20:57 , Aug 15, 2019 |  BC Extra  |  Company News

Harmony crosses finish line with Wakix for narcolepsy

FDA approved Wakix pitolisant Thursday, almost two years after Harmony gained U.S. rights to the narcolepsy drug. During 2017-18, Harmony raised $295 million to push it through registration. In October 2017, Harmony Biosciences LLC (Plymouth...
19:46 , Oct 13, 2017 |  BC Week In Review  |  Financial News

Harmony raises $270M, licenses narcolepsy drug

On Oct. 6, CNS company Harmony Biosciences LLC (Plymouth Meeting, Pa.) said it raised $270 million in an equity round from Valor Equity Partners, Fidelity Management & Research Co., HBM Healthcare Investments, Vivo Capital, venBio,...
22:53 , Oct 6, 2017 |  BC Extra  |  Financial News

Harmony raises $270M, licenses narcolepsy drug

CNS company Harmony Biosciences LLC (Plymouth Meeting, Pa.) said it raised $270 million in an equity round from Valor Equity Partners, Fidelity Management & Research Co., HBM Healthcare Investments, Vivo Capital, venBio, Novo Holdings A/S...
08:00 , Dec 7, 2015 |  BC Week In Review  |  Clinical News

Wakix pitolisant regulatory update

EMA’s CHMP recommended approval of Wakix pitolisant from Bioprojet to treat narcolepsy with or without cataplexy. The product is a histamine H3 receptor (HRH3) antagonist. Bioprojet Pharma S.a.r.l. , Paris, France   Product: Wakix pitolisant...
08:00 , Feb 16, 2015 |  BioCentury  |  Product Development

The straight dopa

Laboratoires Pierre Fabre S.A. thinks the dopamine D3 receptor hypothesis of schizophrenia hasn't been fully tested yet because the compounds that failed earlier trials didn't engage enough of the receptors. To avoid that problem, the...
07:00 , Sep 30, 2013 |  BioCentury  |  Regulation

Wake-up call

Narcolepsy patients told FDA and companies at the agency's latest patient-focused drug development meeting they want a better balance of alertness and sleep. Specifically, this means better resolution of excessive daytime sleepiness - their worst...
07:00 , Jun 11, 2007 |  BC Week In Review  |  Clinical News

1-{3-[3- regulatory update

EMEA's Committee for Orphan Medicinal Products (COMP) issued a positive opinion to grant Orphan Drug designation 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine hydrochloride, a histamine H3 receptor antagonist, to treat narcolepsy. Bioprojet Pharma , Paris, France   Product: 1-{3-[3-(4-chlorophenyl)propoxy]propyl}piperidine hydrochloride...