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Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Rilzabrutinib
Therapeutic Area: Immunology Product Name: PRN1008
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 November 18, 2020
Details:
In addition, following positive Phase 1/2 study results, a Phase 3 study evaluating rilzabrutinib for ITP has been initiated. Rilzabrutinib received orphan drug designation from the FDA for the treatment of ITP in October 2018.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Sutimlimab
Therapeutic Area: Immunology Product Name: BIVV009
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 14, 2020
Details:
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease.
Sanofi Active Ingredient Solutions cover both APIs sales & CDMO.
Lead Product(s): Sutimlimab
Therapeutic Area: Immunology 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 14, 2020
Details:
Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s. If approved, sutimlimab would be the first and only approved treatment for these patients.
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Lead Product(s): Viaskin peanut
Therapeutic Area: Immunology Product Name: DBV712
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 10, 2020
Details:
New analyses of clinical studies investigating epicutaneous immunotherapy to treat peanut allergy with a patch (DBV712 250 µg) will be presented at the virtual American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting.
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Lead Product(s): Viaskin peanut
Therapeutic Area: Immunology Product Name: DBV712
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 02, 2020
Details:
Viaskin™ is based on epicutaneous immunotherapy, or EPIT™, DBV’s method of delivering biologically active compounds to the immune system through intact skin.
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Lead Product(s): Viaskin peanut
Therapeutic Area: Immunology Product Name: DBV712
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 August 04, 2020
Details:
Food and Drug Administration has issued a Complete Response Letter regarding the Company’s Biologics License Application for investigational Viaskin™ Peanut (DBV712), a non-invasive, once-daily epicutaneous patch to treat peanut allergies in children ages 4 to 11 years.
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Lead Product(s): Inolimomab
Therapeutic Area: Immunology Product Name: Leukotac
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 July 23, 2020
Details:
Inolimomab has shown a robust and long-lasting response Rate in steroid-refractory acute graft versus host disease (SR-aGvHD) in a randomized multicentre controlled parallel-group Phase 3 study (INO-107 - EUDRACT 2007-005009-24).
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