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01.09.25 - 13:12
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FDA approves Eisai and Biogen′s Leqembi Iqlik BLA for early Alzheimer′s (PBR)
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This new dosing option enables patients with mild cognitive impairment or mild dementia to receive treatment at home, following an initial intravenous (IV) administration. Leqembi Iqlik, administered through
The post FDA approves Eisai and Biogen's Leqembi Iqlik BLA for early Alzheimer's appeared first on Pharmaceutical Business review....
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30.08.25 - 10:13
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Marktstart für Alzheimer-Mittel Lecanemab in Deutschland (DPA-AFX)
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BERLIN (dpa-AFX) - Der zur Alzheimer-Therapie zugelassene Antikörper Lecanemab kommt am 1. September in Deutschland offiziell auf den Markt. Österreich und Deutschland seien die ersten EU-Länder, in denen das unter dem Namen Leqembi vertriebene Mittel ......
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30.08.25 - 00:25
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US FDA approves Leqembi® IQLIK ™ (lecanemab-irmb) subcutaneous injection for maintenance dosing for the treatment of early Alzheimer′s disease (Cision)
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Stockholm, August 29, 2025 – BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for once weekly lecanemab subcutaneous injection for maintenance dosing. LEQEMBI IQLIK autoinjector is indicated for maintenance dosing to treat Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease, collectively referred to as early AD, in the U.S. LEQEMBI IQLIK will be launched on October 6, 2025.
The U.S. brand name for the...
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28.08.25 - 08:48
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BioArctic: Interim Report for the period April - June 2025 (PR Newswire)
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Increasing Leqembi® royalties and new partnership with Novartis STOCKHOLM, Aug. 28, 2025 /PRNewswire/ -- Events during the second quarter 2025 The European Commission granted Marketing Authorisation (MA) for Leqembi® (lecanemab), triggering a milestone payment of EUR 20 M from Eisai The......
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28.08.25 - 08:45
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BioArctic: Interim Report for the period April - June 2025 (PR Newswire)
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Increasing Leqembi® royalties and new partnership with Novartis STOCKHOLM, Aug. 28, 2025 /PRNewswire/ -- Events during the second quarter 2025 The European Commission granted Marketing Authorisation (MA) for Leqembi® (lecanemab), triggering a milestone payment of EUR 20 M from Eisai The......
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28.08.25 - 08:06
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Interim Report for the period April – June 2025 (Cision)
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Increasing Leqembi® royalties and new partnership with Novartis
Events during the second quarter 2025
· The European Commission granted Marketing Authorisation (MA) for Leqembi® (lecanemab), triggering a milestone payment of EUR 20 M from Eisai
· The EU granted Exidavnemab orphan designation for multiple system atrophy (MSA) and the European Patent Office extended patent protection until 2041
· Approval to include MSA patients in the phase 2a study with exidavnemab
· BioArctic's partner Eisai issued Leqembi sales forecast of JPY 76.5 billion for its fiscal year 2025 (Apr-25 –...
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26.08.25 - 13:03
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Medical Affairs Leader Dr. Kirk Shepard Joins BP Logix′s Life Sciences Strategic Advisory Board (Business Wire)
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Renowned Medical Affairs executive and MAPS co-founder Dr. Kirk Shepard steps up to help guide the next wave of digital innovation in the life sciences sector.SAN DIEGO--(BUSINESS WIRE)--#MedicalAffairs--As part of its mission to drive innovation in Medical Affairs automation, BP Logix is pleased to announce the appointment of Dr. Kirk Shepard to the company's Life Sciences Strategic Advisory Board.
Dr. Shepard is a globally recognized expert in Medical Affairs who brings more than 30 years of deep operational knowledge and thought leadership to the Advisory Board.
He currently serves as Chief Medical Officer at PDS Biotech. His prior roles include Chief Medical Officer and Head of Global Medical Affairs Oncology at Eisai, as well as senior leadership positions at Takeda, Boehringer Ingelheim, Baxter, and Baxalta.
He is also a co-founder and former President of the Medical Affairs Professional Society (MAPS), which boasts more than 15,000 members. His upcoming book, Voices of Oncology (Forbes Books, Sept...
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26.08.25 - 08:36
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Novartis: Deal mit skandinavischen Biotech – Aktie startet durch (Der Aktionaer)
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Der Pharma-Riese Novartis geht eine weitere Forschungskooperation ein. Mit dem schwedischen Unternehmen BioArctic, dem eigentlichen Entdecker des Alzheimer-Medikaments Leqembi (Lecanemab), soll zunächst ein neuer Wirkstoffkandidat entwickelt werden. Die Skandinavier holen sich damit nach Eisai und Bristol Myers Squibb einen weiteren Pharma-Giganten als Partner ins Boot....
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25.08.25 - 09:33
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Leqembi® (lecanemab) launched in the EU today (PR Newswire)
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STOCKHOLM, Aug. 25, 2025 /PRNewswire/ --BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the launch of Leqembi in the EU started in Austria on August 25, 2025, and will be launched in Germany on September 1, 2025. Leqembi received the European Commission......
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