Impel NeuroPharma said that the Phase 3 STOP-301 safety and tolerability study of INP104 intranasal dihydroergotamine (DHE) for the treatment of migraine has gotten underway, with the first patient dosed. The company announced plans for the study in June 2018. According to Impel, recruitment for the study, which will gather data at 24 weeks and 52 weeks of … [Read more...] about Impel initiates Phase 3 study of intranasal DHE for migraine
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Vectura announces results from two studies of VR647 in pediatric asthma patients
Vectura has announced results from a pharmacokinetic study of its VR647 nebulized budesonide inhalation suspension in asthma patients aged 4 to 8 and a methodology study of the use of a mouthpiece with the VR647 nebulizer (the Akita Jet nebulizer) by children aged 1 to 4. In January 2017, Vectura announced that it had received FDA approval of its IND for pediatric … [Read more...] about Vectura announces results from two studies of VR647 in pediatric asthma patients
Recall of oxymetazoline nasal spray due to P. aeruginosa contamination
Florida-based Product Quest Manufacturing has recalled a lot of CVS Health 12 Hour Sinus Relief Nasal Mist oxymetazoline nasal spray due to contamination with Pseudomonas aeruginosa. The company said that it had not received reports of any adverse events but acknowledged that use of a nasal spray contaminated with P. aeruginosa could potentially lead to deadly … [Read more...] about Recall of oxymetazoline nasal spray due to P. aeruginosa contamination
Milestone Pharmaceuticals initiates Phase 3 study of Etripamil for PSVT
Milestone Pharmaceuticals said that it has initiated a Phase 3 clinical study of etripamil, an intranasal calcium channel antagonist for the treatment of paroxysmal supraventricular tachycardia (PSVT). Results from a Phase 2 study of etripamil were announced in May 2017, and in August of that year, the company said that it had raised $55 million for Phase 3 … [Read more...] about Milestone Pharmaceuticals initiates Phase 3 study of Etripamil for PSVT
Eurocine Vaccines reports positive safety and tolerability results from study of Immunose Flu
Eurocine Vaccines said that results from a study of its Immunose Flu intranasal flu vaccine in adults aged 50-70 showed no serious adverse events and only minimal experiences of discomfort. The study, which took place during the 2017/18 flu season, enrolled 298 subjects at 5 locations in Sweden. The subjects, who had a mean age of 63, were divided into treatment … [Read more...] about Eurocine Vaccines reports positive safety and tolerability results from study of Immunose Flu
New partnership formed for development of inhaled gene therapy for cystic fibrosis
Boehringer Ingelheim, the UK Cystic Fibrosis Gene Therapy Consortium (GTC), Imperial Innovations, and Oxford BioMedica have formed a partnership for development of an inhaled therapy designed to introduce a healthy copy of the CFTR gene into lung cells. Boehringer Ingelheim will finance the development and has acquired the option to license exclusive global … [Read more...] about New partnership formed for development of inhaled gene therapy for cystic fibrosis
Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development
Savara has acquired rights to an amikacin/fosfomycin inhalation solution that was being developed by Cardeas Pharma for the treatment of ventilator associated pneumonia and has appointed former Cardeas Pharma CEO A. Bruce Montgomery as a strategic advisor, the company said. The company also announced a public offering of common stock, with shares priced at $11.50 … [Read more...] about Savara acquires rights to inhaled antibiotic, appoints new strategic advisor, and provides update on Molgradex development
Clinical development program for Penthrox put on hold
After meeting with the FDA regarding the clinical program for US approval of its Penthrox methoxyflurane inhaler, Medical Developments International (MVP) said that it expects to receive a clinical hold letter from the agency within the next two months. Penthrox is currently approved for the treatment of pain in numerous countries, including Canada, and much of … [Read more...] about Clinical development program for Penthrox put on hold
Windtree Therapeutics to use upgraded aerosol delivery system for Phase 3 studies
Windtree Therapeutics said that it has completed design verification of a new version of its aerosol delivery system (ADS) for Aerosurf inhaled KL4 surfactant for the treatment of respiratory distress syndrome (RDS) in premature infants and plans to use the new system in Phase 3 studies of the drug. The company said that Mack Medical is preparing to manufacture the … [Read more...] about Windtree Therapeutics to use upgraded aerosol delivery system for Phase 3 studies
Pulmatrix announces additional results from Phase 1/1b trial of Pulmazole
Pulmatrix has announced that the 3rd part of its Phase 1/1b study of Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma has been completed and "successfully achieved all objectives." Results from parts 1 and 2 of the study were announced in June 2018. According to the company, 17 patients … [Read more...] about Pulmatrix announces additional results from Phase 1/1b trial of Pulmazole