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    [{"orgOrder":0,"company":"AmideBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Grants Orphan Drug Designation to Amidebio's Glucagon Analog for the Treatment of Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"AmideBio","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Grants Rare Pediatric Disease Designation to Amide Bio's Glucagon Analog for the Treatment of Congenital Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"IND Enabling"},{"orgOrder":0,"company":"AmideBio","sponsor":"NIDDK","pharmaFlowCategory":"D","amount":"$2.7 million","upfrontCash":"Undisclosed","newsHeadline":"AmideBio Awarded SBIR Phase IIB Grant to Support Pre-Clinical Development of its Long-Acting Stable Glucagon Analog for the Treatment of Hyperinsulinism","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Peptide","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Preclinical"}]

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              AmideBio Awarded SBIR Phase IIB Grant to Support Pre-Clinical Development of its Long-Acting Stable Glucagon Analog for the Treatment of Hyperinsulinism

              Details:

              This two-year grant will allow AmideBio to select a long-acting soluble stable glucagon candidate and do the necessary work to support the filing of an Investigational New Drug (IND) application with the FDA at the end of the grant period.

              Lead Product(s): Glucagon

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: Preclinical Product Type: Peptide

              Partner/Sponsor/Collaborator: NIDDK

              Deal Size: $2.7 million Upfront Cash: Undisclosed

              Deal Type: Funding October 04, 2022

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              U.S. FDA Grants Rare Pediatric Disease Designation to Amide Bio's Glucagon Analog for the Treatment of Congenital Hyperinsulinism

              Details:

              US Food and Drug Administration Offices of Pediatric Therapeutics and Orphan Products Development granted a rare pediatric disease designation to AmideBio’s glucagon analog (AB‐G023) for the treatment of congenital hyperinsulinism (CHI).

              Lead Product(s): AB-G023

              Therapeutic Area: Genetic Disease Product Name: AB-G023

              Highest Development Status: IND Enabling Product Type: Peptide

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable August 20, 2020

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              U.S. FDA Grants Orphan Drug Designation to Amidebio's Glucagon Analog for the Treatment of Congenital Hyperinsulinism

              Details:

              AB-G023 is a solution stable, soluble glucagon analog designed to overcome the limitations of glucagon. Glucagon is an effective treatment for congenital hyperinsulinism, but rendered impractical for long term administration given its instability in solution.

              Lead Product(s): AB-G023

              Therapeutic Area: Genetic Disease Product Name: Undisclosed

              Highest Development Status: IND Enabling Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable April 23, 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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