Pneuma Respiratory, which introduced a digital soft mist inhaler in November 2017, has announced the appointment of former Boehringer Ingelheim VP of Respiratory Products Steven Kesten as its new President and Chief Medical Officer. Since leaving Boehringer Ingelheim in 2010, Kesten has held VP and Chief Medical Officer positions at Uptake Medical and Cytori … [Read more...] about Pneuma Respiratory appoints Steven Kesten as President and Chief Medical Officer
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Trelegy Ellipta approved in Canada
According to GSK and Innoviva, the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI has been approved in Canada for the treatment of COPD in patients for whom treatment with an ICS/LABA combination is inadequate. Trelegy Ellipta should be available in Canada sometime in June of this year, the companies said. Trelegy Ellipta was approved in the US in … [Read more...] about Trelegy Ellipta approved in Canada
Sunovion launches Lonhala Magnair glycopyrrolate inhalation solution in the US
Sunovion Pharmaceuticals has launched Lonhala Magnair glycopyrrolate inhalation solution for the treatment of COPD in the US, the company said. Lonhala Magnair, also known as SUN-101/eFlow, was approved by the FDA in December 2017. In May 2017, the FDA issued a complete response letter to Sunovion's initial NDA for Lonhala Magnair, which had been accepted for … [Read more...] about Sunovion launches Lonhala Magnair glycopyrrolate inhalation solution in the US
TFF Pharmaceuticals raises $14 million for DPI development
A Texas-based startup called TFF Pharmaceuticals announced that it raised $14 million in a Series A preferred stock offering and that it plans to use the funds for development of dry powder formulations for the treatment of a wide variety of pulmonary diseases. The company said that it has an exclusive license to thin film freezing (TFF) technology developed at … [Read more...] about TFF Pharmaceuticals raises $14 million for DPI development
Promius Pharma submits NDA for intranasal sumatriptan for migraine headaches
Dr. Reddy's subsidiary Promius Pharma has submitted an NDA for its DFN-02 intranasal sumatriptan for the treatment of migraine headaches, the company said. The DFN-02 formulation includes Aegis Therapeutics' Intravail absorption enhancer; Aegis received a US patent for formulations of triptans including Intravail in 2012. In June 2016, Promius announced that a … [Read more...] about Promius Pharma submits NDA for intranasal sumatriptan for migraine headaches
Insmed submits NDA for ALIS for the treatment of NTM lung infections caused by MAC
Insmed has submitted an NDA for ALIS amikacin liposome inhalation suspension for the treatment of nontuberculous mycobacterial (NTM) lung infections caused by Mycobacterium avium complex (MAC), the company said. In September 2017, Insmed announced that it would seek accelerated approval for ALIS from the FDA based on positive results from the Phase 3 CONVERT … [Read more...] about Insmed submits NDA for ALIS for the treatment of NTM lung infections caused by MAC
Boehringer Ingelheim publishes results of study comparing Stiolto Respimat and Spiriva Respimat for COPD
Boehringer Ingelheim has published results from the 52-week DYNAGITO study in The Lancet Respiratory Medicine showing that the Stiolto Respimat tiotropium bromide/olodaterol soft mist inhaler produced a 7% greater reduction in moderate-to-severe COPD exacerbations than the Spiriva Respimat tiotropium bromide SMI. According to BI, that reduction was "not reaching the … [Read more...] about Boehringer Ingelheim publishes results of study comparing Stiolto Respimat and Spiriva Respimat for COPD
Arch Biopartners gets US patent for its AB569 antibacterial inhalation solution
According to Arch Biopartners, the US Patent and Trademark Office has issued US Patent 9,925,206, “Compositions and Methods for Treating Bacterial Infection,” which covers the composition of AB569 sodium nitrite/ethylenediaminetetraacetic acid (EDTA), to the University of Cincinnati. Arch acquired an exclusive license for AB569 from the university in March 2016 … [Read more...] about Arch Biopartners gets US patent for its AB569 antibacterial inhalation solution
Convexity Scientific launches Flyp handheld ultrasonic nebulizer
US-based Convexity Scientific has announced the availability of its Flyp handheld ultrasonic nebulizer, which the company says received FDA clearance in May 2017. The Flyp nebulizer is lighter weight than a smartphone, the company said, with a rechargeable lithium-ion battery, and delivers most medications in about 7 minutes. Convexity is selling the Flyp nebulizer … [Read more...] about Convexity Scientific launches Flyp handheld ultrasonic nebulizer
Verona reports positive Phase 2b results for RPL554
Verona Pharma has announced that a Phase 2b study of its RPL554 inhaled PDE3/PDE4 inhibitor met its primary endpoint, demonstrating significant improvement in FEV1 compared to placebo at 4 weeks in patients with moderate-to-severe COPD for all 4 doses tested. The study also met secondary endpoints, with significant improvements in 12-hour average FEV1, respiratory … [Read more...] about Verona reports positive Phase 2b results for RPL554