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Lead Product(s): Remestemcel-L
Therapeutic Area: Immunology Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 01, 2020
Details:
While the ODAC of the FDA voted that the available data support the efficacy of remestemcel-L in children with SR-aGVHD, the FDA suggests that Mesoblast conduct at least one more study in adults and/or children to provide further proof of the effectiveness of remestemcel-L.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Immunology Product Name: Ryoncil
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 14, 2020
Details:
Oncologic Drugs Advisory Committee of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL™) in pediatric patients with steroid-refractory acute graft versus host disease.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 25, 2020
Details:
Trial results underpin Mesoblast’s Biologics License Application to seek approval of its product candidate RYONCIL for pediatric steroid-refractory acute graft versus host disease, which has been accepted for priority review by the USFDA.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 01, 2020
Details:
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of September 30, 2020, and if approved, Mesoblast will make RYONCIL immediately available in the United States.
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Lead Product(s): Remestemcel-L
Therapeutic Area: Immunology Product Name: Undisclosed
Highest Development Status: Phase III Product Type: Cell and Gene therapy
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 02, 2020
Details:
The data shows effectiveness of remestemcel-L in children with SR-aGVHD, with particular efficacy and survival benefit in patients with the most severe forms of aGVHD.
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