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    [{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK\u2019s Five Studies of Phase 3 ASCEND Programme of Daprodustat for Patients with Anaemia Due To CKD Meets Primary Endpoints","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Hematology","graph2":"Phase III"},{"orgOrder":0,"company":"GSK","sponsor":"","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anaemia Due to Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Medicines Agency (EMA) Accepts Marketing Authorisation Application for Daprodustat","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"US Food and Drug Administration Accepts New Drug Application for Daprodustat","therapeuticArea":"Hematology","highestDevelopmentStatus":"Phase III","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Phase III"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Announces Update on US FDA Regulatory Review of Daprodustat in Anaemia of Chronic Kidney Disease","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Reports Outcome From US FDA Advisory Committee Meeting On Daprodustat For Anaemia Of CKD","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Reports Outcome From US FDA Advisory Committee Meeting on Daprodustat for Anaemia of CKD","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Jesduvroq (daprodustat) Approved By US FDA For Anaemia of Chronic Kidney Disease in Adults on Dialysis","therapeuticArea":"Nephrology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Nephrology","graph2":"Approved"},{"orgOrder":0,"company":"GSK","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"GSK Receives Positive CHMP Opinion Recommending Authorisation of Daprodustat for Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis","therapeuticArea":"Hematology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"June 2023","url1":"","url2":"","graph1":"Hematology","graph2":"Approved"}]

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              GSK

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              GSK Receives Positive CHMP Opinion Recommending Authorisation of Daprodustat for Symptomatic Anaemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance...

              Details:

              Jesduvroq (daprodustat) is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) used for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: Jesduvroq

              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 26, 2023

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              GSK

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              Jesduvroq (daprodustat) Approved By US FDA For Anaemia of Chronic Kidney Disease in Adults on Dialysis

              Details:

              Jesduvroq (daprodustat), a HIF-PHI, which inhibis of oxygen-sensing prolyl hydroxylase enzymes stabilises hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia.

              Lead Product(s): Daprodustat

              Therapeutic Area: Nephrology Product Name: Jesduvroq

              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 February 01, 2023

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              GSK

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              GSK Reports Outcome From US FDA Advisory Committee Meeting On Daprodustat For Anaemia Of CKD

              Details:

              Duvroq (daprodustat), a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: Duvroq

              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 October 27, 2022

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              GSK

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              GSK Reports Outcome From US FDA Advisory Committee Meeting on Daprodustat for Anaemia of CKD

              Details:

              Duvroq (daprodustat), a HIF-PHI, belongs to a novel class of oral medicines being studied for the treatment of anaemia of CKD in adult patients not on dialysis and on dialysis.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: Duvroq

              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 October 27, 2022

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              GSK

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              • Development Update
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              GSK Announces Update on US FDA Regulatory Review of Daprodustat in Anaemia of Chronic Kidney Disease

              Details:

              Studies demonstrated that Duvroq (daprodustat) improved or maintained Hb within target level, and primary safety analysis of populations showed that daprodustat achieved non-inferiority of MACE compared to standard of care, both non-dialysis and dialysis patient settings.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: Duvroq

              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 06, 2022

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              GSK

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              US Food and Drug Administration Accepts New Drug Application for Daprodustat

              Details:

              Regulatory submission of daprodustat for treatment of anaemia of chronic kidney disease based on ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: GSK1278863

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 19, 2022

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              European Medicines Agency (EMA) Accepts Marketing Authorisation Application for Daprodustat

              Details:

              The MAA based on positive data from ASCEND Phase III clinical trial programme for GSK1278863 (daprodustat), a HIF-PHI met co-primary efficacy and safety endpoints also, approved in Japan as Duvroq for patients with renal anaemia.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: GSK1278863

              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 March 01, 2022

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              GSK

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              GSK Announces Positive Phase III Efficacy and Safety Data for Daprodustat in Patients with Anaemia Due to Chronic Kidney Disease

              Details:

              GSK1278863 (Daprodustat) is first oral HIF-PHI to clearly show positive efficacy, along with no increased cardiovascular risk as assessed in primary analysis. Daprodustat is currently approved in Japan as Duvroq for patients with renal anaemia.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: GSK1278863

              Highest Development Status: Approved Product Type: Small molecule

              Partner/Sponsor/Collaborator:

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable November 05, 2021

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              GSK’s Five Studies of Phase 3 ASCEND Programme of Daprodustat for Patients with Anaemia Due To CKD Meets Primary Endpoints

              Details:

              The most commonly reported adverse events in patients receiving daprodustat across the ASCEND programme included hypertension, diarrhoea, dialysis hypotension, peripheral edema, and urinary tract infection.

              Lead Product(s): Daprodustat

              Therapeutic Area: Hematology Product Name: GSK1278863

              Highest Development Status: Phase III Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable July 16, 2021

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