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.
Global Pharmaceutical Dosage Solutions Company
Lead Product(s): Abelacimab
Therapeutic Area: Hematology Product Name: Undisclosed
Highest Development Status: Undisclosed Product Type: Large molecule
Partner/Sponsor/Collaborator: Anthos Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership June 11, 2020
Details:
The agreement furthers Anthos Therapeutics mission to develop Abelacimab for patients at risk of thrombotic events, which are currently underserved by conventional anti-coagulant 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 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): Narsoplimab
Therapeutic Area: Hematology Product Name: OMS721
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Narsoplimab, an inhibitor of mannan-binding lectin-associated serine protease-2 (MASP-2), the effector enzyme of the lectin pathway and activator of the coagulation cascade, is being studied for the treatment of HSCT-TMA patients at high risk for poor outcomes.
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Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 22, 2020
Details:
Two analyses of pooled data from the roxadustat global Phase 3 development program to be presented during the American Society of Nephrology Kidney Week 2020 Reimagined.
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Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 20, 2020
Details:
For roxadustat, more than 40 abstracts present safety and efficacy outcomes in anaemia of chronic kidney disease.
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Lead Product(s): Roxadustat
Therapeutic Area: Hematology Product Name: ASP1517
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: FibroGen, Inc
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 19, 2020
Details:
Abstracts include presentations of the Phase 3 DOLOMITES study and a Japanese Phase 3 CL-0310 study, with both studies evaluating roxadustat versus darbepoetin alfa as a treatment for patients with anemia of CKD not on dialysis.
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Lead Product(s): OMS906
Therapeutic Area: Hematology Product Name: OMS906
Highest Development Status: Phase I Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
The presentation included data demonstrating that a single dose of OMS906 in an animal study demonstrated a decrease of mature CFD and an increase and accumulation in pro-CFD levels that remained detectable for more than three weeks.
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Lead Product(s): Narsoplimab
Therapeutic Area: Hematology Product Name: OMS721
Highest Development Status: Phase III Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 15, 2020
Details:
These updated data and analyses form the basis of regulatory review and product labeling. The BLA also includes data from the HSCT-TMA compassionate-use program, which are highly consistent with the clinical trial data.
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Lead Product(s): FTH1
Therapeutic Area: Hematology Product Name: BioFe
Highest Development Status: Undisclosed Product Type: Large molecule
Partner/Sponsor/Collaborator: SRS Life Sciences Pte ltd
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement October 13, 2020
Details:
The agreement provides SRS exclusive rights for sales, marketing, and distribution of Sidero’s patented biologic iron, BioFeTM, for the management of iron deficiency and related disorders in India and Southeast Asia.
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