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)
0
Europe
0
Canada
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
0
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
Details:
NUWIQ is a recombinant antihemophilic factor [coagulation factor VIII] indicated in adults and children with Hemophilia A for treatment and control of bleeding episodes, perioperative management of bleeding, and routine prophylaxis to reduce the frequency of bleeding episodes.
Lead Product(s): Simoctocog Alfa
Therapeutic Area: Genetic Disease Product Name: Nuwiq
Highest Development Status: ApprovedProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 05, 2021
Details:
MOTIVATE trial comprised regimens of human cell line-derived recombinant FVIII Nuwiq® or the plasma-derived FVIII products octanate® or wilate® for the management of patients with hemophilia A and inhibitors.
Lead Product(s): Simoctocog Alfa
Therapeutic Area: Genetic Disease Product Name: Nuwiq
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Octapharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 28, 2021
Details:
The NuProtect study was a prospective, multinational, open-label, non-controlled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®.
Lead Product(s): Simoctocog Alfa
Therapeutic Area: Genetic Disease Product Name: Nuwiq
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2021