Drug Trials Test Bold Plan to Slow Alzheimer’s

Image via Wikipedia From the NY Times
By GINA KOLATA
Published: July 16, 2010

Marilyn Maldonado is not quite sure why she is at the Memory Enhancement Center in the seaside town of Oakhurst, N.J.

“What are we waiting for?” she asks. About 10 minutes later, she asks again. Then she asks again.

She is waiting to enter a new type of Alzheimer’s drug study that will, in the boldest effort yet, test the leading hypothesis about how to slow or stop this terrifying brain disease.

The disease is defined by freckles of barnacle-like piles of a protein fragment, amyloid beta, in the brain. So, the current thinking goes, if you block amyloid formation or get rid of amyloid accumulations — plaque — and if you start treatment before the disease is well under way, you might have a chance to alter its course.

On Tuesday, that plan got a new push. The National Institute on Aging and the Alzheimer’s Association proposed new guidelines for diagnosis to find signs of Alzheimer’s in people who do not yet have severe symptoms, or even any symptoms at all.

F.D.A. Panel Votes Against Obesity Drug

F.D.A. Panel Votes Against Obesity Drug
By ANDREW POLLACK
Published: July 15, 2010 From the NY Times

A federal advisory committee voted narrowly against endorsing a drug vying to become the first new prescription medicine for obesity in more than a decade, signaling heightened concerns for possible health risks associated with a new generation of diet pills.

The advisory committee to the Food and Drug Administration voted 10 to 6 that the safety concerns, like increased heart rate, possible birth defects and psychiatric problems, overrode the potential benefits of the drug, called Qnexa and developed by Vivus.

Vivus' Qnexa Not Recommended By FDA Advisory Committee

Image via Wikipedia The U.S. Food and Drug Administration has refused to recommend the Vivus Inc (NASDAQ: VVUS) diet drug Qnexa for approval. Citing multiple safety concerns, the panel narrowly rejected recommending the pill, which studies had shown to be effective in helping overweight people lose weight. While the FDA is not bound to the recommendations of its panels, it follows them most of the time.

Vivus Inc.'s FDA Review Of Weight Loss Drug Qnexa could Hint At Future Approval For Arena And Orexigen

Tomorrow is a big day for Vivus, Inc. and stock VVUS. Vivus is preparing tomorrow for the FDA's Endocrinologic and Metabolic Drugs Advisory Committee review panel on the weight loss drug Qnexa. I wrote an article on this subject last year based on their Phase III clinical trial results titled Vivus's Qnexa Drug Approval Makes It a Nice Trade, and was impressed with the long-term growth potential in the $40B weight loss industry.