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[{"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Active Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"},{"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda: Subcutaneous Formulation Of Vedolizumab Receives Positive CHMP Opinion","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"},{"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Releases Takeda From Commitment to Divest Shire\u2019s Pipeline Compound SHP647","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"New Molecular Entity","date":"May 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"},{"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Accepts New Drug Application for Review, for Takeda\u2019s TAK-721 for the Treatment of Eosinophilic Esophagitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"December 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Takeda Pharmaceutical"},{"company":"Kissei Pharmaceutical","sponsor":"EA Pharma","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Results of Phase III Clinical Study of AJM300 for Treatment of Ulcerative Colitis Conducted in Japan (AJM300\/CT3 Study)","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Kissei Pharmaceutical"},{"company":"Taiho Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiho Submits NDA for NK1 Receptor Antagonist Fosnetupitant for Prevention of 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"},{"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"}]

Taiho Pharmaceutical

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Taiho Submits NDA for NK1 Receptor Antagonist Fosnetupitant for Prevention of Gastrointestinal Symptoms Associated with Cancer Chemotherapy

Details:

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 Pharmaceutical

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New Drug Application for Oral Disintegrated Tablet Formulation of TAKECAB® for Treatment of Acid-Related Disease

Details:

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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Kissei Pharmaceutical

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Results of Phase III Clinical Study of AJM300 for Treatment of Ulcerative Colitis Conducted in Japan (AJM300/CT3 Study)

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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Takeda Pharmaceutical

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U.S. FDA Accepts New Drug Application for Review, for Takeda’s TAK-721 for the Treatment of Eosinophilic Esophagitis

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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Takeda Pharmaceutical

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European Commission Releases Takeda From Commitment to Divest Shire’s Pipeline Compound SHP647

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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Takeda Pharmaceutical

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Takeda: Subcutaneous Formulation Of Vedolizumab Receives Positive CHMP Opinion

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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Takeda Pharmaceutical

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Investigational Subcutaneous Formulation of Vedolizumab Achieves Clinical Remission at Week 52 in Active Crohn’s Disease

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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