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23 May 2021Big PharmaAlex Baldwin

House passes Biden-backed orphan drug reform

The US House of Representatives has passed a bill to amend exclusivity laws for drugs on the US Food and Drug Administration’s orphan drugs list.

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Americas
Eleventh Circuit finds FDA fell foul of Orphan Drug Act
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More on this story

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4 October 2021   The US Court of Appeals for the Eleventh Circuit has found that the US Food and Drug Administration violated the exclusivity of a patent covering a drug for a rare autoimmune disorder, by approving the same treatment specifically for children.
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11th circ ‘eviscerated’ orphan drug rights, says petition
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