Data from a 26-week head-to-head Phase 3 study show that the Ultibro Breezhaler indacaterol/glycopyrronium DPI produced greater improvement in the lung function of COPD patients with or without a history of moderate-to-severe exacerbations compared to Seretide Accuhaler (Advair Diskus), Novartis has announced. The company says that it intends to file a regulatory … [Read more...] about Novartis announces positive results from Phase 3 study of Ultibro vs Seretide (Advair)
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NanoBio to present data on intranasal herpes vaccine
NanoBio Corporation has announced that it will present promising pre-clinical study data of its nano-emulsion (NE)-adjuvanted intranasal herpes simplex virus-2 (HSV-2) vaccine at the Annual Conference on Vaccine Research. NanoBio Senior VP of Vaccine Research Ali Fattom explained that the company "will present data from pre-clinical guinea pig studies … [Read more...] about NanoBio to present data on intranasal herpes vaccine
Positive Phase 2b results for Civitas Therapeutics’ inhaled L-dopa
Civitas Therapeutics has announced positive results from a Phase 2b trial of its CVT-301 inhaled L-dopa for the treatment of Parkinson's disease symptoms. The company is developing CVT-301 based on its proprietary ARCUS particle engineering and dry powder inhaler technology. The randomized, double-blind study involved 86 Parkinson's patients at multiple study … [Read more...] about Positive Phase 2b results for Civitas Therapeutics’ inhaled L-dopa
New Phase 3 study of FF/VI for COPD announced
GSK and Theravance have announced a Phase 3 study of fluticasone furoate (FF)/vilanterol (VI) (the Relvar Ellipta DPI) including Japanese COPD patients. In July 2013, GSK withdrew its application for Relvar for the treatment of COPD in Japan because the available Japanese patient data at the time showed that the FF component failed to produce a statistically … [Read more...] about New Phase 3 study of FF/VI for COPD announced
Genoa announces additional positive results for inhaled pirfenidone
Genoa Pharmaceuticals has announced that studies conducted in conjunction with McMaster University have shown that peak pirfenidone activity can be achieved by lung levels of the drug that remain for only a short period of time. Genoa previously announced that its GP-101 inhaled pirfenidone demonstrated greater anti-fibrotic effects with smaller doses than oral … [Read more...] about Genoa announces additional positive results for inhaled pirfenidone
Study shows nasal spray has potential to prevent the flu
Researchers from the University of St. Andrews, the University of Edinburgh, and St. Jude's Children's Research Hospital have published data demonstrating that a nasal spray designed to prevent the influenza virus from binding with receptors in the respiratory tract provided complete protection against flu in mice. The study, published in the Proceedings of the … [Read more...] about Study shows nasal spray has potential to prevent the flu
Theravance begins Phase 2b study of LAMA inhalation solution
Theravance has initiated a dose-ranging Phase 2b study of its TD-4208 long-acting muscarinic antagonist (LAMA), the company announced. The study will compare four different dosages of TD-4208 and placebo, all delivered once daily via jet nebulizer, in about 350 patients with moderate to severe COPD over a 28-day period. According to the company, "The goal of … [Read more...] about Theravance begins Phase 2b study of LAMA inhalation solution
Study shows intranasal ketamine can provide antidepressant effects within 24 hours
Researchers from the Icahn School of Medicine at Mount Sinai have demonstrated that a single 50 mg dose of a ketamine nasal spray could alleviate depressive symptoms in patients with treatment-resistant major depressive disorder within 24 hours. The authors conclude that, "This study provides the first controlled evidence for the rapid antidepressant effects of … [Read more...] about Study shows intranasal ketamine can provide antidepressant effects within 24 hours
GSK plans to make respiratory drugs more available in sub-Saharan Africa
As part of a planned five-year initiative to improve healthcare in Africa, GlaxoSmithKline has announced that it plans to make more of its existing drugs available in Africa and has specified the Ventolin albuterol inhaler as an example. The company's announcement also said that it would invest up to £100 million in its existing manufacturing facilities in Kenya and … [Read more...] about GSK plans to make respiratory drugs more available in sub-Saharan Africa
Mixed results in Phase 2 study of Arikayce for NTM lung infections
Insmed has announced that in a Phase 2 clinical trial of Arikayce (formerly Arikace) inhaled liposomal amikacin for nontuberculous mycobacterial (NTM) lung infections, the product failed to produce a statistically significant reduction in mycobacterial density; however, it did meet a secondary endpoint, with significantly more patients treated with Arikayce having … [Read more...] about Mixed results in Phase 2 study of Arikayce for NTM lung infections