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Demise of Intercept’s NASH Program Highlights Safety Hurdles Facing the Space

Demise of Intercept’s NASH Program Highlights Safety Hurdles Facing the Space

BioSpace

Intercept Pharma

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Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

Intercept restructures as Ocaliva's NASH hopes dashed again with FDA rejection

Fierce Pharma

Intercept Pharma

obeticholic acid

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Future of Intercept’s NASH drug in doubt after FDA panel rejection

Future of Intercept’s NASH drug in doubt after FDA panel rejection

BioPharma Dive

Intercept Pharma

obeticholic acid

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FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

FDA staff unsure NASH drug’s ‘modest’ benefits outweigh safety risks

BioPharma Dive

obeticholic acid

Intercept Pharma

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FDA schedules adcomms for Entasis' antimicrobial treatment, Intercept's NASH hopeful

FDA schedules adcomms for Entasis' antimicrobial treatment, Intercept's NASH hopeful

Endpoints

Intercept Pharma

sulbactam-durlobactam

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FDA accepts Intercept’s resubmitted NDA for obeticholic acid

FDA accepts Intercept’s resubmitted NDA for obeticholic acid

Clinical Trials Arena

Intercept Pharma

obeticholic acid

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By summer solstice, we'll know the fate of Intercept's NASH drug

By summer solstice, we'll know the fate of Intercept's NASH drug

Endpoints

Intercept Pharmaceuticals

obeticholic acid

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Ocaliva fails NASH trial just as Intercept charts path toward FDA application

Ocaliva fails NASH trial just as Intercept charts path toward FDA application

Fierce Pharma

Intercept Pharma

obeticholic acid

clinical trials

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Two years after CRL, Intercept will meet with FDA later this month to discuss new analysis of NASH drug

Two years after CRL, Intercept will meet with FDA later this month to discuss new analysis of NASH drug

Endpoints

Intercept Pharma

obeticholic acid

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Intercept, awaiting needed trial data, pulls its NASH drug application in Europe

Intercept, awaiting needed trial data, pulls its NASH drug application in Europe

BioPharma Dive

Intercept Pharma

obeticholic acid

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Intercept CEO lays into FDA after NASH drug rejection

Intercept CEO lays into FDA after NASH drug rejection

Pharmaforum

Intercept Pharma

obeticholic acid

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FDA rejects Intercept’s pitch for NASH as CEO fires back at the agency’s ‘evolving’ guidelines

FDA rejects Intercept’s pitch for NASH as CEO fires back at the agency’s ‘evolving’ guidelines

Endpoints

Intercept Pharmaceuticals

obeticholic acid

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Intercept hits regulatory snag at FDA, likely delaying NASH drug’s approval

Intercept hits regulatory snag at FDA, likely delaying NASH drug’s approval

MedCity News

Intercept Pharma

obeticholic acid

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While expected, Intercept's approval delay adds to NASH uncertainty

While expected, Intercept's approval delay adds to NASH uncertainty

BioPharma Dive

Intercept Pharma

obeticholic acid

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Intercept's NASH decision delayed by FDA, but don't panic: analysts

Intercept's NASH decision delayed by FDA, but don't panic: analysts

Fierce Pharma

Intercept Pharmaceuticals

obeticholic acid

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2 NASH drugmakers have wildly different Mondays

2 NASH drugmakers have wildly different Mondays

Biopharma Dive

Intercept Pharmaceuticals

CymaBay Therapeutics

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Intercept aims to triple sales force as it gears up for potential NASH launch

Intercept aims to triple sales force as it gears up for potential NASH launch

Fierce Pharma

Intercept Pharma

obeticholic acid

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Intercept Tries to Outrun Pharma in Race for the Next Blockbuster

Intercept Tries to Outrun Pharma in Race for the Next Blockbuster

Bloomberg

Intercept Pharmaceuticals

obeticholic acid

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Intercept Pharma is One Step Closer to Filing for Approval of First NASH Treatment

Intercept Pharma is One Step Closer to Filing for Approval of First NASH Treatment

BioSpace

Intercept Pharmaceuticals

obeticholic acid

clinical trials

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