Shares of Tarrytown, NY-based Regeneron (NASDAQ: [[ticker:REGN]]) were down 4 percent in morning trading to $54.95 on news that the FDA has delayed its decision on the company’s macular degeneration drug by three months. The company had initially expected to hear by August 20 if the drug, called aflibercept (Eyelea), would be approved. But the FDA classified Regeneron’s recent responses to questions regarding the chemistry, manufacturing, and controls as a “major amendment” to the original approval application, according to a press release, and extended the date for a decision to November 18. The drug addresses a multibillion-dollar market and thus is expected to be Regeneron’s first major foray into the commercial pharmaceutical market.
Author: Arlene Weintraub
Arlene is an award-winning journalist specializing in life sciences and technology. She was previously a senior health writer based out of the New York City headquarters of BusinessWeek, where she wrote hundreds of articles that explored both the science and business of health. Her freelance pieces have been published in USA Today, US News & World Report, Technology Review, and other media outlets. Arlene has won awards from the New York Press Club, the Association of Health Care Journalists, the Foundation for Biomedical Research, and the American Society of Business Publication Editors. Her book about the anti-aging industry, Selling the Fountain of Youth, was published by Basic Books in September 2010.
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