Biogen BIIB and Japan-based partner, Eisai, announced an update regarding the regulatory review of an application seeking the approval of Leqembi (lecanemab) for mild cognitive impairment due to ...
in.investing.com on MSN23h
Biocon Gets EU Nod for Ustekinumab Biosimilar; Valuation Signals UpsideBiologics Ltd (BBL), a subsidiary of Biocon Limited, has secured a major regulatory milestone with the European Commission ...
The European Commission (EC) has already approved Valneva’s chikungunya vaccine Ixchiq for use in individuals aged 18 years ...
CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee ...
Eisai and Biogen update on lecanemab's EU regulatory review for early Alzheimer’s disease treatment following positive CHMP opinion. Eisai Co., Ltd. and Biogen Inc. have provided an update on ...
These will be discussed at the CHMP meeting in February 2025 ... Alzheimer's disease and is entitled to payments in connection with regulatory approvals, and sales milestones as well as royalties ...
Additionally, the CHMP will review the clarity of risk minimization ... with the latter leading the clinical development and regulatory submissions. Though the companies co-commercialize and ...
These will be discussed at the CHMP meeting in February 2025 ... Eisai serves as the lead for lecanemab’s development and regulatory submissions globally with both Eisai and Biogen co ...
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