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Lead Product(s): Human fibrinogen
Therapeutic Area: Hematology Product Name: Fibryga
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 March 29, 2021
Details:
The supplement approvals resulted in new product labeling for Octaplas™, Pooled Plasma (Human), Solvent/Detergent (S/D) Treated Solution for Intravenous Infusion, and fibryga®, Fibrinogen (Human) Lyophilized Powder for Reconstitution.
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Lead Product(s): Simoctocog Alfa
Therapeutic Area: Genetic Disease Product Name: Nuwiq
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 February 22, 2021
Details:
The NuProtect study was a prospective, multinational, open-label, non-controlled phase III study initiated in March 2013 to assess the immunogenicity, efficacy and safety of Nuwiq®.
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Lead Product(s): Virally inactivated human AB serum
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Undisclosed Product Type: Large molecule
Recipient: Akron Biotech
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Partnership January 20, 2021
Details:
Partnership Aims to Enhance Safety of Human Serum from Viruses. Under the agreement, Akron Biotech will produce Human AB Serum converted from Octaplas®, which is Octapharma’s pooled, solvent/detergent treated human plasma product.
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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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