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
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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
Atai Life Sciences initiates Phase 1 trial of INB-01 intranasal gelling excipient
Atai Life Sciences announced that it has initiated a Phase 1 proof-of-concept trial of its INB-01, an excipient designed to cause gelling of liquid nasal sprays when the aerosol deposits in the nasal cavity. In July 2021, Atai said that it was launching a company called Innaris Bio to develop the sol-gel technology for use in intranasal CNS drug formulations in … [Read more...] about Atai Life Sciences initiates Phase 1 trial of INB-01 intranasal gelling excipient
Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint
According to Milestone Pharmaceuticals, the Phase 3 RAPID (formerly NODE 301b) trial of etripamil nasal spray in patients with paroxysmal supraventricular tachycardia (PSVT) has met its primary endpoint, demonstrating that almost two thirds of patients using etripamil converted to sinus rhythm within half an hour while less than a third of patients using a placebo … [Read more...] about Phase 3 trial of Milestone’s etripamil nasal spray for PSVT meets primary endpoint
Avalyn Pharma names Lyn Baranowski as CEO
Avalyn Pharma, which is developing its AP01 pirfenidone inhalation solution for the treatment of idiopathic pulmonary fibrosis (IPF), has named Lyn Baranowski as CEO, succeeding Bruce Montgomery. Baranowski was most recently Chief Operating Officer of Altavant Sciences and has extensive experience in commercial and business roles at pharmaceutical companies, including … [Read more...] about Avalyn Pharma names Lyn Baranowski as CEO