Tower Mains Weekly Newsletter
Company Updates
New Course: Conducting Laboratory Investigations. When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause and prevent recurrence. Our new ‘Conducting Laboratory Investigations’ course is designed to equip you with the skills and knowledge to conduct a successful investigation. Our next open course date is the 22nd of November 2023 or if you are interested in this training for your organisation at a time of your choosing, please get in touch at training@towermains.com. For further information, click here.
Regulatory Updates
MHRA guidance updates
- Medicines: reclassify your product. On 6th October, the Medicines and Healthcare products Regulatory Agency (MHRA) revised the date under the sub-heading ‘Legal status of substances’ to 30th September (formerly 31st March) in the guidance on applying to move a medicine to a different classification. Click to view source
- Full pack dispensing of valproate-containing medicines. On 11th October, guidance was published for dispensing valproate-containing medicines in the manufacturer’s original full pack, following amendments to the Human Medicines Regulations (HMRs). Click to view source
FDA guidance updates
- Testing and labelling medical devices for safety in the Magnetic Resonance environment. On 10th October, the US Food and Drug Administration (FDA) published final guidance providing recommendations on testing to assess the safety and compatibility of medical devices in a magnetic resonance (MR) environment and the recommended format for magnetic resonance imaging safety information in medical device labelling. Click to view source
- Submission of premarket notifications for Magnetic Resonance diagnostic devices. On 10th October, final guidance was published to provide recommendations on the information to support premarket submissions for a magnetic resonance diagnostic device (MRDD). The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of MRDD submissions. Click to view source
- Data standards catalog. On 12th October, the FDA published the final version of its Data Standards Catalog which lists the data standards and terminologies that the agency supports for use in regulatory submissions to better enable the evaluation of safety, effectiveness, and quality of FDA-regulated products. Click to view source
- Quality considerations for Topical Ophthalmic drug products. On 12th October, draft guidance was published to discuss certain quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye. Click to view source
Industry Updates
EMA adopts revised transparency rules for the EU CTIS
On 6th October, the European Medicines Agency (EMA) announced it has adopted revised transparency rules for the publication of information on clinical trials submitted through the Clinical Trials Information System (CTIS). The updated rules strike a balance between the transparency of information and the protection of commercially confidential information, and benefit patients, because key clinical trial information, that patients flagged as being most relevant for them, is published early. Another key change is the removal of the deferral mechanism, which allowed sponsors to delay the publication of certain data and documents for up to seven years after the end of the trial to protect personal data and commercially confidential information (CCI).
EMA issues highlights from latest Management Board meeting
On 6th October, the EMA issued highlights from its Management Board meeting held on the 5th of October 2023. Topics include clinical trials in the EU, the EMA mid-year report for 2023, and COVID-19.
AstronauTx completes £48m Series A financing for Alzheimer’s disease
On 9th October, AstronauTx Ltd., a biotech company developing novel treatments for Alzheimer’s disease and other neurodegenerative disorders, announced the completion of a £48 million Series A financing. The proceeds of the financing will be used to advance the company’s portfolio of small-molecule drugs, including a clinical study in patients with Alzheimer’s disease for the lead programme.
Edinburgh University to house to UK’s first next-generation supercomputer
On 9th October, the UK Government announced that the University of Edinburgh will be the preferred location for the first phase of the new Exascale supercomputer. Once operational, it will provide high-performance computing capability for key research and industry projects across the UK. It will help researchers model all aspects of the world, test scientific theories and improve products and services in areas such as artificial intelligence, drug discovery, climate change, astrophysics, and advanced engineering.
Scottish Medicines Consortium publishes advice on 12 medicines
On 9th October, the Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHS Scotland, published advice on 12 medicines. Medicines accepted included those for a variety of conditions including breast, bowel and prostate cancer, and Von Hippel-Lindau (VHL) disease
UKRI awards three projects £25m for future vaccine development
On 10th October, the UK Research and Innovation (UKRI) announced it has awarded £25m to three projects designed to build our understanding of viruses and how the immune system reacts to different challenges. These projects are just three of several investments in ways to investigate and better manage future infectious disease threats, and the funding is part of Tackling infections, one of UKRI’s five strategic themes. The three projects awarded funding are:
- The G2P2 virology consortium: keeping pace with SARS-CoV-2 variants
- IMMPROVE: Immune Memory and Mechanisms of Protection from Vaccines
- Evolutionarily smart vaccine strain selection for proactive vaccinology
Innovative automation could see faster access to ground-breaking stem cell treatment
On 11th October, the MHRA revealed that the safe manufacture of potentially life-saving stem cells through innovative automation and machine learning could give patients faster access to stem cell treatments in the future. This followed a special event at the MHRA’s South Mimms Laboratories where experts and UK Stem Cell Bank (UKSCB) alumni met to celebrate two decades of supporting innovation in research and the clinic and to look to the future of advanced therapeutics.
FDA establishes Digital Health Advisory Committee to explore complex issues related to DHTs
On 11th October, the FDA announced the creation of a new Digital Health Advisory Committee to explore the complex, scientific and technical issues related to digital health technologies (DHTs), such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. Aiming to be fully operational in 2024, the committee will advise the FDA on issues related to DHTs, providing relevant expertise and perspective to help improve the agency’s understanding of the benefits, risks, and clinical outcomes associated with the use of DHTs.
Streamlined scheme for lowest-risk clinical trials marks start of MHRA overhaul of regulation
On 12th October, the MHRA announced that the UK healthcare system, patients and life sciences sector are set to benefit from a new scheme that will see the time taken by the agency to approve the lowest-risk clinical trials reduced by more than 50%. Initial applications for the lowest-risk Phase 3 and 4 trials will be processed by the MHRA within 14 days instead of the statutory 30 days, provided the sponsor can demonstrate the trial meets the MHRA’s criteria, including by confirming there are no known safety issues with the medicine being investigated. Details of this have also been published in MHRA guidance on how to apply for a clinical trial in the UK.
Issue Number: WN00133
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