Receipt of long-acting injectable antiretroviral therapy among people with HIV in Southern US states: an assessment using electronic health records and claims data by Yiyang Liu, Rebecca J. Fisk-Hoffman, Maitri Patel, Robert L. Cook, Mattia Prosperi

“…Abstract Background In January 2021, the United States (US) Food and Drug Administration (FDA) approved the first long-acting injectable antiretroviral therapy (LAI ART) regimen for the treatment of HIV providing an alternative to daily oral regimens. …”
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Data mining and safety analysis of voriconazole in patients with a hematological malignant tumor based on the FAERS database: differences between children and adults by Hao Li, Hao Li, Manxue Jiang, Manxue Jiang, Xiaona Pan, Lingti Kong, Lingti Kong, Lingti Kong

“…We assessed the adverse drug events (ADEs) of voriconazole in this population based on the US Food and Drug Administration Adverse Event Reporting System (FAERS) database to improve understanding of the safety of voriconazole.Research design and methodsADE reports for patients with a hematological malignant tumor using voriconazole between the first quarter of 2004 to the first quarter of 2024 were retrieved. …”
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Safety assessment of tolvaptan: real-world adverse event analysis using the FAERS database by Peiyang Cao, Qian Wang, Yan Wang, Qing Qiao, Liyuan Yan

“…ObjectiveThis study aims to analyze the adverse drug events (ADEs) associated with tolvaptan in the Food and Drug Administration Adverse Event Reporting System database from the fourth quarter of 2009 to the second quarter of 2024.MethodsAfter standardizing the data, various signal detection techniques, including Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network, and Multi-Item Gamma Poisson Shrinker, were employed for analysis.ResultsAmong the 7,486 ADE reports where tolvaptan was the primary suspected drug, a total of 196 preferred terms were identified, spanning 24 different system organ classes. …”
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High-risk adverse events in two types of single inhaler triple-therapy: a pharmacovigilance study based on the FAERS database by Zhishen Ruan, Chunbin Wang, Shasha Yuan, Yiling Fan, Bo Xu, Xiaodong Cong, Dan Li, Qing Miao

“…BUD/GLY/FOR (2020Q3-2024Q3) and FF/UMEC/VI (2018Q1-2024Q3) report files were downloaded from the U.S. Food and Drug Administration’s (FDA) Adverse Event Reporting System (FAERS) database. …”
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Environmental sustainability profiles assessment of HPLC stability indicating method for quantitation of piracetam and vincamine in pharmaceutical medications by Samya Sh. Alenezi, Ayman A. Gouda, Ragaa El Sheikh, Niaf A. Badahdah, Muneer E Alzuhiri, Ali H. Magrabi, Asim L. Jilani, Ahmed S. Darwish

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Принципы использования рекомбинантных аденоассоциированных вирусов в исследованиях и терапии by Марченко С.А., Ланшаков Д.А.

“…В 2023 г. Food and Drug Administration (FDA – Управление по контролю качества пищевых продуктов и лекарственных средств, США) был одобрен препарат Roctavian для лечения гемофилии A на основе AAV. …”
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Therapeutic potential of monomethyl fumarate and aluminum ion combination in alleviating inflammation and oxidative stress in psoriasis by Hang Han, Guojiang Zhang, Yuanyuan Yang, Chenxi Li, Xiandeng Li, Ling Zhong, Zan Chen, Jianxia Xiong, Tao Cai, Lingjuan Zhang, Xiao Zhang, Qinjian Zhao

“…Monomethyl fumarate (MMF), which has been approved by the US Food and Drug Administration in 2020 for multiple sclerosis, has demonstrated efficacy in psoriasis management. …”
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Utility of Integrated Analysis of Pharmacogenomics and Pharmacometabolomics in Early Phase Clinical Trial: A Case Study of a New Molecular Entity by Jaeseong Oh, Sojeong Yi, Namyi Gu, Dongseong Shin, Kyung-Sang Yu, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang

