Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Polpharma's Investigational Biosimilar Shows PK/PD Comparability To Entyvio® For IBD
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 Ulcerative Colitis.
Brand Name : PB016
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 21, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio®
Details : AVT16 (vedolizumab) is an integrin receptor antagonist indicated in adults for the treatment of moderately to severely active ulcerative colitis & crohn's disease.
Brand Name : AVT16
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 25, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Takeda’s ENTYVIO® for Crohn’s Disease Maintenance Therapy
Details : Entyvio (vedolizumab) binds to α4β7 integrin, blocking interaction with integrins, and is being evaluated for moderately to severely active Crohn’s disease.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 18, 2024
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 27, 2023
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 13, 2023
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 27, 2023
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 27, 2023
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Immunology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 18, 2023
Lead Product(s) : Vedolizumab
Therapeutic Area : Immunology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab,Ciprofloxacin
Therapeutic Area : Gastroenterology
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 17, 2021
Lead Product(s) : Vedolizumab,Ciprofloxacin
Therapeutic Area : Gastroenterology
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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.
Brand Name : Entyvio
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 12, 2020
Lead Product(s) : Vedolizumab
Therapeutic Area : Gastroenterology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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