Eisai

Biogen to Realign Resources for Alzheimer's Disease Franchise

Retrieved on: 
Wednesday, January 31, 2024
Growth, Trial of the century, Research, Patient, Safety, BIIB, FDA, Investment, Food, Lecanemab, Disease, Eisai, Pharmaceutical industry

CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth.

Key Points: 
  • CAMBRIDGE, Mass., Jan. 31, 2024 (GLOBE NEWSWIRE) -- Biogen Inc. (Nasdaq: BIIB) today announced plans to reprioritize its resources in Alzheimer’s disease (AD), a strategic therapeutic area expected to drive near and long-term growth.
  • A large portion of the resources released resulting from termination of the ADUHELM program will be redeployed in Biogen’s AD franchise.
  • “As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs.
  • Biogen has recorded a one-time charge of approximately $60 million related to close out costs for the program in the fourth quarter of 2023.

Can-Fite Expands the Out-Licensing Deal with Ewopharma to Include the Pancreatic Cancer Indication

Retrieved on: 
Tuesday, January 30, 2024
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Hepatocellular carcinoma, CANF, Fatty liver disease, Pancreatic cancer, Psoriasis, HCC, CEE, Inflammation, NASH, Eisai, Pharmaceutical industry

to include the pancreatic cancer indication of Can-Fite.

Key Points: 
  • to include the pancreatic cancer indication of Can-Fite.
  • Ewopharma AG exercised its right to expand the distribution agreement to include the indication of pancreatic cancer and the transaction terms of the distribution agreement are applicable to such indication.
  • In addition to Can-Fite, Ewopharma AG has distribution agreements with many leading healthcare companies including Eisai and Biogen.
  • “We are very pleased to expand the distribution agreement with Ewopharma, a leader in pharmaceutical distribution in Central Eastern Europe and Switzerland and include the pancreatic cancer indication.

Merck’s KEYTRUDA® (pembrolizumab) Reduced the Risk of Death by 38% Versus Placebo as Adjuvant Therapy for Patients With Renal Cell Carcinoma (RCC) at an Increased Risk of Recurrence Following Nephrectomy

Retrieved on: 
Saturday, January 27, 2024
Research, FDA, Clinical Trials, Biotechnology, General Health, Pharmaceutical, Health, Science, Oncology, Other Science, MSD, Dana–Farber Cancer Institute, Renal cell carcinoma, Death, VEGF, Patient, M1, OS, RCC, Harvard Medical School, ASCO, Survival, DFS, Medicine, Society, NED, Cancer, Nephrectomy, Kidney, Risk, Recurrence, Disease, Safety, Eisai, Merck & Co., CPS, Rated R, MRK, Pharmaceutical industry

At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo.

Key Points: 
  • At 48 months, the estimated OS rate was 91.2% for patients who received KEYTRUDA compared to 86.0% for patients who received placebo.
  • Treatment-related adverse events (TRAEs) occurred in 79.1% of patients (n=386) in the KEYTRUDA arm and 53.0% of patients (n=263) in the placebo arm.
  • Grade 3-4 TRAEs occurred in 18.6% of patients in the KEYTRUDA arm and 1.2% of patients in the placebo arm.
  • Treatment-related adverse events resulting in discontinuation of any treatment occurred in 18.2% of patients in the KEYTRUDA arm and 0.8% of patients in the placebo arm.

Eisai Aims to Advance Genitourinary Cancer Treatment with New Research at ASCO GU 2024

Retrieved on: 
Thursday, January 18, 2024
Senior, Role, Renal cell carcinoma, Patient, Research, Meta-analysis, Rescue coordination centre, RCC, ASCO, Everolimus, Pivotal, Society, Apoptosis, Disease, Safety, Eisai, FDA, Abstract, Pharmaceutical industry

NUTLEY, N.J., Jan. 18, 2024 /PRNewswire/ --  Eisai announced today the presentation of research in renal cell carcinoma (RCC) during the 2024 American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium (#GU24) which is taking place in-person in San Francisco, California and online from January 25-27. Notable presentations include a rapid oral abstract session featuring subgroup analyses from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial, which evaluated lenvatinib (LENVIMA®), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, plus pembrolizumab (KEYTRUDA®), Merck's anti-PD-1 therapy, versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (aRCC) (NCT02811861; Abstract: #364).

