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Amgen has become the latest drugmaker to file a lawsuit against HHS over the federal government’s attempts to force pharma companies to provide 340B drug discounts to contract pharmacies. Read More
Biogen and Eisai’s lecanemab — the antiamyloid antibody that recently posted the best-ever Alzheimer’s disease (AD) phase 3 data — shouldn’t cost more than $20,600 per year to be considered a cost-effective therapy for the disease, according to a new draft analysis by the Institute for Clinical and Economic Review (ICER). Read More
In this special report, Drug Industry Daily examines the progress made this year in pursuit of lower drug prices. Part 1 focuses on efforts by lawmakers and the Biden administration.Read More
The FDA has updated its draft guidance for generic drugmakers on submitting controlled correspondence to the agency to include new review goals under the reauthorization of the Generic Drug User Fee Amendments (GDUFA III). Read More
The Institute for Clinical and Evidence Review (ICER) has tackled two disparate pricing regimens, suggesting that Pfizer cut the cost of its COVID-19 antiviral treatment Paxlovid by more than 80 percent and that ublituximab, TG Therapeutics’ potential blockbuster for multiple sclerosis (MS), wouldn’t be worth more than $55,081 per year if approved. Read More
A federal court has entered a consent decree against Qualgen — an Oklahoma outsourcing facility that has had multiple, previous run-ins with the FDA — prohibiting the compounder from distributing drugs across state lines. Read More
Many of the riders and amendments left on the cutting room floor in September when Congress passed user fee legislation have now been taken up again in a year-end omnibus spending package, a draft of which was released this week. Read More
HHS argues that the program would violate a criminal ban on any remuneration to induce purchase of any item “for which payment may be made in whole or in part under a federal health care program.” Read More
The Department of Health and Human Services (HHS) is pressing the Supreme Court to squash Pfizer’s appeal challenging the U.S. anti-kickback statute, filing a petition which lays out the department’s opposition to the patient assistance program Pfizer created to cover costs of its highest-priced drug. Read More