August 2012
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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,… Read more . . .
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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… Read more . . .
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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… Read more . . .
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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… Read more . . .
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Acorda Therapeutics has submitted a marketing authorization application to the EMA for its Inbrija levodopa DPI for the treatment of OFF periods in Parkinson’s disease patients, the company said. The application is supported by data… Read more . . .
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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… Read more . . .
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