The Age of Orphans
Orphan medicines are available for a larger number of diseases and patients than ever before.
Orphan Drugs
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Read more: The Age of Orphans -
Read more: Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives Tackling Salami Slicing and Indication Stacking in Orphan Drug Innovation Incentives
Are the incentive mechanisms for orphan drug development working as they should?
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Read more: Mortal Sins of Orphan Drug Development: How to Save the Lost Souls Mortal Sins of Orphan Drug Development: How to Save the Lost Souls
Before we can consider ways to address excessive pricing for orphan drugs, we must first diagnose the underlying problem.
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Read more: CeBIL Annual Symposium 2021 – Orphan Drug Innovation: Needs and Priorities CeBIL Annual Symposium 2021 – Orphan Drug Innovation: Needs and Priorities
What are the most pressing priorities for developing new drugs for rare diseases, and how can legal research help meet these needs?
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
The selections feature topics ranging from increases in Internet searches for hydroxychloroquine following promotional remarks by the president, to an evaluation of health gains from orphan drugs to an assessment of clinical trials supporting new FDA drug approvals.
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Read more: Monthly Round-Up of What to Read on Pharma Law and Policy Monthly Round-Up of What to Read on Pharma Law and Policy
By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…
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Read more: PhRMA Sues HHS (Again) For Trying To Expand 340B Discounts To Orphan Drugs PhRMA Sues HHS (Again) For Trying To Expand 340B Discounts To Orphan Drugs
By Rachel Sachs For all those who have been following the ongoing fight between pharmaceutical companies and HHS over the 340B Program’s coverage of orphan drugs (I know you’re out there), last week PhRMA filed a new complaint challenging HRSA’s interpretive rule on the subject under the APA. For all those who are not (but…
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Read more: Clinical Trials of Primary Care Drugs: Could Smaller Be Better? Clinical Trials of Primary Care Drugs: Could Smaller Be Better?
By Kate Greenwood Cross-Posted at Heath Reform Watch Lately it seems that each passing day brings another article about the cost of orphan drugs. Earlier this week at FiercePharma, Tracy Staton reported that the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) has asked Alexion Pharmaceuticals to justify the price of its drug…