NVA237, a once daily, long acting muscarinic agent (LAMA) DPI for the treatment of COPD, met its primary endpoint of improved bronchodilation compared to placebo after 12 weeks. The glycopyrronium bromide dry powder formulation was licensed to Novartis by Sosei and Vectura in 2005. Novartis announced the results in its first quarter 2011 earnings report, along … [Read more...] about NVA237 meets primary endpoint in Phase 3 study
News
Axcan to acquire Mpex and its inhaled levofloxacin
European specialty pharma company Axcan will acquire Mpex Pharmaceuticals and its lead candidate, Aeroquin levofloxacin inhalation solution for the treatment of Pseudomonas aeruginosa infections in CF patients, which is currently in Phase 3 trials. Axcan plans to complete development of Aeroquin itself and spin off Mpex's other assets into a separate company. Mpex … [Read more...] about Axcan to acquire Mpex and its inhaled levofloxacin
New date for MannKind end-of-review meeting
The FDA has rescheduled its end-of-review meeting with MannKind Corporation regarding Afrezza inhaled insulin for May 4, 2011. The agency had earlier cancelled the meeting, which had been scheduled for April 15, due to a potential government shutdown. At one time, the FDA had planned to complete its review by December 29, 2010 but requested additional time to … [Read more...] about New date for MannKind end-of-review meeting
Research shows intranasal vaccination with IL-12 highly effective
Dennis Metzger of Albany Medical College (Albany, New York) has presented research at the Society for General Microbiology Spring Conference demonstrating the effectiveness of using interleukin-12 (IL-12) in combination with intranasally-delivered vaccines to boost immune response. The study tested the effectiveness of these vaccines in mice against influenza virus, … [Read more...] about Research shows intranasal vaccination with IL-12 highly effective
Almirall announces that it will start clinical program on new COPD drug
By mid-2012, Almirall plans to begin clinical studies on a new inhaled drug for the treatment of COPD called LAS190792, the company has announced. The drug is a dry powder formulation of a dual, long-acting Muscarinic Antagonist β2 Agonist (MABA). The product will be Almirall's third inhalation drug developed in its Genuair multi-dose DPI. A statement from the … [Read more...] about Almirall announces that it will start clinical program on new COPD drug
TOBI Podhaler gets market authorization in Canada
Novartis Canada has announced that it has received a Notice of Compliance from Health Canada for its TOBI Podhaler tobramycin DPI for the treatment of Pseudomonas aeruginosa infections in cystic fibrosis patients. The product has been approved for CF patients aged six and older. The TOBI Podhaler has had orphan drug designation in the EU since 2003. According to … [Read more...] about TOBI Podhaler gets market authorization in Canada
Pfizer sells Capsugel to KKR
Kohlberg Kravis Roberts & Co (KKR) will buy Pfizer's Capsugel business for just under $2.4 billion. In addition to its Vcaps hydroxypropyl methyl cellulose (HPMC) capsules for dry powder inhalation products, Capsugel also manufactures the Xcelodose micro-dosing systems, used for filling DPI capsules. Capsugel's corporate headquarters will remain in New Jersey, and … [Read more...] about Pfizer sells Capsugel to KKR
Meda submits NDA for Dymista
Soon after announcing positive Phase 3 results for Dymista and saying that it would file an NDA for the product by mid-2011, Meda announced that it has gone ahead with the filing. Dymista is a fixed combination azelastine hydrochloride and fluticasone propionate nasal spray for the treatment of seasonal allergic rhinitis. In the most recent announcement, Meda has … [Read more...] about Meda submits NDA for Dymista
Biota gets US government contract for inhaled laninamivir
The Office of Biomedical Advanced Research and Development Authority (BARDA), an agency within the US Department of Health and Human Services under the Office of the Assistant Secretary for Preparedness and Response, has awarded a $231 million contract to Australian drug development company Biota for development of a laninamivir dry powder inhaler. The product, called … [Read more...] about Biota gets US government contract for inhaled laninamivir
Dymista 40% better than fluticasone alone in Phase 3 study
According to Meda Pharmaceuticals, a Phase 3 trial has shown that its Dymista nasal spray, a combination formulation of azelastine hydrochloride and fluticasone propionate, produced a 40% greater improvement in nasal symptoms than fluticasone alone. Meda is presenting the results at the 2011 annual meeting of the American Academy of Asthma, Allergy and Immunology … [Read more...] about Dymista 40% better than fluticasone alone in Phase 3 study