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              Astellas Pharma

              • Development Update

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              JAPAN Japan

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              BE PHARMA 2020

              Participation Not Confirmed

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              Roxadustat Reports Non-Inferiority to Darbepoetin in Phase 3 DOLOMITES Study of Anemia in Non-Dialysis-Dependent Patients with CDK

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              Lead Product(s): Roxadustat

              Therapeutic Area: Hematology Product Name: Undisclosed

              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 June 08, 2020

              Details:

              The data showed non-inferiority of roxadustat to darbepoetin alfa in the correction of hemoglobin levels during the first 24 weeks of treatment, meeting the study's primary endpoint.

              Astellas Pharma

              • Development Update

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              JAPAN Japan

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              BE PHARMA 2020

              Participation Not Confirmed

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              European Medicines Agency Accepts Astellas' Marketing Authorization Application for Roxadustat

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              Lead Product(s): Roxadustat

              Therapeutic Area: Hematology Product Name: Undisclosed

              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 May 20, 2020

              Details:

              The MAA is supported by positive results from a pivotal Phase 3 program, which involved more than 9,000 patients worldwide.

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