Latest Mesalazine Stories
HEIDELBERG, Germany, April 10, 2013 /PRNewswire/ -- IND paves the way for the US element of a global Phase III development program with LT-02 in conjunction with European licensee Dr. Falk Pharma GmbH, whose pivotal study will start in Q4 2013 Lipid Therapeutics announces today that it has successfully filed its first US IND for its lead product LT-02 and is now in a position to proceed with a planned Phase III trial in the US in...
OKLAHOMA CITY, Aug. 28, 2012 /PRNewswire/ -- Altheus Therapeutics announced today it has randomized its first patient in a comparator-controlled Phase 2 efficacy study of Zoenasa®, a novel combination therapy for ulcerative colitis (UC). Zoenasa is a fixed-dose combination of mesalamine (current standard of care in UC) plus a second potent anti-inflammatory agent not previously used in this indication. In multiple animal models and one human study the combination has shown to be...
PHILADELPHIA, Pennsylvania, March 30, 2012 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced top-line results of the PREVENT2 trial, a phase 3 investigational study of once-daily SPD476, MMX(R) mesalamine in patients with a history of diverticulitis.[1] The study, conducted in 10 countries worldwide including the United States, did not meet the primary endpoint in reducing the rate of recurrence of...
PHILADELPHIA, July 18, 2011 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda(R) (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult...
PHILADELPHIA, July 18, 2011 /PRNewswire/ -- Shire plc (LSE: SHP; NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Lialda® (mesalamine) Delayed Release Tablets for the maintenance of remission in patients with ulcerative colitis. This approval is based on results from a six-month study demonstrating the safety and effectiveness of Lialda in maintaining endoscopic remission in adult patients. This...
HEIDELBERG, Germany, June 22, 2011 /PRNewswire/ -- - Primary Endpoint Met Lipid Therapeutics, a biotechnology company focused on novel treatments for inflammatory bowel disease, today announced positive topline results from a Phase IIb clinical trial with its lead product, LT-02, in patients with ulcerative colitis. LT-02 is a controlled release formulation of phosphatidylcholine that has been specifically designed to treat ulcerative colitis by improving the barrier...
Causes of IBD explored including 'hygiene hypothesis'The American College of Gastroenterology published a new evidence-based systematic review on the management of Inflammatory Bowel Disease (IBD) as a supplement to The American Journal of Gastroenterology (AJG) for April 2011, a special issue entirely dedicated to IBD. This clinical monograph, based on a comprehensive meta-analysis, offers new graded recommendations on medical management of IBD, a chronic digestive disorder which includes...
OKLAHOMA CITY, Jan. 6, 2011 /PRNewswire/ -- Altheus Therapeutics, Inc., announced that it has completed a two dose, double-blind, active-controlled Phase I clinical trial of the safety and tolerability of Zoenasa(TM) Rectal Suspension in adult patients with left-sided, or distal, ulcerative colitis. No serious adverse events were experienced by patients in this study. "We are excited to have achieved this milestone, as it prepares Altheus to begin our planned Phase II clinical program to...
ARDEE, Ireland, Aug. 24 /PRNewswire-FirstCall/ -- Warner Chilcott plc (Nasdaq: WCRX) today announced that it has received the Food and Drug Administration's ("FDA's") response to a citizen petition it had filed regarding its ASACOL and ASACOL HD products. In its petition, Warner Chilcott requested that the FDA (1) issue bioequivalence guidance for mesalamine delayed-release tablets, (2) not approve any abbreviated new drug applications ("ANDAs") referencing ASACOL and/or ASACOL HD unless...
WALTHAM, Mass., Aug. 2 /PRNewswire/ -- Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that 63 percent of surveyed U.S. gastroenterologists prescribe Abbott's Humira off-label for the treatment of ulcerative colitis. According to the new report entitled Treatment Algorithms in Ulcerative Colitis, surveyed gastroenterologists most often prescribe Humira for ulcerative colitis for patients with loss of response,...
