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    [{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-initiated Clinical Trial of Ultrahigh-dose Mecobalamin for Amyotrophic Lateral Sclerosis in Japan","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of Amyotrophic Lateral Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"},{"orgOrder":0,"company":"Eisai","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for The Indication of Amyotrophic Lateral Sclerosis","therapeuticArea":"Neurology","highestDevelopmentStatus":"Phase III","country":"JAPAN","productType":"Large molecule","productStatus":"Approved","date":"January 2024","url1":"","url2":"","graph1":"Neurology","graph2":"Phase III"}]

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              Eisai

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              Eisai Submits New Drug Application for Mecobalamin Ultrahigh-Dose Formulation in Japan for The Indication of Amyotrophic Lateral Sclerosis

              Details:

              Methycobal (methylcobalamin) is the active form of vitamin B12. It is indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.

              Lead Product(s): Methylcobalamin

              Therapeutic Area: Neurology Product Name: Methycobal

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable January 26, 2024

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              Eisai

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              Ministry of Health, Labour and Welfare Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progre...

              Details:

              Mecobalamin (generic name, development code: E0302) is approved and marketed as Methycobal®, a 500 µg injection of mecobalamin indicated for the treatment of peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.

              Lead Product(s): Methylcobalamin

              Therapeutic Area: Neurology Product Name: E0302

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 27, 2022

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              Eisai

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              Eisai Initiates Preparation for New Drug Application, Based on the Results of an Investigator-initiated Clinical Trial of Ultrahigh-dose Mecobalamin for Amyotrophic Lateral...

              Details:

              An analysis of Study 761 suggested that ultrahigh-dose E0302 (methylcobalamin) prolonged survival period and suppressed progression in ALS patients who commenced treatment within 12 months of ALS onset.

              Lead Product(s): Methylcobalamin

              Therapeutic Area: Neurology Product Name: E0302

              Highest Development Status: Phase III Product Type: Large molecule

              Partner/Sponsor/Collaborator: Not Applicable

              Deal Size: Not Applicable Upfront Cash: Not Applicable

              Deal Type: Not Applicable May 10, 2022

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              Supriya Lifescience Methylcobalamin
              HTBA Methylcobalamin
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