19:39 , Jun 23, 2017 |  BC Week In Review  |  Clinical News

Egalet receives CRL for 10 and 15 mg doses of pain drug Oxaydo

Egalet Corp. (NASDAQ:EGLT) said it received a complete response letter from FDA regarding a prior approval supplement for 10 and 15 mg dose strengths of oral Oxaydo oxycodone (Aversion). FDA requested more information about the...
20:44 , Feb 10, 2017 |  BC Week In Review  |  Financial News

Acura Pharmaceuticals proposes follow-on

On Feb. 3, pain and drug delivery company Acura Pharmaceuticals Inc. (NASDAQ:ACUR) proposed to raise up to $5 million in a follow-on. Acura Pharmaceuticals Inc. (NASDAQ:ACUR), Palatine, Ill. ...
22:29 , Dec 7, 2016 |  BC Week In Review  |  Clinical News

Oxaydo regulatory update

Egalet said it submitted an sNDA to FDA for oral Oxaydo oxycodone to support an abuse-deterrent label claim for the IV route of abuse. Oxaydo is approved to manage acute and chronic moderate to severe...
07:00 , Oct 31, 2016 |  BC Week In Review  |  Company News

Acura, KemPharm deal

Acura granted KemPharm rights to develop and commercialize up to three immediate-release candidates using Acura’s version abuse-deterrent technology. KemPharm said it will develop KP415, a prodrug of methylphenidate and a ligand, to treat ADHD; KP201...
07:00 , Sep 28, 2015 |  BC Week In Review  |  Company News

Acura, Egalet sales and marketing update

Egalet launched Oxaydo oxycodone in the U.S. for managing acute and chronic moderate to severe pain. Oxaydo, an immediate-release oxycodone tablet without niacin utilizing Acura’s Aversion abuse-deterrent technology, is formulated to deter abuse. The wholesale...
07:00 , Jul 13, 2015 |  BC Week In Review  |  Financial News

Acura completes private placement

Acura Pharmaceuticals Inc. (NASDAQ:ACUR), Palatine, Ill.   Business: Neurology, Drug delivery   Date completed: 2015-07-01   Type: Private placement   Raised: $7.6 million   Shares: 9.8 million   Price: $0.78   Shares after offering: 59...
08:00 , Mar 2, 2015 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes...
08:00 , Jan 12, 2015 |  BC Week In Review  |  Company News

Acura, Egalet deal

Acura granted Egalet exclusive, worldwide rights to commercialize Oxaydo oxycodone tablets formulated to deter abuse. Oxaydo (formerly Oxecta ) is approved in the U.S. to treat acute and chronic moderate to severe pain. Acura will...
07:00 , Oct 27, 2014 |  BC Week In Review  |  Clinical News

Vycavert hydrocodone bitartrate/acetaminophen regulatory update

Acura said FDA denied on procedural grounds the company's formal dispute resolution request to the agency for Vycavert, the biotech's abuse-deterrent formulation of hydrocodone bitartrate and acetaminophen to treat pain. The biotech said the dispute...
07:00 , Sep 29, 2014 |  BC Week In Review  |  Clinical News

Vycavert hydrocodone bitartrate/acetaminophen regulatory update

On Sept. 15, Acura said it submitted a formal dispute resolution request to FDA for Vycavert, the biotech's abuse-deterrent formulation hydrocodone bitartrate and acetaminophen to treat pain. The biotech said the dispute pertains to the...