Medical Letter on the CDC & FDA
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Drug Development
Inhaled drug maker encouraged by U.S. FDA panel's decision on Exubera
October 23rd, 2005
BioSante Pharmaceuticals, Inc., (BPA) expressed encouragement by the U.S. Food & Drug Administration (FDA) advisory panel's recommended approval of Pfizer, Inc.'s Exubera inhaled insulin therapy, and noted superior results in preclinical studies with its own inhalable insulin delivery system. "The FDA Advisory Panel's recommended approval of Exubera is highly encouraging as we continue to develop our own inhaled insulin therapy," said Stephen M. Simes, president and chief executive officer of BioSante. "The most recent study found our aerosolized pulmonary insulin formulation offered equivalent insulin bioavailability compared to subcutaneous...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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