Tower Mains Weekly Newsletter
Company Updates
Katarina: Celebrating 10 years at Tower Mains
Join us in celebrating a milestone as we honour Katarina Eghan, who is marking an incredible ten years with Tower Mains. Since joining our team in 2013, Katarina has made a huge impact on the company, bringing her expertise and dedication to every aspect of her work. Click here to hear directly from Katarina as she reflects on her journey with us.
Regulatory Updates
MHRA guidance updates
- Send and receive information on ADRs. On 30th April, the Medicines and Healthcare products Regulatory Agency (MHRA) added guidance on how marketing authorisation holders should inform the agency of a signal or an adverse drug reaction (ADR) to a medicine. Click to view source
FDA clarifies approach to genomic alterations in animals
On 1st May, the US Food and Drug Administration (FDA) took steps to advance its regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s commitment to further modernise its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictability, and efficiency. The two documents released, final Guidance for Industry (GFI) #187A, “Heritable Intentional Genomic Alterations in Animals: Risk-Based Approach,” and draft revised GFI #187B, “Heritable Intentional Genomic Alterations in Animals: The Approval Process,” are intended to help industry understand the existing statutory and regulatory requirements as they apply to IGAs in animals and to inform the public about the FDA’s process for regulating them.
Further FDA guidance updates
- Cancer clinical trial eligibility criteria: Laboratory values. On 25th April, draft guidance was added to provide recommendations regarding eligibility criteria for clinical trials of investigational drugs regulated by CDER and CBER for the treatment of cancer. Specifically, this guidance includes recommendations for selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial participants. Click to view source
- Raw data for safety and effectiveness studies. On 28th April, draft guidance was added with recommendations to sponsors on the submission of raw data. In addition, this guidance discusses how the Center for Veterinary Medicine (CVM) uses the raw data during the review of new animal drug applications and how the raw data allows the CVM to have confidence in the information used to make regulatory decisions. Click to view source
- Considerations for the use of human- and animal-derived materials in the manufacture of cell and gene therapy and tissue-engineered medical products. On 29th April, the FDA published draft guidance with recommendations regarding assuring the safety, quality, and identity of materials of human and animal origin used in the manufacture of these products. Click to view source
- Recognition and use of a standard for uniform blood and blood component container labels. On 29th April, draft guidance was issued describing a system of uniform container labels for blood and blood components intended for transfusion or for further manufacturing use. Click to view source
EU and the Republic of Korea pave way towards mutual recognition and regulatory harmonisation
On 26th April, the European Medicines Agency (EMA) announced that, together with the European Commission’s Directorate-General for Health and Food Safety (DG SANTE), it has signed a working arrangement with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for the exchange of confidential information on medical and medicinal products. This new partnership between the two regulatory authorities is an important step towards mutual recognition and regulatory harmonisation to improve human and animal health.
Industry Updates
MPE launches the Myeloma and AL Amyloidosis European Clinical Trial Navigator
On 23rd April, Myeloma Patients Europe (MPE) launched the English version of the Myeloma and AL Amyloidosis European Clinical Trial Navigator, an online search tool to learn about and find clinical trials for myeloma, monoclonal gammopathy of undetermined significance (MGUS), smouldering multiple myeloma (SMM) and AL amyloidosis in Europe. With this tool, MPE wants to facilitate the search of clinical trials for these conditions and provide to patients, carers and advocates a patient-friendly tool not only to find clinical trials but also to know about their availability and location.
ETH Zurich researchers use AI to design new drugs based on protein structures
On 23rd April, ETH Zurich announced researchers have developed a new generative AI-based computer process to develop drug molecules based on the three-dimensional surface of proteins with which the molecules are to interact. Together with pharmaceutical company Roche as well as other cooperation partners, the team tested the process by searching for molecules that interact with proteins in the PPAR class – proteins that regulate sugar and fatty acid metabolism.
FDA issues warning over the sale and distribution of unauthorised plastic syringes made in China
On 24th April, the FDA issued a further warning letter that describes violations related to the sale and distribution of unauthorised plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the US. The warning letter issued also describes violations related to quality system regulations for syringe products.
FDA takes action to ensure the safety and effectiveness of laboratory developed tests
On 29th April, the FDA announced actions taken to help to ensure the safety and effectiveness of laboratory developed tests (LDTs), which are used in a growing number of health care decisions and about which concerns have been raised for many years. The agency announced a final rule today amending the FDA’s regulations to make explicit that IVDs are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory. It also issued a policy to phase out its general enforcement discretion approach for LDTs. The agency also issued targeted enforcement discretion policies for certain categories of IVDs manufactured by laboratories.
Outcome of MHRA review of neuropsychiatric reactions with montelukast
On 29th April, the MHRA announced further measures to be introduced to ensure patients who are prescribed montelukast for the treatment of asthma are informed of the risk of neuropsychiatric reactions.
Latest Drug Safety Update from MHRA issued
On 29th April, the MHRA published the April edition of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines.
MHRA outlines its strategic approach to AI
On 30th April, the MHRA outlined its strategic approach to artificial intelligence (AI). Following the publication of the Government’s white paper ‘A pro-innovation approach to AI regulation’, published in 2023, the MHRA has taken significant steps in the past 12 months to adopt its recommendations in the work we do based on five key strategic principles. These principles encompass safety, security and robustness; appropriate transparency; fairness, accountability and governance; and contestability and redress.
FDA Voices: A milestone in facilitating the development of safe and effective biosimilars
On 30th April, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., Director, Center for Drug Evaluation and Research. This follows last week’s approval of the 50th biosimilar, reflecting the markedly increased availability of biosimilar products – products that treat a wide range of chronic and severe illnesses, and which have already had an important impact on patient access.
ETF recommends updating COVID-19 vaccines to target new JN.1 variant
On 30th April, the EMA’s Emergency Task Force (ETF) recommended updating COVID-19 vaccines to target the new SARS-CoV-2 variant JN.1 for the 2024/2025 vaccination campaign. In making its recommendation, the ETF consulted the World Health Organisation (WHO), international partners and marketing authorisation holders for Covid-19 vaccines. The ETF also considered a wide range of data, including data on the evolution of the virus and data from animal studies on the effects of candidate vaccines targeting JN.1.
Issue Number: WN00160
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