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 at the University of Birmingham's Healthcare Technologies Institute, and Birmingham Biotech acquired the rights to the nasal spray … [Read more...] about Birmingham Biotech launches NoriZite gelling nasal spray for the prevention of viral infections in the UK
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FDA issues warning letter to Nephron for cGMP violations
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 not refer specifically to any inhalation products but notes that the company recently recalled a lot of an injection product and suspended manufacturing of … [Read more...] about FDA issues warning letter to Nephron for cGMP violations
United Therapeutics request for review of PTAB decision on Tyvaso patent is denied
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 United Therapeutics' Tyvaso inhaled treprostinil, are valid. United Therapeutics had requested both a POP review of the … [Read more...] about United Therapeutics request for review of PTAB decision on Tyvaso patent is denied
Silgan Dispensing launches Gemini BE nasal pump
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 specific formulations for a perfect performance fit and quick time-to-market." The company says that the pump's spray characteristics can be … [Read more...] about Silgan Dispensing launches Gemini BE nasal pump
Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 gets underway
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 the World Health Organization's Solidarity Trial Vaccines trial. The Phase 3 study is expected to enroll up to 20,000 healthy adults in countries … [Read more...] about Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 gets underway
Covis announces positive results from Phase 3 trial of Duaklir and Eklira in Asia
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 alone and vs formoterol alone, as well as for Eklira vs placebo. Covis acquired global rights to Duaklir and Eklira from … [Read more...] about Covis announces positive results from Phase 3 trial of Duaklir and Eklira in Asia
CDMO Micro-Sphere expands its inhalation capabilities
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 as a containment system for handling high potency compounds. Micro-Sphere also announced that its manufacturing license … [Read more...] about CDMO Micro-Sphere expands its inhalation capabilities
FDA accepts NDA for ARS Pharmaceuticals’ Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis
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 announced that they would merge, with the resulting company operating as ARS Pharmaceuticals and focused on … [Read more...] about FDA accepts NDA for ARS Pharmaceuticals’ Neffy epinephrine nasal spray for the treatment of allergic reactions, including anaphylaxis
Lupin acquires US rights to Brovana inhalation solution and Xopenex HFA MDI
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 since 2006, and Lupin launched an authorized generic of the inhalation solution in June 2021. Xopenex was initially approved for the treatment of asthma … [Read more...] about Lupin acquires US rights to Brovana inhalation solution and Xopenex HFA MDI
Hibiocy enters contract with Genscript for manufacturing of Covitrap nasal spray for the prevention of COVID-19
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 clinical trial and commercial manufacturing of Covitrap, as well as work on development of new products. The company said that … [Read more...] about Hibiocy enters contract with Genscript for manufacturing of Covitrap nasal spray for the prevention of COVID-19