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Eisai’s Lecanemab Rejected by Australia’s TGA for Early Alzheimer’s Treatment
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Japan-based Eisai Co., Ltd (TYO: 4523) announced that the Therapeutic Goods Administration (TGA) of Australia has refused to approve its lecanemab for the treatment of early Alzheimer’s disease (AD), specifically for mild cognitive impairment due to AD and mild AD dementia. Background and PartnershipsEisai entered into a licensing agreement with…
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BioArctic AB Secures Global Rights to PyroGlu-Aβ Antibody Program in BMS Deal
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Sweden-based BioArctic AB (OTCMKTS: BRCTF) has announced a significant licensing agreement with US pharmaceutical giant Bristol-Myers Squibb (BMS, NYSE: BMY). The deal grants BMS global exclusive development and commercialization rights to BioArctic’s PyroGlutamate-amyloid (PyroGlu-Aβ) antibody program, which includes BAN1503 and BAN2803. Under the agreement, BioArctic retains the option to co-commercialize…
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Eisai and BioArctic Set December Launch for Alzheimer’s Drug Leqembi in Japan
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Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) have announced the launch of Leqembi (lecanemab) in the Japanese market on December 20. The amyloid-beta (Aβ)-targeting drug received its second global approval in Japan earlier this year and has been incorporated into the National Health Insurance (NHI) system. Leqembi is indicated for…
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Japan’s MHLW Approves Eisai and BioArctic’s Leqembi for Alzheimer’s Treatment
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The Ministry of Health, Labour and Welfare (MHLW) in Japan has granted approval to Eisai (TYO: 4523) and BioArctic (STO: BIOA-B) for their amyloid-beta (Aβ)-targeting drug, Leqembi (lecanemab), as a treatment for slowing the progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD). This marks…
