Company News
We were delighted to be well represented at the Research Quality Association (RQA) 2026 International QA Virtual Conference last month.
Nicole Ainsworth, Stacey Harding, Rosemary Ichaba, and Anna Lothian all contributed to the programme, covering topics including veterinary GCP, audit challenges in GxP environments, and environmental sustainability within pharma and quality assurance.
It was a great couple of days of learning, collaboration and discussion with peers across the sector!
Regulatory Updates
WHO Launches Free Online Course to Strengthen Clinical Trial Standards
On 5th May, the World Health Organisation (WHO) announced the launch of a new free online course, “WHO Good Practices for Clinical Trial Design and Implementation,” aimed at strengthening global standards for designing and conducting clinical trials. The self-paced course translates WHO guidance into practical training to improve trial quality, ethical oversight, and research capacity worldwide.
FDA Expands AI Capabilities and Consolidates Data Systems
On 6th May, the FDA announced the launch of Elsa 4.0, an upgraded internal AI tool designed to support staff across the agency. The FDA also completed the consolidation of more than 40 data systems into a single platform, HALO, to improve access to information and streamline operations. The agency says these developments will help modernise workflows and support more efficient regulatory processes.
MHRA Seeks Views on Medical Device Regulation Updates
On 11th May, the MHRA announced a public consultation inviting feedback on proposed updates to UK medical device and in vitro diagnostic regulations. The changes aim to strengthen patient safety, support innovation, and improve the efficiency of bringing safe and effective medical technologies to market, while modernising the regulatory framework in Great Britain.
MHRA Launches UK-Wide Consultation on Redefining Gene Therapy Medicines
On 11th May, the MHRA launched a UK-wide consultation on proposed updates to the legal definition of gene therapy medicinal products (GTMPs). The changes aim to modernise regulation to reflect advances in gene editing, synthetic biology, and new manufacturing technologies, ensuring the framework remains fit for rapidly evolving scientific developments while maintaining existing standards of safety, quality, and efficacy.
FDA Launches Initiative to Advance Drug Repurposing
On 11th May, the FDA announced a new initiative to explore drug repurposing to address unmet medical needs, particularly in chronic and rare diseases. The agency is seeking input from patients, researchers and healthcare professionals on approved medicines that may have potential new uses, to accelerate access to treatments by building on existing safety and clinical data.
EU Reaches Agreement on Critical Medicines Act
On 12th May, the European Commission announced a provisional agreement between the European Parliament and the Council on the Critical Medicines Act. The legislation aims to improve the availability and security of essential medicines across the EU by strengthening supply chains, increasing manufacturing capacity, and reducing the risk of shortages.
MHRA Supports Northern Ireland Life Sciences Sector with New Belfast Hub
On 13th May, the MHRA announced the launch of a new regulatory hub in Belfast, hosted by Invest Northern Ireland, to strengthen collaboration with the region’s growing life sciences sector. The hub will foster closer engagement among regulators, industry, and academia, including in-person expert sessions to support innovation, clinical research, and the faster development of medicines and medical technologies.
VMD Launches New Online Contact Form to Streamline Enquiries
On 18th May, the UK’s Veterinary Medicines Directorate (VMD) announced the launch of a new online contact form that will become the main route for handling general enquiries, complaints, and Freedom of Information requests. The system replaces multiple email and callback routes and is intended to improve consistency, efficiency, and response times across the organisation.
MHRA Expands Support for Wales Life Sciences Sector with New Engagement Programme
On 19th May, the MHRA announced a new programme of events and enhanced engagement with industry, researchers, the NHS, and government partners across Wales to strengthen the region’s life sciences sector. The initiative aims to bring regulatory expertise closer to Welsh innovators, supporting faster development of medical technologies and improved access to new treatments.
EMA Reports Early Progress on 2030 Clinical Trial Targets
On 20th May, the EMA, together with the European Commission and the Heads of Medicines Agencies, published its first report tracking progress towards new 2030 clinical trial targets. The report shows early improvements in clinical research activity, including more multinational trials being authorised and a higher proportion of trials recruiting participants within 200 days of application, as part of wider efforts to strengthen the EU’s clinical research environment and improve access to innovative medicines.
