Eisai

Development of Prediction Model for Brain Amyloid-Beta Accumulation Using Wristband Sensor

Retrieved on: 
Friday, December 29, 2023

TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.

Key Points: 
  • TOKYO, Dec 29, 2023 - (JCN Newswire) - Oita University and Eisai Co., Ltd. (Eisai) hereby announce the development of the world's first machine learning model to predict amyloid beta*1 (Aβ) accumulation in the brain using a wristband sensor.
  • This model is expected to enable screening for brain Aβ accumulation, which is an important pathological factor of Alzheimer's disease*2 (AD), simply by collecting biological and lifestyle data from daily life.
  • The key to maximizing treatment effects of the medicine is detecting Abeta accumulation in the brain of patients with mild cognitive impairment before the onset of symptoms.
  • This machine learning model is able to predict brain Aβ accumulation using readily available non-invasive variables.

Eisai Submits Marketing Authorization Application in Japan for Anticancer Agent Tasurgratinib for Biliary Tract Cancer with Fgfr2 Gene Fusion

Retrieved on: 
Tuesday, December 19, 2023

TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.

Key Points: 
  • TOKYO, Dec 19, 2023 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has submitted a marketing authorization application in Japan for its in-house discovered fibroblast growth factor (FGF) receptor (FGFR1, FGFR2, FGFR3) selective tyrosine kinase inhibitor tasurgratinib succinate (generic name, development code: E7090, "tasurgratinib") for biliary tract cancer with FGFR2 gene fusion.
  • In Japan, tasurgratinib has received orphan drug designation for a prospective indication for unresectable biliary tract cancer with FGFR2 gene fusion by the Ministry of Health, Labour and Welfare, (MHLW).
  • This application is based on the results of a multicenter, open-label, single-arm clinical phase II trial (Study 201) in Japan and China conducted by Eisai.
  • Study 201 enrolled patients with unresectable biliary tract cancer with FGFR2 gene fusion previously treated with gemcitabine-based combination chemotherapy.

Eisai and Mizuho Sign Sustainability-Linked Loan Agreement

Retrieved on: 
Thursday, December 14, 2023

TOKYO, Dec 14, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Mizuho Bank, Ltd. announced today that the companies have signed a sustainability-linked syndicated loan agreement, which comes into effect today.

Key Points: 
  • TOKYO, Dec 14, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Mizuho Bank, Ltd. announced today that the companies have signed a sustainability-linked syndicated loan agreement, which comes into effect today.
  • Under the concept of human health care (hhc), Eisai aims to effectively achieve social good in the form of relieving anxiety over health and reducing health disparities.
  • With the funds raised through this agreement, Eisai will promote the creation of social impact through the elimination of diseases of poverty (neglected tropical diseases, malaria, tuberculosis, etc.
  • This agreement has undergone a third-party review* by Rating and Investment Information, Inc. (R&I) regarding its compliance with the Sustainability-Linked Loan Principles issued by the Loan Market Association and other organizations, as well as the Green Loan and Sustainability-Linked Loan Guidelines issued by Japan's Ministry of the Environment.

Eisai and Merck & Co., Inc., Rahway, NJ, USA Provide Update on Phase 3 LEAP-001 Trial Evaluating LENVIMA (lenvatinib) Plus KEYTRUDA (pembrolizumab) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Monday, December 11, 2023

The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination.

Key Points: 
  • The safety profile of LENVIMA plus KEYTRUDA was consistent with that observed in previously reported studies evaluating the combination.
  • We are grateful to the patients, their loved ones, and the investigators whose participation is what makes scientific advancement possible."
  • LENVIMA plus KEYTRUDA is approved in the U.S., the EU, Japan and other countries for the treatment of certain types of advanced endometrial carcinoma following prior systemic therapy in any setting and advanced renal cell carcinoma (RCC).
  • Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

Eisai to Present Latest Data on Perampanel at The 77th American Epilepsy Society (AES) Annual Meeting

Retrieved on: 
Wednesday, November 22, 2023

Major presentations include the design and outcomes of a clinical research evaluating the safety of perampanel versus placebo (Poster No.

Key Points: 
  • Major presentations include the design and outcomes of a clinical research evaluating the safety of perampanel versus placebo (Poster No.
  • 1.493), and the data of evaluating the effects of perampanel on cognitive function and sleep (Poster No.
  • Eisai pursues its mission to provide "seizure freedom" to a greater number of patients with epilepsy.
  • Eisai remains committed further to addressing the diverse needs of, and increasing the benefits provided to, patients with epilepsy and their families.

LEQEMBI Wins Best New Drug And Clinical Advance of The Year at The Scrip Awards 2023

Retrieved on: 
Monday, November 20, 2023

The Scrip Awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry.

