FDA approves new drug Leqembi to treat early Alzheimer’s disease
By
Alicia Lasek
Jan 09, 2023
The newly approved drug Leqembi (lecanemab) may slow progression of cognitive decline due to Alzheimer’s disease, trial data show. CMS says it may rethink Medicare coverage of drugs in Leqembi’s...
Lack of clinical use prompts Biogen to halt real-world Aduhelm drug trial
By
Alicia Lasek (f3)
Jun 28, 2022
The pharmaceutical firm Biogen has stopped a real-world clinical trial for its federally approved Alzheimer’s disease drug aducanumab (Aduhelm).
Drugmakers ask FDA to approve another Alzheimer’s drug, similar to Aduhelm
By
Alicia Lasek
Sep 29, 2021
Drugmakers Eisai and Biogen are putting the Food and Drug Administration to the test with a request to approve a second Alzheimer’s drug that works like aducanumab (Aduhelm), the new, yet controversial,...
New Alzheimer’s drug Aduhelm has no clinical benefit, panel of medical experts concludes
By
Alicia Lasek
Jul 21, 2021
The drug does not improve upon the current standard of care for Alzheimer’s disease, say advisers to the Institute for Clinical and Economic Review, a drug pricing watchdog.
Slow buy-in: Only 3% of neurologists have written Aduhelm prescriptions so far
By
Alicia Lasek
Jul 15, 2021
Neurologists are very aware of Biogen’s newly approved Alzheimer’s drug, but few have prescribed it so far, a real-time study of the brand’s market launch has found.
Clinical briefs for Thursday, July 15
By
Alicia Lasek
Jul 15, 2021
FDA adds provider warning to J&J vaccine regarding rare neurological disorder … Biogen’s dementia drug Aduhelm could cost Medicaid up to $2.2 billion a year … Biden to nominate West Virginia’s...
FDA calls for investigation into its approval of controversial Alzheimer’s drug
By
Alicia Lasek
Jul 12, 2021
The acting chief of the Food and Drug Administration has called for an investigation into the events leading up to the approval of Biogen’s brain plaque-clearing dementia drug aducanumab (Aduhelm).
Criticism, confusion and hope: new Alzheimer’s drug receives messy welcome
By
Alicia Lasek
Jun 15, 2021
Clinicians’ responses to the controversial approval of Aduhelm range between excitement and disapproval, with questions abounding on how to advise patients on treatment and the cost to patients and...
FDA approves first drug to slow Alzheimer’s in controversial decision
By
Alicia Lasek
Jun 07, 2021
The evidence convincingly shows that aducanumab (Aduhelm) removes beta amyloid — a hallmark of Alzheimer’s — from the brain, slowing the disease’s progression and giving patients and families much-needed...
Biogen launches new trial of Alzheimer’s drug aducanumab
By
Alicia Lasek
Apr 29, 2021
The new trial, called EMBARK, will re-dose patients who took part in the drug’s earlier clinical studies. It is expected to be one of the largest clinical trials in Alzheimer’s disease, the company...