Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA guidance updates
- Clinical investigations. On 25th October, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Click to view source
- Medicines Pipeline data. On 25th October, the MHRA added the Medicines Pipelines webinar to guidance on how Marketing Authorisation Holders can provide information on planned or potential future submissions to the MHRA. Click to view source
- MHRA phase I accreditation scheme. On 31st October, the updated ‘Request for acceptance as a phase I principal investigator for first in human trials’ document was added to guidance on how to join the phase I accreditation scheme. Click to view source
Global regulators call for coordinated action to improve mpox vaccine access amid rising cases
On 25th October, it was announced that international regulators have released a report on the development, clinical trials, and availability of vaccines and therapeutics for mpox, following a workshop organised by the EMA and the International Coalition of Medicines Regulatory Authorities (ICMRA). This comes after the WHO declared mpox a public health emergency in August 2024, amid rising cases in Central and West Africa, particularly linked to evolving strains of the virus. The regulators underscored the necessity for large clinical trials to provide the evidence needed for quicker development and approval of mpox treatments, advocating for a coordinated approach to effectively manage current and future public health emergencies.
In Vitro Diagnostics Roundtable announced
On 28th October, the Food and Drug Administration (FDA) announced a hybrid meeting, the In Vitro Diagnostics (IVD) Roundtable, scheduled for the 12th of November 2024. The meeting aims to enhance communication between the FDA and the IVD industry, with options for participants to attend either in-person or virtually. For more information, visit the FDA website.
FDA guidance updates
- M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms. On 30th October, the FDA published final guidance to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post-approval phases for orally administered immediate-release (IR) 5 solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, 6 capsules, and granules/powders for oral suspension.
European Commission to host event on hospital exemption and its role in boosting patient access
On 21st November, the European Commission will be hosting a full-day online event, titled “Implementation of the Hospital Exemption in the EU and Its Role in Boosting Innovation and Patient Access to Innovative Therapies.” The event aims to address knowledge gaps about the Hospital Exemption’s functioning across EU Member States and will include experts from academia, the biotech industry, and national authorities. Participants will discuss the impact of this pathway on patient access to advanced therapies and engage in meaningful discussions on the subject.
Industry Updates
FDA warns against use of BioZorb implantable markers due to migration risks
On 25th October, issued a safety communication advising against the use of BioZorb marker devices, which are implantable radiographic markers. This warning follows reports of issues, including the potential for the markers to migrate from their intended locations, which could complicate imaging and treatment. The FDA recommends that healthcare providers stop using these devices and assess any patients who have had them implanted.
FDA updates information on medical device cybersecurity
On 28th October, the FDA shared up-to-date information on cybersecurity for medical devices. Like other electronic devices, medical devices can be susceptible to security breaches, which could affect their safety and performance. Drawing on patient feedback and partnerships with industry, government agencies, and healthcare organisations, the FDA is committed to enhancing and updating its medical device cybersecurity policies.
Shockwave Medical completes enrolment in ground-breaking all-female coronary IVL study
On 28th October, Shockwave Medical, Inc., part of Johnson & Johnson MedTech, announced the completion of enrolment in EMPOWER CAD, the first prospective all-female study of percutaneous coronary intervention (PCI) in complex calcific disease. The study seeks to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and patients will subsequently be followed out for three years.
WHO report highlights resurgence of tuberculosis
On 29th October, the World Health Organisation (WHO) released a new report on tuberculosis revealing that around 8.2 million people were newly diagnosed with TB in 2023 – the highest figure since WHO began global TB monitoring in 1995. This represents a significant rise from 7.5 million reported in 2022, placing TB again as the leading infectious disease killer in 2023, surpassing COVID-19. The report highlights mixed progress in the global fight against TB, with persistent challenges such as significant underfunding.
Dementia Trials Accelerator set to increase number of clinical trial participants to “tens of thousands”
On 29th October, the UK Dementia Research Institute announced that the Dementia Trials Accelerator has secured £20 million in government funding to boost UK participation in dementia clinical trials to tens of thousands. Led by the UK Dementia Research Institute and Health Data Research UK, the initiative aims to swiftly identify individuals at risk of early-stage dementia for expanded participation in accessible clinical trials, playing a vital role in scaling up these trials to expedite access to treatments. It will also aim to accelerate the development of new dementia treatments and address recruitment challenges, as often nearly 80% of potential volunteers are excluded.
Sugemalimab approved to treat adult patients with non-small cell lung cancer
On 30th October, the MHRA approved the medicine sugemalimab (Eqjubi) to treat adult patients with a type of lung cancer called ‘non-small cell lung cancer’. Sugemalimab is a monoclonal antibody that works by attaching to the target called programmed death-ligand 1 (PD-L1). Cancer cells with PD-L1 may switch off some cells of the immune system. By blocking PD-1, sugemalimab stops the cancer switching off immune cells and increasing the immune system’s ability to kill cancer cells.
Issue Number: WN00186
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