According to Insmed, the company has filed an MAA for its Arikayce liposomal amikacin for inhalation, and it has been informed by the EMA that the only remaining issue, a review of the Pediatric Investigation Plan (PIP) by the agency's Pediatric Committee, should be finished by the first quarter of 2015. A trial of Arikayce for the treatment of resistant … [Read more...] about Insmed provides update on its pipeline
Medical
GSK to change color of Relvar Ellipta
GSK has announced that it will change the color of the Relvar Ellipta fluticasone/vilanterol DPI starting in January 2015. The company said that it will remove the color blue from the inhaler and its packaging and will change the mouthpiece cover and packaging to yellow. Pharmacists had expressed concerns that patients would be confused because the color blue has been … [Read more...] about GSK to change color of Relvar Ellipta
Acorda announces start of Phase 3 study for inhaled L-dopa
Acorda Therapeutics has announced the enrollment of the first patient in a Phase 3 study of CVT-301 inhaled L-dopa for the treatment of OFF episodes in Parkinson’s disease (PD). The study is expected to enroll about 345 patients. CVT-301 was initially developed by Civitas Therapeutics which was acquired by Acorda earlier this year. Acorda Chief Medical Officer … [Read more...] about Acorda announces start of Phase 3 study for inhaled L-dopa
Lightlake announces new trial of intranasal naloxone for opioid overdose
Lightlake Therapeutics has announced that it has begun a new trial of its intranasal naloxone for the reversal of opioid overdose. According to the company, it plans to file a New Drug Application with the FDA if the results from this study are positive. Earlier this year, Lightlake announced that it had received funding for the study from the National Institute … [Read more...] about Lightlake announces new trial of intranasal naloxone for opioid overdose
Positive Phase 1 results for Milestone’s intranasal calcium channel antagonist
Milestone Pharmaceuticals has announced that a Phase 1 clinical trial of an intranasal formulation of its MSP-2017 calcium channel antagonist for possible treatment of paroxysmal supraventricular tachycardia (PSVT) showed that the drug has a rapid onset, along with other promising PK properties, and was well tolerated at doses up to 140 mg. The company said that it … [Read more...] about Positive Phase 1 results for Milestone’s intranasal calcium channel antagonist
LSTM gets grant to study nasal spray flu vaccine versus pneumococcal bacteria
The Bill and Melinda Gates Foundation has awarded a $2.5 million grant to researchers at Liverpool School of Tropical Medicine (LSTM) for a study to determine the effects of nasal spray flu vaccine on pneumococcal bacteria. The 2-year study, to be conducted in conjunction with the Royal Liverpool University Hospital, will recruit almost 300 volunteers, half of … [Read more...] about LSTM gets grant to study nasal spray flu vaccine versus pneumococcal bacteria
RespiTech team gets grant for development of inhalable Smartdrops technology
The Australian Research Council has awarded a $521,800 grant to Daniela Traini and Paul Young of the Woolcock Institute's RespiTech group and Patrick Spicer of the University of New South Wales for development of inhalable "Smartdrops" for drug delivery to the lung. The three-year project is designed to develop a microfluidics-based process for creating … [Read more...] about RespiTech team gets grant for development of inhalable Smartdrops technology
Additional Positive Phase 3 study results for AVP-825 intranasal sumatriptan
Avanir Pharmaceuticals has published results from the Phase 3 TARGET study of its AVP-825 intranasal sumatriptan powder compared to placebo for the treatment of migraine. The article appears in the January 2015 issue of Headache. Earlier this year, the company announced positive results from the Phase 3 COMPASS study that compared AVP-825 to oral … [Read more...] about Additional Positive Phase 3 study results for AVP-825 intranasal sumatriptan
Monaghan Medical presents data showing possible under-dosing from continuous nebulizers
US-based Monaghan Medical, which sells breath actuated nebulizers manufactured by Trudell Medical International (TMI), is presenting data at CHEST 2014 from a study showing that continuous nebulizers may under-dose medication. According to Monaghan changes in a patient's inspiratory/expiratory (I/E) ratio during tidal breathing can result in variable … [Read more...] about Monaghan Medical presents data showing possible under-dosing from continuous nebulizers
Sunovion reports results from dose ranging study of glycopyrrolate inhalation solution
Sunovion Pharmaceuticals has announced that all 4 dose levels of its SUN-101 glycopyrrolate inhalation solution tested in a Phase 2 study produced statistically significant improvements in lung function. The 28-day randomized, double-blind, placebo-controlled study involved more than 280 COPD patients and compared 12.5 mcg, 25 mcg, 50 mcg, and 100 mcg doses of SUN-101 … [Read more...] about Sunovion reports results from dose ranging study of glycopyrrolate inhalation solution