In this exclusive interview with ONdrugDelivery, Aaron Mann discusses how Kindeva is positioned to move forward as a major CDMO specialising in inhalation and transdermal dosage forms, having been formed from 3M’s drug delivery in May 2020. We also cover the impact of Covid-19, environmental sustainability, and current challenges faced by the pharmaceutical industry.
Researchers from the Human Cell Atlas Lung Biological Network, have identified two specific cell types in the nose as likely initial infection points for COVID-19 coronavirus, and cells in the eye and some other organs that also contain the viral-entry proteins. They also predict how a key entry protein is regulated with other immune system genes and reveals potential targets for the development of treatments to reduce transmission.
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.
BIOHAVEN GIVEN FDA GO-AHEAD TO BEGIN PHASE II TRIAL OF INTRANASAL VAZEGEPANT IN COVID-19 LUNG INFLAMMATION
Biohaven is to initiate a Phase II trial within weeks of intranasal vazegepant, its third-generation, high-affinity, selective small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease. The clinical trial will assess the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response which in some cases can be fatal in COVID-19.
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.
Heli Chauhan details the myriad challenges facing the OINDP market, with a particular emphasis on nasal spray devices, when it comes to testing products on a mass-production scale, such as a lack of adequate testing equipment and the need to capture accurate data consistently. She goes on to offer a solution in the form of Indizo®, Proveris’ automated nasal spray testing apparatus.
Pascale Farjas, Alain Regard, and Céline Petitcolas discuss the steps taken when designing a nasal spray device for the growing bioequivalence market and the key competencies, including experience with regulations and regulatory agencies in numerous geographic regions, that Nemera can offer throughout the process.