Eisai

KEYTRUDA® (pembrolizumab) Plus LENVIMA® (lenvatinib) Demonstrates Long-Term, Durable Survival Benefit Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

Retrieved on: 
Thursday, May 25, 2023
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, MSD, Senior, Hepatocellular carcinoma, Pharming, Sunitinib, Survival, Everolimus, RECIST, Head, DO, Cancer, Patient, Stomatitis, Risk, NYSE, Fatigue, Texas Oncology, Diarrhea, Pembrolizumab, FACP, MRK, Research, Lung cancer, Merck & Co., Hypertension, LEAP, HIV disease progression rates, IMDC, Esophageal cancer, Memorial Sloan Kettering Cancer Center, PD-1, Abstract, Death, Safety, Lenvatinib, Overalls, Multimedia, PFS, CR, Stomach, ORR, Acral lentiginous melanoma, IRC, Progression-free survival, RCC, CI, OS, Drug, Trae tha Truth, MSKCC, Hypothyroidism, EDT, ASCO, American Society of Clinical Oncology, Cancer Treatment Centers of America, Physician, Quality of life (healthcare), Annual general meeting, Nausea, Interpretation, Society, Pharmaceutical industry, Dietary supplement, Merck, EU, Eisai

After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).

Key Points: 
  • After four years of follow-up, KEYTRUDA plus LENVIMA maintained a clinically meaningful OS benefit versus sunitinib, reducing the risk of death by 21% (HR=0.79 [95% CI, 0.63-0.99]).
  • The 24- and 36-month estimated OS rates were 80.4% and 66.4% for KEYTRUDA plus LENVIMA versus 69.6% and 60.2% for sunitinib, respectively.
  • Results from the final pre-specified OS analysis were consistent with the superior results versus sunitinib from the primary OS analysis of the CLEAR/KEYNOTE-581 trial.
  • Grade ≥3 treatment-related adverse events (TRAE) occurred in 74.1% of patients who received KEYTRUDA plus LENVIMA versus 60.3% of patients who received sunitinib.

Advanced Infusion Care (AIC) now offers Eisai infusion therapy LEQEMBI™ (Lecanemab-irmb) humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody

Retrieved on: 
Tuesday, May 23, 2023
General Health, Health, Pharmaceutical, Nursing, Managed Care, Insurance, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Accreditation Commission for Health Care, Patient, Physician, AIC, ACHC, URAC, Alzheimer's disease, Disease, Medical device, Pharmaceutical industry, Eisai

Advanced Infusion Care, a division of AIS Healthcare, now offers LEQEMBI™, developed by Eisai Co., Ltd., for the treatment of patients with Alzheimer’s disease.

Key Points: 
  • Advanced Infusion Care, a division of AIS Healthcare, now offers LEQEMBI™, developed by Eisai Co., Ltd., for the treatment of patients with Alzheimer’s disease.
  • The nationally accredited home infusion teams at AIC collaborate closely with physicians to provide specialized infusion services to patients in their home or at an infusion suite setting.
  • “We’re proud to be able to add LEQEMBI to our growing list of infusion therapies,” said Jud Hall, President at AIC.
  • “This therapy from Eisai can help us provide a new treatment option for patients with Alzheimer’s disease.”
    LEQEMBI is indicated for the treatment of Alzheimer's disease.

Eisai Delivers New Data and Highlights Continued Progress of Oncology Portfolio and Pipeline at ASCO 2023

Retrieved on: 
Tuesday, May 23, 2023
CREB-binding protein, Carcinoma, Abstract, Senior, CBP, Cancer, Research, Trial of the century, ASCO, American Society of Clinical Oncology, Patient, Physician, Sorafenib, Oncology nursing, Annual general meeting, ADC, Poster, FDA, Survival analysis, Society, HCC, Safety, Nivolumab, Pharmaceutical industry, Eisai

NUTLEY, N.J., May 23, 2023 /PRNewswire/ -- Eisai announced today the presentation of research across various types of cancer from its oncology portfolio and pipeline during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting (#ASCO23), which is taking place virtually and in-person in Chicago, Illinois from June 2 to 6.

