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Posts tagged “Salix”

December 21, 2011

Premium Lock Salix's pill version of Relistor succeeds in phase 3; NDA expected in 2012

Salix Salix released successful phase 3 clinical trial results for the oral version of Relistor and now plans to submit a new drug application for the compound in the middle of 2012.

November 15, 2011

Premium Lock Salix faces tough questions from FDA about expanded use of drug

Salix 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.

Updated November 15, 2011

Premium Lock FDA raises questions about Salix drug; shares fall 10%

Salix Triangle-based Salix wants to expand use of its bowel drug but the FDA raised questions that concern an analyst who follows the company.

November 11, 2011

Premium Lock California drug firm terminates potential blockbuster deal with Salix

Salix "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."

November 9, 2011

Premium Lock Salix acquires NJ pharma firm for $300M; earnings soar

Salix "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.

August 31, 2011

Premium Lock FDA to consider additional use for Salix drug

Salix Salix and drug partner Progenics Pharmaceuticals want to expand Relistor's use to treat opioid-induded constipation in patients taking the drugs for non-cancer pain.

August 9, 2011

Premium Lock Salix faces a delay in OK for wider use of drug

Salix Data from proposed irritable bowel syndrome drug Xifaxan faces further review, Salix says. The FDA rejected Xifaxan as IBS tgreatment in March.

May 9, 2011

Premium Lock Salix faces suit from drug development partner

Salix The Raleigh-based company says that the suit's charges "are without merit."

April 20, 2011

Premium Lock Salix wins more patent coverage of diarrhea drug

Salix The Raleigh-based company expects Xifaxan sales to top $300 million this year.

March 1, 2011

Premium Lock Salix profit tops Street estimates, but revenue, forecast miss

Salix The Raleigh-based pharmaceutical firm, whose stock was rocked last week by at FDA delay, reports sharp increase in profits and revenues from fourth quarter a year ago.

Updated February 25, 2011

Premium Lock FDA delay sends Salix shares plunging 23%

Salix The Raleigh-based pharmaceutical firm says the FDA wants more information about possible expanded use of a drug to treat non-constipation irritable bowel syndrome.

February 7, 2011

Premium Lock Salix licenses constipation drug in deal that could total $350M

Salix The Raleigh-based pharmaceutical firm signs a deal with N.Y.-based Progenics for the drug Relistor. Clinical trials are underway on an oral version of the drug, which now is administered by injection.

Updated January 6, 2011

Premium Lock Study: Salix drug shows promise against irritable bowel syndrome

Salix Report in New England Journal of Medicine says antibiotic Xifaxan shows promise.

Updated November 9, 2010

Premium Lock Salix revenues, profits soar on sales of drug

Salix The Triangle-based pharmaceutical firm beats Wall Street expectations with a 5-cent per share profit. Its revenues surge 23 percent from a year ago.

October 20, 2010

Premium Lock Salix invests up to $130M in colon cancer detection agent

Salix Salix believes Lumacan will boost effectiveness of colonoscopies and produce annual sales topping $500 million. The Raleigh-based pharmaceutical firm pays $4 million up front for rights to the drug from Norway-based Photocure.

Updated October 4, 2010

Premium Lock FDA extends Salix drug review three months

Salix Review date pushed out three months for added use of drug-maker's Xifaxan tablets, but the company sees no problem.

Tags: Salix
Updated August 10, 2010

Premium Lock Salix shares rally after FDA grants priority review to use of irritable bowel drug

Salix Raleigh-based company also reports huge surge in revenues for second quarter.

May 28, 2010

Premium Lock Salix raises $300 million through debt sale

Salix The Raleigh-based firm said Thursday it would sell $200 million in debt. Proceeds will be used in part for product commercialization, research and development and clinical trials, Salix says.

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