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As global cases of monkeypox continue to increase, the World Health Organization (WHO) is recommending two smallpox vaccines for off-label use against monkeypox and one that has been approved for prevention of monkeypox. Read More
The Supreme Court unanimously ruled that the Department of Health and Human Services (HHS) can’t reduce its payment rates for only a certain group of hospitals — namely, 340B Drug Discount Program hospitals — without first conducting a survey of hospitals’ acquisition costs for each covered outpatient drug. Read More
“After more than a decade of price increases in seemingly coordinated fashion, a month’s supply is priced at $529 for Eliquis and $516 for Xarelto,” they said. Read More
Amylyx’s potentially pricey amyotrophic lateral sclerosis (ALS) drug AMX0035 can only be cost-effective if it costs no more than $18,200 per year — much less than Radicava, the only approved ALS drug, which ticks in at $171,000 per year. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously, 21-0, yesterday in favor of FDA emergency authorization for Moderna’s two-dose COVID-19 vaccine series in children between age six months and five years and Pfizer’s three-dose COVID-19 vaccine series in children between age six months and four years. Read More
The FDA’s Center for Drug Evaluation and Research (CDER) is looking past the pandemic in its current goals for 2022, says Director Patrizia Cavazzoni, focusing on initiatives on rare diseases, real-world data (RWD), supply chain surveillance and increased patient engagement in drug development. Read More