Regeneron’s REGEN-COV2 is First Antibody Cocktail for COVID-19 to Receive FDA Emergency Use Authorization

First treatment of any kind to have prospectively confirmed and statistically significant anti-viral activity against SARS-CoV-2

Authorized for recently diagnosed, mild to moderate COVID-19 in high-risk patients

Initial doses of REGEN-COV2 will be made available to approximately 300,000 patients, with no medication out-of-pocket costs, under U.S. government allocation programContinue reading

Banner Health recommends alternatives to in-person gatherings this Thanksgiving

PHOENIX (November 17, 2020) – The United States is experiencing uncontrollable spread of COVID-19, and social gatherings are an important contributor to the rise in COVID-19 cases. Banner Health advises that individuals evaluate the risk level of their Thanksgiving plans and consider safer alternatives for those activities that present a higher risk of contracting or spreading the virus.Continue reading

Moderna’s COVID-19 Vaccine Candidate Meets its Primary Efficacy Endpoint in the First Interim Analysis of the Phase 3 COVE Study

  • First interim analysis included 95 participants with confirmed cases of COVID-19
  • Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001)

Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 monthsContinue reading

Pfizer and BioNTech Announce Vaccine Candidate Against COVID-19 Achieved Success in First Interim Analysis from Phase 3 Study

  • Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis
  • Analysis evaluated 94 confirmed cases of COVID-19 in trial participants
  • Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected
  • Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November
  • Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints

Continue reading

NIH begins large clinical trial to test immune modulators for treatment of COVID-19

The National Institutes of Health has launched an adaptive Phase 3 clinical trial to evaluate the safety and efficacy of three immune modulator drugs in hospitalized adults with COVID-19. Some COVID-19 patients experience an immune response in which the immune system unleashes excessive amounts of proteins that trigger inflammation — called a “cytokine storm” — that can lead to acute respiratory distress syndrome, multiple organ failure and other life-threatening complications. The clinical trial aims to determine if modulating that immune response can reduce the need for ventilators and shorten hospital stays. The trial, known as ACTIV-1 Immune Modulators (IM), will determine if the therapeutics are able to restore balance to an overactive immune system.Continue reading

An Open Letter from Daniel O’Day, Chairman & CEO, Gilead Sciences: October 8, 2020

Daniel O’Day – October 08, 2020

With today’s publication of new data on remdesivir in the New England Journal of Medicine, we have the clearest picture yet of the medicine’s impact on COVID-19. Over the past months, we had already generated a wealth of clinical data on the benefits of remdesivir, providing much-needed hope to patients and healthcare providers worldwide. On the basis of this data, remdesivir has been approved or authorized for temporary use to treat COVID-19 in more than 50 countries worldwide. Today’s peer-reviewed data come from the gold standard randomized, double-blind, placebo-controlled Phase 3 study led by the U.S National Institute of Allergy and Infectious Diseases (NIAID). They provide new information that expands on the benefits of remdesivir and offer greater hope than ever in the fight against COVID-19.Continue reading