Copley Scientific CEO Mark Copley answers questions about the importance of the test environment for OIP testing Why is the test environment so important for inhaler testing? Due to a broad range of factors, including interaction between formulation, device, and patient, orally inhaled product (OIP) testing is naturally more variable than testing for simple … [Read more...] about Q&A with Mark Copley: Reducing Inhaler Testing Variability Through Test Environment Control
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Micro-Sphere adds lab-scale electrostatic spray drying capabilities
CDMO Micro-Sphere, which offers spray drying and capsule filling for DPI formulations, said that it has now added new particle engineering R&D space with FluidAir PolarDry electrostatic spray drying technology. The company recently announced the addition of new inhalation testing laboratory space at its site in Monteggio, Switzerland. The PolarDry system works at … [Read more...] about Micro-Sphere adds lab-scale electrostatic spray drying capabilities
Intravacc initiates Phase 1 trial of Avacc 10 intranasal vaccine as a COVID-19 booster
Intravacc announced that it has initiated a Phase 1 trial of Avacc 10 intranasal SARS-CoV-2 subunit vaccine, which the company is developing as a booster. Avacc 10 is based on the same outer membrane vesicles (OMV) technology as the company's intranasal vaccines against gonorrhea and betacoronavirus vaccines. Intravacc had announced in June 2020 that it would develop … [Read more...] about Intravacc initiates Phase 1 trial of Avacc 10 intranasal vaccine as a COVID-19 booster
Vistagen announces planned Phase 1 trial of new formulation of PH10 nasal spray
After receiving a "Study May Proceed" letter from the FDA, Vistagen has announced plans for a Phase 1 trial of a re-formulated version of PH10 pherin nasal spray. The new Phase 1 study is expected to begin in early 2023 as part of plans to develop the nasal spray for the treatment of major depressive disorder. A previous Phase 2a trial of PH10 for that indication … [Read more...] about Vistagen announces planned Phase 1 trial of new formulation of PH10 nasal spray
Nuance Pharma takes steps towards marketing Bentrio nasal spray in Hong Kong and Macau
Nuance Pharma has announced a deal with DKSH Business Unit Healthcare for commercialization of Bentrio, an API-free, bentonite-based OTC nasal spray for protection against allergens and viruses, in Hong Kong and Macau. Bentrio is currently marketed in several countries in Europe for allergic rhinitis, and in the US, the nasal spray received 510(k) clearance in June … [Read more...] about Nuance Pharma takes steps towards marketing Bentrio nasal spray in Hong Kong and Macau
Adherium’s Hailie sensor gets 510(k) clearance for use with Ventolin, Advair, and Flovent MDIs
Adherium announced that the FDA has granted 510(k) clearance for use of Adherium's next-generation Hailie inhaler sensor with GSK's Ventolin, Advair, and Flovent MDIs. The company had announced submission of the 510(k) application in August 2022. Adherium CEO Rick Legleiter said, "This is the third 510(k) market clearance of the next-generation Hailie sensors … [Read more...] about Adherium’s Hailie sensor gets 510(k) clearance for use with Ventolin, Advair, and Flovent MDIs
Opiant completes rolling NDA submission for OPNT003 intranasal nalmefene
According to Opiant Pharmaceuticals, the submission of its NDA for OPNT003 nalmefene nasal spray for the treatment of opioid overdose has been completed, and the FDA's decision on acceptance of the application is expected in February 2023. The company announced that it had initiated the rolling NDA submission at the beginning of June 2022. Aptar Pharma’s Unit Dose … [Read more...] about Opiant completes rolling NDA submission for OPNT003 intranasal nalmefene
Hyloris announces plans to develop an intranasal TRPV1 agonist for the treatment of idiopathic rhinitis
Belgium-based Hyloris Pharmaceuticals announced that it has added an intranasal TRPV1 agonist (HY-083) for the treatment of idiopathic rhinitis to its pipeline. TRPV1 (transient receptor potential cation channel subfamily V member 1) is overexpressed in the nasal mucosa in idiopathic rhinitis. According to the company, "Hyloris’ treatment approach is to activate and … [Read more...] about Hyloris announces plans to develop an intranasal TRPV1 agonist for the treatment of idiopathic rhinitis
Aerovate Therapeutics publishes data from Phase 1 trial of AV-101 imatinib DPI
Aerovate Therapeutics has published data from a Phase 1 study of its AV-101 dry powder imatinib showing that the inhaled formulation resulted in significantly lower systemic exposure compared to oral imatinib. The company announced the initiation of the IMPAHCT trial Phase 2b/3 of AV-101 in patients with pulmonary arterial hypertension (PAH) in December 2021. The … [Read more...] about Aerovate Therapeutics publishes data from Phase 1 trial of AV-101 imatinib DPI
Warner C. Greene appointed President and CSO of InvisiShield Technologies
InvisiShield Technologies, which is developing a human antibody nasal spray designed to prevent SARS-CoV-2 infection, has announced the appointment of Gladstone Institute of Virology and Immunology founding director Warner C. Greene as President and Chief Scientific Officer. Greene will continue in his role at Gladstone Institutes, where he is Senior Investigator, … [Read more...] about Warner C. Greene appointed President and CSO of InvisiShield Technologies