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On the heels of unanimous recommendations last week by its vaccines advisory committee, the FDA granted Emergency Use Authorization (EUA) on Friday for Moderna’s COVID-19 vaccine for children between six months and 17 years and for Pfizer-BioNTech’s COVID-19 vaccine for children between six months and four years. Read More
The Federal Trade Commission (FTC) has warned drugmakers and pharmacy benefit managers (PBM) that it will be stepping up enforcement of alleged illegal bribes and rebates that hinder patient access to cheaper drugs. Read More
After endeavoring to do so throughout much of the pandemic, the World Trade Organization (WTO) has reached an agreement that allows developing countries to produce their own generic versions of COVID-19 vaccines. Read More
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