Boehringer Ingelheim has launched the Combivent Respimat ipratropium bromide/albuterol soft mist inhaler for the treatment of COPD in the United States. The Combivent Respimat includes enough doses for 30 days, compared to the Combivent MDI, which provides only enough medication for 25 days of treatment. The Combivent MDI, which uses a CFC propellant, will be … [Read more...] about Combivent Respimat soft mist inhaler now available in US
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Pulmatrix gets funding from Cystic Fibrosis Foundation Therapeutics for development of PUR118
Cystic Fibrosis Foundation Therapeutics (CFFT) will provide up to $1.4 million to Pulmatrix to support Phase 1b trials of Pulmatrix's lead candidate, PUR118, for the treatment of CF. The collaboration between the nonprofit affiliate of the Cystic Fibrosis Foundation and Pulmatrix also includes "introductions to world-class cystic fibrosis academic researchers and … [Read more...] about Pulmatrix gets funding from Cystic Fibrosis Foundation Therapeutics for development of PUR118
Pearl Therapeutics completes Phase 2b study of glycopyrrolate MDI
Pearl Therapeutics says that it has completed a Phase 2b dose-ranging study of its PT001 glycopyrrolate (GP) metered dose inhaler in patients with moderate-to-severe COPD. The randomized, double-blind study included 6 doses from 18 µg to 600 ng twice daily. According to Pearl, it will present data from its dose-ranging studies of PT001 at "appropriate medical … [Read more...] about Pearl Therapeutics completes Phase 2b study of glycopyrrolate MDI
New CEO for Insmed
Arikace developer Insmed Incorporated has appointed Will Lewis, co-founder of Aegerion Pharmaceuticals, to succeed Tim Whitten as President and Chief Executive Officer. According to the company, Whitten has resigned from the board of directors as well, and Lewis will join the board. Donald J. Hayden, Jr., who was appointed Executive Chairman earlier this year, … [Read more...] about New CEO for Insmed
Perrigo files ANDA for albuterol MDI, Teva sues for patent infringement
Teva has filed a lawsuit in the US District Court for the District of Delaware against Perrigo and Catalent after Perrigo filed an ANDA for a generic version of Teva's ProAir HFA albuterol sulfate MDI. The suit alleges infringement of US patents 7,566,445 (Medicinal aerosols and methods of delivery thereof) and 7,105,152 (Suspension aerosol formulations). The '445 … [Read more...] about Perrigo files ANDA for albuterol MDI, Teva sues for patent infringement
Civitas Therapeutics appoints Bryan Stuart as Chief Business Officer
Civitas Therapeutics has appointed Bryan Stuart as Chief Business Officer. Civitas, which was spun off from Alkermes, is developing carrier-free inhaled drugs based on its ARCUS particle engineering platform and inhaler. The company's lead candidate is CVT-301 inhaled L-dopa for the treatment of Parkinson's disease. Civitas CEO Glenn Batchelder said, “We are very … [Read more...] about Civitas Therapeutics appoints Bryan Stuart as Chief Business Officer
FDA committee recommends approval of tobramycin inhalation powder
The Anti-Infective Drugs Advisory Committee (AIDAC) of the FDA voted 13 to 1 in favor of approval of Novartis's tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa-infected cystic fibrosis patients six years old and older. Briefing materials for the meeting had questioned the safety and efficacy of TIP and whether it had any advantages compared to … [Read more...] about FDA committee recommends approval of tobramycin inhalation powder
FDA approves Apotex azelastine nasal spray
The FDA has approved a generic equivalent to Meda's Astepro, an azelastine nasal spray, 0.1876MG, manufactured by Apotex. Meda filed a patent infringement suit in January 2012 after Apotex submitted its ANDA. The two companies settled after a similar suit regarding Apotex's generic version of Astelin in 2008. View the FDA approval history. … [Read more...] about FDA approves Apotex azelastine nasal spray
Tiotropium plus olodaterol improve lung function in Phase 2 study
According to Boehringer Ingelheim, a combination of tiotropium and olodaterol delivered using the Respimat soft mist inhaler significantly improved 24-hour FEV1 in COPD patients compared to olodaterol monotherapy at all doses tested. The 4-week double-blind study with 232 COPD patients testing doses of tiotropium of 1.25, 2.5, and 5 μg with either 5 μg or 10 μg of … [Read more...] about Tiotropium plus olodaterol improve lung function in Phase 2 study
Aradigm gets new method of treatment patent for nicotine inhaler
The United States Patent and Trademark Office has issued a method of treatment patent to Aradigm for its inhaled nicotine formulations. US Patent No. 8,256,433, for Systems and Methods for Effecting Cessation of Tobacco Use, provide exclusivity for the systems until January 7, 2024. Aradigm President and CEO Igor Gonda commented, “Tobacco smoking remains an … [Read more...] about Aradigm gets new method of treatment patent for nicotine inhaler