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CRISPR screen reveals modifiers of rAAV production including known rAAV infection genes playing an unexpected role in vector production by Emily E. O’Driscoll, Sakshi Arora, Jonathan F. Lang, Beverly L. Davidson, Ophir Shalem

“…Recombinant adeno-associated virus (rAAV) vectors are an effective and well-established tool in the growing gene therapy field, with five U.S. Food and Drug Administration-approved AAV-mediated gene therapies already on the market and numerous more in clinical trials. …”
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Cardiovascular toxicity of tisagenlecleucel in children and adolescents: analysis of spontaneous reports submitted to FAERS by Ganggang Wang, Lin Su, Yanjun Liu, Xiaohan Yang, Yi Li, Qi Mei, Qi Mei, Wen Gao

“…However, further research is required to better define its safety profile.ObjectivesTo determine the cardiovascular toxicity of tisagenlecleucel in children and adolescents.MethodsThe US Food and Drug Administration’s Adverse Event Reporting System was searched to identify cardiovascular adverse events (CVAEs) related to tisagenlecleucel in pediatric patients up to the age of 18 years.ResultsThe median time to onset of tisagenlecleucel-associated CVAEs was shorter than that of tisagenlecleucel-associated non-CVAEs (3 days [interquartile range (IQR) 1, 6] vs. 7 days [IQR 2, 54]). …”
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Haemophagocytic lymphohistiocytosis in patients treated with immune checkpoint inhibitors: analysis of WHO global database of individual case safety reports by Alessandro Ceschi, Roberta Noseda, Raffaela Bertoli, Laura Müller

“…We retrieved the individual case safety reports reporting HLH in association with ipilimumab, nivolumab, pembrolizumab, atezolizumab, avelumab or durvalumab, gathered in the database starting from the ICIs’ approval dates by the US Food and Drug Administration. The main outcome measures were co-suspected drugs, concurrent irAEs, HLH clinical, haematological and coagulation features, concomitant infections, HLH median time to onset and outcome.Results Among 49′883 ICI-related ADRs collated in VigiBase as of September 30th, 2018, HLH was reported in 38 cases of which 34 (90%) mentioned ICIs as the solely suspected drugs. …”
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CAR T-cell detection scoping review: an essential biomarker in critical need of standardization by Naomi Taylor, Nirali N Shah, David P Turicek, Victoria M Giordani, Josquin Moraly

“…Focusing on 21 clinical trials from the USA, featuring a Food and Drug Administration-approved CAR T-cell construct or one of its predecessors, 105 manuscripts were screened and 60 were selected for analysis, based on the inclusion of CAR T-cell expansion and persistence data. …”
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Active case detection and treatment of malaria in pregnancy using LAMP technology (LAMPREG): a pragmatic randomised diagnostic outcomes trial—study protocol by Mekonnen Teferi, Claire Kamaliddin, Hiwot Tilahun, Rediet Fikru Gebresenbet, Zelalem Mekonnen Bekele, Banchamlak Tegegne, Delenasaw Yewhalaw, Abebe Genetu Bayih, Dylan R Pillai, Filmona Mekuria, Getaneh Alemu, Beka Raya, Omar Abdullah, Taye Teka, James Cheaveau, Ruth Legese, Hiwot Asmerom, Ermias Hundito, Ebrahim Nursefa, Samuel Ayele

“…The primary outcome of the study is to measure birth weight.Ethics and dissemination The study was approved by the following ethical research boards: Armauer Hansen Research Institute/ALERT Ethics Review Committee (FORM AF-10-015.1, Protocol number PO/05/20), the Ethiopia Ministry of Science and Higher Education National Research Ethics Review Committee (approval SRA/11.7/7115/20), the Ethiopia Food and Drug Administration (approval 02/25/33/I), UCalgary Conjoint Health Research Ethics Board (REB21-0234). …”
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Drug-induced autoimmune-like hepatitis: A disproportionality analysis based on the FAERS database. by Wangyu Ye, Yuan Ding, Meng Li, Zhihua Tian, Shaoli Wang, Zhen Liu

