|Promising events now that the reverse split has taken place...|
Wednesday December 21, 8:00 am ET
Supply Chain Qualified and Commercial Manufacturing Line Fully Operational
HAYWARD, CA--(MARKET WIRE)--Dec 21, 2005 -- Aradigm Corporation (NasdaqNM:ARDM - News) today announced the completion of manufacturing of pivotal and clinical batches of its Intraject Sumatriptan product on its commercial-scale manufacturing line. With the successful transfer of technology and analytical methods to the company's Contract-Manufacturing Partners, final product release testing is currently underway and, pending partnering of the product, would be available for a pivotal bioequivalence trial in 2006.
Thursday January 5, 8:15 am ET
HAYWARD, CA--(MARKET WIRE)--Jan 5, 2006 -- Aradigm Corporation (NasdaqNM:ARDMD - News) today announced that it has filed a request for orphan drug designation with the United States Food and Drug Administration (FDA) for its liposomal ciprofloxacin product for the management of cystic fibrosis (CF).
Such designation provides a company with seven years of marketing exclusivity for a selected drug approved by the FDA along with regulatory assistance, reduced filing fees and possible tax credits.