Tower Mains Weekly Newsletter
Company Updates
Good practices are good practices and at the core of this lies data integrity and the ability to use that to reconstruct what worked and what didn’t, which is why Tower Mains collaborated with Glasgow Caledonian University to reinforce why these – particularly good documentation and recording – are important in academia and for working in industry. This programme aimed to emphasise the fundamentals of quality systems and good practices and start the students on the scientific journey of “a fail is a valid result” and something to be investigated and understood, not ignored, or swept aside.
It’s been an exciting time engaging with and helping lay the foundation for the bright and innovative futures of the next generation of scientists and regulatory professionals!
If you’re looking to upskill your team, look no further than our Conducting Laboratory Investigations course, designed to equip participants with the skills and knowledge to conduct a successful investigation. For more information, click here.
Regulatory Updates
MHRA guidance updates
- Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF). On 17th November, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance to replace the previous requirement to submit a Type IA(IN) variation and an accompanying eCTD sequence following updates to the UK PSMF and UK QPPV information. Click to view source
- Medicines: notes for applicants and holders of a manufacturer licence. On 17th November, guidance was updated to help applicants and licence holders get and maintain a manufacturer licence – MHRA guidance note 5. Click to view source
- Medicines marketing authorisation: change of ownership. On 17th November, guidance on how to change the ownership from one marketing authorisation (MA) holder to another was updated to reflect the new process and form. Click to view source
- International Recognition Procedure. On 20th November, the MHRA added information on the Eligibility Checker and submitting a Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle in the guidance on how to use the International Recognition procedure for medicines licensing applications. Click to view source
FDA guidance updates
- Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act. On 17th November, the US Food and Drug Administration (FDA) published final guidance to address section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as added by section 3121 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), Pub. L. No. 116-136 (March 2020), as it relates to notifying the FDA of a permanent discontinuance or interruption in the manufacturing of a device that is likely to lead to a meaningful disruption in the supply of that device during or in advance of a public health emergency (PHE). Click to view source
- Translation of Good Laboratory Practice Study Reports: Questions and Answers. On 20th November, draft guidance was published to provide information to sponsors and nonclinical laboratories regarding the language translation of study reports for studies conducted in compliance with good laboratory practice (GLP) regulations (21 CFR part 58) submitted to the FDA for review. Click to view source
- COVID-19: Developing Drugs and Biological Products for Treatment or Prevention. On 22nd November, final guidance was published to assist sponsors in the clinical development of drugs and biological products for the treatment or prevention of COVID-19. This guidance describes the FDA’s current recommendations for phase 2 and phase 3 trials with a focus on trial population, trial design, efficacy endpoints, safety considerations, and statistical considerations. Click to view source
Industry Updates
LifeArc-UKDRI partnership invests £14.5m into neurodegeneration research
On 16th November, LifeArc and the UK Dementia Research Institute (UKDRI) announced the investment of £14.5m into seven neurodegeneration research projects as part of their £30m strategic partnership. The funds have been allocated to support major projects seeking to develop new tests, treatments and medical devices to help the more than 1 million people in the UK living with neurodegenerative conditions including Alzheimer’s disease, motor neuron disease, frontotemporal dementia (FTD) and Parkinson’s disease.
CDRH takes steps to advance further discussions on pulse oximeters
On 16th November, the FDA’s Center for Devices and Radiological Health (CDRH) announced that a virtual public meeting of the Anaesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee to discuss pulse oximeters will be held on 2nd February 2024. The meeting will include discussions about a new approach to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters submitted for premarket review, taking into consideration a patient’s skin pigmentation and patient-reported race and ethnicity.
BHF and UKDRI announce first UK Centre for vascular dementia research
On 16th November, the UKDRI announced a new partnership with the British Heart Foundation (BHF) to establish the UK’s first research centre dedicated to finding new treatments to prevent, halt and ultimately find cures for vascular dementia. The BHF will invest £7.5m over the next five years so the Centre can drive forward pioneering research and the UK DRI will contribute £1.5m as well as enable access to its cutting-edge technology and research centres.
CVM antimicrobial stewardship in FY 2023 and beyond
On 20th November, the FDA’s Center for Veterinary Medicine (CVM) published a Perspectives with CVM blog post in recognition of World Antimicrobial Awareness Week 2023, held from 18th-24th November. The post highlights what CVM is doing to address antimicrobial resistance and preserve the effectiveness of these critical and life-saving drugs.
FDA warns against Neptune’s Fix products or any other product with tianeptine
On 21st November, the FDA warned consumers not purchase or use any Neptune’s Fix products, or any other product with tianeptine — a potentially dangerous substance that is not FDA-approved for any medical use but is illegally sold with claims to improve brain function and treat anxiety, depression, pain, opioid use disorder and other conditions. FDA has received severe adverse event reports after the use of Neptune‘s Fix products, including seizures and loss of consciousness leading to hospitalisation.
AstraZeneca launches health-tech business to accelerate innovation across the life sciences sector
On 20th November, AstraZeneca launched Evinova, set to be a leading provider of digital health solutions to better meet the needs of healthcare professionals, regulators and patients. Evinova will prioritise bringing to market established and scaled digital technology solutions already being used globally by AstraZeneca to optimise clinical trial design and delivery, which will reduce the time and cost of developing new medicines, bring care closer to home for patients and reduce the lumber on health systems. It will also pursue opportunities in digital remote patient monitoring and digital therapeutics with a pipeline of digital innovations in these areas.
Genentech and NVIDIA enter strategic AI research collaboration
On 21st November, Genentech announced a multi-year strategic research collaboration with NVIDIA that couples Genentech’s artificial intelligence (AI) capabilities, extensive biological and molecular datasets, and research expertise with NVIDIA’s world-leading accelerated computing capabilities and AI to speed up drug discovery and development. The collaboration is designed to enhance Genentech’s advanced AI research programs by transforming its generative AI models and algorithms into a next-generation AI platform, accelerating the discovery and delivery of novel therapies and medicines to people.
Alladapt’s allergy treatment receives FDA fast-track designation
On 22nd November, Alladapt Immunotherapeutics, a clinical-stage biopharmaceutical company developing prescription therapeutics to address IgE-mediated food allergy, announced that ADP101, its investigational multi-food oral immunotherapy (mOIT) designed to simultaneously treat allergy to one or more of the world’s most significant food allergens, received Fast Track Designation from the FDA. ADP101 is the most advanced multi-food OIT pharmaceutical candidate in development.
European Commission releases agenda for 101st Pharmaceutical Committee meeting
On 22nd November, the European Commission published the agenda of the 101st meeting of the Pharmaceutical Committee that is being held on Thursday, 23rd November.
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@tower mains.com with the subject “Weekly Newsletter Please.”