Each month, we scan the regulatory landscape to bring you the latest developments shaping pharmaceutical and biotechnology innovation. In this roundup, you’ll find key publications that caught our attention, plus a curated summary of the most important regulatory news. Our goal is to highlight what matters, cut through the noise, and keep you up to date on changes that could impact drug development and market access in the UK, Europe and the US.
Regulatory Affairs News
The EMA recommended the withdrawal of marketing authorisations for levamisole medicines
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended withdrawing medicines containing levamisole from the European Union (EU) market after concluding that their benefits no longer outweigh their risks for treating parasitic worm infections in adults and children.
An EU-wide safety review confirmed that levamisole can cause leukoencephalopathy, a rare but serious condition that damages the brain’s white matter and can be debilitating or life-threatening. Evidence showed the condition may occur after a single dose, with symptoms appearing up to several months later. No measures to reduce the risk or identify higher-risk groups were found.
PRAC based its recommendation on safety monitoring data, reports of serious cases, scientific literature, and input from independent experts and the World Health Organisation. As alternative treatments for parasitic worm infections are available in the EU and levamisole is used for generally mild infections, PRAC concluded that the medicine’s risks outweigh its benefits and recommended withdrawing its marketing authorisations.
The EMA drafted a concept paper on the non-clinical development and evaluation of microbiome-based medicinal products
The EMA published a concept paper proposing to develop a reflection paper on the non-clinical evaluation of microbiome-based medicinal products to support a harmonised regulatory approach across the EU for clinical trials and marketing authorisation applications under Directive 2001/83/EC.
Microbiome-based medicines present unique scientific and regulatory challenges that are not adequately addressed by existing guidance. Currently, there is no specific regulatory framework for their non-clinical evaluation. Traditional pharmacological and toxicological methods are often not fully suitable, particularly for assessing biodistribution, safety and pharmacodynamic models used to support dose selection and efficacy.
The proposed reflection paper aims to clarify current regulatory thinking and provide guidance to developers. Without tailored guidance, developers may face greater uncertainty, inconsistent regulatory submissions and evaluations, and potential delays in the development of microbiome-based therapies.
The EMA and FDA set common principles for AI in medicine development
The EMA and FDA have jointly established ten principles for good AI practice across the medicines lifecycle. These principles provide broad guidance on the use of AI in evidence generation and monitoring, covering stages from early research and clinical trials to manufacturing and safety monitoring.
They are intended for medicines developers, as well as marketing authorisation applicants and holders, and will inform future AI guidance in different jurisdictions while supporting international regulatory collaboration. In the EU, guideline development is already underway, building on EMA’s 2024 AI reflection paper.
As AI use in medicines development continues to grow, regulators emphasise the need for strong governance and risk mitigation to ensure safety and compliance. The initiative reflects broader regulatory efforts, including the European Commission’s Biotech Act proposal and the European medicines agencies network strategy to 2028, which promote responsible AI use to accelerate innovation while protecting patient and animal safety.
New age threshold for blood tests to detect ovarian cancer
The National Institute for Health and Care Excellence (NICE) published an update to its guideline on suspected cancer, which proposes age-adjusted thresholds for the CA125 blood test to better reflect how ovarian cancer risk changes with age. Currently, all women are referred for further investigation if CA125 levels reach 35 IU/mL, regardless of age. NICE states this fixed threshold may miss cancers in older women, while causing unnecessary investigations in younger women.
The update also notes that CA125 testing alone is not sufficiently accurate for women under 40 years, and recommends that General Practitioners consider arranging an ultrasound scan directly for those with persistent symptoms.
Additional proposals include introducing a new threshold for urgent investigation in people aged 60 years and over who experience unexplained weight loss of more than 5% over 6 months. The guideline also highlights the need for further research on when unexpected bleeding in women taking hormone replacement therapy (HRT) should trigger investigation for endometrial cancer, reflecting rising HRT prescriptions in England.
NICE recommends a take-at-home pill for advanced prostate cancer
NICE has recommended talazoparib (Talzenna®), in combination with enzalutamide for adults with metastatic prostate cancer. The treatment is intended for patients who cannot receive chemotherapy and are unable to tolerate or take abiraterone plus prednisolone, a current standard therapy.
Taken as a once-daily pill at home, the combination offers a convenient treatment option that may also reduce pressure on National Health Service (NHS) services. Talazoparib works by blocking an enzyme that repairs damaged DNA in certain cancer cells, causing them to die.
Clinical trials showed improved outcomes: overall survival increased to 45.8 months, compared with 37 months for enzalutamide alone, while progression-free survival increased to 33.1 months versus 19.5 months. Around 2,400 people in England are eligible. The recommendation follows recent NICE approvals of darolutamide and abiraterone for metastatic prostate cancer, with talazoparib provided to the NHS through a confidential discount agreement.
The MHRA updated guidance for GLP-1 prescribers and patients
The MHRA updated product information for healthcare professionals and patients to highlight the small risk of severe acute pancreatitis associated with GLP-1 receptor agonists and dual GLP-1/GIP receptor agonists, commonly known as GLP-1 medicines.
Acute pancreatitis is a recognised but uncommon side effect of these medicines, although in very rare cases complications can be severe. Patients and clinicians are advised to watch for symptoms such as severe, persistent abdominal pain that may spread to the back, nausea, and vomiting, and to seek urgent medical attention if they occur.
GLP-1 medicines are used to treat Type 2 Diabetes, support weight management and reduce cardiovascular risk. A study from University College London estimated that 1.6 million adults in England, Wales and Scotland used GLP-1 medicines for weight loss between early 2024 and early 2025. The Yellow Card Biobank initiative is also investigating whether genetic factors influence pancreatitis risk.
The MHRA approved brensocatib as the first medicine to treat non-cystic fibrosis bronchiectasis
The MHRA granted marketing authorisation for brensocatib (Brinsupri®) to treat patients aged 12 years and older with non‑cystic fibrosis bronchiectasis (NCFB) who have experienced two or more flare-ups in the past 12 months.
NCFB is a chronic condition in which lung airways become damaged, leading to persistent cough and mucus production. The disease can affect anyone but is more common in older adults.
Brensocatib works by targeting dipeptidyl peptidase 1 (DPP1), a protein involved in lung inflammation. By blocking DPP1 activity, the medicine helps prevent flare-ups and may improve symptoms. It is taken once daily as an oral tablet.
Publications that caught our eye
- Unlocking the potential of disease prevention through regulatory science. Nature reviews drug discovery.
- Insights from ESMO Immuno-Oncology Congress 2025. Nature cancer.
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