H&T Presspart and Cohero Health have officially launched the eMDI connected metered dose inhaler (eMDI), which integrates with Cohero Health's BreatheSmart inhaler tracking and lung function measurement platform. The two companies initially announced the eMDI project at RDD in April 2016. The eMDI contains embedded sensors that record inhaler usage in addition to a … [Read more...] about H&T Presspart and Cohero Health launch the eMDI
News
Nanopharm appoints Arron Danson as Head of Device Development
OINDP development specialist Nanopharm has appointed Arron Danson as Head of Device Development, the company said. Danson has extensive experience in the development of pulmonary and nasal delivery devices, having worked at companies such as Vectura, Coalesce Product Development, and, most recently, Kinneir Dufort. Nanopharm, which announced the appointment of … [Read more...] about Nanopharm appoints Arron Danson as Head of Device Development
GSK files regulatory submission for triple combination DPI in EU
GlaxoSmithKline and Innoviva have announced that GSK has filed an MAA with the European Medicines Agency for its fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD. In November 2016, GSK submitted an NDA for the FF/UMEC/VI product in the US. GSK Head, Respiratory Therapy Area Unit, R&D, Dave Allen said, “Many patients with COPD are already … [Read more...] about GSK files regulatory submission for triple combination DPI in EU
Impel NeuroPharma raises $36 million for development of intranasal CNS products
Intranasal drug developer Impel NeuroPharma has received $21 million in the initial tranche of a Series C financing round, with another $15 million available on completion of development and business milestones, the company said. Investors venBIO, 5AM Ventures and Vivo Capital, contributed equally. Impel NeuroPharma CEO John Hoekman said, “The nasal cavity is a … [Read more...] about Impel NeuroPharma raises $36 million for development of intranasal CNS products
Relvar Ellipta approved in Japan for the treatment of COPD
GlaxoSmithKline and Innoviva have announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the 100/25 mcg strength of the Relvar Ellipta fluticasone furoate/vilanterol DPI for the treatment of COPD. Both the 100/25 mcg and 200/25 mcg strengths of Relvar Ellipta have been approved in Japan for the treatment of asthma since 2013. GSK … [Read more...] about Relvar Ellipta approved in Japan for the treatment of COPD
Aradigm announces top line results from Phase 3 trials of Pulmaquin for non-CF bronchiectasis
Aradigm Corporation has announced that top-line results from the Phase 3 ORBIT-3 and ORBIT-4 trials of Pulmaquin inhaled ciprofloxacin for the treatment of P. aeruginosa lung infections in patients with non-cystic fibrosis bronchiectasis (non-CF BE) demonstrated increase in time to the first exacerbation, the primary endpoint, that was not statistically significant in … [Read more...] about Aradigm announces top line results from Phase 3 trials of Pulmaquin for non-CF bronchiectasis
Intertek adds MDRS capabilities to OINDP development services
Intertek has announced the addition of morphologically-directed Raman spectroscopy (MDRS) capabilities to its OINDP analytical and development services with the acquisition of a Malvern Instruments Morphologi G3-ID. MDRS has the ability to distinguish API particle from excipient particles in nasal suspensions, allowing for direct measurement of API particle size … [Read more...] about Intertek adds MDRS capabilities to OINDP development services
Avanir appoints Richard Malamut Senior VP of R&D, CMO
Avanir Pharmaceuticals, which launched its Onzetra Xsail intranasal dry powder sumatriptan in the US in May 2016, has announced the appointment of Richard Malamut as Senior VP, Research and Development and Chief Medical Officer. Malamut was most recently Senior VP of Global Clinical Development and Head of Pain, Oncology, Neuropsychiatry and NTEs at Teva … [Read more...] about Avanir appoints Richard Malamut Senior VP of R&D, CMO
Teva to market Syqe cannabis inhaler in Israel
Teva Israel and Syqe Medical have announced that Teva will distribute Syqe's cannabis inhaler in Israel, with Syqe responsible for manufacturing the inhaler and cartridges. No financial terms were disclosed. The Syqe device delivers 100 mcg doses using heat and controlled air flow plus cartridges filled with "structurally modified" raw plants. According to Teva, … [Read more...] about Teva to market Syqe cannabis inhaler in Israel
Merxin announces launch of generic blister DPI
Device developer Merxin has announced the availability of its MRX001 "off the shelf" multidose dry powder inhaler. According to an announcement on the website of Merxin sister company Aedestra, the blister-based DPI is designed for developers of generic combination products planning to submit a 505(j) application. Earlier this year, Merxin announced the launch … [Read more...] about Merxin announces launch of generic blister DPI