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- PMLiVE

Capsigen

Biogen Idec building

Biogen’s Qalsody recommended by CHMP to treat rare form of ALS

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

Biogen Idec building

Biogen receives EC approval for Skyclarys in Friedreich’s ataxia patients

The company gained access to the drug through its $7.3bn acquisition of Reata Pharmaceuticals

Biogen Idec building

Biogen to discontinue Alzheimer’s drug Aduhelm in favour of Eisai-partnered Leqembi

The post-marketing confirmatory study of the intravenous treatment will now be terminated

- PMLiVE

FDA publishes final industry guidance for CAR-T and gene therapies

The new guidance can also be applied to other genetically modified lymphocyte products, including  CAR NK cells

- PMLiVE

AstraZeneca and Cellectis enter gene therapy partnership worth over $2.2bn

The deal gives AZ access to Cellectis’ gene editing technologies and manufacturing capabilities

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’s Actemra biosimilar approved by FDA to treat adult and paediatric arthritis

Tofidence is now the first biosimilar referencing Actemra to gain approval from the US regulator

Biomarin

BioMarin announces first patient dosed with haemophilia A gene therapy in Europe

The therapy was granted conditional marketing authorisation by the EC in August 2022

regeneron headquarters

Regeneron to acquire Decibel Therapeutics in deal worth up to $213m

The transaction expands the company’s gene therapy and hearing loss pipeline

- PMLiVE

NICE publishes draft guidance not recommending CSL’s haemophilia B gene therapy

The company has been seeking approval for use of the therapy in adults with severe or moderately severe haemophilia B without a history of factor IX inhibitors

Biogen Idec building

Biogen to acquire Reata for approximately $7.3bn

The deal gives Biogen access to a recently launched therapy for Friedreich's ataxia

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

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