chronic kidney disease patient News
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Osprey Medical, Inc. Awarded Premier Purchasing Agreement for DyeVert™ PLUS Contrast Reduction System
Osprey Medical (ASX: OSP) today is announcing that its DyeVert Plus Contrast Reduction System was awarded a group purchasing agreement as a Technology Breakthroughs award with Premier Inc. (Premier), a leading healthcare improvement company. Osprey Medical’s DyeVert Plus System is the only technology cleared by the U. S. Food & Drug Administration for contrast reduction and real-time ...
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Cara Therapeutics Announces Biomarker Data from KALM-1 and KALM-2 Trials of KORSUVA (difelikefalin) Injection Selected for Presentation at National Kidney Foundation Spring Clinical Meetings 2022
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced biomarker data from the KALM-1 and KALM-2 clinical trials evaluating KORSUVA™ (difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus in patients undergoing ...
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Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure or premature death Kerendia (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD and T2D The approval is based on the ...
By Bayer AG
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Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study
U.S. Food and Drug Administration (FDA) granted label update for Kerendia (finerenone) to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) FIGARO-DKD investigated the efficacy and safety of finerenone versus placebo in addition to standard of care on the reduction of CV ...
By Bayer AG
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Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes
Finerenone, a non-steroidal, selective mineralocorticoid receptor (MR) antagonist, is recommended by CHMP for marketing authorization for the treatment of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) CHMP opinion is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of finerenone on kidney and cardiovascular outcomes in patients ...
By Bayer AG
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Bayer to present new cardiorenal data for Kerendia (finerenone) across a broad range of patients with early to late-stage chronic kidney disease and type 2 diabetes
New post-hoc analyses from the prespecified pooled analysis FIDELITY will provide insights into the effects of finerenone on kidney and cardiovascular outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline, as well as by baseline HbA1c, HbA1c variability, and diabetes duration in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) An exploratory ...
By Bayer AG
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Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes
Despite available treatment options, many patients with chronic kidney disease (CKD) and type 2 diabetes (T2D) are progressing to kidney failure and premature death Kerendia (finerenone) is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with CKD associated with T2D The approval in China ...
By Bayer AG
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Kapruvia® approved by European Commission for the treatment of moderate-to-severe pruritus in hemodialysis patients
First approved therapy in Europe for the treatment of chronic kidney disease (CKD)-associated pruritus in hemodialysis patients First launches in Europe expected in H2 2022 Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that the European Commission has granted marketing authorization to Kapruvia® (difelikefalin) for the ...
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Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes
Kerendia is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular (CV) outcomes in patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) The approval is based on the results of the Phase III FIDELIO-DKD study investigating the efficacy and safety of Kerendia on kidney and CV outcomes in ...
By Bayer AG
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New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy
Exploratory analysis of the FIGARO-DKD study with finerenone, a non-steroidal, selective mineralocorticoid receptor antagonist, indicated a reduction in renal outcomes in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), as seen in the FIDELIO-DKD study Analysis of the FIDELIO-DKD study highlighted that early reduction of urine albumin-to-creatinine ratio (UACR) with ...
By Bayer AG
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Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes
CHMP opinion is based on the results from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study in patients with chronic kidney disease (CKD) and type 2 diabetes (T2D), which included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD associated with T2D The positive data from FIGARO-DKD demonstrated that finerenone significantly reduced the ...
By Bayer AG
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Kapruvia® receives positive CHMP opinion for the treatment of moderate-to-severe pruritus in hemodialysis patients
Committee for Medicinal Products for Human Use (CHMP) recommends approval of Kapruvia® (difelikefalin) as first therapy in Europe for the treatment of chronic kidney disease associated-pruritus (CKD-aP) in hemodialysis patients European Commission decision for EU Marketing Authorization is expected in Q2 2022 Kapruvia® is approved in the U.S. under the trade name KORSUVA™ ...
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Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes
European Commission granted approval for a label update to extend the indication of Kerendia™ to early stages of chronic kidney disease (CKD) associated with type 2 diabetes (T2D) and to include findings from the Phase III FIGARO-DKD cardiovascular (CV) outcomes study FIGARO-DKD included approximately 7,400 patients across a broad range of disease severity, including stages 1-4 CKD ...
By Bayer AG
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Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients
Cara Therapeutics, Inc. (Nasdaq: CARA), an early commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd., and its sublicensee Kissei Pharmaceutical Co., Ltd., confirmed the primary endpoint was achieved in a Japanese Phase 3 clinical study ...
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GE Healthcare to Distribute Osprey Medical’s Technology to Address Angiography Based Acute Kidney Injury (AKI)
GE Healthcare and Osprey Medical Inc. (ASX:OSP) (Osprey) today announced a strategic alliance under which GE Healthcare will exclusively distribute Osprey’s product portfolio in Europe, Russia, Middle East, Africa, Central Asia and Turkey. Osprey’s DyeVert™ contrast minimization devices, complemented by GE Healthcare's range of iodinated x-ray contrast media, offer healthcare ...
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Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease
For children and adolescents with chronic kidney disease (CKD), as for adults, the unmet need is high for new treatments to delay disease progression and preserve kidney function / The Phase III study FIONA will investigate the effect of finerenone in pediatric patients with CKD and severely increased proteinuria Bayer announced today the initiation of the FIONA study, a multicenter, randomized, ...
By Bayer AG
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Marizyme is Pleased to Announce the Appointment of David Barthel as CEO
Marizyme Inc. (“Marizyme” or the “Company”) (OTCQB:MRZM), is pleased to announce the hiring of Mr. David Barthel as the Chief Executive Officer for Marizyme. In his role Mr. Barthel will look to advance the Company’s technology pipeline and stay committed to the commercialization efforts of DuraGraft in Europe and Asia while focusing on the FDA submissions for ...
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New real world study data on reduced risk of adverse kidney outcomes for Xarelto compared to VKA
In the prospective observational XARENO study, after a two year follow up period, Xarelto was associated with a reduced risk of adverse kidney outcomes and all-cause mortality in patients with non-valvular atrial fibrillation (NVAF) and advanced chronic kidney disease (CKD), compared to vitamin K antagonists (VKA) XARENO evaluated the impact of Xarelto in patients with NVAF and CKD, given that ...
By Bayer AG
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