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28.11.25 - 06:36
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New drug application for subcutaneous formulation of Leqembi[®] submitted in Japan (Cision)
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Stockholm, Sweden, November 28, 2025 – BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have filed a new drug application for Leqembi (lecanemab) for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency (PMDA). If approved, lecanemab would be the first and only anti-amyloid treatment in Japan to offer an at-home injection from the initiation of treatment for this progressive, deadly disease.
The application is based on data from multiple subcutaneous (SC)...
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25.11.25 - 17:30
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Wisner Baum Unleashes RICO to Expose Big Pharma′s Hidden Fraud (PR Newswire)
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In a groundbreaking class action, Wisner Baum LLP is invoking the civil RICO statute to hold Takeda and Eli Lilly accountable for allegedly concealing the cancer risks of diabetes drug Actos. The case, now nationally certified, seeks treble damages and sets a precedent for confronting......
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25.11.25 - 13:42
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Eisai completes U.S. rolling sBLA submission for Leqembi® Iqlik™ (lecanemab-irmb) as a subcutaneous starting dose (Cision)
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Stockholm, Sweden, November 25, 2025 – BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that they have completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab subcutaneous autoinjector (SC-AI), Leqembi Iqlik, as a weekly starting dose after the FDA granted Fast Track Status. Upon acceptance of the sBLA, the FDA will set a PDUFA date (Prescription Drug User Fee Act) for review completion. If approved for initiation dosing, Leqembi Iqlik would be the first and only anti-...
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24.11.25 - 14:12
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Shimadzu Medical Systems USA announces the release of the SC15 (PR Newswire)
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LONG BEACH, Calif., Nov. 24, 2025 /PRNewswire/ -- Shimadzu Medical Systems USA (SMS), a division of Shimadzu Precision Instruments, Inc. (SPI) which is fully owned by Shimadzu Corporation, Japan, is excited to announce the release of the SC15 in the United States. Mobile C-arm systems are......
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21.11.25 - 14:06
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Innovent, first Chinese firm to market weight-loss drug, joins Hang Seng Index (SCMP)
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Innovent Biologics will join the Hang Seng Index next month in the latest quarterly review as the compiler of the city's stock benchmark presses ahead with its plan to increase the number of constituents to 100.
The biotech firm, based in eastern Jiangsu province, has become the only new constituent of the blue-chip indicator, one month after it signed an US$11.4 billion outsourcing deal with Japan's Takeda Pharmaceuticals to co-develop and commercialise three specific investigational cancer......
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19.11.25 - 10:45
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Nxera Introduces Employee Stock Ownership Plan (J-ESOP) for Employees Residing in Japan (GlobeNewswire EN)
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Tokyo, Japan and Cambridge, UK, 19 November 2025 – Nxera Pharma Co. Ltd (“Nxera” or “the Company; TSE 4565) announces that its Board of Directors have decided to replace the current Restricted Share Unit (“RSU”) Plan with the Employee Stock Ownership Plan (J-ESOP) (hereinafter referred to as the "Plan" and a trust established under the trust agreement to be concluded with Mizuho Trust & Banking Co., Ltd. with respect to the Plan, is referred to as the "Trust"), which grants the Company's shares to employees residing in Japan, and to establish the Share Benefit Rules (hereinafter referred to as 'Share Benefit Rules') as set out below. This Plan provides benefits based on points upon retirement etc., thereby providing employees with tax benefits and mitigating the concentration of sales of the Company shares at specific points in time that often occur under RSU Plans....
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