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Biogen to pay $900m to settle whistleblower’s MS drug kickback lawsuit

For pursuing the case, the former employee will receive about $250m

- PMLiVE

Biogen’s tofersen shows promise in rare form of ALS in new data analysis

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

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Pfizer/BioNTech BA.4/BA.5 COVID-19 booster receives CHMP recommendation

If an authorisation is granted, doses of the bivalent booster will be available to all 27 EU member states

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Sanofi halts recruitment for trials assessing MS treatment

The pause in enrolment follows advice issued by the Independent Data Monitoring Committee

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Biogen and Eisai share latest lecanemab results for the treatment of Alzheimer’s disease

Eisai presented the data at the Alzheimer’s Association International Conference (AAIC)

- PMLiVE

Positive results for Biogen’s lupus drug published in NEJM

Around 90% of people with lupus are women, a condition for which there is currently no cure

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FDA grants priority review to Biogen’s tofersen for genetic form of ALS

The approval follows a failed phase 3 study, but the treatment showed promise in patients with SOD1-ALS

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Bristol Myers Squibb’s Opdualag approved by CHMP for melanoma

If approved by the EC, Opdualag would be the first LAG-3 blocking antibody combination available in Europe

- PMLiVE

AstraZeneca’s Tezspire recommended for approval in the EU by CHMP

The recommendation is for the treatment of severe asthma as an add-on therapy for patients 12 years and above

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Sandoz’s application for MS biosimilar accepted by FDA

The proposed ‘first-of-a-kind’ biosimilar matched the reference medicine, Biogen’s Tysabri, in terms of efficacy, safety and immunogenicity

- PMLiVE

Gilead’s COVID-19 drug Veklury recommends for approval by CHMP

If approved by the EC, Veklury will become the only direct-acting antiviral with full marketing authorisation in the EU

- PMLiVE

FDA grants Priority Review for Biogen and Eisai’s lecanemab for early Alzheimer’s disease

Lecanmab is being evaluated in the ongoing phase 3 Clarity Alzheimer's clinical trial

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