Gilead Warns Over Heart Drug After Patient Problems
The drug maker says nine patients who were taking its hepatitis C drugs in tandem with amiodarone, a heart drug, developed slow heartbeats, and one died from cardiac arrest. Elsewhere, Biogen's Alzheimer's drug shows promise in slowing the disease.
Gilead Warns After Hepatitis Patient On Heart Drug Dies
Gilead Sciences Inc. said nine patients taking its hepatitis C drugs Harvoni or Sovaldi along with the heart treatment amiodarone developed abnormally slow heartbeats and one died of cardiac arrest. Three required a pacemaker to be inserted. The patients were all taking amiodarone, with three also using Harvoni, five receiving Sovaldi with Bristol-Myers Squibb Co.’s daclatasvir and one on Sovaldi with Johnson & Johnson’s Olysio. Gilead said the combinations aren’t recommended and it will update its product labeling. (West, 3/21)
The Wall Street Journal:
Biogen’s Alzheimer’s Drug Impresses In Early Trial
A Biogen Idec Inc. drug that targets plaque buildup in the brain slowed cognitive decline in patients with early and mild forms of Alzheimer’s disease in a small, early-stage study, lifting the company’s stock to all-time highs and adding to the debate on how to treat the debilitating disease. (Walker, 3/20)
The New York Times:
Biogen Reports Its Alzheimer’s Drug Sharply Slowed Cognitive Decline
An experimental drug for Alzheimer’s disease sharply slowed the decline in mental function in a small clinical trial, researchers reported Friday, reviving hopes for an approach to therapy that until now has experienced repeated failures. The drug, being developed by Biogen Idec, could achieve sales of billions of dollars a year if the results from the small trial are replicated in larger trials that Biogen said it hoped to begin this year. Experts say that there are no really good drugs now to treat Alzheimer’s. (Pollack, 3/20)
And The Wall Street Journal looks at regulation of medical devices --
The Wall Street Journal:
Do The FDA’s Regulations Governing Medical Devices Need To Be Overhauled?
Medical devices can save lives, but in recent years it has become clear how hazardous they are when they malfunction: metal hips that fail; bloodstream filters that fracture and prove lethal; defibrillator wires that break down. The Food and Drug Administration works at striking the proper balance between insisting on safety but not standing in the way of innovative products that promote health and well-being. In doing so, it’s dealing with increasingly complex products of the software and digital age, including some aimed directly at consumers, such as medical apps. (Burton, 3/22)