Insmed says that it is pleased with results from its ongoing CLEAR-110 extension study of Arikace inhaled liposomal amikacin for the treatment of P. aeruginosa infections in cystic fibrosis patients. Data from 98 patients who completed the first year of the two-year study showed that Arikace was well tolerated, the company said, and patients experienced continued … [Read more...] about Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients
Medical
Another recall of acetylcysteine inhalation solution
Ben Venue Laboratories has voluntarily recalled a single lot of 30 ml vials of acetylcysteine 10% inhalation solution due to a glass particle visible in one of the vials. The recall affects lot #2005479 which has an expiration date of March 2014. According to Ben Venue, "There have been no complaints or adverse events related to a piece of glass in vials of this … [Read more...] about Another recall of acetylcysteine inhalation solution
Chattem launches Nasacort Allergy 24HR nasal spray in US
Sanofi US consumer healthcare division Chattem has announced that Nasacort Allergy 24HR Nasal Spray is now available over the counter in the United States. The FDA approved the triamcinolone acetonide nasal spray as an OTC treatment for allergies in October 2013. Chattem CEO Zan Guerry commented, “Now that Nasacort Allergy 24HR is available over-the-counter, the … [Read more...] about Chattem launches Nasacort Allergy 24HR nasal spray in US
Phase 2 study of Prosonix drug-only glycopyrronium MDI produces positive results
Prosonix has announced that a Phase 2 clinical study of its PSX1002 glycopyrronium bromide MDI in 37 COPD patients demonstrated statistically significant improvement in lung function compared to placebo for a range of doses. PSX1002 is a drug-only suspension formulation created using Prosonix's proprietary particle engineering technology. The study also showed … [Read more...] about Phase 2 study of Prosonix drug-only glycopyrronium MDI produces positive results
Positive Phase 2b results for Evoke intranasal gastroparesis drug
Evoke Pharma has published a Phase 2b study demonstrating superior efficacy of intranasal metoclopramide compared to oral metoclopramide for the management of diabetic gastroparesis symptoms. The study appears in an upcoming issue of Neurogastroenterology & Motility and appears online ahead of publication. The six-week open-label, parallel design study involved 89 … [Read more...] about Positive Phase 2b results for Evoke intranasal gastroparesis drug
Vivaldi and NIAID sign agreement on intranasal flu vaccine
Vivaldi Biosciences has signed an agreement with the NIH's National Institute of Allergy and Infectious Diseases (NIAID) for co-research and development of live attenuated influenza vaccine (LAIV) candidates against the H7N9 strain of influenza A. The company says that it and NIAID will work together to create LAIVs using H7N9 genes inserted into Vivaldi's master … [Read more...] about Vivaldi and NIAID sign agreement on intranasal flu vaccine
More approvals for AirFluSal Forspiro
Sandoz has announced that it received marketing authorization for the AirFluSal Forspiro salmeterol/fluticasone DPI for the treatment of asthma and COPD from Sweden and Hungary. The company's version of Advair has also been approved by Denmark and Germany in the past month. Sweden approved both the 50-500µg and 50-250µg dosage forms, while Hungary approved only … [Read more...] about More approvals for AirFluSal Forspiro
Iliad Biotechnologies to collaborate with French organizations on intranasal pertussis vaccine
Iliad Biotechnologies has licensed technology from Institut Pasteur de Lille, Inserm, National University of Singapore, and National University of Ireland Maynooth related to a live attenuated Bordetella pertussis vaccine, and the company says that it will work with the French National Institute of Health and Medical Research's subsidiary Inserm Transfert and Institut … [Read more...] about Iliad Biotechnologies to collaborate with French organizations on intranasal pertussis vaccine
Study links obesity to immune changes leading to asthma
A study published online December 15, 2013 in Nature Medicine shows that mice allowed to become obese develop specific immune system changes leading to airway hyper-reactivity. Researchers at Boston Children’s Hospital found that mice fed a high fat diet to the point of obesity experienced increases in IL-1β, interleukin 17A, ILC3 cells, and NLRP3 in lung cells, all … [Read more...] about Study links obesity to immune changes leading to asthma
Fresenius Kabi announces availability of acetylcysteine inhalation solution
Fresenius Kabi USA has announced the availability of 10 ml vials of 20% acetylcysteine inhalation solution. Acetylcysteine inhalation solution has been on the FDA’s drug shortage lists since 2011, in part due to a shutdown of a Luitpold facility. Fresenius Kabi launched 30 ml vials of the product in 2012. According to the current FDA drug shortage list, 10 ml vials … [Read more...] about Fresenius Kabi announces availability of acetylcysteine inhalation solution