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- PMLiVE

Bioverativ

- PMLiVE

EMA begins rolling review of Sanofi, GSK’s COVID-19 vaccine

Rolling review launched based on preliminary results from lab studies and early clinical studies

- 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

- PMLiVE

Sanofi signs $1bn licence agreement for Eureka’s novel multiple myeloma drug

Multiple myeloma is the second most common blood cancer

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

Sanofi reception

Sanofi to invest €400m annually in mRNA vaccines facility

French pharma company will build end-to-end R&D of ‘next-generation’ mRNA vaccines

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

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

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

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