Company News
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Regulatory News
EMA issues concept paper to revise Parkinson’s disease clinical trial guideline
On 4th November, the European Medicines Agency (EMA) published a concept paper calling for a revision of the guideline on clinical investigation of medicinal products for the treatment of Parkinson’s disease, expanding its scope to cover newer scientific developments, biomarker‑driven trials, non‑motor symptoms, and related neurodegenerative conditions. The revision will also consider the inclusion of patients using device‑based therapies, long-term treatment regimens, and broaden to other movement disorders (e.g. essential tremor, multiple system atrophy). Public consultation for the proposed update opens on the 30th of November and will run until 31st March 2026.
FDA appoints Richard Pazdur as Director of Drug Evaluation and Research
On 11th November, it was announced that Richard Pazdur, M.D., a 26‑year agency veteran and founder of its Oncology Centre of Excellence, has been appointed Director of the Centre for Drug Evaluation and Research (CDER). In this role, he will oversee the review, safety, and approval of prescription and over‑the‑counter medicines in the U.S.
EMA improves scientific advice for medicines tackling public‑health threats
On 17th November, the EMA announced that its Emergency Task Force (ETF) will now offer enhanced scientific advice to developers working on medicines and vaccines targeting public‑health emergencies, including antimicrobial resistance (AMR). Under the new framework, developers can request combined guidance covering regulatory, clinical‑trial and ethics aspects early in the development process. This aims to align clinical‑trial requirements and marketing‑authorisation expectations from the outset, speeding up development and approval of treatments for high-priority threats.
MHRA warns MAHs to improve GTIN and barcode accuracy as automation expands
On 18th November, the MHRA Inspectorate published a blog post explaining that as pharmacies and hospitals increasingly use automation (robotic dispensing, barcode scanning, electronic prescribing), the reliability of that automation hinges on accurate product‑identification data. If the printed Global Trade Item Number (GTIN) or the 2D barcode (which encodes GTIN, batch number, expiry date) is incorrect, missing, or unreadable, it can lead to stock rejection, dispensing errors, delays, or patient harm. The MHRA Inspectorate urges marketing‑authorisation holders to ensure unique and correct GTINs, accurate barcode encoding, barcode readability verification before release, and avoidance of GTIN reuse across different products.
Professor Alastair Denniston: The future regulation of AI in healthcare
On 19th November, the MHRA published an article outlining Professor Alastair Denniston’s vision for a modern regulatory framework governing the use of artificial intelligence in healthcare. As Chair of the newly formed National Commission on the Regulation of AI in Healthcare, Denniston emphasises that future AI regulation must ensure systems are safe, rapidly deployable, and trusted by both clinicians and patients. He highlights the need for adaptive, proportionate oversight to keep pace with technological advances, describing AI as a transformative moment for medicine. A forthcoming call for evidence will invite contributions from healthcare professionals, industry, and the public.
MHRA sets out 2026 insurance expectations for Phase 1 and CTIMP Sponsors
On 25th November, the MHRA Inspectorate published a blog explaining that, under new clinical‑trial regulations coming into force on 28 April 2026, sponsors of Phase 1 trials (and other CTIMPs) must include evidence of insurance or indemnity with their Research Ethics Committee (REC) application. The guidance clarifies that while the sponsor must secure adequate insurance to cover liabilities arising from trial design and conduct, research sites (especially non‑NHS ones) must perform their own checks, verifying that the cover is appropriate, that no problematic exclusions exist, and documenting all checks in the Trial Master File (TMF). This aims to ensure full clarity and accountability around insurance arrangements before trials begin, reinforcing patient safety and research‑site responsibility under the updated regulatory framework.
Managing bacillus risks in aseptic processing
On 25th November, the MHRA Inspectorate warned of rising Bacillus spore contamination in aseptic‑processing facilities. Because these spores resist standard alcohol cleaning, sites are urged to use validated sporicidal sanitisation, review contamination‑control procedures, and report any Grade A/B contamination to support national monitoring.
