According to GlaxoSmithKline, the company has submited a new drug application (NDA) to the US FDA for a once-daily fluticasone furoate (FF) dry powder inhaler for the treatment of asthma. The NDA is for 100mcg and 200mcg doses of FF delivered by the Ellipta DPI. The FDA approved GSK and Theravance's Breo Ellipta fluticasone furoate/vilanterol DPI for the treatment … [Read more...] about GSK submits NDA for fluticasone furoate DPI
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Adasuve inhaled loxapine launched in Austria
Alexza Pharmaceuticals and Grupo Ferrer have launched Adasuve loxapine inhalation powder for the treatment of agitation in schizophrenic patients in Austria, the companies said. Ferrer is working with Vienna-based AOP Orphan Pharmaceuticals to commercialize Adasuve in Austria. Alexza President and CEO Thomas B. King commented, "With the launch of Adasuve in … [Read more...] about Adasuve inhaled loxapine launched in Austria
Settlement in Accuhale suit against AstraZeneca
Acacia Research has announced a settlement in its patent infringement suit against AstraZeneca. The suit, Accuhale vs. AstraZeneca, was filed in December 2011, shortly after Acacia announced that it had acquired patents for inhaler technology from “a major medical company.” No terms were disclosed. The suit claimed that AstraZeneca's Symbicort pMDI infringed on US … [Read more...] about Settlement in Accuhale suit against AstraZeneca
Puget Technologies says it will develop intranasal cannabinoids
Florida-based Puget Technologies has announced that its subsidiary Cannabis Biotech has initiated a research project to develop an intranasal formulation of cannabinoids, saying that the "project is targeted towards those who desire the benefits of medical marijuana but do not want the harmful effects or stigma of smoking it." The company said that the project will be … [Read more...] about Puget Technologies says it will develop intranasal cannabinoids
Coster to provide MDI filling line for Catalent
Aerosol component and filling specialist Coster has announced that it will develop and construct a 150 can/minute MDI filling line for Catalent Pharma Solutions's Inhalation Center of Excellence in Research Triangle Park, NC. Catalent announced a $20 million expansion of its inhalation capabilities at the RTP center in January 2013. According to Coster, the line will … [Read more...] about Coster to provide MDI filling line for Catalent
Striverdi Respimat approved in the EU
Boehringer Ingelheim has announced the approval of Striverdi Respimat olodaterol SMI for the treatment of COPD in the United Kingdom, Denmark and Iceland, noting that additional approvals in EU countries "will follow in due course." Boehringer Ingelheim Corporate Senior VP Medicine Klaus Dugi commented, "The improvements in lung function and quality of life seen … [Read more...] about Striverdi Respimat approved in the EU
Discovery Labs submits IND for Aerosurf
Discovery Laboratories has submitted an investigational new drug (IND) application for its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants, the company has announced. Assuming the FDA review proceeds without objection, the company says, enrollment in a planned Phase 2 study could be initiated in the 4th … [Read more...] about Discovery Labs submits IND for Aerosurf
Savara gets $1.7 million for AeroVanc development
Cystic Fibrosis Foundation Therapeutics (CFFT) has awarded Savara Pharmaceuticals $1.7 million for further development of AeroVanc inhaled vancomycin for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) lung infection in cystic fibrosis patients. CFFT is a nonprofit affiliate of the Cystic Fibrosis Foundation that supports discovery and development … [Read more...] about Savara gets $1.7 million for AeroVanc development
Insmed provides update on Arikace for NTM
Insmed has announced that it anticipates discussions with the EMA by the end of 2013 regarding Arikace inhaled liposomal amikacin for the treatment of nontuberculous mycobacterial (NTM) lung disease and that it has already initiated the Scientific Advice Working Party (SAWP) process. The company says that it is also looking to take advantage of a "globally … [Read more...] about Insmed provides update on Arikace for NTM
Dance Biopharm to partner with Harmony Asset for inhaled insulin
Under a new joint venture, Harmony Asset will pay development costs for Dance Biopharm's Adagio inhaled insulin in Asian countries, including Korea, India, Indonesia and Australia, Dance has announced. The agreement excludes Japan. Harmony will have majority ownership of the joint venture, and the board of directors will be comprised of an equal number of … [Read more...] about Dance Biopharm to partner with Harmony Asset for inhaled insulin