The U.S. FDA granted Renalytix plc de novo marketing authorization for its prognostic test for chronic kidney disease (CKD). Kidneyintelx is an artificial intelligence-enabled prognostic testing platform to guide treatment decisions for adults with type 2 diabetes and diabetes-related early stage chronic kidney disease.
A non-invasive retinal exam may soon enable clinicians to visualize the future for patients at risk of chronic kidney disease (CKD). When combined with an artificial intelligence algorithm, an exam accurately predicted CKD prior to symptom onset in a study published in Digital Medicine.
Given the high prevalence of chronic kidney disease and the impact of renal fibrosis on the prognosis of these patients, there is a need for novel diagnostic tools to be able to detect pathological changes earlier and thus avoid progression to later stages of the disease.
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease that are not on dialysis.
Shenzhen Salubris Pharmaceuticals Co. Ltd. received marketing approval from China’s NMPA for enarodustat as a treatment for anemic patients with chronic kidney disease (CKD) that are not on dialysis.
Chronic kidney disease (CKD) is the 10th leading cause of death in the United States because of the increased risk for cardiovascular mortality. The major functional cell type of the kidney, tubular epithelial cells (TECs), possess a limited ability to regenerate tissues. Infections can cause proximal G2/M cell cycle arrest, senescence and paracrine secretion of the profibrotic cytokines transforming growth factor-β1 (TGF-β1) and connective tissue growth factor (CTGF), which stimulate extracellular matrix production ultimately leading to loss of the epithelial phenotype in TECs. Identification of targets controlling the G2/M cell cycle arrest in TECs may enable the development of therapeutics that can prevent CKD progression.
Cardiorenal SAS reported it has been granted a breakthrough device designation by the U.S. FDA for its Tenor at-home blood potassium measuring device. The Tenor smart device combines multiple technologies, app and cloud capabilities to assist patients with chronic kidney disease in measuring their blood potassium levels from home, obtaining results in under five minutes.
Symmetric dimethylarginine (SDMA) is one of the byproducts of protein methylation, and it has been previously identified as an independent cardiovascular risk factor in patients with chronic kidney disease. The majority of SDMA is excreted through renal tubules; however, its effect on kidney in pathological conditions is not fully understood. In a recent study, researchers from Shuguang Hospital aimed to investigate the role of SDMA in renal tubulointerstitial fibrosis.
Fibrogen Inc. and its co-development partners for roxadustat, Astrazeneca plc and Astellas Pharma Inc., were dealt a major blow May 5 as the oral hypoxia-inducible factor prolyl hydroxylase inhibitor failed to meet its primary efficacy endpoint in a phase III trial in patients with anemia caused by transfusion-dependent lower-risk myelodysplastic syndromes (MDS).
Alebund Pharmaceuticals Ltd. raised ¥200 million (US$29 million) in a pre-C financing round to support the clinical trials of its candidates for kidney disease. It also secured $800 million through a syndicated bank loan to build a manufacturing facility for small-molecule drugs in the Chinese city of Yangzhou, Jiangsu province, as it lays the groundwork for future commercialization.
