Dimerix Ltd. has out-licensed lead candidate DMX-200 to Advanz Pharma Corp. for focal segmental glomerulosclerosis (FSGS) in a carve-out deal that grants commercialization rights to Advanz in the European Union, the U.K., Switzerland, Canada, Australia and New Zealand.
Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
Rona Therapeutics Co. Ltd. and Keymed Biosciences Co. Ltd. formed a collaboration to jointly discover and develop first-in-class siRNA therapeutics for glomerulonephritis, also known as severe kidney diseases.
Maze Therapeutics Inc. recently presented data from preclinical studies of a small-molecule APOL1 pore function inhibitor, MZ-301, describing the compound’s in vitro and in vivo activity. APOL1 G1 and G2 genetic variants are associated with an increased risk of progressive kidney diseases in African ancestry people. There are no APOL1-targeted therapies addressing the underlying driver of these diseases.
GSK plc may have pushed the door open Oct. 26 for the use of a new class of oral drugs to treat anemia in U.S. patients with chronic kidney disease who are dialysis dependent. The U.S. FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13-3 that the benefits of GSK’s daprodustat outweighed the risks in that population. However, the committee didn’t push the door wide enough for patients not on dialysis, voting 5-11 on the question of whether the drug’s benefits outweighed its risk in the nondialysis population, even though that group conceivably could see a greater benefit. The test now is whether the FDA will follow the committee’s lead.
Hoping its drug, daprodustat, can succeed in the U.S. where two other hypoxia-inducible factor prolyl hydroxylase inhibitors (HIF-PHIs) have failed so far, GSK plc will present its case Oct. 26 to the FDA’s Cardiovascular and Renal Drugs Advisory Committee for the drug's potential use as a treatment for anemia in patients with chronic kidney disease regardless of dialysis dependency.
The U.S. FDA granted digital therapeutics company Bodyport Inc. 510(k) clearance for its heart monitoring weight scale. The digital solution includes sensors and algorithms that measure hemodynamic biomarkers to assess heart function and fluid status when patients take their daily weight. San Francisco-based Bodyport told BioWorld the platform is for heart failure (HF) patients in the U.S.
PERTH, Australia – The independent data safety monitoring board of the global REMAP-CAP COVID-19 study has uncovered a concerning safety signal in treatment arms that include an angiotensin converting enzyme inhibitor and an angiotensin receptor blocker in patients with severe COVID-19, and it has recommended that recruitment be suspended for those treatment arms.
Applaud Medical Inc. has secured breakthrough device designation from the FDA for its acoustic enhancer technology to be used in conjunction with ureteroscopy with laser lithotripsy (URS-LL) for the fragmentation of calcium-based urinary stones. The San Francisco-based company is currently enrolling subjects in an FDA-approved pivotal trial evaluating the technology’s safety and efficacy.
