Kidney Surgery News
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Ovivo’s Women for Water presents: Astrid Kloosterman
Career Progression Through Adaptability and Education Choosing a career path can be a daunting task, and it’s not uncommon for people to change their minds before discovering their true aspiration. However, staying determined to find your passion is essential to finding the career you will love. Astrid is a great example of how a person can find their true calling and choose to pursue ...
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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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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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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) 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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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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AlloVir Reports Blinded, Preliminary, Phase 2 Data Supporting the Ongoing Study of Posoleucel, a Multi-Virus-Specific T Cell Therapy, for the Treatment of BK Viremia in Kidney Transplant Recipients
Phase 2 study completed enrollment ahead of schedule Posoleucel well-tolerated with no cases of graft rejection observed to date Overall decline in median BK viral load among patients completing 12 weeks of dosing with posoleucel or placebo (2:1 randomization) Posoleucel detected up to 12 weeks after last infusion Topline, unblinded study results from all 61 patients expected to be released ...
By AlloVir
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OSE Immunotherapeutics Announces Dosing of the First Participant in a Phase 1 Study of VEL-101/FR104, a Novel Investigational Drug for Kidney Transplant Immunosuppression
OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) today announced that the first participant has been dosed in a Phase 1 Study of VEL-101/FR104 [NCT05238493], a study sponsored and conducted by its partner in transplantation, Veloxis Pharmaceuticals, Inc., an Asahi Kasei company. VEL-101/FR104 is a novel investigational maintenance immunosuppressive agent being developed for prevention ...
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AlloVir Reports First Quarter 2022 Financial Results
Initiated posoleucel registrational study to prevent six devastating viral infections and now enrolling high-risk allo-HCT patients in the U.S., Western Europe and Asia FDA granted RMAT designation to posoleucel for Phase 3 multi-virus prevention indication with an estimated annual addressable patient population of 40,000 allo-HCT patients Progressed enrollment in three Phase 3 studies for ...
By AlloVir
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FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for Prevention of Multiple Life-Threatening Infections from Six Viruses in Allogeneic Hematopoietic Cell Transplant Patients
AlloVir (Nasdaq: ALVR), a late clinical-stage allogeneic T cell immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its lead investigational multi-virus-specific T cell therapy, posoleucel, for the prevention of clinically significant infections and disease from six devastating viruses ...
By AlloVir
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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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Sangamo Therapeutics Announces Dosing of First Patient in Phase 1/2 Clinical Study of Investigational CAR-Treg Cell Therapy TX200 in Kidney Transplantation
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced dosing of the first patient in the Phase 1/2 STEADFAST clinical study evaluating TX200, a wholly-owned autologous Chimeric Antigen Receptor Regulatory T Cell (CAR-Treg) cell therapy product candidate for the prevention of immune-mediated rejection in HLA-A2 mismatched kidney transplantation from a living donor. ...
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Home Dialysis Patients Face Postcode Lottery of Care, New Report Finds
QUANTA Dialysis Technologies Ltd (“QUANTA” or the “Company”), a medical technology company committed to making kidney care more accessible with its SC+ haemodialysis system, has released a new report that suggests people with kidney failure who wish to do home dialysis face unequal access across the UK. The Bridging the Gap report finds that failure to offer such treatment ...
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Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease
Single pivotal trial to initiate later this month targets the broad patient population with two APOL1 mutations and proteinuric kidney disease Pathway for accelerated approval using an interim analysis at Week 48 of eGFR slope, supported by reduction in proteinuria Final analysis evaluating eGFR slope at approximately two years serves as basis for U.S. approval Vertex Pharmaceuticals ...
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`Bilirubin` to eliminate inflammation... Vilix, the world`s first pharmaceutical drug
Bilirubin, which causes jaundice in humans, has been in the spotlight as an anti-inflammatory substance since the 1930s. The phenomenon that rheumatoid inflammation disappears when a patient with rheumatoid arthritis suffers from jaundice was discovered by Philip Hench, a professor at the Mayo Clinic in the United States, who was awarded the Nobel Prize in Physiology or Medicine. Attempts to drug ...
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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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CloudCath Announces $12 Million Series A Financing for Technology Enabling Remote, Real-Time Complication Monitoring for At-Home Dialysis
A July 2019 White House executive order on kidney care (the Advancing American Kidney Health Initiative) proposed that 80% of new patients with end-stage renal disease (ESRD) be treated with either kidney transplantation or home dialysis by 2025, a significant increase from current rates, which are below 20%. “End-stage renal disease, one of the costliest chronic diseases in the U.S., is ...
By CloudCath
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AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook
Three ongoing Phase 3 registrational studies of posoleucel expected in 2022, targeting treatment and prevention indications with no approved therapies Expanded enrollment in Phase 2 proof-of-concept study of posoleucel for the preemptive treatment of BK viremia in kidney transplant recipients; initial data submitted for presentation in 1H 2022 Advancing two additional virus-specific T cell ...
By AlloVir
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Sangamo Therapeutics to Present Data From Its Next-Generation Technologies at 2022 Annual Meeting of the American Society of Gene & Cell Therapy (ASGCT)
Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced that the American Society of Gene & Cell Therapy (ASGCT) has accepted eight Sangamo abstracts for presentation at the 25th ASGCT Annual Meeting being held May 16-19, 2022, in-person in Washington, D.C. and in a virtual format. Presentations will focus on the progression of Sangamo’s pre-clinical ...
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Biocon Q3FY22 Revenue at Rs 2,223 Cr, Up 18%; EBITDA at Rs 537 Cr, Up 25%; Biosimilars Up 28% at Rs 981 Cr; Research Services Up 10% at Rs 641 Cr; Generics Up 7% at Rs 607 Cr
Biocon Ltd (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceuticals company, today announced its consolidated financial results for the third quarter ended December 31, 2021. Commenting on the results, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said, “Biocon’s consolidated Q3FY22 revenues grew by 18% YoY to Rs 2,223 Crore, driven by a strong performance ...
By Biocon
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