Regulatory
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PureIMS announced that a Phase 1 PK study that compared the company’s Levodopa Cyclops to Inbrija levodopa DPI, demonstrated “high comparability with a marketed inhaled levodopa product,” with faster initial absorption and no safety or… Read more . . .
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Liquidia Corporation announced that it has initiated the ASCENT open-label safety and tolerability study of Yutrepia (LIQ861) treprostinil DPI in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD). The 52-week study is expected… Read more . . .
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Members of the United States Senate Committee on Health, Education, Labor, and Pensions (HELP) have sent letters to the CEOs of AstraZeneca, Boehringer Ingelheim, GSK, and Teva asserting that “There is no reason for inhalers… Read more . . .
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Firebrick Pharmaceuticals announced that it has withdrawn its appeal of a decision by the Therapeutic Goods Administration (TGA), which refused to approve the company’s Nasodine povidone-iodine nasal spray as a treatment for the common cold.… Read more . . .
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According to Milestone Pharmaceuticals, the FDA has refused to file the company’s NDA for etripamil nasal spray for the treatment of paroxysmal supraventricular tachycardia (PSVT) and has “requested clarification about the time of data recorded for… Read more . . .
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According to Liquidia Corporation, the company will immediately take steps toward getting final FDA approval of Yutrepia treprostinil DPI now that the US Court of Appeals has upheld a decision by the Patent Trial and Appeal… Read more . . .
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The FDA has extended the review period for Optinose’s sNDA seeking approval of Xhance fluticasone propionate nasal spray for the treatment of chronic sinusitis in patients without nasal polyps, Optinose said. Xhance was originally approved… Read more . . .
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An FDA warning letter to Cipla dated November 17, 2023 cites numerous problems found in a February 2023 inspection of Cipla’s metered dose inhaler manufacturing facility in Pithampur, Madhya Pradesh, India. Among the issues cited… Read more . . .
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According to Ethris, a clinical trial authorization (CTA) that the company submitted to the UK Medicines and Healthcare Products Regulatory Agency (MHRA) in June 2023 has been approved, and Ethris expects to initiate a Phase… Read more . . .
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Orexo said that the FDA has accepted the company’s NDA for OX124 intranasal dry powder high dose naloxone for the reversal of opioid overdose and has set a PDUFA date of July 15, 2024. The… Read more . . .
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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
October 19-October 20: MVIC Autumn Training 2026, Lund, Sweden
October 21-October 22: MVIC Symposium, Lund, Sweden
October 28-October 30: Deutches Aerosol Therapie Symposium (DATS), Marburg, Germany
November 10-November 11: Rescon Europe 2026, Porto, Portugal