Belgian biopharmaceutical company Ablynx has announced positive results from a Phase 1 of its ALX-0171 inhaled Nanobody for the treatment of respiratory syncytial virus (RSV) infections. According to the company, the study demonstrated the safety and tolerability of ALX-0171 delivered by nebulizer. The double-blind, randomized trial tested six dose levels ranging … [Read more...] about Ablynx completes Phase 1 study of inhaled nanobody for RSV
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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
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
Rigel initiates Phase 2 study of inhaled SYK inhibitor for asthma
Rigel Pharmaceuticals says that it has begun a Phase 2 clinical study of its R343 nhaled SYK inhibitor that is being evaluated as a potential treatment for allergic asthma. The 8-week study, called SITAR (SYK Inhibition for Treatment of Asthma with R343), will compare two doses R343 and placebo in approximately 270 adult asthma patients and is expected to be completed … [Read more...] about Rigel initiates Phase 2 study of inhaled SYK inhibitor for asthma
Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair
Almirall has opened a new affiliate in Toronto, Canada. Having a presence in Canada will help the company roll out its recently approved aclidinium DPI for COPD, among other drugs, Almirall says. The company will co-market aclidinium as Tudorza Pressair with Forest Laboratories. In Europe, aclidinium bromide inhalers are being marketed as the Eklira Genuair and … [Read more...] about Almirall opens Canadian affiliate, presents positive Phase 3 results for Eklira Genuair
Study finds that inhaled budesonide for children reduces adult height
A study by the Childhood Asthma Management Program (CAMP) Research Group published online in the New England Journal of Medicine on September 3 finds that children who received 400 μg of inhaled budesonide daily for 4-6 years had a mean adult height 1.2 cm less than children who received placebo. The researchers obtained height measurements from 943 participants out … [Read more...] about Study finds that inhaled budesonide for children reduces adult height
FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
The FDA briefing materials for the September 5, 2012 meeting of the Anti-Infective Drugs Advisory Committee, which will consider the use of Novartis's Tobi tobramycin inhalation powder (TIP) for the treatment of P. aeruginosa infections in cystic fibrosis patients, question both the efficacy and safety of the product, especially when compared to TOBI tobramycin … [Read more...] about FDA questions for Novartis about Tobi Podhaler prior to advisory committee meeting
Positive Phase 3 results for QVA 149, filings expected by the end of the year
According to Novartis, the latest Phase 3 study of the QVA149 indacaterol/glycopyrronium DPI demonstrated a significant reduction in exacerbations of moderate-to-severe COPD compared to the Seebri Breezhaler glycopyrronium bromide DPI alone. The company says that it plans to submit regulatory filings in Europe and Japan by the end of 2012 and in the US at the end of … [Read more...] about Positive Phase 3 results for QVA 149, filings expected by the end of the year
Positive Phase 3 results for Inavir DPI to prevent flu
Daiichi Sankyo has announced positive Phase 3 results for its Inavir laninamivir octanoate hydrate dry powder inhaler as a prophylactic antiviral. According to the company, the study found that Inavir produced statistically significant reductions in influenza infection compared to placebo among household members in contact with patients infected with influenza A or B, … [Read more...] about Positive Phase 3 results for Inavir DPI to prevent flu
Positive Phase 2 results for Lightlake’s naloxone nasal spray
Lightlake Therapeutics has announced what it called "very encouraging preliminary results" from a Phase 2 clinical trial of its naloxone nasal spray for the treatment of binge eating disorder. According to the company, the randomized, double-blind, placebo controlled trial demonstrated a 56% greater reduction in the amount of time that patients who received the spray … [Read more...] about Positive Phase 2 results for Lightlake’s naloxone nasal spray