Investigational new drugs for the treatment of chronic renal failure: an overview of the literature
Expert Opin Investig Drugs. 2024 Mar 1. doi: 10.1080/13543784.2024.2326624. Online ahead of print.ABSTRACTINTRODUCTION: Chronic kidney disease (CKD) is widespread throughout the world, with a high social and health impact. It is considered a 'silent killer' for its sudden onset without symptoms in the early stages of the disease.The main goal of nephrologists is to slow the progression of kidney disease and treat the associated symptoms with a range of new medications.AREAS COVERED: The aim of this systematic review is to analyze the new investigational drugs for the treatment of chronic renal failure. Data were obtained f...
Source: Expert Opinion on Investigational Drugs - March 2, 2024 Category: Drugs & Pharmacology Authors: Chiara Terzo Guido Gembillo Valeria Cernaro Elisa Longhitano Vincenzo Calabrese Chiara Casuscelli Luigi Peritore Domenico Santoro Source Type: research
The novel cytotoxic polybisphosphonate osteodex decreases bone resorption by enhancing cell death of mature osteoclasts without affecting osteoclastogenesis of RANKL-stimulated mouse bone marrow macrophages
In conclusion, ODX does not inhibit osteoclast formation but inhibits osteoclastic bone resorption by decreasing osteoclast numbers through enhanced cell death of mature osteoclasts. (Source: Investigational New Drugs)
Source: Investigational New Drugs - March 1, 2024 Category: Drugs & Pharmacology Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
Product Development within the National Institutes of Health Radiation and Nuclear Countermeasures Program
Radiat Res. 2024 Feb 26. doi: 10.1667/RADE-23-00144.1. Online ahead of print.ABSTRACTThe Radiation and Nuclear Countermeasures Program (RNCP) at the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) was established to facilitate the development of medical countermeasures (MCMs) and diagnostic approaches for use in a radiation public health emergency. Approvals for MCMs can be very challenging but are made possible under the United States Food and Drug Administration (FDA) Animal Rule, which is designed to enable licensure of drugs or biologics when clinical efficacy studies ...
Source: Radiation Research - February 26, 2024 Category: Physics Authors: David R Cassatt Andrea L DiCarlo Olivia Molinar-Inglis Source Type: research
First-line treatment of driver gene-negative metastatic lung adenocarcinoma with malignant pleural effusion: Should chemotherapy be combined with an immune checkpoint inhibitor or bevacizumab?
SummaryPatients with metastatic lung adenocarcinoma (MLA) and malignant pleural effusion (MPE) without driver gene mutations have a poor prognosis. None of the standard treatment strategies is recommended for such patients. We retrospectively analyzed the efficacy of the first-line treatment for this specific population: standard platinum-based doublet chemotherapy (CT), CT plus an immune checkpoint inhibitor (CT plus ICI), and CT plus bevacizumab (CT plus Bev). A total of 323 eligible patients were enrolled: CT alone (n = 166), CT plus Bev (n = 72), and CT plus ICI (n = 85). Treatment efficacy assessments were...
Source: Investigational New Drugs - February 22, 2024 Category: Drugs & Pharmacology Source Type: research
A phase 1b open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of py314 in combination with pembrolizumab in patients with advanced renal cell carcinoma
In this study, the combination of PY314 and pembrolizumab was investigated in patients with CPI-refractory RCC. Eligible patients had clear cell RCC with disease progression on prior CPI either in combination or sequentially with VEGF-TKI. Patients were treated with PY314 10 mg/kg in combination with pembrolizumab 200 mg IV every 21 days. The primary objective was to assess safety and tolerability and secon dary objectives included pharmacokinetics and anti-tumor activity by RECIST v1.1. Seventeen patients were enrolled with a median age of 67 years, 82% male, 100% had prior CPI, and 76% had received three or more prior...
Source: Investigational New Drugs - February 19, 2024 Category: Drugs & Pharmacology Source Type: research
Targeting LEF1-mediated epithelial-mesenchymal transition reverses lenvatinib resistance in hepatocellular carcinoma
SummaryAcquired resistance is a significant hindrance to clinical application of lenvatinib in unresectable hepatocellular carcinoma (HCC). Further in-depth investigation of resistance mechanisms can help to develop additional therapeutic strategies to overcome or delay resistance. In our study, two lenvatinib-resistant (LR) HCC cell lines were established by treatment with gradient increasing concentration of lenvatinib, named Hep3B-LR and HepG2-LR. Interestingly, continuous lenvatinib treatment reinforced epithelial-mesenchymal transition (EMT), cell migration, and cell invasion. Gene set enrichment analysis (GSEA) enric...
Source: Investigational New Drugs - February 19, 2024 Category: Drugs & Pharmacology Source Type: research
