Advanced therapeutics

Advanced therapy medicinal products

The development of medicine, biomicrobiology and biotechnology has led to the emergence of a category of medicinal product that use gene therapy, somatic cell therapy and engineered tissues for preventing, treating or even curing human diseases. The novelty, complexity and diversity of such products has demanded new regulatory tools to allow an appropriate balancing of the risks and the benefits for the patients. EU and UK legislation regulates this category of products as ‘advanced therapy medicinal products (ATMPs)’ in order to ensure the highest level of protection of public health and to take into account their specific challenges, in particular with regard to clinical trials, manufacturing and pharmacovigilance.

There are three categories of ATMPs that are based on genes, cells (including stem cells), and tissues, respectively. ATMPs are a type of what is known as regenerative medicine (which refers to methods to replace or regenerate human cells, tissues or organs in order to restore or establish normal function and includes cell therapies, tissue engineering, gene therapy and biomedical engineering as well as more traditional treatments

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Latest Life Sciences News

Life Sciences weekly highlights—26 February 2026

This week's edition of Life Sciences weekly highlights includes a Law 360 analysis on the Court of Appeal dismissing Salts Healthcare Ltd’s renewed attempts to find Pelican Healthcare Ltd liable for infringing one of its patents over an ostomy bag and an analysis by Hepworth Browne of the UK Supreme Court’s ruling in Emotional Perception AI Ltd v Comptroller-General of Patents, in which the court reshaped the foundations of UK patent law by reorientating the assessment of exclusions to patentability. Also included, is news that the Court of Appeal dismissed the appeals in a biotechnology patent dispute regarding the production of microbial oil for nutritional products, the EU General Court issued orders in challenges concerning the revised Urban Wastewater Treatment Directive (UWWTD) on the grounds of admissibility, not addressing the substantive question of the legality of the Extended Producer Responsibility (EPR) scheme, the MHRA and NICE have jointly published guidance on the Integrated Scientific Advice service, EFPIA published a report assessing the economic and societal contribution of industry-sponsored clinical trials in Europe as well as a comparative analysis of biopharmaceutical strategies across ten countries, and news that the UK Research and Innovation announced its first AI strategy, the Department for Science, Innovation and Technology (DSIT) announced £150m for three UK Research and Innovation programmes, as well as MHRA updates reporting a rise in clinical investigations, the launch of a fee waiver pilot for small firms, a statement on the paused PATHWAYS clinical trial, and enforcement action involving the seizure of unlicensed weight loss medicines, among other stories.

EFPIA and Medicines for Europe call for suspension of UWWTD EPR scheme implementation

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Commission adopts recommendation on diagnostic reference levels for medical radiation procedures

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MHRA raids two premises seizing unlicensed weight loss medicines

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