Tower Mains Weekly Newsletter
Company Updates
We Are Hiring: Principal Associate, Clinical QA
We are looking for an experienced individual to join our team in support of clinical audit and consultancy services supporting GCP training, audit, and client QAU and QMS development. The role is flexible and can be adapted to the right person for hours and travel. For more information, please click here.
Regulatory Updates
MHRA guidance updates
- Established Medicines marketing authorisation application process changes. On 11th March, the Medicines and Healthcare products Regulatory Agency (MHRA) updated the marketing authorisation application process for Established Medicines. Click to view source
FDA guidance updates
- Developing drugs for the treatment of early Alzheimer’s disease. On 12th March, the US Food & Drug Administration (FDA) published draft guidance to assist sponsors in the clinical development of drugs for the treatment of the stages of sporadic Alzheimer’s disease (AD) that occur before the onset of overt dementia. It revises the previous draft guidance for industry of the same name issued on February 16, 2018. Click to view source
- E2D(R1) post-approval safety data: Definitions and standards for management and reporting of individual case safety reports. On 13th March, draft guidance was made available on definitions and standards for post-approval individual case safety reporting, as well as good case management practices. This was originally based on the content of the ICH E2A guideline (which provides guidance on pre-approval safety data management), considering how the terms and definitions should be applied in the post-approval phase of the product life cycle. Click to view source
- Annual reportable labelling changes for new drug applications and abbreviated new applications for non-prescription drug products. On 13th March, draft guidance was published providing recommendations to applicants of approved new drug applications (NDAs) and abbreviated new drug applications (ANDAs) for non-prescription drug products on documenting minor labelling changes in the next annual report and providing examples of minor labelling changes that may be submitted in an annual report. The recommendations in this draft guidance address the types of minor labelling changes that may be appropriate to submit in an annual report to ensure that consumers have timely access to the most current labelling for a non-prescription drug product to ensure the product’s safe and effective use. Click to view source
Industry Updates
Wegovy® approved in the US to reduce risk of cardiovascular problems in overweight or obese adults
On 8th March, Novo Nordisk announced that the FDA has approved a label expansion for Wegovy® based on a supplemental New Drug Application (sNDA) for the indication of reducing risks of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with either overweight or obesity and established cardiovascular disease (CVD).
European Commission releases fact sheets relating to medicines in the EU
On 11th March, the European Commission published the following fact sheets:
- Access to medicines in all Member States
- Addressing shortages of medicines and ensuring security of supply
- Steering innovation to address unmet medical needs
UK government to tackle potential bias in the design and use of medical devices
On 11th March, the UK government announced action to tackle potential bias in the design and use of medical devices, in response to the Equity in Medical Devices: Independent Review identifying the extent and impact of ethnic and other biases. The action includes:
- Working with the MHRA to ensure regulations for medical devices are safe for patients, regardless of their background, while allowing more innovative products to be placed on the UK market.
- Driving forward work to remove racial bias in datasets, including ensuring diverse skin tones are included in data used by researchers for clinical studies.
- Collaborating with partners to improve transparency of data used in developing medical devices using artificial intelligence (AI), as well as AI products which influence clinical decisions.
The MHRA also published a response to the review, stating that it is fully committed to ensuring equitable access to safe, effective, and high-quality medical devices for all individuals who use them.
Positive study results pave way for development of the first oral treatment for obstructive sleep apnoea
On 11th March, Desitin, a company specialising in neurological and psychiatric therapeutics, reported positive study results from its FLOW study with 298 patients: nocturnal breathing pauses in patients with obstructive sleep apnoea (OSA) were significantly reduced, thus meeting the primary endpoint of the study. With these positive results, a reliable basis for the final clinical phase 3 development of the first oral treatment for OSA has been established.
European Commission proposes new measures for better lifecycle management of medicine authorisations
On 12th March, the European Commission announced it intends to amend the variation legislation for medicines, to make the lifecycle management of medicines more efficient and better adapted to the modern context. The Regulation, which is part of the EU’s Pharmaceutical Strategy for Europe, adapts the current system for variations to marketing authorisations, to make it more efficient, reduce administrative burdens and better respond to scientific and technological advances.
Modified MAGEC X system for early onset scoliosis treatment can now be used in the UK
On 12th March, the MHRA announced the UK suspension of the MAGnetic Expansion Control (MAGEC) System (modified MAGEC X system only) has been lifted. The agency is satisfied that the manufacturer, NuVasive Specialized Orthopaedics (NSO), has put in place sufficient measures to provide reassurance about the safety of this device. The MAGnetic Expansion Control X (MAGEC X) system is an orthopaedic spinal rod for use in skeletally immature patients less than 10 years of age. It helps correct spinal deformities as the child grows, minimising the need for repeated invasive surgeries to correct the spinal curve. All previous generations of the MAGEC system (MAGEC 1,1.5, 2B) remain suspended in the UK and should not be implanted.
AbbVie’s Produodopa approved to treat Parkinson’s disease patients in Scotland
On 13th March, the Scottish Medicines Consortium (SMC) announced that AbbVie’s Produodopa has been accepted for use within NHS Scotland to treat advanced levodopa-responsive Parkinson’s disease (PD). This consortium also published advice on four other drugs including Olaparib (Lynparza®) for use together with another cancer medicine for treating patients with advanced prostate cancer.
King’s College scientists develop a novel pipeline to create custom cell culture devices
On 14th March, Kings College London (KLC) announced that scientists at the UK Dementia Research Institute at the Institute of Psychiatry, Psychology & Neuroscience have developed a process enabling custom cell culture device creation. The SOL3D pipeline is cheaper, versatile, highly reproducible and allows any wet lab, regardless of equipment, expertise, or field, to produce their own customised systems.
Issue Number: WN00153
Would you like a personal copy of the Tower Mains Weekly Newsletter directly to your mailbox each month? Just send an email to info@towermains.com with the subject “Weekly Newsletter Please.”