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Safety and efficacy of the ROCK-2-inhibitor Belumosudil in cGvHD treatment - a retrospective, German-Swiss multicenter real-world data analysis.
Bone Marrow Transplant
January 2025
Department of Internal Medicine III, University Hospital Regensburg, Regensburg, Germany.
Belumosudil is a first in class ROCK2-inhibitor approved by the FDA for the 3rd line treatment of chronic graft-versus-host disease (cGvHD). In this retrospective real-world analysis, we report safety and efficacy data of belumosudil treatment from 5 German/Swiss transplant centers. A total of 33 adult patients (median age 59 years) with moderate (n = 2) or severe (n = 31) cGvHD were treated on individual request due to lack of EMA approval.
View Article and Find Full Text PDFWhat are clinically significant anti-drug antibodies and why is it important to identify them.
Front Immunol
December 2024
translational Pharmacokinetics Pharmacodynamics (tPKPD), Genentech Inc., San Francisco, CA, United States.
The FDA has released new draft guidance to standardize how immunogenicity of protein therapeutics is described in product labels. A key aspect to this new guidance is that companies should describe anti-drug antibodies that have clinical significance in addition to reporting ADAs' incidence. Factors to consider when determining clinical significance include if those antibodies have a significant effect on the drug's pharmacokinetics, pharmacodynamics, efficacy, and/or safety.
View Article and Find Full Text PDFUS regulatory compliance for medical combination products: an overview.
Front Med Technol
December 2024
Advance Academic Programs, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC, United States.
This article provides a high-level overview of US regulatory review and approval processes for the growing field of medical combination products (CPs; those merging drugs with devices and/or biological products). US law defines drugs, medical devices, and CPs in specific ways, and the components of a CP are still subject to their respective regulations while combined. The Food and Drug Administration's Office of Combination Products (OCP) oversees the review and classification of CPs, which is based on their primary mode of action.
View Article and Find Full Text PDFBreast Implant Surgery: The Importance of Informed Health Care Decisions and Outcome Monitoring.
Plast Aesthet Nurs (Phila)
December 2024
Jessica Prothe, BSN, RN, is a Graduate Nursing Student at Northern Illinois University, DeKalb, Illinois.
Breast implant surgery is a popular, globally performed, and frequently requested cosmetic and reconstructive surgical procedure. Breast implant surgery can cause implant-associated systemic symptoms and types of implant-associated cancers, so it is vital to monitor patient outcomes. Most patients who undergo breast implant surgery do not experience health problems.
View Article and Find Full Text PDFPopulation Pharmacokinetics of Meropenem Across the Adult Lifespan.
Clin Pharmacokinet
December 2024
Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, VIC, Australia.
Background And Objective: We conducted an opportunistic pharmacokinetic study to evaluate the population pharmacokinetics of meropenem, an antimicrobial commonly used to treat Gram-negative infections in adults of different ages, including older adults, and determined optimal dosing regimens.
Methods: A total of 99 patients were included. The population pharmacokinetic models used had two compartments: zero-order input and linear elimination.
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