A novel inhaled formulation of the approved antihelminthic drug, niclosamide, is under development at the College of Pharmacy at The University of Texas at Austin for COVID-19. The compound was recently confirmed to exhibit antiviral efficacy in SARS-COV-2 infected cells and indeed was more potent compared with chloroquine, lopinavir and remdesivir, the group said.
Nicolas Schwenck and Michael Hahn summarise the critical success factors for bringing a new vibrating membrane nebuliser for a drug-device combination product to the market. They highlight opportunities and pitfalls – starting from the evaluation phase, through the development phase and finally during commercialisation.
Specialist respiratory drug product news publication OINDP News, has reported progress from several intranasal and inhaled COVID-19 vaccine development programmes, including from Altimmune, APEPTICO, a partnership between Neurimmune and Ethris, and a partnership between UW–Madison, FluGen and Bharat Biotech.
Theravance Biopharma is advancing TD-0903, a lung-selective nebulised Janus kinase inhibitor (JAKi) into clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury (ALI) in patients hospitalised COVID-19 patients. The goal is the prevention of disease progression to ARDS.
Insmed implements corporate initiatives in response to the novel coronavirus (SARS-CoV-2) global pandemic including a remote working policy to allow infectious disease specialists and pulmonologists to focus on treating patients and containing the virus. Arikares trainers will now offer remote training and onboarding for patients who initiate treatment with ARIKAYCE.
As Biocorp prepares for the market launch of its connected injector pen add-on, Mallya, Eric Dessertenne and Arnaud Guillet share insights about key steps in the company’s development. The article discusses the many partnership Biocorp has entered in to, and includes a mini-interview with Sergio Monti, Plant Manager for one such partner, V.A.R.I.
David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.