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    [{"orgOrder":0,"company":"Intercept Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intercept Announces First Patient Dosed in Phase 2 Study of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"},{"orgOrder":0,"company":"Intercept Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Intercept Pharmaceuticals Receives FDA Orphan Drug Designation for the Fixed-Dose Combination of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis (PBC)","therapeuticArea":"Hepatology (Liver, Pancreatic, Gall Bladder)","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2023","url1":"","url2":"","graph1":"Hepatology (Liver, Pancreatic, Gall Bladder)","graph2":"Phase II"}]

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              Intercept Pharmaceuticals

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              Intercept Pharmaceuticals Receives FDA Orphan Drug Designation for the Fixed-Dose Combination of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis (PBC)

              Details:

              USFDA has granted orphan drug designation for the combination of ocaliva (obeticholic acid), a farnesoid X receptor agonist and bezafibrate, a PPAR agonist, for the treatment of individuals with primary biliary cholangitis.

              Lead Product(s): Obeticholic Acid,Bezafibrate

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Ocaliva

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 16, 2023

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              Intercept Pharmaceuticals

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              Intercept Announces First Patient Dosed in Phase 2 Study of OCA and Bezafibrate for the Treatment of Primary Biliary Cholangitis

              Details:

              Bezafibrate, a pan-peroxisome proliferator-activated receptor (pan-PPAR) agonist, has been studied for the treatment of PBC, carries the potential to help patients achieve reductions in ALP and bilirubin while improving pruritus.

              Lead Product(s): Bezafibrate,Oeticholic Acid

              Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Undisclosed

              Highest Development Status: Phase II Product Type: Small molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 11, 2022

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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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