API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
Under the terms of this agreement, AcedrA will register, promote and commercialize Trogarzo (Ibalizumab-uiyk), a CD4-directed post-attachment HIV-1 inhibitor for the treatment of human immunodeficiency virus type 1 (HIV-1) infection, in the MENA region.
Lead Product(s): Ibalisumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Trogarzo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AcedrA BioPharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement March 18, 2024
Details:
sBLA submission with FDA for Trogarzo (Ibalizumab-uiyk), a CD4-directed post-attachment HIV-1 inhibitor is approved for the treatment of adults infected with MDR HIV-1 in Europe.
Lead Product(s): Ibalisumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Trogarzo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 06, 2021
Details:
Theratechnologies plans to launch Trogarzo® on a country-by-country basis across Europe as it gains reimbursement in each individual country. In addition, the Company received regulatory approval in Israel for Trogarzo® and is working to secure pricing and reimbursement.
Lead Product(s): Ibalisumab
Therapeutic Area: Infections and Infectious Diseases Product Name: Trogarzo
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Italian Medicines Agency
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 26, 2021