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orphan drugs

FDA is Advancing the Goals of the Orphan Drug Act

FDA is Advancing the Goals of the Orphan Drug Act

FDA Voice

Orphan Drug Act

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FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions

FDA Determines that Deuterated Compounds are NCEs and Different Orphan Drugs Versus Non-deuterated Versions

FDA Law Blog

deuterated drugs

Teva Pharmaceutical

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FDA Plots Elimination of the Orphan Drug Designation Request Backlog

FDA Plots Elimination of the Orphan Drug Designation Request Backlog

RAPS.org

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Orphan drug market set to climb above $200B: Report

Orphan drug market set to climb above $200B: Report

Fierce Pharma

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FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority

FDA User Fee Package Includes “Technical Corrections” to Address Orphan Drug Clinical Superiority

FDA Law Blog

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Celgene, BMS, Novartis expected to top 2022 orphan drug market worth $209B: report

Celgene, BMS, Novartis expected to top 2022 orphan drug market worth $209B: report

Fierce Pharma

Bristol-Myers Squibb

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Grunenthal snags a PhIII-ready orphan drug in Thar Pharma buyout

Grunenthal snags a PhIII-ready orphan drug in Thar Pharma buyout

Endpoints

Thar Pharmaceuticals

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Ionis’s Orphan Drug in Third Phase of Clinical Trials

Ionis’s Orphan Drug in Third Phase of Clinical Trials

Market Realist

Ionis Pharmaceuticals

clinical trials

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Galena Biopharma Receives Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302

Galena Biopharma Receives Two Orphan Drug Designations for GALE-301 and GALE-301/GALE-302

Yahoo

Galeana Biopharma

GALE-301/GALE-302

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Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR Petition

Just When FDA Thought It Was Out, They Pull It Back In: AstraZeneca Raises 505A(o) and Orphan Drug Exclusivity Carve-Outs in CRESTOR Petition

FDA Law Blog

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FDA More Than Doubles the Number of Orphan Drug Designation Revocations Overnight

FDA More Than Doubles the Number of Orphan Drug Designation Revocations Overnight

FDA Law Blog

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Why Has Teva Pharmaceutical Targeted Orphan Diseases?

Why Has Teva Pharmaceutical Targeted Orphan Diseases?

Yahoo/Market Realist

Teva Pharmaceutical

hyperkinetic movement disorders

Huntington's disease

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Oxigene's pancreatic cancer treatments granted orphan drug status in Europe

Oxigene's pancreatic cancer treatments granted orphan drug status in Europe

Marketwatch

pancreatic cancer

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Orphan Drugs On a Roll, A Look Into the 2016 Orphan Space

Orphan Drugs On a Roll, A Look Into the 2016 Orphan Space

Yahoo/Accesswire

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Looking ahead at orphan drugs' future: More breakthroughs, exploding sales

Looking ahead at orphan drugs' future: More breakthroughs, exploding sales

BioPharma Dive

Sumitomo Dainippon

obeticholic acid

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Orphan drug sales expected to grow 12% by 2020

Orphan drug sales expected to grow 12% by 2020

Medical Marketing and Media

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Four New Patents Issued, PROCYSBI® Granted Additional U.S. Orphan Exclusivity

Four New Patents Issued, PROCYSBI® Granted Additional U.S. Orphan Exclusivity

Yahoo

Raptor Pharmaceutical

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Shire's Baxalta Acquisition: An Orphan Drugs Market Dream?

Shire's Baxalta Acquisition: An Orphan Drugs Market Dream?

Forbes

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Five Prime Therapeutics Receives FDA Orphan Drug Designation for FPA008 in Pigmented Villonodular Synovitis (PVNS)

Five Prime Therapeutics Receives FDA Orphan Drug Designation for FPA008 in Pigmented Villonodular Synovitis (PVNS)

Yahoo

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How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute?

How Effective is a “Depomed Threat” at Resolving an Orphan Drug Clinical Superiority Dispute?

FDA Law Blog

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