Aerogen Pharma and Lyomark Pharma have announced a partnership for development and commercialization of AP-002, a nasally-inhaled surfactant based on Lyomark's Alveofact bovine lung surfactant for the treatment of respiratory distress syndrome (RDS) in pre-term infants. According to Aerogen, the company has also initiated a Phase 2 study of AP-002 in Australia, with … [Read more...] about Aerogen and Lyomark Pharma partner on nasally-inhaled surfactant for RDS
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Savara gets $5 million from CFFT for AeroVanc development
Savara has received a development award of up to $5 million from Cystic Fibrosis Foundation Therapeutics (CFFT), which will support the Phase 3 AVAIL study of the AeroVanc DPI for the treatment of MRSA lung infections in cystic fibrosis patients, the company said. In 2013, CFFT awarded the company $1.7 million for Phase 2 development of AeroVanc. Savara announced … [Read more...] about Savara gets $5 million from CFFT for AeroVanc development
Study shows improved lung function for patients switching from Seretide (Advair) to Ultibro (Utibron)
Novartis has announced that the FLASH study met its primary endpoint, demonstrating that switching COPD patients from Seretide (Advair) salmeterol/fluticasone Ultibro Breezhaler (Utibron Neohaler) indacaterol/glycopyrronium significantly improved lung function. The safety and tolerability of both inhalers was found to be similar. In 2014, Novartis announced results … [Read more...] about Study shows improved lung function for patients switching from Seretide (Advair) to Ultibro (Utibron)
Phase 3 study of inhaled amikacin in intubated and mechanically ventilated patients fails to meet primary endpoint
Bayer has announced the failure of the Phase 3 INHALE study of Amikacin Inhale inhalation solution for the treatment of gram-negative pneumonia in intubated and mechanically ventilated patients with Gram-negative pneumonia to demonstrate superiority in an inhaled placebo and therefore the failure of the study to meet either its primary or secondary endpoints. … [Read more...] about Phase 3 study of inhaled amikacin in intubated and mechanically ventilated patients fails to meet primary endpoint
Study shows Anoro Ellipta superior to Stiolto Respimat for improving lung function in COPD patients
GSK and Innoviva have published data from a study in which Anoro Ellipta umeclidinium/vilanterol demonstrated superior lung function improvement in COPD patients compared to Stiolto Respimat tiotropium/olodaterol. The data were published in Advances in Therapy and at the 2017 CHEST meeting. The study, which enrolled 236 COPD patients, measured trough FEV1 at 8 … [Read more...] about Study shows Anoro Ellipta superior to Stiolto Respimat for improving lung function in COPD patients
Theravance Biopharma opens corporate office in Dublin, Ireland
Theravance Biopharma has opened a corporate office in Dublin, Ireland and plans to hire 30 new employees over the next 2 years, the company said. The company also announced that it and its partner Mylan had presented additional data from 2 Phase 3 trials of TD-4208 inhaled revefenacin at the 2017 CHEST meeting. Topline results from the Phase 3 trials were released … [Read more...] about Theravance Biopharma opens corporate office in Dublin, Ireland
Novoteris announces plans for Phase 2a trial of Thiolanox for NTM lung infections
Novoteris has announced that Health Canada has okayed a planned Phase 2a clinical trial of the company's Thiolanox inhaled nitric oxide gas for the treatment of non-tuberculous mycobacteria (NTM) lung infections. The study will enroll 10 patients excluded from an ongoing Phase 2 trial of Thiolanox in cystic fibrosis patients. In 2015, the company received $2.8 … [Read more...] about Novoteris announces plans for Phase 2a trial of Thiolanox for NTM lung infections
Impel Neuropharma initiates Phase 1 trial of INP104 intranasal dihydroergotamine
Impel NeuroPharma has announced the initiation of a Phase 1 trial of INP104 intranasal dihydroergotamine (DHE), which the company is developing for the treatment of acute migraine headache. The bioavailability study, which is taking place in Australia, will compare INP104 to an approved intravenous DHE formulation and to Valeant's Migranal DHE nasal spray, the … [Read more...] about Impel Neuropharma initiates Phase 1 trial of INP104 intranasal dihydroergotamine
Evoke announces positive results for Gimoti metoclopramide nasal spray PK study
Evoke Pharma says that a comparative exposure PK study has shown that 2 out of 3 doses of its Gimoti metoclopramide nasal spray demonstrated bioequivalence to oral metoclopramide and, based on those results, the company plans to submit a 505(b)(2) NDA for Gimoti early in 2018. Evoke is developing Gimoti for the treatment of diabetic gastroparesis. In December … [Read more...] about Evoke announces positive results for Gimoti metoclopramide nasal spray PK study
Spyryx Biosciences initiates Phase 2 study of SPX-101 for cystic fibrosis
Spyryx Biosciences has announced the initiation of the Phase 2 HOPE-1 study of SPX-101, an inhaled SPLUNC1-derived peptide, in cystic fibrosis patients. The 28-day study is designed to enroll as many as 78 CF patients and will compare two doses of SPX-101 against a placebo. In June 2017, Spyryx announced an increase in an award from Cystic Fibrosis Foundation … [Read more...] about Spyryx Biosciences initiates Phase 2 study of SPX-101 for cystic fibrosis