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GW Pharmaceuticals nears US new drug application for epilepsy drug

Mon, 26th Sep 2016 12:57

(ShareCast News) - GW Pharmaceuticals said it planned to apply to market its cannabis-derived treatment for childhood-onset epilepsy early next year after the drug produced strong results from its late-stage clinical trail.Epidiolex, the investigational cannabidiol medicine developed by GW, generated an average 42% reduction in monthly drop seizures when patients with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy, took a 20mg/kg/day dose.The final-phase clinical trial for the treatment of seizures associated placebo produced a 17% reduction in monthly seizures, while patients taking 10mg/kg/day Epidiolex achieved a median reduction in monthly drop seizures of 37%.This is the third positive Phase 3 trial for Epidiolex reported in 2016 and the second trial and second positive outcome in patients with Lennox-Gastaut syndrome.Orrin Devinsky, principal investigator for the trial at the New York University Langone Medical Center's Comprehensive Epilepsy Center, said the second positive outcome "demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy".He added: "The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy."Justin Gover, GW's chief executive officer, said this latest trial also showed Epidiolex is likely to have an effective dose range, "allowing for dose flexibility to address individual patient needs".
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14 Mar 2016 12:41

UPDATE 2-Cannabis drug succeeds in epilepsy, doubling value of GW Pharma

* Epidiolex succeeds in Dravet syndrome clinical trial * Shares surge 125 pct on hopes for $1 billion-plus sales (Adds CEO interview, latest shares, sales forecast) By Ben Hirschler LONDON, March 14 (Reuters) - An experimental cannabis-based drug has successfully treated child

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14 Mar 2016 12:19

LONDON MARKET MIDDAY: Miners Lead FTSE As GW Pharmaceuticals Lifts AIM

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14 Mar 2016 11:44

UPDATE: GW Pharmaceuticals Shares Double On Epidiolex Trial Results

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14 Mar 2016 11:33

GW Pharmaceuticals rockets on positive results for Dravet epilepsy tests

(ShareCast News) - Shares in GW Pharmaceuticals rocketed up more than 120% after revealed exciting results of its cannabis-based treatment for children with a rare form of epilepsy. The company's first major paediatric epilepsy trial for its Epidiolex drug achieved its primary endpoint with high sta

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14 Mar 2016 11:09

GW Pharmaceuticals Sees Positive Phase III Epidiolex Study Results

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14 Mar 2016 11:07

GW Pharma cannabis drug succeeds in epilepsy trial, shares leap

LONDON, March 14 (Reuters) - An experimental cannabis-based drug has successfully treated children with a rare form of severe epilepsy in a keenly anticipated clinical trial, sending shares in its maker GW Pharmaceuticals 25 percent higher on Monday. The study of GW's Epidiolex in Dravet sy

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10 Feb 2016 12:23

GW Pharmaceuticals First Quarter Loss Widens As It Drives Pipeline

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10 Feb 2016 12:06

GW Pharma losses increase ahead of key epilepsy trial results

(ShareCast News) - Cannabis-derived medicines specialist GW Pharmaceuticals posted a £17.7m loss in the first quarter as it gears up to report data from four Phase 3 trials for its Epidiolex product. GW made £3.7m revenue in the three months to 31 December from its Sativex, less than half the £8.0m

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3 Feb 2016 16:05

Earnings, Trading Statements Calendar - Week Ahead

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20 Jan 2016 14:50

Marijuana Inc. eyes Mexico as drug liberalization looms

By Gabriel Stargardter MEXICO CITY, Jan 20 (Reuters) - Many top companies cashing in on legal cannabis are considering a bet on Mexico after a Supreme Court decision raised hopes for a legalization of medical and recreational marijuana in a country reeling from years of gruesome drug violen

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15 Jan 2016 17:54

UPDATE 5-French drug trial disaster leaves one brain dead, five injured

* All trials of drug from Portugal's Bial suspended * "This is unprecedented" - French health minister * Drug aimed at tackling mood and anxiety issues (Adds Bial reaction, minister quotes, details) By Matthias Blamont PARIS, Jan 15 (Reuters) - One person has been left b

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24 Dec 2015 12:09

GW Pharmaceuticals Epidiolex Data Published In Medical Journal

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16 Dec 2015 16:32

DIRECTOR DEALINGS: GW Pharmaceuticals Non-Executive Sells Shares

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8 Dec 2015 06:44

GW Pharmaceuticals Annual Loss Widens On Higher Costs, Revenue Dip

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30 Nov 2015 16:19

Earnings, Trading Statements Calendar - Week Ahead

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