News
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The FDA has announced a funding opportunity for a research project titled “Development of Clinically Relevant In Vitro Performance Test for Generic OIDPs: Physiologically Relevant Models for Aerodynamic Particle Size Distribution Analysis.” Two grants of… Read more . . .
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The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of MannKind’s Afrezza inhaled insulin for both Type 1 and Type 2 diabetes. The vote was 13-1 in agreement that the product… Read more . . .
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The organizers of the recent Orlando Inhalation Conference have made all of the presentations from the meeting available to the public. Approximately 200 OINDP specialists gathered March 18-20, 2014 at the University of Florida Research… Read more . . .
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As part of a planned five-year initiative to improve healthcare in Africa, GlaxoSmithKline has announced that it plans to make more of its existing drugs available in Africa and has specified the Ventolin albuterol inhaler… Read more . . .
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Skyepharma revenues were up 25% in 2013, the company said, in large part due to increased sales of its Flutiform fluticasone/formoterol MDI. The company also announced that it will seek to raise £112 million through… Read more . . .
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Meeting documents for the upcoming April 1 meeting of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) on MannKind’s Afrezza inhaled insulin include questions about the efficacy of Afrezza compared to subcutaneous insulin and… Read more . . .
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Summit Biosciences has announced the successful completion of an FDA preapproval inspection of its Lexington, KY manufacturing facility. The company, a spin-off of the University of Kentucky College of Pharmacy, said that the inspection is… Read more . . .
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Contract research organization Next Breath has announced that it has been certified as a Center for Pharmaceutical Equivalence (EQFAR) by the Brazilian National Health Surveillance Agency (ANVISA) subsequent to a week-long audit of its quality… Read more . . .
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NanoBio has announced that Merck has acquired exclusive rights to NanoBio’s NanoStat nanoemulsion adjuvant for an intranasal respiratory syncytial virus (RSV) vaccine. Merck also acquired non-exclusive rights to the adjuvant for use in an intranasal… Read more . . .
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Avanir Pharmaceuticals has announced that the FDA has accepted its new drug application for the company’s AVP-825 dry powder intranasal sumatriptan for the treatment of migraine headaches. The 505(b)(2) NDA was filed in January 2014.… Read more . . .
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