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Inflammatory Phase Articles & Analysis

9 news found

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

Reflecting the positive data from the pivotal Phase III FIGARO-DKD study on the reduction of the risk of cardiovascular events, the ...

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

In Japan, Kerendia obtained approval by the Japanese Ministry of Health, Labour, and Welfare (MHLW) based on the results of both pivotal Phase III studies with finerenone in CKD and T2D in March 2022. Based on the results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization in the European Union in February 2022 and was approved by the ...

ByBayer AG


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

(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. ...

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

” Based on the positive results of the FIDELIO-DKD Phase III study, Kerendia was granted marketing authorization in the European Union in February 2022 and was approved by the U.S. ...

ByBayer AG


AOBiome’s B244 demonstrated positive results from its Phase 2b trial for both Pruritus (Itch) and Appearance of Atopic Dermatitis (Eczema)

AOBiome’s B244 demonstrated positive results from its Phase 2b trial for both Pruritus (Itch) and Appearance of Atopic Dermatitis (Eczema)

AOBiome Therapeutics, a clinical stage biotechnology company focused on transforming human health by developing topical biologic therapies for systemic inflammatory conditions, announced positive pivotal Phase 2b results from its trial evaluating B244 in both pruritus (itch) and appearance of atopic dermatitis (eczema). ...

ByAOBiome Therapeutic, LLC


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 approval of Kerendia in the EU is based on the results of the pivotal Phase III FIDELIO-DKD study, presented at the American Society of Nephrology’s (ASN) Kidney Week 2020 and simultaneously published in the New England Journal of Medicine (NEJM) in October 2020. ...

ByBayer AG


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

In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. The Phase III study programme with finerenone, FINEOVATE, currently comprises five Phase III studies, FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD and FIONA. ...

ByBayer AG


Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease

Bayer extends clinical development program for finerenone with Phase III study in children and adolescents with chronic kidney disease

MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. The Phase III study program with finerenone, FINEOVATE, currently comprises five Phase III studies: FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF, FIND-CKD and FIONA. The initiation ...

ByBayer AG


New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

New data from finerenone clinical trial program reinforces renal and cardiovascular benefits in patients with CKD and T2D independent of baseline therapy

In T2D, MR overactivation is thought to contribute to CKD progression and cardiovascular damage which can be driven by metabolic, hemodynamic or inflammatory and fibrotic factors. The Phase III study program with finerenone, FINEOVATE, currently comprises four Phase III studies: FIDELIO-DKD, FIGARO-DKD, FINEARTS-HF and FIND-CKD. Having ...

ByBayer AG

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