Eisai

Oligomerix Publishes Preclinical Data on Novel Small Molecule Therapeutic in Development for Alzheimer’s Disease and Rare Neurodegenerative Diseases

Retrieved on: 
Wednesday, August 9, 2023

Earlier this year, Oligomerix announced first-in-human dosing of OLX-07010 in a Phase 1a clinical trial.

Key Points: 
  • Earlier this year, Oligomerix announced first-in-human dosing of OLX-07010 in a Phase 1a clinical trial.
  • The self-association of tau protein into progressively larger aggregates and tau tangles is a common pathological process in AD and multiple rare inherited neurodegenerative diseases such as PSP and FTD.
  • Since tau tangles and amyloid plaques are hallmarks of AD, treating both could be more beneficial to patients than targeting a single pathology.
  • Compared to controls, oral treatment with the drug over four months significantly prevented the development of tau aggregates in this mouse model.

Black Health Matters Summit and Expo Comes to Harlem Week

Retrieved on: 
Wednesday, August 9, 2023

NEW YORK, Aug. 9, 2023 /PRNewswire/ -- On Thursday, August 17th, 2023, the Black Health Matters Harlem Week Health Summit & Expo will be held at the historic Alhambra Ballroom, 2116 Adam Clayton Powell, Jr. Blvd., New York, NY 10027, from 9:00 AM to 3:00 PM EST. BHM has teamed up with the Harlem Chamber of Commerce and Harlem Week to offer this free, one-day health expo for the community. The BHM Health Summit & Expo links medical clinicians and specialists in health, wellness and chronic illness who are eager to bring health awareness to the public. The community will be treated to stimulating and informative panel discussions, presentations, a fitness session, and free health screenings and immunizations. Complimentary breakfast and lunch will be offered, and FREE giveaways and prizes will also be distributed throughout the day. To register, go to www.bhmharlemweeksummit.com.

Key Points: 
  • NEW YORK, Aug. 9, 2023 /PRNewswire/ -- On Thursday, August 17th, 2023, the Black Health Matters Harlem Week Health Summit & Expo will be held at the historic Alhambra Ballroom, 2116 Adam Clayton Powell, Jr.
  • BHM has teamed up with the Harlem Chamber of Commerce and Harlem Week to offer this free, one-day health expo for the community.
  • The BHM Health Summit & Expo links medical clinicians and specialists in health, wellness and chronic illness who are eager to bring health awareness to the public.
  • The Black Health Matters Harlem Week Summit & Expo is sponsored by Amgen, AstraZeneca, Eisai, Genentech, GSK, and Janssen Oncology.

Cognition Therapeutics Reports Second Quarter 2023 Financial Results and Business Update

Retrieved on: 
Tuesday, August 8, 2023

PURCHASE, N.Y., Aug. 08, 2023 (GLOBE NEWSWIRE) --  Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage neuroscience company developing drugs that treat neurodegenerative disorders by regulating cellular damage response pathways (the “Company” or “Cognition”), today reported financial results for the second quarter ended June 30, 2023 and provided recent business updates.

Key Points: 
  • PURCHASE, N.Y., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Cognition Therapeutics, Inc. (Nasdaq: CGTX), a clinical-stage neuroscience company developing drugs that treat neurodegenerative disorders by regulating cellular damage response pathways (the “Company” or “Cognition”), today reported financial results for the second quarter ended June 30, 2023 and provided recent business updates.
  • We anticipate full study results to be available in the fourth quarter of 2023.
  • Research and development expenses were $8.5 million for the second quarter ended June 30, 2023, compared to $9.1 million for the same period in 2022.
  • ET, to discuss the second quarter corporate and financial update.

Eisai Presents Latest Analysis of Lecanemab's Effect on Biomarker Changes and Subcutaneous Dosing at The Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
Thursday, July 20, 2023

TOKYO and CAMBRIDGE, Mass., July 19, 2023 /PRNewswire/ -- Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Christopher A. Viehbacher, "Biogen") announced today that the results of a detailed analysis of the Phase 3 Clarity AD study demonstrated that lecanemab-irmb (generic name, U.S. brand name: LEQEMBI®) treatment showed reductions in amyloid-beta (Aβ) pathology and downstream biomarker changes. This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023. The U.S. Food and Drug Administration (FDA) granted traditional approval for LEQEMBI for the treatment of Alzheimer's disease (AD) on July 6, 2023.

Key Points: 
  • This analysis, and the latest findings on the lecanemab subcutaneous (SC) formulation currently under development, were presented at the Alzheimer's Association International Conference (AAIC) 2023.
  • These outcomes suggested lecanemab impacts A/T/N+ biomarkers involved in the AD pathophysiology and exerts biological effects that demonstrate slowing of disease progression.
  • In an exposure/bioavailability and modeling study comparing intravenous (IV) and subcutaneous (SC) dosing of lecanemab, the bioavailability of SC dosing of lecanemab was shown to be approximately 50% of that of IV dosing.
  • 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.

Latest data on lecanemab to be presented at Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
Wednesday, July 12, 2023

STOCKHOLM, July 11, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab, an anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease, at the Alzheimer's Association International Conference (AAIC).

Key Points: 
  • STOCKHOLM, July 11, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab, an anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease, at the Alzheimer's Association International Conference (AAIC).
  • The conference will be held in Amsterdam, the Netherlands and virtually from July 16 to 20, 2023.
  • Presentation of results of Aβ, tau, neurodegeneration, gliosis, and imaging biomarkers in the Phase III, Clarity AD study of lecanemab (#80907)

Latest data on lecanemab to be presented at Alzheimer's Association International Conference (AAIC) 2023

Retrieved on: 
Wednesday, July 12, 2023

STOCKHOLM, July 11, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab, an anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease, at the Alzheimer's Association International Conference (AAIC).

Key Points: 
  • STOCKHOLM, July 11, 2023 /PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai will present the latest findings on lecanemab, an anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer's disease, at the Alzheimer's Association International Conference (AAIC).
  • The conference will be held in Amsterdam, the Netherlands and virtually from July 16 to 20, 2023.
  • Presentation of results of Aβ, tau, neurodegeneration, gliosis, and imaging biomarkers in the Phase III, Clarity AD study of lecanemab (#80907)

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

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.

Adcendo Appoints Experienced Drug Developer Dr. Lone H. Ottesen as Chief Medical Officer

Retrieved on: 
Tuesday, June 20, 2023

Dr. Ottesen is a highly accomplished drug developer with extensive global clinical development experience across oncology and immune-oncology with a track record of more than 20 years in both early- and late-phase clinical development.

Key Points: 
  • Dr. Ottesen is a highly accomplished drug developer with extensive global clinical development experience across oncology and immune-oncology with a track record of more than 20 years in both early- and late-phase clinical development.
  • Dr. Ottesen held roles of increasing seniority in Global Oncology Development at GSK, Eisai and most recently at AstraZeneca, where
    she was Global Clinical Head in Late-Stage Clinical Development.
  • She joins Adcendo from Circio, formerly known as Targovax, where she was Chief Medical Officer and previously Chief Development Officer.
  • Lone Ottesen, incoming Chief Medical Officer at Adcendo, said "ADCs are at the forefront of a paradigm shift in cancer chemotherapy, and I am excited to join Adcendo to shape its IND-enabling activities and clinical plans.

Adcendo Appoints Experienced Drug Developer Dr. Lone H. Ottesen as Chief Medical Officer

Retrieved on: 
Tuesday, June 20, 2023

Dr. