The European Medicines Agency on Wednesday affirmed that it is bringing an infringement procedure against Roche (RHHBY.OB), claiming that the company did not properly check out some 80,000 reports of issues received from U.S. patients and doctors relating to 19 of the firm’s drugs, including the top performers Herceptin and Avastin. Roche could be penalized by as much as 5 percent of its yearly revenues if found guilty.
Shares of United Therapeutics Corporation (NASDAQ:UTHR) go over the cliff on word that on Wednesday the FDA rejected the firm’s new drug application for treprostinil, which is an oral treatment for high blood pressure. The agency said that it is uncertain as to whether another evaluation would help reverse its decision, but did indicate that if the company elects to conduct a further trial, it should consider a fixed dose design and more frequent dosing.
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The drug maker XOMA (NASDAQ:XOMA) will to offer 13.33 million shares of common stock at $3 per share, and intends to use the proceeds for ongoing development and testing of its diabetes treatments gevokizumab and XMet platform, along with other corporate purposes.
Discovery Laboratories (NASDAQ:DSCO) shares sharply dip but rebound on the news that the commercial intro of its Surfaxin liquid medication to treat Infant Respiratory Distress Syndrome will probably be postponed until the second quarter of next year. The launch had previously been planned to occur by the end of the current year.