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  • Regulatory NewsRegulatory News

    Catalyst Sues FDA Over Approval of Rival Drug

    Catalyst Pharmaceuticals on Wednesday sued the US Food and Drug Administration (FDA) because of the agency’s recent approval of rival Jacobus Pharmaceutical Company’s Ruzurgi (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). Ruzurgi, which was approved by FDA in May for children with LEMS, will likely compete off-label with Catalyst’s Firdapse (amifampridine), which first won approval in November 2018 but has a list price about twice as...
  • Regulatory NewsRegulatory News

    Catalyst Defends $375,000 Price Tag for Previously Free Drug

    In response to questions from Sen. Bernie Sanders (I-VT) on the price tag of a new orphan drug, Catalyst Pharmaceuticals on Thursday explained how much it had to invest in Firdapse (amifampridine) to bring it to market and how the previously experimental version of the drug should not be the standard of care. Firdapse is the first drug approved by FDA to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder that affects patients' muscles and nerves....
  • Regulatory NewsRegulatory News

    Tropical Disease PRV Fix Didn’t Stop Novartis From Winning Another

    Back in 2017, a new law was enacted, known as the FDA Reauthorization Act (FDARA), which contained not only the new user fee programs for pharmaceuticals, medical devices, generics and biosimilars, but also a slight tweak to the tropical disease priority review voucher (PRV) program. The change was meant to ensure that companies winning PRVs (which means that they can sell such PRVs for potentially $100 million) actually performed some of the clinical work to bring ...