Tower Mains Weekly Newsletter
Regulatory Updates
MHRA issues latest Drug Safety Update newsletter
On 26th September, the Medicines and Healthcare products Regulatory Agency (MHRA) issued the September issue of its Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines.
FDA releases draft guidance on defining durations of use for certain medically important antimicrobial drugs for food animals
On 26th September, the US Food and Drug Administration (FDA) released a draft guidance to provide recommendations on how animal drug sponsors may voluntarily establish a defined duration of use for certain approved medically important antimicrobial animal drugs with indications that currently lack a defined duration of use. This guidance provides information to sponsors of certain antimicrobial animal drug products who are interested in voluntarily establishing appropriately defined durations of therapeutic administration to food-producing animals where none currently exist.
Further FDA guidance updates
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. On 27th September, final guidance was published, providing the FDA’s recommendations regarding cybersecurity device design, labelling, and the documentation that the FDA recommends be included in premarket submissions for devices with cybersecurity risk. Click to view source
ECHA’s screening finds REACH registrations in breach of update obligation
On 27th September, the European Chemicals Agency (ECHA) announced that following two campaigns during 2021-2023 to remind companies of their obligation to keep their REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) registrations up to date, 57 registrations have been reported to the national enforcement authorities for further action. The two targeted campaigns were run to support the EU Commission’s Implementing Regulation (EU) 2020/1435, which entered into force in December 2020. This regulation clarifies the deadlines for registrants to update their registrations as per REACH Article 22.
Health Canada launches consultation on draft guidance for determining medical device application type
Health Canada is seeking feedback from medical device manufacturers and stakeholders on the draft guidance for determining medical device application type. The guidance explains the different application types and is aimed at helping manufacturers determine whether certain medical devices, including components and parts, should be combined and submitted as 1 device license or authorisation application. The consultation will close on 10th November 2023.
Industry Updates
Pfizer’s ABRYSVO™ for RSV recommended by CDC Advisory Committee
On 22nd September, the Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) in favour of recommending ABRYSVO™ – Pfizer’s bivalent RSV prefusion F (RSVpreF) vaccine – as a maternal immunisation. The shot is expected to confer protection against RSV-associated lower respiratory tract infection in infants through the first six months of life.
WHO tool launched to benchmark ethics oversight of health-related research involving human participants
On 25th September, the World Health Organisation (WHO) announced the launch of the WHO tool for benchmarking ethics oversight of health-related research involving human participants. Developed by WHO’s Regulatory System Strengthening, Regulation and Safety Unit and the Health Ethics & Governance Unit, it is intended to assist countries in evaluating their capacity to provide appropriate ethical oversight of health-related research and to promote best practices in research ethics oversight, to enhance public trust in health research, and to ensure that the rights and safety of humans involved in health-related research are adequately protected.
Valo Health and Novo Nordisk to collaborate to develop novel treatments for cardiometabolic diseases
On 25th September, Novo Nordisk A/S and Valo Health, Inc. announced their partnership to discover and develop novel treatments for cardiometabolic diseases based on Valo’s large human dataset and computation powered by artificial intelligence (AI). In addition to target discovery and validation as part of the collaboration, Novo Nordisk is licensing three preclinical drug discovery programmes in cardiovascular diseases discovered and developed by Valo using the Opal Computational Platform™.
CSL Seqirus reaches vaccine agreement with UKHSA
On 26th September, CSL Seqirus announced that it has signed an agreement with the UK Health Security Agency (UKHSA) to develop and supply pandemic influenza vaccines in the event of an influenza pandemic. Under the terms of the agreement, should a pandemic be declared, the UK government would have the option to purchase more than 100 million doses of pandemic vaccines from the CSL Seqirus manufacturing plant in Liverpool in a rapid timeframe.
Acesion wins €45m in Series B funding to develop atrial fibrillation therapy
On 26th September, Acesion Pharma, a biotech company pioneering first-in-class novel therapies for atrial fibrillation (AF), announced it secured an oversubscribed €45M Series B financing round. The equity financing was co-led by new US-based investors Canaan and Alpha Wave and with participation by the Global BioAccess Fund, as well as existing investor Novo Holdings. The financing will be used to advance the clinical development of AP31969, an SK ion channel inhibitor optimised for chronic oral treatment of AF.
Sandoz receives EC approval for Tyruko®, the first and only biosimilar for multiple sclerosis in Europe
On 26th September, Sandoz, a company focused on generic and biosimilar medicines, announced that the European Commission (EC) granted marketing authorisation for the first and only biosimilar Tyruko®. The biosimilar has been approved for all multiple sclerosis (MS)-related settings where Biogen’s Tysabri is currently used, including relapsing-remitting MS, clinically isolated syndrome (CIS), and active secondary progressive disease, in addition to Crohn’s disease.
Issue Number: WN00131
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