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Eisai Submits New Drug Application for Subcutaneous Formulation of "LEQEMBI(R)" for the Treatment of Early Alzheimer's Disease in Japan
Nov 28, 2025 22:00 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has filed a new drug application for "LEQEMBI(R)" (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
More info..
Eisai Submits New Drug Application for Subcutaneous Formulation of "LEQEMBI(R)" for the Treatment of Early Alzheimer's Disease in Japan
Nov 28, 2025 22:00 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has filed a new drug application for "LEQEMBI(R)" (brand name, generic name: lecanemab) seeking approval for a subcutaneous formulation (subcutaneous autoinjector: SC-AI) as a new route of administration to Japan's Pharmaceuticals and Medical Devices Agency (PMDA).
More info..
JFCR, NEC, and Taiho to Develop Cancer Vaccines Utilizing Whole-Genome Information
Nov 28, 2025 18:41 JST
The Japanese Foundation for Cancer Research (JFCR), NEC Corporation (NEC), and Taiho Pharmaceutical Co., Ltd. (Taiho) have signed a three-party joint research (Joint Research) agreement aimed at developing new cancer vaccines through the utilization of whole-genome information.
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JFCR, NEC, and Taiho to Develop Cancer Vaccines Utilizing Whole-Genome Information
Nov 28, 2025 18:41 JST
The Japanese Foundation for Cancer Research (JFCR), NEC Corporation (NEC), and Taiho Pharmaceutical Co., Ltd. (Taiho) have signed a three-party joint research (Joint Research) agreement aimed at developing new cancer vaccines through the utilization of whole-genome information.
More info..
Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) IQLIK(TM) (lecanemabirmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
Nov 26, 2025 18:42 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI(R)) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status.
More info..
Eisai Completes Rolling Submission to US FDA for LEQEMBI(R) IQLIK(TM) (lecanemabirmb) Supplemental Biologics License Application as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer's Disease Under Fast Track Status
Nov 26, 2025 18:42 JST
Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has completed the rolling submission of the Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for lecanemab-irmb (U.S. brand name: LEQEMBI(R)) subcutaneous autoinjector (SC-AI), LEQEMBI IQLIK, as a weekly starting dose after the FDA granted Fast Track Status.
More info..
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in the United Kingdom
Nov 17, 2025 21:08 JST
Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI(R)" (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
More info..
"LEQEMBI(R)" (lecanemab) IV Maintenance Dosing for the Treatment of Early Alzheimer's Disease Approved in the United Kingdom
Nov 17, 2025 21:08 JST
Eisai Co., Ltd. and Biogen Inc. announced today that humanized anti- soluble aggregated amyloid-beta (Aβ) monoclonal antibody "LEQEMBI(R)" (generic name: lecanemab) has been approved for once every four weeks intravenous (IV) maintenance dosing by the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom.
More info..
JFCR and NEC Confirm Research Results for Developing Individualized Neoantigen Cancer Vaccines Using Whole-Genome Data
Nov 10, 2025 17:01 JST
The Japan Foundation of Cancer Research (JFCR) and NEC Corporation (NEC; TSE: 6701) have confirmed research results supporting the development of a novel personalized neoantigen cancer vaccine using whole-genome data (*1).
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JFCR and NEC Confirm Research Results for Developing Individualized Neoantigen Cancer Vaccines Using Whole-Genome Data
Nov 10, 2025 17:01 JST
The Japan Foundation of Cancer Research (JFCR) and NEC Corporation (NEC; TSE: 6701) have confirmed research results supporting the development of a novel personalized neoantigen cancer vaccine using whole-genome data (*1).
More info..
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