Jobs
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The FDA has granted Fast Track designation to Renovion’s ARINA-1 nebulized mucolytic for the prevention of bronchiolitis obliterans syndrome in patients who have had a bilateral lung transplant, which will allow the company to take… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) has scheduled a meeting on May 11, 2023 to review the ARS Pharmaceuticals’ NDA for Neffy intranasal epinephrine for the treatment of anaphylaxis and other Type 1 allergic reactions. The… Read more . . .
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The FDA has approved Emergent Biosolutions’ sNDA for OTC sales of Narcan naloxone nasal spray, 4 mg, for reversal of opioid overdose. Narcan was first approved for prescription use in the US in 2015. The… Read more . . .
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Tiziana Life Sciences says that after receiving feedback from the FDA following a Type C meeting, the company plans to move forward with a Phase 2 trial of intranasal foralumab, a human anti-CD3 mAb, in… Read more . . .
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MannKind Corporation has named former Acorda Therapeutics COO Lauren Sabella as Executive VP, Chief Operating Officer. Sabella’s experience includes 12 years at Acorda, first as Chief Commercial Officer and then as COO; she previously served in a… Read more . . .
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Avalyn Pharma has published data from its Phase 1b ATLAS study evaluating the safety of AP01 nebulized pirfenidone in patients with idiopathic pulmonary fibrosis over 72 weeks. In the article, the authors report that treatment-related adverse… Read more . . .
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Charles G. Thiel, one of the most influential scientists working in respiratory drug delivery over the past 7 decades, passed away on March 10, 2023 at the age of 94. In 1956, Thiel and co-workers… Read more . . .
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Catalent and Harm Reduction Therapeutics (HRT) announced that they have signed a commercial supply agreement for the manufacture of HRT’s RiVive intranasal naloxone. The news comes shortly after HRT said that it would receive an… Read more . . .
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According to Harm Reduction Therapeutics (HRT), the court handling the bankruptcy of Purdue Pharma has approved an additional $9 million in Purdue funds to be used by HRT to prepare for possible commercialization of RiVive… Read more . . .
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Vistagen said that a Phase 3 open label safety study of fasedienol (PH94B, aloradine) nasal spray for the treatment of social anxiety disorder (SAD) found that up to 4 daily doses of 3.2 µg was well-tolerated,… Read more . . .
Upcoming Events
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December 9-December 11: DDL 2026, Edinburgh, Scotland
April 27-30: RDD Europe 2027, Antibes, France
May 12-13: USP Joint Workshop: Quality and Product Performance Testing of Orally Inhaled and Nasal Drug Products, Rockville, MD, USA
June 30: RespireX 2027, Boston, MA, USA