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- PMLiVE

Codiak BioSciences

- PMLiVE

FDA leaders offer perspective on accelerated approval of Biogen’s Aduhelm

Leaders maintain that Aduhelm fits into the regulatory paradigm of the FDA’s accelerated approval pathway

Biogen Idec building

Biogen pays InnoCare $125m upfront for potential multiple sclerosis treatment

Orelabrutinib is currently being evaluated in a phase 2 trial in relapsing-remitting MS

- 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

- 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

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

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

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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