CyanVac subsidiary Blue Lake Biotechnology has presented interim data from a Phase 1 trial of its BLB201 intranasal vaccine against respiratory syncytial virus (RSV) that demonstrate an increase in serum antibody responses from baseline in just under two thirds of subjects aged 18-59, with viral shedding observed in 21% of this age cohort following vaccination. The … [Read more...] about Blue Lake announces interim data from Phase 1 trial of BLB201 intranasal vaccine against RSV
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Viatris to acquire Oyster Point Pharma
Tyrvaya varenicline nasal spray maker Oyster Point Pharma announced that its board of directors has approved the company's plans to be acquired by Viatris for $11 per share at closing plus up to $2 per share if Oyster Point achieves certain performance goals for 2022. The FDA approved Tyrvaya for the treatment of dry eye disease in October 2021. Oyster Point is also … [Read more...] about Viatris to acquire Oyster Point Pharma
Meissa announces positive Phase 1c data from a study of its intranasal RSV vaccine in infants and toddlers
Meissa Vaccines is presenting Phase 1c data from a study of its MV-012-968 intranasal live attenuated RSV vaccine candidate in 66 children aged 6-36 months demonstrating that the highest dose of the vaccine evaluated induced an immune response in 89% of RSV-naïve subjects, with a serum neutralizing antibody response induced in 78% of the subjects. According to … [Read more...] about Meissa announces positive Phase 1c data from a study of its intranasal RSV vaccine in infants and toddlers
FDA provides funding for Simulations Plus and University of Florida project for validation of PBPK models for inhaled drugs
According to modeling software company Simulations Plus, the FDA has awarded the company a contract for a project that is intended to improve models of pulmonary absorption of inhaled drugs, with a goal of creating "the foundation of a viable alternative to in vivo studies for the establishment of bioequivalence (BE) for OIDPs." The company said that Rodrigo … [Read more...] about FDA provides funding for Simulations Plus and University of Florida project for validation of PBPK models for inhaled drugs
TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
TFF Pharmaceuticals announced that it has been working with Aptar Pharma on a project to develop dry powder vaccines based on TFF's thin film freezing particle manufacturing platform and Aptar Pharma’s Unidose (UDS) nasal powder delivery device. According to the company, Aptar Pharma presented data from the project at the recent Vaccines Summit 2022 and will present … [Read more...] about TFF Pharmaceuticals developing dry powder vaccines delivered via an Aptar Pharma nasal device
Arest announces positive Phase 1 results for APN01 inhaled alunacedase alfa
Apeiron Respiratory Therapies (Arest), a subsidiary of Invios, announced that a Phase 1 SAD/MAD study of its APN01 nebulized alunacedase alfa in 40 healthy subjects met all endpoints. Both Arest and Invios were spun off from the original developer of APN01, Apeiron Biologics, earlier this year. Arest is developing APN01, a soluble recombinant human angiotensin … [Read more...] about Arest announces positive Phase 1 results for APN01 inhaled alunacedase alfa
Copley Scientific launches new accessory for improved comparability between abbreviated and full resolution impactor measurements
OINDP testing experts Copley Scientific have announced the introduction of the new Volume and Resistance Compensator (VRC), which is designed to make abbreviated impactor measurements (AIM) more comparable to full resolution impactor measurements when measuring aerodynamic particle size distribution (APSD). According to the company, the VRC can be especially … [Read more...] about Copley Scientific launches new accessory for improved comparability between abbreviated and full resolution impactor measurements
Renovion initiates Phase 2 trial of ARINA-1 inhaled mucolytic in non-CF bronchiectasis patients
Renovion and the COPD Foundation have announced the initiation of a Phase 2 trial of Renovion's ARINA-1 nebulized glutathione / bicarbonate / ascorbic acid in patients with non-CF bronchiectasis (NCFBE). The COPD Foundation announced in September 2021 that it was partnering with Renovion on development of ARINA-1 for the treatment of COPD and NCFBE. The company is … [Read more...] about Renovion initiates Phase 2 trial of ARINA-1 inhaled mucolytic in non-CF bronchiectasis patients
Pieris Pharmaceuticals initiates Phase 1 trial of its PRS-220 inhaled anticalin
Pieris Pharmaceuticals has announced the initiation of a Phase 1 study of PRS-220, an anticalin inhalation solution that targets connective tissue growth factor (CTGF), which the company is developing for the treatment of fibrotic lung diseases, including idiopathic pulmonary fibrosis (IPF). In June 2021, Pieris announced that it would develop PRS-220 for IPF and for … [Read more...] about Pieris Pharmaceuticals initiates Phase 1 trial of its PRS-220 inhaled anticalin
FDA grants Fast Track designation to Codagenix’s CodaVax intranasal vaccine against RSV
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 now says that the Phase 1 dose escalation study in children aged 6 months to 5 years is expected to start after the … [Read more...] about FDA grants Fast Track designation to Codagenix’s CodaVax intranasal vaccine against RSV