Key Points: 
  • The Scrip Awards, now in its 19th year, celebrates the best innovations and achievements of the international biopharma industry.
  • The award for Clinical Advance of the Year recognizes the success of a new drug product in a clinical trial that is expected to lead to an advance in healthcare.
  • It was awarded for the success of the Phase III Clarity AD study of LEQEMBI.
  • Eisai and Biogen deeply appreciate the cooperation of people living with AD and healthcare professionals who participated in LEQEMBI's clinical studies.

AdaptIV Infusion Now Offering Leqembi® Infusion Therapy for Alzheimer's Patients at Sugar Land Clinic

Retrieved on: 
Thursday, December 21, 2023

SUGAR LAND, Texas, Dec. 21, 2023 /PRNewswire-PRWeb/ -- AdaptIV Infusion, a state-of-the-art ambulatory infusion clinic specializing in autoimmune disorders, complex chronic conditions, and health and wellness therapies, is now one of a select few facilities administering Leqembi® (lecanemab-irmb) infusion treatments for patients with early-stage Alzheimer's disease at their newly opened Sugar Land, TX location.

Key Points: 
  • AdaptIV Infusion in Sugar Land, TX, administering Leqembi® infusions for early-stage Alzheimer's, providing crucial care for patients with this condition.
  • SUGAR LAND, Texas, Dec. 21, 2023 /PRNewswire-PRWeb/ -- AdaptIV Infusion, a state-of-the-art ambulatory infusion clinic specializing in autoimmune disorders, complex chronic conditions, and health and wellness therapies, is now one of a select few facilities administering Leqembi® (lecanemab-irmb) infusion treatments for patients with early-stage Alzheimer's disease at their newly opened Sugar Land, TX location.
  • AdaptIV Infusion's facility in Sugar Land, TX, is conveniently located to serve residents of Sugar Land, Richmond, Rosenberg, Missouri City, Stafford, and the greater Houston area.
  • For more information on AdaptIV Infusion and infusion therapy, visit their website at http://www.adaptivinfusion.com .

Rocket Pharmaceuticals Appoints R. Keith Woods to Board of Directors

Retrieved on: 
Tuesday, December 12, 2023

Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced the appointment of R. Keith Woods as an independent, non-executive director to its Board of Directors.

Key Points: 
  • Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT), a leading late-stage biotechnology company advancing an integrated and sustainable pipeline of genetic therapies for rare disorders with high unmet need, today announced the appointment of R. Keith Woods as an independent, non-executive director to its Board of Directors.
  • Mr. Woods is a seasoned executive with more than 30 years of experience spanning commercialization, global operations, business strategy and supply chain.
  • “I’m thrilled to welcome Keith to our Board of Directors, who brings deep industry expertise and invaluable experience to the Rocket Board as we build upon our commercial and operational infrastructure to support our anticipated first product launches for severe Leukocyte Adhesion Deficiency (LAD-I) and Fanconi Anemia (FA),” said Gaurav Shah, M.D., Chief Executive Officer of Rocket Pharma.
  • Earlier in his career, Mr. Woods held commercial and sales positions of increasing responsibility at Roche, Amgen and Eisai.

Merck and Eisai Provide Update on Phase 3 LEAP-001 Trial Evaluating (pembrolizumab) Plus LENVIMA® (lenvatinib) as First-Line Treatment for Patients with Advanced or Recurrent Endometrial Carcinoma

Retrieved on: 
Friday, December 8, 2023

Key Points: 
  • View the full release here: https://www.businesswire.com/news/home/20231208830310/en/
    At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study’s prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel).
  • The safety profile of KEYTRUDA plus LENVIMA was consistent with that observed in previously reported studies evaluating the combination.
  • The companies will work with investigators to share the results with the scientific community.
  • Results from the LEAP-001 trial do not affect the current approved indications for the KEYTRUDA plus LENVIMA combination or other ongoing trials from the LEAP clinical program.

LEQEMBI® to be launched in Japan for Alzheimer's disease on December 20

Retrieved on: 
Wednesday, December 13, 2023

LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in Japan on September 25, 2023.

Key Points: 
  • LEQEMBI obtained manufacturing and marketing approval for the indication of slowing progression of mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD) in Japan on September 25, 2023.
  • The launch, planned for December 20, will make Japan the second country to have the product on the market, following the U.S.
    "This is a great Christmas present!
  • Alzheimer's disease patients in Japan will now have access to the first disease modifying treatment.
  • This gives hope for the large aging population in Japan with a great need for new treatment options," says Gunilla Osswald, CEO of BioArctic.