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Details:
FDA has approved its nAbCyte™ Anti-AAVRh74var HB-FE Assay, a companion diagnostic (CDx) to determine patient eligibility for treatment with BEQVEZ™ (fidanacogene elaparvovec-dzkt), Pfizer's recently FDA-approved hemophilia B gene therapy.
Lead Product(s): Fidanacogene elaparvovec
Therapeutic Area: Genetic Disease Product Name: Beqvez
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 29, 2024
Details:
Beqvez (fidanacogene elaparvovec) is an adeno-associated virus (AAV)-based gene therapy designed to introduce in the transduced cells a functional copy of the FIX gene encoding a high-activity FIX variant. It is approved for the treatment of adults with moderate to severe hemophilia B.
Lead Product(s): Fidanacogene elaparvovec
Therapeutic Area: Genetic Disease Product Name: Beqvez
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 26, 2024
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.
Lead Product(s): Fidanacogene elaparvovec
Therapeutic Area: Genetic Disease Product Name: Beqvez
Highest Development Status: ApprovedProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2024
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.
Lead Product(s): Fidanacogene elaparvovec
Therapeutic Area: Genetic Disease Product Name: PF-06838435
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 27, 2023
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.
Lead Product(s): Fidanacogene elaparvovec
Therapeutic Area: Genetic Disease Product Name: PF-06838435
Highest Development Status: Phase IIIProduct Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 29, 2022
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