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Aduhelm

- PMLiVE

AbbVie, Biogen and Pfizer collaboration creates new resource for genetic exome sequence analysis

Companies have created 'world’s largest' resource for genetic exome sequence analysis

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

- PMLiVE

Biogen doses first patient in phase 3 systemic lupus erythematosus study

Biogen has initiated the late-stage study based on positive results from the phase 2 LILAC study

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

- PMLiVE

Biogen, Sage’s depression therapeutic zuranolone hits primary endpoint in phase 3

Biogen and Sage signed a $3.1bn deal last year to jointly develop potential depression therapies

- PMLiVE

Biogen reports new data backing long-term benefit of Spinraza

Company also revealed new analysis suggesting benefits associated with a higher therapy dose

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

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