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
Medical
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
Phase 2b study of Oyster Point’s nasal spray for dry eye disease meets primary endpoints
Oyster Point Pharma has announced that the Phase 2b PEARL study of its OC-02 intranasal nicotinic acetylcholine receptor (nAChR) agonist for the treatment of dry eye disease demonstrated a statistically significant increase in production of tear film as well as a statistically significant reduction in symptoms for patients using OC-02 compared to placebo. The … [Read more...] about Phase 2b study of Oyster Point’s nasal spray for dry eye disease meets primary endpoints
Pulmatrix announces results from Phase 1/1b trial of its Pulmazole itraconazole DPI
According to Pulmatrix, a recent Phase 1/1b study of its Pulmazole (PUR1900) itraconazole DPI for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in asthma patients with asthma showed that total systemic exposure in healthy volunteers was significantly lower than historical levels for oral itraconazole and that the drug was well tolerated at all doses … [Read more...] about Pulmatrix announces results from Phase 1/1b trial of its Pulmazole itraconazole DPI
Impel plans for Phase 3 study of intranasal DHE for migraine
According to Impel NeuroPharma, the FDA has given the company a notice to proceed with clinical study of INP101 intranasal dihydroergotamine (DHE) for the treatment of acute migraine. A Phase 3 study is expected to begin enrolling patients in the second half of this year. The company said that it had recently submitted an investigational new drug application to the … [Read more...] about Impel plans for Phase 3 study of intranasal DHE for migraine
Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
Levo Therapeutics has announced that it plans to initiate a Phase 3 trial of LV-101 intranasal carbetocin for the treatment of Prader-Willi syndrome (PWS) before the end of 2018. The company said that it acquired rights to the formulation from Ferring Pharmaceuticals in August 2017 and is now publishing results from a Phase 2 study sponsored by Ferring that concluded … [Read more...] about Levo Therapeutics to restart development of intranasal carbetocin for Prader-Willi syndrome
Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Canadian biotech Arch Biopartners has announced that it will put an ongoing Phase 1 safety study of its AB569 ethylenediaminetetraacetic acid (EDTA)/sodium nitrite bactericidal inhalation solution on hold and will ask the FDA for a pre-IND meeting for AB569. The study began recruiting volunteers in February 2018. Arch Biopartners CEO Richard Muruve said, “We have … [Read more...] about Arch Biopartners puts Phase 1 trial of AB569 on hold, will request pre-IND meeting with FDA
Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations
Insys Therapeutics said that preliminary data from a Phase 1 pharmacokinetics study comparing its intranasal epinephrine formulation to EpiPen intramuscular epinephrine in 60 subjects with seasonal allergies showed similar bioavailability and rapid drug absorption for the nasal spray. The company did not provide any details. Insys announced initiation of the study … [Read more...] about Insys says PK study shows intranasal epinephrine bioavailability similar to intramuscular formulations