Wells Outlines Paths for VIVUS (VVUS) Following CHMP Denial of Qsiva Marketing App
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VIVUS (VVUS) Formally Denied MAA for Qsiva by CHMP; Cites Concern Over Cadio, Nervous System Effects
October 18, 2012 5:31 PM EDTVIVUS, Inc. (Nasdaq: VVUS) announced that is has received the formal opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) following their October 15-18 meeting.
As expected, the CHMP recommended against approval of the Marketing Authorization... More
VIVUS (VVUS) Submits Amdendment to REMS for Qsymia to Expand Distribution
October 17, 2012 7:04 AM EDTVIVUS, Inc. (Nasdaq: VVUS) announced that it has submitted an amendment to the Risk Evaluation and Mitigation Strategy (REMS) for Qsymia. The proposed REMS modification would allow dispensing through a broader range of certified pharmacies, specifically select retail pharmacies, to increase access while meeting all requirements of the REMS. The REMS... More
Not Expecting E.U. Approval for Vivus' (VVUS) Qsiva, Could be a Plus for Orexigen (OREX) - Analyst
September 21, 2012 12:19 PM EDTShares Vivus (NASDAQ: VVUS) are getting slapped 11 percent Friday following news that the company expects EU regulators to recommending against... More
