Orphan Drugs in North America - Drug Discovery TOE

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This edition of the Drug Discovery TOE depicts trends across orphan drugs in North America. Compared with standard drugs, orphan drugs involve fewer clinical trial issues. Typically, orphan drugs spend less time in regulatory review, comprise smaller phase III trial sizes, and are more likely to be approved by the US Food and Drug Administration (FDA) because they represent significant therapeutic advances for really unsolved problems. This and the higher chance of FDA approval makes many companies to penetrate the market. However, innovation is critical. Strategic partnerships and tactical regulatory planning that allow for optimizing budgets and exploiting research and clinical expertise are crucial for devel

Table of Contents

Orphan Drugs in North America - Drug Discovery TOETrend OverviewOrphan Drugs Orphan DrugsTechnology Profiles of Orphan Drugs in North AmericaAdvancing Therapeutics for Lysosomal Storage DisordersTargeting Post-Transcriptional Control Processes Increasing Focus on Rare Diseases Synthetic Retinoid Products to Treat Rare Diseases Investigational Drug for Treatment of Cystic FibrosisChronic Lymphocytic Leukemia gets New Drug TreatmentRare Wilson’s Disease Treatment Witnesses Unprecedented SuccessAppendixPatent AnalysisPatent Analysis (Continued)Patent Analysis (Continued)Industry InteractionsIndustry Interactions (Continued)




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