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
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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
Freeman Technology wins Queen’s Award for Enterprise
Freeman Technology has won a 2012 Queen’s Award for Enterprise in the category of International Trade. The company previously won a Queen’s Award in the category of Innovation for its powder characterization technology. Managing Director Tim Freeman commented, "Freeman Technology’s first Queen’s Award in 2007 celebrated our development of the FT4 Powder Rheometer … [Read more...] about Freeman Technology wins Queen’s Award for Enterprise
CHMP issues positive opinion on flutiform
The EMA's Committee for Medicinal Products for Human Use ("CHMP") has issued a positive opinion on SkyePharma's MAA for its flutiform fluticasone propionate/formoterol fumarate MDI for the treatment of asthma. The MAA had been referred to CHMP after the concerned member states failed to reach consensus on the application. According to SkyePharma, the company … [Read more...] about CHMP issues positive opinion on flutiform
Synairgen announces positive Phase 2 results for inhaled interferon beta
UK-based Synairgen has announced positive data from a Phase 2 trial of its SNG001 inhaled interferon beta as protection against the common cold and other respiratory viral infections in asthma patients. According to the company, SNG001 showed statistically significant improvements compared to placebo in prevention of symptom worsening during the first week of … [Read more...] about Synairgen announces positive Phase 2 results for inhaled interferon beta
Mylan expands respiratory capabilities in Ireland
Mylan has announced that it will invest up to $100 million annually over a five-year period to add a total of 500 new jobs to its work forces in Dublin and Galway, Ireland by 2016. The investment includes funding for R&D and manufacturing in solid dose and injectables in addition to the respiratory area. Mylan currently employs approximately 700 people in Ireland at … [Read more...] about Mylan expands respiratory capabilities in Ireland
FivePrime to discover asthma/COPD compounds for GSK
Biologics discovery company Five Prime Therapeutics has announced a deal with GlaxoSmithKline giving GSK "exclusive access to FivePrime’s drug discovery platforms in up to six programs to identify first-in-class agents and new mechanisms relevant to refractory asthma and chronic obstructive pulmonary disease (COPD)." This is the second discovery deal between the two … [Read more...] about FivePrime to discover asthma/COPD compounds for GSK