On May 17, the U.S. FDA authorized a booster of Pfizer’s vaccine for kids ages 5 to 11 years. The action comes as major cities are announcing a rise in cases. Additionally, COVID-19 would have claimed over 110,000 more lives in 2021 if not for the Pfizer-BioNTech vaccine, according to a Pfizer-sponsored report on the first year of the U.S. vaccination program.
The U.S. Food and Drug Administration decided not to authorize the antidepressant fluvoxamine to treat COVID-19, saying the data has not shown the drug to be an effective therapeutic for fighting the virus.
Sage Therapeutics Inc.’s drug helped improve depressive symptoms after three days in a late-stage study, but investor concerns over how long the treatment’s effect would last sent the drug developer’s shares down 17% on February 16.
The inexpensive antidepressant fluvoxamine might help keep patients with Covid-19 from developing severe disease, according to a study published in The Lancet Global Health. Researchers found in another study that the coronavirus can infect cells of the inner ear, which may help explain the balance problems, hearing loss and tinnitus (ringing in the ears) experienced by some Covid-19 patients.
Sage Therapeutics’ experimental depression drug showed significant improvement in symptoms compared to placebo in a late-stage study.
Researchers at Washington University School of Medicine in St. Louis published the results of a clinical trial evaluating an antidepressant, fluvoxamine, for early treatment for Covid-19.
Luye Pharma Group submitted a new drug application to the U.S. Food and Drug Administration for LY03005, a new chemical drug for the treatment of major depressive disorder.
CVS Health Corp. and the drugstore chain’s Omnicare unit were sued by the U.S. government, which accused them of fraudulently billing Medicare and other programs for drugs for older and disabled people without valid prescriptions.
Sage Therapeutics Inc.’s experimental fast-acting drug aimed at treating severe depression failed a closely-watched study, sending shares down 60 percent and erasing about $4.6 billion of the drugmaker’s market value.
When major depressive disorder does not respond to at least two different types of antidepressant treatments in a moderate-to-severe depressive episode, it’s reclassified as treatment-resistant depression (TRD). South San Francisco-based VistaGen Therapeutics’ AV-101 failed to meet the primary efficacy endpoints for TRD in a Phase II clinical trial.