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Biomedical Approaches and Disparities in HIV Prevention
Human immunodeficiency virus (HIV) remains a significant public concern, with certain groups disproportionately impacted. Pre-exposure prophylaxis (PrEP) for HIV prevention was approved by the Food and Drug Administration in 2012. However, stark disparities persist in PrEP access and uptake, leaving those at highest risk of acquiring HIV without knowledge of, access to, and uptake of PrEP. Nurses play a key role in eliminating the causes of these disparities that occur at the individual, provider, and systemic level. It is imperative that we increase PrEP knowledge, access, and use, especially in groups most at risk for ac...
Source: Nursing Clinics of North America - April 25, 2024 Category: Nursing Authors: Jared Carter-Davis, Ellen Seymour Source Type: research

Food and Drug Omnibus Reform Act: A Critical Course Correction
On December 29, 2022, the Consolidated Appropriations Act, 2023 (Public Law No. 117-328) was signed into law, containing the Food and Drug Omnibus Reform Act of 2022 (FDORA), which introduces significant reforms to the US Food and Drug Administration (FDA).1 This paper highlights select provisions of FDORA that, in our view, have broad implications for the clinical and pharmaceutical sectors, such as promoting clinical trial diversity, revising the accelerated approval process, modernizing clinical trial operations, updating marketing exclusivities, expanding cosmetics regulation, and fortifying infant formula oversight. (...
Source: Mayo Clinic Proceedings - April 24, 2024 Category: Internal Medicine Authors: Aditya Narayan, I. Glenn Cohen, Eli Y. Adashi Tags: Perspectives and controversies Source Type: research

Reduction of product composition variability using pooled microbiome ecosystem therapy and consequence in two infectious murine models
In this study, we compared the metagenomic profile of pooled products to corresponding single donor-derived products. We demonstrated that pooled products are more homogeneous, diverse, and enriched in beneficial bacteria known to produce anti-inflammatory short chain fatty acids compared to single donor-derived products. We then evaluated pooled products' efficacy compared to corresponding single donor-derived products in Salmonella and C. difficile infectious mouse models. We were able to demonstrate that pooled products decreased pathogenicity by inducing a structural change in the intestinal microbiota composition. Sin...
Source: Cancer Control - April 23, 2024 Category: Cancer & Oncology Authors: Julie Reygner Johanne Delannoy Marie-Th érèse Barba-Goudiaby Cyrielle Gasc Beno ît Levast Enora Gaschet Laurent Ferraris St éphane Paul Nathalie Kapel Anne-Judith Waligora-Dupriet Frederic Barbut Muriel Thomas Carole Schwintner Bastien Laperrousaz Nat Source Type: research

Reduction of product composition variability using pooled microbiome ecosystem therapy and consequence in two infectious murine models
In this study, we compared the metagenomic profile of pooled products to corresponding single donor-derived products. We demonstrated that pooled products are more homogeneous, diverse, and enriched in beneficial bacteria known to produce anti-inflammatory short chain fatty acids compared to single donor-derived products. We then evaluated pooled products' efficacy compared to corresponding single donor-derived products in Salmonella and C. difficile infectious mouse models. We were able to demonstrate that pooled products decreased pathogenicity by inducing a structural change in the intestinal microbiota composition. Sin...
Source: Applied and Environmental Microbiology - April 23, 2024 Category: Microbiology Authors: Julie Reygner Johanne Delannoy Marie-Th érèse Barba-Goudiaby Cyrielle Gasc Beno ît Levast Enora Gaschet Laurent Ferraris St éphane Paul Nathalie Kapel Anne-Judith Waligora-Dupriet Frederic Barbut Muriel Thomas Carole Schwintner Bastien Laperrousaz Nat Source Type: research

Exploring the role of histone deacetylase and histone deacetylase inhibitors in the context of multiple myeloma: mechanisms, therapeutic implications, and future perspectives
AbstractHistone deacetylase inhibitors (HDACis) are a significant category of pharmaceuticals that have developed in the past two decades to treat multiple myeloma. Four drugs in this category have received approval from the U.S. Food and Drug Administration (FDA) for use: Panobinonstat (though canceled by the FDA in 2022), Vorinostat, Belinostat and Romidepsin. The efficacy of this group of drugs is attributed to the disruption of many processes involved in tumor growth through the inhibition of histone deacetylase, and this mode of action leads to significant anti-multiple myeloma (MM) activity. In MM, inhibition of hist...
Source: Experimental Hematology and Oncology - April 23, 2024 Category: Cancer & Oncology Source Type: research

Stilbenes: a journey from folklore to pharmaceutical innovation
Arch Microbiol. 2024 Apr 22;206(5):229. doi: 10.1007/s00203-024-03939-z.ABSTRACTIn modern times, medicine is predominantly based on evidence-based practices, whereas in ancient times, indigenous people relied on plant-based medicines with factual evidence documented in ancient books or folklore that demonstrated their effectiveness against specific infections. Plants and microbes account for 70% of drugs approved by the USFDA (U.S. Food and Drug Administration). Stilbenes, polyphenolic compounds synthesized by plants under stress conditions, have garnered significant attention for their therapeutic potential, bridging anci...
Source: Archives of Microbiology - April 22, 2024 Category: Microbiology Authors: Gursharan Kaur Rajinder Kaur Gurleen Kaur Sodhi Nancy George Santosh Kumar Rath Harleen Kaur Walia Vagish Dwibedi Sanjai Saxena Source Type: research

