Salix Pharmaceuticals (NASDAQ:SLXP) must wait a little longer for a regulatory decision on its constipation treatment Relistor. An approval decision was expected on April 27. But the U.S. Food and Drug Administration has notified the Raleigh, North Carolina company that it needs more time. The new target date to issue an approval decision is July […]
Gastrointestinal treatments firm Salix Pharmaceuticals (NASDAQ:SLXP) aims to raise $600 million in debt financing. The Raleigh, North Carolina company has priced the $600 million offering of convertible senior notes, which is open to qualified institutional investors. Salix could raise up to $90 million more if purchasers exercise overallotment options. Interest on the notes will be […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
AIDS patients who frequently suffer from diarrhea may now finally see some light at the end of the tunnel for a new drug developed to help them. The U.S. Food and Drug Administration has granted priority review for Salix Pharmaceuticals‘ (NASDAQ:SLXP) crofelemer and an approval decision on the drug candidate could come by June 5. […]
Gastrointestinal therapeutics firm Salix Pharmaceuticals (NASDAQ:SLXP) is pressing ahead with a drug candidate to treat diarrhea in AIDS patients despite a deteriorating relationship with its drug partner that has led to a contract dispute and dueling lawsuits. Raleigh, North Carolina-based Salix today filed a New Drug Application for crofelemer, a filing that comes more than […]
The Salix Pharmaceuticals (NASDAQ:SLXP) irritable bowel syndrome drug candidate that failed to win U.S. Food and Drug Administration approval earlier this year is on its way to starting another phase 3 clinical trial. The Raleigh, North Carolina company said an FDA advisory committee has accepted the company’s proposed clinical trial design studying Xifaxan for irritable […]
When Salix Pharmaceuticals (NASDAQ:SLXP) disclosed that the U.S. Food and Drug Administration would not approve its drug Xifaxan for the new indication of irritable bowel syndrome, the gastrointestinal treatments company made clear it believed its drug met all of the targets needed for approval. Now we’re starting to see how much more ground the drug […]
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Salix Pharmaceuticals‘ (NASDAQ:SLXP) drug partner Napo Pharmaceuticals has terminated the collaboration agreement between the two companies over Salix’s failure to advance a promising anti-diarrhea drug for AIDS patients fast enough for the California company. Termination of the collaboration to develop the drug candidate crofelemer was effective Nov. 4 — a year to the date of […]
The U.S. Food and Drug Administration will review a constipation drug marketed by Salix Pharmaceuticals (NASDAQ:SLXP) to consider adding a new indication for the product. Relistor is an injectable drug approved in 2008 to treat constipation in seriously ill patients who take pain-killing opioid medication. Opioids relieve pain by acting on receptors in the spinal […]
Salix Pharmaceuticals (NASDAQ:SLXP) needs another clinical study on its irritable bowel syndrome treatment, which means it could take two more years for the drug to secure regulatory approval. That’s two more years than the gastrointestinal therapeutics company planned for. Salix expected to get U.S. Food and Drug Administration approval for the drug Xifaxan in the […]
Three years ago, Salix Pharmaceuticals (NASDAQ:SLXP) licensed a promising compound with the goal of developing a new treatment for chronic diarrhea in HIV patients. Morrisville, North Carolina-based Salix paid Napo Pharmaceuticals $5 million up front and pledged up to $300 million in milestone payments. But now Napo Pharmaceuticals wants to get out of the deal […]
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Salix Pharmaceuticals (NASDAQ:SLXP) believes that there’s enough solid data available now to warrant U.S. Food and Drug Administration approval of its new irritable bowel syndrome drug and at a meeting with the agency next month, the company will ask regulators to approve it. If the FDA wants more work done on the drug, Salix CEO […]
Salix Pharmaceuticals (NASDAQ:SLXP) is still working through issues that kept regulators from approving a drug for irritable bowel syndrome, but the North Carolina company is securing additional patent rights on the compound for other indications. Morrisville, North Carolina-based Salix announced Wednesday that the U.S. Patent and Trade Office has issued three patents relating to rifaximin, […]
Salix Pharmaceuticals is extending an agreement with an Indian pharmaceutical partner to give Salix exclusive global rights, except for India, to a key drug-delivery technology. Morrisville, North Carolina-based Salix (NASDAQ:SLXP) in 2009 licensed the drug delivery technology from Mumbai, India-based Lupin Pharmaceuticals. Salix uses that technology in its gastrointestinal drug rifaximin, marketed as Xifaxan. Salix […]
The U.S. Food and Drug Administration's formal letter explaining why it won't approve Salix Pharmaceuticals drug Xifaxan has finally arrived. But the North Carolina company isn't saying what exactly the FDA wants in order to approve Xifaxan for nonconstipation irritable bowel syndrome.
The U. S. Food and Drug Administration has signaled it will not approve an irritable bowel syndrome treatment being developed by Morrisville, North Carolina-based Salix Pharmaceuticals. Salix says it won't know more details until it formally receives a complete response letter from the FDA.