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

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

Kiran N. Meekings2012

Article2012

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

Kiran N. Meekings · Cory S.M. Williams · John E. Arrowsmith

161 citations·0/0 files stored·Drug Discovery Today

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Pharmaceutical Economics and Policy Intellectual Property and Patents Health Systems, Economic Evaluations, Quality of Life

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References

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

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

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2012Orphan Drugs for Rare Diseasesarticle · 3 shared references 2012Paying for the Orphan Drug System: break or bend? Is it time for a new evaluation system for payers in Europe to take account of new rare disease treatments?article · 2 shared references 2023Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapyarticle · 2 shared references 2019Estimating the clinical cost of drug development for orphan versus non-orphan drugsarticle · 2 shared references 2013Reconciling uncertainty of costs and outcomes with the need for access to orphan medicinal products: a comparative study of managed entry agreements across seven European countriesarticle · 2 shared references 2012Rare diseases, orphan drugs, and their regulation in Asia: Current status and future perspectivesreview · 2 shared references

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Year2012

Typearticle

Published2012-02-17

VenueDrug Discovery Today

ISSN-L1359-6446

Languageen

Citations161

Files0 public / 0

ShelfPharmaceutical Economics and Policy

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doi10.1016/j.drudis.2012.02.005

openalex_workW2032012623

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2014

Orphan drugs policies: a suitable case for treatment

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