Regulatory
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Adherium announced that the FDA has granted 510(k) clearance for use of Adherium’s next-generation Hailie inhaler sensor with GSK’s Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August… Read more . . .
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According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA’s decision on acceptance of the application is expected in… Read more . . .
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The FDA has issued a notice in the Federal Register titled, “Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use.” The agency says that its preliminary opinion is that autoinjectors with doses up… Read more . . .
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According to Viatris, the US District Court for the Northern District of West Virginia has determined that US Patent No. 10,166,247, which covers AstraZeneca’s Symbicort budesonide / formoterol MDI, is invalid. In March 2021, the same court upheld… Read more . . .
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The FDA’s Pulmonary-Allergy Drugs Advisory Committee (PADAC) voted 16 to 1 that the benefit of Avillion and AstraZeneca’s PT027 albuterol / budesonide MDI for the treatment of asthma in adults outweighs the risks. However, the… Read more . . .
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According to Codagenix, the FDA has granted Fast Track designation to the company’s CodaVax-RSV live-attenuated intranasal vaccine candidate against respiratory syncytial virus (RSV). Earlier this year, the FDA cleared an IND for CodaVax-RSV. The company… Read more . . .
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On October 11, 2022, the FDA issued a lengthy warning letter to Nephron SC, a manufacturer of inhalation solutions and suspensions as well as a contract manufacturer of other sterile drug products. The letter does… Read more . . .
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According to Liquidia, the US Patent and Trademark Office’s Precedential Opinion Panel (POP) will not review a July 2022 Patent Trial and Appeals Board (PTAB) decision which determined that none of the claims in US Patent No. 10,716,793, which covers… Read more . . .
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According to Silverback Therapeutics and ARS Pharmaceuticals, the FDA has accepted ARS’s NDA for its Neffy intranasal epinephrine for the treatment of allergic reactions, including anaphylaxis, with a PDUFA date set for mid-2023. The two companies recently… Read more . . .
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According to CDMO GenScript ProBio, the company has signed an agreement with Thai company Hibiocy for manufacturing of Covitrap, an intranasal antibody cocktail for the prevention of COVID-19. GenScript said that the deal includes both… Read more . . .
Upcoming Events
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October 21-October 22: MVIC Symposium, Lund, Sweden
November 10-November 11: Rescon Europe 2026, Porto, Portugal
December 9-December 11: DDL 2026, Edinburgh, Scotland