News
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MannKind Corporation has announced that FDA is no longer requiring a Risk Evaluation and Mitigation Strategy (REMS) communication plan for Afrezza inhaled insulin. Afrezza was approved in the US in June 2014, with the FDA… Read more . . .
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According to GlaxoSmithKline and Innoviva, the FDA has approved an expanded indication for the Trelegy Ellipta fluticasone furoate/umeclidinium/vilanterol DPI, allowing the use of Trelegy Ellipta for COPD patients with airflow limitation or with acutely worsening… Read more . . .
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A US company called Honu Xpress says that it has acquired a license for the Mystabis cannabis MDI which it claims “provides pressurized metered-doses of cannabis oil directly to the lung’s capillaries with little to… Read more . . .
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A US biotech company called AOBiome Therapeutics said that it has initiated a Phase 2 study of an ammonia oxidizing bacteria (AOB) nasal spray for the prevention of episodic migraine. According to AOBiome, the nasal… Read more . . .
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Swedish inhaled product developer Iconovo has announced a deal with Japanese pharmaceutical company TOA for development of Iconovo’s ICOone unit dose dry powder inhaler for the treatment of asthma and COPD. TOA’s Nishihongo facility includes… Read more . . .
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Belgian pharmaceutical company UCB has acquired the rights to Proximagen’s USL261 midazolam nasal spray for $150 million up front and potential milestone payments of up to $220 million, the company said. An NDA for USL261… Read more . . .
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Copley Scientific CEO Mark Copley discusses the recently published USP Chapter <1602> for testing “Spacers & Valved Holding Chambers Used with Inhalation Aerosols” Q: What does this new USP Chapter cover? A: Chapter <1602>, published… Read more . . .
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Swedish instrument company Inhalation Sciences has announced the appointment of Lena Heffler as its new CEO effective May 7, 2018. She will succeed Fredrik Sjövall, who is expected to become Chairman of the Board. Heffler… Read more . . .
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The FDA has issued a revised draft guidance, “Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Products – Quality Considerations.” The guidance is scheduled for publication in the Federal Register on April 19, 2018;… Read more . . .
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Insys Therapeutics has announced that it plans to advance clinical research of a breath activated dronabinol (THC) inhaler in the second half of 2018. The company said that it plans to develop the inhaler for… Read more . . .
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