHTs) users, and the Commission published an interim evaluation of the EU4Health Programme, among other stories.

This week's edition of Life Sciences weekly highlights includes an analysis by Covington & Burlington LLP of the MHRA’s statement of policy intent to provide early access to innovative medical devices (Early Access Service) placed on the Great Britain market and a Law360 analysis of the Unified Patent Court’s (UPC) Court of Appeal ruling that questions of the UPC’s framework or procedures are outside the jurisdiction of the European Court of Justice because the UPC agreement is not a directive, regulation or act of the EU. Also included, is news that the Swiss Agency for Therapeutic Products (Swissmedic) has started accepting voluntary registrations of medical devices on swissdamed in advance of mandatory registration; two reports compare regulator approval rates and timelines for new drugs in the US, Japan, Europe and Australia, showing Japan leads with the shortest review times but half of all new drugs are submitted in the US first; the Competition and Markets Authority’s Subsidy Advice Unit accepted a request from the Office for Life Sciences to review its proposed Life Sciences Large Investment Portfolio scheme and the MHRA published guidance on plans to streamline the assessment of some substantial modifications to clinical trial approvals.

This week's edition of Life Sciences weekly highlights includes news that the UK AI Bill completed its second reading on 22 March 2024 and the Advocate General Nicholas Emiliou’s Opinion regarding the Illumina-Grail merger cases was published recommending that the Court of Justice should set aside the General Court’s judgment which it found to be a misinterpretation of the Merger Regulation. Also included is news that the MHRA released guidance on the clinical investigation of electrical aspects of medical devices for certification markings, and news that the Advertising Standards Authority (ASA) upheld a complaint regarding a misleading ad for cranberry tablets which was found to make unsubstantiated health claims about their impact on bladder and urinary tract health, among other stories.

This week's edition of Life Sciences weekly highlights includes news that the MHRA has launched a consultation on its draft rare disease therapies regulatory framework, and that the European Commission has published analysis underpinning its proposed Biotech Act, aimed at strengthening biotechnology and biomanufacturing in the EU. Also included is news that Medicines for Europe and Medicines for Ireland have welcomed an Irish High Court referral to the Court of Justice concerning the Extended Producer Responsibility scheme under the Urban Wastewater Treatment Directive, and that the Commission has adopted a Global Health Resilience Initiative to strengthen EU action on global health threats, supply chains and preparedness. Further developments include MedTech Europe publishing a joint industry statement urging preservation of the EU Digital Omnibus simplification agenda, Team-NB publishing a legal expert opinion that proposed Article 50 of the MDR and IVDR revision, concerning Notified Body fees and conformity assessment obligations, would disproportionately interfere with Notified Bodies’ freedom to conduct a business under Article 16 of the EU Charter, and the MHRA updating the MHRA-NICE Real World Evidence Scientific Dialogue programme following its relaunch, among other stories.

This week's edition of Life Sciences weekly highlights includes a news analysis by Taylor Wessing on the impact of the EU AI Act on medical device regulation and Law360 analysis of the CAT's judgment reinstating almost identical fines of £69m against Pfizer and Flynn Pharma for abusing its market dominance and charging the NHS excessive prices for a key epilepsy treatment but with differing reasoning from the CMA. Also included, is news that the European Commission provided guidance on the gradual roll-out of EUDAMED and published its findings from its evaluation of Commission Regulation (EU) 316/2014 (the Technology Transfer Block Exemption Regulation or TTBER) and news that the European pharmaceutical industry has called for urgent policy reforms to support Europe’s biopharma SMEs.

This week's edition of Life Sciences weekly highlights includes news that the UK government has launched a five-year investment programme that was agreed as part of the 2024 voluntary scheme for branded medicines which will direct up to £400m investment funds to three main life sciences objectives including 75% towards expanding commercial clinical trial capacity in part through establishing 18 new clinical trial hubs. Also included, is news that the European Commission proposed implementing legislation that would amend the common specifications for class D diagnostic tests for certain parasites and viruses, an international guideline was adopted that will establish a harmonised framework for extrapolating drug development data from adult clinical trials to paediatric populations from 25 January 2025 and the MHRA launched a consultation on the international guideline for the use of real-world data for safety assessments of medicines, among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis by Freshfields Bruckhaus Deringer on the MHRA roadmap for a new medical device regulatory framework issued in January. Also included is news that the MHRA released guidance on new process changes for the assessment of established medicines in force from1 March 2024, the Medical Devices (In Vitro Diagnostic Devices etc) (Amendment) Regulations 2024 comes into force on 21 March 2024, the European pharmaceutical industry together with 34 stakeholders including MedTech Europe have expressed concerns regarding the draft text of the European Health Data Space (EHDS) currently in EU trilogue negotiations and news that the British pharmaceutical industry published a report which explores patient access challenges to clinical trials and proven treatments, among other news.

