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- PMLiVE

Alzheimer’s

- PMLiVE

FDA acting commissioner Janet Woodcock requests independent review of Aduhelm approval

Approval of Biogen's Alzheimer's disease treatment has raised concerns over FDA staff interactions with the company

Biogen Idec building

FDA narrows label for Biogen’s Aduhelm to only include mild forms of Alzheimer’s disease

Reflects the patient population included in clinical trials of anti-amyloid treatment

- PMLiVE

GlaxoSmithKline agrees $2.2bn dementia mAb deal with Alector

The focus of the deal is two clinical-stage monoclonal antibodies in development for a number of neurodegenerative diseases

Biogen Idec building

ICER says price of Biogen’s Aduhelm should be much lower

US cost-effectiveness watchdog’s analysis estimates current annual list price of $56,000 could be reduced to $3,000 to $8,400

- PMLiVE

Breakthrough therapy designated for Lilly’s investigational Alzheimer’s drug donanemab

The BTD is based on data from the phase 2 TRAILBLAZER-ALZ study in early symptomatic Alzheimer's patients

Biogen Idec building

Biogen plans confirmatory trial as FDA documents show struggle over Aduhelm approval

Confirmatory trial is planned to be completed ahead of nine-year time frame

- PMLiVE

Roche’s gantenerumab improves biomarkers in inherited form of Alzheimer’s disease

However, anti-amyloid antibody did not show evidence of cognitive benefit for patients

Biogen Idec building

Biogen discontinues clinical development of anti-tau antibody for Alzheimer’s disease

The drug failed to meet the primary efficacy endpoint in a phase 2 study

Biogen Idec building

Biogen to begin shipping newly approved Alzheimer’s treatment in two weeks

Just days after the drug was approved by the FDA advisory panel, two of its members have resigned

- PMLiVE

FDA approves Biogen’s aducanumab for Alzheimer’s disease in ‘landmark’ decision

FDA is requiring Biogen to conduct a new randomised, controlled clinical trial to verify the drug’s clinical benefit for Alzheimer’s patients

- PMLiVE

Annovis Bio’s lead therapeutic shows ‘significant improvements’ in Alzheimer’s, Parkinson’s

Patients from a small phase 2a study saw their ADAS-Cog11 scores improve by 4.4 points

- PMLiVE

Alzheimer’s disease: the search for a cure

To ensure the successful discovery and development of new dementia therapies, key gaps in the field need to be addressed

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