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
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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
Trimel Pharmaceuticals changes its name to Acerus
Natesto intranasal testosterone developer Trimel Pharmaceuticals Corporation has announced that it has a new name: Acerus Pharmaceuticals Corporation. Acerus President and CEO Tom Rossi commented, “We are very excited to officially launch our new corporate identity with a name that aligns to our Company’s value proposition. The name Acerus is derived from the … [Read more...] about Trimel Pharmaceuticals changes its name to Acerus
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
Invion raises A$1 million through private placement
Invion Limited, which is developing several inhaled drugs, has announced a private placement in which it is issuing 71.5 million ordinary shares at $0.014 per share to "a US institutional investor" for a total of about A$1 million. The company says that it will use the proceeds for working capital. Invion Managing Director and CEO Greg Collier commented, "Invion is … [Read more...] about Invion raises A$1 million through private placement
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
Study examines DPI device/formulation interactions
A study by researchers from King's College London, the University of Parma, and inhalation testing specialist Intertek evaluating the interdependence of DPI formulation and device factors has been published in the International Journal of Pharmaceutics. The article, titled "Formulating powder–device combinations for salmeterol xinafoate dry powder inhalers," appeared … [Read more...] about Study examines DPI device/formulation interactions
Study finds that CF patients would give up 5+ years of their lives to use a DPI instead of a standard nebulizer
A study published online in the American Journal of Pharmaceutical Benefits on August 20, 2015 found that approximately 90% of adult cystic fibrosis patients surveyed preferred using a dry powder inhaler to using a standard nebulizer if the cost is the same. On average, the patients said that they would be willing to give up 5.3 years of life, out of an expected 40 … [Read more...] about Study finds that CF patients would give up 5+ years of their lives to use a DPI instead of a standard nebulizer
Advanced Inhalation Therapies files for IPO
Israeli biopharmaceutical company Advanced Inhalation Therapies (AIT), which recently received orphan drug status in Europe for its inhaled nitric oxide for the treatment of cystic fibrosis, has filed with the US Securities and Exchange Commission (SEC) for an initial public offering. The company is looking to raise up to $36 million to support Phase 2 development of … [Read more...] about Advanced Inhalation Therapies files for IPO