12:44 , Mar 27, 2019 |  BioCentury  |  Product Development

GW’s next act

As Epidiolex’s launch continues to ramp up, GW Pharmaceuticals’ next act will be to take the plunge with its cannabinoid platform into larger, more complex neurobehavioral indications, and even cancer. Not surprisingly, the rise of...
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...