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 for the intranasal formulation compared to oral betahistine in humans. The company is developing AM-125 intranasal betahistine … [Read more...] about Auris Medical announces pre-clinical and Phase 1 PK data for intranasal betahistine
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Impel Neuropharma announces positive Phase 1 results for INP104 intranasal DHE
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 in Cmax and AUC compared to Migranal DHE nasal spray. INP104 was also well tolerated, the company … [Read more...] about Impel Neuropharma announces positive Phase 1 results for INP104 intranasal DHE
Trudell Medical study shows better asthma control for patients using AeroChamber Plus anti-static VHC
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 chamber (VHC) compared to patients using non-anti-static holding chambers. The study, published in Pulmonary Therapy in … [Read more...] about Trudell Medical study shows better asthma control for patients using AeroChamber Plus anti-static VHC
Kevin Gordon named President and CFO of Liquidia Technologies
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 was most recently Executive VP and Chief Operating Officer of Quintiles. He held various business development … [Read more...] about Kevin Gordon named President and CFO of Liquidia Technologies
Proveris Scientific announces appointment of Chip Leveille as President
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 BioScale, Helicos, Affymetrix, and Zymark Corporation. Leveille commented, "I am very excited to lead Proveris in … [Read more...] about Proveris Scientific announces appointment of Chip Leveille as President
RDD 2018 set to explore hot topics in Tucson
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 technology exhibitions and a week full of networking opportunities. The RDD 2018 program sessions include: • Frontiers in Lung Biology • Exploring the … [Read more...] about RDD 2018 set to explore hot topics in Tucson
Dauntless Pharmaceuticals gets orphan drug designation for intranasal octreotide
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 President and CEO Joel Martin commented, "The FDA's decision to grant DP1038 orphan drug designation for the … [Read more...] about Dauntless Pharmaceuticals gets orphan drug designation for intranasal octreotide
In Phase 3 trial, AstraZeneca’s PT010 triple combination MDI meets 6 out of 7 primary endpoints
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, and PT009 budesonide/formoterol fumarate, PT010 demonstrated … [Read more...] about In Phase 3 trial, AstraZeneca’s PT010 triple combination MDI meets 6 out of 7 primary endpoints
FDA accepts revefenacin NDA for review
Theravance Biopharma and Mylan have announced that the NDA for revefenacin (TD-4208) inhalation solution for the treatment of COPD the companies submitted in November 2017 has been accepted for review by the FDA, with a PDUFA target date of November 13, 2018. According to the companies, the agency has said that it is not currently planning to have an advisory … [Read more...] about FDA accepts revefenacin NDA for review
Aradigm receives CRL for Linhaliq
Aradigm Corporation has received a complete response letter from the FDA in response to its NDA for Linhaliq dual release inhaled ciprofloxacinfor the treatment of P. aeruginosa infections in non-cystic fibrosis bronchiectasis (NCFBE) patients, the company said. An FDA advisory committee recently voted against recommending approval of the application. According to … [Read more...] about Aradigm receives CRL for Linhaliq