Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
We are thrilled to be attending the BioCap 2024 Conference on Thursday 26th September, hosted by Bionow.
Are you also attending? Our Head of QA, Shona Ross, and Head of Operations, Lianne Roeling, will be there to say hello!
Regulatory Updates
MHRA launches new strategy to enhance patient safety communications
On 17th September, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a new strategy to enhance safety communications on World Patient Safety Day. The initiative aims to transform how information about medicines and medical devices is shared with patients and healthcare professionals, promoting clearer messaging and better accessibility.
MHRA guidance updates
- Labelling and packaging of medicinal products for human use following agreement of the Windsor Framework. On 13th September, the MHRA updated information on implementing labelling and packaging requirements for medicinal products for human use under the Windsor Framework. Click to view source
New chair elected for EMA’s Orphan Medicinal Products Committee
On 16th September, the European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) announced the election of Tim Leest as its new chair. The COMP plays a crucial role in advising on orphan designations, which help facilitate the availability of medicines for the diagnosis, prevention or treatment of rare diseases that are life-threatening or serious.
FDA’s Digital Health Advisory Committee to hold first meeting in November 2024
On 16th September, the US Food and Drug Administration (FDA) announced the inaugural meeting of its Digital Health Advisory Committee will take place on the 20th-21st November 2024. The committee will focus on total product lifecycle considerations for generative AI-enabled medical devices, examining how this technology may affect the safety and effectiveness of such devices. Topics will also include premarket performance evaluation, risk management, and post-market performance monitoring for generative AI-enabled products.
FDA guidance updates
- Considerations for Generating Clinical Evidence from Oncology Multiregional Clinical Development Programs. On 16th September, the FDA published draft guidance with recommendations to sponsors who are planning global clinical development programs for drugs intended to treat cancer, on improving the evidence obtained from one or more multiregional clinical trials (MRCTs) intended to support a marketing application. Click to view source
- Study Data Technical Conformance Guide. On 16th September, guidance was published to provide technical recommendations to sponsors for the submission of animal and human study data and related information in a standardised electronic format in certain investigational new drug applications (INDs), new drug applications (NDAs); abbreviated new drug applications (ANDAs); and certain biologics license applications (BLAs). Click to view source
- Integrating Randomised Controlled Trials for Drug and Biological Products into Routine Clinical Practice. On 17th September, the FDA issued draft guidance aimed at supporting the conduct of randomised controlled drug trials with streamlined protocols and procedures that focus on essential data collection, allowing the integration of research into routine clinical practice. Click to view source
- Conducting Clinical Trials with Decentralised Elements. On 17th September, final guidance was published providing recommendations for sponsors, investigators, and other interested parties regarding the implementation of decentralised elements in clinical trials. Click to view source
Industry Updates
WHO launches access mechanism for mpox vaccines, treatments, and tests
On 13th September, the World Health Organization (WHO) announced the establishment of a mechanism, in collaboration with its partners, to ensure equitable access to vaccines, treatments, and tests for mpox. This initiative aims to improve global response efforts and address the needs of affected communities, particularly in low- and middle-income countries and will facilitate the allocation of resources and enhance collaboration among stakeholders to combat the disease effectively.
Eli Lilly’s dermatitis treatment EBGLYSS™ receives green light from FDA
On 13th September, Eli Lilly and Company announced that the FDA has approved EBGLYSS™, a targeted IL-13 inhibitor, for the treatment of adults and children 12 years of age and older who weigh at least 40 kg with moderate-to-severe atopic dermatitis that is not well controlled despite treatment with topical prescription therapies.
New therapy that targets tau tangles shows promise for Alzheimer’s
On 16th September, it was announced that a team of scientists from the Medical Research Council Laboratory of Molecular Biology (MRC LMB) and the UK Dementia Research Institute (UK DRI) at the University of Cambridge have developed promising new therapies that selectively target and remove aggregated tau tangles to treat Alzheimer’s disease (AD). Their research, detailed in two separate papers published in Cell and Science, indicates that these therapies could also be effective for other neurodegenerative diseases characterised by protein aggregation, including motor neurone disease, Huntington’s disease, and Parkinson’s disease.
Monoclonal antibodies offer hope for tackling antimicrobial resistance
On 16th September, the University of Cambridge announced that its researchers have developed a monoclonal antibody drug, using a technique involving genetically engineered mice, which may help prevent infection from Acinetobacter baumannii, a bacteria associated with hospital-acquired infections, which is particularly common in Asia.
Daiichi Sankyo-Merck’s phase 3 lung-cancer study meets primary endpoint
On 17th September, Daiichi Sankyo and Merck & Co. announced that the Phase 3 clinical trial evaluating patritumab deruxtecan in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who received prior EGFR tyrosine kinase inhibitor (TKI) treatment met its primary endpoint of progression-free survival (PFS). Patritumab deruxtecan is a specifically engineered potential first-in-class HER3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
Gavi to buy 500,000 mpox vaccine doses from Bavarian Nordic
On 18th September, Bavarian Nordic A/S and Gavi, the Vaccine Alliance announced an advance purchase agreement (APA) to secure 500,000 doses of the MVA-BN® mpox vaccine to be supplied to countries in Africa impacted by the mpox outbreak. The vaccines will be funded by Gavi’s First Response Fund, a new financial mechanism created in June 2024 to make cash rapidly available to purchase vaccines in health emergencies.
Issue Number: WN00180
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