Opiant Pharmaceuticals has announced that, based on feedback from the FDA and positive data from a Phase I clinical study, the company plans to pursue a 505(b)(2) development path for its OPNT003 intranasal nalmefene for the treatment of opioid overdose. OPNT003 is formulated using Aegis Therapeutics' Intravail absorption enhancer, which Opiant licensed in 2017. … [Read more...] about Opiant Pharmaceuticals developing intranasal nalmefene for the treatment of opioid overdose
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Teva launches QVAR RediHaler in the US
Teva Pharmaceutical Industries has announced the US launch of its QVAR RediHaler beclomethasone dipropionate HFA MDI, which was approved by the FDA in August 2017 for the treatment of asthma in patients aged 4 years and older. The RediHaler is a breath actuated device and requires no shaking or priming. The company is discontinuing sales of the previous version of … [Read more...] about Teva launches QVAR RediHaler in the US
Savara’s IND for Moldgradex study approved
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 December 2017. The approval allows the company to enroll patients in the ongoing Phase 3 IMPALA study at sites in the … [Read more...] about Savara’s IND for Moldgradex study approved
Propeller Health gets ISO 13485:2016 certification
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 Scripts and expanded partnership with GSK. Propeller Health Regulatory and Quality Assurance … [Read more...] about Propeller Health gets ISO 13485:2016 certification
Auris Medical announces pre-clinical and Phase 1 PK data for intranasal betahistine
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
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