Posts tagged: ciprofloxacin
Aradigm Receives FDA Orphan Drug Designation For Ciprofloxacin For Inhalation In Bronchiectasis
Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced it has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for ciprofloxacin for inhalation for the management of bronchiectasis (BE). Previously, Aradigm received orphan drug designations from FDA for liposomal ciprofloxacin for inhalation for the management of bronchiectasis ...
Aradigm Completes Enrollment In Phase 2b Study Of Inhaled Ciprofloxacin For The Management Of Respiratory Infections In Bronchiectasis
Aradigm Corporation (OTCBB:ARDM) announced the last patient was enrolled in a Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (CFI, ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE), a severe progressive respiratory disease for which there is currently no approved treatment in the U.S. BE is ...
Enrollment complete in Aradigm’s inhaled ciprofloxacin Phase 2b study in non-cystic fibrosis bronchiectasis
Aradigm Corporation announced the last patient was enrolled in a Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (CFI, ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE), a severe progressive respiratory disease for which there is currently no approved treatment in the U.S.
Aradigm to present Phase 1 studies of inhaled liposomal ciprofloxacin at 2010 ERS Congress
Aradigm Corporation today announced it is presenting data on September 22, 2010, from its Phase 1 studies at the ERS Annual Congress in Barcelona, Spain. The podium presentation elaborates on the pharmacokinetic parameters of ciprofloxacin in the blood and sputum samples that were observed in the healthy volunteers and non-cystic ...
Bayer HealthCare Pharmaceuticals’ ciprofloxacin DPI granted FDA orphan drug designation for CF treatment
Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration for ciprofloxacin dry powder inhaler for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis patients. A similar designation has already been granted by the European Medicines Agency.
FDA Grants Bayer HealthCare Pharmaceuticals Orphan Drug Designation for Investigational Ciprofloxacin Dry Powder Inhaler for the Treatment of Cystic Fibrosis
WAYNE, N.J. , March 11 /- Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A ...
Aradigm initiates dosing in Phase 2b trial of inhaled liposomal ciprofloxacin formulations in BE patients
Aradigm Corporation today announced that it dosed the first patient in the U.S. as part of its ORBIT-1 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial, an international, randomized, double-blind, placebo-controlled Phase 2b study designed to evaluate the Company's inhaled liposomal ciprofloxacin (ARD-3100) in patients with non-cystic fibrosis bronchiectasis (BE) under a ...
Aradigm Doses First Patient In Long-Term Phase 2 Study Of A Novel Inhaled Ciprofloxacin Formulation For The Management Of Respiratory Infections
Aradigm Corporation (OTCBB:ARDM) (the "Company") announced that the first patient was dosed in a 6-month, multicenter, international Phase 2 clinical trial of a novel version of inhaled ciprofloxacin (ARD-3150) in 40 adult patients with non-cystic fibrosis bronchiectasis. The randomized, double-blind, placebo-controlled trial will be conducted in Australia and ...
Aradigm Receives Orphan Drug Designation For Inhaled Liposomal Ciprofloxacin To Treat Cystic Fibrosis In Europe
Aradigm Corporation (OTCBB:ARDM) (the "Company") announced yesterday that the European Medicines Agency (EMEA) granted Orphan Drug Designation to the Company's inhaled liposomal ciprofloxacin drug product candidate for the treatment of lung infections associated with cystic fibrosis ("CF").