In what U.S. FDA commissioner Stephen Hahn billed as “a major milestone” in testing for the COVID-19 pandemic, the FDA has granted an emergency use authorization (EUA) to Ellume Ltd., of East Brisbane, Australia, for the company’s COVID-19 home test. The rapid lateral-flow test for antigen detection can be obtained without prescription and will return results to the at-home user in 20 minutes, according to the FDA’s Dec. 15 statement.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbott, Anitoa, Binx Health, Ellume, Exero Medical, Genetesis, Horiba, Roche, Seaspine, Switch Health.
A new FDA assessment of the data behind an emergency use authorization filing for Moderna Inc.'s COVID-19 vaccine candidate, issued in advance of a Dec. 17 meeting of the Vaccines and Related Biological Products Advisory Committee, affirmed efficacy claims for the product and identified "no specific safety concerns that would preclude issuance of an EUA."
DUBLIN – Bowing to public and political pressure, the EMA has brought forward its review of BNT-162b2, the mRNA-based COVID-19 vaccine jointly developed by Pfizer Inc. and Biontech SE, to Dec. 21, more than a week ahead of its originally scheduled date of Dec. 29.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Algo, Athenex, Astrazeneca, Can-Fite, Cyxone, Fortress, Genentech, IO Biotech, Nascent, Prometheus, Rafael, Takeda, Xentria.
Following a recent string of emergency use authorizations (EUA) for their jointly developed COVID-19 vaccine, BNT-162b2, Pfizer Inc. and Biontech SE said Dec. 14 that results from an ongoing German trial have helped illustrate "the multiple arms of the immune system that are activated" by the product to fight SARS-CoV-2. Separately, Moderna Inc. raised to 200 million the number of doses of its COVID-19 vaccine candidate it will supply to the U.S. government.
TORONTO – The Medipines AGM100, which was developed by Orange County, Calif.-based Medipines Corp. to detect respiratory impairment caused by chronic obstructive pulmonary disease (COPD), has been recruited in the fight against COVID-19 in Canada. Described by company CEO and coinventor Steve Lee as “the world's first noninvasive lung monitor for gas exchange measurement,” the device is undergoing advanced testing.
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