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Amgen Inc. (NASDAQ:AMGN) reports that the FDA has approved a new indication for Prolia, as a treatment to increase bone mass in men who suffer osteoporosis and are at high risk for fracture. Prolia represents the first FDA-approved subcutaneous injection that is administered every six months. Evaluations of men with low bone mineral density who took the treatment, resulted in significantly greater bone density gains when compared to a placebo.
Vivus, Inc. (NASDAQ:VVUS) anticipates that a panel in Europe will reject the authorization of its obesity drug Qsiva, even though the product won FDA approval in July. The firm expects a formal decision on October, after which it could appeal or resubmit its application upon rejection of Qsiva.
The FDA will permit ViroPharma Incorporated (NASDAQ:VPHM) to restart clinical trials of the subcutaneous injection of its Cinryzed drug in combination with rHuPH20, which is a platform for administering medicines in this way. The agency believes that “safety signals” regarding antibodies to rHuPH20 detected in another firm’s product development are limited to that product’s program. Shares of Viro jumped, but those of its partner Halozyme Therapeutics, Inc. (NASDAQ:HALO) skyrocketed.
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