drug approval

To get potentially lifesaving drugs to patients faster, the U.S. Food and Drug Administration is allowed to approve some drugs -- those that address unmet medical needs -- based on fewer trials than usual. But it turns out that many of the pharmaceutical companies fail to conduct follow-up trials to prove the drugs work.

Shares of drugmaker InterMune have more than doubled in premarket trading after a European advisory panel backed the company's experimental lung treatment Esbriet (pirfenidone), something the biotech failed to accomplish in the U.S.

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.

AstraZeneca and Pozen announced Monday that their pain reliever Vimovo for the treatment of arthritis had received positive agreement for approval by the 23 E.U. nations. Vimovo is a combination drug that reduces the risk of ulcers for frequent NSAID users.

InterMune shares soared over 60% after hours after it came closer to FDA approval of its experimental treatment for a fatal lung disease. An advisory panel voted to approve the drug despite questionable effectiveness, given that the disease has no cure and patients need reason to hope.