TORONTO – The Government of Canada is fast tracking importation of two U.S. manufactured test kits for COVID-19, issuing an interim order for sale of the Cobas SARS-CoV-2 diagnostic test kit developed by Pleasanton, Calif.-based Roche Molecular Systems Inc. and Waltham, Mass.-based Thermo Fisher Scientific Inc.’s Taqpath COVID-19 Combo Kit.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Battelle, Electrocore, Ossdsign, Zoll.
The newest angle in the partnership between Johnson & Johnson and the U.S. federal government, part of the company’s $1 billion commitment to COVID-19 R&D, is designed to drive its lead candidate into the clinic by year-end and to increase its vaccine manufacturing worldwide.
As the coronavirus pandemic rages on, biopharma companies are being forced to respond to multiple challenges that could derail their existing business plans. Already companies are reporting that, in therapeutic indications not involving COVID-19, their ongoing and planned clinical trials are being interrupted or delayed by the pressures now being imposed on global health care systems.
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.
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.
