The US FDA has granted “Expanded Access Emergency Use” to Vero Biotech immediately to use its proprietary inhaled nitric oxide (iNO) delivery system, GENOSYL DS, in the treatment of cardiopulmonary symptoms associated with COVID-19. The agency recently approved GENOSYL (NO) gas, for inhalation for the treatment of persistent pulmonary hypertension of the newborn.
N4 demonstrating utility of Nuvec® vaccine delivery system in COVID-19 vaccines using COVID-19 DNA plasmid
Springboard is now offering: design reviews / risk assessments of COVID-19 related medical devices at no charge; answering ad hoc requests for advice on devices relevant to COVID-19 at no charge; device development expertise, including a willingness to tackle short term projects on a not-for profit basis; submission of services to the UK Gov call for businesses to help make NHS ventilators.
The world, and our industry with it, has entered an unfamiliar and difficult period. I would like to take this opportunity to update you on how ONdrugDelivery can and will continue to provide its services uninterrupted, and tell you about some specific initiatives we're launching to help our readers, authors and clients across the global industry.
John Cahill, Director, Senior Consultant, Quality & Compliance, PharmaLex Ireland, provides an update on the status of several COVID-19 vaccine and therapeutic development programmes, emphasising the considerable efforts being made by industry, regulatory agencies and others, to accelerate development in what is normally, due to the need for stringent regulation, a notoriously slow-moving sector.
Windtree Therapeutics plans a pilot study to assess its KL4 surfactant's ability to impact key respiratory parameters in ventilated COVID-19 patients. The COVID-19 virus infects the specific cells that make pulmonary surfactant and is believed to result in inadequate levels of functional surfactant.
eTheRNA launches international consortium, starts development of cross-strain protective CoV-2 mRNA vaccine
Catalent has noted that many governments of the countries where it operates have recognised its work as essential meaning all Catalent operating facilities remain open. The company also said it was working with several customers on COVID-related antivirals, vaccines, and treatments for symptoms and effects of the disease.
With precision metal components being used in inhalers & similar devices, Advanex acknowledges critical role in supply chain
Elcam Medical facilities Recognised by local authorities as essential, enabling continuation of production
Lexaria Bioscience Expands Pharma Division for development of Lipophilic Antivirals against COVID-19
ACG has released a letter to its customers in response to the COVID-19 outbreak, and reaffirmed its commitment to providing uninterrupted supply of its products and services, and factories in all locations around the world are working at full capacity. ACG has also ensured the supply of its own raw materials for many months.
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.
Andreas Schneider highlights how the ever-increasing interest in device platforms raises concerns around the broad availability of lookalike autoinjectors that may result in inappropriate medication usage. He summarises a recent empirical study1 providing insights into which device attributes drive device distinguishability.