01:32 , Mar 25, 2015 |  BC Extra  |  Company News

Management tracks

The Innovative Medicines Initiative (IMI) named Marc de Garidel as chair of its governing board. Garidel succeeds Roch Doliveux, who retired last year. Garidel is chairman and CEO of Ipsen Group (Euronext:IPN; Pink:IPSEY). Infectious disease...
08:00 , Nov 5, 2012 |  BC Week In Review  |  Clinical News

Lixivaptan regulatory update

Cornerstone said FDA issued a complete response letter for an NDA for lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH). According...
01:11 , Nov 2, 2012 |  BC Extra  |  Company News

Cornerstone receives lixivaptan complete response

Cornerstone Therapeutics Inc. (NASDAQ:CRTX) said FDA issued a complete response letter for an NDA for lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic...
07:00 , Sep 17, 2012 |  BC Week In Review  |  Clinical News

Lixivaptan regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee recommended against approval of Cornerstone's lixivaptan to treat hypervolemic hyponatremia associated with chronic heart failure (CHF) and euvolemic hyponatremia associated with syndrome of inappropriate antidiuretic hormone (SIADH). The...
01:44 , Sep 12, 2012 |  BC Extra  |  Company News

FDA reviewer gives mixed recommendation on lixivaptan

An FDA reviewer recommended approval of lixivaptan from Cornerstone Therapeutics Inc. (NASDAQ:CRTX) for one of two proposed indications that will be discussed at Thursday's meeting of the Cardiovascular and Renal Drugs Advisory Committee. In briefing...
07:00 , Jul 30, 2012 |  BC Week In Review  |  Clinical News

Lixivaptan regulatory update

FDA's Cardiovascular and Renal Drugs Advisory Committee will meet on Sept. 13 to discuss an NDA from Cornerstone for lixivaptan to treat symptomatic hypervolemic hyponatremia associated with heart failure and euvolemic hyponatremia associated with syndrome...
01:52 , Jul 25, 2012 |  BC Extra  |  Company News

FDA to discuss Cornerstone's lixivaptan

FDA's Cardiovascular and Renal Drugs Advisory Committee will meet on Sept. 13 to discuss an NDA from Cornerstone Therapeutics Inc. (NASDAQ:CRTX) for lixivaptan to treat symptomatic hypervolemic hyponatremia associated with heart failure and euvolemic hyponatremia...
07:00 , Mar 19, 2012 |  BC Week In Review  |  Clinical News

Lixivaptan regulatory update

FDA accepted for review an NDA from Cornerstone for lixivaptan to treat hyponatremia. The PDUFA date is Oct. 29. Cornerstone gained the selective vasopressin V2 receptor antagonist through its January acquisition of cardiovascular disease company...
00:55 , Mar 14, 2012 |  BC Extra  |  Company News

FDA to review CRTX 080 for hyponatremia

FDA accepted for review an NDA from Cornerstone Therapeutics Inc. (NASDAQ:CRTX) for CRTX 080 to treat hyponatremia. The PDUFA date is Oct. 29. Cornerstone gained the selective vasopressin V2 receptor antagonist through its January acquisition...
08:00 , Jan 9, 2012 |  BC Week In Review  |  Company News

Cardiokine, Cornerstone Therapeutics deal

Cornerstone acquired cardiovascular disease company Cardiokine. Cardiokine shareholders will receive $27.3 million in cash up front and will be eligible for up to $137 million in sales milestones for hyponatremia compound lixivaptan , plus 8%...