The U.S. FDA issued a May 9 warning letter to Cue Health Inc., of San Diego, following what may have been a routine inspection, but the inspection disclosed that the company had made changes to a COVID test that was granted market access via the emergency use authorization program.
A licensing deal worth potentially up to $1.2 billion with Sanofi SA has breathed new life into Novavax Inc., which has struggled to compete in the COVID-19 space with powerhouses Pfizer Inc. and Moderna Inc.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
Right on cue, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is scheduling its first in-person advisory committee meetings since the COVID-19 pandemic. Speaking during a May 6 webinar hosted by the Alliance for a Stronger FDA, CDER Director Patrizia Cavazzoni said the center was preparing to go back to in-person adcoms, adding that the first step likely would be a hybrid model.
There is still a need for developing more potent and broadly neutralizing vaccines against SARS-CoV-2 with improved durability. At the recent ESCMID meeting, Astrazeneca plc presented a new mRNA vaccine against the SARS-CoV-2 virus that encodes for self-assembling virus-like particle (VLP) antigens.
Tocris Cookson Ltd., Helmholtz Zentrum fur Infektionsforschung GmbH and University of Lübeck have described proteolysis targeting chimeras (PROTACs) comprising cereblon (CRBN) ligands covalently bonded to non-structural protein 3 (nsp3; PL-PRO) (SARS-CoV-2; COVID-19 virus) targeting moiety through linker reported to be useful for the treatment of SARS-CoV-2 infection (COVID-19).
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
The latest World Health Organization’s (WHO) Pandemic Agreement falls short of protecting all countries in future pandemics, said international patient groups and public health organizations.
Researchers from State University of New Jersey (Rutgers) and Oklahoma State University have published preclinical data for a novel a SARS-CoV-2 papain-like protease (PLpro) inhibitor being developed as an antiviral candidate for the treatment of COVID-19.
Looking beyond the U.S. biopharma industry, Sen. Bernie Sanders (I-Vt.) is now pushing the International Federation of Pharmaceutical Manufacturers and Associations to get on board with the World Health Organization’s proposed Pandemic Accord aimed at making diagnostics, treatments and vaccines available to everyone who needs them.
