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Find Approved Hematology Drugs in Clinical Development

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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): Ferric Derisomaltose

            Therapeutic Area: Hematology Product Name: Monofer

            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 29, 2021

            Details:

            Monofer® is the first of the latest generation of innovative IV irons to be made available to patients in the Chinese health care system and is expected to expand the use of IV irons across multiple therapeutic areas.

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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): Argatroban

            Therapeutic Area: Hematology Product Name: Undisclosed

            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 22, 2021

            Details:

            Caplin Steriles has been granted final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Argatroban injection, 50 mg/50 ml (1 mg/ml), single-dose vial presentation, it said in a filing to BSE.

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            Lead Product(s): Roxadustat

            Therapeutic Area: Hematology Product Name: Evrenzo

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: FibroGen, Inc

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable December 18, 2020

            Details:

            US FDA has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anaemia of chronic kidney disease (CKD).

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            Lead Product(s): Polysaccharide iron complex

            Therapeutic Area: Hematology Product Name: Li Fei Neng

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: RTW Investments

            Deal Size: $181.0 million Upfront Cash: Undisclosed

            Deal Type: Series D Financing December 08, 2020

            Details:

            Proceeds from the financing will be used in the ongoing research and development of Nuance's existing products and business development of potential new assets.

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            Lead Product(s): Human Fibrinogen

            Therapeutic Area: Hematology Product Name: Fibryga

            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 December 03, 2020

            Details:

            Octapharma to present multiple clinical trial posters on the efficacy and safety of fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution, for Intravenous Use to treat congenital and acquired bleeding disorders.