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CPhI North America CPhI North America
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20-22 May, 2025
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22-25 April, 2025
AACR Annual meetingAACR Annual meeting
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25-30 April, 2025
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03 Mar 2025
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https://www.prnewswire.com/news-releases/therapeutic-goods-administration-decides-not-to-register-lecanemab-in-australia-302389834.html
01 Mar 2025
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/eu-regulator-not-updating-opinion-eisai-biogens-alzheimers-drug-2025-02-28/
27 Feb 2025
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/eisai-part-ways-121-employees-amid-new-us-restructuring-effort
14 Nov 2024
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761269
02 Jul 2024
// Nick Paul Taylor FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/bms-axes-eisai-adc-pact-3-years-after-paying-650m-would-be-elahere-rival
28 Jun 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/eisai-biogen-launch-alzheimers-drug-leqembi-china-2024-06-28/
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18610
Submission : 1992-08-14
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33691
Submission : 2019-03-27
Status : Active
Type : II
Details:
Based on discussions with MHLW and PMDA, Eisai applied to PMDA for permission to utilize "prior assessment consultation" process for BAN2401 (lecanemab), an investigational anti-amyloid beta protofibril antibody with aim of shortening review period for treatment of early AD.
Lead Product(s): Lecanemab
Therapeutic Area: Neurology Brand Name: BAN2401
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Biogen
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 03, 2022
Details : Based on discussions with MHLW and PMDA, Eisai applied to PMDA for permission to utilize "prior assessment consultation" process for BAN2401 (lecanemab), an investigational anti-amyloid beta protofibril antibody with aim of shortening review period for t...
Product Name : BAN2401
Product Type : Antibody
Upfront Cash : Inapplicable
April 03, 2022
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Eisai Inc is a supplier offers 3 products (APIs, Excipients or Intermediates).
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