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Mitsubishi Tanabe Pharma Corporation

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Latest From Mitsubishi Tanabe Pharma Corporation

AnGes To Withdraw, Refile HGF Gene Therapy In Japan

If finally fully approved in its first indication, the HGF gene therapy could become a first-in-class therapy for PAD - but only after years of challenges in clinical trials.

Japan Gene Therapy

Quality Issues Star In US FDA Complete Response Letter Trio

Rocket Pharmaceuticals’ gene therapy Kresladi, Daiichi Sankyo/Merck’s patritumab deruxtecan, and AbbVie’s foscarbidopa/foslevodopa (ABBV-951) received CRLs because of manufacturing concerns.

Complete Response Letters Manufacturing

Lead Daiichi/Merck ADC Collab HER3-DXd Hit With CRL

While there were no issues of efficacy or safety behind a new US CRL for Daiichi Sankyo/Merck & Co's anti-HER3 antibody-drug conjugate patritumab, the FDA decision marks a hit to the companies' first ADC collaboration and the latest in a string of regulatory blows to Japanese firms in the US.

Complete Response Letters United States

CalciMedica Eyes Success In Pancreatitis, Acute Kidney Injury

Phase IIb data for Auxora in an acute pancreatitis subpopulation is expected to set up the CRAC channel inhibitor for Phase III in that indication while suggesting positive read-through for AKI.

Clinical Trials Drug Approval Standards
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  • Pharmaceuticals
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  • Other Names / Subsidiaries
    • BIXEN Corporation
    • Medicago Inc.
    • Mitsubishi Tanabe Pharma America, Inc. (MTPA)
    • Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA)
    • Mitsubishi Tanabe Pharma Singapore Pte. Ltd.
    • NeuroDerm, Ltd. (NDRM)
    • PT Mitsubishi Tanabe Pharma Indonesia
    • Mitsubishi Tanabe Pharma (Thailand)
    • MT Pharma Singapore PTE. Ltd.
    • Tai Tien Pharmaceuticals Co., Ltd.
    • Tanabe Research Laboratories U.S.A.
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