MHRA Proposes New Framework to Accelerate Rare Disease Treatment Development
On 21st May, the MHRA announced the launch of a public consultation on a proposed new regulatory framework designed to accelerate the development and approval of therapies for rare diseases. The plans aim to create a more flexible, risk-proportionate pathway to improve patient access to innovative treatments while maintaining strict standards of safety, quality, and efficacy.
EMA CVMP Publishes Highlights From Latest Meeting
On 22nd May, the EMA’s Committee for Veterinary Medicinal Products (CVMP) published its meeting highlights covering 19–21 May 2026. The Committee issued positive opinions on several veterinary medicines, including new vaccines for cats and poultry, as well as updates to existing products. It also reviewed scientific advice, pharmacovigilance signals, and new or revised guidelines aimed at improving veterinary medicine regulation and safety across the EU.
MHRA Welcomes Jason Bonander as Chief Digital and Technology Officer
On 27th May, the MHRA announced that Jason Bonander has officially started his role as Chief Digital and Technology Officer. He joins from the US Centres for Disease Control and Prevention (CDC), where he served as Chief Information Officer, bringing over 25 years of experience in digital leadership, cybersecurity, and health informatics to support the MHRA’s ongoing digital transformation and modernisation of regulatory systems.
MHRA Issues May Safety Roundup
On 28th May, the MHRA published its latest Safety Roundup, summarising recent medicines recalls, medical device alerts, field safety notices, and other key safety communications issued to healthcare professionals.
Published Guidance
US Food & Drug Administration (FDA) – Draft Guidances
- 13th May: Development of Non-Opioid Analgesics for Chronic Pain. Describes the FDA’s current recommendations regarding phase 3 trials for prescription non-opioid analgesic products being developed to treat chronic pain.
- 13th May: Stimulant Use Disorders: Developing Drugs for Treatment. To assist sponsors in the clinical development of drugs for the treatment of stimulant use disorders.
- 13th May: Development of Local Anaesthetic Drug Products With Prolonged Duration of Effect. Reflects the Agency’s current recommendations regarding drug development and trial design issues relevant to the study of local anaesthetic drug products with prolonged duration of effect for which submission of a new drug application (NDA) is planned.
- 13th May: Development of Non-Opioid Analgesics for Acute Pain. Intended to assist sponsors in the development of alternatives to opioids for the management of acute pain.
- 13th May: Opioid Analgesic Drugs: Considerations for Benefit-Risk Assessment Framework. Describes the benefit-risk assessment framework that the 17 Agency uses in evaluating whether applications for opioid analgesic drugs meet the standard for 18 approval under section 505 of the Federal Food, Drug, and Cosmetic Act.
- 28th May: Oncology Pharmaceuticals: Streamlined Nonclinical Safety Studies for Biologics and Conjugated Products. Recommendations for general toxicology to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of certain oncology pharmaceuticals.
- 2nd June: Leveraging Prior Knowledge in the Development of Human Gene Therapy Products Incorporating Genome Editing. Recommendations on how sponsors may consider leveraging prior knowledge to increase review efficiency and accelerate product development across multiple programs.
European Medicines Agency (EMA)
- 29th May: EMA recommendation to update the antigenic composition of authorised COVID-19 vaccines for 2026-2027. Intended to ensure vaccines remain closely matched to currently circulating strains and continue to provide strong protection against COVID-19 as the virus evolves.
Updated Guidance
MHRA
- 7th May: Find product information about medicines. Updated Additional Monitoring list April 2026
- 12th May: Borderline products: how to tell if your product is a medicine. MHRA Guidance Note 8: ‘A guide to what is a medicinal product’ has been replaced with a slightly amended version.
- 13th May: Medical devices: ask for a regulatory advice meeting from the MHRA. Amended title and copy within the ‘what is this service for’ and ‘limitations of MHRA advice’ sections.
