Tower Mains Weekly Newsletter
Company Updates
New Course: Conducting Laboratory Investigations
When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course is designed to equip you with the skills and knowledge to conduct a successful investigation. Our next open course date is the 22nd of November 2023 or if you are interested in this training for your organisation at a time of your choosing, please get in touch at training@towermains.com. For further information, click here.
Tower Mains Promotion
We are delighted to announce that Victoria Macleod has been promoted to Senior Associate. Victoria joined our team in 2021 with a background in events, marketing, and clinical settings, and supports the company in marketing and operations. Congratulations, Victoria!
Regulatory Updates
MHRA guidance updates
- International Recognition Procedure. On 6th November, the Medicines and Healthcare products Regulatory Agency (MHRA) added additional guidance to address common queries about the International Recognition Procedures. Click to view source
- Common issues identified during clinical trial applications. On 6th November, added a link to updated guidance on recommendations related to contraception and pregnancy testing in clinical trials. Click to view source
FDA guidance updates
- Submitting patient-reported outcome data in cancer clinical trials. On 6th November, the US Food and Drug Administration (FDA) published final guidance providing technical specifications for submitting patient-reported outcome (PRO) data collected in cancer clinical trials to support a marketing application for a medical product in oncology, where a PRO is a type of clinical outcome assessment (COA) used to collect patient experience data. Click to view source
- Submitting clinical trial datasets and documentation for clinical outcome assessments using item response theory. On 6th November, final guidance was published technical specifications for the submission of clinical outcome assessment (COA) data that use Item Response Theory (IRT) and supplements the FDA Center for Drug Evaluation and Research (CDER) Patient-Focused Drug Development (PFDD) Methodological Guidance Series. Click to view source
FDA announces its recognition of key consensus standard to support device sponsors as they address cybersecurity concerns
On 6th November, the FDA announced its recognition of a key consensus standard to support device sponsors as they address cybersecurity concerns – ANSI/AAMI SW96:2023 Standard for medical device security – Security risk management for device manufacturers. Published by the American National Standards Institute, Inc., and the Association for the Advancement of Medical Instrumentation, it aligns with existing international safety risk management standards and quality systems expectations and provides direction to sponsors on how to consider and address cybersecurity risks in device design and development.
Industry Updates
Innoviva and GARDP reveal positive results for antibiotic to treat gonorrhoea
On 1st November, the Global Antibiotic Research & Development Partnership (GARDP), in collaboration with Innoviva Specialty Therapeutics, a subsidiary of Innoviva, Inc., announced that zoliflodacin, a first-in-class antibiotic, met its primary endpoint in an unprecedented global pivotal Phase 3 clinical trial. Study investigators found that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment with intramuscular (IM) injection of ceftriaxone and oral azithromycin, a current global standard of care regimen.
MHRA authorises treatment for non-small cell lung cancer in adults
On 3rd November, the MHRA announced the authorisation of a new medicine called Krazati, a treatment for a type of non-small cell lung cancer (NSCLC) in adults that have a mutation and produce KRAS G12C, a rare protein that causes the cancer cells to grow out of control. Krazati attaches to the protein and stops it from working, which may slow down or stop the growth of the cancer.
New hubs receive funding to address challenges of vaccine manufacturing and delivery in LMICs
On 3rd November, the UK Minister for Health and Secondary Care, Will Quince, announced the launch of four new hubs to address the challenges of vaccine manufacturing and delivery in low- and middle-income countries (LMICs). The hubs received a share of £33 million of UK aid funding via the Department of Health and Social Care (DHSC) and a further £1.5 million from the Engineering and Physical Sciences Research Council (EPSRC) and will be led by experts at UCL, the University of Oxford, Imperial College London, and the University of Sheffield.
MHRA launches #MedSafetyWeek campaign
On 6th November, the eighth annual #MedSafetyWeek campaign was launched by the MHRA. Part of a global campaign involving 88 countries, the initiative runs from 6th-12th of November and aims to improve patient safety by encouraging reporting of any suspected side effects from medicines and adverse incidents associated with medical devices. With this year’s theme being ‘Who can report?’, the campaign focuses on the key role that every patient, carer and healthcare professional has in reporting suspected side effects and adverse incidents with medical devices, and the positive impact this can have on patient safety.
MHRA authorises enzyme inhibitor to prevent breast cancer in post-menopausal women
On 6th November, the MHRA announced the authorisation of Anastrozole as a preventative treatment for post-menopausal women at moderate or high risk of breast cancer.
First electronic product information published for selected human medicines
On 6th November, the Heads of Medicines Agencies (HMA), the European Commission (EC) and EMA published for the first time electronic product information (ePI) for selected human medicines harmonised across the EU. The product information of a medicine includes its summary of product characteristics, labelling and package leaflet. These documents accompany every medicine authorised in the EU and explain how they should be prescribed and used. They can all be found, often as a PDF document, on the websites of EU regulators with a printed package leaflet also provided in the medicine’s box.
ICH issues press release from ICH Assembly Meeting
On 8th November, the International Council for Harmonisation (ICH) issued an update from its in-person Assembly on 31st October & 1 November 2023, in Prague, Czech Republic in parallel with meetings of 16 Working Groups and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee.
FDA approves new medication for chronic weight management
On 8th November, the FDA announced that it had approved the Zepbound (tirzepatide) injection for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol) for use, in addition to a reduced calorie diet and increased physical activity.
ICMRA marks 10th anniversary
On 8th November, the International Coalition of Medicines Regulatory Authorities (ICMRA) marked its 10th anniversary by releasing anniversary footage and an infographic detailing key milestones achieved since the coalition formed. For a decade, ICMRA has brought together leaders of medicines regulatory authorities to safeguard public health by providing strategic leadership, enhancing collaboration, and developing approaches to jointly address shared health challenges, such as the COVID-19 pandemic.
Issue Number: WN00137
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