The Different Forms of Flowers on Plants of the Same Species

"LEQEMBI Intravenous Infusion" (Lecanemab) Approved for the Treatment of Alzheimer's Disease in Japan

Retrieved on: 
Monday, September 25, 2023
Amyloid-related imaging abnormalities, PMID, Outline, Clinical trial, Marketing, The New England Journal of Medicine, Deficit spending, Pathology, Ministry of Health, Labour and Welfare, Research, Brain, Siderosis, History, MCI, The Different Forms of Flowers on Plants of the Same Species, Clarity, Ministry, ARIA, Dementia, HIV disease progression rates, Patient, Immunoglobulin G, Superficial siderosis, PLOS One, Co-promotion, Ministry of Health (Kuwait), Therapy, Headache, Neurotoxicity, Disease, ADCS, Pharmaceutical industry, Alzheimer's disease, Biogen, Amyloid beta, Health, Eisai

Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.

Key Points: 
  • Japan is the second country to grant approval, following the traditional approval in the U.S. in July 2023.
  • In the Clarity AD clinical trial, treatment with LEQEMBI reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
  • "Today LEQEMBI received approval, making it the first approved anti-amyloid Alzheimer's disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease in Japan.
  • In Japan, Eisai and Biogen Japan will co-promote LEQEMBI, with Eisai distributing the product as the Marketing Authorization Holder.

Eisai Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea

Retrieved on: 
Thursday, June 8, 2023
Disease, Alzheimer's disease, Ministry of Food and Drug Safety, BIIB, Lecanemab, MFDS, Brain, The Different Forms of Flowers on Plants of the Same Species, Ministry, Clarity, Eisai, Co-promotion, AD, Neurotoxicity, Pharmaceutical industry, Biogen, Food

This application is the first application for lecanemab in Asia outside of Japan and China.

Key Points: 
  • This application is the first application for lecanemab in Asia outside of Japan and China.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
  • Lecanemab, Aducanumab, and Gantenerumab - Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease.

EISAI TO PRESENT THE LATEST ALZHEIMER'S DISEASE PIPELINE AND RESEARCH, INCLUDING LECANEMAB AND ANTI-MTBR TAU ANTIBODY E2814, AT THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE (AAIC) 2023

Retrieved on: 
Wednesday, July 12, 2023
PMID, Huber loss, Onset, Brain, Comorbidity, The Different Forms of Flowers on Plants of the Same Species, Eisai, MRI, Pharmacokinetics, PLOS One, Co-promotion, Immunogenicity, Medical imaging, Pharmaceutical industry, Alzheimer's disease, Safety

This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety.

Key Points: 
  • This release discusses investigational uses of agents in development and is not intended to convey conclusions about efficacy or safety.
  • There is no guarantee that such investigational agents will successfully complete clinical development or gain health authority approval.
  • Sehlin D, Englund H, Simu B, Karlsson M, Ingelsson M, Nikolajeff F, Lannfelt L, Pettersson FE.
  • Lecanemab, Aducanumab, and Gantenerumab — Binding Profiles to Different Forms of Amyloid-Beta Might Explain Efficacy and Side Effects in Clinical Trials for Alzheimer's Disease.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer's Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, Alzheimer's disease, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, Ministry of Health, Labour and Welfare, Brain, Medication, Pharmaceuticals and Medical Devices Agency, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, Eisai, The Different Forms of Flowers on Plants of the Same Species, Prescription Drug User Fee Act, PMDA, National Medical Products Administration, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Medical imaging, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

Health Canada Accepts New Drug Submission for Lecanemab as Treatment for Early Alzheimer’s Disease

Retrieved on: 
Tuesday, May 16, 2023
Priority review, The New England Journal of Medicine, Plaque, NDS, MHLW, Marketing, Neurotoxicity, Food, Advisory Committee, European Medicines Agency, Medicines and Healthcare products Regulatory Agency, Lecanemab, BIIB, Ministry of Health, Labour and Welfare, Brain, Pharmaceuticals and Medical Devices Agency, Medication, Oncology Drug Advisory Committee, EMA, Clarity, Ministry, The Different Forms of Flowers on Plants of the Same Species, Eisai, Prescription Drug User Fee Act, Headquarters, PMDA, National Medical Products Administration, Corporation, Co-promotion, PDUFA, Ministry of Health (Kuwait), MAA, AD, FDA, Phase, Health Canada, BLA, NMPA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Disease, Pharmaceutical industry, Biogen, Health

Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.

Key Points: 
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • Lecanemab was approved under the accelerated approval pathway in the U.S. and was launched in the U.S. on January 18, 2023.

EISAI PRESENTED NEW ANALYSES OF ARIA AND QOL ON LECANEMAB IN CLARITY AD AT THE AD/PD™ 2023 ANNUAL MEETING

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Disease, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Incidence, QOL, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, 2023 International Conference on Climate Resilient Pakistan, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity, Eisai

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer's Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, Edema, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Eisai, QOL, Incidence, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer’s Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Comet Introduces Kangas, An Open Source Smart Data Exploration, Analysis and Model Debugging Tool for Machine Learning

Retrieved on: 
Wednesday, November 16, 2022
Software, Mobile, Wireless, Internet, Professional Services, Electronic Design Automation, Data Management, Technology, Security, Engineering, Audio, Video, Finance, Manufacturing, Etsy, Student, ML, Uber, Computer, Machine learning, Joshua T. Mendell, Multimedia, The Different Forms of Flowers on Plants of the Same Species, Research, Purpose Built Communities, MLOps, Apache, Management, Publishing, Mobile phone, Medical device, Comet, Kangas, Zappos

Open sourced to democratize large scale visual dataset exploration and analysis for the computer vision and machine learning community, Kangas helps users understand and debug their data in a new and highly intuitive way.

Key Points: 
  • Open sourced to democratize large scale visual dataset exploration and analysis for the computer vision and machine learning community, Kangas helps users understand and debug their data in a new and highly intuitive way.
  • A key component of data-centric Machine Learning is being able to understand how your training data impacts model results and where your model predictions are wrong, said Gideon Mendels, CEO and co-founder of Comet.
  • Open Source: Kangas is 100% open source and is built by and for the ML community.
  • Interoperability and flexibility are inherent in Comets value proposition, and Comet aims to expand on that value through open source contributions, added Mendels.