Panel discusses PBM reform and Medicaid omnibus, status of 340B reform and medical aid in dying
Health News Illinois convened a panel of experts this week to recap the recently-concluded legislative session.
Panelists discuss effects of federal changes to medical research, potential cap on indirect costs
A panel of experts joined Health News Illinois this week to discuss the state of medical research, specifically in light of major upheaval at the National Institutes of Health that […]
Ocaliva for NASH Gets Thumbs Down From FDA Advisors
A panel of FDA’s outside experts said obeticholic acid (Ocaliva) does not have a favorable risk-benefit profile for treating nonalcoholic steatohepatitis (NASH) with pre-cirrhotic liver fibrosis, and recommended against accelerated approval of the drug. On Friday, the Gastrointestinal Drugs Advisory Committee voted 12-2 (with two abstentions) that the improvements in liver scarring seen in the […]
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 […]
FDA Panel Supports Tofersen for Rare Genetic ALS
A panel of FDA advisors voted unanimously that plasma neurofilament light chain (NfL), a biomarker of neurodegeneration, is a reasonable surrogate endpoint in amyotrophic lateral sclerosis (ALS) associated with a mutation in the SOD1 gene (SOD1-ALS). In a 9-0 vote on Wednesday, the agency’s Peripheral and Central Nervous System Drugs Advisory Committee said the available […]
FDA Panel Backs Full Approval of Paxlovid for COVID-19
An FDA panel recommended the agency grant full approval to nirmatrelvir-ritonavir (Paxlovid) for treating high-risk COVID-19. By a vote of 16-1 on Thursday, the Antimicrobial Drugs Advisory Committee said the totality of evidence supports the traditional approval of the oral antiviral, which has been widely used since late 2021 under an emergency use authorization to […]
Second RSV Vaccine for Older Adults Gets Thumbs Up From FDA Advisors
A panel of FDA’s outside advisors recommended the agency approve GSK’s respiratory syncytial virus (RSV) vaccine for older adults, a day after backing Pfizer’s RSV vaccine candidate for that same population. By votes of 12-0 on efficacy and 10-2 on safety, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) said the available data support […]
FDA Advisers Reject Nuplazid for Alzheimer’s Disease Psychosis
An FDA advisory panel rejected pimavanserin (Nuplazid) for the treatment of hallucinations and delusions in patients with Alzheimer’s disease psychosis on Friday. In a vote of 9-3, the Psychopharmacologic Drugs Advisory Committee decided against recommending the drug for approval for these patients, citing a slew of shortcomings in supporting trial data. This could have been […]
NCCN Reverses on Guideline Change for Surveillance in Prostate Cancer
After protest by urologists and patient advocates, the prostate cancer panel of the National Comprehensive Cancer Network (NCCN) reversed itself on Tuesday, with new guideline language restoring active surveillance (AS) as a preferred approach for “most” men with low-risk prostate cancer. In September, the NCCN panel had published guidelines that eliminated the word “preferred” for […]
FDA Panel Backs Pfizer Booster for Select Groups
An FDA advisory panel recommended emergency use authorization (EUA) of a booster dose of the Pfizer/BioNTech COVID-19 vaccine (Comirnaty) for individuals 65 and older, and those judged to be at high risk of severe COVID-19. On Friday, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 18-0 that the known and potential benefits […]