News
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The FDA has published notice of an online meeting of the Pulmonary-Allergy Drugs Advisory Committee (PADAC) to take place on November 8, 2022 for the purpose of discussing Avillion and AstraZeneca’s NDA (214070) for PT027… Read more . . .
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MannKind Corporation announced today that a Phase 1 study of MNKD-101 clofazimine demonstrated that the inhalation suspension was well tolerated at doses up to 90 mg/day over 7 days and identified no safety issues. The company… Read more . . .
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Hoth Therapeutics said that a preclinical study conducted at North Carolina State University demonstrated that the company’s HT-004 inhaled antisense oligonucleotide significantly reduced lung inflammation in mice following an ovalalbumin challenge. According to Hoth, HT-004… Read more . . .
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The United States District Court for the District of Delaware has ruled that Liquidia’s Yutrepia treprostinil DPI would infringe claims contained in US patents 9,593,066 and 10,716,793, which cover United Therapeutics’ Tyvaso inhaled treprostinil; however,… Read more . . .
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The European Patent Office (EPO) has granted Orexo a patent (EP 3962455B1) covering the company’s OX640 intranasal dry powder adrenaline, which is in Phase 1 development for the emergency treatment of anaphylaxis. According to the… Read more . . .
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Aptar Pharma said that it has acquired US-based design firm Metaphase Design Group and will integrate the company into its subsidiary Noble, which Aptar acquired in 2019. Noble launched its Human Factors Plus (HF+) services… Read more . . .
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Hikma Pharmaceuticals has launched Ryaltris olopatadine / mometasone nasal spray in the US, the company said. Hikma acquired US rights to Ryaltris in February 2020, and the FDA approved Glenmark’s NDA for the nasal spray… Read more . . .
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According to Lupin, the MHRA has approved company’s Lutio tiotropium bromide inhalation powder, a generic version of Boehringer Ingelheim’s Spiriva Handihaler. The approval is the second for a Lupin OINDP in the UK; the MHRA… Read more . . .
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Savara has announced the resignation of Badrul Chowdhury as Chief Medical Officer, effective September 9, 2022. Chowdhury, a former Director of the FDA’s Division of Pulmonary, Allergy, and Rheumatology Products, joined Savara as CMO in November… Read more . . .
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Adherium has submitted a 510(k) application for use of its next generation Hailie inhaler monitoring sensor with Teva’s ProAir albuterol MDI and its generic albuterol HFA MDI, the company said. Recently, the company filed a… Read more . . .
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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
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