VIVUS

FDA approves STENDRA for ED

Thursday, September 18, 2014 02:21 PM

The FDA has approved a supplemental new drug application (sNDA) for Vivus’ STENDRA (avanafil). STENDRA now is the only FDA-approved erectile dysfunction (ED) medication indicated to be taken as early as approximately 15 minutes before sexual activity.

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Ariad appoints Alexander J. Denner to board of directors

Monday, February 24, 2014 12:26 PM

Ariad Pharmaceuticals, an integrated global oncology company, has appointed Alexander J. Denner, Ph.D., to a two-year term on the company's board of directors, effective immediately. With the addition of Denner, who is the chief investment officer and founding partner of Sarissa Capital Management LP, the board now comprises nine directors, eight of whom are independent. The company also will appoint another independent director to the board, who will be selected by the board and be subject to Denner's concurrence.

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Vivus, Sanofi ink agreement

Friday, December 13, 2013 01:57 PM

Biopharmaceutical company Vivus has entered into a license and commercialization agreement with Sanofi to commercialize avanafil on an exclusive basis in Africa, the Middle East, Turkey and the Commonwealth of Independent States (CIS) including Russia. Sanofi will be responsible for obtaining regulatory approval in its territories. Sanofi intends to market avanafil under the trade name Spedra or Stendra.

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Vivus, Auxilium ink license agreement

Monday, October 14, 2013 02:18 PM

Vivus has signed an agreement providing Auxilium Pharmaceuticals the exclusive rights to market Stendra (avanafil) in the U.S. and Canada. The companies also signed a commercial supply agreement by which Vivus will be responsible for the manufacture and supply of Stendra to Auxilium. Stendra is an oral therapy approved by the FDA for the treatment of erectile dysfunction (ED).

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Vivus board appoints new chairman, CEO

Wednesday, July 24, 2013 03:00 PM

Biopharmaceutical company Vivus’ board of directors has appointed Michael Astrue chairman and Anthony Zook chief executive officer.

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VIVUS, First Manhattan reach settlement agreement

Friday, July 19, 2013 02:21 PM

Mountain View-based pharma company Vivus and New York-based First Manhattan (FMC), an owner-managed and operated investment advisory firm and the owner of 9.9% of Vivus’ outstanding shares, said they have entered a settlement agreement regarding their proxy contest related to Vivus’ 2013 annual meeting.

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FDA approves Stendra for ED

Monday, April 30, 2012 03:45 PM

The FDA has approved Stendra (avanafil) tablets for the treatment of erectile dysfunction (ED), marking the first new prescription agent approved in nearly a decade for the condition that afflicts as many as 30 million men in the U.S., according to biopharmaceutical company Vivus.

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FDA advisory committee recommends Qnexa for approval

Monday, February 27, 2012 10:03 AM

The FDA Endocrinologic and Metabolic Drugs Advisory Committee has recommended Vivus’ adult obesity drug Qnexa be granted marketing approval by the FDA.

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FDA reviews NDA for VIVUS' Qnexa

Tuesday, December 27, 2011 11:11 AM

VIVUS has reported that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA is scheduled to review the Company's New Drug Application (NDA) for Qnexa for the treatment of obesity on February 22, 2012. VIVUS resubmitted the NDA on seeking approval to market Qnexa in the United States. The FDA has accepted the NDA for review. The target date for the FDA to complete its review of the Qnexa NDA is April 17, 2012.

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VIVUS resubmits NDA for Qnexa

Monday, October 17, 2011 11:37 AM

VIVUS has resubmitted the New Drug Application (NDA) for Qnexa to the FDA. The resubmission follows an agreement reached in September 2011 with officials of the endocrine and metabolic division of the FDA on the filing strategy for Qnexa. The NDA resubmission seeks approval for an initial indication for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients or overweight patients with weight-related co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity (abdominal obesity). The proposed labeling for Qnexa includes a contraindication for women of childbearing potential.  The NDA resubmission also includes a proposed Risk Evaluation and Mitigation Strategy (REMS).

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December 15

Cancer Treatment Centers of America chooses WCG as its exclusive IRB, sheds five local hospital IRBs

Five southern research groups form public-private network to help save time, money for clients with early-stage biologics

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Growing adoption of feasibility review committees
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