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Jan 5, 2025 | 
link.springer.com | Novartis Institutes |Boehringer Ingelheim
AbstractIn the International Council for Harmonisation (ICH) guidance on General Principles for Planning and Design of Multi-Regional Clinical Trials (E17), it is important to evaluate the consistency of treatment effect across regions in a multi-regional clinical trial (MRCT). In this paper, we elaborated on some basic considerations to evaluate consistency.
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Sep 12, 2024 | 02266-x/fulltext&sz=64)
jbc.org | Novartis Institutes
KEYWORDSPRC2 inhibitorsadipocyte differentiationPPARγC/EBPα sarcomaIntroductionEpigenetic mechanisms provide a programed framework to canalize cell identities along the differentiation path, playing critical roles in embryonic development. A typical example is the chromatin state of bivalency, characterized by the co-occurrence of histone H3 lysine 4 trimethylation (H3K4me3) and lysine 27 trimethylation (H3K27me3) on the promoters of critical developmental genes (1).
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Sep 4, 2024 | 
aacrjournals.org | Novartis Institutes
Clonal hematopoiesis (CH) is more common in older persons and has been associated with an increased risk of hematological cancers and cardiovascular diseases. The most common CH mutations occur in the DNMT3A and TET2 genes and result in increased proinflammatory signaling.
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Dec 18, 2023 | 
chemistry-europe.onlinelibrary.wiley.com | Tao Liu |Evan Judd |Novartis Institutes |Lei Jin
Supporting Information As a service to our authors and readers, this journal provides supporting information supplied by the authors. Such materials are peer reviewed and may be re-organized for online delivery, but are not copy-edited or typeset. Technical support issues arising from supporting information (other than missing files) should be addressed to the authors.
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Dec 14, 2023 | 
ashpublications.org | Novartis Institutes
Subjects: Hematopoiesis and Stem Cells, Myeloid Neoplasia, Red Cells, Iron, and Erythropoiesis Subjects: Hematopoiesis and Stem Cells, Myeloid Neoplasia, Red Cells, Iron, and Erythropoiesis Subjects: Hematopoiesis and Stem Cells, Myeloid Neoplasia, Red Cells, Iron, and Erythropoiesis Anemia of inflammation (AI) is a condition of usually mild to moderately decreased hemoglobin observed in systemic inflammatory conditions, including various autoimmune diseases, obesity, diabetes mellitus,...
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Nov 27, 2023 | 
academic.oup.com | Novartis Institutes
Serosurveys are a widely used tool to estimate the cumulative incidence, i.e. the fraction of a population that have been infected by a given pathogen. These surveys rely on serological assays that measure the level of pathogen-specific antibodies. Because antibody levels are waning, the fraction of previously infected individuals that have sero-reverted increases with time past infection.
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Sep 1, 2023 | 00286-0&sz=64)
cell.com | Cong Zhang |Novartis Institutes |Konstantin Shestopaloff |Benjamin Hollis
SummaryResponse to the anti-IL17 monoclonal antibody secukinumab is heterogeneous, and not all participants respond to treatment. Understanding whether this heterogeneity is driven by genetic variation is a key aim of pharmacogenetics and could influence precision medicine approaches in inflammatory diseases.
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Aug 26, 2023 | 
jneuroinflammation.biomedcentral.com | Novartis Institutes
We first investigated the efficacy of remibrutinib in the HuMOG EAE mouse model, a model in which B cells have been shown to be the dominant APC [30, 32, 44]. For this study, we selected remibrutinib doses of 3 and 30 mg/kg according to the rodent pharmacokinetic profile of remibrutinib [26]. These doses showed intermediate and near-maximal peripheral pharmacodynamic efficacy, respectively, in a preparatory BTK occupancy study at the 24 h post last dose trough timepoint (Additional file 1: Fig.
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Jun 22, 2023 | 
frontiersin.org | Novartis Institutes
Elvis H. Cui1
Allison Goldfine2
Michelle Quinlan3
David James3
Oleksandr Sverdlov3*
1University of California, Los Angeles, United States
2Novartis Institutes for BioMedical Research, United States
3Novartis (United States), United States
The final, formatted version of the article will be published soon.
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Apr 20, 2023 | 
trialsjournal.biomedcentral.com | Novartis Institutes |KU Leuven
ReferencesEuropean Medicines Agency (EMA). Committee for medicinal products for human use. Guideline on Data Monitoring Committees, 2006 https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-data-monitoring-committees_en.pdf. Food and Drug Administration (FDA). Guidance for Clinical Trial Sponsors: Establishment and Operation of Clinical Trial Data Monitoring Committees, 2006. https://www.fda.gov/media/75398/downloadBuhr KA, Downs M, Rhorer J, Bechhofer R, Wittes J.
