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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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More on this story

Americas
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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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.
Big Pharma
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.

More on this story

Americas
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.
Generics
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.
Big Pharma
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.

More on this story

Americas
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.
Generics
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.
Big Pharma
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.