[{"orgOrder":0,"company":"Zeria Pharmaceutical","sponsor":"Kyowa Kirin","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Kyowa Kirin Terminates ASACOL\u00ae deal with Zeria Pharmaceutical","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"February 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Zeria Pharmaceutical"},{"orgOrder":0,"company":"Taiho Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiho Pharma Submits Application for Additional Dosage and Administration of 5-HT3 Receptor Antagonist Aloxi\u00ae for Pediatric Patients","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Taiho Pharmaceutical"},{"orgOrder":0,"company":"Daiichi Sankyo","sponsor":"RedHill Biopharma","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"RedHill Biopharma Announces New Agreement with Daiichi Sankyo for Movantik\u00ae","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Daiichi Sankyo"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Provides Update on U.S. Development Program for the Subcutaneous Formulation of ENTYVIO\u00ae for Moderate to Severe Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"September 2020","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 Safety and Efficacy of Subcutaneous Entyvio Sustained During Long-term Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"October 2020","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 Submits NDA to Manufacture and Market Darvadstrocel In Japan for Complex Perianal Fistulas in Adult Patients with Crohn\u2019s Disease","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Cell and Gene therapy","productStatus":"Approved","date":"February 2021","url1":"","url2":"","graph1":"Cell and Gene therapy","graph2":"Takeda Pharmaceutical"},{"orgOrder":0,"company":"Kyowa Kirin","sponsor":"Cumberland Pharmaceuticals","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Cumberland Pharmaceuticals Acquires Sancuso\u00ae From Kyowa Kirin North America","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Kyowa Kirin"},{"orgOrder":0,"company":"Taiho Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Taiho Pharmaceutical Obtains Approval to Manufacture and Market NK1 Receptor Antagonist Arokaris\u00ae I.V. Infusion 235mg in Japan","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Taiho Pharmaceutical"},{"orgOrder":0,"company":"Otsuka Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Introducing New B240 Tablets Effortless Way to Consume a Unique Ingredient for Maintenance of Physical Condition","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"July 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Otsuka Pharmaceutical"},{"orgOrder":0,"company":"Takeda Pharmaceutical","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Takeda Receives Approval to Manufacture and Market Entyvio\u00ae Subcutaneous Injection in Japan for the Maintenance Treatment of Moderate to Severe Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"March 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 BLA Resubmission for Investigational Subcutaneous Administration of Entyvio\u00ae (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"April 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":"U.S. FDA Approves Subcutaneous Administration of Takeda's ENTYVIO\u00ae (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis","therapeuticArea":"Gastroenterology","highestDevelopmentStatus":"Approved","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"September 2023","url1":"","url2":"","graph1":"Large molecule","graph2":"Takeda Pharmaceutical"}]
Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Entyvio (vedolizumab) is a humanized mAb that binds and blocks α4β7 integrin interaction, which is indicated for the treatment of subcutaneous administration of moderately to severely active ulcerative colitis.
Entyvio (vedolizumab) is a humanized mAb that binds and blocks α4β7 integrin interaction with MAdCAM-1, inhibiting the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue.
Entyvio (vedolizumab) is a humanized mAb that binds and blocks α4β7 integrin interaction with MAdCAM-1, inhibiting the migration of memory T-lymphocytes across the endothelium into inflamed gastrointestinal parenchymal tissue.
Products under BODYMAINTÉ (lactiplantibacillus pentosus ONRICb0240) brand contain lactic acid bacterium B240 to support day-to-day conditioning. New B240 Tablets are small, easy-to-swallow tablets conceived to encourage ongoing consumption of this same lactic acid bacteria.
Lead Product(s):
Lactiplantibacillus Pentosus ONRICb0240
The approval is based on results of a Phase III clinical study (CONSOLE6) comparing the efficacy and safety of Arokaris® versus fosaprepitant in patients receiving highly emetogenic chemotherapy in combination with palonosetron and dexamethasone.
Under the terms of the agreement, Cumberland will acquire U.S. rights to SANCUSO (Granisetron) and will assume full commercial responsibility for the product - including its marketing, promotion, distribution, manufacturing and medical support activities.
Darvadstrocel is a suspension of allogeneic expanded adipose-derived stem cells for complex perianal fistulas in adult patients with non-active or mildly active luminal CD. The filing included data from Japanese Study Darvadstrocel-3002 and the ADMIRE-CD trial.
Interim analysis from VISIBLE OLE study showed long-term findings consistent with the known safety profile of vedolizumab with maintained rates of clinical remission and corticosteroid-free clinical remission.
Takeda has received Complete Response Letter from the U.S. FDA in response to the submission of a BLA for an investigational subcutaneous formulation of Entyvio® (vedolizumab) for maintenance therapy in adults with moderate to severe ulcerative colitis (UC).
RedHill and Daiichi Sankyo replaced their co-commercialization agreement for Movantik® with a new royalty-bearing agreement, under which RedHill will maintain sole and exclusive responsibility for the commercialization of Movantik® in the U.S.