Tower Mains Weekly Newsletter

Company Updates

We have exciting news! Tower Mains is delighted to announce the following promotions 

  • Our Associate Director and Head of Operations Lianne Roeling will be expanding her Business Development role, specifically to support the growth of our training services.  
  • Naomi Ervine who has been promoted to Principal Associate. Naomi will be coordinating our training services and will continue to be part of the Clinical and Quality Management team. 
  • Rita Silvestre has been promoted to Senior Associate and will take on additional responsibilities within the Clinical and Quality Management team and will extend our ISO 9001 capabilities.  
  • Nicole LeBlanc has been promoted to Senior Associate and will take on additional responsibilities within the QA team. 

Managing Director, Dr Andrew Waddell, commented, “Congratulations to all four on their well-deserved promotions. We will also be announcing an expansion of the Tower Mains team in the near future.” 

Regulatory Updates

MHRA updates its guidance on clinical trials for medicines 

On 9th August, the MHRA removed one of the SUSAR reporting routes from the Suspected Unexpected Serious Adverse Reactions (SUSARs) section in the guidance for clinical trials for medicines. The guidance provides information on changing protocol, updating authorisation, reporting safety issues, submitting safety updates, and completing an end-of-trial study report. 

Click to view source  

Industry Updates

FDA: Breakthrough Devices Program 

On 3rd August, the US Food and Drug Administration (FDA) updated its list of Breakthrough Devices that have been authorised for marketing. The list now includes more than 50 Breakthrough Devices authorised for marketing and the online metrics show the number of granted device designations by fiscal year and by clinical panel. The Breakthrough Devices Program provides patients and health care providers with timely access to medical devices by speeding up their development, assessment, and review while preserving the statutory standards consistent with the FDA’s mission to protect and promote public health. 

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MHRA Inspectorate: Decommission of eSUSAR 

On 3rd August, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the retirement of the eSUSAR website in favour of Individual Case Safety Reports (ICSR) Submissions, which will provide users with a more robust and transparent way of expediting suspected unexpected serious adverse drug reactions (SUSARs) from Clinical Trials of Investigational Medicinal Products. The website will be decommissioned at the end of September 2022 and only SUSARS via ICSR Submissions portal will be accepted from 1st October 2022. 

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FDA issues warning letter to GLP facility

On 3rd August, the FDA published a warning letter sent to a GLP facility in California. The violations include failure to retain all raw data, documentation, protocols, final reports, and specimens and failure to ensure that each individual engaged in the study had the education, training, and/or experience to enable them to perform their assigned functions.

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MHRA and CAP warn against illegal ‘hayfever injection’ adverts online 

On 4th August, the Advertising Standards Authority, the MHRA, and the Committees of Advertising Practice (CAP) issued a joint enforcement announcement about the advertising of Kenalog injections online. Kenalog is not licensed for the treatment of hayfever in the UK, although it is offered by some beauty and aesthetics clinics, under the personal responsibility of an individual prescriber, and advertised widely on social media. The enforcement notice warns all organisations offering the medicine as a hayfever treatment to stop advertising it on their social media or website. 

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FDA approves first targeted therapy for HER2-low breast cancer 

On 5th August, the FDA approved Enhertu, the first approved therapy targeted to patients with the HER2-low breast cancer subtype, which is a newly defined subset of HER2-negative breast cancer. The approval is based on a DESTINY-Breast04 clinical trial that enrolled 557 adult patients with unresectable or metastatic HER2-low breast cancer. The results showed improvement in both progression-free survival and overall survival in people with unresectable or metastatic HER2-low breast cancer. Patients with HER2-low breast cancer are eligible for Enhertu if they have received prior chemotherapy in the metastatic setting, or their cancer returned during, or within 6 months of completing, adjuvant chemotherapy. 

Click to view source View on AstraZeneca website 

Verona’s Ensifentrine meets primary endpoint in Phase 3 ENHANCE-2 Trial for COPD 

On 8th August, Verona Pharma plc announced its top-line Phase 3 ENHANCE-2 trial results evaluating nebulized ensifentrine for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The ENHANCE-2 trial has successfully met its primary endpoint, as well as secondary endpoints demonstrating improvements in lung function, and significantly reduced the rate and risk of COPD exacerbations. Ensifentrine is a dual inhibitor of the enzymes phosphodiesterase 3 and 4, combining bronchodilator and anti-inflammatory activities in one compound. 

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Monkeypox: FDA issues emergency use authorisation for JYNNEOS to increase vaccine supply 

On 9th August, the FDA issued an emergency use authorisation (EUA) for the JYNNEOS vaccine to allow healthcare providers to use the vaccine by intradermal injection for individuals 18 years of age and older who are at high risk for monkeypox infection. This will increase the total number of doses available for use by up to five-fold. The EUA also allows for use of the vaccine in individuals younger than 18 years of age determined to be at considerable risk of monkeypox infection; in these individuals, JYNNEOS is administered by subcutaneous injection. 

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Issue Number: WN00073

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