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FDA accepts new drug application from Vivus

BY Alaric DeArment

MOUNTAIN VIEW, Calif. — The Food and Drug Administration has accepted a regulatory approval application for a drug made by Vivus for treating erectile dysfunction.

Vivus said it expected the Food and Drug Administration to complete its review of the application for avanafil by April 29, 2012.

"We are pleased with FDA’s acceptance of our NDA," Vivus president Peter Tam said. "If approved, avanafil could be a valuable treatment alternative for the 18 million men in the United States that suffer from ED."

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drjone says:
Dec-07-2011 02:20 pm

I personally do not see how this drug will not be approved. While the FDA makes the supreme judgment, there seems to be little apprehension in its overall efficacy and side effects. The short duration between ingestion and working of the drug seem very favorable compared to other PDE5 inhibitors currently on the market.
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GPhA names new president and CEO

BY Alaric DeArment

WASHINGTON — The Generic Pharmaceutical Association has named Ralph Neas as its new president and CEO, the group said Wednesday.

Neas, currently president and CEO of the National Coalition on Health Care, replaces Kathleen Jaeger, who stepped down as president and CEO of GPhA in May 2010 after eight years with the organization. The GPhA said it planned to spend September introducing Neas to stakeholders in a broad outreach effort.

"As those in Washington and across the country continue to look for savings in our healthcare system, it is clear that the greater use of generic medications is a safe and effective way to reduce costs while providing patients with the same quality care they have come to rely on," GPhA board chairman and Watson Pharmaceuticals president and CEO Paul Bisaro said. "Ralph is a proven national leader and consensus builder who has made a career out of working with Republicans and Democrats to forge coalitions that produce pragmatic compromises to advance the best interests of the country."

Neas has worked closely with the generic drug industry over the last three years, promoting generics as a way of saving money while he led the NCHC, and the GPhA will be working with the NCHC’s Cost Containment Alliance.

"I am honored to have been selected by GPhA to lead the association at such a critical time for the generic industry and for the nation," Neas said. "Generic medications have long established themselves as a vital component in lowering our country’s healthcare costs by providing patients with quality care at a lower cost."

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Safeway raises $10.4 million for Muscular Dystrophy Association

BY Allison Cerra

PLEASANTON, Calif. — After ending its five-week fundraising campaign to benefit the Muscular Dystrophy Association’s efforts to develop treatments and assist people coping with neuromuscular diseases, Safeway announced that its stores raised $10.4 million for the organization.

The campaign, which ran from Aug. 1 through Labor Day, marked Safeway’s 10th annual fundraising effort. Safeway has raised more than $58 million for muscular dystrophy charities.

"We are grateful to our customers and employees for their support and commitment to helping MDA find cures for some of the most debilitating diseases that face medical science," said Larree Renda, EVP and chair of the Safeway Foundation. "The funds we raised will support medical advances as well as services and therapies designed to help people with neuromuscular disease."

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