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Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications.
AAPS PharmSciTech
January 2025
School of Pharmaceutical Sciences, Delhi Pharmaceutical Sciences and Research University, New Delhi, India, 110017.
The biopharmaceutical industry has witnessed significant growth in the development and approval of biosimilars. These biosimilars aim to provide cost-effective alternatives to expensive originator biosimilars, alleviating financial pressures within healthcare. The manufacturing of biosimilars is a highly complex process that involves several stages, each of which must meet strict regulatory standards to ensure that the final product is highly similar to the reference biologic.
View Article and Find Full Text PDFEstimating future heat-related and cold-related mortality under climate change, demographic and adaptation scenarios in 854 European cities.
Nat Med
January 2025
Environment & Health Modelling (EHM) Lab, Department of Public Health Environment & Society, London School of Hygiene & Tropical Medicine, London, UK.
Previous health impact assessments of temperature-related mortality in Europe indicated that the mortality burden attributable to cold is much larger than for heat. Questions remain as to whether climate change can result in a net decrease in temperature-related mortality. In this study, we estimated how climate change could affect future heat-related and cold-related mortality in 854 European urban areas, under several climate, demographic and adaptation scenarios.
View Article and Find Full Text PDFAge-dependent differences in breast tumor microenvironment: challenges and opportunities for efficacy studies in preclinical models.
Cell Death Differ
January 2025
Laboratory of Hematology-Oncology, European Institute of Oncology IRCCS, Via Ripamonti 435, 20141, Milan, Italy.
Immunity suffers a function deficit during aging, and the incidence of cancer is increased in the elderly. However, most cancer models employ young mice, which are poorly representative of adult cancer patients. We have previously reported that Triple-Therapy (TT), involving antigen-presenting-cell activation by vinorelbine and generation of TCF1-stem-cell-like T cells (scTs) by cyclophosphamide significantly improved anti-PD-1 efficacy in anti-PD1-resistant models like Triple-Negative Breast Cancer (TNBC) and Non-Hodgkin's Lymphoma (NHL), due to T-cell-mediated tumor killing.
View Article and Find Full Text PDFHow to: share and reuse data - challenges and solutions from PrIMAVeRa project.
Clin Microbiol Infect
January 2025
Infectious Diseases and Microbiology Division, Hospital Universitario Virgen Macarena; Department of Medicine, University of Seville; Instituto de Biomedicina de Sevilla (IBiS)/Consejo Superior de Investigaciones Científicas (CSIC), Seville, Spain; CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain.
Background: Data sharing accelerates scientific progress and improves evidence quality. Even though journals and funding institutions require investigators to share data, only a small part of studies made their data publicly available upon publication. The procedures necessary to share retrospective data for re-use in secondary data analysis projects can be cumbersome.
View Article and Find Full Text PDFProspective Validation of CAR-HEMATOTOX and a simplified version predict Survival in Patients with Large B-Cell Lymphoma treated with anti-CD19 CAR T-cells: data from CART-SIE study.
Transplant Cell Ther
January 2025
Chair of Hematology, University of Milan; Division of Hematology and Stem Cell Transplantation, Fondazione IRCCS Istituto Nazionale dei Tumori di Milano.
Background: Anti-CD19 CAR T-cells have revolutionized outcomes in relapsed/refractory large B-cell lymphomas. Long-term follow-up underscored the role of hematological toxicity in non-relapse mortality, largely driven by infections, leading to the development of the CAR-HEMATOTOX (HT) score for predicting neutropenia. The European scientific community (EHA/EBMT) later reached a consensus, defining a new entity: immune effector cell-associated hematotoxicity (ICAHT).
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