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    [{"orgOrder":0,"company":"Ono Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"ONO Submits Supplemental Application for Approval for Opdivo\u00ae to Expand the Use in Recurrent Gastric Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase II\/ Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Oncology","graph2":"Phase II\/ Phase III"},{"orgOrder":0,"company":"Nordic Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Positive EMA Opinion for the Use of Teysuno in Metastatic Colorectal Cancer","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Taiho Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiho Pharmaceutical Obtains Additional Indication of \"Postoperative Adjuvant Chemotherapy for Hormone Receptor-Positive and HER2-Negative Breast Cancer at High Risk of Recurrence\" for Oral Anticancer Agent TS-1","therapeuticArea":"Oncology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"November 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Phase III"}]

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              Taiho Pharmaceutical

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              Taiho Pharmaceutical Obtains Additional Indication of "Postoperative Adjuvant Chemotherapy for Hormone Receptor-Positive and HER2-Negative Breast Cancer at High Risk of Rec...

              Details:

              TS-1 is a combination of three pharmacological compounds: tegafur, an antimetabolite agent that, after absorption by the gastrointestinal tract, is converted into the anticancer agent fluorouracil (5-FU); gimeracil (5-chloro-2, 4-dihydroxypyridine, or CDHP).

              Lead Product(s): Tegafur,Gimeracil

              Therapeutic Area: Oncology Product Name: TS-1

              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 November 24, 2022

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              Nordic Pharma

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              Positive EMA Opinion for the Use of Teysuno in Metastatic Colorectal Cancer

              Details:

              Based on the positive opinion from EMA, Teysuno (Tegafur) an oral fluoropyrimidine will be indicated in adults for the treatment of advanced gastric cancer when given in combination with cisplatin.

              Lead Product(s): Tegafur,Gimeracil,Oteracil

              Therapeutic Area: Oncology Product Name: Teysuno

              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 04, 2022

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              Ono Pharmaceutical

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              ONO Submits Supplemental Application for Approval for Opdivo® to Expand the Use in Recurrent Gastric Cancer

              Details:

              The supplemental application for approval for Opdivo® has been filed based on the data from the following 2 clinical studies: CheckMate -649 study (ONO-4538-44) and ATTRACTION-4 study (ONO-4538-37.

              Lead Product(s): Nivolumab,Oxaliplatin,Tegafur

              Therapeutic Area: Oncology Product Name: Opdivo

              Highest Development Status: Phase II/ Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable December 10, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
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