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    [{"orgOrder":0,"company":"Baylx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"BAYLX,INC. Received US FDA Clearance of IND Application for Cord Tissue Mesenchymal Stem Cells","therapeuticArea":"Immunology","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Immunology","graph2":"Phase I"},{"orgOrder":0,"company":"Baylx","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Baylx Receives US FDA Clearance of Covid-19 IND Application for Umbilical Cord Tissue Mesenchymal Stem Cells Product","therapeuticArea":"Infections and Infectious Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Cell and Gene therapy","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Infections and Infectious Diseases","graph2":"Phase I"}]

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              Baylx Receives US FDA Clearance of Covid-19 IND Application for Umbilical Cord Tissue Mesenchymal Stem Cells Product

              Details:

              This is Baylx’s second IND clearance from FDA in three months. In early June this year, Baylx also received the clearance of an IND from US FDA for the same hUC-MSC product BX-U001, for the treatment of rheumatoid arthritis (RA).

              Lead Product(s): Human umbilical cord tissue mesenchymal stem cells

              Therapeutic Area: Infections and Infectious Diseases Product Name: BX-U001

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

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable September 11, 2020

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              Baylx

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              BAYLX,INC. Received US FDA Clearance of IND Application for Cord Tissue Mesenchymal Stem Cells

              Details:

              U.S. Food and Drug Administration (FDA) has cleared Baylx's Investigational New Drug (IND) application for BX-U001, a fresh, non-frozen human umbilical cord tissue mesenchymal stem cells (hUC-MSC) product in patients with Rheumatoid Arthritis (RA).

              Lead Product(s): BX-U001

              Therapeutic Area: Immunology Product Name: Undisclosed

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

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable June 05, 2020

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              Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.
              ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
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