GlaxoSmithKline has submitted an NDA in the US for its fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) dry powder inhaler for the treatment of COPD, according to an announcement from GSK and Innoviva. The product will be delivered by GSK's Ellipta device. Earlier this year, GSK announced that it would file the submission by the end of 2016 … [Read more...] about GSK submits NDA for triple combination DPI for COPD
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US federal judge rules that Teva’s mometasone furoate nasal spray does not infringe on Merck’s patent
On November 14, 2016, Judge Sue Robinson of the US District Court for the District of Delaware issued a ruling upholding Merck's US patent 6,127,353 but finding that Teva's mometasone nasal spray ANDA does not infringe the claims of that patent. Merck filed suit against Teva in July 2014 after Teva submitted an ANDA for the product to the FDA. Much of the … [Read more...] about US federal judge rules that Teva’s mometasone furoate nasal spray does not infringe on Merck’s patent
Study shows significant reduction in hospitalizations for children using Smartinhaler
Results from a study of Adherium's Smartinhaler adherence monitoring system showing a 5-fold reduction in hospitalizations over a one-year period for children with poorly controlled asthma who used the device have been published online by the journal Thorax. The STAAR study also found that adherence among the 38 children who completed the study using the … [Read more...] about Study shows significant reduction in hospitalizations for children using Smartinhaler
New smart inhaler company Aerobit partners with Eularis
Aerobit, a smart inhaler company founded in the UK in June 2016 by Ali Molyed, who previously founded payment automation company AccessPay, has announced an agreement with pharmaceutical bit data analysts Eularis. According to the Aerobit web site, its device is designed as a sensor jacket that fits over a standard MDI and that connects to the cloud via bluetooth. … [Read more...] about New smart inhaler company Aerobit partners with Eularis
Pharmaxis partners with Woolcock Institute on development of tobramycin DPI
Pharmaxis will collaborate with the Woolcock Institute of Medical Research to develop a tobramycin dry powder inhaler for the treatment of cystic fibrosis, the company has announced. A A$421,545 grant from the Australian National Health and Medical Research Council (NHMRC) will fund the research to develop a dry powder formulation for delivery by Pharmaxis's Orbital … [Read more...] about Pharmaxis partners with Woolcock Institute on development of tobramycin DPI
Sanofi and MannKind finalize agreement on return of Afrezza rights
According to MannKind Corporation, it has reached an agreement with Sanofi regarding the return of rights to Afrezza inhaled insulin, in which "All issues arising out of the license and collaboration agreement, the supply agreement, the promissory note, the security agreement and the transition agreement are resolved." In January 2016, Sanofi announced that it … [Read more...] about Sanofi and MannKind finalize agreement on return of Afrezza rights
AMBER announces NIH funding for development of DPI
Irish science center AMBER (Advanced Materials and BioEngineering Research), located at Trinity College Dublin, has announced that investigator Anne Marie Healy has received a €600,000 grant from the US National Institutes of Health (NIH) for development of a new mucolytic therapy dry powder inhaler. Clinical trials are expected to begin within five years. … [Read more...] about AMBER announces NIH funding for development of DPI
Mucosis initiates Phase 1 trial of its intranasal RSV vaccine
Mucosis has initiated a Phase 1 study of its SynGEM intranasal respiratory syncytial virus (RSV) vaccine, the company said. In January 2016, Mucosis announced that it had received a €3.7 million grant from the Wellcome Trust for Phase 1 and Phase 2a studies. The Phase 1 study will be conducted at Imperial College London and will involve 48 healthy adults. The … [Read more...] about Mucosis initiates Phase 1 trial of its intranasal RSV vaccine
Teleflex Medical recalls intranasal delivery device
According to numerous sources, Teleflex Medical has voluntarily recalled multiple lots of its LMA MAD intranasal delivery device because the devices are failing to aerosolize the drug. The recall notification says, "Teleflex Medical is recalling these products as they may not deliver a fully atomized plume of medication. Teleflex Medical has received complaints … [Read more...] about Teleflex Medical recalls intranasal delivery device
Propeller Health inhaler monitoring platform gets 510(k) clearance for use with the Ellipta DPI
Propeller Health has announced that its inhaler monitoring platform has received 510(k) clearance from the FDA for use with the Ellipta dry powder inhaler. The company had announced a deal with GSK to develop a sensor for the Ellipta DPI in December 2015. GSK Head of Respiratory R&D Dave Allen commented, "While it is still in the early stages of development, the … [Read more...] about Propeller Health inhaler monitoring platform gets 510(k) clearance for use with the Ellipta DPI