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Health Canada allows a controversial rare disease drug back on the market
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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.
Greetings and welcome to the Catalyst Pharmaceuticals First Quarter 2021 Results Conference Call. [Operator Instructions]
It is now my pleasure to introduce your host, Ms. Alicia Grande, Vice President, Chief Financial Officer and Treasurer. Thank you. You may begin.
Alicia Grande
Vice President, Chief Financial Officer and Treasurer
Good morning, everyone, and thank you for joining our conference call to discuss Catalyst s first quarter 2021 financial results and corporate highlights. Leading the call today, we have Patrick McEnany, Chairman and Chief Executive Officer. We are joined by Dr. Steven Miller, Chief Operating Officer and Chief Scientific Officer, and Jeffrey Del Carmen, Chief Commercial Officer. For the question and for the Q&A session, we also have Dr. Gary Ingenito, Chief Medical and Regulatory Officer.
Author Bio
After producing excellent results in Marketing Operations for over 16 years, and being a business owner prior to that, Jeff has developed a strong understanding of business success and a keen eye for data and detail. Combined with investing experience going back 30 years to his first investment in mutual funds, his knowledge and interests have led him to the role of a contract writer for The Motley Fool.
For under-the-radar companies, it s important to make sure any positive news finds its way to the eyes or ears of investors. The first quarter of 2021 is evidence of that for one small player dedicated to treating rare diseases in the pharmaceutical market.
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