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

Alzheimer’s Disease Data Initiative Launches, Critical Path for Alzheimer’s Disease Consortium to Partner

CPAD will partner with ADDI to build better tools for researchers around the world to access, use and share dementia-related data to accelerate the development of new and more effective treatments for Alzheimer’s disease

TUCSON, Ariz., November 17, 2020 — The Critical Path Institute’s (C-Path) Critical Path for Alzheimer’s Disease (CPAD) Consortium today announced its participation as a Partner with the Alzheimer’s Disease Data Initiative (ADDI), a 501(c)(3) medical research organization which launched today. ADDI is dedicated to advancing scientific breakthroughs in the treatment of Alzheimer’s disease (AD) and related dementias.Continue reading

PhRMA Announces First-Ever, Industry-Wide Principles on Clinical Trial Diversity

“The industry’s new clinical trial diversity principles are an important step toward greater health equity,” said Stephen J. Ubl, president and chief executive officer of PhRMA. “We are addressing issues of mistrust and working to reduce systemic issues that deter communities of color from participating in clinical trials, so that those patients who want to participate, can.”
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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