| Higher Sales Boost Glaxo's Net Sales of swine-flu vaccine helped GlaxoSmithKline's first-quarter profit rise 19%, though some countries have tried to reduce orders. 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 |
Trading FDA, Clinical Trial Binary Events: Cumberland Pharma Mike Havrilla submits:Below are some Regulatory Catalyst Index updates for companies with recent FDA and clinical trial related news...Shares of Cumberland Pharma (NASDAQ:CPIX) have shed approximately 65% of market value since its initial public offering (IPO) last August at $17 per share.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 |
Biotech Haircut: Abbott to Cut 3,000 Jobs After Absorbing Solvay Pharmalot submits: And the industry job cuts keep on coming. Abbott Labs (ABT) is now cutting about 3,000 jobs and phasing out some R&D work. Jobs will be cut from commercial, R&D, manufacturing and staff operations, primarily at Solvay locations in Europe, such as The Netherlands and Germany. As part of the cuts, the Solvay US headquarters in Marietta, Georgia, will be shuttered. The move comes roughly one year after Abbott purchased Solvay’s drug business for $6.2 billion, but failed last month to find a buyer for the Solvay vaccine business, a deal that some believed could fetch $600 million or more. An Abbott spokeswoman says certain R&D programs will be discontinued, such as traumatic brain injury, cardio/metabolic indications, and diabetes, but the drugmaker is not exiting work from specific therapeutic categories. For those curious about the fate of the Solvay vaccine biz, the cell-based vaccine program will be among the programs to be ended, but egg-based vaccine research will continue.Complete Story » seekingalpha.com |