Medical
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Savara has submitted an investigational new drug application for Molgradex inhaled recombinant human GM-CSF for the treatment of autoimmune pulmonary alveolar proteinosis (PAP) to the FDA, the company said. In May 2017, the company said… Read more . . .
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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… Read more . . .
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Insys Therapeutics has announced the initiation of a Phase 1 proof-of-concept study to determine whether an epinephrine nasal spray for the treatment of anaphylaxis is bioequivalent to intramuscular injection of epinephrine. The trial will compare… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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