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- PMLiVE

Biogen’s Alzheimer’s drug Aduhelm

Biogen Idec building

Biogen’s Qalsody granted FDA accelerated approval for rare form of ALS

Mutations in the SOD1 gene are responsible for approximately 2% of all cases

Biogen Idec building

Biogen and Eisai’s Alzheimer’s drug associated with positive long-term health outcomes

A simulation model estimated lecanemab to potentially slow the rate of disease progression

Biogen Idec building

Biogen and Eisai’s Alzheimer’s drug to be covered by US Veterans Health Administration

US veterans in the early stages of the disease who meet VHA criteria will be eligible for coverage

- PMLiVE

FDA grants priority review for traditional approval of Biogen and Eisai’s Alzheimer’s drug

Leqembi was granted accelerated approval in the US earlier this year

Biogen Idec building

Safety-related change to label for Biogen’s Alzheimer’s drug Aduhelm approved by FDA

Larger areas of bleeding on the brain have been reported in some patients taking the drug

Biogen Idec building

Biogen and Eisai’s Alzheimer’s drug receives FDA accelerated approval

An application has also been submitted for US approval under the traditional pathway

- PMLiVE

bluebird bio sells second FDA priority review voucher for $95m

The company sold its first voucher to Dutch biotech Argenx for $102m

Biogen Idec building

Biogen and Alcyone Therapeutics partner in deal worth over $50m

The companies hope to improve treatments for spinal muscular atrophy and amyotrophic lateral sclerosis

Biogen Idec building

Biogen and Genentech sign royalty agreement for blood cancer drug glofitamab

Genentech will have sole decision-making rights on glofitamab's commercialisation in the US

- PMLiVE

FDA approves Ferring’s Adstiladrin as first gene therapy for bladder cancer

Non-muscle-invasive bladder cancer represents around 75% of all new bladder cancer cases

- PMLiVE

Roche’s COVID-19 antibody receives FDA approval for hospitalised adults

The decision makes Actemra the first FDA-approved monoclonal antibody to treat COVID-19

- PMLiVE

FDA lifts partial clinical hold on bluebird bio’s sickle cell gene therapy studies

The company can now resume the enrolment and treatment of patients aged two to 17 years

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