St. Renatus has announced the completion of adult and pediatric Phase 3 clinical studies of its nasal mist dental anesthesia and says that it is now working on data analysis with the goal of submitting an NDA for the product in 2014. The nasal anesthetic numbs the upper teeth without affecting the patient's lips or face. St. Renatus CEO Steve Merrick commented, "We … [Read more...] about St. Renatus completes Phase 3 studies on intranasal dental anesthetic
Medical
AANMA objects to Primatene HFA
Tonya Winders, President and CEO of Allergy & Asthma Network Mothers of Asthmatics (AANMA) will speak in opposition to the approval of Primatene HFA at the upcoming joint meeting of the FDA's Nonprescription Drugs Advisory Committee and Pulmonary Allergy Drugs Committee, the organization has announced. The AANMA contends that Armstrong's OTC Primatene HFA … [Read more...] about AANMA objects to Primatene HFA
Insmed provides update on ongoing study of Arikace for P. aeruginosa infections in CF patients
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
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