Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.
Company Updates
RQA 2024 International QA Conference
This week, some of the Tower Mains team have been at the Research Quality Association (RQA) 2024 International QA Conference in Brighton. It’s been a fantastic experience, with the opportunity to connect with both new and familiar faces, as well as hear from industry experts!
Regulatory Updates
#MedSafetyWeek 2024 highlights efforts to prevent medication side effects
On 4th November, the ninth annual #MedSafetyWeek launched with regulators from 94 countries and 107 organisations taking part across the globe. With a focus on preventing side effects from medications, the initiative aims to raise awareness about the importance of reporting suspected side effects to regulatory authorities such as the Medicines and Healthcare products Regulatory Agency (MHRA).
MHRA to relaunch Innovative Licensing and Access Pathway to accelerate access to new medicines
On 6th November, the MHRA outlined plans for the relaunch of the Innovative Licensing and Access Pathway (ILAP), aimed at accelerating patient access to transformative new medicines. The pathway, which will reopen for applications in March 2025, is designed to expedite the development and delivery of innovative medicines by integrating the expertise of the regulatory and health technology assessment systems and NHS bodies. The ILAP will be more responsive to the evolving needs of the life sciences sector, having been significantly updated since its initial launch in 2021. Full details of the revised pathway will be published in January 2025.
MHRA guidance updates
- Advertising and Promotion following agreement of the Windsor Framework. On 7th November, the MHRA released guidance outlining the implementation of changes to advertising and promotion of medicines approved in the UK, effective from 1st January 2025. Click to view source
FDA guidance updates
- Study Data Technical Conformance Guide – Technical Specifications Document. On 31st October, the FDA published guidance intended to provide technical recommendations to sponsors for the submission of animal and human study data and related information in a standardised electronic format in new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs) and certain biologics license applications (BLAs).
ICH releases updated training materials for ICH Q9(R1) Quality Risk Management
On 2nd November, the International Council for Harmonisation (ICH) announced the release of updated training materials related to ICH Q9(R1) Quality Risk Management (QRM). The revised materials are designed to support the implementation of the updated ICH Q9(R1) guideline, offering detailed guidance on how to assess and manage risks to product quality throughout the pharmaceutical lifecycle.
Industry Updates
LumiThera receives FDA approval for treatment to improve vision in dry AMD patients
On 4th November, LumiThera Inc., a medical device company offering photobiomodulation (PBM) treatment for ocular damage and disease, announced the FDA has authorised marketing of Valeda® Light Delivery System for the treatment of patients with dry age-related macular degeneration (AMD), a leading cause of central vision loss. Treatment with the device after approximately two years can provide an average improvement in vision equivalent to around one line on an eye chart.
Elsevier strengthens support for The Pistoia Alliance to advance AI in life sciences
On 4th November, Elsevier, a global leader in information and analytics, announced its continued commitment to The Pistoia Alliance, a not-for-profit organisation dedicated to fostering greater collaboration in the life sciences. This partnership aims to address the common challenges related to AI adoption within the pharmaceutical and research communities. It will focus on equipping these organisations with the tools, capabilities, and knowledge necessary to effectively leverage AI in drug discovery, while ensuring that its use remains safe, ethical, and efficient.
Arcellx announces positive results for anitocabtagene autoleucel in relapsed or refractory multiple myeloma
On 5th November, Arcellx Inc, a biotechnology company reimagining cell therapy through the development of innovative immunotherapies for patients with cancer and other incurable diseases, announced impressive results from its studies on anitocabtagene autoleucel (anito-cel) for treating relapsed or refractory multiple myeloma. The findings will be presented at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition taking place from the 7th-10th December in San Diego.
MHRA issues latest Drug Safety Update
On 6th November, the MHRA published the November edition of the Drug Safety Update newsletter from the agency and its independent advisor, the Commission on Human Medicines.
FDA proposes removing oral phenylephrine from OTC nasal decongestants
On 7th November, the FDA proposed removing oral phenylephrine as an active ingredient in over-the-counter (OTC) nasal decongestants due to concerns about its effectiveness. The proposal follows a review of available data showing that oral phenylephrine does not effectively relieve nasal congestion. It addresses effectiveness, not safety, and does not affect products with other active ingredients, such as acetaminophen or dextromethorphan, that may include oral phenylephrine.
Johnson & Johnson MedTech obtains US approval for VARIPULSE™ ablation platform for AFib
On 7th November, Johnson & Johnson MedTech announced its VARIPULSE™ Pulsed Field Ablation (PFA) platform has received FDA approval for the treatment of drug-refractory paroxysmal atrial fibrillation (AFib). The VARIPULSE™ platform is the first PFA system fully integrated with the CARTO™ 3 Electro-anatomical Mapping System, enabling enhanced precision, safety, and efficiency in AFib treatment. The approval is supported by data from the admIRE study, which showed a 100% procedural success rate and 85% peak primary effectiveness after 12 months, with minimal adverse events and 25% of procedures performed without fluoroscopy.
Issue Number: WN00187
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