Orphan Drug Exclusivity Keeps Biosimilars Off the Market ...
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Orphan Drug Exclusivity Keeps Biosimilars Off the Market, Study Says ... Investigators found that manufacturers appear to be exploiting orphan ... BusinessPracticeSeeAll>BusinessDevelopmentLegalPolicyPracticeRegulatoryAboutContactAdvisoryBoardDoNotSellMyInformationTerms&
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- 1Market exclusivity: orphan medicines | European Medicines ...
Expiry of market exclusivity ... When the period of market exclusivity for an indication ends, th...
- 2Designating an Orphan Product: Drugs and Biological ...
The Orphan Drug Act (ODA) provides for granting special status to a drug or biological product (“...
- 3ORPHAN DRUGS IN THE UNITED STATES: - National ...
development in the rare disease space by offering grants, tax credits for clinical trial costs, w...
- 4Court ruling in orphan drug lawsuit reframes outlook on ...
Under orphan-drug exclusivity, the FDA may not approve another sponsor's application for the same...
- 5Orphan Drugs in the United States - IQVIA
