Posts tagged “Salix”
Salix Pharmaceuticals and the American Liver Foundation back a new documentary about hepatic encephalopathy, or HE, which was directed by Academy Award winner Cynthia Wade.
Salix Pharmaceuticals announced on Monday a 62 percent increase in its first quarter revenue for 2012 with total product revenue at $171.1 million thanks in part to the company's leading drug Xifaxan.
An approval decision was expected on April 27. But the U.S. Food and Drug Administration has notified the Raleigh-based company that it needs more time. The new target date to issue an approval decision is July 27.
Salix says it will repurchase outstanding convertible senior notes that are due in 2028. The company also plans to repurchase up to $75 million of its outstanding common stock and will also use proceeds for corporate purposes.
In the news: Visilink's LED wireless; MercuryGate grows; Salix drug trial; Furiex cuts losses; iContact donations; Software Toolbox update
Local tech briefs: Cary-based Visilink unveils LED-based wireless; Cary firm MercuryGate expands to Asia; Salix launches new drug trial; Furiex cuts its losses; iContact donates $200,000; Charlotte firm updates automation software.
Salix is preparing for new set of Xifaxan phase 3 clinical trials studying the irritable bowel syndrome indication, which puts approval about two years away. But first the company will meet with an FDA advisory panel on Wednesday, eight months after receiving the complete response letter from the agency declining approval on Xifaxan as a new IBS treatment.
"Napo believes Salix has materially breached the collaboration agreement by unnecessarily stalling the advancement of this compound," Napo Pharmaceuticals says. "Most notably, Salix has failed to file an NDA one year after a highly successful phase 3 clinical trial or to prepare for commercial manufacture of the drug -- critical tasks that were fundamental to its responsibilities."
"The acquisition of Oceana expands our product portfolio of innovative products, furthers the diversification of Salix's base business and provides immediate added revenue," says Salix CEO Carolyn Logan.