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    [{"orgOrder":0,"company":"Incyte Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Incyte Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig\u00ae for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves Supplemental New Drug Application for Takeda\u2019s ICLUSIG\u00ae (ponatinib) for Chronic-Phase CML","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Approves Supplemental New Drug Application for Takeda\u2019s ICLUSIG\u00ae for Adult Patients with Resistant or Intolerant Chronic-Phase CML","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Phase 3 Trial of ICLUSIG\u00ae (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL, a Setting with No Targeted Treatments Approved in the US","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG\u00ae (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG\u00ae (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]

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              Takeda Pharmaceutical

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              Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

              Details:

              Iclusig (ponatinib) is a kinase inhibitor targeting BCR::ABL1. It is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy.

              Lead Product(s): Ponatinib

              Therapeutic Area: Oncology Product Name: Iclusig

              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 19, 2024

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              Takeda Pharmaceutical

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              Takeda Announces U.S. FDA Approval of Supplemental New Drug Application (sNDA) for ICLUSIG® (ponatinib) in Adult Patients with Newly Diagnosed Ph+ ALL

              Details:

              Iclusig (ponatinib), a Tyrosine kinase inhibitor receives Supplemental New Drug Application approval by the U.S. FDA. It is indicated for the treatment of adult patients with Ph+ Acute Lymphoblastic Leukemia.

              Lead Product(s): Ponatinib

              Therapeutic Area: Oncology Product Name: Iclusig

              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 19, 2024

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              Takeda Pharmaceutical

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              Phase 3 Trial of ICLUSIG® (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL, a Setting with No Targeted Treatments Approved in the US

              Details:

              ICLUSIG (ponatinib) is the only pan-mutational and third-generation tyrosine kinase inhibitor (TKI), targeting BCR:ABL1 and all known single, treatment-resistant mutations, including the most resistant T315I mutation.

              Lead Product(s): Ponatinib

              Therapeutic Area: Oncology Product Name: Iclusig

              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, 2022

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              Takeda Pharmaceutical

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              U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® (ponatinib) for Chronic-Phase CML

              Details:

              The updated label includes an optimized, response-based ICLUSIG dosing regimen in CP-CML with a daily starting dose of 45 mg and, upon achieving ≤1% BCR-ABL1IS, dose reduction to 15 mg.

              Lead Product(s): Ponatinib

              Therapeutic Area: Oncology Product Name: Iclusig

              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 December 19, 2020

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              Takeda Pharmaceutical

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              U.S. FDA Approves Supplemental New Drug Application for Takeda’s ICLUSIG® for Adult Patients with Resistant or Intolerant Chronic-Phase CML

              Details:

              Updated ICLUSIG Label will Prove Practice-Changing, Expanding Indication to Chronic Phase-CML Patients with Resistance or Intolerance to At Least Two Prior Tyrosine Kinase Inhibitors. New Dosing Regimen Optimizes Benefit-Risk Profile, Providing Efficacy & Improving Safety.

              Lead Product(s): Ponatinib

              Therapeutic Area: Oncology Product Name: Iclusig

              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 December 19, 2020

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              Incyte Corporation

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              Incyte Interim Data from the Open Label Phase 2 OPTIC Study of Iclusig® for Chronic Phase-CML Presented at the ASCO and EHA Virtual Meetings

              Details:

              Data from the interim analysis of the Phase 2 OPTIC trial show that response-based dosing regimens of Iclusig can optimize benefit-risk profile in patients with resistant or intolerant chronic phase-chronic myeloid leukemia (CML).

              Lead Product(s): Ponatinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 29, 2020

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