“…This study aimed to systematically identify drugs linked to DI-ALH by analyzing adverse event reports from the U.S. Food and Drug Administration's (FDA) Adverse Event Reporting System (FAERS) database.…”
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Safety profiles of sevoflurane in pediatric patients: a real-world pharmacovigilance assessment based on the FAERS database by Chuang Yang, Bangjian Deng, Qiang Wen, Pei Guo, Xiang Liu, Chen Wang

“…ObjectiveThis study aimed to evaluate the safety profile of sevoflurane in pediatric populations using real-world data.MethodsData were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) from the first quarter of 2004 to the third quarter of 2024. …”
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The Effect of Lithium on Inflammation-Associated Genes in Lipopolysaccharide-Activated Raw 264.7 Macrophages by Raymond T. Makola, Vusi G. Mbazima, Matlou P. Mokgotho, Vincent S. Gallicchio, Thabe M. Matsebatlela

“…Lithium remains the preferred Food and Drug Administration- (FDA-) approved psychiatric drug for treatment of bipolar disorders since its medical establishment more than half a century ago. …”
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Adverse events in different administration routes of amiodarone: a pharmacovigilance study based on the FDA adverse event reporting system by Jingrong Yang, Mengfan You, Jingxin Wang, Rongfei Sun, Lili Han, Xiaonan Liu, Kaibin Niu, Kaidi Xing, Juanping Sun, Wenge Su, Yifei Wang

“…This study aims to address this gap by utilizing the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) to investigate the spectrum and timing of AEs related to amiodarone administration through disproportionality analysis and stratification methods.MethodsData from the FAERS database were analyzed using disproportionality analysis and reporting odds ratio (ROR) methods for comparative analysis, and the Weibull distribution for time-to-adverse-event analysis. …”
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Assessing patient risk, benefit and outcomes in drug development: an observational study of regorafenib clinical trials by Matt Vassar, Vinay Prasad, Ryan McIntire, Alyson Haslam, Brody Dennis, Chance Bratten, Griffin K Hughes, Andriana M Peña, Chase Ladd, Brooke Gardner, William Nowlin, Reagan Livingston, Jordan Tuia

“…Cumulative risk to patients increased over time while ORR stayed consistently low.Conclusions Our findings suggest that since regorafenib’s original Food and Drug Administration (FDA) approval, the risk profile for its original indication increased. …”
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Evaluating the Effectiveness of mRNA-1273.815 Against COVID-19 Hospitalization Among Adults Aged ≥ 18 Years in the United States by Amanda Wilson, Neloufar Rahai, Ekkehard Beck, Elisha Beebe, Brian Conroy, Daina Esposito, Priya Govil, Hagit Kopel, Tianyi Lu, James Mansi, Morgan A. Marks, Katherine E. Mues, Rohan Shah, Michelle Skornicki, Tianyu Sun, Astra Toyip, Mitra Yousefi, David Martin, Andre B. Araujo

“…Abstract Introduction In September 2023 the Food and Drug Administration (FDA) approved an updated mRNA COVID-19 vaccine targeting the XBB.1.5 sublineage. …”
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Adverse drug events (ADEs) risk signal mining related to eculizumab based on the FARES database by Xi-Feng Wang, Lu-Ri Bao, Ta-La Hu, Rui-Feng Xu, Wu-Niri Gao, Jing-Yuan Wang, Jian-Rong Zhao, Zhen-Li Fu, Shu-Fang Wang, Yan Meng

“…The current study was conducted to assess real-world adverse events (AEs) associated with eculizumab through data mining of the FDA Adverse Event Reporting System (FAERS).MethodsDisproportionality analyses, including Reporting Ratio Ratio (ROR), Proportional Reporting Ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS) algorithms were used to quantify the signals of eculizumab-associated AEs.ResultsA total of 46,316 eculizumab-related ADEs reports were identified by analyzing 19,418,776 reports in the U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database. …”
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