This week's edition of Life Sciences weekly highlights includes several analyses: 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 in the UK, analysis of the Court of Appeal allowing Abbott’s appeal and overturning the revocation of its European (UK) patent for a continuous glucose monitoring (CGM) device, and a Law360 analysis of regulators in the US and EU jointly releasing a set of agreed-upon principles intended to guide the use of AI in drug development. Also included is news that the MHRA has updated a suite of guidance in support of its Innovative Licensing and Access Pathway (ILAP), and has formally assumed the role of chair of the Access Consortium for 2026, succeeding Swissmedic, the Patents Court ruled on case management matters in patent revocation and infringement proceedings in Merck Sharp & Dohme (UK) Ltd v Halozyme Inc, as well as news that the Commission launched a public consultation on the evaluation of EU plant variety rights legislation and the MHRA has published guidance to help users assess digital mental health technologies (DMHTs), among other stories.

This week's edition of Life Sciences weekly highlights includes news analysis of Patent Court’s decision in an inventor’s long-running patent dispute from January this year that turned on a comparison of the witness inventor’s memory of events with contemporaneous documents to assess the precise timing of the invention used to interpret a service agreement which allegedly operated to assign a part of the patent’s entitlement rights. Also included, is news that the CMA has accepted final commitments from Vifor Pharma addressing concerns about its abuse of dominance in the supply of intravenous (IV) iron treatments for NHS patients in the UK that involved the disparagement of a competitor product and the Court of Appeal has dismissed an appeal against the CAT’s Lundbeck decision upholding that the respondents had validly made their ‘follow-on’ claim within the 2-year limitation period that seeks damages against the appellant pharmaceutical companies which were fined £500 million and found to have concluded unlawful agreements(pay-to-delay) to keep generics of citalopram from the market has caused the NHS damages for the artificially inflated price it paid during that time. Further news included is that aprovisional agreement on the Regulation governing compulsory licensing for crisis management purposes has been reached, the ACMD produced a report that includes recommendations on classification and schedulingof semi-synthetic cannabinoids not currently regulated by the definition of CBD, and the ASA have found two ads are in breach of the code, in particular for using language that implied unwarranted medical and health claims in a TikTok video ad for AirDoctor LLC t/a AmazingAir and a Facebook ad for a supplement from Viva Research Ltd t/a Vivanmn, among other stories.

This week's edition of Life Sciences weekly highlights includes analysis by Herbert Smith Freehills LLP of the UK Court of Appeal judgment confirming it cannot deviate from previous UK precedent on second medical use SPCs (Merck Serono v Comptroller-General of Patents), analysis by Arnold & Porter of the Court of Justice decision clarifying whether various promotional schemes offered by pharmacists such as discounts or rewards schemes constitute ‘advertising of medicines’ under Directive 2001/83/EC, as well as, Law360 analyses of the Court of Appeal’s injunction decision striking a compromise to permit rival Glenmark to ship supplies of its generic already packed in trucks without progressing to retail sales (AstraZeneca v Glenmark Pharmaceuticals), the impact of the Unified Patent Court asserting its authority to hear claims involving UK patents, reporting of a nonbinding opinion advising the Court of Justice to uphold a €60.5m fine against Teva and Cephalon for an alleged pay-for-delay conspiracy and the impact of the new EU Product Liability Directive on tech and AI. Also included, is news of the ICO levying a £3.07m fine against Advanced Computer Software Group following a 2022 ransomware attack that compromised personal data including NHS patient data, the European Commission publishing an Explanatory Guide to the microplastics restriction regulation, of MHRA CEO Dame June Raine’s retirement, and the DHSC dispute resolution panel ruling that B. Braun is liable for scheme rebate payments because its off-contract sales of a branded sedative do not qualify for exceptional central procurement exemption under VPAS due to NHS England procurement, among several other important stories.