Our weekly newsletter provides you with the latest industry news, developments and regulatory agency updates.

Company Updates

Key Considerations for a Good Lab Investigation

When things don’t go to plan in a laboratory, a good investigation is pivotal to understanding what went wrong and ensuring all necessary steps have been taken to identify the error, understand the root cause, and prevent recurrence.

Our Senior Associate, Anna Lothian, has compiled some of her top tips to help you maximise the effectiveness of your laboratory investigations. To read, click on this link.

Regulatory Updates

Two new advice pilots launched to improve clinical trials in the EU

On 10th June, the Accelerating Clinical Trials in the EU (ACT EU) initiative – a collaboration between the European Medicines Agency (EMA), the Heads of Medicines Agencies (HMA) in the Member States and the European Commission – launched two advice pilots aimed at improving the quality of applications for clinical trials. By strengthening the coordination of the European medicines regulatory network, these advice pilots offer applicants additional support to enhance the quality of their applications for marketing and/or clinical trial authorisation.

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Artificial Intelligence Program: Research on AI/ML-Based Medical Devices

On 10th June, the US Food & Drug Administration (FDA) updated the Artificial Intelligence (AI) Program: Research on AI/Machine Learning (ML) Based Medical Devices web page to include six new web pages about the Office of Science and Engineering Laboratories regulatory science research activities related to AI/ML.

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ICH releases highlights from June Assembly meeting

On 12th June, the International Council for Harmonisation (ICH) issued highlights from its in-person Assembly held on 4th-5th June in Fukuoka, Japan. This was in parallel with meetings of 13 Working Groups and preceded by meetings of the ICH Management Committee and the MedDRA Management Committee. Topics include new areas of harmonisation, progress on ICH guideline development and important revisions.

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Industry Updates

WHO appoints Director-General Special Envoy for Chronic Respiratory Diseases

On 6th June, the World Health Organisation (WHO) announced the appointment of Mr José Luis Castro as WHO Director-General Special Envoy for Chronic Respiratory Diseases. The appointment of Mr Castro aims to support WHO by highlighting the significance of respiratory health.

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US researchers develop AI blood test to provide a reliable way to identify lung cancer

On 6th June, the Johns Hopkins Kimmel Cancer Center announced its researchers, in collaboration with other institutions, have developed and validated a liquid biopsy test using artificial intelligence (AI) to help identify lung cancer earlier. The team plans to seek approval from the FDA for lung cancer screening and plans to determine whether a similar approach could be used to detect other types of cancer.

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Dundee University’s latest research could lead to drugs to benefit Parkinson’s patients

On 7th June, the University of Dundee revealed its scientists have uncovered the inner relay of a molecular switch that protects the brain against the development of Parkinson’s disease. The research provides new potential strategies to develop drugs that may benefit patients with disease.

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ICL receives £10m gift to advance heart and lung research

On 7th June, the Imperial College London (ICL) announced it has been gifted a £10m donation from the Victor Dahdaleh Charitable Foundation to advance heart and lung research. The funds will support the refurbishment of the Dr Victor Phillip Dahdaleh Building – a new home for world-changing lung research at Imperial’s Hammersmith Hospital Campus – and create the Dr Victor Phillip Dahdaleh Graduate Centre for Respiratory and Cardiac Sciences at the National Heart and Lung Institute (NHLI). In addition, a further £2.5m donation will support the establishment of Dr Victor Phillip Dahdaleh Graduate Fellowships over the next three years.

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Serac’s imaging agent marks a breakthrough in endometriosis detection

On 7th June, Serac Healthcare Limited, a clinical radiopharmaceutical company developing an innovative molecular imaging agent, and the Nuffield Department of Women’s and Reproductive Health at the University of Oxford announced that further data has been presented from the “Detecting Endometriosis expressed integrins using technetium-99m” (DETECT) imaging study, indicating that 99mTc-maraciclatide is capable of imaging superficial peritoneal endometriosis, the earliest stage of the disease.

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FDA launches CDER Emerging Drug Safety Technology Program (EDSTP)

On 10th June, the FDA launched the Emerging Drug Safety Technology Program (EDSTP), which will administer the Emerging Drug Safety Technology Meeting (EDSTM) Program. The EDSTP is specifically focused on the use of artificial intelligence (AI) and other emerging technologies in pharmacovigilance (PV) and is part of the Center for Drug Evaluation and Research’s (CDER) multifaceted approach to enhance mutual learning of where and how specific innovations, such as AI, can best be used across the drug product lifecycle.

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AstraZeneca’s Tagrisso granted Priority Review for unresectable, Stage III EGFR-mutated lung cancer

On 10th June, AstraZeneca announced its supplemental New Drug Application (sNDA) has been accepted and granted Priority Review by the FDA for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT). If approved, Tagrisso will be indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.

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Glenmark Pharma gets FDA approval for capsules used to treat stomach issues

On 12th June, Glenmark Specialty SA announced it has received final approval from the FDA for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg, determined by the FDA to be bioequivalent1 to Nexium®2 24 HR Delayed-Release Capsules for the treatment of stomach and oesophagus issues like acid reflux and ulcers by reducing stomach acid.

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Issue Number: WN00166

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