Eurocine Vaccines has received authorization from the Swedish Medical Products Agency for a Phase 1/2 clinical study of its intranasal quadrivalent influenza vaccine Immunose Flu during the current flu season, the company said. Eurocine Vaccines also ran a Phase 1/2 study of Immunose Flu in 2016. Immunose Flu is based on the company's Endocine nasal vaccine … [Read more...] about Eurocine Vaccines announces Phase 1/2 study of Immunose Flu vaccine
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Respimat gets Ease of Use Commendation from the Arthritis Foundation
Boehringer Ingelheim announced that its Respimat soft mist inhaler has received an Ease of Use Commendation from the Arthritis Foundation. In order to receive the commendation, products submitted by manufacturers to the Arthritis Foundation for consideration undergo assessment at the Intuitive Design Applied Research Institute. Arthritis Foundation Senior VP, … [Read more...] about Respimat gets Ease of Use Commendation from the Arthritis Foundation
FLUIDDA announces research collaboration with UCSF
Functional respiratory imaging specialist FLUIDDA has announced a new research collaboration with a team at the University of California, San Francisco led by Professor John Fahy that will use FLUIDDA technology "to understand the effects of pathologic mucus on lung function and on the deposition patterns of inhaled therapeutics." FLUIDDA CEO Jan De Backer said, … [Read more...] about FLUIDDA announces research collaboration with UCSF
3P Innovation launches new robotic capsule and device filler
3P Innovation has announced the launch of a new version of its R500 Robotic Capsule and Device Filler which is scalable and capable of filling inhalers directly as well as filling capsules. According to 3P, the filler can now be used for commercial production as well as for clinical development of both pure API inhalation powders and blended formulations. The … [Read more...] about 3P Innovation launches new robotic capsule and device filler
Nebulizer maker HCmed gets investment from Vivo Capital
Deepro nebulizer maker HCmed has announced that Vivo Capital's PANDA Fund has become a strategic investor as of December 27, 2017, saying, "As a healthcare focused investment firm, Vivo will fully support HCmed’s strategic plan to expand in the hand-held nebulizer markets to help relive [sic] global burden of respiratory disease, such as COPD, asthma and cystic … [Read more...] about Nebulizer maker HCmed gets investment from Vivo Capital
Savara appoints Peter Ginsberg as VP of Business Development
Inhaled drug developer Savara has announced the appointment of Peter Ginsberg as VP of Business Development. Ginsberg was most recently VP of Business Development at BioDelivery Sciences International and had previously held business development positions at a number of companies, including United Therapeutics and Surmodics. He also has experience as a biotechnology … [Read more...] about Savara appoints Peter Ginsberg as VP of Business Development
Liquidia announces initiation of Phase 3 trial of trepostinil DPI for PAH
A Phase 3 trial of Liquidia Technologies' LIQ861 treprostinil DPI for the treatment of pulmonary arterial hypertension (PAH) is underway, the company said. The study is expected to enroll a minimum of 100 PAH patients in the US, with topline data anticipated in 2019. LIQ861, a dry powder formulation based on Liquidia’s PRINT particle engineering technology, is one … [Read more...] about Liquidia announces initiation of Phase 3 trial of trepostinil DPI for PAH
OraPharma to co-promote Sprix nasal spray in the US
Egalet Corporation has terminated a co-promotion agreement with Septodont, the company said, and is now partnered with Valeant's OraPharma division for co-promotion of Sprix ketorolac tromethamine nasal spray to US dentists and oral surgeons. Sprix has been approved by the FDA since 2010 for short-term treatment of moderate-to-severe pain. Under the terms of the … [Read more...] about OraPharma to co-promote Sprix nasal spray in the US
Janssen publishes results from Phase 2 trial of intranasal esketamine for depression
Janssen Research & Development has published data from a Phase 2 study of its intranasal esketamine that demonstrate rapid improvement of symptoms in patients with treatment-resistant depression. The study was conducted from 2014-2015, and results were published in JAMA Psychiatry on December 27, 2017. The trial enrolled 126 patients diagnosed with major … [Read more...] about Janssen publishes results from Phase 2 trial of intranasal esketamine for depression
FDA workshop offers insights on OINDP development and BE assessment
By Lei Zhang, PhD, Deputy Director, Office of Research and Standards The FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs (OGD), Office of Research and Standards, Division of Therapeutic Performance has made great strides in new approaches that demonstrate therapeutic equivalence for locally-acting orally-inhaled and nasal drug products … [Read more...] about FDA workshop offers insights on OINDP development and BE assessment