News
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According to Hovione, the United States Patent and Trademark Office (USPTO) has granted the company a patent for its XCAPs capsule-based dry powder inhaler. The European Patent Office granted the company a patent for the… Read more . . .
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The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for MannKind’s Afrezza inhaled insulin by three months, according to MannKind. The original date was April 15, 2014; the new date is July… Read more . . .
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On April 2, 2014, the FDA issued a draft guidance for fentanyl citrate nasal spray.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 . . .
Upcoming Events
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July 13-July 16: 2026 ISAM Congress, Taipei, Taiwan
September 15-September 18: DDL New Researcher Network Summer Event, London, UK
September 16-September 17: IPAC-RS 2026 Nasal Innovation Forum, Jersey City, NJ, USA
September 24-September 25: Inhaled & Nasal Biologics | DNA Forum, Cambridge, UK
October 14-October 15: Advancing Bioequivalence Frameworks for Inhalation and Nasal Drug Products: Optimizing In Vitro, In Vivo, and In Silico Methods, Rockville, MD, USA