August 2012
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The FDA has now approved Teva’s ProAir RespiClick albuterol DPI for the treatment of asthma in patients aged 12 and older, the company said. Teva had announced tentative approval of the product, which was previously… Read more . . .
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Insmed Incorporated has announced that it is offering 10 million shares of its common stock at $20.65 per share, which it expects to generate net proceeds of about $194 million. The company says that it… Read more . . .
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Par Specialty Pharmaceuticals (formerly called Strativa Pharmaceuticals) has launched a single use version of Nascobal cyanocobalamin nasal spray for the treatment of pernicious anemia and other vitamin B12 deficiencies, the company said. The FDA approved… Read more . . .
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According to GSK, the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved its Encruse Ellipta umeclidinium DPI for the treatment of COPD, and the company plans to launch the product in Japan sometime… Read more . . .
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According to Invion Limited, the company “has received a positive response” from the FDA during a pre-IND meeting regarding its INV102 inhaled nadolol for the treatment of asthma and COPD. Invion is developing the drug… Read more . . .
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Verona Pharma has announced what it calls “encouraging interim results” from a Phase 1/2 study of a new formulation of its RPL554 PDE3/4 inhibitor for the treatment of COPD exacerbations. The company had announced the… Read more . . .
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Arikayce inhaled liposomal amikacin developer Insmed Incorporated has announced the appointment of Eugene Sullivan, a former FDA Deputy Director of the Division of Pulmonary and Allergy Products, as Chief Medical and Scientific Officer. Sullivan has… Read more . . .
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A public/private partnership in Louisville, Kentucky called AIR Louisville will distribute 2,000 Propeller Health inhaler sensors to asthma patients across the city as part of a 2-year data collection program, according to Propeller. The FDA… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) and Drug Safety and Risk Management Advisory Committee have voted 16-4 to recommend the approval of GSK’s Breo Ellipta fluticasone/vilanterol DPI for the treatment of asthma in patients… Read more . . .
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AstraZeneca has announced that data from two Phase 3 studies of its PT003 glycopyrronium/formoterol MDI for the treatment of COPD showed statistically significant improvements in lung function for patients using PT003 compared to each of… Read more . . .
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