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Lead Product(s): Pegfilgrastim
Therapeutic Area: Hematology Product Name: Nyvepria
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 11, 2020
Details:
The FDA approval was based on the review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of NYVEPRIA to its reference product.
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Lead Product(s): Carglumic Acid
Therapeutic Area: Hematology Product Name: Carbaglu
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 26, 2021
Details:
U.S. FDA has approved a new indication for CARBAGLU® (carglumic acid) tablets 200mg as adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to propionic acidemia (PA) or methylmalonic acidemia (MMA) in pediatric and adult patients.
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Lead Product(s): Ferumoxytol
Therapeutic Area: Hematology Product Name: Feraheme
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Covis Pharma
Deal Size: $647.0 million Upfront Cash: $647.0 million
Deal Type: Acquisition November 16, 2020
Details:
The acquisition adds AMAG's key products Feraheme®, Makena® and Ciraparantag to Covis' pipeline as it carries out its mission of expanding patient access to much needed therapies.
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Lead Product(s): Vadadustat
Therapeutic Area: Hematology Product Name: Vafseo
Highest Development Status: Approved Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 16, 2020
Details:
INNO2VATE evaluated the efficacy and safety of vadadustat, Akebia's investigational oral HIF-PHI, versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis.
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Lead Product(s): Ravulizumab
Therapeutic Area: Hematology Product Name: Ultomiris
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
New data from 2 Phase 3 extension trials showing similar safety, consistent and durable efficacy of ULTOMIRIS® through 52 weeks when used to treat adults with paroxysmal nocturnal hemoglobinuria who are 65 and above than those who are 65 years old or younger to be presented.
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Lead Product(s): Luspatercept
Therapeutic Area: Hematology Product Name: Reblozyl
Highest Development Status: Approved Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 04, 2020
Details:
Data analyses from the Phase 3 MEDALIST and BELIEVE trials find treatment with luspatercept maintains health-related quality of life in patients with lower-risk myelodysplastic syndromes and transfusion-dependent beta-thalassemia, respectively.
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