Tag: Emergency Use Authorization
Johnson & Johnson Single-Shot COVID-19 Vaccine Unanimously Recommended for Emergency Use Authorization by FDA Advisory Committee
the staff of the Ridgewood blog
New Brunswick NJ, Johnson & Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson & Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial.
BREAKING: Moderna to apply for Emergency use Authorization for COVID-19 Vaccine Candidate Today
the staff of the Ridgewood blog
CAMBRIDGE Mass , Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis. The data analysis indicates a vaccine efficacy of 94.1%. Safety data continue to accrue and the study continues to be monitored by an independent, NIH-appointed Data Safety Monitoring Board (DSMB). The Company also announced that today, Moderna plans to request an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and conditional approval from the European Medicines Agency (EMA). The Phase 3 study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
Food and Drug Administration (FDA) has issued an emergency use authorization for emergency use of convalescent plasma
President Trump announced Sunday that the Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for convalescent plasma for emergency use to treat patients sickened by the novel coronavirus as a therapeutic.
Trump, who has been looking to announce progress in fighting the virus, touted the news as a “historic breakthrough” against the “Chine virus” at a White House news conference on Sunday, saying it would “dramatically expand access to this treatment.Not resisting further temptation the President hoped the press had a great time at their convention.
New Rutgers Saliva Test for Coronavirus Gets FDA Approval
the staff of the Ridgewood blog
New Brunswick NJ,
The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to Rutgers’ RUCDR Infinite Biologics and its collaborators for a new collection approach that utilizes saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, the first such approval granted by the federal agency.
The new saliva collection method, which RUCDR developed in partnership with Spectrum Solutions and Accurate Diagnostic Labs (ADL), will allow for broader population screening than the current method of nose and throat swabs.
Continue reading New Rutgers Saliva Test for Coronavirus Gets FDA Approval
US FDA issued an Emergency Use Authorization for the Battelle Critical Care Decontamination System, which is designed to decontaminate N95 respirators allowing healthcare workers to safely reuse them
the staff of the Ridgewood blog
Ridgewood NJ, according to Johns Hopkins Center for Health Security the US FDA issued an Emergency Use Authorization for the Battelle Critical Care Decontamination System, which is designed to decontaminate N95 respirators in order to allow healthcare workers to safely reuse them (as many as 20 times) and extend existing inventory in health systems across the country. The system utilizes hydrogen peroxide vapor to “destroy bacteria, viruses and other contaminants, including…SARS-CoV-2,” and it can process up to 80,000 masks per day. The FDA initially limited the throughput to 10,000 masks per day, but the system is now permitted to operate at full capacity. The system is currently in use in Ohio, and Battelle intends to deploy units to New York, Washington state, and Washington, DC.