Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA guidance updates
- International Recognition Procedure. On 24th May, the Medicines and Healthcare products Regulatory Agency (MHRA) added information and a new webinar link to guidance on how to use the procedure for medicines licensing applications. Click to view source
- Topical corticosteroids and withdrawal reactions. On 29th May, the MHRA published a major update of advice following further review of topical steroid withdrawal reactions and the introduction of new potency labelling. Click to view source
FDA guidance updates
- Platform Technology Designation Program for Drug Development. On 29th May, draft guidance was published providing details on the implementation of the platform technology designation program established by section 506K of the Federal Food, Drug, and Cosmetic Act (FD&C Act). It outlines eligibility factors for receiving a platform technology designation, potential benefits of receiving a designation, how to leverage data from designated platform technologies, how to discuss a planned designation request as part of a milestone meeting, the recommended content of a designation request submission, and the review timelines for a designation request. Click to view source
ICH Updates
- ICH M12 Guideline reaches step 4 of the ICH Process. On 24th May, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) announced the ICH M12 guideline “Drug Interaction Studies” and “Drug Interaction Studies Questions and Answers” reached Step 4 of the ICH Process on 21st May 2024. The guideline provides recommendations to promote a consistent approach in designing, conducting, and interpreting enzyme- or transporter-mediated in vitro and clinical drug-drug interaction (DDI) studies during the development of a therapeutic product. The supporting Q&A is intended to provide additional clarification and improve the harmonisation of drug interaction assessment.
- ICH M14 draft Guideline reaches Step 2 of the ICH process. On 24th May, it was announced that the ICH M14 draft guideline on “General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilise Real-World Data for Safety Assessment of Medicines” reached Step 2 of the ICH process on 21st May 2024. The draft guideline outlines recommendations and high-level best practices for the conduct of these studies, to streamline the development and regulatory assessment of study protocols and reports.
Industry Updates
NHS England and NICE announce plan to adopt innovative medical technologies quicker
On 23rd May, NHS England and the National Institute for Health and Care Excellence (NICE) announced proposals outlining a new route for MedTech developers to access NHS funding to fast-track clinically and cost-effective products for use by the healthcare system. The plans will ensure the growing number of innovative products recommended by NICE can be introduced in the NHS on a large scale to improve patient outcomes. The proposals have been developed by NHS England and NICE with input from the Department of Health and Social Care and other partners, including the Office for Life Science (OLS) and the MHRA.
EMA releases meeting highlights from latest Committee for Veterinary Medicinal Products
On 24th May, the European Medicines Agency (EMA) released the outcomes of the latest Committee for Veterinary Medicinal Products (CVMP) meeting held on the 21st and 22nd of May. These include CVMP opinions on veterinary medicinal products, scientific advice, and organisational matters.
FDA opens new grant application period for animal drugs for minor uses and minor species
On 24th May, the FDA opened a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species or to treat minor species (MUMS drugs). Grants awarded through the MUMS program support the agency’s continuing mission to ensure that safe and effective animal drugs are available for a wide range of species and conditions.
LifeArc and ALS TDI join forces to develop new clinical tools for ALS and MND
On 24th May, LifeArc and ALS Therapy Development Institute (ALS TDI) announced a partnership to identify, validate, and develop new clinical tools for amyotrophic lateral sclerosis (ALS) and motor neurone disease (MND) prognosis and drug development. The partnership will focus on validating MMP-9 and TIMP-1 as minimally invasive biomarkers for ALS, and the research will use serum and plasma samples from people living with ALS, through the ALS Research Collaborative (ARC) study. By correlating the levels of these biomarkers with longitudinal and cross-sectional clinical data, the project aims to develop a kit for use in both clinical and research settings for prognosis and potential monitoring of the disease.
BHF awards £35 million funding to UK universities for cardiovascular disease research
On 24th May, the British Heart Foundation (BHF) announced that nine leading universities will benefit from a £35 million funding injection to help strengthen world-leading cardiovascular disease research in the UK. The funding, through our Research Excellence Awards scheme, will support universities to cultivate world-class research environments that encourage collaboration, inclusion, and innovation, and enable visionary scientists to drive lifesaving breakthroughs.
Amgen secures FDA approval for first interchangeable biosimilar for two rare diseases
On 28th May, the FDA approved Amgen’s Bkemv as the first interchangeable biosimilar to Soliris to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:
- the treatment of patients with paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis; and
- the treatment of patients with atypical haemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
EMA publishes annual report highlighting progress in science, medicines, and health in 2023
On 30th May, the EMA published its annual report 2023 detailing the agency’s contributions to public and animal health in the EU. With a fresh layout and new interactive features, the report offers insights into the evaluation and monitoring of human and veterinary medicines and key achievements in EMA’s three major strategic areas in 2023: cancer medicines, data-driven medicine regulation, and transparency and communication.
Issue Number: WN00164
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