Vectura has announced a new US partnership for its VR506, which it describes as "an ICS for the treatment of asthma" and as "clinical stage asthma monotherapy delivered using Vectura’s proprietary technology." Elsewhere, the company has identified the product as a fluticasone propionate DPI. According to Vectura, it has signed the new agreement for development … [Read more...] about Vectura announces new partnership for generic fluticasone propionate DPI
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Allergan gets another CRL for Semprana (formerly Levadex) inhaled DHE
According to Allergan, the FDA has issued another Complete Response Letter (CRL) in response to Allergan's NDA for Semprana inhaled dihydroergotamine (formerly Levadex) for the treatment of acute migraine. Allergan acquired the product when it acquired MAP Pharmaceuticals in early 2013. MAP had already received a CRL for Levadex in early 2012. In April 2013, … [Read more...] about Allergan gets another CRL for Semprana (formerly Levadex) inhaled DHE
Respiratory Technology Group at WIMR gets grant for development of inhaled vaccines
The Australian Research Council (ARC) has awarded a 3-year, $482,738 linkage grant titled "One for all and all for one- Engineering a drug delivery platform for DNA vaccines to the lung" to members of the Respiratory Technology team at the Woolcock Institute of Medical Research (WIMR) and Evonik Industries. The partnership aims to develop a new, low-cost technology … [Read more...] about Respiratory Technology Group at WIMR gets grant for development of inhaled vaccines
FDA approves MannKind’s Afrezza inhaled insulin (updated)
The US FDA has announced the approval of MannKind Corporation's Afrezza inhaled insulin for the treatment of diabetes. The PDUFA date for Afrezza had been set for July 15, 2014 after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of the product on April 2, 2014. The product will have a boxed warning about bronchospasm … [Read more...] about FDA approves MannKind’s Afrezza inhaled insulin (updated)
Freeman offers new ebook with useful information for DPI developers
Powder characterization specialist Freeman Technology is offering a free 35-page downloadable booklet titled "An Introduction to Powders" that includes information particularly useful for development and optimization of dry powder inhalers, the company says. Authored by Managing Director Tim Freeman, the book examines the interactions of particles with air and … [Read more...] about Freeman offers new ebook with useful information for DPI developers
CDC advisory committee recommends intranasal flu vaccine over injection for children
The US Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended that children aged 2-8 should get a nasal spray flu vaccine if available instead of an injection. The CDC director must approve the recommendation before it becomes an official CDC policy. The FDA approved MedImmune's FluMist Quadrivalent … [Read more...] about CDC advisory committee recommends intranasal flu vaccine over injection for children
Presspart adds two to its Inhalation Product Technology Centre team
Device component company Presspart Manufacturing has announced that former Lupin pulmonary research scientist Abhay Singh and former Sanofi QC readiness analyst Jacqueline Green have joined Presspart's Inhalation Product Technology Centre (IPTC) team. Singh has been hired as Senior Analyst, Green as Research Analyst. In late 2012, Presspart announced that it had … [Read more...] about Presspart adds two to its Inhalation Product Technology Centre team
Second Phase 3 trial of Aradigm’s Pulmaquin gets underway
According to Aradigm, the first patient in the Phase 3 ORBIT-4 (Once-daily Respiratory Bronchiectasis Inhalation Treatment) trial of Pulmaquin inhaled ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis has been dosed. The other Phase 3 trial, ORBIT-3, began in April 2014. Both 48-week double-blind trials expect to enroll about 255 patients and … [Read more...] about Second Phase 3 trial of Aradigm’s Pulmaquin gets underway
Verona Pharma halts development of inhaled antitussive
Verona Pharma has announced that it will stop development of its VRP700 inhaled antitussive after the drug failed to produce statistically significant reduction in cough frequency compared to placebo in a Phase 2a clinical trial. The trial evaluated the efficacy of a single dose of VRP700 in 20 idiopathic pulmonary fibrosis patients with severe chronic cough. … [Read more...] about Verona Pharma halts development of inhaled antitussive
Teva, Perrigo, and Catalent reach settlement in ProAir HFA case
Under the terms of a newly reached settlement, Perrigo and Catalent will be able to market limited quantities of their generic version of Teva's Proair HFA albuterol MDI starting in December 2016. Beginning in July 2018, the companies will be licensed to market unlimited quantities of the product. No other details of the settlement were disclosed. Teva had filed … [Read more...] about Teva, Perrigo, and Catalent reach settlement in ProAir HFA case