A day of anticipation ended in disappointment as Salix Pharmaceuticals Ltd. and Progenics Pharmaceuticals Inc. received a complete response letter late Friday from the FDA for injectable Relistor (methylnaltrexone bromide) for opioid-induced constipation in adult patients with chronic, noncancer pain, which has not responded to treatment with laxatives. Read More
Executives of biopharma companies got a little good news and a lot of bad news when an appeals court, in a split decision, upheld the federal exclusion of three former Purdue Frederick Co. officials, clearing the way for more corporate officers to be forced out of the industry over off-label drug promotion. Read More
Until quite recently, if you talked about a cure, AIDS researchers assumed you were either a fool or an ACT UP activist. Now, three patients appear to have been cured. Read More
LONDON – Apogenix GmbH announced better-than-expected results from the final analysis of its Phase II controlled study of APG101 in the second-line treatment of glioblastoma multiforme, reporting median progression-free survival of 19.7 weeks in the treated group compared to 10.8 weeks in the control arm. Read More
• Arena Pharmaceuticals Inc., of San Diego, transferred the Belviq (lorcaserin hydrochloride) new drug application to partner Eisai Inc., of Woodcliff Lake, N.J., which establishes Eisai as the marketing authorization holder responsible for regulatory activities in the U.S. related to commercialization of the obesity drug, including pharmacovigilance requirements. Belviq gained FDA approval last month. Read More
• Tonix Pharmaceuticals Holding Corp., of New York, reported that data from a comparative pharmacokinetic (PK) and bioavailability trial supported the continued development of TNX-102 (cyclobenzaprine) 2.4 mg sublingual tablets for bedtime administration to improve core fibromyalgia symptoms. Read More
• Forest Laboratories Inc., of New York, commented on the Delaware Court of Chancery's decision to deny investor Carl Icahn's demands for access to certain books and records of the company, stating that the firm is "pleased with the Court's decision," and adding that the firm will comply with the ruling, "which essentially gives Mr. Icahn the documents we had previously offered him." Read More
• Bristol-Myers Squibb Co., of New York, and AstraZeneca plc, of London, said results of analyses show that Onglyza (saxagliptin) 5 mg demonstrated improvements across key measures of blood sugar control compared to placebo in adults with Type II diabetes who are at high risk for cardiovascular disease. Read More
