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.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Asklepios, Bayer, Imunon and Lumicell.
In a study from the PHOSP-COVID and ISARIC-4C consortia in the U.K., researchers have discovered inflammatory processes taking place during what is termed “long COVID.” Long COVID is defined by the World Health Organization (WHO) as the continuation or development of new symptoms for 3 or more months after the initial SARS-CoV-2 infection. It is estimated that 1 in 10 SARS-CoV-2 infections results in long COVID, thus affecting about 65 million people worldwide.
SARS-CoV-2 could proliferate in the lungs causing severe COVID-19 through a special type of immune cell. A group of scientists from Stanford University observed how this coronavirus infected interstitial macrophages through a CD209 receptor, triggering the inflammatory response observed in hospitalized patients.
