ISTA Pharmaceuticals has announced results from a Phase 2 randomized, placebo-controlled, parallel-group environmental clinical study of its Beposone bepotastine besilate/steroid nasal spray for the treatment of seasonal allergic rhinitis. According to the company, the study showed that Beposone produced statistically significant improvements in nasal symptoms of … [Read more...] about Positive Phase 2 topline results for ISTA’s Beposone nasal spray
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Asmanex Twisthaler shortage
The FDA issued a drug shortage alert for the Asmanex Twisthaler 110 mcg mometasone furoate inhalation Powder, 30 inhalation units, as of April 26, 2012. According to the FDA web site, the shortage is due to manufacturing delays and the expected duration is unknown. The 110 mcg dose Asmanex Twisthaler is recommended for the treatment of asthma in children ages 4-11 … [Read more...] about Asmanex Twisthaler shortage
Team Consulting introduces new API-only dry powder inhaler technology
Team Consulting is introducing its new Occoris inhaler engine technology designed specifically for the delivery of API-only formulations for systemic therapies. The flexible Occoris system offers repeatable delivery of a wide range of dose sizes with no carrier necessary, Team says, facilitating pulmonary delivery of vaccines, analgesics, insulin, and other … [Read more...] about Team Consulting introduces new API-only dry powder inhaler technology
Aptar launches new capsule-based inhaler
Aptar Pharma has announced the launch of the Twister capsule-based dry powder inhaler. The new DPI is intended to provide a cost-effective dry powder alternative to metered dose inhalers (MDIs), especially in the third world, the company says, with the aim of permitting "a wider range of asthma sufferers to not only gain better access to medication but also become … [Read more...] about Aptar launches new capsule-based inhaler
Pharmaxis gets marketing authorization for bronchitol in Europe
The European Commission has granted marketing authorization to Pharmaxis for its Bronchitol mannitol inhalation powder for the treatment of cystic fibrosis in patients 18 and over. In October 2011, the CHMP adopted a positive opinion regarding approval of the drug after several prior negative opinions. The company will officially launch the product in Europe at … [Read more...] about Pharmaxis gets marketing authorization for bronchitol in Europe
Savara’s AeroVanc inhaled vancomycin well tolerated in Phase 1a study
Savara Pharmaceuticals has announced top-line data from a Phase 1a study of its AeroVanc vancomycin hydrochloride inhalation powder for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) infections in cystic fibrosis patients. According to the company, the study, which compared single ascending doses of AeroVanc with intravenous vancomycin in healthy … [Read more...] about Savara’s AeroVanc inhaled vancomycin well tolerated in Phase 1a study
SKBP licenses diazepam nasal spray to Hanmi
SK Biopharmaceuticals has licensed its diazepam nasal spray for an undisclosed amount to Seoul, Korea-based Hanmi Pharmaceuticals, giving Hanmi marketing rights for China and Korea. Hanmi expects to launch the nasal spray in Korea in 2013 and in China in 2015. In the US, SKBP licensed the product to Neuronex, which was acquired by Accorda earlier this year. SKBP … [Read more...] about SKBP licenses diazepam nasal spray to Hanmi
Novartis expected to file NDAs for QVA149 and NVA237 in 2014
According to Sosei, Novartis and the FDA have agreed on Phase 3 trial design for QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide, which should put the company on track to file an application for NVA237 early in 2014 and an application for QVA149 by the end of that year. Novartis licensed NVA 237 from Sosei and Vectura. Both Sosei and … [Read more...] about Novartis expected to file NDAs for QVA149 and NVA237 in 2014
MicroDose Therapeutx completes Phase 1 studies of inhaled antiviral fusion inhibitor for RSV
Two Phase 1 studies of MDT-637 inhaled antiviral fusion inhibitor for the treatment of RSV infection have demonstrated that the drug is well tolerated and causes no significant changes in lung function, MicroDose Therapeutx has announced. The double-blind, randomized, placebo-controlled dose-ranging studies also showed that MDT-637 reached the respiratory tract at … [Read more...] about MicroDose Therapeutx completes Phase 1 studies of inhaled antiviral fusion inhibitor for RSV
3MDDS expands pMDI manufacturing capacity
3M Drug Delivery Systems has announced an expansion of its pressurized metered dose inhaler (pMDI) manufacturing capacity at its Northridge, CA facility. The company is adding a pressure fill line to the existing cold fill line in the Northridge facility, which is one of four 3MDDS MDI filling sites worldwide. The company also announced the establishment of a … [Read more...] about 3MDDS expands pMDI manufacturing capacity