August 2012
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Allergan, which recently acquired MAP Pharmaceuticals, has announced that it has received a Complete Response Letter (CRL) from the FDA in regard to its NDA for Levadex inhaled dihydroergotamine for the treatment of migraines. The… Read more . . .
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Almirall and Forest Laboratories have announced that a 6-month Phase 3 study of their aclidinium bromide/formoterol fumarate dry powder fixed dose combination delivered by the Genuair (Pressair) inhaler for the treatment of COPD demonstrated statistically… Read more . . .
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Bayer HealthCare has announced the initiation of its Phase 3 program to evaluate the efficacy and safety of Amikacin Inhale in patients with Gram-negative pneumonia who are intubated and mechanically ventilated and being treated with… Read more . . .
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According to Discovery Laboratories its Aerosurf aerosolized surfactant development program “currently remains on track for the Phase 2 clinical program in the fourth quarter of 2013” and is unaffected by the FDA’s recent questions about… Read more . . .
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Canadian respiratory drug developer Asmacure has dosed the first subjects in a Phase 1/2 clinical trial of its ASM-024 inhalation powder for the treatment of asthma, the company says. According to the company, “ASM-024 has… Read more . . .
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According to Activaero, a Phase 2 trial of a budesonide suspension delivered using its FAVORITE (Flow and Volume Controlled Inhalation Technology) system in children with mild to moderate asthma improved asthma control, reduced treatment times,… Read more . . .
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The FDA draft guidance on albuterol sulfate MDIs published April 8, 2013 includes recommendations for a total of 7 studies, including 5 in vitro studies, 1 PK study, and 1 PD study to establish bioequivalence.… Read more . . .
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In addition to scientific sessions, Day 3 of ISAM 2013 included awards presentations and the organization’s general assembly meeting. During the awards ceremony, Bill Bennett presented the Jurai Ferin award to Patrice Diot of the… Read more . . .
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The first session of Day 2 of the 2013 ISAM Congress concerned “Aerosol Deposition at the Extremes: . . . Read more Read more . . .
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On the first full day of the International Society of Aerosol Medicine (ISAM) 2013 Congress, Congress Chair Bill Bennett welcomed approximately 330 delegates to the University of North Carolina, Chapel Hill. Many of the delegates… Read more . . .
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