Legal Notebook: Catalyst’s Suit vs. FDA Is Tossed, Avonex Patent Invalidity Verdict Is Reinstated
Court finds US FDA did not impede Catalyst orphan exclusivity for Firdapse as it approved different indication for competing product. Biogen loses 10-year patent battle against competing multiple sclerosis drug makers.
You may also be interested in...
Suit against agency reveals internal discussions to approve Jacobus' Ruzurgi despite Catalyst's orphan exclusivity for the same drug; Sen. Bernie Sanders urged FDA to address price of Catalyst's Firdapse (amifampridine).
Lawsuit seeking invalidation of rare disease treatment's approval in Lambert-Eaton myasthenic syndrome encompasses policy trifecta of exclusivity, drug pricing, and expanded access issues.
From the rise of DTC to the shadow of Caronia, Abrams, the long-time head of the Office of Prescription Drug Promotion, monitored dramatic changes in the pharmaceutical marketplace and regulatory environment. He retired from FDA on 23 October after a tenure marked as much by careful research projects and copious guidances as it was by promotional and legal upheavals.