All Data
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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): 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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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 October 23, 2020
Details:
PRO2TECT data show vadadustat achieved primary and key secondary efficacy endpoints in each study, but did not meet the primary safety endpoint.
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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 October 12, 2020
Details:
ULTOMIRIS 100 mg/mL is an advancement in the treatment experience for patients with aHUS and PNH, as it reduces average annual infusion times by approximately 60 percent compared to ULTOMIRIS 10 mg/mL while delivering comparable safety and efficacy.
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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 October 01, 2020
Details:
With this deal, Covis gains access to AMAG’s two commercial therapies, Makena, indicated for women with risk of preterm birth in singleton pregnancies and Feraheme indicated treat iron deficiency anaemia in CKD patients and for whom oral iron is not suitable or ineffective.
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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 September 29, 2020
Details:
Health Canada has approved REBLOZYL® (luspatercept) for the treatment of adult patients with red blood cell (RBC) transfusion-dependent anemia associated with beta(β)-thalassemia.
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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 September 25, 2020
Details:
ULTOMIRIS is the first and only long-acting C5 inhibitor for aHUS and is administered every other month for adults and children (20 kg or more) and monthly for children (<20 kg).
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