Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA launches consultation on the International Council for Harmonisation (ICH) M14
On 29th August, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of Pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines. The agency invites UK stakeholders and other ICH members to participate in this consultation after which, the feedback will be reviewed and discussed by the ICH M14 Expert Working Group (EWG).
Further MHRA updates
- Notify MHRA about a clinical investigation for a medical device. On 27th August, the MHRA added the new Quarterly Summary Reports (QSR) template to its guidance on how to notify the MHRA of the intention to carry out a clinical investigation for medical devices. Click to view source
European Commission issues Q&A document on Clinical Trials Regulation (EU) No 536/2014
On 28th August, the European Commission released an updated Questions and Answers document on the Clinical Trials Regulation (EU) No 536/2014, amended and endorsed through written procedure by the Clinical Trials Coordination and Advisory Group.
FDA to clarify final guidance on remanufacturing medical devices
On the 10th of September, the US Food & Drug Administration (FDA) will host a webinar to discuss its final guidance for remanufacturing medical devices. The event is aimed to clarify distinctions between device servicing and remanufacturing, offer regulatory guidance and ensure stakeholders understand compliance responsibilities.
Further FDA updates
- Electronic Submission Template for Medical Device De Novo Requests. On 23rd August, the FDA published final guidance providing the standards for submitting De Novo Requests by electronic format, a timetable for establishing these standards, and criteria for waivers of and exemptions from the requirements to meet a statutory requirement. Click to view source
- Mammography Quality Standards Act and Regulation Amendments: Small Entity Compliance Guide. On 23rd August, final guidance was published to explain the actions a small entity is required to take to comply with the Mammography Quality Standards Act (MQSA) rule and its implementing regulations. It also includes policy and recommendations previously found in the Policy Guidance Help System. Click to view source
- Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. On 29th August, final guidance was published to help manufacturers further understand and utilise the Voluntary Summary Malfunction Reporting (VMSR) Program, an established voluntary program by which manufacturers may submit certain malfunctions related to devices with certain product codes to the FDA in a summary format every quarter. Click to view source
Industry Updates
FDA expands indications of first device for automated insulin dosing in type 2 diabetes patients
On 26th August, the FDA expanded the indications of the Insulet SmartAdjust technology, an interoperable automated glycemic controller, to include the management of type 2 diabetes in individuals 18 years and older. Previously used for type 1 diabetes, this device adjusts insulin delivery by connecting to an insulin pump and glucose monitor and provides a new, automated option for managing insulin therapy, which could reduce the burden of frequent manual dosing.
Regeneron’s Ordspono™ approved for treatment of two types of blood cancers in EU
On 26th August, Regeneron Pharmaceuticals, Inc. announced that the European Commission has granted approval for Ordspono™ (odronextamab) to treat adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. As Regeneron’s first approved bispecific antibody, Ordspono™ offers a ready-to-use treatment that can be administered in an outpatient setting, aiming for the possibility of complete remission.
Pancreatic Cancer Europe and myTomorrows collaborate to improve clinical trial access
On 27th August, Pancreatic Cancer Europe (PCE), a multi-stakeholder platform that brings together experts from all over Europe, announced a new partnership with myTomorrows, a global health technology company connecting patients with all possible treatment options to improve care for patients with pancreatic cancer. The partnership will integrate myTomorrows’ extensive database into PCE’s platform, featuring a new search widget to streamline the discovery of relevant clinical trials enabling patients, caregivers, and healthcare professionals to benefit from easier access to trial information and expert support from myTomorrows’ patient navigators.
Bavarian Nordic receives approval of Smallpox and Mpox vaccine in Singapore
On 27th August, Bavarian announced that Singapore’s medicines regulatory authority, Health Sciences Authority (HSA), has approved JYNNEOS® (MVA-BN) for the prevention of smallpox and mpox disease in adults 18 years of age and older determined to be at high risk for smallpox or mpox infection. This marks the transition to full approval for JYNNEOS in Singapore.
Eli Lilly releases Zepbound® single-dose vials, expanding supply and access for adults living with obesity
On 27th August, Eli Lilly released Zepbound® (tirzepatide) single-dose vials, expanding access to obesity treatment by offering a new, more affordable self-pay option. The vials – available in 2.5 mg and 5 mg doses – are at a 50% or greater discount compared to the list price of all other incretin (GLP-1) medicines for obesity. The single-dose vials help patients achieve significant weight loss and address the growing demand for obesity treatment.
Issue Number: WN00177
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.”