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Mylan and Theravance Biopharma initiate Phase 3 trials of revefenacin for COPD

Theravance Biopharma and Mylan announced that they have initiated Phase 3 studies for TD-4208 revefenacin inhalation solution for the treatment of COPD. The Phase 3 program includes 2 12-week efficacy studies plus a 12-month safety study and is expected to enroll 2,300 patients. The two companies announced in February 2015 that they would partner on development of the … [Read more...] about Mylan and Theravance Biopharma initiate Phase 3 trials of revefenacin for COPD

AZTherapies begins Phase 3 study of inhaled Alzheimers therapy

AZTherapies announced that it has initiated a Phase 3 study of its ALZT-OP1 DPI for the treatment of early stage Alzheimer's disease. ALZT-OP1 is a dry powder formulation of cromolyn and ibuprofen that is delivered by a proprietary inhaler called Azhaler-D; AZTherapies licensed the technology from Massachusetts General Hospital. The company said that it plans to be … [Read more...] about AZTherapies begins Phase 3 study of inhaled Alzheimers therapy

FDA accepts Teva’s sNDA for ProAir Respiclick for pediatric use

Teva has announced the FDA's acceptance of a supplemental new drug application (sNDA) for the ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 4 to 11. The FDA approved ProAir RespiClick for the treatment of asthma in patients 12 and older in March 2015. Teva Senior VP, Teva Global Respiratory R&D, Tushar Shah commented, “The acceptance … [Read more...] about FDA accepts Teva’s sNDA for ProAir Respiclick for pediatric use

KAER Biotherapeutics gets SBIR grant for aerosol delivery of surfactant

KAER Biotherapeutics has received a $291,000 Phase 1 Small Business Innovation Research (SBIR) grant from the National Heart Lung and Blood Institute of the National Institutes of Health for “Aerosol delivery of Surfactant for ARDS,” the company said. The grant will fund a study of surfactant aerosolization and delivery for the treatment of acute respiratory distress … [Read more...] about KAER Biotherapeutics gets SBIR grant for aerosol delivery of surfactant

Breo/Relvar Ellipta study shows reduction in deaths not statistically significant

GSK and Theravance have announced that a study called SUMMIT (Study to Understand Mortality and MorbidITy in COPD ) showed that COPD patients treated with the Breo/Relvar Ellipta fluticasone furoate/vilanterol DPI had lower risk of dying than those treated with placebo, but the difference was not statistically significant. Almost 16,500 COPD patients who had either a … [Read more...] about Breo/Relvar Ellipta study shows reduction in deaths not statistically significant

Serendex to begin Phase 2 trial of inhaled molgramostim

According to Serendex Pharmaceuticals, German regulators have cleared the way for the company to initiate a phase 2 clinical trial of inhaled molgramostim (Molgradex) for the treatment of pneumonia-associated acute respiratory distress syndrome (ARDS). Earlier this year, the company announced that it had partnered with the Universities of Giessen and Marburg Lung … [Read more...] about Serendex to begin Phase 2 trial of inhaled molgramostim

Aegis Therapeutics gets patents for intranasal delivery of triptans

Aegis Therapeutics has announced that it received its first Russian patent (No. 2554814), titled, “Compositions for drug administration.” The patent covers formulations of triptans for the treatment of migraine that use Aegis’ Intravail transmucosal absorption enhancers. According to the company, the Intravail formulation results in the achievment of clinically … [Read more...] about Aegis Therapeutics gets patents for intranasal delivery of triptans