Tower Mains Weekly Newsletter
Company Updates
Boost your skills and knowledge with one of our expert-led courses. With spaces available, it’s not too late to book one of our May dates…
? 22nd May: Fundamentals of Good Laboratory Practice, led by Andrew Waddell
? 23rd May: Fundamentals of Good Clinical Practice, led by Fiona Waddell
All our training Is led by an expert in the field, who use their experience and expertise to bring their topic alive with information, and real-life examples.
Find further information on each course on our website, or if you are interested in discussing your specific training requirements, please don’t hesitate to contact training@towermains.com.
Regulatory Updates
MHRA Inspectorate Blog: ICH E6(R3) Good Clinical Practice guidance consultation
On 2nd May, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the future public consultation concerning the ICH E6(R2) Good Clinical Practice (GCP) guideline. The E6(R3) overarching principles, Annex 1, Glossary and 3 Appendices will replace the current E6(R2) and are anticipated to reach Step 2 soon. An MHRA GCP Stakeholder Engagement Meeting is also planned to be held concerning this document during the consultation period. Invitations to current contacts for this existing stakeholder engagement process will be sent out in due course, and further announcements on the consultation will be made on the MHRA website.
Further MHRA guidance updates
- Breast Implant Associated Anaplastic Large Cell Lymphoma (BIA-ALCL): On 28th April, the guidance on Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) was updated. This included information on a project to better understand how patients and the public perceive the risks and additional information about clinical stakeholders. Click to view source
- Medicines that you cannot export from the UK or hoard: On 28th April, Glucagon was added to the list of medicines that cannot be exported from the UK or hoarded. Click to view source
FDA to take additional steps to advance decentralised clinical trials
On 2nd May, the US Food and Drug Administration (FDA) announced it is taking additional steps to support the use of decentralised clinical trials (DCTs) for drugs, biologics, and devices, where some or all the trial-related activities occur at locations other than traditional clinical trial sites. The agency issued draft guidance with recommendations for sponsors, investigators, and other stakeholders regarding the implementation of DCTs to advance medical product development and research. Examples of decentralised elements include obtaining laboratory tests at a local facility rather than a research medical centre or conducting a clinical follow-up visit in the trial participant’s home using telemedicine.
Further FDA guidance updates
- Nonclinical biodistribution considerations for gene therapy products. On 2nd May, final guidance was published to provide harmonised recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidelines aim to facilitate the development of investigational GT products while avoiding unnecessary use of animals, per the 3Rs (reduce/refine/ replace) principles. It replaces the draft guidance entitled “S12 Nonclinical Biodistribution Considerations for Gene Therapy Products” issued on 9th September 2021. Click to view source
- Q9(R1) Quality Risk Management: On 3rd May, the FDA announced the availability of a revision of the “Q9 Quality Risk Management” guidance. The revision addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality in Quality Risk Management (QRM) work, lack of clarity on risk-based decision-making, and high levels of subjectivity in risk assessments and QRM outputs. It replaces the draft guidance “Q9(R1) Quality Risk Management” issued on 15th June 2022. Click to view source
Review of transparency rules for the EU CTIS
On 3rd May, the European Medicines Agency (EMA) announced the public consultation to review the transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The review seeks to stimulate the discussion on the best possible approaches to balance clinical trial transparency with confidentiality requirements while simplifying the modalities of use of CTIS to improve user experience and reduce the risk of data breaches. Any changes in the CTIS functionalities that may be required following the consultation will maintain the high benchmark for transparency provided by the Clinical Trials Regulation (CTR). Stakeholders are invited to send their comments via an online form by midnight (CET) on 28 June 2023.
Industry Updates
Two Non-Executive Directors reappointed to MHRA Board
On 28th April, the Department of Health and Social Care announced the reappointment of Amanda Calvert and Michael Whitehouse OBE as Non-Executive Directors of the MHRA from 1st September 2023.
Medical devices – extended acceptance of CE-marked medical devices on the UK market
On 28th April, the MHRA announced that a statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE-marked medical devices on the market in the UK. Subject to approval this will mean that CE-marked medical devices will be accepted on the market beyond the current deadline of 30th June 2023.
Consumers warned of the potential dangers of Apetamin
On 28th April, the FDA warned consumers that it had reviewed several incidents of serious adverse events associated with the use of Apetamin, a drug being marketed illegally for weight gain and figure augmentation. Apetamin is not an FDA-approved product and although the FDA has restricted the import of the drug, it continues to find its way into the market and is being heavily promoted and sold online. Click to view source
First drug for anaemia in cats with chronic kidney disease conditionally approved in the US
On 1st May, the FDA conditionally approved Varenzin-CA1, the first drug for the control of nonregenerative anaemia associated with chronic kidney disease (CKD) in cats. Non-regenerative anaemia can be a fatal condition because the cat’s bone marrow is not able to produce enough red blood cells to replace the older or damaged red blood cells that are naturally removed from the blood, resulting in the inability for oxygen to be carried from the lungs throughout the body. The agency encourages cat owners to work with veterinarians to report adverse events or side effects potentially related to the use of any drug, including Varenzin-CA1.
Cybersecurity incident preparedness and response tips released by FDA
On 1st May, the FDA released its third video on the topic of cybersecurity for medical devices. This new video features Dr Mark Jarrett, Chief Quality Officer from Northwell Health and focuses on how to prepare for a cybersecurity event and how to help ensure patient safety during a prolonged cybersecurity event.
Destiny Pharma and SporeGen® announce update on research collaboration
On 2nd May, Destiny Pharma, a clinical-stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, announced encouraging results from its collaboration with SporeGen, a UK biotechnology company working exclusively on Bacillus and its applications. The results of the study support the original hypothesis that SPOR-COV nasal spray can rapidly stimulate an immune response that primes the human immune system against influenza and coronavirus-type viral threats such as COVID-19. The companies are excited by the results of the research studies and are planning future studies and seeking partners for the next stage of development.
First Respiratory Syncytial Virus vaccine approved by FDA
On 3rd May, the FDA approved Arexvy, the first respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age and older. The agency is requiring the company to conduct a post-marketing study to assess the signals of serious risks for Guillain-Barré syndrome and ADEM, and in addition, although not an FDA requirement, the company has committed to assess atrial fibrillation in the post-marketing study.
First Respiratory Syncytial Virus vaccine approved by FDA
On 4th May, BioSenic – a clinical-stage company specialising in serious autoimmune and inflammatory diseases and cell repair – announced the submission of a key patent in the use of its ATO platform. The patent covers the use of a new quantitative method to evaluate the impact of medications destined at changing the course of the chronic form of the Graft versus Host Disease (cGvHD) and will allow the development of an industrial biomarker analysis kit which could be available worldwide.
Issue Number: WN00110
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