Lecanemab

Biologics License Application for Lecanemab Designated for Priority Review by China National Medical Products Administration

Retrieved on: 
måndag, februari 27, 2023
Ministry of Health, Labour and Welfare, Lecanemab, Ministry, BIIB, Corporation, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, The New England Journal of Medicine, Brain, Research, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Headquarters, National Medical Products Administration, Co-promotion, Medicines and Healthcare products Regulatory Agency, EMA, MAA, PMDA, AD, Pharmaceuticals and Medical Devices Agency, Clarity, Medication, MCI, Food, NMPA, Phase, MHLW, Procedure, Pharmaceutical industry, Medical device, Health, Eisai, Biogen

In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.

Key Points: 
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • In the U.S., lecanemab was granted accelerated approval by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • On the same day, Eisai submitted a supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.

Global Alzheimer’s Platform Foundation (GAP) President Blasts CMS’ “Unprecedented and Pernicious” Discrimination Against People with Alzheimer’s Disease

Retrieved on: 
torsdag, februari 23, 2023
Congress, Quality of life, Lecanemab, CED, Disease, Life, Insurance, FDA, Patient, CMS, Hope, Pernicious, Medicare, Centers for Medicare & Medicaid Services, Caregiver, Memory, Physician, Pharmaceutical industry

CMS’s latest decision on disease-modifying therapies for Alzheimer’s patients is effectively a coverage denial for this entire class of drugs, and patients will needlessly die as a result of it.

Key Points: 
  • CMS’s latest decision on disease-modifying therapies for Alzheimer’s patients is effectively a coverage denial for this entire class of drugs, and patients will needlessly die as a result of it.
  • This decision continues the agency’s unprecedented and pernicious actions against the Alzheimer’s community, which take treatment options — and hope — away from people with this heinous disease.
  • In its latest decision, CMS continues to erect additional barriers to access in the form of a ‘coverage with evidence’ (CED) requirement on an already FDA-approved drug.
  • This denies access to poor, rural and medically underserved communities — and CMS’s past CED initiatives demonstrate this.

Bellevue Asset Management AG: Emerging Markets Healthcare sector comeback

Retrieved on: 
onsdag, februari 22, 2023
Pharmacy, Government, Lecanemab, Private Asset Management, Graubündner Kantonalbank, Daiichi Sankyo, Investment, Zanubrutinib, Breast cancer, WuXi Biologics, Patient, Cardiology, Business administration, Hip, Biogen, Zurich University of Applied Sciences/ZHAW, Policy, Health care, BeiGene, Growth, Health, Applied science, COVID, Multiple myeloma, BTK, Apollo Hospitals, AstraZeneca, Elective surgery, Cancer, Zurich University, Sun Pharma, Pharmaceutical industry

After a string of difficult years, a trend reversal is under way in emerging market healthcare stocks.

Key Points: 
  • After a string of difficult years, a trend reversal is under way in emerging market healthcare stocks.
  • In the Bellevue Emerging Markets Healthcare Fund, the China allocation is more than 60% and in the Bellevue Asia Pacific Healthcare Fund it is about 40%.
  • Remo Krauer has been a Senior Portfolio Manager Healthcare Funds & Mandates at Bellevue Asset Management since 2018.
  • Previously, he worked at Zürcher Kantonalbank, first as Senior Portfolio Manager, then as Head Portfolio Construction for Private Asset Management.

Emory Healthcare Engages Linus Health on Initiative to Expand Early Detection of Alzheimer’s Disease and Other Dementias

Retrieved on: 
torsdag, februari 16, 2023
Health Technology, Health, Neurology, Brain, Dementia, IPad, Lecanemab, Myenteric plexus, Patient, Digital technology, Internal medicine, Research, Emory Healthcare, Goizueta, Health care, Disease, Deficit spending, FDA, PCP, Cognition, Doctor of Philosophy, MD, Medical imaging

Linus Health , a digital health company focused on transforming brain health, today announced that the Goizueta Institute @Emory Brain Health and The Seavey Clinic at Emory Healthcare are working with the company to implement innovative digital cognitive assessments in primary care.

Key Points: 
  • Linus Health , a digital health company focused on transforming brain health, today announced that the Goizueta Institute @Emory Brain Health and The Seavey Clinic at Emory Healthcare are working with the company to implement innovative digital cognitive assessments in primary care.
  • The collaboration is designed to evaluate and operationalize the use of digital technology to help primary care providers (PCPs) spot Alzheimer’s disease and other dementias at their earliest stages and intervene as early as possible.
  • An estimated 50 million people around the world currently have Alzheimer’s disease and other dementias and that number is growing by almost 10 million people every year.
  • “Emory Healthcare is a brain health pioneer and we’re honored that they’ve chosen us to support their efforts to improve patients’ lives through earlier detection and intervention.

Linus Health Earns Numerous Awards as Digital Health Pioneer in Alzheimer’s and Other Dementia

Retrieved on: 
tisdag, januari 24, 2023
Health, Technology, Neurology, Health Technology, Software, General Health, Artificial Intelligence, Biomarker, IPad, Linus, Acquisition, Built-in, Davos, Tech, Ecosystem, Deficit spending, Invention, Dementia, Mass, Doctor of Philosophy, Nursing, Pharmaceutical industry, Lecanemab, Association of British HealthTech Industries, Medtech

Linus Health , a digital health company focused on transforming brain health, today announced that it recently won awards in several prominent recognition programs, including Mass Technology Leadership Council’s (Mass TLC) Tech Top 50 Awards, BostInno’s Fire Awards , and Built In Boston’s 2023 Best Places to Work Awards .

Key Points: 
  • Linus Health , a digital health company focused on transforming brain health, today announced that it recently won awards in several prominent recognition programs, including Mass Technology Leadership Council’s (Mass TLC) Tech Top 50 Awards, BostInno’s Fire Awards , and Built In Boston’s 2023 Best Places to Work Awards .
  • In October, Linus Health received top honors as “Technology of the Year” in the Healthcare Tech category of Mass TLC's Tech Top 50 award program.
  • Linus Health also earned recognition in the 2022 BostInno Fire Awards program as one of the stand-outs in Medtech and Healthtech.
  • Most recently, Built In featured Linus Health on its 2023 Best Places to Work in Boston list.

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
fredag, juli 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.

Eisai presented latest data from the lecanemab clinical program at AAIC 2021

Retrieved on: 
fredag, juli 30, 2021
Branches of biology, Amyloidosis, Monoclonal antibodies, Biology, Health sciences, Alzheimer's disease, Lecanemab, Clinical trial, Amyloid beta, Amyloid, Crenezumab, Gantenerumab

The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.

Key Points: 
  • The presentations included the latest data for the investigational anti-amyloid beta antibody lecanemab (BAN2401), for which the FDA recently granted Breakthrough Therapy designation.
  • In an oral presentation, baseline characteristics and results from the preliminary screening of the Phase 3 clinical study, AHEAD 3-45, for preclinical (asymptomatic) Alzheimer's disease, were presented.
  • For the first time, clinical outcome data from a small cohort of the large Phase 2b open label extension study were presented.
  • "It's very encouraging to see that Eisai's broad clinical program for lecanemab continues to deliver data in support of the effects on both amyloid in the brain and cognitive outcomes.