BC Extra | Aug 19, 2019
Company News

Aug. 19 Company Quick Takes: PharmaMar gets bump on FDA timeline in SCLC; plus Shionogi, Vanda and Moderna

PharmaMar seeking accelerated approval of SCLC candidate PharmaMar S.A. (Madrid:PHM) climbed €0.46 (29%) to €2.06 after the company said that based on the results of dialogue with FDA, it will submit an NDA next quarter...
BC Week In Review | Mar 9, 2018
Clinical News

Vanda's Hetlioz meets in Phase III for jet lag disorder

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) reported data from the double-blind, U.S. Phase III JET8 trial in 318 healthy volunteers undergoing a circadian challenge of an eight hour advance to their usual bedtime to induce jet lag...
BC Week In Review | Feb 16, 2018
Clinical News

Neurim's PedPRM meets in Phase III for insomnia in children with autism

In October, Neurim Pharmaceuticals Ltd. (Tel Aviv, Israel) reported data from a Phase III trial in 125 children ages 2-18 with autism or neurogenetic diseases and insomnia showing that PedPRM melatonin met the primary endpoint...
BC Week In Review | Oct 10, 2016
Clinical News

Piromelatine: Phase II started

Neurim began the double-blind, placebo-controlled, U.S. Phase II ReCOGNITION trial to evaluate 5, 20 and 50 mg oral piromelatine once daily for 26 weeks in about 500 patients treated with stable doses of acetylcholinesterase inhibitors....
BC Week In Review | Jul 13, 2015
Clinical News

Hetlioz tasimelteon regulatory update

The European Commission approved an MAA from Vanda for Hetlioz tasimelteon to treat non-24-hour sleep-wake disorder in blind adults. FDA approved the melatonin MT1 and MT2 receptor agonist in January. The product has Orphan Drug...
BC Week In Review | Apr 27, 2015
Clinical News

Hetlioz tasimelteon regulatory update

EMA’s CHMP recommended approval for Hetlioz tasimelteon from Vanda to treat non-24-hour sleep-wake disorder in blind adults. FDA approved the melatonin MT1 and MT2 receptor agonist in January. The product has Orphan Drug status in...
BC Extra | Apr 25, 2015
Company News

CHMP backs Opdivo and Hetlioz, spurns Lympreva

EMA's CHMP issued several recommendations on Friday, backing marketing authorization of candidates from Bristol-Myers Squibb Co. (NYSE:BMY) and Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) while declining to recommend one from Biovest International Inc. (Minneapolis, Minn.). CHMP recommended...
BC Extra | Oct 30, 2014
Financial News

Vanda raises $58M in follow-on

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) raised $58 million through the sale of 5 million shares at $11.60 in a follow-on underwritten by Jefferies; Piper Jaffray; JMP Securities; and Canaccord. The neurology company proposed the offering on...
BC Week In Review | Sep 22, 2014
Company News

Takeda, Meiji Seika Pharma deal

Takeda granted Meiji Seika exclusive Japanese co-promotion rights to Rozerem ramelteon to treat insomnia. Meiji will begin promotional activities for the melatonin MT1 and MT2 receptors agonist on Oct. 1, mainly targeting psychiatric institutions covered...
BC Week In Review | Jun 9, 2014
Clinical News

Hetlioz tasimelteon regulatory update

Vanda said EMA accepted for review an MAA for Hetlioz tasimelteon to treat non-24 hour sleep wake disorder. FDA approved the melatonin MT1 and MT2 receptor agonist in January. The product has Orphan Drug status...
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