BioSpace4h
Biogen, Eisai Continue Leqembi’s European Rally as CHMP Reaffirms Positive Opinion
Leqembi’s application now moves forward to the European Commission, which will issue a formal verdict for the injection that ...
pharmaphorum4h
Australia stands firm on 'no' to Alzheimer's drug Leqembi
Eisai and Biogen have been unable to persuade the medicines regulator in Australia to approve their Alzheimer's disease ...
The Pharma Letter5h
Australia’s Leqembi rejection ‘sad for all patients’
The Therapeutic Goods Administration (TGA) of Australia has declined the approval of Leqembi (lecanemab) as a treatment for ...
The Committee For Medicinal Products For Human Use (CHMP) Reaffirms Positive Opinion For Lecanemab In Early Alzheimer's Disease
Lecanemab is the result of a strategic research alliance between Eisai and BioArctic. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble ...
Therapeutic Goods Administration decides not to register lecanemab in Australia
BioArctic AB's (publ) (NASDAQ: BIOA B) (STOCKHOLM: BIOA B) partner Eisai announced today that the Therapeutic Goods Administration (TGA) ...
Armed robbery in Revesby10h
TGA Confirms Decision To Not Register Lecanemab
In October 2024, the TGA made the decision not to register lecanemab (LEQEMBI) on the Australian Register of Therapeutic Goods (ARTG) for the ...