Weekly highlights

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Each week we provide a round-up of key legal developments in the life sciences sector curated by our life sciences legal team. This includes

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Latest Life Sciences News

MHRA announces strengthened dependency warnings on medicines for pain, anxiety and insomnia

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced measures to highlight the risks of dependence and addiction associated with medicines commonly prescribed for pain, anxiety and insomnia. The changes apply to medicines including gabapentinoids, benzodiazepines and Z-drugs, which will now carry a warning on packaging stating: ‘May cause addiction, dependence and withdrawal reactions.’ Patient information leaflets will also be updated to provide clearer information on dependence and addiction, guidance on tapering treatment, and information to support communication between patients and healthcare professionals during treatment. The Commission on Human Medicines (CHM) supported the development of patient-facing resources highlighting key safety messages, including warnings not to use the medicines with opioids or alcohol and not to share medication with others.

MHRA announces new clinical trial regulations to take effect from April 2026

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced new clinical trial regulations due to take effect from April 2026, introducing a fast-track notification route for lower-risk trials affecting approximately one in five studies and a 14-day assessment route for phase 1 trials using a stepwise approach. The regulations will enable better use of early safety data from overseas studies meeting UK standards and introduce new MHRA capability to assess computer model simulations, including in-silico trials. The announcement accompanies data showing clinical trial applications received by the MHRA rose by 9% between January and November 2025 compared with the same period in 2024, with trials involving healthy volunteers increasing by 16%, first-in-human trials rising by 5%, and UK-first trials growing by 7%. MHRA scientific advice meetings on clinical trials increased by 75% over the same period. The reforms support the Government's target to reduce the time from trial application to first participant to 150 days and align with the 10 Year Health Plan for England.

Life Sciences weekly highlights—8 January 2026

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.

Myriad wins UPC ruling as GXD-Bio breast cancer patent is revoked

MLex: The Unified Patent Court revoked GXD-Bio’s breast cancer testing patent, rejecting infringement claims against Myriad’s EndoPredict breast cancer test and clearing the way for continued European marketing after finding added subject matter.

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