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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.
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Lead Product(s): Human Immune Globulin
Therapeutic Area: Immunology Product Name: Octagam
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 November 06, 2020
Details:
The ProDERM study was the first pivotal randomised clinical trial to evaluate IVIg for dermatomyositis. In an initial 16-week double-blind placebo-controlled period, patients were randomised to receive either high-dose octagam® 10% (2g/kg) or placebo every four weeks.
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Lead Product(s): Immune globulin, human - ifas
Therapeutic Area: Oncology Product Name: Panzyga
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 September 17, 2020
Details:
The double-blind, randomised, placebo-controlled, prospective, multicentre phase III PRO-SID study was designed to assess the efficacy and safety of Panzyga®, a human immunoglobulin for intravenous administration, as primary prophylaxis in patients with CLL and SID.
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Lead Product(s): Immune globulin, human - ifas
Therapeutic Area: Psychiatry/Psychology Product Name: Panzyga
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 September 03, 2020
Details:
The primary objective of the trial is to evaluate if PANZYGA® is superior to placebo (0.9% w/v sodium chloride) for reducing the severity of symptoms associated with PANS in pediatric patients.
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Lead Product(s): Human Immune Globulin
Therapeutic Area: Infections and Infectious Diseases Product Name: Octagam
Highest Development Status: Phase IV Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 15, 2020
Details:
The data shows that IVIG treatment reduces inflammation, which is associated with poor clinical outcomes and death, and points to an increase in survival, in critically ill COVID-19 patients, when compared to a control group.
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Lead Product(s): Human Immune Globulin
Therapeutic Area: Infections and Infectious Diseases Product Name: Octagam
Highest Development Status: Phase IV Product Type: Large molecule
Partner/Sponsor/Collaborator: University of California San Diego School of Medicine
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Funding June 03, 2020
Details:
The randomized open label study is evaluating the standard of care (SOC) plus intravenous immunoglobulin (IVIG) compared to SOC alone in the treatment of COVID-19 infection, specifically in preventing mechanical ventilation in COVID-19 patients requiring high-flow oxygen.
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Lead Product(s): Immune globulin
Therapeutic Area: Cardiology/Vascular Diseases Product Name: Undisclosed
Highest Development Status: Undisclosed Product Type: Large molecule
Partner/Sponsor/Collaborator: Norton Heart & Vascular Institute in Louisvill
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration May 28, 2020
Details:
Octapharma USA is donating Octagam® 10% and cutaquig® 16.5%, the company’s intravenous immunoglobulin (IVIG) and subcutaneous immunoglobulin (SCIG), for the study. BioMatrix will be donating patient education, including instruction in subcutaneous injection.
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Lead Product(s): Human Normal Immunoglobulin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
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 May 20, 2020
Details:
The objective of the randomized, double-blind, placebo-controlled, multicenter study is to determine if high-dose Octagam® 10% therapy will slow or stop respiratory deterioration in patients with severe coronavirus disease.
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Lead Product(s): Normal Human Immunoglobulin
Therapeutic Area: Neurology Product Name: Undisclosed
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 May 18, 2020
Details:
The results of the study confirmed the efficacy of Panzyga® in adults with CIDP at the standard dose of 1.0 g/kg every 3 weeks.
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Lead Product(s): Immunoglobulin
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Undisclosed Product Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 16, 2020
Details:
The trial is entitled Randomized Open Label Study of Standard of Care Plus Intravenous Immunoglobulin (IVIG) Compared to Standard of Care Alone in the Treatment of COVID-19 Infection.
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