Renal Diseases

FDA Rejects Tricida’s NDA for Veverimer for Treatment of Metabolic Acidosis and Slowing of Kidney Disease Progression in Patients with Metabolic Acidosis Associated with CKD

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Tricida, Inc. (Nasdaq: TCDA), a pharmaceutical company focused on the development and commercialization of its drug candidate, veverimer (TRC101), a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD), announced today that it received a Complete Response Letter (CRL) from …

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Farxiga Met All Primary and Secondary Endpoints in Groundbreaking Phase 3 Trial for the Treatment of Patients with CKD

WILMINGTON, Del.–(BUSINESS WIRE)–High-level results from FARXIGA®’s (dapagliflozin) Phase III DAPA-CKD trial showed a statistically significant and clinically meaningful effect on its primary endpoint of a composite of worsening of renal function or risk of death (defined as a composite endpoint of ≥50% sustained decline in estimated glomerular filtration rate (eGFR), …

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Centogene and Molecular Health Announce an Exclusive Collaboration With the Aim to Transform the Development of Orphan Drugs

CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN and HEIDELBERG, Germany, July 27, 2020 (GLOBE NEWSWIRE) — Centogene N.V. (Nasdaq: CNTG), a commercial-stage company focused on rare diseases that transforms real-world clinical and genetic data into actionable information for patients, physicians, and pharmaceutical companies, and Molecular Health, a leading company in …

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FDA Grants Priority Review to Alnylam’s Lumasiran for the Treatment of Primary Hyperoxaluria Type 1

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) for lumasiran, an investigational RNAi therapeutic targeting hydroxyacid oxidase 1 (HAO1) – the gene encoding glycolate oxidase (GO) – in development for the …

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FDA Approves a Label Update for Lokelma to Include Dosing Guidance for Treatment of Hyperkalemia in ESRD on Hemodialysis

WILMINGTON, Del.–(BUSINESS WIRE)–Today, the US Food and Drug Administration (FDA) approved a label update in the US for AstraZeneca’s LOKELMA® (sodium zirconium cyclosilicate) to include a dosing regimen specifically to treat hyperkalemia in patients with end-stage renal disease on chronic hemodialysis. The approval by the US FDA was based on positive results …

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Phase 3 Trial of Farxiga Will Be Stopped Early After Overwhelming Efficacy in Patients with Chronic Kidney Disease

WILMINGTON, Del.–(BUSINESS WIRE)–The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for FARXIGA (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped early following a recommendation from an independent Data Monitoring Committee (DMC) based on its determination of overwhelming efficacy.   The decision to stop the trial early was made following …

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FDA Grants Fast Track Designation to Empagliflozin for the Treatment of Chronic Kidney Disease

INGELHEIM, Germany, and INDIANAPOLIS, Ind.–(BUSINESS WIRE)–The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of empagliflozin to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY) announced. The …

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Mallinckrodt Initiates Rolling Submission of NDA to the FDA for Terlipressin for Treatment of Patients with Hepatorenal Syndrome Type 1

STAINES-UPON-THAMES, United Kingdom, March 2, 2020 /PRNewswire/ — Mallinckrodt plc (NYSE: MNK), a global biopharmaceutical company, today announced it initiated the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for terlipressin, an investigational agent being investigated for the treatment of hepatorenal syndrome type 1 (HRS-1), by submitting its clinical …

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Cara Therapeutics Announces Positive Topline Data from Mid-Stage Trial of Oral Korsuva in CKD Patients with Moderate-to-Severe Pruritus

STAMFORD, Conn., Dec. 03, 2019 (GLOBE NEWSWIRE) — Cara Therapeutics, Inc. (Nasdaq: CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, today announced positive topline results from its Phase 2 dose-ranging trial of Oral KORSUVA™ (CR845/difelikefalin) …

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Ardelyx Announces Positive Results from its Phase 3 Study Evaluating Tenapanor in CKD Patients on Dialysis

FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ — Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for …

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