- 13th May: Medicines Pipeline data. Updated to add a new spreadsheet, Generics Pipeline Data, and updated wording to reflect this.
- 13th May: Medical devices: conformity assessment and the UKCA mark. Added the latest conformity assessment routes flow chart.
- 14th May: Clinical investigations for medical devices. Updated the section ‘Applications for an investigative medicinal product and medical device – IMP+Device’ with the latest guidance. A further update was made on the 19th of May, which included notes to the ‘Fee waiver programme details’ section.
- 19th May: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guidelines. Added a link to ‘Q13 – Continuous Manufacturing of Drug Substances and Drug Products’.
- 19th May: Innovative Licensing and Access Pathway (ILAP). Updated the ‘Innovation Passport List’.
- 22nd May: Project Orbis. Added ‘HYRNUO’ to the list of Orbis Project approvals.
FDA – Final Guidances
- 8th May: Clostridioides difficile Infection: Developing Drugs for Treatment, Reduction of Recurrence, and Prevention. To assist sponsors in the clinical development of drugs to support an indication of treatment, reduction of recurrence, or prevention of Clostridioides difficile infection (CDI).
- 8th May: Post approval Pregnancy Safety Studies. Recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by the FDA.
- 8th May: Pulmonary Tuberculosis: Developing Drugs for Treatment. To assist sponsors in the clinical development of new antibacterial drugs for the treatment of pulmonary tuberculosis (TB).
- 20th May: M11 Clinical Electronic Structured Harmonised Protocol. Includes three documents – a guidance, a template, and a technical specification document. The guidance provides the rationale and recommendations for implementing a harmonised digital clinical trial protocol. The template features standardised content structure and formatting, including headers and common text elements. The technical specification document contains harmonised terminologies and standardised data fields to enable electronic exchange of clinical protocol information.
- 20th May: Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations. Recommendations to sponsors planning to conduct food-effect (FE) studies for orally administered drug products under investigational new drug applications (INDs) to support new drug applications (NDAs) and supplements to these applications for drugs being developed under section 505 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355).
- 28th May: Content of Human Factors Information in Medical Device Marketing Submissions. Provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be documented and included in medical device marketing submissions, including premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs), and humanitarian device exemption (HDE) applications.
- 28th May: Content of Human Factors Information in Medical Device Marketing Submissions. Provides a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be documented and included in medical device marketing submissions, including premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs), and humanitarian device exemption (HDE) applications.
- 28th May: Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application. Recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements.
- 29th May: Q8, Q9, and Q10 Questions and Answers (R5). Reflects the current working procedure of the ICH Quality Implementation Working Group (Q-IWG) for implementing the Q8, Q9, and Q10 guidances.
- 2nd June: M15 General Principles for Model-Informed Drug Development. General recommendations for the planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD).
- 2nd June: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers. General recommendations for the planning, model evaluation, and documentation of evidence derived from model-informed drug development (MIDD).
EMA
- 1st June: Pharmacovigilance-related regulatory recommendations for centrally authorised veterinary medicinal products during 2026. Updated pharmacovigilance recommendations for centrally authorised veterinary medicinal products for 2026, including proposed changes to product information based on post-marketing safety data and ongoing monitoring of adverse reactions across EU-authorised veterinary medicines.
Industry News
FDA Grants Seventh Approval Under Priority Voucher Programme
On 8th May, the FDA announced the seventh approval under its Commissioner’s National Priority Voucher (CNPV) pilot programme. The approval was granted to Bizengri (zenocutuzumab-zbco), the first treatment approved for adults with advanced NRG1 fusion-positive cholangiocarcinoma, a rare and aggressive bile duct cancer. The FDA said the programme is helping to accelerate the review of therapies that address significant unmet medical needs.
MHRA Strengthens Warnings for Finasteride and Dutasteride
On 11th May, the MHRA issued updated safety advice to strengthen warnings about potential psychiatric and sexual dysfunction linked to finasteride and a similar product, dutasteride. Existing UK patient alert cards for finasteride – introduced in 2024 – remain in place.
