Important pharmacy news and late-breaking industry information updated daily.
Medicare could approve coverage of some "breakthrough" medical devices the same day that FDA green-lights them, under a proposed rule published September 1 in the Federal Register. The Trump administration plan aims to address the nearly year-and-a-half gap between FDA approval and CMS coverage decisions on new medical devices.
FDA announced Friday that it has expanded the scope of the existing emergency use authorization (EUA) for remdesivir (Veklury—Gilead Sciences) to cover all patients hospitalized with suspected or laboratory-confirmed COVID-19.
FDA issued a warning Thursday about the risks to consumers of alcohol-based hand sanitizers that are packaged in containers that may appear as food or drinks.
Medicaid managed care companies are working with the Ohio Department of Medicaid to act on a 2019 law that recognizes pharmacists as providers in Ohio. Since getting wind of what pharmacists are capable of doing for patients, three Medicaid managed care plans in Ohio have launched programs of their own to pay pharmacists as medical providers. Additional plans are expected to make announcements in the coming months.
FDA has issued an emergency-use authorization for a low-cost, rapid-response COVID-19 antigen test from Abbott Laboratories. The BinaxNOW COVID-19 Ag Card—which uses technology similar to home pregnancy tests—is intended for use by medical professionals, is about the size of a credit card, and provides results in about 15 minutes.
The Department of Justice's (DOJ) antitrust division has charged Teva Pharmaceutical's U.S. arm with fixing prices on cholesterol medication and other drugs. DOJ brought the case in a Pennsylvania federal court, accusing Teva Pharmaceuticals USA of anti-competitive conduct that resulted in at least $350 million in overcharges to consumers.
Annual influenza vaccination is recommended for all persons aged 6 months and older who do not have contraindications, said CDC's Advisory Committee on Immunization Practices (ACIP) in its 2020—21 influenza statement.
The scientific community is distancing itself from the Trump administration's claim that convalescent blood plasma curtails COVID-19 deaths by 35%. The president, along with the heads of FDA and HHS, cited the statistic on Sunday as they announced emergency authorization of the treatment.
FDA on Sunday issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients.
A new guideline from the American College of Physicians and the American Academy of Family Physicians calls for topical NSAIDs to be used as a first-line treatment for acute pain lasting no more than 4 weeks from non–low back, musculoskeletal injuries.