Denise Myshko

The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.

Mobile devices for patients to report symptoms associated with immune checkpoint inhibitors address an unmet need.

The full results from the Emperor-Preserved trial show Jardiance reduces the risk of hospital and death from heart failure.

Greater uptake of hepatitis C medication may help improve the health of Medicaid enrollees and reduce the economic burden of untreated hepatitis C on the U.S. healthcare system, the authors said.

The combination bamlanivimab and etesevimab can resume use and distribution to treat mild-to-moderate COVID-19 but only in states where variants resistant to the therapy are low.

Tecentriq loses indication, Xarelto is approved for reduce risks of cardiovascular events, Tibsovo is approved for rare cancer, Skytrofa is a new, once-weekly growth hormone, and supplemental application is filed Orencia graft-versus-host disease.

Bluebook Rx is a new solution that helps employers and plan sponsors better understand and optimize their prescription drug spending.

The new model indicates a small initial impact on new drugs coming to the market, but an impact that grows over time.

Study results reported in JAMA Network Open show that financial incentives are only modestly effective in getting more people to get way screened for colorectal cancer.

ICER’s policy recommendations suggest payers establish step therapy with less expensive systemic agents to allow patients and clinicians to choose from multiple options.

ICER calculations using real-world data would result in major price cuts of three therapies — Takhzyro, Haegarda, and Cinryze — if they were to meet commonly used cost-effective thresholds.

FDA approves Opdivo, Jardiance for new indication, Jemperli gets accelerated approval for solid tumors, and Lilly’s rapid-acting insulin, Lyumjev is approved for administration via an insulin pump.

The report found that mavacamten offers benefits but was above the threshold of $150,000 per quality-adjusted life-years.

At a placeholder price of $75,000 per year for mavacamten used along with standard first-line treatment for symptomatic obstructive hypertrophic cardiomyopathy was above the threshold of $150,000 per QALY.

Including patients in the decision-making process, the authors said, is an important component of patient-centered health care.

The monoclonal antibody had been given an emergency use authorization to treat COVID-19, but the recent spike in cases is driving a shortage in supply.

The move, effective July 15, was the result of a generic now being available.

Positive trial results were reported in The Lancet last year. The FDA is scheduled (the PDUFA date) to make a decision on the application for approval early next year.

All stakeholders together incur about $93.3 billion in costs for implementing, contesting, and navigating drug utilization management.

Another FDA approval and two additional applications for Keytruda have been submitted; a generic for Chantix and a sleep disorder treatment is approved; and a complete response letter has been issued for an anemia therapy.

This is the first approval of generic version of Chantix, and it comes just weeks after a recall of the brand-name drug.

The potassium-lowering agent was associated with a 20% relative reduction in costs related to outpatient, inpatient, and emergency department visits.

Four products on the preferred list this year will be excluded next year.

A decision on the plaque psoriasis therapy is expected in the second quarter of 2022.

Current drug shortages based on FDA data, prepared by Formulary Watch.

AstraZeneca gets FDA nod for Saphnelo, BMS pulls indication for Istodax, Merck to seek another use for Keytruda, Tecentriq is granted priority review for NSCLC and COVID-19 cocktail gets expanded EUA.

A single application targets the infection without entering the circulatory system.

The sickle cell disease therapy will now be on the Preferred Drug List.

Newly approved drugs put the brakes on particular “driver mutations,” that when unimpeded, rev up the runaway cell growth and division that characterizes cancer.

This is the first new approval for lupus in a decade.