Biotech’s strangest fight is now international
Catalyst Pharmaceuticals, the drug company fighting with a family-run firm over a costly rare-disease drug, thinks the FDA is unfairly harming its business. And now it’s accusing Canada of doing the same.
As STAT’s Ed Silverman reports, Catalyst is suing Health Canada over its decision to endorse a competing treatment from Jacobus Pharmaceuticals, claiming regulators used Catalyst’s data to evaluate the other drug.
The move follows Catalyst’s 2019 lawsuit against the FDA, which accused the agency of breaking the law by approving Jacobus’s drug specifically to curtail Catalyst’s monopoly. The issue has played into the heated national debate over the rising cost of prescription medicines. For years, Jacobus distributed its drug for free under a compassionate use program sanctioned by the FDA, while Catalyst charged roughly $375,000 after it won FDA approval in late 2018.
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As STAT’s Ed Silverman reports, Catalyst is suing Health Canada over its decision to endorse a competing treatment from Jacobus Pharmaceuticals, claiming regulators used Catalyst’s data to evaluate the other drug.
The move follows Catalyst’s 2019 lawsuit against the FDA, which accused the agency of breaking the law by approving Jacobus’s drug specifically to curtail Catalyst’s monopoly. The issue has played into the heated national debate over the rising cost of prescription medicines. For years, Jacobus distributed its drug for free under a compassionate use program sanctioned by the FDA, while Catalyst charged roughly $375,000 after it won FDA approval in late 2018.
Read more.
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