Briefing documents that were released ahead of the Gastrointestinal Drugs Advisory Committee (GIDAC) meeting for short bowel drug Gattex (teduglutide) held "no surprises" according the drugmaker, NPS Pharmaceuticals Inc. Read More
A successful, earlier-stage trial with its oral, serotonin-reducing therapy for carcinoid syndrome helped Lexicon Pharmaceuticals Inc. figure out dosing in a Phase III study, the start of which made news at the same time that the company disclosed results from the Phase II experiment with LX-1032, or telotristat etiprate. Read More
In recent months, Gilead Sciences Inc. appeared to be in the driver's seat in the race for an all-oral, interferon-free hepatitis C virus (HCV) regimen. However, Abbott's posting of the first Phase III trial of its combination HCV regimen on ClinicalTrials.gov puts Gilead on notice that it won't cross the finish line unchallenged. Read More
• Addex Therapeutics SA, of Geneva, said it raised gross proceeds of $10.3 million in a private placement to international institutional investors. The company sold 918,025 shares priced at CHF10.50 (US$11.25) per share. Read More
• Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., said updated data from its Phase II trial of oral sapacitabine in older patients with intermediate-2 or high-risk myelodysplastic syndromes after treatment failure with front-line hypomethylating agents such as Vidaza (azacitadine, Celgene Corp.) and/or Dacogen (decitabine, Astex Pharmaceuticals Inc.) showed a median overall survival rate to date for all 63 patients of 252 days, or about eight months. Read More
• Endocyte Inc., of West Lafayette, Ind., said data published in the Archives of Pathology & Laboratory Medicine showed that 72 percent of adenocarcinomas and 51 percent of squamous cell carcinomas of the lung were positive for the folate receptor. Read More
• Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported preliminary results from a study showing treatment with melt-in-the-mouth desmopressin, an orally disintegrating tablet, reduced period limb movements (PLMS) in children with nocturnal enuresis (bedwetting). Read More
• Roche AG, of Basel, Switzerland, lost its appeal in the federal circuit to get a preliminary injunction against generic formulations of its bisophosphonate Boniva (ibandronate) for the treatment of osteoporosis. Read More