The Global Alliance for Genomics and Health is marshaling expertise in biomedical research and data sharing policy to propel bench-to-bedside translation of genomics in parallel with many of the BioSHaRE-EU initiatives described at length in this Issue. Worldwide representation of institutions, funders, researchers, and patient advocacy groups at the Global Alliance is testament to a shared ideal that sees maximizing the public good as a chief priority of genomic innovation in health. The Global Alliance has made a critical stride in this regard with the development of its Framework for Responsible Sharing of Genomic and Health-related Data.(1) This article first discusses the human rights pillars that underlie the Framework and mission of the Global Alliance. Second, it outlines the Global Alliance's use of data governance policies through a number of demonstration projects. Finally, the authors describe how the Global Alliance envisions international data sharing moving forward in the postgenomic era.
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http://dx.doi.org/10.1089/bio.2016.0005 | DOI Listing |
Dermatitis
January 2025
Arcutis Biotherapeutics, Inc., Westlake Village, CA, USA.
Safety and efficacy of roflumilast cream 0.15% for atopic dermatitis (AD) were demonstrated in two 4-week phase 3 trials. Evaluate long-term safety, tolerability, and efficacy of roflumilast cream 0.
View Article and Find Full Text PDFEur Psychiatry
January 2025
Collaborative Antwerp Psychiatric Research Institute (CAPRI), University of Antwerp, Antwerp, Belgium.
Background: Recent years show an exponential increased interest ("renaissance") in the use of psychedelics for the treatment of mental disorders and broader. Some of these treatments, such as psilocybin for depression, are in the process of formal regulation by regulatory bodies in the US (FDA) and Europe (EMA), and as such on the brink of real-world implementation. In the slipstream of these developments increasing commercial initiatives are taking shape.
View Article and Find Full Text PDFJ Infect Dis
January 2025
Division of Global Health Equity, Brigham and Women's Hospital, Boston, MA, United States.
Introduction: Most drug-resistant tuberculosis (DR-TB) occurs due to transmission of unsuspected or ineffectively treated DR-TB. The duration of treatment to stop person-to-person spread of DR-TB is uncertain. We evaluated the impact of novel regimens, including BPaL, on DR-TB transmission using the human-to-guinea pig (H-GP) transmission model.
View Article and Find Full Text PDFDiabetes Obes Metab
January 2025
Eli Lilly and Company, Indianapolis, Indiana, USA.
Aims: This analysis evaluated whether gastrointestinal (GI) adverse events (AEs) including nausea, vomiting, diarrhoea (N/V/D) and dyspepsia were associated with weight reduction with tirzepatide across the SURMOUNT-1 to -4 trials.
Materials And Methods: SURMOUNT-1 to -4 were global Phase 3 clinical trials evaluating the safety and efficacy of tirzepatide among participants with obesity or overweight with or without type 2 diabetes (T2D). Participants were randomly assigned to receive once weekly subcutaneous tirzepatide or placebo.
Implement Sci Commun
January 2025
Department of Obstetrics and Gynecology, Division of Maternal and Fetal Medicine, University of North Carolina School of Medicine, Chapel Hill, NC, 27599, USA.
Background: Pregnancy related hypertension is a leading cause of preventable maternal morbidity and mortality in the US, with consistently higher rates affecting racial minorities. Many complications are preventable with timely treatment, in alignment with the Alliance for Innovation on Maternal Health's Patient Safety Bundle ("Bundle"). The Bundle has been implemented successfully in inpatient settings, but 30% of preeclampsia-related morbidity occurs in outpatient settings in North Carolina.
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