FDA Update and Applications Awaiting Approval (CTIC NSPH, AUXL)
Cell Therapeutics, Inc. (Public, NASDAQ:CTIC) recently released their second quarter figures for 2009 and stated it was a transforming quarter for the company, in which they eliminated 44.5% of their outstanding debt. They also released data on their latest drug at the American Society of Clinical Oncology Annual Meeting and have also completed their submission of the New Drug Application to the U.S. Food and Drug Administration.
The data presented was, phase III results in June that were hopeful and now the announcement on August 24, 2009 the CTIC Company has secured funding to complete the pre-clinical trials for their drug Pixantrone to treat refractory aggressive non-Hodgkin’s Lymphoma.
In other biotech news, Auxilium Pharmaceuticals, Inc. (Public, NASDAQ:AUXL) filed the Biologics License Application for their drug to treat Dupuytrent’s contracture called XIAFELEX in February, and are awaiting their date of August 28, 2009 by the Prescription Drug User Fee Act. This new medication will battle the progressive disease of connective tissue that lies beneath the skin in the palm causing fingers to contract. The only option till now has been surgery to correct the contracted fingers of people suffering from Dupuytrent’s contracture.
Nanosphere, Inc. (Public, NASDAQ:NSPH) has announced that they have submitted a 510(k) application to the FDA for their influenza and respiratory syncytial virus test (RSV), complete with sample to result automation. The company believes this will have a greater sensitivity than the rapid tests that are currently available and will combine ease of use with a faster turnaround time.
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FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA – Based on the user fee goal date – April 23, if pixantrone is approved, CTIC estimates that pixantrone could be available to patients in the U.S. early in the second quarter of 2010.