Results 171 to 180 of about 138,358 (278)

Zuranolone: A case study in (regulatory) rush to judgement?

British Journal of Clinical Pharmacology, EarlyView.
Abstract Sage, in collaboration with Biogen, submitted a new drug approval for zuranolone for postpartum depression (PPD) and major depressive disorder (MDD) in December 2022. In August 2023, the US Food and Drug Administration granted approval for PPD but denied approval for MDD.
Lisa Cosgrove, Milutin Kostic, Barbara Mintzes, Gianna D'Ambrozio, Allen Shaughnessy   +4 more
wiley   +1 more source

Framing a Consent Form to Improve Consent Understanding and Determine How This Affects Willingness to Participate in HIV Cure Research: An Experimental Survey Study. [PDF]

J Empir Res Hum Res Ethics, 2021
Sauceda JA, Dubé K, Brown B, Pérez AE, Rivas CE, Evans D, Fisher CB.   +6 more
europepmc   +1 more source

Do drugs approved via expedited approval pathways have therapeutic advantages? A systematic review and meta‐analysis

British Journal of Clinical Pharmacology, EarlyView.
Regulators use expedited approval pathways to speed market approval and patient access to promising new drugs. However, there is uncertainty about whether these pathways are successful in approving drugs with significant therapeutic advantages. This systematic review aims to examine the safety, effectiveness and cost‐effectiveness of drugs approved via
Ashleigh Hooimeyer, Eliza J. McEwin, Zhicheng Wang, Joel Lexchin, Barbara Mintzes   +4 more
wiley   +1 more source

Inflammation‐driven variability in drug metabolism: Insights from voriconazole treatment of HSCT recipients

British Journal of Clinical Pharmacology, EarlyView.
Aims Voriconazole is commonly used to prevent fungal infections after haematopoietic stem cell transplantation (HSCT). Although its metabolism is influenced by CYP2C19 genetics and inflammation, their combined effect is rarely considered in clinical practice, and integrated analyses remain limited.
Sylvia D. Klomp, Martijn L. Manson, Henk‐Jan Guchelaar, Stefan Böhringer, Esther H. M. van Egmond, Peter A. von dem Borne, Jesse J. Swen   +6 more
wiley   +1 more source

The evolving therapeutic landscape of spinal muscular atrophy – A scoping review of investigational agents, emerging delivery technologies and strategic innovations

British Journal of Clinical Pharmacology, EarlyView.
Spinal muscular atrophy (SMA) is a severe neuromuscular disease with emerging therapeutic complexity. This review aims to systematically map the global pipeline of investigational treatments for SMA. Using ClinicalTrials.gov and complementary international registries, we identified 21 planned or ongoing interventional trials from 2020 to 2025 targeting
Andrej Belančić, Patrick Eustaquio, Elvira Meni Maria Gkrinia, Ivana Stević, Eugen Javor, Yun Wah Lam, Slobodan Janković, Dinko Vitezić   +7 more
wiley   +1 more source

Synergistic HIV latency reversal from an in vitro screen of epigenetic and kinase inhibitors

Journal of Virus Eradication, 2017
D. Irlbeck, Y. Zhao, A. Axtman, B. Zuercher, L. Ingerman-James   +4 more
doaj   +1 more source

Timothy Ray Brown: The Serendipitous Hero of HIV Cure Research [PDF]

AIDS Research and Human Retroviruses, 2020
Thomas J, Hope, Nichole R, Klatt, Jonah B, Sacha, Paula M, Cannon   +3 more
openaire   +2 more sources

Mapping opioid exposure through prescription data and postmortem analysis of opioid drugs in multiple tissues

British Journal of Clinical Pharmacology, EarlyView.
Background and Purpose Although opioids are central to end of life (EoL) care, tissue‐level opioid exposure remains poorly understood. The objective of this study was to characterize the relationship between prescription‐derived morphine equivalent daily dose (MEDD) and measured morphine concentrations across multiple organs.
Niamh Higgins, Alan Wells, Nimish Patel, Nicole Muttera, Mattia Trunfio, Alessandra Manca, Amedeo De Nicolò, Micol Ferrara, Stefano Bonora, Jessica Cusato, Alice Palermiti, Antonio D'Avolio, Marissa Borochoff, Patricia K. Riggs, Elizabeth Hastie, Rabia S. Atayee, Stephanie Solso, Cheryl Dullano, Vanessa Gomez‐Moreno, Tara Tenenbaum, Robert Deiss, Davey M. Smith, Antoine Chaillon, Sara Gianella   +23 more
wiley   +1 more source

24 HIV-specific, ex vivo expanded T cell therapy (HXTC) for HIV clearance: feasibility, safety and efficacy

Journal of Virus Eradication, 2017
Julia M. Sung, JoAnnD Kuruc, Matthew Clohosey, Amanda Crooks, Shabnum Patel, Lauren Roesch, Patrick Hanley, CRussell Cruz, Nancie Archin, JosephJ Eron, Nilu Goonetilleke, Cliona M. Rooney, Catherine M. Bollard, David M. Margolis, Cynthia L. Gay   +14 more
doaj   +1 more source

Active surveillance of drug safety in healthcare data: Sequential monitoring of bacterial and serious urinary tract infection risk in sodium‐glucose cotransporter 2 inhibitor users

British Journal of Clinical Pharmacology, EarlyView.
Abstract Introduction Active surveillance of adverse events using healthcare data is emerging as complementary to the monitoring of spontaneous reports and stand‐alone pharmacoepidemiologic studies. The risk of urinary tract infections (UTIs) was listed as a special warning for sodium‐glucose cotransporter‐2 inhibitors (SGLT2is) when marketed in Europe
Haoxin Le, Dilsad Simay Peker, Lukas Frederic Westphal, Nikolai Brun, Christine Erikstrup Hallgreen, Morten Andersen   +5 more
wiley   +1 more source