A Phase 2b study of Aradigm's inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchietasis has shown a significant reduction in Pseudomonas aeruginosa colony forming units per gram of sputum (CFUs) over a 28-day treatment period. The double blind ORBIT-1 (Once-Daily Respiratory Bronchiectasis Inhalation Treatment) study involved 95 patients in … [Read more...] about Positive results for Aradigm drug in bronchiectasis study
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Pearl heading into new Phase 2 studies for COPD combination inhaler
Pearl Therapeutics is advancing its PT003 combination inhaler for COPD, and the products individual components, into a new series of Phase 2 trials in patients with moderate-to-severe COPD. The individual compounds are PT001, glycopyrrolate, and PT005, their formoterol fumarate. The Phase 2 studies include randomized, double-blind studies of PT001 compared to … [Read more...] about Pearl heading into new Phase 2 studies for COPD combination inhaler
Lamellar gets orphan designation for inhaled CF drug
Lamellar Biomedical's LMS-611, an inhaled Lamellasome, an artificial lamellar body, for the treatment of patients with cystic fibrosis has received orphan drug designation from the European Commission. CF patients' lungs may be missing lamellar bodies that can serve as lubricants and surfactants. The company says that it has data showing that LMS-611 has "significant … [Read more...] about Lamellar gets orphan designation for inhaled CF drug
Mystic Pharmaceuticals receives patent for intranasal drug packaging technology
The “Deep Draw Container Forming Method” developed by Mystic Pharmaceuticals for packaging of intranasal drugs for use with its VersiDoser and VRx2 intranasal delivery systems has been awarded US Patent No. 7,963,089. Both delivery systems use the proprietary unit dose blister packaging. The VersiDoser uses liquid-filled blisters, while the VRx2 reconstitutes freeze … [Read more...] about Mystic Pharmaceuticals receives patent for intranasal drug packaging technology
Generex reboots buccal insulin spray development program
After receiving written guidance from the FDA in late May, says Generex, it has revised its development program for its Oral-lyn buccal insulin spray. A reorganized medical/regulatory group within the company will focus its efforts on providing information requested by the agency regarding the product's "preclinical, clinical, toxicology, manufacturing, and regulatory … [Read more...] about Generex reboots buccal insulin spray development program
BMJ article links Respimat inhaler to increased mortality
An article by Johns Hopkins researchers published in the BMJ, the British Medical Journal, suggests that patients using the Respimat tiotropium soft mist inhaler for the treatment of COPD are 52% more likely to die than those inhaling a placebo from a soft mist inhaler. "What we think is going on is that the mist inhaler is delivering a higher concentration of … [Read more...] about BMJ article links Respimat inhaler to increased mortality
Pfizer puts Sandwich site up for sale
The UK site where Pfizer has performed inhalation R&D is now on the market as "Discovery Park." The company announced the closing of the site, which employed 2400 people, in February 2011. Although a representative said, "The name Discovery Park reflects our hope that the site will continue, in part at least, to be a centre for research and development," the sales … [Read more...] about Pfizer puts Sandwich site up for sale
Teva begins shipping generic version of Nasacort AQ
According to Perrigo Company, which is partnered with Teva on a generic triamcinolone acetonide nasal spray, Teva has begun shipping the product. Perrigo developed the nasal spray, which is a generic equivalent of Sanofi's Nasacort AQ, and is manufacturing it. The US FDA approved the application for the product for the treatment of nasal symptoms resulting from … [Read more...] about Teva begins shipping generic version of Nasacort AQ
Hovione files patent for new DPI
Hovione has announced the filing of an international patent for its new XCaps dry powder inhaler. According to the company, the XCaps DPI is "a device which only requires two steps to inhalation and which only has two components plus a dust cover," and which it says can generate fine particle fractions greater than 70%. XCaps is available for license as part of … [Read more...] about Hovione files patent for new DPI
SPARC announces plans to launch new DPI
Sun Pharma Advanced Research Company (SPARC) has announced completion of Phase 3 studies for a new dry powder inhaler and its intention to launch a product based on the novel DPI in India by the end of the 2nd quarter of the fiscal year. In addition, the company said, it plans to file an IND in the US by the end of the fiscal year. The DPI delivers a dry powder … [Read more...] about SPARC announces plans to launch new DPI