| FDA Committee Votes to Reject AstraZeneca RSV Drug: Biotech's Latest Mishaps The Burrill Report submits: The U.S. Food and Drug Administration's Antiviral Drugs Advisory Committee has recommended that the agency reject MedImmune’s application to begin marketing motavizumab, a monoclonal antibody for the prevention of serious respiratory syncytial virus disease in high-risk infants. The committee's recommendation, which was made with a 14 to 3 vote, calls for additional clinical trials of motavizumab. The recommendation will be considered by FDA reviewers in their evaluation of the Biologics License Application for the antibody. “We continue to believe motavizumab offers a meaningful clinical benefit to patients at high risk for a very common and serious illness," says Genevieve Losonsky, vice president, clinical development, infectious disease at MedImmune, the worldwide biologic unit for AstraZeneca (AZN). The U. S. Food and Drug Administration informed AstraZeneca that it would not approve the company’s new drug application for Axanum (aspirin/esomeprazole magnesium) tablets. The company said it also received a letter from the agency informing it that it would not approve its supplemental new drug application Nexium (esomeprazole magnesium). AstraZeneca is currently evaluating the letters from the FDA and said it will continue discussions with the agency to determine next steps with respect to both applications and respond to the agency’s request for additional information. AstraZeneca submitted both applications to the FDA on April 30, 2009, seeking approval for Axanum, for the risk reduction of low dose ASA-associated gastric and/or duodenal ulcers in patients at risk. The Nexium applications was submitted for the risk reduction of low-dose aspirin-associated peptic ulcers.Complete Story » seekingalpha.com |
AstraZeneca Loses Bid on Fine AstraZeneca lost its bid to overturn an antitrust fine imposed on the pharmaceuticals company in 2005 for trying to squeeze out competition for its ulcer capsule Losec. online.wsj.com |
New Hope in Fatigue Fight Researchers said they identified a family of retroviruses in patients with chronic fatigue syndrome, opening up a potentially promising new avenue of treatment for a disease that afflicts as many as four million Americans and 17 million people world-wide. online.wsj.com |
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