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Phase 3 trial of Glenmark’s Ryaltris nasal spray meets its primary endpoint

Glenmark Pharmaceuticals has announced that a 52-week Phase 3 trial of its Ryaltris mometasone furoate/olopatadine hydrochloride nasal spray for the treatment of perennial allergic rhinitis (PAR) met its primary and secondary endpoints. The company said that it plans to submit an NDA for Ryaltris for seasonal allergic rhinitis (SAR) early in 2018. Earlier this … [Read more...] about Phase 3 trial of Glenmark’s Ryaltris nasal spray meets its primary endpoint

Mucodel announces positive results for study of intranasal naloxone

Mucodel Pharma has announced that a PK study of its intranasal naloxone met its endpoints and showed that the formulation based on its Co-Gel technology delivered the dose of naloxone faster than both an intranasal spray and intramuscular injection. in February 2017, the Mucodel filed a citizen petition with the FDA challenging the the safety of intranasal … [Read more...] about Mucodel announces positive results for study of intranasal naloxone

Aerogen and Lyomark Pharma partner on nasally-inhaled surfactant for RDS

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

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