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Orphan drug development: an economically viable strategy for biopharma R&D

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References

2007Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers510 cited
2010The importance of new companies for drug discovery: origins of a decade of new drugs344 cited
2011Pricing and reimbursement of orphan drugs: the need for more transparency261 cited
2011Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer230 cited
2010Rare diseases, orphan drugs and their regulation: questions and misconceptions182 cited
2009The US Orphan Drug Act: Rare disease research stimulator or commercial opportunity?166 cited

Cited by

2017Drug discovery effectiveness from the standpoint of therapeutic mechanisms and indications148 cited
2023Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy133 cited
2019Estimating the clinical cost of drug development for orphan versus non-orphan drugs127 cited
2017Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients’ health needs?113 cited
2014Value-Based Reimbursement Decisions for Orphan Drugs: A Scoping Review and Decision Framework99 cited
2017What Is the Purpose of the Orphan Drug Act?99 cited
2014Orphan drugs policies: a suitable case for treatment84 cited

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2014Incremental cost per quality-adjusted life year gained? The need for alternative methods to evaluate medical interventions for ultra-rare disorders73 cited

2014Opportunity Cost of Funding Drugs for Rare Diseases66 cited

2016Profitability and Market Value of Orphan Drug Companies: A Retrospective, Propensity-Matched Case-Control Study66 cited

2018Orphan Drugs and Their Impact on Pharmaceutical Development65 cited

2014Shining a light in the black box of orphan drug pricing60 cited

2013Financing drug discovery for orphan diseases60 cited