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Gastrointestinal Symptoms Associated with Cancer Chemotherapy","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Taiho Pharmaceutical"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Drug Application for Oral Disintegrated Tablet Formulation of TAKECAB\u00ae for Treatment of Acid-Related Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO\u00ae (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Small molecule","graph2":"Takeda Pharmaceutical"}]

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            Details:

            TAK-721 (budesonide oral suspension) is a novel mucoadherent topically active oral viscous formulation of budesonide, formulated specifically as an investigational treatment for eosinophilic esophagitis (EoE).

            Lead Product(s): Budesonide

            Therapeutic Area: Gastroenterology Product Name: TAK-721

            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 September 20, 2023

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            Entyvio (vedolizumab) is a humanized mAb that binds and blocks α4β7 integrin interaction, which is investigated for the treatment of subcutaneous administration of moderately to severely active Crohn’s disease.

            Lead Product(s): Vedolizumab

            Therapeutic Area: Gastroenterology Product Name: Entyvio

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 13, 2023

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            Taiho Pharmaceutical has submitted to the Japanese Ministry of Health, Labour and Welfare a new drug application for an NK1 receptor antagonist antiemetic drug for gastrointestinal symptoms (nausea and vomiting) associated with cancer chemotherapy.

            Lead Product(s): Fosnetupitant Chloride

            Therapeutic Area: Gastroenterology Product Name: Pro-NETU

            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 March 23, 2021

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            Takeda has applied for approval to manufacture and market TAKECAB® OD 10 mg and TAKECAB® OD 20 mg as additional formulations of TAKECAB® 10 mg and TAKECAB® 20 mg, developed by Takeda for treating acid-related disease.

            Lead Product(s): Vonoprazan Fumarate

            Therapeutic Area: Gastroenterology Product Name: Takecab

            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 March 22, 2021

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            Details:

            Primary endpoint was achieved in Phase III clinical study (AJM300/CT3) of AJM300 (nonproprietary name: carotegrast methyl), which EA Pharma and Kissei Pharmaceutical have developed for treatment of ulcerative colitis.

            Lead Product(s): Carotegrast Methyl

            Therapeutic Area: Gastroenterology Product Name: AJM300

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: EA Pharma

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable January 13, 2021

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            Details:

            If approved, TAK-721 will be the first FDA-approved treatment for the chronic inflammatory disease, and Takeda plans to use the trade name Eohilia. The TAK-721 development program is the first and largest EoE Phase 3 clinical trial program in the U.S. to report results.

            Lead Product(s): Budesonide

            Therapeutic Area: Gastroenterology Product Name: TAK-721

            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 December 15, 2020

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            Details:

            Takeda will discontinue the current SHP647 clinical trial program, and it will be providing all eligible trial participants with the opportunity to have continued access to SHP647 in a post-trial access study.

            Lead Product(s): Ontamalimab

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 28, 2020

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            Details:

            If approved, vedolizumab will become the only maintenance therapy for ulcerative colitis or Crohn's disease with both intravenous and subcutaneous formulations across the European Union.

            Lead Product(s): Vedolizumab

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 28, 2020

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            Details:

            At week 52, significantly more patients on vedolizumab SC compared to placebo were in clinical remission meeting the study’s primary endpoint.

            Lead Product(s): Vedolizumab

            Therapeutic Area: Gastroenterology Product Name: Undisclosed

            Highest Development Status: Phase III Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 14, 2020

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