Novartis has launched its once-daily Arcapta Neohaler indacaterol inhalation powder 75 mcg for the maintenance treatment of COPD in the US. The FDA approved the indacaterol product at the 75 mcg level in July 2011 but rejected higher doses. The agency explained its reasoning in an article in the New England Journal of Medicine in December 2011. In Europe, where … [Read more...] about Novartis launches the Arcapta Neohaler in the US
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Omega Pharma acquires Beconase nasal spray from GSK
Belgian over the counter (OTC) specialist Omega Pharma has acquired several OTC products from GSK, including Beconase beclomethasone nasal spray. The deal, which also includes brands Lactacyd, Abtei, Solpadeine, Zantac, and Nytol totaled €470 million in cash. GSK CFO Simon Dingemans commented, "The divestment of our non-core brands in Europe builds on the recent … [Read more...] about Omega Pharma acquires Beconase nasal spray from GSK
Argenta to provide respiratory modeling service to AstraZeneca
AstraZeneca has entered into a multi-year agreement with Galapagos subsidiaries BioFocus and Argenta to collaborate on discovery of compounds for the treatment of respiratory and inflammatory diseases. The deal allows AstraZeneca the use of Argenta's respiratory models, including those for asthma, COPD, and inflammation. The companies did not disclose the financial … [Read more...] about Argenta to provide respiratory modeling service to AstraZeneca
Alexza reports loss of $40.5 million for 2011, reworks agreement with Grupo Ferrer
Alexza Pharmaceuticals, whose lead product, Adasuve Staccato loxapine is under review by the FDA and the EMA, has reported a net loss of $40.5 million for the year ended December 31, 2011. The company also announced that Grupo Ferrer, its partner on Adasuve in Europe and Latin America, has purchased stock in Alexza in lieu of a potential future milestone payment. … [Read more...] about Alexza reports loss of $40.5 million for 2011, reworks agreement with Grupo Ferrer
Nycomed launches Omnaris nasal spray in the Middle East
Nycomed says that it is now marketing its Omnaris ciclesonide nasal spray for the treatment of allergic rhinitis in the United Arab Emirates (UAE). The company, a subsidiary of Takeda, says that it will launch Omnaris in other Middle East countries by the end of 2012. According to a recent survey sponsored by Nycomed, allergic rhinitis affects over a third of UAE … [Read more...] about Nycomed launches Omnaris nasal spray in the Middle East
Aradigm gets FDA clearance for Phase 3 trial of Pulmaquin
The FDA has cleared Aradigm's Investigational New Drug Application (IND) for a Phase 3 clinical trial of Pulmaquin dual release ciprofloxacin for inhalation in non-cystic fibrosis bronchiectasis. The Phase 3 program include two one-year placebo-controlled trials with 250 patients each. The company announced plans for the trials in December, 2011. Aradigm President … [Read more...] about Aradigm gets FDA clearance for Phase 3 trial of Pulmaquin
Hovione hires Colin Minchom as VP of its particle design business unit
Hovione has appointed Colin Minchom, formerly Patheon's VP of Pharmaceutical Development Services for North America, as VP of its Particle Design Business Unit. Minchom has almost 30 years experience in drug development, especially in dosage forms and delivery, and is a member of the USP expert committee on small molecules. He is also chair of the planning committee … [Read more...] about Hovione hires Colin Minchom as VP of its particle design business unit
Teva’s ProAir HFA MDI with dose counter approved by FDA
The FDA has approved Teva's ProAir HFA albuterol metered dose inhaler with a dose counter for the treatment and prevention of bronchospasm in patients 4 years of age and older. According to the company, the new product will be available by the end of 2012. Teva Global Respiratory Research and Development Senior VP Tushar Shah explained: “The dose counter is … [Read more...] about Teva’s ProAir HFA MDI with dose counter approved by FDA
Hi-Tech Pharmacal acquires line of homeopathic nasal sprays
Specialty pharmaceutical manufacturer Hi-Tech Pharmacal will pay a total of $2.5 million plus up to to $1.75 million in royalties to Dynova Laboratories for a line of homeopathic nasal sprays including the Sinus Buster and Allergy Buster brands, which Hi-Tech will sell through its Health Care Products OTC division. The Sinus Buster formulation includes capsaicin, and … [Read more...] about Hi-Tech Pharmacal acquires line of homeopathic nasal sprays
FDA issues warning letter on inhalable caffeine
The FDA has issued a warning letter to Breathable Foods, the manufacturer of AeroShot inhalable caffeine for "false or misleading statements in the labeling of their product." The agency is also questioning the safety of the inhaler, including the possibility that users may inhale the formulation into their lungs, that children will use the product, and that AeroShot … [Read more...] about FDA issues warning letter on inhalable caffeine