August 2012
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Esketamine (Spravato) and sumatriptan (Tosymra) nasal sprays are among the latest set of product specific draft guidances published by the FDA. Earlier this year, the agency published a product specific guidance for sumatriptan nasal powder.… Read more . . .
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Partner Therapeutics (PTx) has announced the initiation of the iLeukPulm Phase 2 trial of an inhaled formulation of its Leukine sargramostim in hospitalized COVID-19 patients in respiratory distress. Partner recently signed a $35 million contract… Read more . . .
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Altimmune has announced that a preclinical study of its intranasal COVID-19 vaccine candidate AdCOVID has demonstrated a strong immune response in the lungs of mice, particularly in the stimulation of CD8+ T cells. In July… Read more . . .
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Union Therapeutics said that a Phase 1 SAD/MAD trial of UNI911 dry powder niclosamide in 44 healthy volunteers was completed successfully, confirming the safety of the inhaled formulation. The company recently acquired an option for… Read more . . .
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Virpax Pharmaceuticals said that it has acquired exclusive North American rights to Nanomerics’ MMS019 nasal powder, which it calls a “high density molecular masking spray” and which is intended to block viruses from taking hold in… Read more . . .
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The FDA has approved Lupin’s generic version of Teva’s ProAir HFA albuterol MDI for the treatment of asthma, the company said. Lupin said that it will manufacture the inhaler at its facility in Indore, India.… Read more . . .
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Medical Developments International (MVP) has announced that it will buy back the European Union rights to its Penthrox methoxyflurane inhaler from Mundipharma for €3 million, plus a 5% royalty up to a maximum of €5… Read more . . .
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Verona Pharma has announced the initiation of a Phase 2b trial of its ensifentrine MDI for the treatment of COPD in the UK, with results expected in the first half of 2021. In March 2020,… Read more . . .
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According to Lannett, the company has signed an agreement with Chinese inhaled drug developer Respirent for exclusive rights to distribute Respirent’s generic version of GSK’s Flovent Diskus fluticasone propionate DPI, which is in early development.… Read more . . .
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The FDA has accepted a supplemental NDA for United Therapeutics’s Tyvaso treprostinil inhalation solution for the treatment of pulmonary hypertension associated with interstitial lung disease (PH-ILD), the company said. In February 2020, United Therapeutics announced… Read more . . .
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