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FDA Panel Votes Against Broad Talazoparib-Enzalutamide Label in Prostate Cancer

An FDA advisory committee on Wednesday unanimously voted against recommending approval of the PARP inhibitor talazoparib (Talzenna) plus enzalutamide (Xtandi) for all patients with metastatic castration-resistant prostate cancer (mCRPC). In an 8-0 vote, members of the Oncologic Drugs Advisory Committee (ODAC) said the available data from the TALAPRO-2 trial do not support a favorable risk-benefit […]

What’s Happening With the Medicare Drug-Price Negotiation Lawsuits?

Over the past year, drugmakers and lobbyists have filed 10 different lawsuits against the federal government’s efforts to lower prescription drug costs via the Medicare Drug Price Negotiation Program. It’s still early days for these cases, but so far the government has won “every substantive motion,” Zachary Baron, JD, of the O’Neill Institute for National […]

Lancet Menopause Series Wants to Change How Society Views ‘The Change’

Researchers warned against the “over-medicalization” of menopause in a four-paper series in The Lancet, and argued for a fresh approach that goes beyond the treatment of specific symptoms. The series focused on four areas for changing how we view menopause — ranging from healthcare providers adopting an “empowerment model” to support women; optimizing health after […]

Latest COVID Shots Protect Against Serious Outcomes

The recently updated COVID vaccines showed protection against serious virus-related outcomes in immunocompetent adults, data from the CDC’s IVY and VISION networks showed. From September 2023 to January 2024, vaccine effectiveness (VE) against COVID-related emergency department or urgent care encounters landed at 47% (95% CI 44-50), while protection against hospitalizations associated with the coronavirus ranged […]

COVID-19 Booster Shots Can Wait

Vaccines against SARS-CoV-2 are proving quite safe and highly effective in the prevention of COVID-19, especially severe and/or fatal disease. Over half of the U.S. population has initiated immunization and more than three out of four people in the U.S. over the age of 65 have completed vaccination. The promising vaccine roll-out and reductions in […]

RSV Vaccine Benefits Probably Outweigh Small Neurologic Risk, CDC Advisors Say

The benefits of vaccination against respiratory syncytial virus (RSV) for adults ages 60 and older probably outweigh the small risk of vaccine-related Guillain-Barré syndrome (GBS), the CDC’s Advisory Committee on Immunization Practices (ACIP) reaffirmed. In a presentation on the second day of the ACIP’s 2-day meeting, Amadea Britton, MD, of the CDC’s RSV adult vaccination […]

Bivalent Vax Protected Kids From Symptomatic COVID

During the 2022-2023 respiratory season, the bivalent COVID vaccines had an effectiveness of 54% against infection and 49% against symptomatic COVID in children and adolescents ages 5 to 17 years, a new study in JAMA showed. In this interview, Melissa Briggs Hagen, MD, MPH, of the CDC’s Coronavirus and Other Respiratory Viruses Division, discusses the […]

Fracture Risk Bumped With Testosterone Therapy in Hypogonadal Men

Testosterone treatment didn’t offer protection against fractures in men with hypogonadism, a TRAVERSE subtrial indicated. Compared with placebo, men who were on a testosterone gel actually had a significantly higher risk for fracture (HR 1.43, 95% CI 1.04-1.97), found Peter Snyder, MD, of the University of Pennsylvania in Philadelphia, and colleagues. During the median 3.19-year […]

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