MHRA and NICE secure £2 million from Wellcome for safer digital mental‑health tools
On 27th November, the MHRA and National Institute for Health and Care Excellence (NICE) announced they have received £2 million funding from Wellcome Trust to further their work on the regulation and evaluation of digital mental‑health technologies. The funding will support the development of clear, proportionate guidance for products such as symptom‑tracking apps, AI-powered assessments and virtual‑reality therapies, ensuring they meet robust standards of safety and effectiveness. The initiative aims to give users, clinicians and developers greater clarity and confidence, while supporting responsible innovation.
MHRA publishes latest Safety Roundup
On 27th November, the Medicines and Healthcare products Regulatory Agency (MHRA) published the November issue of the monthly Safety Roundup, summarising the latest safety advice on medicines and medical devices for healthcare professionals and patients.
EMA PRAC issues latest meeting highlights
On 27th November, the EMA published the highlights from its Pharmacovigilance Risk Assessment Committee (PRAC) meeting, summarising safety reviews, ongoing monitoring, and pharmacovigilance activities for medicines across the EU.
ICH Assembly Meeting updates
On 26th November, the International Council for Harmonisation (ICH) issued a press release following its Assembly meeting in Singapore on 18th–19th November 2025, held in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).
FDA deploys new agentic AI systems to strengthen regulatory decision-making
On 1st December, the FDA expanded its AI capabilities by deploying new agentic AI systems, aiming to improve how it analyses data, supports regulatory decisions, and enhances overall operational efficiency. The initiative is part of the agency’s broader effort to responsibly integrate advanced AI technologies to strengthen public health outcomes and modernise its internal processes.
Published Guidance
US Food & Drug Administration (FDA) – Draft Guidances
- 25th November: Cross-Centre Master Files: Where to Submit. Provides recommendations to master file holders, regarding where (i.e., to which FDA centre) to submit a master file that is referenced in and intended to support more than one regulatory submission for which the lead centre may vary or where the information may need to be reviewed by more than one centre to support review of the referencing submission(s).
- 28th November: Q3E Guideline for Extractables and Leachables. Presents a holistic framework and process for the assessment and control of extractables and leachables (E&L) for pharmaceutical products.
- 28th November: Current Good Manufacturing Practice for Medical Gases. Intended to assist manufacturers of medical gases in complying with regulations for current good manufacturing practice (CGMP) that become effective on 18th December 2025.
European Medicines Agency (EMA)
- 17th November: Guidance for stepwise PIPs. Guidance on Stepwise Paediatric Investigation Plans (sPIPs) was published, providing information to developers on submitting a paediatric development plan in stages rather than all at once. Companies can initially provide a partial plan when key information, such as dose or age groups, is not yet known and then update the plan later as more data becomes available. This approach provides flexibility in planning clinical trials for children while ensuring regulatory oversight.
Updated Guidance
Medicines and Healthcare products Regulatory Agency (MHRA)
- 7th November: Access, new active substance and biosimilar work-sharing initiatives. Dupixent (dupilumab) was added to the ‘Overview of MHRA NASWSI approvals’ table in the
- 12th November: Early Access to Medicines Scheme: Overview. The table in the ‘Dates for submission, Day 1 and Day 45’ section has been updated in the guidance.
- 24th November: Clinical investigations for medical devices. Several updates were made, including updates to the Flow Chart for GB Clinical Investigations to better align with UK MDR, the expansion of the GB Flow Chart Accompanying Guidance, with examples, and the re-linking of CI biological safety guidance.
- 25th November: Medicines: apply for a variation to your marketing authorisation. Updates were made to section 3.1: ‘Implementation of new guidelines’.
FDA – Final Guidances
- 17th November Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. This final guidance is intended to assist abbreviated new drug application (ANDA) applicants that reference a drug product intended for parenteral, ophthalmic, or otic use in seeking approval of a drug that is qualitatively (Q1) different or quantitatively (Q2) different from the reference listed drug (RLD) with respect to the pH adjuster(s).
