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Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 25-28 November 2024

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New safety information for healthcare professionals Veoza (fezolinetant): new recommendations to minimise risk of liver injury The PRAC has agreed to a direct healthcare professional communication (DHPC) informing of the risk of drug-induced liver injury (DILI) with Veoza (fezolinetant) and has recommended monitoring of liver function before and during treatment. Veoza is a medicine used to treat moderate-to-severe vasomotor symptoms (also referred to as hot flushes or night sweats) associated with menopause. The committee considered a review of the potential risk of fezolinetant to cause drug-induced liver injury based on information from all available sources, including reports of suspected side effectsand studies published in the scientific literature. Severe elevations of the liver enzymes alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (>10x upper limit of normal) with concurrent elevations in bilirubin and/or alkaline phosphatase (ALP) have been reporte...
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Cell therapy weekly: partnerships for advancing cell and gene therapies

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This week: Partnerships to advance cell and gene therapies have been announced, focusing on three key areas: developing gene therapies, enhancing cell and gene therapy manufacturing and developing treatments for difficult-to-treat conditions. The news highlights:Centers of excellence for gene therapy research Advancing cell and gene therapy manufacturing Developing therapies for difficult-to-treat conditions Centers of excellence for gene therapy research The Medical Research Centre (MRC), part of UK Research and Innovation (UKRI; both Swindon, UK) is establishing two Centers of Research Excellence (CoRE) to advance therapies for untreatable diseases, each receiving up to roughly US$64 million over 14 years aiming to transform treatments for diseases such as heart disease, immune disorders and neurodegenerative diseases like Huntington’s disease. Oxford University (UK) will lead the MRC/BHF CoRE in Advanced Cardiac Therapies, which will be co-funded with the British Heart Foundati...
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