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- PMLiVE

Belviq

Biogen Idec building

Biogen/Eisai’s Alzheimer’s disease drug shows promise as subcutaneous formulation

Eisai said it aims to apply for US approval of SC Leqembi by the end of March 2024

Biogen Idec building

Biogen/Eisai’s Alzheimer’s disease drug shows promise as a subcutaneous formulation

Leqembi was granted traditional approval in the US earlier this month as a bi-weekly intravenous infusion

Biogen Idec building

Biogen/Eisai’s Alzheimer’s disease drug granted full FDA approval

Leqembi was granted accelerated approval earlier this year for patients with early Alzheimer's disease

Biogen Idec building

Biogen/Eisai’s Alzheimer’s drug backed by FDA advisory committee for traditional approval

Leqembi was granted accelerated approval by the FDA in January for patients with early AD

- PMLiVE

MSD and Eisai’s combination therapy recommended by NICE for advanced endometrial cancer

More than 9,700 people are diagnosed with womb cancer each year in the UK

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

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

- 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

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