Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Regulatory Updates
MHRA updates
- Good laboratory practice (GLP) for safety tests on chemicals. On 19th August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the list of current UK GLP compliance programme members. Click to view source
- AI Airlock: the regulatory sandbox for AIaMD. On 21st August, a webinar was added to the collection of information on the MHRA’s AI Airlock, a regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD). The pilot project will focus on a small number of products, across a range of medical device regulatory issues, with different sections of healthcare or clinical disciplines and levels of product regulatory maturity, and aims to enhance the understanding and accelerate solutions to novel regulatory challenges for AIaMD. It opened for applications after the above webinar on the 23rd of July 2024. Click to view source
ICH E11A Guideline reaches Step 4 of the ICH Process
On 21st August, the International Council for Harmonisation (ICH) announced that the ICH E11A Guideline has reached Step 4 of the ICH Process. This guideline provides recommendations and promotes international harmonisation of paediatric extrapolation to support the development and authorisation of paediatric medicines.
FDA updates
- Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA. On 20th August, the US Food & Drug Administration (FDA) published final guidance providing recommendations on product-specific guidance (PSG) meetings between the FDA and a prospective applicant preparing to submit to the FDA or an applicant that has submitted to the FDA, an abbreviated new drug application (ANDA) under the Federal Food, Drug and Cosmetic Act (FD&C Act). The document provides detailed instructions on how to request, prepare for, and conduct these meetings, ensuring a clear pathway for drug approvals. Click to view source
- Predetermined Change Control Plans for Medical Devices. On 21st August, draft guidance was published to propose a policy for Predetermined Change Control Plans (PCCPs) and recommendations on the information to include in a PCCP in a marketing submission for a device. It recommends that a PCCP for a device describe the planned device modifications, the associated methodology to develop, validate, and implement those modifications, and an assessment of the impact of those modifications. This approach aims to ensure continued device safety and effectiveness while reducing the need for additional marketing submissions for implementing each modification described in the PCCP. Click to view source
Industry Updates
First-of-its-kind Syphilis Diagnostic test granted marketing authorisation by FDA
On 16th August, the FDA granted marketing authorisation to NOW Diagnostics for the First to Know Syphilis Test. The diagnostic test identifies Treponema pallidum antibodies, crucial for the early detection of syphilis, which is vital for timely treatment and preventing transmission. The test provides an at-home result without a prescription, in approximately 15 minutes, which individuals can use to better inform next steps with a health care provider.
Lazertinib with amivantamab-vmjw for non-small lung cancer approved in US
On 19th August, the FDA approved Lazertinib (Lazcluze, Janssen Biotech, Inc.) in combination with amivantathe mab-vmjw (Rybrevant, Janssen Biotech, Inc.) for the first-line treatment of non-small cell lung cancer (NSCLC) with specific genetic mutations.
QuantaMatrix’s uRAST technology revolutionises sepsis treatment with rapid 13-hour antimicrobial testing
On 19th August, QuantaMatrix, a leader in clinical microbiology diagnostics, announced the development of ‘uRAST’ (Ultra-Rapid Antimicrobial Susceptibility Testing), the world’s fastest all-in-one antimicrobial testing technology. Traditional antimicrobial testing methods can take days, often too long for effective sepsis treatment, however, the uRAST technology eliminates the need for the initial blood culture process, providing accurate results within just 13 hours after blood sampling. The breakthrough has been published in the prestigious scientific journal Nature, marking a significant achievement for the diagnostic industry in South Korea.
eXmoor Pharma’s GMP cell and gene therapy manufacturing facility receives license from MHRA
On 20th August, eXmoor Pharma announced it has been granted a license by the MHRA, enabling its Cell & Gene Therapy Centre to offer a full range of good manufacturing practice (GMP)-grade services for cell and gene therapies including manufacture, fill/finish, packaging, labelling, and shipping to global clinical sites. This follows a successful inspection of the centre in Bristol, marking the end of a two-year project to design, build and bring online a 65,000 sq. ft state-of-the-art advanced therapies manufacturing facility.
Yellow Card Biobank seeks participants for study of genetic links to side effects
On 21st August, it was announced that the Yellow Card Biobank, a collaboration between the MHRA and Genomics England, is seeking participants for a study on the genetic links of drug side effects, particularly those linked to direct-acting oral anticoagulants (DOACs) and allopurinol. By collecting biological samples from affected patients, the study aims to identify genetic traits that may predispose individuals to these adverse reactions, ultimately supporting the development of pharmacogenetic testing strategies.
Lecanemab approved in UK for early-stage Alzheimer’s treatment
On 22nd August, it was announced that Lecanemab, a treatment for early-stage Alzheimer’s disease, has been approved for use by the MHRA. It is the first drug of its kind to target the underlying disease processes of Alzheimer’s by reducing amyloid-beta plaques in the brain and offers new hope for patients and families dealing with the early stages of this debilitating condition.
Issue Number: WN00176
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