| Two Drugs Can Make Cancers Less Fatal New uses for two established cancer drugs significantly increased the time patients survived without their disease progressing, in studies that provide fresh evidence of how cancer is often becoming a chronic disease. online.wsj.com |
Bayer Cancer Drug Fails to Meet Primary Goal Bayer said cancer treatment Nexavar failed to reach its primary goal of extending the lives of patients with a certain advanced form of lung cancer in a late-stage clinical trial. online.wsj.com |
FDA, Clinical Trial Binary Events: Amarin, Amicus, Labopharm Mike Havrilla submits:Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news... Amarin Corp. (NASDAQ:AMRN) has a conference call scheduled for Tuesday 10-August at 11am (ET) and plans to provide an update on its financials and a progress update on the two ongoing pivotal Phase 3 studies (MARINE and ANCHOR) for AMR101 as a purified, prescription-grade omega-3 fatty acid compound that is being evaluated for the treatment of high triglycerides. Complete Story » seekingalpha.com |
FDA Committee Rejects Expanded Use of Jazz Drug on Abuse Concerns: Biotech's Latest Failures The Burrill Report submits: A joint advisory committee of the U.S. Food and Drug Administration overwhelmingly voted against the approval of Jazz Pharmaceuticals' (JAZZ) drug Xyreme for fibromyalgia because of concerns that the risks exceed the benefits. The drug, sodium oxybate, is a central nervous system depressant. It is also known as gamma-hydroxybutyrate or GHB, widely referred to as ‘the date rape drug.” The committee, which voted 20-2 against recommending approval, was concerned about potential abuse of the drug. The drug is currently approved as a treatment for narcolepsy.The U.S. Food and Drug Administration told Cumberland Pharmaceuticals (CPIX) that it would need an additional three months to review its drug Acetadote as a treatment for patients with non-acetaminophen acute liver failure. The FDA now expects to act on the company’s application to market the drug in December 2010. Acetadote was launched by Cumberland in 2004 as the first U.S.-approved injectable drug to treat acetaminophen overdose. In 2006, the FDA approved Acetadote for use in pediatric patients.Complete Story » seekingalpha.com |
Alliance Healthcare Services Schedules Conference Call and Webcast to Review Third Quarter 2010 Financial Results [Business Wire] - Alliance HealthCare Services announced today that it will host a conference call and webcast on Thursday, October 28, 2010 at 8:30 a.m. Eastern Time to discuss the Company’s third quarter 2010 financial results, which are scheduled to be released after the market closes on Wednesday, October 27, 2010. us.rd.yahoo.com |