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Details:
PB016 (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for the treatment of Ulcerative Colitis.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: PB016
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 21, 2024
Details:
Entyvio (vedolizumab) is a humanized monoclonal antibody that specifically binds to the α4β7 integrin & blocks the interaction of α4β7 integrin. It is being evaluated for the treatment of moderately to severely active crohn’s disease.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 18, 2024
Details:
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.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 27, 2023
Details:
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2023
Details:
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.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 27, 2023
Details:
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.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 27, 2023
Details:
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.
Lead Product(s): Vedolizumab
Therapeutic Area: Immunology Product Name: Entyvio
Highest Development Status: Phase IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 18, 2023
Details:
The positive opinion from the CHMP was based on the EARNEST trial, which assessed the safety and efficacy of Entyvio (vedolizumab) IV if approved it Will Be the First Authorized Treatment in Europe for active chronic pouchitis.
Lead Product(s): Vedolizumab,Ciprofloxacin
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 17, 2021
Details:
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.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 12, 2020
Details:
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).
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Entyvio
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 02, 2020
Details:
Through transactions such as this, Royalty Pharma is furthering our goal of accelerating innovation and making the life sciences research and development ecosystem more efficient and productive.
Lead Product(s): Vedolizumab
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Royalty Pharma
Deal Size: $94.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition March 05, 2020
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 IIIProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 28, 2020
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 IIIProduct 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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Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
