Healthcare Biz Report: Sarepta FILES Sales Agreement, Salix’ FDA Ruling Delayed

Sarepta Therapeutics (SRPT) has filed with the Securities and Exchange Commission an at-the-market equity offering sales agreement with Citadel Securities to sell up to $40 million of its common stock.

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Celgene Corporation (NASDAQ:CELG) owns 16 percent in GlobeImmune, and intends to raise as much as $65 million in an initial public offering, by selling 5 million shares at between $11 and $13. The biotech GlobeImmune develops treatments for cancer and infectious diseases based on its Tarmogen platform and holds a partnership with Gilead along with Celgene.

Johnson & Johnson’s (NYSE:JNJ) Janssen Research & Development division, which is a part of the Janssen Pharmaceutical Companies of Johnson & Johnson, says that the FDA has granted Priority Review to the New Drug Application (submitted June 29th) for bedaquiline to treat pulmonary, multi-drug resistant tuberculosis in adults as part of combination therapy. This designation is granted to medicines that might offer major advances in care, or supply a treatment option in cases for which no adequate therapy exists. Through guidelines of the Prescription Drug User Fee Act, the agency will drive to finalize its review within six months of the NDA submission.

A ruling on Salix Pharmaceuticals, Ltd.’s (NASDAQ:SLXP) crofelemer drug for for the treatment of HIV-related diarrhea, has been put on hold by the FDA until the end of the first quarter of 2013. Discussions between Salix and the FDA are currently concentrating on the output and control of the crofelemer active pharmaceutical ingredient.

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