FDA Panel Endorses mAb to Prevent RSV in Infants
An FDA advisory committee on Thursday gave strong backing to a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease (LRTD) in infants as well as in at-risk children up to 24 months of age. In a unanimous vote, all 21 members of the Antimicrobial Drugs Advisory Committee agreed that the […]
Antibody for Infant RSV Prevention to Face FDA Panel
An FDA advisory committee on Thursday will consider whether to recommend a shot of a monoclonal antibody against respiratory syncytial virus (RSV) to prevent lower respiratory tract disease in both infants and in at-risk children up to age 2 years. The Antimicrobial Drugs Advisory Committee will examine a biologics license application approval for nirsevimab, a […]
FDA Panel Gives Strong Backing to RSV Vaccine for Protecting Infants
An FDA panel on Thursday gave a strong endorsement for what could become the first maternal respiratory syncytial virus (RSV) vaccine approved for protecting infants against the annual scourge. In a unanimous vote, all 14 members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said that the available data support the efficacy of […]
Experts Call for PBM Transparency During Senate Hearing
Most expert witnesses at a hearing of the Senate Finance Committee on Thursday agreed that pharmacy benefit managers (PBMs) — middlemen between the drug companies and insurers — drive up the prices of prescription drugs, leaving patients with higher out-of-pocket costs, and offered a range of suggestions on how to curb PBM abuses. Historically, PBMs […]
Federal Judge Strikes Down ACA’s Preventive Care Coverage Requirements
A federal judge on Thursday struck down the Affordable Care Act (ACA) provision requiring all insurers to cover certain preventive services free of charge, angering the law’s supporters. “Individual Plaintiffs need not comply with the preventive care coverage recommendations of the U.S. Preventive Services Task Force (USPSTF) issued on or after March 23, 2010 [the […]
John Fetterman’s Candor About His Depression Is A Revelation
When Sen. John Fetterman (D-Pa.) revealed Thursday that he’d checked himself into the hospital to receive treatment for clinical depression, his office provided a simple, straightforward explanation: Pennsylvania’s newly elected Democrat is ill and needs medical care before returning to work. The statement wasn’t dissimilar to those others lawmakers have put out when they’re sick […]
Jake Tapper Says His Daughter ‘Almost Died’ From Appendicitis After Misdiagnosis
Jake Tapper said Thursday that his 15-year-old daughter, Alice, “almost died” last year from appendicitis after she was misdiagnosed at the hospital. The CNN anchor shared his family’s terrifying experience in a segment, noting that 7.4 million patients are misdiagnosed each year out of about 130 million annual emergency department visits, according to a report […]
Thumbs Down for Genetic Test for Opioid Use Disorder, FDA Advisors Say
An FDA advisory committee on Thursday voted strongly against AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). In an 11-2 decision, the Clinical Chemistry and Clinical Toxicology Devices Advisory Committee said the probable benefits of the AvertD device did not outweigh its probable risks, taking into account risks and benefits of […]
Genetic Testing for Opioid Use Disorder Heads to FDA Advisors
On Thursday, members of the FDA’s Clinical Chemistry and Clinical Toxicology Devices Advisory Committee will meet to discuss AvertD, a prescription genetic risk assessment tool for opioid use disorder (OUD). AvertD detects the presence or absence of 15 single nucleotide polymorphisms (SNPs) to help identify adults with an increased genetic risk of OUD. It’s intended […]
House Bill Would Fix Glitch in Medicare Non-Emergency Ambulance Transport Program
WASHINGTON — Rep. Buddy Carter (R-Ga.) will introduce a bill in the House on Thursday that is aimed at fixing problems with Medicare’s program for non-emergency ambulance transport for certain low-income beneficiaries, MedPage Today has learned. The Repetitive, Scheduled Non-Emergent Ambulance Transport (RSNAT) prior authorization model started in 2014 as a project of the Centers […]