FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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Find Clinical Drug Pipeline Developments & Deals by CSL Behring

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            Lead Product(s): Garadacimab

            Therapeutic Area: Infections and Infectious Diseases Product Name: CSL312

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 07, 2020

            Details:

            In this study, approximately 124 adult patients testing positive for the SARS CoV-2 infection will be randomized to receive either CSL312 or placebo, in addition to standard of care (SOC) treatment. The primary endpoint being the incidence of tracheal intubation or death.

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            Lead Product(s): Albutrepenonacog Alfa

            Therapeutic Area: Genetic Disease Product Name: Idelvion

            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 July 03, 2020

            Details:

            EMA has approved the new Summary of Product Characteristics, which includes information about new, extended dosing options for IDELVION® CSL Behring's novel, long-acting recombinant albumin fusion protein for treating haemophilia B.

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            Lead Product(s): Etranacogene dezaparvovec

            Therapeutic Area: Genetic Disease Product Name: AMT-061

            Highest Development Status: Phase III Product Type: Cell and Gene therapy

            Recipient: uniQure

            Deal Size: Undisclosed Upfront Cash: $450.0 million

            Deal Type: Licensing Agreement June 24, 2020

            Details:

            The AMT-061 program, currently in Phase 3 clinical trials, could be one of the first gene therapies to provide potentially long-term benefits to patients with hemophilia B.

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            Lead Product(s): Stem cell gene therapy

            Therapeutic Area: Genetic Disease Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Cell and Gene therapy

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable June 02, 2020

            Details:

            Initially, the alliance will develop treatment options for patients with two rare, life-threatening primary immunodeficiency diseases -- Wiskott-Aldrich Syndrome (WAS) and X-linked Agammaglobulinemia (XLA).

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            Lead Product(s): Immunoglobulin G 285-292

            Therapeutic Area: Immunology Product Name: Undisclosed

            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 April 21, 2020

            Details:

            Positive results were observed from the expanded infusion parameters of Hizentra for most patients across all three cohorts.

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            Lead Product(s): SAB-185

            Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Recipient: SAb Biotherapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Partnership April 08, 2020

            Details:

            The therapeutic candidate, SAB-185, is generated from SAB’s proprietary DiversitAbTM platform producing large volumes of human polyclonal antibodies targeted specifically to SARS-CoV-2.

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            Lead Product(s): Chemokine-derived antifibrotic peptides

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Recipient: University of Pittsburgh

            Deal Size: $0.2 million Upfront Cash: Undisclosed

            Deal Type: Partnership February 13, 2020

            Details:

            Universities awarded $250,000 research grants as part of the CSL Behring-Science Center Research Acceleration Initiative.

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            Lead Product(s): Human Rho D Immune Globulin

            Therapeutic Area: Dermatology Product Name: Undisclosed

            Highest Development Status: Phase II Product Type: Large molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable February 11, 2020

            Details:

            CSL Behring advances Ig clinical trial program to address need in treating serious autoimmune disease.

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            Lead Product(s): Undisclosed

            Therapeutic Area: Immunology Product Name: Undisclosed

            Highest Development Status: Undisclosed Product Type: Large molecule

            Partner/Sponsor/Collaborator: SAb Biotherapeutics

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration January 07, 2020

            Details:

            The collaborations will explore the possibility and the potential of new therapies to treat challenging autoimmune, infectious and idiopathic diseases by leveraging SAB’s DiversitAb™ platform.