Health & Fitness
Fri, October 15, 2010Thu, October 14, 2010Wed, October 13, 2010Tue, October 12, 2010Mon, October 11, 2010Sun, October 10, 2010Sat, October 9, 2010Fri, October 8, 2010Thu, October 7, 2010Wed, October 6, 2010Tue, October 5, 2010Mon, October 4, 2010Sun, October 3, 2010Fri, October 1, 2010Thu, September 30, 2010Wed, September 29, 2010Tue, September 28, 2010Mon, September 27, 2010Sun, September 26, 2010Sat, September 25, 2010Fri, September 24, 2010Thu, September 23, 2010Human Genome Sciences Receives Complete Response Letter from FDA on ZALBINa" BLA for Chronic Hepatitis C
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Published in Health and Fitness on Tuesday, October 5th 2010 at 11:06 GMT by Market Wire🞛 This publication is a summary or evaluation of another publication
ROCKVILLE, Md.--([ BUSINESS WIRE ])--Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced that, as expected, it has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Companya™s Biologics License Application (BLA) for 900-mcg ZALBINa" (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. HGS and Novartis have decided not to develop ZALBIN further.
HGS, Human Genome Sciences and ZALBIN are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciencesa™ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of Human Genome Sciencesa™ unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials and regulatory approvals, Human Genome Sciencesa™ ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, Human Genome Sciencesa™ dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Companya™s filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of todaya™s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.