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    [{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib for Treatment of NSCLC Patients ","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Foundation Medicine","sponsor":"Takeda Pharmaceutical","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Foundation Medicine and Takeda Announce Collaboration To Develop FoundationOne\u00aeCDx and FoundationOne\u00aeLiquid CDx","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Gets FDA Priority Review for NDA for Mobocertinib as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda\u2019s EXKIVITY\u2122 Approved by U.S. FDA as the First Oral Therapy Designed for Patients with EGFR Exon20 Insertion+ NSCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda\u2019s Exkivity\u00ae (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"FoundationOne","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FoundationOne\u00aeLiquid CDx Receives FDA-Approval as a Companion Diagnostic for EXKIVITY\u00ae (mobocertinib) to Identify Patients with EGFR Exon 20 Insertion Mutations in Advanced Non-Small Cell Lung Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Provides Update on EXKIVITY\u00ae (mobocertinib)","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"October 2023","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"}]

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              Takeda Pharmaceutical

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              Takeda Provides Update on EXKIVITY® (mobocertinib)

              Details:

              Exkivity® (mobocertinib) is a kinase inhibitor of the EGFR that irreversibly binds to and inhibits EGFR exon 20 insertion mutations at lower concentrations than wild type (WT) EGFR. It is being investigated for EGFR Exon 20 Insertion mutations in advanced NSCLC.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: Exkivity

              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 02, 2023

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              FoundationOne

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              FoundationOne®Liquid CDx Receives FDA-Approval as a Companion Diagnostic for EXKIVITY® (mobocertinib) to Identify Patients with EGFR Exon 20 Insertion Mutations in Advanc...

              Details:

              Exkivity® (mobocertinib) is a kinase inhibitor of the EGFR that irreversibly binds to and inhibits EGFR exon 20 insertion mutations at lower concentrations than wild type (WT) EGFR. It is being investigated for EGFR Exon 20 Insertion mutations in advanced NSCLC.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: Exkivity

              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 May 04, 2023

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              Takeda Pharmaceutical

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              Takeda’s Exkivity® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

              Details:

              Exkivity (mobocertinib) is an oral tyrosine kinase inhibitor specifically designed to selectively target epidermal growth factor receptor (EGFR) Exon20 insertion mutations. It is currently approved for the treatment of NSCLC with EGFR Exon20 insertion mutations.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: Exkivity

              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 January 11, 2023

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              Takeda Pharmaceutical

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              Takeda’s EXKIVITY™ Approved by U.S. FDA as the First Oral Therapy Designed for Patients with EGFR Exon20 Insertion+ NSCLC

              Details:

              EXKIVITY, which was granted priority review and received Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation from the FDA, is the first and only approved oral therapy specifically designed to target EGFR Exon20 insertion mutations.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: Exkivity

              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 15, 2021

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              Takeda Pharmaceutical

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              Takeda Gets FDA Priority Review for NDA for Mobocertinib as a Treatment for EGFR Exon20 Insertion+ Metastatic Non-Small Cell Lung Cancer

              Details:

              The NDA for mobocertinib is primarily based on results from the Phase 1/2 trial, which is evaluating the safety and efficacy of oral mobocertinib in patients with mNSCLC.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: TAK-788

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 28, 2021

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              Foundation Medicine

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              Foundation Medicine and Takeda Announce Collaboration To Develop FoundationOne®CDx and FoundationOne®Liquid CDx

              Details:

              Collaboration aims at developing blood-based companion diagnostics for use with marketed and investigational treatments in Takeda’s late-stage lung cancer portfolio. Companion diagnostics, if approved, would be used to identify patients who may be eligible for mobocertinib.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: TAK-788

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Takeda Pharmaceutical

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration September 18, 2020

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              Takeda Pharmaceutical

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              Takeda Presents New Data Highlighting Scientific Advancements in Lung Cancer at ESMO Virtual Congress

              Details:

              Takeda is featuring updated 10-month follow-up results from the Phase 1/2 trial of mobocertinib (TAK-788), demonstrating mobocertinib achieved a duration of response of more than one year in the trial’s study population of patients with EGFR Exon20 insertion+ metastatic NSCLC.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: TAK-788

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 18, 2020

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              Takeda Pharmaceutical

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              Takeda Announces U.S. FDA Breakthrough Therapy Designation for Mobocertinib for Treatment of NSCLC Patients

              Details:

              Breakthrough Therapy Designation is based on the overall response rate and the long-term benefit seen in patients who responded in a Ph 1/2 study evaluating the safety and efficacy of mobocertinib.

              Lead Product(s): Mobocertinib

              Therapeutic Area: Oncology Product Name: Undisclosed

              Highest Development Status: Phase I/ Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 27, 2020

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