Key Points: 
  • Eisai entered into a joint development agreement with BlissBio for BB-1701 with option rights for a strategic collaboration in April 2023.
  • A Phase 1/2 clinical study of BB-1701 in the U.S. and China for HER2-expressing solid tumors is currently underway.
  • There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval.
  • These abstracts will be made available on Thursday, May 25, 2023 at 5:00 PM EDT.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Marketing Authorisation Application for lecanemab submitted in Great Britain: BioArctic

Retrieved on: 
Monday, May 22, 2023
CET, Health care, Lecanemab, Brain, Clarity, Eisai, Co-promotion, Marketing Authorisation Application, MAA, Innovation, AD, Neurotoxicity, MHRA, Disease, Pharmaceutical industry, Biogen

Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).

Key Points: 
  • Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway (ILAP).
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.

Societal value of lecanemab in Japan published in Neurology and Therapy

Retrieved on: 
Wednesday, May 17, 2023
Neurology, Eisai, Quality of life, Health, AD, CET, Caregiver, Co-promotion, Pharmaceutical industry, Biogen

The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce medical costs, public care costs and caregiver burden for individuals with early AD and their caregivers in Japan.

Key Points: 
  • The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce medical costs, public care costs and caregiver burden for individuals with early AD and their caregivers in Japan.
  • 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.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • The information was released for public disclosure, through the agency of the contact person below, on May 17, 2023, at 01.30 a.m. CET.

Societal value of lecanemab in Japan published in Neurology and Therapy

Retrieved on: 
Wednesday, May 17, 2023
Neurology, Eisai, Quality of life, Health, AD, CET, Caregiver, Co-promotion, Pharmaceutical industry, Biogen

The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce medical costs, public care costs and caregiver burden for individuals with early AD and their caregivers in Japan.

Key Points: 
  • The paper concluded that lecanemab treatment would improve health and humanistic (quality of life) outcomes and reduce medical costs, public care costs and caregiver burden for individuals with early AD and their caregivers in Japan.
  • 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.
  • BioArctic has the right to commercialize lecanemab in the Nordic region and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • The information was released for public disclosure, through the agency of the contact person below, on May 17, 2023, at 01.30 a.m. CET.

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.

NeuroTrauma Sciences Announces Key Appointments to its Executive Leadership Team

Retrieved on: 
Wednesday, May 10, 2023
Harvard School of Dental Medicine, PPD, KU Leuven, Research and development, NTS, Medical Affairs Bureau, Pfizer, Senior, University of Brussels, Traumatic brain injury, Université Laval, Stroke, New product development, MBA, Thermo Fisher Scientific, CMO, Concordia University, Harvard T.H. Chan School of Public Health, CNS, DSM-IV codes, Bachelor of Science, Central nervous system, Eisai, Public health, Doctor of Science, MD, Columbia Business School, Tropical medicine, Master of Science, Bernhard Nocht Institute for Tropical Medicine, Quality assurance, Growth, Shirin David, Merck, Regulatory affairs, Biostatistics, MPH, VC, Epidemiology, Imperial College London, Injury, Management, Pharmaceutical industry, Neuroscience

Dr. de Somer brings more than 30 years of leadership in the biopharmaceutical industry to the NTS management team in his role as Chief Medical Officer.

Key Points: 
  • Dr. de Somer brings more than 30 years of leadership in the biopharmaceutical industry to the NTS management team in his role as Chief Medical Officer.
  • He held clinical development leadership responsibilities in Europe, the UK, and the US at Sandoz/Novartis Pharmaceuticals.
  • "We are pleased to welcome these industry veterans to our leadership team," said Carl Long, Chief Executive Officer.
  • We will value their leadership and direction as we advance NTS-104 through the clinic."