August 2012
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Orexo announced that it has resubmitted an NDA for OX124 naloxone nasal powder for the reversal of opioid overdose. In February 2023, the company announced that it had submitted an NDA for OX124 and then… Read more . . .
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The FDA issued a document on September 8, 2023 titled “Application of Human Factors Engineering Principles for Combination Products: Questions and Answers,” which is the final version of a draft guidance titled “Human Factors Studies… Read more . . .
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According to Evoke Pharma, the company has received a notice of allowance from the US Patent and Trademark Office (USPTO) for patent application No. 17/366,829 (“Nasal Formulations of Metoclopramide”). The patent will cover the composition of Evoke’s… Read more . . .
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NurExone Biologic announced that the company has received feedback from the FDA following a pre-IND meeting regarding NurExone’s ExoPTEN intranasal exosome therapy and now plans to submit an IND by the end of this year… Read more . . .
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Oxford Science Enterprises and Harrington Discovery Institute at University Hospitals, together with the University of Edinburgh’s Old College Capital venture investment fund, have created a startup called AlveoGene to develop inhaled gene therapies based on… Read more . . .
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US-based CDMO Renaissance Lakewood, which offers a wide range of services for nasal spray development and manufacturing, has announced a significant expansion of its laboratories in New Jersey, the company said. The expansion is part… Read more . . .
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Copley Scientific has announced the launch of its new Patient Exhalation Simulator (PES) for use in dry powder inhaler development. According to Copley, the PES simulates exhalation into a DPI prior to inhalation of the… Read more . . .
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US-based Avalyn Pharma has announced the appointment of former Aerami Therapeutics Chief Development Officer Melissa Rhodes as Chief Operating Officer, a newly created position. Avalyn, which is developing AP01 inhaled pirfenidone and AP02 inhaled nintedanib for… Read more . . .
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According to Verona Pharma, the FDA has accepted the company’s NDA for its nebulized ensifentrine (RPL554) for the treatment of COPD with a PDUFA target date of June 26, 2024. The company submitted the NDA… Read more . . .
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According to Liquidia Corporation, United Therapeutics has filed a new patent infringement suit in the US District Court for the District of Delaware in response to Liquidia’s submission of an sNDA for Yutrepia treprostinil DPI to add… Read more . . .
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