FDA indicates no new trials needed for Epix agent

Epix Pharmaceuticals has received some good news from the FDA. Regulators did not approve Vasovist, a blood-pool imaging agent, but did indicate that they won't need additional clinical trials for the agent. That news helped push up the company's shares by 17 percent in early trading. An injection of Vasovist is intended to give physicians a three-dimensional view of arteries and veins.

"The FDA has now accepted that the image acquisition in the four previously conducted Phase III studies was of sufficient quality to potentially provide substantial evidence of the efficacy of Vasovist," President Andrew Uprichard said in a statement. "In its letter, the FDA stated that it recommends the currently available images from the pivotal studies be re-analyzed as the core of evidence needed to support the potential approval of Vasovist."

- read the report [1] on Vasovist from MarketWatch

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