Healthcare Biz Roundup: Hemispherx’s New drug APPLICATION, Regulus PARTNERS With AstraZeneca

Shares of Hemispherx Biopharma, Inc. (AMEX:HEB) jump on word that the FDA has accepted the company’s complete response submission for its New Drug Application for Ampligen, which treats Chronic Fatigue Syndrome. The agency set a user-fee date of Feb. 2nd of next year, which indicates a possible approval decision by then.

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Rosetta Genomics Ltd. (NASDAQ:ROSG) has won Frost & Sullivan’s 2012 North American Next Generation Diagnostics Entrepreneurial Company of the Year Award for its endeavors with cancer biomarkers and micro-RNA-based diagnostics.

Regulus Therapeutics partners in a strategic alliance with AstraZeneca Group plc (NYSE:AZN) through which to discover, develop, and commercialize microRNA therapeutics for three exclusive targets that are currently in pre-clinical development. The targets concentrate upon cardiovascular and metabolic diseases and oncology. Through the agreement, the latter firm will make an equity investment and an upfront payment to Regulus.

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