PI3K Inhibitor Fails to Pass Muster With FDA Advisory Committee
The FDA’s Oncologic Drugs Advisory Committee (ODAC) made a clean sweep of its 2-day meeting, deciding that the PI3K inhibitor duvelisib (Copiktra) does not offer a favorable risk-benefit ratio for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). By an 8-4 vote, the panel came down on the side of the FDA […]
FDA Advisors Back Fecal Microbiome Treatment for Recurrent C. Diff
An FDA advisory board recommended the agency approve a fecal microbiota transfer (FMT) product for recurrent Clostridium difficile infections. By a vote of 13-4 on Thursday, the Vaccines and Related Biological Products Advisory Committee (VRBPAC), said RBX2660 was effective for treating patients with recurrent C. diff infections who failed first-line antimicrobial therapy. Safety landed in […]
U.S. Task Force Recommends All Adults Under 65 Be Screened For Anxiety
A U.S. advisory group of medical experts recommended all patients under the age of 65 be screened for anxiety for the first time, a major effort that hopes to expand mental health care as the toll of the COVID-19 pandemic continues to climb. The group, the U.S. Preventative Services Task Force, released its draft recommendation […]
Opinion | ‘I Really Feel We Need the Human Data’: What We Heard This Week
“I really feel we need the human data.” — Pablo Sanchez, MD, of the CDC’s Advisory Committee on Immunization Practices, who cast the only vote against recommending the new bivalent boosters due to the lack of clinical trial data. “It could cause a lot of anxiety in people.” — Sean McGann, MD, an emergency physician […]
MedPAC Commissioners Mull Proposals to Change Part B Drug Payment
WASHINGTON — Members of the Medicare Payment Advisory Commission (MedPAC) spoke up Friday in favor of considering new approaches to the way Medicare pays for Part B drugs. “I think we’re going in the right direction,” said commissioner Gary Poulsen, MBA, of Intermountain Healthcare in Salt Lake City, Utah. “I think this is an improvement.” […]
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 […]
Opinion | Are Omicron-Targeted Boosters Worth It?
The FDA, following the advice of its advisory committee, is advising COVID-19 vaccine manufacturers to reformulate future booster shots to include protection against the BA.4 and BA.5 Omicron variants of SARS-CoV-2. While this decision was not surprising and may have seemed perfunctory to many people, it is worth thinking about the wider context that undergirds […]
FDA Panel Gives Thumbs Up to Omicron-Containing COVID Boosters
An FDA advisory committee voted 19-2 on Tuesday to recommend use of an Omicron-specific component in a future COVID-19 vaccine booster. “We really do need vaccines that provide broader protection against variants that have not yet emerged,” said Melinda Wharton, MD, MPH, associate director of vaccine policy at the CDC, at a remote meeting of […]
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 […]