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- PMLiVE

neurodegenerative disorders

- 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

- PMLiVE

AstraZeneca clears latest hurdle for Alexion acquisition after EU clearance

AZ first announced the proposed acquisition of Alexion in December 2020

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

EU identifies first five ‘promising’ COVID-19 drugs as part of therapeutics strategy

The five therapeutic candidates include a repurposed arthritis med and monoclonal antibodies

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

BMS’s oral AML therapy Onureg receives EU approval

Onureg is the oral version of Vidaza, two of the drugs BMS gained as part of its acquisition of Celgene in 2019

Sanofi reception

Sanofi’s oral therapy Aubagio approved in the EU for paediatric MS patients

EC approval comes a few weeks after the FDA rejected Aubagio in the same patient population

- PMLiVE

Court rules on AZ and EU’s COVID-19 vaccine dispute

The Court in Brussels has ordered AZ to deliver a total of 80.2 million doses to the EU by 27 September 2021

- 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

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