Key Points: 
  • We look forward to engaging in critical scientific exchange to improve outcomes for these patients."
  • A network meta-analysis to assess the efficacy of lenvatinib plus pembrolizumab compared with other first-line treatment options for patients with aRCC will be shared in a poster session (Abstract: #482).
  • 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 via the ASCO website on Monday, January 22, 2024, at 5:00 PM EST (2:00 PM PST).

Eisai Listed as a Global 100 Most Sustainable Corporation for the Eighth Time

Retrieved on: 
Wednesday, January 17, 2024
Environment, Corporate Knights, Patient, Eisai, ESG, Pharmaceutical industry

TOKYO, Jan 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.

Key Points: 
  • TOKYO, Jan 17, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that it has been listed in the 2024 Global 100 Most Sustainable Corporations in the World (Global 100), a global ranking by Canada-based media and investment advisory company, Corporate Knights, Inc.
  • Ranked 35th, Eisai is the highest ranking company among global pharmaceutical companies.
  • Also, Eisai became the highest ranking Japanese company among the three Japanese companies listed in the Global 100 (please visit here for the Global 100 ranking).
  • The Global 100 evaluates the sustainability of more than 6,700 of the world's major corporations based on various corporate initiatives in areas such as ESG (environment, society and governance).

Eisai: The Scientific Advisory Group (SAG) to Convene to Discuss the Marketing Authorization Application for lecanemab in the EU

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Biogen, Committee, MAA

TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • TOKYO, Jan 11, 2024 - (JCN Newswire) - Eisai Co., Ltd. announced today that the Scientific Advisory Group (SAG) will convene to discuss the marketing authorization application (MAA) of lecanemab (generic name, brand name: LEQEMBI), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during FY2023, which ends on March 31, 2024.
  • Eisai expects the European Commission's decision for the MAA of lecanemab in the first quarter of FY2024 ending June 30, 2024, if the opinion from the CHMP is received by March 31, 2024, following discussion by the SAG.
  • Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen Inc. (U.S.) co-commercializing and co-promoting the product and Eisai having final decision-making authority.

The European Medicines Agency's Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab: BioArctic

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Committee, Marketing, MAA, Vaccine

STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during the first quarter of 2024.
  • BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation.

The European Medicines Agency's Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab: BioArctic

Retrieved on: 
Thursday, January 11, 2024
CHMP, European Medicines Agency, SAG, European Commission, Scientific Advisory Group, EMA, Eisai, Committee, Marketing, MAA, Vaccine

STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).

Key Points: 
  • STOCKHOLM, Jan. 11, 2024 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the Scientific Advisory Group (SAG) will convene to discuss the Marketing Authorisation Application (MAA) of lecanemab (generic name, brand name: Leqembi®), which is currently under review by the European Medicines Agency (EMA).
  • The meeting of the SAG is expected to take place during the first quarter of 2024.
  • BioArctic has the right to commercialize lecanemab in the Nordic region, pending European approval, and currently Eisai and BioArctic are preparing for a joint commercialization in the region.
  • This information is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation.

Leqembi® approved for the treatment of Alzheimer's disease in China

Retrieved on: 
Tuesday, January 9, 2024
Patient, MCI, Insurance, Memory, Eisai, Lecanemab, Biomarker, Marketing, Brain, Ageing, Clarity, Pharmaceutical industry

China is the third country to grant marketing approval, following the traditional approval in the United States in July 2023 and Japanese approval in September 2023.

Key Points: 
  • China is the third country to grant marketing approval, following the traditional approval in the United States in July 2023 and Japanese approval in September 2023.
  • Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.
  • Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives.
  • Dosage and administration: The usual dose of lecanemab (recombinant) is 10mg/kg infused intravenously over approximately 1 hour, once every 2 weeks.

Leqembi® approved for the treatment of Alzheimer's disease in China

Retrieved on: 
Tuesday, January 9, 2024
Patient, MCI, Insurance, Memory, Eisai, Lecanemab, Biomarker, Marketing, Brain, Ageing, Clarity, Pharmaceutical industry

China is the third country to grant marketing approval, following the traditional approval in the United States in July 2023 and Japanese approval in September 2023.

Key Points: 
  • China is the third country to grant marketing approval, following the traditional approval in the United States in July 2023 and Japanese approval in September 2023.
  • Leqembi is the first and only approved treatment shown to reduce the rate of disease progression and to slow cognitive and functional decline through this mechanism.
  • Eisai will distribute the product in China and will conduct information provision activities through specialized Medical Representatives.
  • Dosage and administration: The usual dose of lecanemab (recombinant) is 10mg/kg infused intravenously over approximately 1 hour, once every 2 weeks.