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    FDA-&-EMA-New-Drug Approvals(Mid-2020 Recap)-insert
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              MolMed

              • Deals

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              ITALY Italy

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              CAMBODIA PHAR-MED 2020

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              Orchard Therapeutics and MolMed Announce Extension of Gene Therapy Manufacturing Collaboration

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              Lead Product(s): OTL-200

              Therapeutic Area: Genetic Disease Product Name: OTL-200

              Highest Development Status: Phase III Product Type: Cell and Gene therapy

              Partner/Sponsor/Collaborator: Orchard Therapeutics

              Deal Size: Undisclosed Upfront Cash: Undisclosed

              Deal Type: Collaboration July 09, 2020

              Details:

              With the extension of the collaboration, MolMed will continue to support activities related to the development and manufacturing of vectors and drug products for several of Orchard’s investigational ex vivo hematopoietic stem cell (HSC) gene therapies in the upcoming years.

              Italfarmaco S.p.A

              • Development Update

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              CAMBODIA PHAR-MED 2020

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              Italfarmaco Provides Update on Advanced-Stage Clinical Development Program with Givinostat in Duchenne Muscular Dystrophy

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              Lead Product(s): Givinostat

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              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 April 27, 2020

              Details:

              The Interim data from EPYDIS Phase 3 trial shows that the trial is NOT FUTILE and the Independent Data Monitoring Committee recommends trial continuation.

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