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Kidney Transplant Articles & Analysis: Older

30 news found

Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

Kerendia (finerenone) granted expanded indication in the EU for broad range of patients with chronic kidney disease and type 2 diabetes

“Even when blood glucose levels and blood pressure are well-controlled, the risk of kidney disease progression and cardiovascular events remains high in patients with chronic kidney disease and type 2 diabetes,” said Dr. ...

ByBayer AG


Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes

Finerenone receives positive CHMP opinion for EU-label extension for broad range of patients with chronic kidney disease and type 2 diabetes

About Chronic Kidney Disease in Type 2 Diabetes Chronic kidney disease (CKD) is a common and potentially deadly condition that is widely underrecognized. ...

ByBayer AG


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

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

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. ...

ByBayer AG


Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study

Kerendia (finerenone) receives updated label in the U.S. to include findings from Phase III FIGARO-DKD cardiovascular outcomes study

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. ...

ByBayer AG


Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes

Kerendia (finerenone) approved in China for the treatment of adults with chronic kidney disease associated with type 2 diabetes

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. ...

ByBayer AG


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

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

These data were shared today in an oral plenary presentation at the American Transplant Congress (ATC) in Boston (Abstract 387). “Kidney transplant recipients are particularly challenged by BK viremia, which puts the survival of their transplanted graft at risk,” said Anil K. ...

ByKalaris


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 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 ...

ByOSE Immunotherapeutics


AlloVir Reports First Quarter 2022 Financial Results

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 ...

ByKalaris


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

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

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 that commonly impact high-risk adult and pediatric patients following allogeneic hematopoietic cell ...

ByKalaris


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 Announces Dosing of First Patient in Phase 1/2 Clinical Study of Investigational CAR-Treg Cell Therapy TX200 in Kidney Transplantation

“I look forward to the dosing of more patients and seeing data from the study to understand the potential of TX200.” Kidney transplantation is the treatment of choice for patients with end-stage renal disease (ESRD) who must otherwise remain on long-term dialysis. Approximately 21-26% of transplanted kidneys are ...

BySangamo Therapeutics


Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

Bayer receives approval in Japan for Kerendia (finerenone), a new treatment for adults with chronic kidney disease and type 2 diabetes

FIDELIO-DKD (FInerenone in reducing kiDnEy faiLure and dIsease prOgression in Diabetic Kidney Disease) investigated the efficacy and safety of finerenone in comparison to placebo in addition to standard of care on the reduction of kidney failure and kidney disease progression in approximately 5,700 patients with CKD and T2D. ...

ByBayer AG


Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease

Vertex Advances VX-147 Into Pivotal Clinical Development for People With APOL1-Mediated Kidney Disease

The secondary efficacy endpoint is time to composite clinical outcome, which will also be assessed at the final analysis and is defined as a sustained decline of ≥30% from baseline in eGFR, the onset of end-stage kidney disease (i.e., maintenance dialysis for ≥28 days, kidney transplantation or a sustained eGFR of2) or death. ...

ByVertex Pharmaceuticals


`Bilirubin` to eliminate inflammation... Vilix, the world`s first pharmaceutical drug

`Bilirubin` to eliminate inflammation... Vilix, the world`s first pharmaceutical drug

Ischemic reperfusion injury is a common occurrence during organ transplantation. Although such a problem is less common with living transplants, brain-dead transplants are prone to tissue damage and inflammation due to free radicals due to the time the organs are transported. CEO Kim said, “Even though organ transplantation ...

ByBilix Co., Ltd.


Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes

Bayer’s new treatment Kerendia (finerenone) approved in EU for adult patients with chronic kidney disease associated with type 2 diabetes

“The worrying reality is that chronic kidney disease in type 2 diabetes is the leading cause of end-stage kidney disease, which ultimately means that the kidneys no longer support the body’s needs and patients need dialysis or a kidney transplant to stay alive. ...

ByBayer AG


CloudCath Announces $12 Million Series A Financing for Technology Enabling Remote, Real-Time Complication Monitoring for At-Home Dialysis

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%. ...

ByCloudCath


AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook

AlloVir Reports Full-Year 2021 Financial Results and 2022 Outlook

Following a review at the end of last year of initial, blinded safety data from the ongoing posoleucel proof-of-concept (POC) study for BK viremia treatment in adult kidney transplant recipients, the study has been amended to begin enrolling patients with higher viral loads. BKV is detected in up to 20% of kidney transplant ...

ByKalaris


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 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 ...

BySangamo Therapeutics


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 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

This product is indicated for the prophylaxis of organ rejection in adult patients receiving kidney transplants and is available in 180mg and 360mg strengths. In Europe, we received approvals for Everolimus tablets of 2.5mg, 5mg and 10mg strengths and Fingolimod capsule of 0.5 mg strength. ...

ByBiocon


FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for the Treatment of Adenovirus (AdV) Infections in Adults and Children Post-Allogeneic Stem Cell Transplantation

FDA Grants Regenerative Medicine Advanced Therapy (RMAT) Designation to AlloVir’s Posoleucel for the Treatment of Adenovirus (AdV) Infections in Adults and Children Post-Allogeneic Stem Cell Transplantation

Food and Drug Administration (FDA) has granted its lead multi-virus specific T cell (VST) therapy, posoleucel (Viralym-M, ALVR105), Regenerative Medicine Advanced Therapy (RMAT) designation for the treatment of adenovirus (AdV) infection following allogeneic hematopoietic stem cell transplant (allo-HCT). The designation is based on positive results from the Phase 2 CHARMS study. ...

ByKalaris


Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

Bayer receives positive CHMP opinion for finerenone as a new treatment for adult patients with chronic kidney disease associated with type 2 diabetes

“Despite currently available treatment options, many patients with chronic kidney disease associated with type 2 diabetes progress to kidney failure or premature death. ...

ByBayer AG

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