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
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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
Birmingham Biotech launches NoriZite gelling nasal spray for the prevention of viral infections in the UK
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
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