LTC pharmacies pivot after feds call for timeout on J&J COVID vaccine
By
Danielle Brown
Apr 14, 2021
Long-term care pharmacies have stopped using the Johnson & Johnson COVID-19 vaccine and are awaiting further instruction from federal health officials, who recommended the halt while they investigate six...
Drug that targets Alzheimer’s inflammation approved for trial by FDA
By
Alicia Lasek
Feb 09, 2021
An experimental drug meant to treat the “type 3 diabetes” that some scientists believe triggers Alzheimer’s has been approved for a late-stage clinical trial.
Moderna’s vaccine highly effective against COVID-19: FDA review
By
John O'Connor
Dec 16, 2020
Moderna’s COVID-19 vaccine is 94% effective in preventing symptomatic illness, according to information released Tuesday. The initial review’s findings appear to set the table for federal authorization...
‘Most dangerous’ pandemic months ahead, former FDA leader tells providers
By
Danielle Brown
Nov 18, 2020
A former leader of the Food and Drug Administration is warning long-term care providers to stay vigilant and proactive as they head into the “seventh inning” of the coronavirus public health crisis.
FDA advisers vote ‘no’ on drug that may slow Alzheimer’s progression
By
Alicia Lasek
Nov 09, 2020
If approved by the FDA, aducanumab would be the first-ever drug marketed to slow progression of the brain-wasting disease, according to its developer. But an advisory committee was unconvinced of the drug’s...
Expect false positives: FDA letter to providers explains COVID antigen test results
By
Alicia Lasek
Nov 05, 2020
The agency clarifies that rapid antigen tests, “like all diagnostic tests,” are subject to false positive results, especially in low prevalence settings. It offers recommendations for administering...
FDA advisers to vote on first drug to treat Alzheimer’s
By
Alicia Lasek
Oct 28, 2020
Advisers will consider whether to recommend that the amyloid beta-removing drug aducanumab be approved. The FDA has not reviewed an application for a new Alzheimer’s treatment for at least 15 years.
COVID trial vaccines may be inadequate, some FDA advisors fear
By
Alicia Lasek
Oct 26, 2020
The current vaccine trials may be too focused on mild rather than severe disease, some advisors contend. But their arguments got pushback in a meeting streamed on the agency’s YouTube channel.
CDC briefing: Top officials talk up vaccine plans, focus on long-term care
By
Alicia Lasek
Oct 22, 2020
Federal health officials touted transparency and nationwide distribution plans while keeping their eye on Phase 1 vaccine recipients, including LTC residents and workers.
FDA requires abuse warning on Xanax, Valium labels
By
Alicia Lasek
Sep 25, 2020
Benzodiazepine drug labels must now display the FDA’s most serious “boxed warning” following growing reports of sedative abuse, the agency announced Thursday.