The EMA's Committee for Medicinal Products for Human Use said Friday it has started a rolling review of Gilead Sciences Inc.'s antiviral, remdesivir, for the potential treatment of COVID-19. The move put into play one of multiple regulatory tools it has deployed "to speed up the assessment of a promising investigational medicine during a public health emergency."
A multi-institutional group led by the University of California at San Francisco’s Quantitative Biosciences Institute (QBI) has identified more than 200 host proteins that interacted with SARS-CoV-2 viral proteins during infection, creating “a blueprint of how SARS-CoV-2 hijacks human cells,” QBI Director Nevan Krogan told reporters. They then used that blueprint to identify 10 drugs, some FDA approved and some in clinical trials, that were able to inhibit viral growth in cell culture assays, marking them for further study as potential antivirals. The work also identified one compound, dextromethorphan, that appeared to facilitate viral growth.
How U.S. health care emerges from the COVID-19 pandemic is a million-dollar question, as patients, providers, payers and drug manufacturers are adapting to a new reality that’s advancing telehealth and changing how providers interact with patients.
DUBLIN – Shares in Valneva SE rose by as much as 32% during early trading April 30 on news that Pfizer Inc. is paying $130 million up front to in-license its Lyme disease candidate vaccine, VLA-15.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acasti, Akarx, Alpha Cognition, Annovis Bio, Banner Life Sciences, Biocardia, Dova, Galectin, Genmab, Glaxosmithkline, Inmed, Junshi, Marker, Medivir, Neon, Pharming, Seelos, Zentalis.