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 […]
Senate unanimously pass 340B program reforms
Senators unanimously approved a plan Thursday evening to reform Illinois’ 340B program.
Critics Say CDC Advisors’ Infection Control Guidance Isn’t Strong Enough
A CDC advisory committee voted unanimously on Friday to approve draft infection control guidelines, though some critics charge the recommendations don’t go far enough and ignore lessons from the COVID-19 pandemic. At the heart of the controversy is a new “air” category for pathogen transmission, and three levels of air precautions based on how transmissible […]
CDC Advisors Back Therapeutic to Prevent RSV in Infants
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously — 10 to 0 — in favor of nirsevimab (Beyfortus) for protecting a wide swath of at-risk infants from respiratory syncytial virus (RSV). At a meeting on Thursday, ACIP recommended that all infants younger than 8 months who are born during or approaching their first […]
ACIP Endorses 20-Valent Pneumococcal Vaccine for Kids
The CDC’s Advisory Committee on Immunization Practices (ACIP) agreed unanimously on Thursday to include the 20-valent pneumococcal conjugate vaccine (PCV20; Prevnar) as an option for U.S. children. All 14 members voted in favor of the following four proposals: Routine use in children ages 2-23 months: ACIP recommended either the 15-valent PCV (PCV15; Vaxneuvance) or PCV20, […]
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 […]
CDC Panel Backs Novavax COVID Vaccine for Adults
The CDC Advisory Committee on Immunization Practices (ACIP) voted unanimously to recommend Novavax’s COVID-19 vaccine for individuals 18 and up. With a vote of 12-0, the advisory panel endorsed a two-dose primary series of the adjuvanted, protein-based vaccine, which will be administered 3 weeks apart. The recommendation follows FDA’s emergency use authorization last week. Shortly […]
High Court Sides With Docs Accused of ‘Pill Mill’ Operations
WASHINGTON — The Supreme Court on Monday ruled unanimously in support of two doctors convicted of prescribing opioids without a “legitimate” medical purpose, arguing that there should be a higher standard of proof in prosecuting such cases. A provision of the Controlled Substances Act (CSA) declares it a federal crime for a person to knowingly […]
ACIP Backs Moderna’s COVID Shot for Kids 6-17 Years
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Thursday to recommend that children ages 6-17 years receive Moderna’s COVID-19 vaccine. With a 15-0 vote, ACIP endorsed a two-dose primary series of the mRNA vaccine for kids ages 6-11 years (50 mcg per dose) and adolescents ages 12-17 (100 mcg per dose). The […]
CDC’s Advisers Endorse COVID Vaccines in Youngest Kids
The CDC’s Advisory Committee on Immunization Practices (ACIP) voted unanimously on Saturday to recommend that children 6 months and older receive COVID-19 vaccines. As proposed by CDC staff, and now approved by CDC Director Rochelle Walensky, MD, MPH, the recommendations call for a two-dose series of Moderna’s product for children ages 6 months to 5 […]