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Estimating the clinical cost of drug development for orphan versus non-orphan drugs
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Estimating the clinical cost of drug development for orphan versus non-orphan drugs (2019)Estimating the clinical cost of drug deve…Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval (2017)Research and Development Spen…Innovation in the pharmaceutical industry: New estimates of R&D costs (2016)Innovation in the pharmaceuti…Clinical development success rates for investigational drugs (2014)Clinical development success …Orphan drug development: an economically viable strategy for biopharma R&D (2012)Orphan drug development: an e…Pricing and reimbursement of orphan drugs: the need for more transparency (2011)Pricing and reimbursement of …Rare diseases, orphan drugs and their regulation: questions and misconceptions (2010)Rare diseases, orphan drugs a…Orphan drug: Development trends and strategies (2010)Orphan drug: Development tren…The price of innovation: new estimates of drug development costs (2003)Can the pharmaceutical industry reduce attrition rates? (2004)Changing R&D models in research-based pharmaceutical companies (2016)A Comprehensive Map of FDA-Approved Pharmaceutical Products (2018)Estimated Research and Development Investment Needed to Bring a New Medicine to Market, 2009-2018 (2020)How to improve R&D productivity: the pharmaceutical industry's grand challenge (2010)Estimating the budget impact of orphan medicines in Europe: 2010 - 2020 (2011)Orphan drugs: the regulatory environment (2012)Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers (2007)The importance of new companies for drug discovery: origins of a decade of new drugs (2010)Drug discovery effectiveness from the standpoint of therapeutic mechanisms and indications (2017)Ethical imperatives of timely access to orphan drugs: is possible to reconcile economic incentives and patients’ health needs? (2017)Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy (2023)Cost-Effectiveness Analysis and the Consistency of Decision Making (2001)National Institute for Clinical Excellence and its value judgments (2004)QALY maximisation and people's preferences: a methodological review of the literature (2004)Paying 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? (2012)Cost-Effectiveness in Health and Medicine (1996)Essential medicines for universal health coverage (2016)The High Cost of Prescription Drugs in the United States (2016)The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts (2013)Estimated Costs of Pivotal Trials for Novel Therapeutic Agents Approved by the US Food and Drug Administration, 2015-2016 (2018)How Much Does It Cost to Research and Develop a New Drug? A Systematic Review and Assessment (2021)Costs of Drug Development and Research and Development Intensity in the US, 2000-2018 (2024)Effectiveness, safety and costs of orphan drugs: an evidence-based review (2015)Recommendations from the European Working Group for Value Assessment and Funding Processes in Rare Diseases (ORPH-VAL) (2017)Access and Unmet Needs of Orphan Drugs in 194 Countries and 6 Areas: A Global Policy Review With Content Analysis (2020)
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References

  • 2016Innovation in the pharmaceutical industry: New estimates of R&D costs3,352 cited
  • 2014Clinical development success rates for investigational drugs2,531 cited
  • 2017Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval503 cited
  • 2011Pricing and reimbursement of orphan drugs: the need for more transparency261 cited
  • 2010Rare diseases, orphan drugs and their regulation: questions and misconceptions182 cited
  • 2012Orphan drug development: an economically viable strategy for biopharma R&D161 cited
  • 2010Orphan drug: Development trends and strategies137 cited

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