News
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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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Birmingham Biotech has announced the launch of NoriZite carageenan/gellan gum nasal spray for the prevention of viral infections in the UK. The formulation, which is designed to physically block viruses in the nasal cavity, was developed… 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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US-based device maker Silgan Dispensing has announced the launch of its new Gemini BE nasal pump. According to Silgan, the new pump is specifically designed to meet bioequivalence needs and “is adaptable to effectively match… Read more . . .
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Codagenix has announced the initiation of a Phase 3 trial of its CoviLiv live-attenuated intranasal vaccine against COVID-19. The trial, which is being conducted in partnership with the Serum Institute of India, is part of… Read more . . .
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According to Covis Pharma, the Phase 3 AVANT trial of Duaklir aclidinium bromide / formoterol and Eklira (Tudorza) aclidinium bromide DPIs demonstrated statistically significant change in FEV1 from baseline one hour post dose for Duaklir vs Eklira… Read more . . .
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Swiss CDMO Micro-Sphere, which specializes in spray drying and capsule filling, has announced a greater than €5 million expansion of its Monteggio, Switzerland GMP manufacturing facility that includes new inhalation testing laboratory space as well… 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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Lupin Limited announced that it will pay Sunovion $75 million for the rights to Brovana arformoterol inhalation solution and Xopenex HFA levalbuterol MDI. Brovana has been approved in the US for the treatment of COPD… Read more . . .
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