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GSK says “totality of the data” gives it confidence to submit applications for Relovair

GlaxoSmithKline and Theravance have announced the completion of Phase 3 studies of their Relovair fluticasone furoate/vilanterol DPI for COPD. One Phase 3 study for the treatment of asthma remains to be completed. Despite the fact that the studies failed to produce statistically significant improvements in a number of measures, GSK says that it will submit … [Read more...] about GSK says “totality of the data” gives it confidence to submit applications for Relovair

Phase 2 study of ISTA’s bepotastine-steroid nasal spray begins

ISTA Pharmaceuticals says that it has initiated a Phase 2 study of its Beposone bepotastine besilate/steroid combination nasal spray for the treatment of seasonal allergic rhinitis. Approximately 600 patients with allergic rhinitis caused by mountain cedar pollen are expected to take part in the randomized, placebo-controlled, parallel-group environmental study, which … [Read more...] about Phase 2 study of ISTA’s bepotastine-steroid nasal spray begins

Pulmatrix says iSperse data show superiority over lactose blends for DPIs

Pulmatrix has presented data at the 11th US-Japan Symposium on Drug Delivery Systems in Hawaii that it says demonstrate the superiority of its iSPERSE inhalation platform over lactose formulations for combination dry powder inhalers. The iSPERSE technology makes use of a "delivery matrix containing proprietary cationic salt formulations" that allows for increased … [Read more...] about Pulmatrix says iSperse data show superiority over lactose blends for DPIs

Intranasal norovirus vaccine capable of reducing infection

An article published in the December 8, 2011 issue of the New England Journal of Medicine describes a proof of principle study in which an intranasal dry powder vaccine significantly reduced Norwalk virus gastroenteritis and infection in study participants innoculated with Norwalk virus. LigoCyte Pharmaceuticals created the vaccine from virus-like particles since … [Read more...] about Intranasal norovirus vaccine capable of reducing infection

Daily low dose budesonide inhalation not superior to intermittent high dose treatment in young children

According to a study published in the November 24 issue of the New England Journal of Medicine, intermittent administration of a high dose of inhaled budesonide resulted in no more exacerbations over the course of a year in young children with asthma than daily inhalation of a low dose, and the intermittent regimen resulted in significantly lower budesonide exposure. … [Read more...] about Daily low dose budesonide inhalation not superior to intermittent high dose treatment in young children

Single batch of Omnaris nasal spray recalled in Hong Kong

According to the Hong Kong Department of Health (DH), Nycomed (Hong Kong) has voluntarily recalled a batch of Omnaris ciclesonide nasal spray due "a quality defect." The product, from batch number 137930, was manufactured in Germany by Nycomed Gmbh in August 2010. The DH says that it was notified by Nycomed Gmbh that it had found pinholes in some of the foil … [Read more...] about Single batch of Omnaris nasal spray recalled in Hong Kong

Almirall and Forest initiate Phase 3 trial of aclidinium/formoterol DPI

Two Phase 3 studies to evaluate the safety of twice daily doses of a fixed dose combination dry powder formulation of aclidinium bromide and formoterol fumarate in 3,500 patients with moderate to severe COPD have been initiated by Almirall and its US partner, Forest Laboratories. The 24-week studies are taking place in Europe and North America, along with a 52-week … [Read more...] about Almirall and Forest initiate Phase 3 trial of aclidinium/formoterol DPI