Moerae Matrix has initiated a lipopolysaccharide (LPS) challenge study of its MMI-0100 inhaled MAPKAP kinase 2 (MK2) inhibitor to evaluate its safety and tolerability in smokers, the company said. Moerae is developing MMI-0100 as a DPI for the treatment of idiopathic pulmonary fibrosis and other pulmonary diseases and has already conducted one Phase 1 study. In … [Read more...] about Moerae Matrix announces initiation of second Phase 1 study of inhaled MK2 inhibitor
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Adapt Pharma submits NDA for Narcan nasal spray
Adapt Pharma has submitted an NDA for Narcan naloxone nasal spray for the treatment of opioid overdose to the FDA, the company has announced. In June 2015, Adapt said that it had initiated a rolling NDA submission. Adapt Chairman and CEO Seamus Mulligan commented, “If FDA approved, Narcan Nasal Spray would allow for the administration of naloxone - the standard … [Read more...] about Adapt Pharma submits NDA for Narcan nasal spray
Investigation into Ansun BioPharma dismissed
Inhaled vaccine developer Ansun BioPharma, formerly NexBio, has announced that the US Attorney's office investigation of misconduct by the company's former CEO and CFO has been dismissed. As part of that investigation, the US Federal Bureau of Investigation (FBI) raided the California headquarters of NexBio in August 2011. According to a January 2015 announcement … [Read more...] about Investigation into Ansun BioPharma dismissed
Invion and Hovione partner on inhaled zafirlukast for asthma
Hovione and Invion will partner on the development of Invion's INV104 zafirlukast DPI for the treatment of asthma, the companies have announced. Hovione will provide the device as well as particle engineering, formulation, and manufacturing services; Invion will take responsibility for pre-clinical and clinical development as well as regulatory submissions. Hovione … [Read more...] about Invion and Hovione partner on inhaled zafirlukast for asthma
Pulmatrix gets two new patents for its iSPERSE inhalation powder technology
The US Patent and Trademark Office has issued Pulmatrix two new patents, US Patent No. 8,992,983, "Respirably dry powder comprising calcium lactate, sodium chloride and leucine" and US Patent No. 9,061,352, "Dry powder formulations and methods for treating pulmonary diseases," the company said. Pulmatrix now has 36 patents covering technology related to the iSPERSE … [Read more...] about Pulmatrix gets two new patents for its iSPERSE inhalation powder technology
Adherium (formerly Nexus6) partners with AstraZeneca
Smartinhaler maker Adherium (formerly Nexus6) has announced a new deal to provide AstraZeneca with devices and sensors for use in asthma and COPD patient support programs. AstraZeneca has already used the Adherium technology in clinical trials. Studies have verified that Smartinhaler use significantly increases adherence to asthma medications both in children and … [Read more...] about Adherium (formerly Nexus6) partners with AstraZeneca
Acorda gets Gates Foundation grant for dry powder lung surfactant development
Acorda Therapeutics has announced that it received a $1.4 million grant from the Bill & Melinda Gates Foundation for development of a dry powder lung surfactant for the treatment of neonatal respiratory distress syndrome (RDS) based on its ARCUS inhalation platform, as well as a delivery system. The company will develop the formulation in conjunction with the … [Read more...] about Acorda gets Gates Foundation grant for dry powder lung surfactant development
Propeller Health’s inhaler monitoring platform approved for use with Diskus and Respimat
Propeller Health has received 510(k) clearance from the FDA to market the Propeller inhaler monitoring platform for use with the Diskus DPI and with the Respimat SMI, the company announced. Two versions of the Propeller platform have previously been approved for use with MDIs, most recently in 2014. The platform includes Bluetooth-enabled sensors that snap onto … [Read more...] about Propeller Health’s inhaler monitoring platform approved for use with Diskus and Respimat
Amneal’s generic version of Tobi inhalation solution approved by FDA
The FDA has approved Amneal Pharmaceuticals's generic version of Tobi tobramycin inhalation solution, the company said. The product is the New Jersey-based generic pharmaceutical company's first inhalation solution. Amneal co-CEO and Chairman Chirag Patel said, "Tobramycin is extremely exciting for us in that it’s a new dosage form for Amneal—proof we’re … [Read more...] about Amneal’s generic version of Tobi inhalation solution approved by FDA
Inhalation Sciences adds new investors
Swedish-based Inhalation Sciences AB (ISAB) has added new minority shareholders Stockholms Affärsänglar (STOAF) and Almi Invest, "with a significant initial capital investment," the company said. According to ISAB, that investment is the first phase out of three. ISAB's PreciseInhale system is used to aerosolize very small amounts of inhalable dry powders for … [Read more...] about Inhalation Sciences adds new investors