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Mesoblast

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Mesoblast Receives Complete Response Letter From the FDA for its BLA for Steroid-Refractory Acute Graft Versus Host Disease in Children

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.

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

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U.S. FDA Advisory Committee Votes in Favor of Ryoncil for Efficacy in Children With Steroid-Refractory Acute Graft Versus Host Disease

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.

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

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Clinical Outcomes Using RYONCIL in Children and Adults With Severe Inflammatory Graft Versus Host Disease Published in Three Articles

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.

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

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Fda Accepts Mesoblast’s Biologics Licence Application For Ryoncil™ And Agrees To Priority Review

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.

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

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Mesoblast Submits Clinical Efficacy And Safety Data To FDA In Rolling Biologics License Application For Remestemcel-L

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.

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

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