SMC Publishes May 2026 Decisions on New Medicines for NHS Scotland
On 11th May, the Scottish Medicines Consortium (SMC) published its latest monthly decisions, recommending a range of new medicines for routine use in NHS Scotland. Key approvals include treatments for advanced bladder cancer, non-small cell lung cancer, small cell lung cancer, and kidney disease, alongside therapies for IgA nephropathy and other serious conditions. One medicine for prurigo nodularis was not recommended due to cost-effectiveness concerns.
EMA Actively Monitoring Cruise Ship Hantavirus Outbreak
On 12th May, the EMA announced it is actively monitoring a hantavirus outbreak linked to a cruise ship in coordination with the EU and international health bodies. The agency said it is tracking developments closely, supporting preparedness efforts, and standing ready to assist in the development and evaluation of potential treatments or vaccines, while public health authorities continue to assess the risk as very low for the general population.
UK Regulatory Flexibility and Partnership Key to Unlocking Life Sciences Potential
On 18th May, Professor Joann Rhodes highlighted the importance of flexible regulation and stronger cross-sector collaboration in unlocking the UK’s life sciences potential. The article emphasises how adaptive regulatory approaches, devolved health system strengths, and closer partnership between government, industry, and healthcare providers can help accelerate innovation while maintaining high standards of safety and quality in medicines and medical technologies.
Risk of Severe Harm from Incorrect Blood Transfusion Giving Sets (DSI/2026/003)
On 20th May, the MHRA issued a Device Safety Information alert warning of the risk of serious patient harm if an intravenous infusion giving set is mistakenly used instead of a blood transfusion giving set during blood or blood component administration. The alert highlights that this error can lead to reduced transfusion rates and red blood cell damage, potentially causing severe clinical complications.
Oxford Announces Urgent Vaccine Efforts for Bundibugyo Ebola Outbreak
On 22nd May, the University of Oxford announced that the Oxford Vaccine Group is collaborating urgently with partners to develop and scale a candidate vaccine targeting the Bundibugyo strain of Ebola linked to the current outbreak in the Democratic Republic of Congo. The team is producing doses of a ChAdOx-based vaccine and accelerating preclinical work in preparation for potential clinical trials, while continuing to follow regulatory and ethical standards.
EMA Recommends First Oral GLP-1 Treatment for Weight Management
On 22nd May, the EMA recommended extending the marketing authorisation for Wegovy to include a once-daily oral tablet for weight management. The treatment, a GLP-1 receptor agonist, is intended for adults with obesity or those who are overweight with at least one weight-related condition. The EMA said the oral option offers a more convenient alternative to injections, with similar safety and effectiveness shown in clinical trials.
FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
On 22nd May, the FDA announced approval of the first treatment for chronic hepatitis delta virus (HDV) infection in adults, including those with compensated liver disease. The therapy, Hepcludex (bulevirtide-gmod), is the first option approved specifically for HDV, a serious liver infection that can lead to cirrhosis, liver failure and cancer in people already infected with hepatitis B. The approval was based on clinical trial data showing improved viral suppression and liver function markers.
Breakthrough Treatment for Rare Overgrowth Syndrome Recommended by EMA
On 22nd May, the EMA recommended approval of Vijoice (alpelisib), the first medicine for treating severe or life-threatening PIK3CA-related overgrowth spectrum (PROS), a group of rare genetic conditions that cause uncontrolled growth of tissues in the body. The treatment is intended for adults and children aged two years and older and works by targeting the enzyme pathway responsible for abnormal cell growth.
MHRA Authorises Rilzabrutinib for Adults with Immune Thrombocytopenia
On 29th May, the MHRA announced the authorisation of rilzabrutinib for the treatment of adults with immune thrombocytopenia (ITP) when prior therapies have been insufficient. The oral Bruton’s tyrosine kinase (BTK) inhibitor is designed to reduce immune-mediated platelet destruction, helping to increase platelet counts and lower the risk of bleeding in patients with this rare autoimmune blood disorder.
