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Business

FDA approval for Breckenridge’s azelastine nasal spray

Florida-based Breckenridge Pharmaceutical has announced the launch of its azelastine HCl nasal spray, a generic version of Meda's Astelin, after receiving final FDA approval of its ANDA. The product is approved for the treatment of seasonal allergic rhinitis in patients aged 5 years and older for the treatment of vasomotor rhinitis in patients 12 years and … [Read more...] about FDA approval for Breckenridge’s azelastine nasal spray

Discovery Labs gets additional funding for development of aerosolized KL4 surfactant

Discovery Laboratories has announced the completion of a public offering that raised over $40 million as well as the receipt of a $1 million supplement from a Phase 2 Small Business Innovation Research (SBIR) grant that was initially announced in October 2014. The grant supports development of Discovery Labs' aerosolized KL4 surfactant for the treatment of … [Read more...] about Discovery Labs gets additional funding for development of aerosolized KL4 surfactant

Allergan confirms submission of ANDA for treprostinil inhalation solution

Allergan has confirmed that it submitted an Abbreviated New Drug Application (ANDA) with the FDA for a generic version of United Therapeutics' Tyvaso treprostinil inhalation solution for the treatment of pulmonary arterial hypertension and says it believes that it is the first applicant to file. In June 2015, United Therapeutics announced that it had received … [Read more...] about Allergan confirms submission of ANDA for treprostinil inhalation solution

Moerae Matrix announces initiation of second Phase 1 study of inhaled MK2 inhibitor

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

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

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

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