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To mitigate COVID-19-related drug shortages, the FDA issued new guidance reminding drug and biologic manufacturers of their legal obligations to notify the agency, in advance, of interruptions or the permanent discontinuance in the manufacturing of certain drugs. It also makes some new recommendations in light of the current emergency.
DUBLIN – Three different vaccine technologies are being deployed in the desperate global effort to combat the SARS-CoV-2 virus, but Rino Rappuoli, chief scientist at the GSK Vaccines arm of Glaxosmithkline plc, said he sees traditional protein-based adjuvanted subunit vaccines, the trusted workhorse of infectious disease prevention, as offering the best bet for delivering a safe and effective vaccine at scale, within the tight timescales necessitated by the present crisis.
HONG KONG – Chengdu, China-based Clover Biopharmaceuticals Inc. has teamed up with Emeryville, Calif.-based Dynavax Technologies Corp. on a research collaboration to develop a vaccine candidate to prevent COVID-19.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algernon, Arvelle, Astrazeneca, Beyondspring, Biocryst, Daiichi, Humanigen, I-Mab, Junshi, Lilly, Orion, Rhythm, Ryvu.
Spry Health Inc., of Redwood City, Calif., a company that focuses on health management technologies and remote patient monitoring, reported the launch of Loop Signal. This solution is a new clinician-led monitoring service using the U.S. FDA-cleared Loop System that aims to reduce avoidable hospital visits and improve at-home monitoring of patients who either have, are suspected of having or at risk for COVID-19.
As the cases of COVID-19 continue to mount around the world, hospitals and other providers are looking to virtual tools, apps and other products to help people check their symptoms and get advice on whether medical intervention is needed. To that end, Dublin-based Medtronic plc has launched two new tools to help clinicians assess, monitor and triage patients with respiratory symptoms and concerns about the coronavirus.
LONDON – The European Commission (EU) is pulling the plug on implementation of the Medical Devices Directive (MDR) on May 26, to free up resources and expertise as countries across Europe struggle to deal with the COVID-19 crisis.
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