17:58 , Sep 28, 2018 |  BC Week In Review  |  Company News

GW to launch Epidiolex in U.S. following DEA reschedule

GW Pharmaceuticals plc (NASDAQ:GWPH) said the U.S. Drug Enforcement Agency has rescheduled Epidiolex cannabidiol to schedule V, the lowest restriction classification, from a schedule I, clearing the way for GW to launch the drug in...
18:58 , Sep 21, 2018 |  BC Week In Review  |  Company News

Corbus gets over 600 endocannabinoid-targeting compounds from Jenrin

Corbus Pharmaceuticals Holdings Inc. (NASDAQ:CRBP) acquired exclusive, worldwide rights to over 600 endocannabinoid system-targeting compounds from Jenrin Discovery LLC (Chadds Ford, Pa.) to treat inflammatory and fibrotic diseases. Jenrin will receive $250,000 upfront and is...
18:55 , Jul 13, 2018 |  BC Week In Review  |  Clinical News

Zynerba refocusing on CBD gel following failed patch readout

Zynerba Pharmaceuticals Inc. (NASDAQ:ZYNE) said it will focus on developing ZYN002 after single and multiple doses of several formulations of ZYN001 failed to achieve target blood levels of 5-15 ng/mL of tetrahydrocannabinol (THC) in a...
16:32 , Apr 20, 2018 |  Regulatory  |  Regulatory

Panel: risk/benefit favorable for GW Epidiolex

An FDA advisory committee voted 13-0 that the benefit-risk profile of Epidiolex cannabidiol from GW Pharmaceuticals plc (NASDAQ:GWPH) was favorable to treat seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome ages two years and...
20:43 , Apr 19, 2018 |  BC Extra  |  Company News

Panel: Risk/benefit favorable for GW's Epidiolex

An FDA advisory committee voted 13-0 on Thursday that the benefit-risk profile of Epidiolex cannabidiol from GW Pharmaceuticals plc (NASDAQ:GWPH) was favorable to treat seizures in patients with Lennox-Gastaut syndrome and Dravet syndrome ages 2...
19:30 , Apr 17, 2018 |  BC Extra  |  Company News

GW posts gain ahead of Epidiolex panel

GW Pharmaceuticals plc (NASDAQ:GWPH) climbed $13.55 (11%) to $134.13 on Tuesday after FDA released briefing documents ahead of an advisory committee's planned April 19 meeting concerning an NDA for Epidiolex cannabidiol to treat Lennox-Gastaut syndrome...
17:15 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

GW's GWP42006 misses in Phase IIa for focal seizures

GW Pharmaceuticals plc (NASDAQ:GWPH) reported preliminary data from a Phase IIa trial in 162 adults with inadequately controlled focal seizures showing that twice-daily GWP42006 as an add-on therapy missed the primary endpoint of reducing focal...
16:19 , Feb 9, 2018 |  BC Week In Review  |  Clinical News

EMA accepts MAA for GW's Epidiolex

GW Pharmaceuticals plc (NASDAQ:GWPH) said EMA accepted for review an MAA for Epidiolex cannabidiol as an adjunctive treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. GW said it expects a decision from EMA...
23:12 , Jan 3, 2018 |  BC Week In Review  |  Clinical News

FDA grants Priority Review to GW's Epidiolex for seizures

GW Pharmaceuticals plc (NASDAQ:GWPH) said FDA accepted and granted Priority Review to an NDA for Epidiolex cannabidiol as an adjunctive treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Its PDUFA date is June...
19:35 , Dec 28, 2017 |  BC Extra  |  Company News

FDA grants Priority Review to GW's Epidiolex for seizures

On Thursday, GW Pharmaceuticals plc (NASDAQ:GWPH) said FDA accepted and granted Priority Review to an NDA for Epidiolex cannabidiol as an adjunctive treatment for seizures associated with Dravet syndrome and Lennox-Gastaut syndrome. Its PDUFA date...