Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
European Commission Approves Pfizer’s DURVEQTIX® Gene Therapy for Hemophilia B
Details : Durveqtix (fidanacogene elaparvovec) is an adeno-associated viral (AAV) vector-based gene therapy approved for the treatment of adults with moderately severe to severe hemophilia B.
Brand Name : Durveqtix
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
July 25, 2024
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Labcorp Receives FDA Approval for Companion Diagnostic for Hemophilia B Gene Therapy
Details : The FDA has approved its nAbCyte Anti-AAVRh74var HB-FE Assay, a companion diagnostic to determine patient eligibility for treatment with Beqvez (fidanacogene elaparvovec).
Brand Name : Beqvez
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
April 29, 2024
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Approves Pfizer’s BEQVEZ™ Gene Therapy for Hemophilia B
Details : Beqvez (fidanacogene elaparvovec) is an AAV-based gene therapy approved for adults with moderate to severe hemophilia B, introducing a functional copy of the high-activity FIX gene.
Brand Name : Beqvez
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
April 26, 2024
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Study Phase : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Health Canada Approves Pfizer Canada's Gene Therapy in Hemophilia B
Details : BEQVEZ (fidanacogene elaparvovec) is an adeno-associated viral (AAV) vector-based gene therapy approved for the treatment of adults with moderately severe to severe hemophilia B.
Brand Name : Beqvez
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
January 03, 2024
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Approved
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Accepts Pfizer’s Application for Hemophilia B Gene Therapy Fidanacogene Elaparvovec
Details : PF-06838435 (fidanacogene elaparvovec) is a novel, investigational gene therapy that contains a bio-engineered AAV capsid and a high-activity variant of human coagulation FIX gene. Currently it is being investigated for Hemophilia B.
Brand Name : PF-06838435
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
June 27, 2023
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Pfizer Announces Positive Top-Line Results from Phase 3 Study of Hemophilia B Gene Therapy Candidate
Details : PF-06838435 (fidanacogene elaparvovec), is a novel, investigational vector that contains a bio-engineered adeno-associated virus (AAV) capsid (protein shell) and a high-activity human coagulation FIX gene.
Brand Name : PF-06838435
Molecule Type : Cell and Gene therapy
Upfront Cash : Not Applicable
December 29, 2022
Lead Product(s) : Fidanacogene elaparvovec
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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