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....
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 million   Placement agent: Roth Capital Partners   Investor:...
08:00 , Mar 2, 2015 |  BioCentury  |  Analyst Picks & Changes

Analyst picks & changes

Analyst picks & changes Analyst picks & changesCompanyBankAnalystCoverageOpinionWk chg2/27 clsAcelRx Pharmaceuticals Inc. (NASDAQ:ACRX)MizuhoMario CorsoUpgradeBuy (from neutral)9%$8.86 Corso also raised his target to $14 from $6 on clinical/regulatory progress toward an anticipated 1Q15 NDA submission for Zalviso...
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...
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...