Tower Mains Weekly Newsletter

Company Updates

Tower Mains is delighted to welcome Olga Pavlovska as Senior Associate. Olga will be providing clinical quality assurance support to our clients.

We are exhibiting at the Virtual European QA Congress 2022 on the 11th and 12th of May. Visit our virtual stand and ask us any QA, Training, and QMS-related questions, or just pop by and say hello.

Industry Updates

EMA issues highlights from the latest PRAC meeting

On 6th May, the European Medicines Agency (EMA) issued meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) held on the 2nd-5th May 2022.

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European Commission issues agenda for next Pharmaceutical Committee

On 4th May, the European Commission issued the agenda for the 99th meeting of the Pharmaceutical Committee, being held on the 11th of May 2022.

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FDA permits marketing for new test to improve diagnosis of Alzheimer’s disease

On 4th May, the US Food and Drug Administration (FDA) permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations found in human cerebral spinal fluid (CSF), which can help physicians decide whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease. The test is aimed to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

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Imfinzi plus chemotherapy granted Priority Review in the US for patients with biliary tract cancer

On 5th May, AstraZeneca announced its supplemental Biologics License Application (sBLA) for Imfinzi, in combination with chemotherapy, has been accepted and granted Priority Review by the FDA for patients with locally advanced or metastatic biliary tract cancer (BTC). The sBLA was based on results from an interim analysis of the TOPAZ-1 Phase III trial presented during the 2022 American Society of Clinical Oncology Gastrointestinal Cancers (ASCO GI) Symposium. The data showed that Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone. An estimated 25% of patients treated with Imfinzi plus chemotherapy were alive at two years compared to 10% treated with chemotherapy alone.

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MHRA updates guidance on the Northern Ireland MHRA Authorised Route

On 5th May, the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on the medicines eligible for supply through the Northern Ireland MHRA Authorised Route (NIMAR). The spreadsheet was replaced with an updated version to include the following listing: ‘Fondaparinux sodium 7.5mg/0.6ml solution for injection, pre-filled syringe’.

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WHO launches first-ever global report on infection prevention and control

On 6th May, the World Health Organisation (WHO) launched the first-ever Global Report on Infection Prevention and Control (IPC) which brings together evidence from scientific literature and various reports, and new data from WHO studies. The report provides a global situation analysis of how IPC programmes are being implemented in countries around the world, including regional and country focuses and addresses the impact and cost-effectiveness of infection prevention and control programmes and the strategies and resources available to countries to improve them. Data from the report shows that where good hand hygiene and other cost-effective practices are followed, 70% of those infections can be prevented.

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FDA announces draft guidance on benefit-risk considerations for product quality assessments

On 9th May, the FDA announced the availability of draft guidance for industry, Benefit-Risk Considerations for Product Quality Assessments. This guidance describes the benefit-risk principles applied by the FDA when conducting product quality-related assessments of chemistry, manufacturing, and controls information submitted for FDA assessment as part of original new drug applications (NDAs), original biologics license applications (BLAs), or supplements to those applications, in addition to other information available to the FDA during its assessment. Comments on the draft guidance can be submitted by the 10th of July.

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FDA approves a new indication for Olumiant for the treatment of COVID-19

On 10th May, the FDA approved a new indication for Olumiant for the treatment of COVID-19 in hospitalised adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Olumiant remains under EUA (Emergency Use Authorisation) status for hospitalised paediatric patients aged two to less than 18 years of age requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. The FDA has revised the Letter of Authorisation and associated fact sheets to remove the population covered under the approved indication.

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MHRA updates mRNA COVID-19 vaccine information to reflect removal of 15-minute observation period

On 10th May, the MHRA updated the mRNA COVID-19 vaccine information to reflect the fact that the 15-minute observation period following vaccination has been removed for individuals aged 12 years and over who have no history of a severe allergic reaction.

View Pfizer/BioNTech vaccine information        View Spikevax vaccine information

MHRA Compliance Monitor Process: CM role and application process

As announced in March 2022, the MHRA has started a pilot for GMP and GDP remediation supervision by eligible consultants acting as Compliance Monitors (CM). The pilot aims to establish a framework for the CM to conduct the remediation work but also report on progress to the MHRA. Following on from the introductory first blog, the second blog – published on the 10th of May – provides details on the CM role and application process.

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Issue Number: WN00060

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