News
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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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Discovery Laboratories has announced that it will switch its focus from Surfaxin lucinactant intratracheal suspension product to development of its Aerosurf aerosolized KL4 surfactant for the treatment of respiratory distress syndrome in premature infants. The… Read more . . .
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In a letter from the FDA to Sunovion dated March 12, 2015, the agency informed the company that all postmarketing requirements and commitments specified after the 2005 approval of the Xopenex HFA levalbuterol MDI have… Read more . . .
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