✦ HHS said on June 9 that the U.S. government will procure approximately 1.7 million courses of Merck & Co.’s investigational antiviral treatment for COVID-19, molnupiravir (MK-4482), pending emergency use authorization or approval from the FDA. The treatment — which is designed to induce viral genome copying errors to prevent the virus from replicating in the human body — is currently being studied in a Phase III trial for its potential to reduce the risk of hospitalization or death in patients who have COVID-19 symptoms for five days or less and are at high risk for severe illness. It has also “demonstrated broad-spectrum activity against other viruses such as influenza, Ebola, and Venezuelan Equine Encephalitis virus,” HHS said.
✦ The White House, HHS and the FDA on June 8 released a report containing several policy recommendations to address “vulnerabilities in U.S. pharmaceutical supply chains” that the COVID-19 pandemic revealed. For its part, HHS will make an initial commitment of about $60 million, sourced from the Defense Production Act appropriation in the American Rescue Plan, “to develop novel platform technologies to increase domestic manufacturing capacity for API [active pharmaceutical ingredients].” The report’s overall policy recommendations, meanwhile, are based on four main themes: boosting local production and fostering international cooperation; promoting research and development that establishes innovative manufacturing processes and production technologies to strengthen supply chain resilience; creating robust quality management maturity to ensure consistent and reliable drug manufacturing and quality performance; and leveraging data to improve supply chain resilience.
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