August 2012
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In addition to ongoing litigation against Liquidia Corporation alleging infringement of patents covering Tyvaso inhaled treprostinil by Liquidia’s Yutrepia treprostinil DPI, United Therapeutics Corporation announced that it is now suing the FDA over its handling… Read more . . .
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ARS Pharmaceuticals said that it intends to file a response to the September 2023 complete response letter to its NDA for Neffy epinephrine nasal spray “early in the second quarter of 2024,” with the response… Read more . . .
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LTR Pharma has announced the initiation of a bioequivalence study of its Spontan vardenafil nasal spray, which the company is developing for the treatment of erectile dysfunction. According to LTR, the study will compare a… Read more . . .
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Health Canada has announced that Apotex is recalling 2 lots of its mometasone nasal spray, a generic of Nasonex, due to possible contamination with Burkholderia cepacia complex. Lot TX5343 has an expiration date of September 2025, and… Read more . . .
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Copley Application Specialist Clair Brooks discusses new EMA guidance on data requirements associated with the transition to low global warming potential (LGWP) propellants in metered dose inhalers and strategies for the successful application of in… Read more . . .
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SaNOtize has initiated a Phase 2 study of its nitric oxide nasal spray (NONS) for the treatment of recurrent acute rhinosinusitis, the company said. The trial is expected to enroll 186 patients who will receive… Read more . . .
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Krystal Biotech announced that inhaled KB707 gene therapy for the treatment of metastasized tumors in the lung that are not successfully treated with standard therapy has been granted Fast Track designation by the FDA. The… Read more . . .
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Oragenics, which describes itself as “a company focused on developing unique, intranasal nanoparticle pharmaceuticals for the treatment of neurological disorders” has announced the resignation of CEO Kimberly Murphy as part of “a mutually agreeable Separation… Read more . . .
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Iconovo has announced the launch of new versions of its nasal ICOone dry powder inhalers and an extended development deal with Danish start-up Kiox Pharmaceuticals. The second generation nasal inhalers, whose development has been supported… Read more . . .
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CDMO Catalent has announced the addition of DPI capsule filling capacity for potent drugs at its facility in the Boston, MA, USA area, including isolators for processing of potent compounds and cleanroom upgrades. According to Catalent,… Read more . . .
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