August 2012
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According to Savara, the FDA has approved an IND the company submitted for Molgradex, an inhaled molgramostim (recombinant human GM-CSF) formulation for the treatment of autoimmune pulmonary alveolar proteinosis (PAP), which the company filed in… Read more . . .
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Inhaler monitoring company Propeller Health has received ISO 13485:2016 certification for medical device quality management systems, the company announced. Propeller cited the ISO certification as a milestone along with its recently announced agreement with Express… Read more . . .
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Auris Medical Holding has announced that a PK study of an intranasal betahistine formulation demonstrated 5-35 times higher bioavailability in dogs compared to oral betahistine, and a Phase 1 study showed 20-40 times higher bioavailability… Read more . . .
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According to Impel NeuroPharma, a Phase 1 proof-of-concept trial of its INP104 intranasal dihydroergotamine (DHE) for the treatment of acute migraine headache demonstrated comparable bioavailability for INP104 to IV DHE and a statistically significant increase… Read more . . .
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Trudell Medical International has announced publication of a retrospective study that found a 13% reduction in emergency room visits for patients using a metered dose inhaler with the company’s AeroChamber Plus Flow-Vu Anti-Static valved holding… Read more . . .
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Liquidia Technologies, which recently published positive Phase 1 results for its LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension, has named former Quintiles executive Kevin Gordon as President and Chief Financial Officer. Gordon… Read more . . .
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OINDP testing specialist Proveris Scientific Corporation has announced the appointment of Chip Leveille as President, effective immediately. Leveille had been the Chief Commercial Officer at the company since April 2016 and previously held positions at… Read more . . .
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The upcoming RDD 2018 meeting, which will take place April 22-26 in Tucson, AZ, features a program designed to address many of the most pressing questions for OINDP developers today, along with extensive poster and… Read more . . .
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The FDA has granted orphan drug designation to Dauntless Pharmaceuticals’ DP1038 intranasal octreotide acetate for the treatment of acromegaly, the company said. Dauntless announced positive Phase 1 results for DP1038 in May 2015. Dauntless Pharmaceuticals… Read more . . .
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AstraZeneca has announced top-line results from the Phase 3 KRONOS trial of its PT010 budesonide/glycopyrronium/formoterol fumarate MDI for the treatment of moderate to severe COPD. Compared to Bevespi Aerosphere glycopyrronium/formoterol fumarate, Symbicort Turbuhaler budesonide/formoterol fumarate,… Read more . . .
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