In a surprise move Tuesday, the FDA rejected Orexigen's proposed new diet drug Contrave, saying the company needed to run another study of its cardiovascular risks. With this rejection, all three of a slate of similar diet drugs from competing pharmaceuticals have been turned back by the agency.
After the U.S. Food and Drug Administration rejected two other weight-loss pills earlier this year, an advisory panel has recommended the approval of Orexigen Therapeutics's Contrave. If the FDA follows the recommendation, Contrave could become the first diet drug to win approval in a decade.
Vivus shares are soaring this morning, even though the U.S. Food and Drug Administration rejected the drugmaker's obesity drug Qnexa yesterday. Investors are hoping that the FDA's rejection, which includes a request for more safety data -- not another clinical trial -- will lead to approval next year.
It's a busy day at the FDA today as panels meet to discuss two new drugs -- one to help weight loss and the other to combat drug addiction -- and decide whether to approve AstraZeneca's new blood thinner medication.
Pharmaceutical company Vivus is getting hammered in Friday tading, sinking more than 50% in the wake of Thursday's vote by an FDA advisory panel against approving its weight-loss drug, Qnexa, based on safety concerns.
Pharmaceutical company Vivus and investors waited anxiously Thursday for the vote of an FDA advisory panel on the weight-loss drug Qnexa. The verdict is in, and by a vote of 9 to 7, panelists didn't support approving the drug as an obesity treatment.
An expert panel will review Vivus' potential blockbuster drug Qnexa on Thursday, with the FDA making a decision in October. The FDA acknowledges the drug's effectiveness in cutting weight, but Qnexa will certainly draw scrutiny over its side effects.
