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Kidney Care Community News
FDA: More data needed to approve terlipressin NDA for hepatorenal syndrome type 1
Although the FDA accepted a new drug application for terlipressin to treat hepatorenal syndrome type 1, the agency has issued a complete response letter to Mallinckrodt plc stating that more data are required before the NDA can be approved.
Kidney complications in young adulthood linked to risk for cognitive decline at midlife
Young adults who experienced episodes of kidney function decline – termed here as having greater end-stage renal disease risk exposure – had lower cognitive performance at middle age, according to a study published in Neurology.
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Satellite Healthcare CEO to retire
Rick Barnett will retire after 6 years as CEO of Satellite Healthcare, the company announced Sept. 11.
Rockwell signs agreement to license Triferic in South Korea
Rockwell Medical Inc. has entered into a license agreement with Jeil Pharmaceutical Co. Ltd. for the rights to commercialize Triferic in South Korea.
Baxter’s dialyzer, recently granted marketing authorization, may improve hemodialysis
Study findings showed Baxter’s medium cut-off dialyzer resulted in greater clearance of larger middle molecules than was seen with standard hemodialysis therapy. The device was recently granted de novo authorization by the FDA.
CPR preferences may differ from other end-of-life care choices for patients on dialysis
Study findings indicated that while most patients on dialysis reported that they wanted CPR performed if their “heart were to stop beating,” these preferences were not always associated with other aspects of end-of-life care.
Akebia: Phase 3 trial results for vadadustat reach efficacy endpoints in patients with CKD
Akebia Therapeutics Inc. said its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat reached primary and key secondary efficacy endpoints in phase 3 PRO2TECT cardiovascular outcomes studies.
Speaker: Cannabis can benefit patients with kidney disease
Cannabis has been long misunderstood as a dangerous narcotic by federal regulators and has medicinal value for patients with chronic kidney disease, a speaker at the American Nephrology Nurses Association’s National Symposium said.
House representative: Despite COVID-19, Congress maintains focus on advancing kidney care
At the virtual Innovations in Dialysis: Expediting Advances Symposium, U.S. Rep. Suzan DelBene, D-Wash., assured the audience that Congress continues its efforts to improve care for patients with kidney disease.
Speaker: Patient preferences can aid FDA in advancing new dialysis devices
A speaker at the virtual Innovations in Dialysis: Expediting Advances Symposium discussed how patient-preference information can be used by the FDA in making regulatory decisions on devices designed for patients with kidney failure.
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Headline News
Severe carbohydrate restriction not necessary for ketosis, weight loss in low-energy diets
November 25, 20242 min read -
Headline News
Triple-digit heat exposure may increase odds of atrial fibrillation
November 16, 20242 min read -
Headline News
Vaccine using live-attenuated malaria parasites shows promise
November 25, 20242 min read