Industry News
CGT Catapult annual review highlights role of advanced therapies in UK growth
On 4th November, CGT Catapult published its 2025 annual review, highlighting the impact of cell and gene therapies on UK public health and economic growth. The organisation supported 70 companies last year, mostly UK SMEs, helping them raise over £177 million. With 17 advanced‑therapy medicinal products approved and reimbursed in the UK and the country hosting 9.5% of global ATMP clinical trials in 2024, CGT Catapult emphasises that these therapies target disease root causes, reduce healthcare burdens, and contribute to the government’s ambition to make the UK a top‑three life‑sciences economy by 2035.
FDA to update hormone replacement therapy warnings
On 10th November, the FDA announced it will remove outdated “black‑box” warnings from many menopause hormone‑replacement therapies (HRT). This decision follows a review of decades of research and provides more balanced information on the benefits and risks of HRT. Warnings related to cardiovascular disease, breast cancer, and probable dementia will be removed, while the boxed warning for endometrial cancer remains for systemic oestrogen‑alone products.
MHRA-led study reveals major inconsistencies in global microbiome research
On 11th November, an international study led by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) revealed significant inconsistencies in how laboratories around the world analyse identical gut-microbiome samples. Using newly developed WHO International Reference Reagents, 23 labs across 11 countries showed wide variability in results, with species-identification accuracy ranging from 63% to 100% and false-positive rates from 0% to 41%. The findings underscore the need for standardised global quality criteria to strengthen the reliability of microbiome-based diagnostics and therapies.
First‑in‑class treatment to delay the onset of Type 1 Diabetes
On 14th November, the EMA recommended marketing authorisation for Teizeild (teplizumab), the first therapy designed to delay progression to stage 3 Type 1 Diabetes in adults and children from age 8. Clinical trials showed it roughly doubled the median time to disease onset, offering the first potential disease‑modifying option for T1D in the EU.
Scottish Brain Sciences opens new Alzheimer’s research centre in Aberdeen
On 14th November, Scottish Brain Sciences opened a new clinical research centre at ONE BioHub in Aberdeen, its third site alongside Edinburgh and St Andrews. The centre will enable people with Alzheimer’s or memory concerns to take part in studies focused on early diagnosis, intervention, and precision medicine approaches to neurodegenerative diseases. Located within ONE BioHub’s life‑sciences ecosystem, the facility provides access to advanced infrastructure and support, helping to scale operations and strengthen Scotland’s position as a hub for neurological research.
EU Commission authorises first treatment for serious chronic lung disease
On 18th November, the European Commission granted EU‑wide marketing authorisation to brensocatib (under the brand name Brinsupri), the first therapy approved for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older. The decision follows a positive scientific assessment by the European Medicines Agency (EMA) and marks an important milestone for a disease that previously had no authorised targeted treatments.
Multi-million-pound backing for cutting-edge projects by UK scientists and innovators
On 18th November, the UK government announced more than £74 million in funding to support a range of cutting-edge life sciences and manufacturing R&D projects. The funding will go towards ambitious efforts such as using AI and robotics to future-proof medicines manufacturing, recycling used nuclear fuel into potential cancer therapies, and improving sustainability in processes like anaesthetic-gas recycling and pharmaceutical production. The announcement underlines the government’s commitment to drive economic growth, advance medical innovation and reinforce the UK’s standing as a global life-sciences hub.
GSK and Imperial launch £45million AI-driven AMR research programme
On 18th November, GSK and the Fleming Initiative announced a £45 million investment to fund six new research programmes aimed at combating antimicrobial resistance (AMR) using AI and advanced scientific approaches. The programmes, starting in early 2026, will target high-priority pathogens including Gram-negative bacteria, fungal infections like Aspergillus, and drug-resistant Staphylococcus aureus (MRSA). The initiative will create around 50 UK-based scientific and academic roles and aims to accelerate the discovery of new antibiotics and antifungals, enhance immune response modelling, improve surveillance using AI, optimise prescribing practices, and inform global AMR policy.
