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Jacobus Pharmaceutical Co. Inc

Latest From Jacobus Pharmaceutical Co. Inc

Regulators Keep Rare Diseases Open For Business

The cost of rare diseases to patients and society at large is 10 times higher than for many of the biggest mass market diseases combined. With 95% of rare diseases lacking a treatment or cure, there is an economic imperative for policymakers to keep encouraging pharmaceutical companies to develop more orphan drug treatments. In Vivo looks at the US and EU regulatory impetus to keep rare diseases open for innovation. 

Rare Diseases FDA

Orphan Exclusivity, Drug-Device Designation Court Rulings Against FDA Would Be Fixed In User Fee Bill

Draft legislation would undo the Catalyst decision prohibiting FDA from providing separate orphan exclusivity periods for different subpopulations and alter the Genus ruling by requiring FDA to treat contrast agents, radioactive drugs and OTC monograph drugs as drugs.

Rare Diseases Legislation

US FDA Orphan Exclusivity Would Revert To Pre-Catalyst Status Under Senate Legislation

Federal court decision said the FDA cannot grant orphan exclusivity for subpopulations of a disease, which agency officials fear could damage pediatric rare disease drug development.

Rare Diseases Legislation

US FDA Loses Orphan Exclusivity Case While HHS Wins Dismissal Of Pfizer Kickback Complaint

In rare loss for FDA, appeals court reverses district court decision tossing Catalyst’s suit over Orphan Drug Act, saying deference should not have been granted to agency’s interpretation. District court finds it is too early to rule on one Pfizer charity co-pay program but backs broad reading of Anti-Kickback Statute.

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