Posts tagged “Salix”
Salix drug receives priority FDA review, but partner wants it back
The Raleigh firm is tied up in a law suit over the development of the drug that's intended to help AIDS patients suffering with diarrhea.
Salix's pill version of Relistor succeeds in phase 3; NDA expected in 2012
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.
Salix faces tough questions from FDA about expanded use of drug
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.
FDA raises questions about Salix drug; shares fall 10%
Triangle-based Salix wants to expand use of its bowel drug but the FDA raised questions that concern an analyst who follows the company.
California drug firm terminates potential blockbuster deal with 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."
Salix acquires NJ pharma firm for $300M; earnings soar
"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.
FDA to consider additional use for Salix drug
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.
Salix faces a delay in OK for wider use of drug
Data from proposed irritable bowel syndrome drug Xifaxan faces further review, Salix says. The FDA rejected Xifaxan as IBS tgreatment in March.
Salix faces suit from drug development partner
The Raleigh-based company says that the suit's charges "are without merit."
Salix wins more patent coverage of diarrhea drug
The Raleigh-based company expects Xifaxan sales to top $300 million this year.
Salix profit tops Street estimates, but revenue, forecast miss
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.
FDA delay sends Salix shares plunging 23%
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.
Salix licenses constipation drug in deal that could total $350M
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.
Study: Salix drug shows promise against irritable bowel syndrome
Report in New England Journal of Medicine says antibiotic Xifaxan shows promise.
Salix revenues, profits soar on sales of drug
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.
