Category Archives: Complete Response Letter

‘Fast’ Progress: Ampligen Activist Ends Hunger Strike

Robert Miller, the patient advocating for Hemispherx Biopharma Inc.’s Ampligen (rintatolimod) for chronic fatigue syndrome by going on a hunger strike in protest of the FDA’s complete response letter, ended the hunger strike over the weekend. Progress was made, he said,…

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He Said What?!?! Best Biotech Quotes of 2011

As BioWorld Insight readers know, our “Word on the Street” column provides a sample of the most entertaining and thought-provoking quotes our staff stumbles upon each week. Some are gathered during interviews, some gleaned from analyst reports, and some overheard…

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The Good, the Bad and . . . the Huh? A 2011 Biotech Recap

The past year brought the biotech sector a mixed bag of news. Some of it was positive – for instance, the FDA picked up its drug approval pace in 2011 and, in some cases, even surprised the most hardened biotech…

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Indecent Disclosure: The Press Release Balancing Act

Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news. Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on…

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