Tower Mains Weekly Newsletter
Company Updates
We are delighted to announce that we have moved our office to Newington Business Centre, 5, Dalkeith Road Mews, Edinburgh, EH16 5GA. We couldn’t be more excited about the possibilities our new office will bring and as we settle into our new space, we remain committed to delivering excellence in what we do!
Regulatory Updates
MHRA guidance updates
- Medical devices: guidance for manufacturers on vigilance. On 3rd August, the Medicines and Healthcare products Regulatory Agency (MHRA) updated guidance on reporting adverse incidents and field safety corrective actions to reflect the latest information regarding the Manufacturer’s On-line Reporting Environment (MORE) portal. Click to view source
- Register medical devices to place on the market. On 3rd August, both the Account Management Reference Guide and Device Registration Reference Guide were updated. Click to view source
- Export medical devices. On 3rd August, the ‘Certificates of Free Sale for Medical Devices’ reference guide was updated in the MHRA guidance on ordering a certificate of free sale to export medical devices outside the UK. Click to view source
- Squamous cell carcinoma (SCC) and different types of lymphomas occurring in the capsule around breast implants. On 7th August, guidance was published following the small number of cases of squamous cell carcinoma (SCC) and different types of lymphoma, found within the fibrous capsule that forms around breast implants. Click to view source
- Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing. On 9th August, clarification was published regarding the recent CMDh Q&A update (version 16). Click to view source
FDA guidance updates
- Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities. On 4th August, the US Food and Drug Administration (FDA) published final guidance providing applicants and manufacturers of drugs, including prescription and over-the-counter (OTC) drug products, with a recommended framework for predicting the mutagenic and carcinogenic potential of NDSRIs that could be present in drug products and recommends acceptable intake (AI) limits for NDSRIs. NDSRIs, which are a subcategory of nitrosamine impurities that share structural similarity to the active pharmaceutical ingredient (API) in drug products, typically lack compound-specific mutagenicity and carcinogenicity data to inform safety assessments. Click to view source
- QTc Information in Human Prescription Drug and Biological Product Labelling. On 8th August, draft guidance was published intended to assist applicants with incorporating QTc interval prolongation-related information into the labelling of non-antiarrhythmic human prescription drugs and biological products. It provides recommendations to help ensure that clinically relevant information on QTc interval prolongation is included in and distributed appropriately across sections of labelling, per regulatory requirements for the content and format of human prescription drug labelling. Click to view source
Industry Updates
FDA authorises Viz.AI’s standalone electrocardiogram (ECG) analysis software to identify HCM
On 3rd August, the FDA authorised marketing for Viz.AI’s Viz HCM, a standalone electrocardiogram (ECG) analysis software to identify patients 18 or older for further follow-up for hypertrophic cardiomyopathy (HCM), a rare condition in which the heart muscle becomes abnormally thick and makes it difficult for the heart to pump blood. This device can analyse recordings from compatible 12-lead ECGs, detect signs associated with HCM, and allow the user to view the ECG and software analysis. The device does not provide a diagnosis of HCM and is not intended for use on patients with implanted pacemakers.
First oral treatment for postpartum depression approved in the US
On 4th August, Sage Therapeutics, Inc. and Biogen Inc. announced the FDA has approved ZURZUVAETM (zuranolone) 50mg to treat postpartum depression (PPD) in adults. It is the first and only oral, once-daily, 14-day treatment that can provide rapid improvements in depressive symptoms for women with PPD and is expected to launch and be commercially available in the fourth quarter of 2023.
Improving medication adherence and patient experience by researching perceptions of generic drugs
The Center for Drug Evaluation and Research (CDER) has published a CDER Conversation where Iilun Murphy, Director of CDER’s Office of Generic Drugs (OGD), discusses how OGD is conducting and funding research to better understand how the office can best educate patients and health care providers about generic drugs. Greater education and outreach to patients about generic drug standards could help dispel misconceptions about the quality and effectiveness of generic drugs. This, in turn, will promote the use of generic drugs, leading to improved medication adherence and better patient outcomes.
Scottish Medicines Consortium publishes advice on five medicines
On 7th August, the Scottish Medicines Consortium (SMC), which advises on newly licensed medicines for use by NHS Scotland, published advice on five medicines including Tezepelumab for extreme asthma and Dapagliflozin for the treatment of chronic heart failure.
Infex Therapeutics candidate nominated for COV-X programme
On 7th August, Infex Therapeutics, a leading anti-infectives specialist, revealed the nomination of a clinical candidate for its in-house developed COV-X programme. The candidate for COV-X – Infex’s novel first-in-class small molecule oral pan-coronavirus PLPRO inhibitor – was selected following excellent in vivo efficacy data in a murine SARS-CoV-2 model that showed a near complete reduction in SARS-CoV-2 viral load in the lungs and an outstanding safety profile when compared to an approved MPRO inhibitor. It targets the key coronavirus PLPRO enzyme, which is essential for viral replication and evasion of host immune response, and is conserved across SARS-CoV-2, SARS-CoV-1, MERS, and all related coronavirus variants so, as a result, COV-X has the potential for broad-spectrum efficacy against new coronaviruses or variants thereof with pandemic potential.
Astex Pharmaceuticals announces research collaboration with MSD
On 8th August, Astex Pharmaceuticals, a pharmaceutical company focused the discovery and development of novel small molecule therapeutics for oncology and diseases of the central nervous system, announced a research collaboration and license agreement with MSD. The collaboration aims to identify small molecule candidates with activity towards a tumour suppressor protein for the treatment of cancer. Under the terms of the agreement, Astex will apply its fragment-based drug discovery platform to develop compounds targeting multiple forms of the p53 tumour suppressor protein and provide MSD with lead compounds for further optimisation and pre-clinical development.
Issue Number: WN00124
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.”