Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Fibrinogen
Therapeutic Area : Hematology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Fibryga® for Fibrinogen Supplementation in Acquired Deficiency
Details : Fibryga is a fibrinogen concentrate which acts as as fibrinogen replacement therapy. It is approved for the treatment of acquired fibrinogen deficiency (AFD).
Brand Name : Fibryga
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 01, 2024
Lead Product(s) : Fibrinogen
Therapeutic Area : Hematology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Von Willebrand Factor/Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Grants Orphan Drug Exclusivity to Wilate for VWD Prophylaxis
Details : Wilate (von Willebrand factor and coagulation factor VIII) promotes platelet aggregation and platelet adhesion on damaged vascular endothelium for the treatment of von Willebrand disease.
Brand Name : Wilate
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 29, 2024
Lead Product(s) : Human Von Willebrand Factor/Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Wilate® is the first USFDA approved von Willebrand factor concentrate indicated for prophylactic treatment across all forms of von Willebrand disease in children and adults above 6 years of age.
Brand Name : Wilate
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 05, 2023
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Von Willebrand Factor/Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Octapharma USA Requests FDA Approval For Wilate® VWD Prophylaxis Supplement
Details : Wilate (von Willebrand factor and coagulation factor VIII) promotes platelet aggregation and platelet adhesion on damaged vascular endothelium for the treatment and control of bleeding episodes and perioperative management of bleeding.
Brand Name : Wilate
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 21, 2023
Lead Product(s) : Human Von Willebrand Factor/Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Pooled Plasma
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
European Authorities Approve Lyophilized S/D Treated Plasma OctaplasLG® for Pre-Hospital Transfusion
Details : Octaplas® is human pooled plasma for infusion of pharmaceutical grade with standardised quality and unique safety profiles used for indications such as in hepatic failure or massive transfusion, substitution therapy in coagulation factor deficiencies et...
Brand Name : Octaplas
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 02, 2023
Lead Product(s) : Human Pooled Plasma
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Von Willebrand Factor/Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : wilate® (human von willebrand factor/coagulation factor VIII complex) is a high-purity human VWF/FVIII concentrate, that undergoes two virus inactivation steps during its production. No albumin is added as a stabiliser.
Brand Name : Wilate
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 05, 2022
Lead Product(s) : Human Von Willebrand Factor/Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Immune Globulin
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Octagam (human immune globulin) 10% is a liquid preparation of highly purified human immunoglobulin for intravenous administration. The results of the study demonstrated that octagam® 10% is an efficacious and well-tolerated treatment for adults with de...
Brand Name : Octagam
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 06, 2022
Lead Product(s) : Human Immune Globulin
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : OCTA8,OCTA12
Therapeutic Area : Genetic Disease
Study Phase : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : OCTA101, (a human-cl rhFVIII and recombinant human von Willebrand Factor fragment dimer/OCTA8) a recombinant FVIII developed for subcutaneous administration in adult patients with severe haemophilia A.
Brand Name : OCTA101
Molecule Type : Large molecule
Upfront Cash : Not Applicable
July 04, 2022
Lead Product(s) : OCTA8,OCTA12
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I/ Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Human Immune Globulin
Therapeutic Area : Immunology
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : U.S. FDA Office of Orphan Products Development has awarded seven years of marketing exclusivity for Octagam® 10%, the first and only intravenous immunoglobulin (IVIg) to be indicated for the treatment of adult dermatomyositis.
Brand Name : Octagam
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 30, 2021
Lead Product(s) : Human Immune Globulin
Therapeutic Area : Immunology
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Simoctocog Alfa
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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 frequenc...
Brand Name : Nuwiq
Molecule Type : Peptide
Upfront Cash : Not Applicable
July 05, 2021
Lead Product(s) : Simoctocog Alfa
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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