Friday, June 19, 2009

New Treatments Should Be Introduced Gradually To Avoid Later Problems, Says Expert

Concerns over whether the tests a treatment undergoes before release onto the market are enough to ensure its long-term safety are raised in an editorial published by BMJ Clinical Evidence today. Dr Vijay Sharma suggests that treatments should be introduced gradually so that evidence can be built up and the treatment can find its proper niche. To illustrate this, he discusses the recent debate on the long-term safety of drug-eluting stents. Complete news at...

Wednesday, June 17, 2009

Bayer Completes Phase II Study On BAY 94-9172 In Alzheimer's Disease Imaging

Bayer Schering Pharma AG, Germany, has completed its first global Phase II study analyzing the sensitivity and specificity of BAY 94-9172 (AV1/ZK) using positron emission tomography (PET) in patients with probable Alzheimer's disease compared to healthy volunteers. BAY 94-9172 binds to the beta amyloid protein in the brain, a pathological hallmark of Alzheimer's disease. More at...

Monday, June 15, 2009

FDA Requests Labeling Change For Leukotriene Modifiers

The U.S. Food and Drug Administration provided further updated safety information on a class of asthma drugs known as leukotriene modifiers. The FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling) regarding neuropsychiatric events (behavior, mood changes) that have been reported in some persons taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). More at...