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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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3 Feb 2021 12:49

Jazz Pharmaceuticals to buy GW Pharmaceuticals for $7.2bn

(Sharecast News) - Jazz Pharmaceuticals has agreed to buy GW Pharmaceuticals for $7.2bn.

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26 Nov 2018 15:49

GW Pharmaceuticals stock flies 4.8% after reporting positive test trial

(Sharecast News) - GW Pharmaceuticals stock rose by 4.8% on Monday after it announced positive test results from new cannabis-based drug trials.

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12 Feb 2017 15:06

Sunday newspaper round-up: Inflation, RBS, Brexit defeat, BAE Systems

(ShareCast News) - Higher food and fuel prices drove inflation to a three-year zenith of 2% in January, up from 1.6% in December, with more increases coming as the year progresses. Figures from the Office for National Statistics are expected to confirm the jump in inflation this week, the Sunday Tel

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28 Oct 2016 16:24

DIRECTOR DEALINGS: GW Pharmaceuticals Chairman Sells 300,000 Shares

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19 Oct 2016 08:20

GW Pharmaceuticals to cancel London listing, keep Nasdaq

(ShareCast News) - GW Pharmaceuticals plans to cancel its shares from trading on AIM on 5 December, with the last day of trading on the 2nd, but will keep its listing on the Nasdaq, where most of its shares are held and traded. The biopharmaceutical company said it will continue to be headquartered

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26 Sep 2016 13:06

UPDATE 1-Third win for cannabis drug in epilepsy sends GW to record high

* Epidiolex cuts seizures in latest LGS clinical study * GW expects to file for U.S. approval in first half 2017 * Reuters previously reported GW received bid interest (Adds analyst comment and further details, updates shares) By Natalie Grover and Ben Hirschler Sept 26

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14 Sep 2016 16:45

DIRECTOR DEALINGS: GW Pharmaceuticals Medical Officer Sells Shares

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7 Sep 2016 19:56

EXCLUSIVE-GW Pharmaceuticals hires investment bank following approaches - sources

(Adds share reaction, background on the company) By Carl O'Donnell and Arno Schuetze Sept 7 (Reuters) - GW Pharmaceuticals Plc, a developer of marijuana-based epilepsy treatments, is working with an investment bank after other drugmakers approached it to express interest in an acquisi

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11 Aug 2016 17:07

UPDATE 2-U.S. agency denies petition to reclassify marijuana

(Adds background, research details, congressman, industry comment) By Doina Chiacu and Bill Berkrot WASHINGTON/NEW YORK, Aug 11 (Reuters) - The U.S. Drug Enforcement Administration on Thursday denied requests to stop classifying marijuana as a dangerous drug with no medical use, leavi

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9 Aug 2016 15:25

GW Pharmaceuticals widens loss as testing ramps up

(ShareCast News) - Cannabinoid-focused pharmaceutical company GW Pharmaceuticals posted financial results for the third quarter ended 30 June on Tuesday. The AIM-traded company reported a loss for the nine months of £46.7m, compared to £32.3m for the nine months ended 30 June 2015. It said the incr

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9 Aug 2016 12:24

UK GDP growth slumps to half previous rate, NIESR data shows

(ShareCast News) - UK economic growth halved in the last three months, according to analysis by a respected independent think tank, which is worse than the market expected and adds credence to predictions that the economy will contract in the third quarter and then fall into recession. Based on its

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18 Jul 2016 15:22

GW Pharmaceuticals Closes US Public Offering, Raising USD289.8 Million (ALLISS)

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13 Jul 2016 15:38

GW Pharmaceuticals keen on $150m US offering

(ShareCast News) - Developer of cannabinoid therapies GW Pharmaceuticals announced on Wednesday that it intends to sell, subject to market and other conditions, $150m of American Depositary Shares representing ordinary shares of GW on the NASDAQ Global Market, in an underwritten US public offering.

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13 Jul 2016 07:00

GW Pharmaceuticals Prices ADS Offering, Raising USD252 Million (ALLISS)

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