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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Warren: Biden must ‘break patent barriers’ to drive down drug costs

26 April 2022 Senator Elizabeth Warren has urged the US Department of Health and Human Services to “break patent barriers” in order to foster competition to lower prescription drug prices.

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11th circ ‘eviscerated’ orphan drug rights, says petition

14 April 2022 New Jersey pharma company Jacobus Pharmaceutical has asked the US Supreme Court to review an 11th Circuit verdict that it claims “eviscerated” decades of precedent regarding Orphan Drug Act exclusivity.

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Eleventh Circuit finds FDA fell foul of Orphan Drug Act

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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Big Pharma

Warren: Biden must ‘break patent barriers’ to drive down drug costs

26 April 2022 Senator Elizabeth Warren has urged the US Department of Health and Human Services to “break patent barriers” in order to foster competition to lower prescription drug prices.

Generics

11th circ ‘eviscerated’ orphan drug rights, says petition

Americas

Eleventh Circuit finds FDA fell foul of Orphan Drug Act

More on this story

Big Pharma

Warren: Biden must ‘break patent barriers’ to drive down drug costs

26 April 2022 Senator Elizabeth Warren has urged the US Department of Health and Human Services to “break patent barriers” in order to foster competition to lower prescription drug prices.

Generics

11th circ ‘eviscerated’ orphan drug rights, says petition

Americas

Eleventh Circuit finds FDA fell foul of Orphan Drug Act