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[{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Daiichi Sankyo Provides Update on CHMP Review of Pexidartinib, a CSF1R Inhibitor for the Treatment of Patients with TGCT","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"},{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Daiichi Sankyo Initiates Phase 2 Trial to Evaluate Pexidartinib in Japanese Patients with TGCT","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II"}]

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            Details:

            In the first part, pexidartinib 800 mg/day (400 mg twice a day on an empty stomach) will be administered to evaluate the tolerability and pharmacokinetics of pexidartinib to determine the initiation of the second part of the study.

            Lead Product(s): Pexidartinib

            Therapeutic Area: Oncology Product Name: PLX3397

            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 April 09, 2021

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            Details:

            CHMP of the European Medicines Agency has adopted a negative opinion on the Marketing Authorization Application For pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT).

            Lead Product(s): Pexidartinib

            Therapeutic Area: Oncology 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 26, 2020

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