Seoul-based Genexine Inc. filed a BLA to gain domestic approval of its follow-on biologic for chronic kidney disease (CKD)-induced anemia, Efesa (efepoetin alfa, GX-E4), to South Korean health regulators on Jan. 25.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
Astrazeneca Korea Co. Ltd. will pull its blockbuster diabetes drug, Forxiga (dapagliflozin), from the South Korean market, a company official confirmed to BioWorld, citing “multiple factors” like increasing local competition and continuing price cuts after patent expiry in 2023.
Awak Technologies Pte Ltd. gained the U.S. FDA’s breakthrough designation for an artificial intelligence (AI)-based kidney disease progression prediction (KDDP) model on Nov. 27, following its $20 million fundraising that marked one of Singapore’s largest med-tech financings in 2023.
G1 and G2 genetic variants of the human APOL1 gene have been previously associated with an increased risk of developing chronic kidney diseases (CKD) in the African American population, and recent studies have shown that inhibition of APOL1 ion channel function could represent a novel therapeutic strategy for the treatment of patients with APOL1-like nephropathies.
African Americans are 10 times more likely to develop chronic kidney disease (CKD) than Americans of European descent in part due to inheritance of one of two high-risk (HR) APOL1 variants (G1/G2, not G0) that are only present in people of West African or Caribbean ancestry. By contrast, these two APOL1 HR variants confer a beneficial resistance to otherwise lethal trypanosomiasis, which is caused by a pathogen endemic to West Africa, but still this ultimately results in a 4-fold increased risk for end-stage kidney disease (ESKD).
“Finally!” Piper Sandler analysts cheered in a research note on Ardelyx Inc., which after spending three years battling the U.S. FDA, secured approval of Xphozah (tenapanor) for treating hyperphosphatemia in adults with chronic kidney disease (CKD). The company will waste no time getting to market, aiming to have the NHE3 inhibitor available to patients next month, marking the first new treatment class for hyperphosphatemia in 30 years.
Novo Nordisk A/S’ semaglutide is making headlines again this week, with a phase IIIb testing the ubiquitous GLP-1 agonist on kidney outcomes halted early for efficacy. The independent data monitoring committee for the trial, dubbed Flow, concluded results from an interim analysis met prespecified efficacy criteria. Final data will read out in the first half of 2024.
Following the receipt of a U.K. Conformity Assessed (UKCA) mark for its kidney function diagnostic software, the CKD Screening Prioritizer (CSP), Gendius Ltd. is hoping to soon receive CE mark and then U.S. FDA approval next year. Given that people with type 2 diabetes are at a higher risk of developing chronic kidney disease, Gendius’ pre-screening software will be “transformative” for patients and health care systems, CEO Rory Cameron told BioWorld in an interview.
The contribution of the soluble form of urokinase-type plasminogen activator receptor (suPAR) as a risk factor for chronic kidney diseases (CKD) is well known. Researchers from Rush University Medical Center, Harvard Medical School and collaborators have now identified D2D3, a suPAR fragment, as responsible for causing double injury, both to the kidney and pancreas, thus resulting in glomerular disease and insulin-dependent diabetes.
