OINDP testing specialist NextBreath has successfully completed an evaluation by the World Health Organization (WHO) Performance Quality System (PQS) as a testing facility for nasal spray vaccine administration. The company is now accredited to perform analytical testing of PQS products, making it one of only two accredited labs in the US and one of only eleven … [Read more...] about Next Breath now a WHO PQS accredited facility for nasal spray vaccine testing
News
Ablynx extends its alliance with Boehringer Ingelheim
Belgian biopharmaceutical company Ablynx has announced that Boehringer Ingelheim will extend funding for discovery, development, and commercialization of Ablynx's Nanobody therapeutics for an additional two years, until September 2014. One of the Ablynx programs ALX-0171, which began Phase 1 trials in December 2011, is an inhaled therapy for respiratory syncytial … [Read more...] about Ablynx extends its alliance with Boehringer Ingelheim
Astepro nasal spray approved in Europe
Meda has announced that its Astepro azelastine nasal spray for the treatment of allergic rhinitis has received registration approval in Europe through the centralized procedure and that it will now begin the national registration processes in individual countries in anticipation of a 2013 launch. Earlier this year, Meda filed suit against Apotex and Perrigo in the US … [Read more...] about Astepro nasal spray approved in Europe
Inhaled gene therapy for CF study gets funding
A £3.1 million grant from the UK National Institute for Health Research (NIHR) and the Medical Research Council (MRC) will fund a gene therapy study in which 130 children and adults with cystic fibrosis will receive either an inhaled placebo or inhaled DNA delivered using lipids. The UK Cystic Fibrosis Gene Therapy Consortium (GTC) is coordinating the trial. The GTC … [Read more...] about Inhaled gene therapy for CF study gets funding
Novartis launches the Arcapta Neohaler in the US
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
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