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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

Adherium’s Smartinhaler SmartTouch for Symbicort sensor gets 510(k) OTC clearance

According to Adherium, the FDA has okayed over-the-counter (OTC) sales of the company's Smartinhaler sensor for AstraZeneca’s Symbicort MDI. The 510(k) OTC clearance will allow patients to purchase the sensor without a prescription at local pharmacies or online. In 2015, Adherium announced that it had partnered with AstraZeneca to provide sensors for use in the … [Read more...] about Adherium’s Smartinhaler SmartTouch for Symbicort sensor gets 510(k) OTC clearance

Evoke announces modification of agreement with Mallinckrodt on Gimoti development

Evoke Pharma announced that an amendment of its agreement with Mallinckrodt allows for deferral of milestone payments due on acceptance of review of the company's NDA for Gimoti intranasal metoclopramide for the treatment of gastroparesis in women and on final approval. The agreement now allows for a single milestone payment that will be due a year after FDA approval … [Read more...] about Evoke announces modification of agreement with Mallinckrodt on Gimoti development

Hovione provides update on expansion of manufacturing sites

Hovione has provided an update on its ongoing expansion of manufacturing sites in Portugal, Ireland and the US, saying that it has already added significant capacity to the Portuguese and US facilities and has plans to add more in Portugal and Ireland over the next 5 years. According to the company, the expansion in facilities has also led to a 39% increase in … [Read more...] about Hovione provides update on expansion of manufacturing sites

Orion gets positive opinion for salmeterol/fluticasone Easyhaler in EU under the decentralized procedure

Orion Corporation has announced that its salmeterol/fluticasone Easyhaler combination DPI has received a positive opinion under the EU's decentralized procedure, with Sweden as the reference member state. Orion had announced in December 2016 that it planned to submit an MAA in early 2017 based on positive results from a PK study. According to Orion, it will now … [Read more...] about Orion gets positive opinion for salmeterol/fluticasone Easyhaler in EU under the decentralized procedure