STOCKHOLM, Nov. 7, 2023 /PRNewswire/ — BioArctic AB’s (publ) (NASDAQ; BIOA B) (Stockholm: BIOA B) partner Eisai today held a presentation on the second quarter of Eisai’s fiscal year, ending March 2024. In addition to presenting sales numbers of 0.4 billion yen for LEQEMBI for the period, Eisai also stated the following; The launch of … Read more
STOCKHOLM, June 10, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® (lecanemab-irmb) 100 … Read more
STOCKHOLM, June 10, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the U.S. Food and Drug Administration’s (FDA) Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) voted unanimously that the data from Eisai’s Phase 3 Clarity AD clinical trial confirms the clinical benefit of LEQEMBI® (lecanemab-irmb) 100 … Read more
STOCKHOLM, June 8, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2] with confirmed amyloid pathology in the brain, to the Ministry of … Read more
STOCKHOLM, June 8, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2] with confirmed amyloid pathology in the brain, to the Ministry of … Read more
STOCKHOLM, May 22, 2023 /PRNewswire/ — BioArctic AB’s (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that they have submitted a Marketing Authorisation Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2] (AD) with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products … Read more
STOCKHOLM, May 22, 2023 /PRNewswire/ — BioArctic AB’s (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that they have submitted a Marketing Authorisation Application (MAA) for lecanemab, an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2] (AD) with confirmed amyloid pathology in the brain, to the UK Medicines and Healthcare products … Read more
Stockholm, May 17, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of results from a simulation study evaluating the societal value of lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2], in the context of the … Read more
Stockholm, May 16, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of results from a simulation study evaluating the societal value of lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2], in the context of the … Read more
STOCKHOLM, May 16, 2023 /PRNewswire/ — BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that Health Canada has accepted a New Drug Submission (NDS) for lecanemab (brand name in the U.S.: LEQEMBI™), an investigational anti-amyloid beta (Aβ) protofibril[1] antibody, for the treatment of early Alzheimer’s disease[2] with confirmed amyloid pathology in the brain. … Read more