MHRA reaffirms safety of childhood vaccination
On 24th November, the MHRA confirmed that childhood vaccines remain safe and highly effective in preventing serious infectious diseases. Drawing on extensive global studies involving millions of children, the agency highlighted that there is no evidence linking vaccines to autism. All UK-approved vaccines undergo rigorous assessment and continuous safety monitoring, and parents are encouraged to follow NHS vaccination guidance.
Gene therapy for spinal muscular atrophy approved in US
On 24th November, the FDA approved Itvisma (onasemnogene abeparvovec‑brve), a gene therapy for patients aged two years and older with Spinal Muscular Atrophy (SMA) caused by SMN1 gene mutations. The therapy delivers a functional SMN1 gene directly to the central nervous system in a single injection, restoring SMN protein production. This approval expands treatment options beyond infants, providing the first gene‑replacement therapy for older children, teens, and adults with SMA.
Three convicted in major MHRA investigation into illegal online supply of medicines
On 25th November, three individuals were convicted following MHRA‑led investigations into a criminal network that supplied unauthorised and controlled medicines online. The group — operating via multiple websites – supplied Class B and C drugs, prescription-only medicines and unauthorised products, distributing nearly two million doses.
Academy of Medical Sciences and Wellcome launch £27.3million partnership
On 25th November, the Academy of Medical Sciences and Wellcome announced a five‑year £27.3 million agreement to support UK health research. The partnership will fund initiatives to strengthen research talent, promote collaboration across academia, industry, and the NHS, and sustain the UK’s biomedical workforce. Key programmes include FLIER, Starter Grants for Clinical Lecturers, and Springboard awards.
eXmoor Pharma and Royal Free London launch UK cell and gene therapy collaboration
On 26th November, eXmoor Pharma and Royal Free London’s Cell and Vector Innovation Centre announced a strategic partnership to create a unified UK pathway for developing and manufacturing cell and gene therapies. The collaboration links early‑phase clinical manufacturing with later‑phase GMP capabilities, streamlining translation from research to clinical trials and eventual commercial delivery.
Sarepta receives FDA approval to begin ENDEAVOR Cohort 8 with ELEVIDYS
On 26th November, Sarepta Therapeutics announced FDA approval to start dosing in Cohort 8 of the ENDEAVOR Phase 1b study. This cohort will evaluate an enhanced immunosuppression regimen using sirolimus alongside ELEVIDYS gene therapy in approximately 25 non‑ambulant Duchenne muscular dystrophy patients. The study aims to reduce the risk of acute liver injury and assess safety and dystrophin expression, with data expected in the second half of 2026.
MHRA‑supported research reveals patterns of vaccine‑derived poliovirus spread
On 27th November, MHRA-supported research analysed 3,893 cases of vaccine-derived poliovirus type 2 (cVDPV2) across 74 outbreaks in 39 countries. The study found that the virus spreads at a consistent median velocity of 2.3 km per day, typically between neighbouring countries, and that higher vaccination coverage slows cross-border transmission by up to 38%. These findings have important implications for global polio‑eradication strategies, highlighting the need for proactive vaccination in both outbreak zones and neighbouring regions.
Lilly lowers price of Zepbound single‑dose vials
On 1st December, Eli Lilly and Company announced a price reduction for Zepbound single-dose vials under its “Self-Pay Journey” programme, making the medication more affordable for people paying out of pocket.
Our Festive Guide to Christmas in Edinburgh
In our latest blog, we’re embracing the magic of the season with our festive guide to Christmas in Edinburgh. From sparkling light trails and lively markets to nostalgic cinema nights, we’ve rounded up the very best ways to enjoy December in our home city. Whether you’re planning a family day out, a romantic evening, or simply looking to soak up the festive atmosphere, Edinburgh has something to enchant everyone at this time of year.
Click here to read more about how to make the most of Christmas in the capital.
Issue Number: WN00204
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