News
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On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray. The guidance offers an in vitro option, saying, “If the test product is qualitatively (Q1) and quantitatively (Q2) the same… Read more . . .
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Swedish pharmaceutical company Meda has confirmed that Mylan approached the company with a takeover offer and that Meda rejected the offer. According to Meda, “All continued discussions between Meda and Mylan have been terminated without… Read more . . .
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Swedish CDMO Recipharm, which has a dedicated DPI manufacturing facility in the UK, has begun trading on the Stockholm stock exchange, according to NASDAQ OMX. Recipharm had announced the IPO in March 2014. Recipharm CEO… Read more . . .
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In anticipation of the potential commercialization of its Arikayce inhaled liposomal amikacin, Insmed has announced a number of management changes designed to “better align the organization with the company’s growth opportunities.” Those changes are: Renu… Read more . . .
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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 . . .
Upcoming Events
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May 10-May 14: RDD 2026, Phoenix, AZ, USA
May 15-May 16: ATS Respiratory Innovation Summit 2026, Orlando, FL, USA
May 17-May 20: ATS International Conference 2026, Orlando, FL, USA
June 10: SMI.London 2026, London, UK
July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan