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
News
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
Positive results for Vectura inhaled heparin formulation
Vectura's VR496, an inhaled dry powder formulation of heparin sodium, has produced positive results in a Phase 2 study in cystic fibrosis patients, says the company. The product has received orphan drug status from both the EMA and the FDA. The study involved 77 CF patients, with 90% completing the 4-week treatment period. Patients treated with VR496 experienced … [Read more...] about Positive results for Vectura inhaled heparin formulation
Study shows tiotropium better than salmeterol for preventing COPD exacerbations
Results from the Prevention Of Exacerbations with Tiotropium in COPD (POET-COPD) study published in the New England Journal of Medicine show a significant reduction in exacerbations for COPD patients treated with tiotropium compared to those treated with salmeterol. The one-year study involved almost 7400 patients with moderate to severe COPD, half of whom were … [Read more...] about Study shows tiotropium better than salmeterol for preventing COPD exacerbations
FDA extends review period for QAB149 (indacaterol)
The FDA has informed Novartis that it needs a three-month extension for its review of data supporting the company's NDA for QAB149 (indacaterol). The new completion date for the review would be July 2011. The agency's Pulmonary-Allergy Drugs Advisory Committee (PADAC) recently voted in favor of approving a 75 mcg dose of the drug but against approval of a 150 mcg … [Read more...] about FDA extends review period for QAB149 (indacaterol)