FDA reviews Avandia safety data
ROCKVILLE, Md. The Food and Drug Administration is reviewing data from a large clinical study of a diabetes drug that some have said increases the risk of heart attacks in patients, the agency said Monday.
The FDA is reviewing the RECORD study, a trial of GlaxoSmithKline’s Type 2 diabetes treatment Avandia (rosiglitazone). The agency said the reviews are ongoing and that it has not made any new recommendations regarding the drug, but will present any new cardiovascular safety data at a public meeting in July. The FDA did not indicate that the announcement was related to a report by the Senate Committee on Finance and an article in The New York Times concerning Avandia.
GSK lashed out at the committee and the Times during the weekend over reports that the British drug maker knew of cardiovascular risks associated with the drug prior to the May 2007 publication of a study about them in the New England Journal of Medicine, saying they were based on unscientific premises.
FDA approves Menveo
CAMBRIDGE, Mass. Novartis has received Food and Drug Administration approval for a vaccine for meningococcal disease, the Swiss drug maker’s vaccines division announced Monday.
The FDA approved Menveo (meningococcal [groups A, C, Y and W-135] oligosaccharide diphtheria CRM197) to prevent meningococcal disease caused by Neisseria meningitidis bacteria.
The disease infects more than 500,000 people each year, killing as many as 1-in-7 who contract it; it is often fatal within 48 hours. About one-in-five who survive have serious side effects, including limb amputations, learning disabilities, seizures and paralysis.
“The FDA approval of Menveo is an important milestone for adolescent immunization in the United States,” Novartis vaccines division head Andrin Oswald said in a statement. “According to CDC estimates, approximately 16 million adolescents between the ages of 11 and 18 are at risk and remain unprotected against meningococcal disease.”
Watson CEO to serve as GPhA chairman
NAPLES, Fla. Watson Pharmaceuticals president and CEO Paul Bisaro will serve as the Generic Pharmaceutical Association’s chairman for 2010-2011, GPhA announced.
Bisaro has led Watson since 2007, after a stint as president and CEO of Barr Labs that began in 1999. He has served on GPhA’s board of directors since 2008, most recently as vice chairman.
“Paul will provide us with a steady hand as GPhA next navigates the often turbulent issues of health reform and the nation’s economic recovery,” GPhA president and CEO Kathleen Jaeger said. “GPhA looks forward to working with him, our board of directors and executive committee in what will be a challenging year.”
The organization also elected Mylan Pharmaceutical president Tony Mauro as vice chairman, New Chemic senior consultant Rosendo Ferran as secretary-treasurer. Nycomed U.S. CEO Paul McGarty, Teva North America president and CEO William Marth, Sandoz president and CEO Christine Mundkur and Zydus Pharmaceuticals president and CEO Joe Renner will serve as at-large members on the board’s executive committee.