Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Medicines that cannot be exported from the UK or hoard. On 30th January, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of medicines that cannot be exported from the UK or hoarded. Click to view source
- Guidance on Valproate use by women and girls. On 30th January, the MHRA updated the ‘Materials and resources’ and ‘Clinical resources’ sections in guidance about the risks of taking valproate medicines during pregnancy. The agency also announced that as of the 31st of January 2024, new regulatory safety measures will be in place to reduce the known harms from valproate. Click to view source
- Updates on how to notify the MHRA of changes to the PV System. On 29th January, the MHRA Inspectorate published a blog on amendments to the guidance on the MHRA website stipulating changes to the way updates to a Marketing Authorisation Holder’s (MAH’s) Pharmacovigilance (PV) system should be notified to the MHRA. Click to view source
FDA guidance updates
- CVM GFI #286 (VICH GL60) – Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products. On 25th January, the US Food & Drug Administration (FDA) published draft guidance regarding good manufacturing practice for the manufacture of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess. Click to view source
- Human Gene Therapy Products Incorporating Human Genome Editing. On 29th January, final guidance was published providing recommendations to sponsors developing human gene therapy products incorporating genome editing (GE) of human somatic cells. It provides recommendations regarding information that should be provided in an Investigational New Drug (IND) application to assess the safety and quality of the investigational GE product, as required in Title 21 of the Code of Federal Regulations 312.23 (21 CFR 312.23). Click to view source
- Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products. On 29th January, final guidance was published to assist sponsors, including industry and academic sponsors, in developing CAR T cell products. It provides CAR T cell-specific recommendations regarding chemistry, manufacturing, and control (CMC), pharmacology and toxicology, and clinical study design. Click to view source
- Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. On 29th January, draft guidance was published to provide expectations for and recommendations on the use of a standardised approach for collecting and reporting race and ethnicity data in submissions including information collected and reported from clinical studies and clinical trials for FDA-regulated medical products. Click to view source
Industry Updates
PlaqueTec and Babraham Institute collaborate on phenotypic screen of coronary artery blood
On 23rd January, PlaqueTec, a company identifying biomarkers to advance precision medicine for coronary artery disease (CAD) and the Flow Cytometry Facility at the Babraham Institute announced a collaboration to develop and improve treatment for coronary artery disease (CAD). Both companies will develop a bespoke cell phenotyping assay for human blood to be used to analyse the blood of patients with CAD participating in PlaqueTec’s BIOPATTERN trial.
State-of-the-art MRC Laboratory of Medical Sciences opens on Imperial College London campus
On 24th January, the Princess Royal officially opened the £120m state-of-the-art Medical Research Council (MRC) Laboratory of Medical Sciences (LMS) building on the Imperial College London (ICL) Hammersmith campus. The new building was designed to amplify the institute’s core strength of bridging the gap between scientists exploring fundamental biological mechanisms and those translating that work into clinical applications and is one of only two laboratories in the UK wholly funded by the MRC.
Four-dose Mounjaro “KwikPen” approved by MHRA for diabetes and weight management
On 25th January, MHRA announced it has approved a four-dose version of diabetes and weight management medicine Mounjaro (tirzepatide) – Mounjaro KwikPen.
International consortium identifies biomarkers for cardiovascular disease in diabetes
On 25th January, it was revealed that an international consortium led by Johns Hopkins University, the Chinese University of Hong Kong and Lund University has identified 13 biomarkers that improve the ability to accurately predict the risk of cardiovascular disease in people with type 2 diabetes. The study was conducted as part of the Precision Medicine in Diabetes Initiative, an international partnership between the American Diabetes Association and the European Association for the Study of Diabetes.
EMA to support the establishment of the African Medicines Agency
On 26th January, the European Medicines Agency (EMA) announced it will use its experience in coordinating intra-regional medicines regulation to support the strengthening of the African regulatory network. The agency has received a grant of ten million euros from the European Commission to support regulatory systems at national and regional levels in Africa, and for the setting up of the African Medicines Agency (AMA), in collaboration with African, European, and international actors.
Rezzayo approved for treatment of adult patients with invasive candidiasis
On 29th January, the MHRA approved the medicine Rezzayo to treat a fungal infection called invasive candidiasis. The active ingredient in Rezzayo, rezafungin, is an antifungal that blocks the action of the enzyme needed by fungal cells to make a molecule that strengthens their cell walls. The approval is supported by evidence from a randomised, double-blind, controlled phase 3 clinical trial involving 187 patients with invasive candidiasis.
FDA revises letter of authorisation for the emergency use authorisation for Paxlovid
On 29th January, the FDA announced a revision to the Paxlovid emergency use authorisation (EUA), stating that EUA-labelled Paxlovid will no longer be authorised for emergency use after March 8, 2024, regardless of the labelled or extended expiration date. However, the Paxlovid EUA will continue to authorise emergency use of Paxlovid manufactured and labelled per the NDA (NDA-labelled Paxlovid) for the treatment of mild-to-moderate COVID-19 in paediatric patients (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalisation or death.
Antimicrobial Sales and Use Platform launched in EU
On 29th January, the EMA announced the launch of the new Antimicrobial Sales and Use (ASU) Platform to support the collection of data by Member States on the sales and use of antimicrobials in animals. As of January 2024, all Member States in the European Union (EU) and European Economic Area (EEA) must submit these data annually to the ASU Platform. This new obligation was introduced by the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) as one of the measures to fight antimicrobial resistance.
Illegal medicines worth more than £30 million seized in the UK in 2023
On 30th January, the MHRA announced that, alongside law enforcement partners, it seized more than 15 million doses of illegally traded medicines with a street value of more than £30 million during 2023. This includes more than two million doses seized during Operation Pangea, the international initiative of global enforcement partners that targets the illegal internet trade in medical products.
Omjjara licensed for anaemic myelofibrosis patients to treat the symptoms of their disease
On 30th January, the MHRA approved the medicine momelotinib (Omjjara) to treat the symptoms experienced by adult myelofibrosis patients who have moderate or severe anaemia. This approval is supported by evidence from a randomised, double-blind phase 3 clinical trial involving 195 patients with myelofibrosis and anaemia, who had previously been treated with a JAK inhibitor.
Clinical trials’ transition to new EU system
On 31st January, the EMA published a reminder that all ongoing clinical trials in the EU must be transitioned to the Clinical Trials Information System (CTIS) by 31 January 2025. This date marks the end of a three-year transition period that began when the Clinical Trials Regulation (CTR) became applicable in the EU. Sponsors of clinical trials expected to continue after 30 January 2025 must consider the time required for Member States to complete the authorisation procedure, which can take up to three months.
Issue Number: WN00147
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