Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Wilate
Product Type : Protein
Upfront Cash : Inapplicable
April 29, 2024
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Fibrinogen
Therapeutic Area : Hematology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : Fibryga
Product Type : Protein
Upfront Cash : Inapplicable
January 08, 2024
Lead Product(s) : Fibrinogen
Therapeutic Area : Hematology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Wilate
Product Type : Protein
Upfront Cash : Inapplicable
May 12, 2023
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Wilate
Product Type : Protein
Upfront Cash : Inapplicable
February 21, 2023
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Human Pooled Plasma
Therapeutic Area : Rare Diseases and Disorders
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Octaplas
Product Type : Other Large Molecule
Upfront Cash : Inapplicable
February 02, 2023
Lead Product(s) : Human Pooled Plasma
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Human Immunoglobulin
Therapeutic Area : Immunology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Octagam
Product Type : Other Large Molecule
Upfront Cash : Inapplicable
June 10, 2022
Lead Product(s) : Human Immunoglobulin
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Wilate
Product Type : Protein
Upfront Cash : Inapplicable
May 12, 2022
Lead Product(s) : Human Coagulation Factor VIII Complex
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : OCTA8,OCTA12
Therapeutic Area : Genetic Disease
Study Phase : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : OCTA101
Product Type : Protein
Upfront Cash : Inapplicable
April 07, 2022
Lead Product(s) : OCTA8,OCTA12
Therapeutic Area : Genetic Disease
Highest Development Status : Phase I/ Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Human Immunoglobulin
Therapeutic Area : Immunology
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Octagam
Product Type : Other Large Molecule
Upfront Cash : Inapplicable
August 30, 2021
Lead Product(s) : Human Immunoglobulin
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Simoctocog Alpha
Therapeutic Area : Genetic Disease
Study Phase : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Nuwiq
Product Type : Protein
Upfront Cash : Inapplicable
May 07, 2021
Lead Product(s) : Simoctocog Alpha
Therapeutic Area : Genetic Disease
Highest Development Status : Approved FDF
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable