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[{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Astrazeneca Presents New Data Across Continuum of Care from its Broad Renal Portfolio at ERA-EDTA 2020 Virtual Congress","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"Napp Pharmaceuticals","sponsor":"Janssen Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Napp Pharmaceuticals Announces European Commission Approval of Invokana\u00ae (canagliflozin) Label Update to Reflect Improved Renal Outcomes in Patients With Diabetic Kidney Disease and Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Napp Pharmaceuticals"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"AstraZeneca Reports Lokelma Label Update Approved in China for Patients with Hyperkalaemia on Chronic Haemodialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"AstraZeneca","sponsor":"Ono Pharmaceutical","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FARXIGA Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type 2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LOKELMA\u00ae Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"},{"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Announces US FDA Approval of Benlysta (Belimumab) for Pediatric Patients With Active Lupus Nephritis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"GSK"},{"company":"AstraZeneca","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Forxiga Approved in China for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type-2 Diabetes","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"AstraZeneca"}]

AstraZeneca

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Forxiga Approved in China for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type-2 Diabetes

Details:

Forxiga (dapagliflozin) also significantly reduced the relative risk of death from any cause by 31% (ARR=2.1%, p=0.0035) compared to placebo6. The safety and tolerability of Forxiga were consistent with the well-established safety profile of the medicine.

Lead Product(s): Dapagliflozin

Therapeutic Area: Nephrology Product Name: Forxiga

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 05, 2022

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GSK

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GSK Announces US FDA Approval of Benlysta (Belimumab) for Pediatric Patients With Active Lupus Nephritis

Details:

BENLYSTA (belimumab), a BLyS-specific inhibitor, is a human monoclonal antibody that binds to soluble BLyS. BENLYSTA does not bind B cells directly. First approved in 2011, it is the first and only approved biologic for both SLE and LN in more than 50 years.

Lead Product(s): Belimumab

Therapeutic Area: Nephrology Product Name: Benlysta

Highest Development Status: Approved Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 27, 2022

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AstraZeneca

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LOKELMA® Granted Fast Track Designation in the US to Reduce Cardiovascular Outcomes in Patients on Chronic Hemodialysis With Hyperkalemia

Details:

The designation is based on the potential of LOKELMA to reduce serious adverse CV outcomes in this patient population, addressing a significant unmet medical need.

Lead Product(s): Sodium Zirconium Cyclosilicate

Therapeutic Area: Nephrology Product Name: Lokelma

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 17, 2021

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AstraZeneca

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FARXIGA Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type 2 Diabetes

Details:

Approval is based on DAPA-CKD Phase III trial in which FARXIGA demonstrated unprecedented reduction in the risk of the composite of worsening of renal function, end stage kidney disease and cardiovascular or renal death.

Lead Product(s): Dapagliflozin

Therapeutic Area: Nephrology Product Name: Farxiga

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Ono Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 30, 2021

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AstraZeneca

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AstraZeneca Reports Lokelma Label Update Approved in China for Patients with Hyperkalaemia on Chronic Haemodialysis

Details:

The approval by the NMPA was based on data from the Phase IIIb DIALIZE trial. The trial showed sustained potassium control pre-dialysis for more patients receiving Lokelma, compared with placebo.

Lead Product(s): Sodium Zirconium Cyclosilicate

Therapeutic Area: Nephrology Product Name: Lokelma

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 24, 2020

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Napp Pharmaceuticals

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Napp Pharmaceuticals Announces European Commission Approval of Invokana® (canagliflozin) Label Update to Reflect Improved Renal Outcomes in Patients With Diabetic Kidney D...

Details:

The European Commission approval is based on the Canagliflozin and Renal Endpoints in Diabetes with Established Nephropathy Clinical Evaluation Phase III renal outcomes trial, which was stopped early based on the achievement of a pre-specified efficacy criterion.

Lead Product(s): Canagliflozin

Therapeutic Area: Nephrology Product Name: Invokana

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Janssen Pharmaceutical

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 02, 2020

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AstraZeneca

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Astrazeneca Presents New Data Across Continuum of Care from its Broad Renal Portfolio at ERA-EDTA 2020 Virtual Congress

Details:

The 20 abstracts being presented, will include data on Lokelma (sodium zirconium cyclosilicate), roxadustat & Farxiga (dapagliflozin) across different stages of CKD and AstraZeneca’s ongoing commitment to exploring treatment options across the full continuum of renal care.

Lead Product(s): Sodium Zirconium Cyclosilicate

Therapeutic Area: Nephrology Product Name: Lokelma

Highest Development Status: Approved Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 05, 2020

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