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, […]
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.
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.
Salix Pharmaceuticals swung to a $24.5 million profit in the fourth quarter but analysts on a conference call to discuss financial results wanted to talk about Xifaxan. The Morrisville, North Carolina company disclosed that the U.S. Food and Drug Administration isn't likely to approve the drug for treating 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.
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Salix Pharmaceuticals, which focuses on gastrointestinal treatments, is paying $60 million to license constipation drug Relistor from Progenics Pharmaceuticals. Morrisville, North Carolina-based Salix could pay up to $90 million in additional milestone payments if the company is able to hit regulatory milestones.