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In an unexpected move, Canada’s Federal Court quashed the approval of a rare disease drug after the manufacturer of a rival medicine claimed that Health Canada had originally issued an “incorrect and unreasonable” endorsement.

In a 63-page ruling, Justice Martine St-Louis set aside the approval issued by the regulator last year. As a result, the government will now have to review the marketing file submitted by Jacobus Pharmaceuticals, a small, family-run company that sells a drug to treat people with a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS. A competitor, Catalyst Pharmaceuticals (CPRX), is seeking to push back the approval until 2028. We asked Jacobus and Health Canada for comment and will update you accordingly.

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