Two Arrested in MHRA’s Largest-Ever Seizure of Unlicensed Weight Loss Medicines
On 29th May, the MHRA announced that two men had been arrested following a raid on a Northamptonshire country estate, where approximately 12,000 doses of unlicensed weight-loss medicines were seized. The operation uncovered a large-scale illicit manufacturing and distribution setup producing and supplying dangerous, unregulated weight-loss treatments, marking the agency’s largest-ever seizure of its kind.
EMA ETF Recommends Updated COVID-19 Vaccines Targeting XFG Variant
On 29th May, the EMA’s Emergency Task Force (ETF) recommended updating COVID-19 vaccines to better target the XFG variant, which is currently circulating in parts of Europe. The recommendation aims to ensure vaccines remain effective against evolving strains of the virus ahead of the next vaccination campaign season.
J&J Reports Breakthrough Phase 3 Data for Erleada in Prostate Cancer
On 31st May, Johnson & Johnson announced positive Phase 3 results showing that Erleada (apalutamide), used before and after surgery in patients with high-risk prostate cancer, significantly reduced the risk of metastasis or death compared with standard care. The findings suggest a potential shift in long-established treatment approaches for early-stage prostate cancer.
Aragen Collaborates on Fast Track Antibody for High-Risk Neuroblastoma
On 2nd June, Aragen announced it will manufacture Renaissance Pharma’s FDA Fast Track–designated monoclonal antibody, Daretabart, as part of an ongoing strategic collaboration. The programme, targeting high-risk neuroblastoma, has progressed from cell line development in the US to commercial-scale GMP manufacturing in India within nine months, supporting faster clinical development and future regulatory submission.
DSV and MDC Partner to Advance Next-Generation Brain Treatments
On 2nd June, Deep Science Ventures and Medicines Discovery Catapult announced a partnership focused on improving drug delivery across the blood–brain barrier. The collaboration aims to accelerate the development of new technologies for treating neurological diseases such as Alzheimer’s, Parkinson’s, and brain cancer by identifying and advancing promising innovation in brain drug delivery.
Contraline Secures $92.5M Series B to Advance Male Contraceptive Development
On 2nd June, Contraline announced the close of a $92.5 million Series B financing round to support the late-stage development of its NES/T male contraceptive gel. The funding will be used to advance Phase 3 clinical trials, scale manufacturing, and progress additional pipeline assets aimed at expanding non-hormonal and hormonal contraceptive options for men.
CDC Highlights Risks Linked to Travel-Related Cosmetic Procedures
On 2nd June, the U.S. Centres for Disease Control and Prevention (CDC) published findings highlighting serious adverse outcomes associated with cosmetic procedures performed during domestic and international travel. The report notes cases of infections, complications and deaths linked to procedures such as liposuction and breast augmentation and warns that medical tourism can increase patient safety risks due to variable standards of care and infection control practices.
Pfizer to Participate in Healthcare Conference Webcast Discussion
On 3rd June, Pfizer announced it will participate in a webcast discussion at the Jefferies Global Healthcare Conference on the 8th of June. The session will feature company leadership and focus on Pfizer’s strategy, pipeline developments, and broader business updates. A replay and transcript will be made available on Pfizer’s investor website following the event.
CelLBxHealth Publishes Whitepaper on Xenograft Platform Applications
CelLBxHealth has published a whitepaper outlining the use of its xenograft-based approaches in circulating tumour cell (CTC) research and preclinical cancer modelling. The document highlights how the platform can support tumour biology studies, drug response testing, and translational oncology research by enabling more advanced in vivo modelling of cancer progression and treatment response.
25 Lessons Learned from Conducting Robust Risk Assessments in Pharmaceutical Environments (GMP, GCP, GVP, GLP)
As part of our 25 Years of Tower Mains series, we’re sharing insights from conducting robust risk assessments across pharmaceutical environments.
In our latest blog, we share 25 lessons learned across GMP, GCP, GVP and GLP settings, highlighting key considerations for areas such as effective risk management, data integrity, inspection readiness, and cross-functional collaboration.
To read more, click here.
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