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| http://dx.doi.org/10.3389/fnut.2023.1194053 | DOI Listing |
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Andexanet alfa: trials just leave us with more questions.
Res Pract Thromb Haemost
January 2025
Department of Cardiovascular Sciences, University of Birmingham, Birmingham, United Kingdom.
Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor (ANNEXA-I), the first ever randomized controlled trial of a reversal agent for direct oral anticoagulants, was published in 2024. The trial, which randomized patients with intracranial hemorrhage to andexanet alfa or usual care, was mandated by the United States Food and Drug Administration as part of its conditional approval in 2018. This approval was originally based on the single-arm trial, The Andexanet Alfa, a Novel Antidote to the Anticoagulation Effects of Factor Xa Inhibitors (ANNEXA-4).
View Article and Find Full Text PDFComparison of good review practices of seven countries participating in the ECOWAS medicines regulatory harmonisation initiative: identifying opportunities for improvement.
Front Med (Lausanne)
January 2025
School of Life and Medical Sciences, University of Hertfordshire, Hatfield, United Kingdom.
Introduction: When implemented by national and regional regulatory agencies good review practices (GRevPs) support the timely high-quality review of medicines for enhanced patients' availability to safe, quality and efficacious innovative and generic products. It is important that all aspects of GRevPs are continuously evaluated and updated to promote the continuous improvement of regulatory systems at national and regional levels. The aim of this study was to assess and compare the GRevPs of the national medicines regulatory agencies (NMRAs) of Burkina Faso, Cote d'Ivoire, Ghana, Nigeria, Senegal, Sierra Leone and Togo, who are active participants of the ECOWASMRH initiative to identify opportunities for improvement.
View Article and Find Full Text PDFInfant respiratory infections modulate lymphocyte homing to breast milk.
Front Immunol
January 2025
Laboratorio de Pediatria Clinica (LIM36), Hospital das Clinicas HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo, Sao Paulo, Brazil.
Introduction: Chemokines and their receptors are essential for leukocyte migration to several tissues, including human milk. Here, we evaluated the homing of T and B lymphocyte subsets to breast milk in response to ongoing respiratory infections in the nursing infant.
Methods: Blood and mature milk were collected from healthy mothers of nurslings with respiratory infections (Group I) and from healthy mothers of healthy nurslings (Group C).
Overweight and glucose/lipid metabolism abnormality associated with SSRIs: a pharmacovigilance study based on the FDA adverse event reporting system.
Front Pharmacol
January 2025
Fengxian Hospital, Southern Medical University, Shanghai, China.
Background: In the past few decades, selective serotonin reuptake inhibitors (SSRIs) became widely used antidepressants worldwide. Therefore, the adverse reactions of patients after SSRI administration became a public and clinical concern. In this study, we conducted a pharmacovigilance study using the Adverse Event Reporting System (FAERS) database of the US Food and Drug Administration.
View Article and Find Full Text PDFSustainable, greenhouse gas derived fermented protein in canine diets-a pilot study.
Front Vet Sci
January 2025
School of Science, STEM College, RMIT University, Melbourne, VIC, Australia.
Sustainability concerns have increased consumer demand for non-animal-derived proteins and the search for novel, alternative protein sources. The nutritional sustainability of the food system without compromising the nutrient quality, composition, digestibility and consumption is pivotal. As with farmed livestock, it is imperative to ensure the well-being and food security of companion animals and to develop sustainable and affordable pet foods.
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