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The FDA has released a list of 223 drugs and medical countermeasures (MCMs) that it considers vital to U.S. patients or critical in a public health emergency, fulfilling a requirement of an executive order issued by President Trump in August. Read More
A growing number of states say they don’t plan to automatically distribute FDA-approved COVID-19 vaccines to their residents. Nevada, Oregon and Washington announced last week that they plan to conduct independent verification before distributing any vaccines. Read More
Despite announcing positive results for its phase 2/3 COVID-19 antibody cocktail trial Thursday, a potential safety signal has led Regeneron to temporarily stop enrolling patients who require high-flow oxygen or mechanical ventilation. Read More
The European Medicines Agency has unveiled a new plan for how drug sponsors and regulators should deal with the risk of N-nitrosamine contamination in sartan drugs. Read More
Shilpa Medicare of Karnataka, India, drew a warning letter from the FDA for multiple violations found during an inspection of its sterile drug manufacturing facility. Read More
New York’s Attorney General (AG) Letitia James says the Suffolk County State Supreme Court will begin jury selection in January for the state’s trial against multiple opioid manufacturers and distributors for their alleged roles in creating the opioid addiction epidemic. Read More
The international medical aid group Doctors Without Borders has called on Sanofi and GlaxoSmithKline (GSK) to make their COVID-19 vaccine available at cost once approved. Read More
The Centers for Medicare & Medicaid Services (CMS) issued two new regulations this week — one a sweeping rule requiring health plans to be transparent about what they pay for medical procedures and drugs, and another seeking to ensure that Medicare, Medicaid and private health plans absorb the cost of a COVID-19 vaccine when one is ready. Read More
Data from Regeneron’s phase 2/3 trial of its COVID-19 antibody cocktail showed the treatment significantly reduced viral load and the number of medical visits needed by nonhospitalized patients, the company said Thursday. Read More
Moderna is still on track to file for Emergency Use Authorization (EUA) for its COVID-19 vaccine in the later part of November and is currently gearing up for worldwide distribution. Read More