Tower Mains Weekly Newsletter
Regulatory Updates
MHRA guidance updates
- Medicines: Apply for a parallel import licence. On 12th September, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on getting a parallel import licence for medicines in the UK, including pharmacovigilance requirements and submitting an application. Click to view source
- Marketing Authorisation Application submission dates. On 12th September, submission dates were updated in guidance on the 150-day national and European Commission decision reliance procedures. Click to view source
FDA guidance updates
- Endogenous Cushing’s Syndrome: Developing Drugs for Treatment. On 8th September, the US Food and Drug Administration (FDA) published draft guidance providing recommendations to sponsors regarding clinical trial designs for drugs intended for the treatment of adults with endogenous Cushing’s syndrome for whom surgery is not an option or has not been curative. The guidance focuses on continued discussions among the FDA’s Division of General Endocrinology, pharmaceutical sponsors, the academic community, and the public. Click to view source
- Use of International Standard ISO 10993-1. On 11th September, final guidance was published to provide further clarification and information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” to support applications to the FDA. Click to view source
- Institutional Review Board (IRB) Review of Individual Patient Expanded Access Submissions for Investigational Drugs and Biological Products. On 11th September, final guidance was published providing recommendations to institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions, including for reviews conducted by a single member of the IRB, to fulfil its obligations under 21 CFR (Code of Federal Regulations) part 56. Click to view source
- Clinical Pharmacology Considerations for Peptide Drug Products. On 11th September, draft guidance was published describing the FDA’s recommendations concerning clinical pharmacology considerations for peptide drug product development programs, including hepatic impairment, drug-drug interactions (DDIs), assessing QTc prolongation risk, and immunogenicity risk and impact on the pharmacokinetics (PK), safety, and efficacy assessment. The intent of this guidance, when finalised, is to assist industry in the conduct of these development programs. Click to view source
Industry Updates
Brainomix enters TIPAL trial to assess its novel IPF biomarker in lung disease
On 8th September, Brainomix, a company specialising in the creation of AI software solutions to enable precision medicine, announced that they will be partnering with the TIPAL trial group to run a sub-study to assess the efficacy of its ground-breaking e-Lung platform. The TIPAL trial, funded by the National Institute of Health Research (NIHR) and sponsored by the Norfolk and Norwich University Hospitals (NNUH) NHS Foundation Trust, is a placebo-controlled 52-week multi-centre study that is evaluating the impact of lansoprazole – a commonly prescribed medication for indigestion, heartburn, and acid reflux – on patients with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). The study will incorporate the company’s e-Lung platform, an AI-powered image processing module and tool that standardizes the quantification of lung fibrosis on high-resolution (HR) CT scans to identify progressive fibrosis patients more accurately.
Couple receive prison sentence for illegal possession and supply of £1.6m of unlicensed medicines
On 8th September, a Berkshire couple were each sentenced to eight months in prison for the illegal possession and intent to supply unlicensed medicines, including prescription-only medicines, valued at £1.6m following investigations by the MHRA.
FDA takes action to approve COVID-19 vaccines to target the current circulating variants
On 11th September, the FDA began approving and authorising for emergency use updated COVID-19 vaccines formulated to target current circulating variants and to provide better protection against serious consequences of COVID-19, including hospitalisation and death. These actions relate to updated mRNA vaccines for 2023-2024 manufactured by ModernaTX Inc. and Pfizer Inc., and consistent with the entirety of the evidence and input from the FDA’s expert advisors, these vaccines have been updated to include a monovalent component that corresponds to the Omicron variant XBB.1.5.
FDA issues warning letters to firms marketing unapproved eye products
On 12th September, the FDA issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law. These warning letters are part of the agency’s ongoing effort to protect US citizens from potentially harmful ophthalmic products.
EMA releases information on the third Veterinary Big Data Stakeholder Forum
The European Medicines Agency (EMA) and the EU Veterinary Big Data Hub released information on the third edition of the Veterinary Big Data Stakeholder Forum. To be held online on the 23rd of November 2023, the event will aim to:
- Report on the EU Veterinary Data Hub activities and the HMA/EMA Veterinary Big Data work plan.
- Resume the discussion on the identified use cases, collect inputs, and learn from existing experiences from stakeholders’ experts.
- Open the floor to discuss upcoming challenges and future needs of big data in the veterinary regulatory domain.
Registration for the webinar closes on 22nd November 2023.
University of Strathclyde spinout Microplate Dx secures £2.5 million to develop diagnostic tech
On 11th September, the University of Strathclyde’s diagnostics spinout Microplate Dx announced it closed a £2.5M seed funding round to develop its point-of-care diagnostic platform which can confirm the presence of bacteria and guide a patient’s doctor to effective treatment by rapidly identifying effective antibiotics to use and which ones to avoid. Combining novel hardware with proprietary data processing algorithms, Microplate Dx has developed a platform for rapid antibiotic susceptibility testing, enabling the optimum antibiotic to be prescribed by a clinician in minutes rather than days.
Eisai establishes new digital business company to develop ‘dementia ecosystem’
On 12th September Eisai Co., Ltd. announced it has established a digital business company to accelerate the development of a dementia ecosystem. The launch builds on the Japanese pharmaceutical company’s expertise in the use of digital health systems to support people with dementia, as well as its established medicines to treat Alzheimer’s disease.
UKRI’s MRC invests £2m in hard-to-tackle cancers
On 12th September, the UK Research and Innovation’s (UKRI) Medical Research Council (MRC) announced it has invested £2m in four research innovation teams to understand and treat cancers with poor survival rates, including those of the brain, lung, and oesophagus. The projects were selected following a two-day ‘sandpit’ event designed to promote new conversations and create teams of researchers across scientific disciplines from clinical, biomedical, engineering, physical and data sciences.
New report reveals impact of UKRI’s COVID-19 research and innovation funding
On 14th September, the UKRI released an independent report revealing the pivotal role played by UK researchers and innovators in tackling the pandemic. The report ‘Impact Evaluation of UKRI’s Research and Innovation Funding Response to COVID-19‘ describes how publicly funded research across the spectrum helped to shape government decision-making, ease the impact of the pandemic and ultimately save lives.
Issue Number: WN00129
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