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Medical

First patients dosed in Phase 1/2 trial of Verona’s RPL554

According to Verona Pharma a Phase 1/2 trial of its RPL554 inhaled PDE3/4 inhibitor for the treatment of COPD has gotten underway with dosing of the first subjects. Plans are for recruitment of up to 120 healthy volunteers and COPD patients in total, with results expected by the end of the year. The trial is testing a new formulation of RPL554 "suitable for … [Read more...] about First patients dosed in Phase 1/2 trial of Verona’s RPL554

Study shows intranasal insulin detemir improves short term memory in Alzheimer’s patients

Researchers at Wake Forest Baptist Medical Center have announced results of a study in which 60 patients with amnesic mild cognitive impairment or mild to moderate Alzheimer's dementia received one of two doses of an insulin detemir nasal spray or placebo for 21 days. According to the authors, patients receiving the higher dose (40 IU), demonstrated significant … [Read more...] about Study shows intranasal insulin detemir improves short term memory in Alzheimer’s patients

Novartis announces NDA submissions for QVA149 and NVA237 DPIs

Novartis has announced that it submitted New Drug Applications to the FDA for both the QVA149 indacaterol/glycopyrronium bromide and NVA237 glycopyrronium bromide DPIs in the fourth quarter of 2014. Both inhalers are meant for the treatment of COPD. In early 2012, the company said that it planned to submit marketing applications for the two products in the US by the … [Read more...] about Novartis announces NDA submissions for QVA149 and NVA237 DPIs

Insmed provides update on its pipeline

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

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

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