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
News: The European Society for Medical Oncology (ESMO) explored how AI is moving beyond image recognition to support surgery, pathology and image-guided intervention.
The article highlights how AI in gastrointestinal (GI) cancer care is moving beyond technical image recognition towards demonstrating meaningful clinical value and improved patient outcomes. In colorectal cancer, the MSIntuit AI algorithm detected microsatellite instability from routine haematoxylin and eosin pathology slides with 96–98% sensitivity. In robotic rectal cancer surgery, a 44-patient study found AI-measured tissue preservation was associated with postoperative urinary dysfunction; combining these measurements with patient age achieved an area under the curve of ~0.81, demonstrating potential for predicting surgical outcomes.
AI may also enhance image-guided treatment. In the prospective MR BRIGHT study, magnetic resonance imaging-guided brachytherapy achieved 95.1% local recurrence-free survival versus 79.9% with computed tomography guidance (p=0.027), while reducing low-dose radiation exposure to healthy liver tissue from 43% to 15%. Overall, the article emphasises AI-enhanced rather than AI-replaced clinicians, with clinical utility becoming the key measure of success.
News: The MHRA launched a 14-day pilot programme for Phase 1 clinical trials
The MHRA launched a pilot to accelerate regulatory assessment of eligible phase 1 clinical trials, aiming to make the UK more competitive for early-stage research while maintaining safety and quality standards. The programme reduces the standard 30-day first-review period to 14 calendar days through a phased rollout during 2026: 28 days from 30 March, 21 days from 29 June, 18 days from 28 September and 14 days from 28 December. Capacity will simultaneously increase from one application per week to four per week (up to 16 per month).
The pathway is specifically for lower-risk phase 1 trials in healthy adult volunteers with established clinical safety data; first-in-human, advanced therapy and complex-design trials are excluded. Sponsors must pre-book limited slots and submit complete, high-quality documentation. Overall, the initiative prioritises speed and predictability without reducing regulatory rigour, potentially enabling earlier trial initiation and strengthening the UK’s attractiveness for clinical research.
News: The MHRA’s ILAP granted Innovation Passports to investigational products for cancer and dementia
The MHRA’s Innovative Licensing and Access Pathway (ILAP) has awarded Innovation Passports to two investigational medicines targeting areas of significant unmet need: BGB-B2033, a biological medicine for hepatocellular carcinoma (liver cancer), and neflamapimod, a small-molecule treatment for dementia with Lewy bodies.
The need is substantial: the UK sees around 7,000 new liver cancer cases annually, while dementia with Lewy bodies accounts for approximately 3 in 20 dementia patients, with an estimated ~100,000 people affected in the UK.
Innovation Passport status provides developers with earlier, coordinated engagement with the MHRA, National Health Service and health technology assessment bodies, aiming to streamline evidence generation, regulatory review and market access. Importantly, the designation does not constitute approval; both medicines remain investigational and must demonstrate safety, effectiveness and value before becoming available to patients.
News: The UK became the first in Europe to approve orforglipron for weight management and type 2 diabetes
The UK has become the first country in Europe to authorise orforglipron (Foundayo), a once-daily oral glucagon-like peptide-1 receptor agonist, for both weight management and type 2 diabetes. Unlike injectable GLP-1 treatments, the tablet can be taken at any time of day without food or water restrictions, potentially offering a more convenient treatment option.
For weight management, it is authorised alongside diet and physical activity for adults with a BMI ≥30, or BMI 27–30 with at least one weight-related comorbidity. It is also approved to improve glycaemic control in inadequately controlled type 2 diabetes. Treatment starts at 0.8 mg daily, escalating to a maximum 17.2 mg.
The approval represents an important expansion of oral GLP-1 therapy; however, orforglipron is not currently available through the NHS, pending assessment by National Institute for Health and Care Excellence.
Publications that caught our eye
- Major objections in EU medicines authorisation applications: an analysis of dossier submissions by small-and medium-sized enterprises. Drug Discovery Today.
- Use of real-world evidence in the U.S. Food and Drug Administration and the European Medicines Agency approvals of oncology products supported by single-arm trials (2022-2025). The Oncologist.
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