Aduhelm
-
Biogen Says Goodbye to Beleaguered Alzheimer’s Drug Aduhelm
Biogen has returned its Aduhelm rights to Neurimmune, the company that initially developed the antibody Alzheimer’s disease drug. But Biogen isn’t abandoning Alzheimer’s, and its pipeline includes drugs that take other approaches to the neurodegenerative disorder.
-
Aduhelm’s loss is a win for value-based drug pricing
Value-based pricing could have shown us with more certainty the real level of effectiveness of Aduhelm. Maybe it is worth paying something for; and value-based contracts are the only way to figure that out.
-
Do you advise self-insured employers? You Can Help Us!
Take part in this survey and share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health and navigation.
-
Biogen pulls Alzheimer’s drug application in Europe as EMA calls data insufficient
Biogen withdrew an application seeking approval in Europe for Alzheimer’s disease drug Aduhelm, a move that follows a negative opinion on the therapy issued by a European Medicines Commission committee last December. The company was unable to persuade European regulators to change their minds about the drug.
-
Final CMS decision limits coverage of Biogen’s Aduhelm to those in clinical trials
Biogen’s Alzheimer’s disease drug Aduhelm will only be covered for Medicare beneficiaries participating in a clinical trial. The final coverage determination will have the effect of limiting use of the drug, but the agency said its decision provides clarity on what drug companies need to show in order to secure Medicare coverage.
-
Biogen slashes price of Alzheimer’s drug by half as CMS coverage decision looms
The price of Biogen Alzheimer’s disease drug Aduhelm will be cut in half at the start of 2022, a move that comes as a Medicare recommendation on coverage is expected early next year. Meanwhile, Biogen is preparing corporate measures projected to save $500 million annually, cost-cutting made necessary in part due to slow market uptake of Aduhelm.
-
Biogen projects confirmatory study for Alzheimer’s drug will take four years
Six months after Biogen was awarded regulatory approval for its Alzheimer’s disease drug Aduhelm, the company is laying out a timeline for the post-marketing study to confirm whether the drug works. The projected four-year study will enroll more than 1,300 patients and will include a placebo control arm.
-
Biogen and Eisai unveil details for five-year, real-world Aduhelm clinical trial
Patients taking new Alzheimer’s disease drug Aduhelm will be evaluated in a real-world study lasting up to five years. Biogen announced plans for the observational study, which is one of three post-marketing clinical programs planned to generate more data about the drug
-
CMS considers coverage of Biogen’s costly new Alzheimer’s drug
CMS plans to review and determine coverage for Biogen’s Aduhelm, the first new Alzheimer’s disease treatment in decades. But the jury is still out on the drug’s effectiveness. Not to mention, its hefty price tag — $56,000 — could drive up Medicare spending.
-
FDA tweaks Aduhelm’s label, narrows use of the Biogen drug to mild Alzheimer’s
The drug label for Biogen Alzheimer’s disease drug Aduhelm has been revised to clarify that its use is for patients with mild forms of the neurodegenerative disorder. The change aligns the prescribing information with the patient population studied in clinical trials.
-
Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
-
Confirming benefit of Biogen Alzheimer’s disease drug will take 8 years
Biogen is still discussing with the FDA the clinical trial design to confirm the benefit offered by its newly approved Alzheimer’s disease drug, Aduhelm. According to a timeline set by the regulator, that clinical trial is not expected to be complete until 2029.
-
FDA picks accelerated approval path to decide in favor of Biogen Alzheimer’s drug
A Biogen Alzheimer’s drug that clears amyloid plaque from the brain has been granted accelerated approved by the FDA. The drug, which will be marketed as Aduhelm, is the first new FDA-approved Alzheimer’s treatment since 2003.