Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA launches new business plan with focus on enabling access to ground-breaking technology
On 7th October, the Medicines and Healthcare products Regulatory Agency (MHRA) launched its new business plan for 2024/25, setting out the agency’s core focus of enabling access to innovative healthcare products while ensuring delivery for all who need its services – patients and the public, healthcare professionals, researchers and developers. It also reflects the exciting developments in regulatory science, which inform the agency’s plan to create a UK network of Centres of Excellence in Regulatory Science.
MHRA guidance updates
- Report safety concerns with insulin pumps and continuous glucose monitoring equipment. On 8th October, guidance was published on how to report suspected adverse incidents and safety concerns with diabetes management equipment to the Yellow Card scheme. Click to view source
- Opportunities for patients and the public to be involved in the work of the MHRA. On 9th October, guidance was published on how the MHRA engages and involves patients and the public in its regulatory decision-making. Click to view source
FDA guidance updates
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers. On 1st October, the US Food and Drug Administration (FDA) published draft guidance with information for sponsors, clinical investigators, institutional review boards, contract research organisations, and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs. Click to view source
ICH releases 2024 Implementation Survey report
On 8th October, the ICH issued the report of the 2024 Implementation Survey, which evaluates the adoption and effectiveness of the ICH guidelines across member regions. The objective of this survey was to help the ICH Management Committee assess whether Regulatory Members met the eligibility criteria for recent elections, provide participating Observers with insights for potential future ICH membership, and identify needs for regulatory training and capacity building.
EMA launches strategy consultation
On 9th October, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) published their draft joint European Medicines Agencies Network Strategy (EMANS) to 2028 for an eight-week public consultation. This is a review and update to the original five-year strategy – developed to cover the period 2021 to 2025 – in response to changes to the regulatory and technological landscape.
Industry Updates
FDA CDRH expands TAP pilot eligibility for breakthrough devices
On 1st October, the FDA’s Center for Devices and Radiological Health (CDRH) announced that breakthrough designated devices reviewed in the Office of Radiological Health and the Division of Ophthalmic Devices are eligible to enrol in the Total Product Life Cycle (TPLC) Advisory Program (TAP) pilot. Additionally, CDRH published a resource entitled “TAP Pilot Engagement Tips”, aimed at helping innovators and collaborators enhance productive engagement between medical device sponsors and non-FDA stakeholders, such as patients and healthcare providers, throughout the design and development process.
Bristol Myers Squibb receives approval for resectable non-small cell lung cancer treatment
On 3rd October, Bristol Myers Squibb announced that the FDA has approved nivolumab (Opdivo) with platinum-doublet chemotherapy as neoadjuvant treatment, followed by single-agent nivolumab after surgery as adjuvant treatment, for adults with resectable non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements.
EMA issues highlights from October Management Board meeting
On 4th October, the EMA issued highlights from the agency’s latest Management Board meeting. Highlights include the ongoing implementation of the EU pharmacovigilance system and efforts to improve regulatory processes. The board also reviewed updates on the agency’s budget and workforce planning, emphasising the need for resources to support its evolving responsibilities.
Merck’s KEYTRUDA® meets primary endpoint of event-free survival in Phase 3 trial
On 8th October, Merck, known as MSD outside of the US and Canada, announced that the Phase 3 KEYNOTE-689 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as a perioperative treatment for patients newly diagnosed with stage III or IVA, resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC) met its primary endpoint of event-free survival (EFS).
Purespring secures £80 million to transform kidney disease treatment with innovative gene therapy
On 9th October, Purespring Therapeutics announced it has raised £80 million in an oversubscribed Series B financing round. Purespring is the first company to successfully treat kidney disease models by directly targeting the podocyte, a specialised cell implicated in approximately 60% of renal diseases, through its proprietary adeno-associated viral (AAV) gene therapy platform. Its platform technology allows working copies of genes to be delivered with high efficiency and specificity to podocytes, opening a new and highly differentiated modality for disease-modifying treatments of a broad range of kidney diseases. The funds will be used to support the company’s pipeline including the initiation of a Phase I/II clinical trial for IgAN, a common, chronic kidney disease primarily affecting young adults.
Heart patient home within hours of live-streamed valve replacement
On 9th October, Sheffield Teaching Hospitals NHS Foundation Trust announced its cardiologists performed a cutting-edge heart valve replacement procedure live to an international audience. The streamlined transcatheter aortic valve implantation (TAVI) showcased Sheffield’s leading role in cardiovascular disease research and enabled the patient to go home within hours of having his faulty heart valve fixed. TAVI offers a less invasive alternative to open-heart surgery, especially for elderly patients and while open-heart surgery remains the gold standard for younger patients, TAVI provides comparable results with quicker recovery.
Issue Number: WN00183
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Contact us here with the subject “Weekly Newsletter Please”