Electronic cigarettes: beneficial for smoking cessation but harmful to public health?
This study is a step toward addressing that uncertainty about how e-cigarettes could be used to promote smoking cessation among... (Source: Emergency Medicine Journal)
Source: Emergency Medicine Journal - April 22, 2024 Category: Emergency Medicine Authors: Kruse, G., Samet, J., Barnoya, J. Tags: Press releases Commentary Source Type: research

Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics
J Clin Pharmacol. 2024 Apr 19. doi: 10.1002/jcph.2435. Online ahead of print.ABSTRACTTrilaciclib is a first-in-class, intravenous cyclin-dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer receiving a platinum/etoposide-containing or topotecan-containing regimen. No dose adjustment is recommended for participants with mild hepatic impairment (HI) based on previous population pharmacokinetic (PK) analysis. This open-label, parallel-group study examined the impact of moderate and severe HI on the PK of tr...
Source: The Journal of Clinical Pharmacology - April 19, 2024 Category: Drugs & Pharmacology Authors: Chao Li Richard A Preston Emily Dumas Andrew Beelen Thomas C Marbury Source Type: research

Effect of Hepatic Impairment on Trilaciclib Pharmacokinetics
J Clin Pharmacol. 2024 Apr 19. doi: 10.1002/jcph.2435. Online ahead of print.ABSTRACTTrilaciclib is a first-in-class, intravenous cyclin-dependent kinase 4 and 6 inhibitor approved for reducing the incidence of chemotherapy-induced myelosuppression in adult patients with extensive-stage small cell lung cancer receiving a platinum/etoposide-containing or topotecan-containing regimen. No dose adjustment is recommended for participants with mild hepatic impairment (HI) based on previous population pharmacokinetic (PK) analysis. This open-label, parallel-group study examined the impact of moderate and severe HI on the PK of tr...
Source: Clinical Lung Cancer - April 19, 2024 Category: Cancer & Oncology Authors: Chao Li Richard A Preston Emily Dumas Andrew Beelen Thomas C Marbury Source Type: research

Themes in e-liquid concept names as a marketing tactic: evidence from Premarket Tobacco Product Applications in the USA
Concept naming of flavours is popular among e-liquid manufacturers.1–3 Rather than explicitly stating a taste or smell, these names convey aesthetics or sensations (eg, unicorn, frostbite, roadhouse), as well as positive health and lifestyle experiences (eg, relaxed, blissful).4 Concept names are frequently accompanied by colourful packaging and bottle designs that reinforce their connotations.1 2 While concept naming is not novel, its impact on youth appeal, as distinct from the flavours themselves, is understudied.5 Concept naming warrants additional attention following US regulatory developments limiting character...
Source: Tobacco Control - April 19, 2024 Category: Respiratory Medicine Authors: Laestadius, L., Vassey, J., Kim, M., Ozga, J., Li, D., Stanton, C., Wipfli, H., Unger, J. B. Tags: Open access Industry watch Source Type: research

Evaluation and Modification of a Shared Decision-Making Tool for Peanut Allergy Management
This study refined the decision aid ’s content to better reflect patients’ and caregivers’ lived experience.Recent FindingsCurrent standard of care for peanut allergy is avoidance, although peanut oral immunotherapy has been approved by the Food and Drug Administration for use in patients 4 –17 years old.SummaryAn advisory board of allergy therapy experts (n = 3) and patient advocates (n = 3) informed modifications to the decision aid. The revised tool underwent cognitive debriefing interviews (CDIs) among adolescents (12–17 years old) with peanut allergy and caregivers of patients 4–17 years old with p...
Source: Current Allergy and Asthma Reports - April 19, 2024 Category: Allergy & Immunology Source Type: research

Establishing robust governance of clinical artificial intelligence software – Why radiologists should lead
The longstanding research and development of artificial intelligence (AI) within the field of Diagnostic Radiology and the larger medical universe has begun to translate into clinically useful tools. As of this publication, there are over 500 AI based radiology applications approved by the Food and Drug Administration (FDA) for commercial sale in the United States.1,2 Additional AI based non-clinical applications are marketed to improve workflow, patient follow-up, and other noninterpretable or nonpatient-facing tasks. (Source: Clinical Imaging)
Source: Clinical Imaging - April 19, 2024 Category: Radiology Authors: Joseph J. Cavallo, Melissa A. Davis Tags: Editorial Source Type: research

Use of the Pfizer Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp.PMID:38635488 | DOI:10.15585/mmwr.mm7315a4 (Source: MMWR Morb Mortal Wkl...)
Source: MMWR Morb Mortal Wkl... - April 18, 2024 Category: Epidemiology Authors: Jennifer P Collins Samuel J Crowe Ismael R Ortega-Sanchez Lynn Bahta Doug Campos-Outcalt Jamie Loehr Rebecca L Morgan Katherine A Poehling Lucy A McNamara Source Type: research

Use of the Pfizer Pentavalent Meningococcal Vaccine Among Persons Aged ≥10 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, 2023
This report summarizes evidence considered for these recommendations and provides clinical guidance for the use of MenACWY-TT/MenB-FHbp.PMID:38635488 | PMC:PMC11037438 | DOI:10.15585/mmwr.mm7315a4 (Source: MMWR Morb Mortal Wkl...)
Source: MMWR Morb Mortal Wkl... - April 18, 2024 Category: Epidemiology Authors: Jennifer P Collins Samuel J Crowe Ismael R Ortega-Sanchez Lynn Bahta Doug Campos-Outcalt Jamie Loehr Rebecca L Morgan Katherine A Poehling Lucy A McNamara Source Type: research