Disappointing data from a Phase 1 study of intranasal delivery of AstraZeneca's ChAdOx1 nCoV-19 vaccine against COVID-19 led researchers from the University of Oxford to conclude that there is a "need for further development of nasal spray vaccines," the university said. The researchers reported the results in The Lancet's eBioMedicine. Intranasal delivery of the … [Read more...] about Intranasal delivery of AstraZeneca’s COVID-19 vaccine fails to elicit sufficient immune response in Phase 1 trial
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United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients
United Therapeutics has announced the initiation of the Phase 3 TETON 2 trial of Tyvaso treprostinil inhalation solution in patients with idiopathic pulmonary fibrosis (IPF). In December 2020, the company announced that the FDA had granted orphan drug designation to treprostinil for the treatment of IPF and had cleared an IND for the Phase 3 TETON program. The TETON 1 … [Read more...] about United Therapeutics announces the initiation of a second Phase 3 trial of Tyvaso in IPF patients
William Schachtner and Axel Perlwitz join Transpire Bio
Transpire Bio, a start-up inhaled drug developer based in Florida, has announced the appointment of two more OINDP experts, naming William Schachtner as Chief Technical Operations Officer and Axel Perlwitz as Chief Regulatory Affairs Officer. Like Transpire CEO Xian-Ming Zeng and Chief Medical Officer Mark Lepore, both Schachtner and Perlwitz previously held positions … [Read more...] about William Schachtner and Axel Perlwitz join Transpire Bio
Ab Initio Pharma now able to manufacture OINDPs for clinical trials
Australian OINDP specialist CDMO Ab Initio announced that the Therapeutic Goods administration of Australia (TGA) has granted the company a license to manufacture finished inhalation products and nasal sprays, in addition to other dosage forms. Ab Initio says that the license allows it to offer services including manufacturing of finished products for clinical trials, … [Read more...] about Ab Initio Pharma now able to manufacture OINDPs for clinical trials
Honeywell begins large-scale production of medical grade Solstice Air HFO-1234ze MDI propellant
Honeywell has begun large scale manufacturing of Solstice Air HFO-1234ze(E), a low global-warming-potential (GWP) MDI propellant, at a facility located in Baton Rouge, LA, USA, the company said. In February 2022, AstraZeneca announced that it would reformulate Breztri budesonide/ glycopyrronium/ formoterol fumarate using Solstice Air as part of a partnership … [Read more...] about Honeywell begins large-scale production of medical grade Solstice Air HFO-1234ze MDI propellant
Intravacc gets funding for intranasal gonorrhea and betacoronavirus vaccines
Dutch intranasal vaccine developer and CDMO Intravacc said that it has received an award of up to $14.6 million from the US National Institute of Allergy and Infectious Diseases (NIAID) to support development of an intranasal vaccine against gonorrhea and another award of up to $4.8 million from the Coalition for Epidemic Preparedness Innovations (CEPI) to support … [Read more...] about Intravacc gets funding for intranasal gonorrhea and betacoronavirus vaccines
Synairgen announces top-line data from Phase 2 ACTIV-2 trial of SNG001 nebulized interferon-beta-1a for mild-to-moderate COVID-19
Synairgen has announced that the Phase 2 ACTIV-2 trial of SNG001 inhaled interferon-beta-1a in non-hospitalized COVID-19 patients failed to show a statistically significant reduction in hospitalization, viral load, safety, or resolution of symptoms compared to placebo, but the study did demonstrate a relative reduction of 86% in hospitalization. Over the course of the … [Read more...] about Synairgen announces top-line data from Phase 2 ACTIV-2 trial of SNG001 nebulized interferon-beta-1a for mild-to-moderate COVID-19
InCarda Therapeutics names Robert Lisicki as CEO
Inhaled flecanide developer InCarda Therapeutics has named former Arena Pharmaceuticals executive Robert Lisicki as CEO, succeeding Grace Colón who the company says "intends to pursue other leadership opportunities within the life science space" but will continue to consult for InCarda. In addition to having served as Chief Commercial Officer at Arena, Lisicki … [Read more...] about InCarda Therapeutics names Robert Lisicki as CEO
Pfizer completes acquisition of Biohaven and its zagevepant nasal spray
Pfizer has completed its acquisition of Biohaven Pharmaceutical, including Biohaven's intranasal zavegepant (BHV-3500) calcitonin gene-related peptide (CGRP) receptor antagonist, the company said. Pfizer announced that it had acquired the ex-US rights to zavegepant and Nurtec ODT rimegepant from Biohaven January 2022. By the time that the FDA accepted Biohaven's NDA … [Read more...] about Pfizer completes acquisition of Biohaven and its zagevepant nasal spray
HCmed Innovations and AeroRx Therapeutics partner on nebulized LABA/LAMA for COPD
Startup inhaled drug developer AeroRx Therapeutics and nebulizer maker HCmed Innovations have announced that they will partner on development of a nebulized LABA/LAMA inhalation solution for the treatment of COPD. AeroRx is a spinoff of iPharma Labs, which was acquired by Kindeva Drug Delivery earlier this year. In March 2022, HCmed announced that it was partnering … [Read more...] about HCmed Innovations and AeroRx Therapeutics partner on nebulized LABA/LAMA for COPD