Global Genes Partner News
May 21, 2018
May 21, 2081
Harmony Biosciences Receives Breakthrough Therapy and Fast Track Designations For Pitolisant
PLYMOUTH MEETING, PA, May 21, 2018 — Harmony Biosciences, LLC (Harmony), today announced that it has received Breakthrough Therapy and Fast Track designations for its investigational product, pitolisant, from the U.S. Food and Drug Administration (FDA). Breakthrough Therapy designation has been granted for pitolisant for the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies. Fast Track designation has been granted for the investigation of pitolisant for the treatment of excessive daytime sleepiness in patients with narcolepsy and the treatment of cataplexy in patients with narcolepsy and is received when a potential new therapy is intended to treat a serious condition and data demonstrate the potential to address an unmet medical need. These designations signal FDA’s interest in the development program for pitolisant and provide opportunities for frequent interaction with the Agency, the ability to request a rolling new drug application (NDA) submission, as well as the potential for expedited review.
May 12, 2018
Catalyst Pharmaceuticals Receives 2017 Beacon Council Award for Contributions in Life Sciences & Healthcare
Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating neuromuscular and neurological diseases, today announced that it has received a 2017 Beacon Award for industry in the Life Sciences & Healthcare category. The Beacon Council is Miami- Dade County’s official economic development organization that recognizes contributions by business to the Miami-Dade economy in the areas of job creation, business expansion, corporate citizenship and leadership.
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