FDAnews Drug Daily Bulletin

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 8–0 against recommending approval of Cornerstone Therapeutics’ lixivaptan to treat hypervolemic hyponatremia associated with heart failure.

Alliance Medical Products, a contract manufacturer of commercial and clinical drugs, failed to follow environmental monitoring plans in classified areas and storage rooms, an FDA Form 483 states.

Impax Laboratories can market generic versions of Genzyme’s kidney disease drugs Renvela and Renagel in 2014 under a settlement with the brand drugmaker.

OTC muscle and joint pain relievers may cause chemical burns in rare cases, U.S. health regulators warned on Thursday.

As the U.S. wrestles with its biggest whooping cough outbreak in decades, researchers appear to have zeroed in on the main cause: The safer vaccine that was introduced in the 1990s loses effectiveness much faster than previously thought.

Lundbeck plans to stop selling a leukemia treatment because of manufacturing and supply difficulties.

Neuralstem, a biotechnology company with no approved products, gained the most ever after saying its stem cell treatment restored paralyzed rats’ ability to move in an early study.

Global pharmaceutical maker Merck said it is leaving the controversial American Legislative Exchange Council — which drafts model bills that are replicated in state legislatures across the country — because of “budget constraints and policy priorities.”

SciClone Pharmaceuticals has announced that Mark Lotter will resign from the position of CEO of the company’s China operations at the end of 2012.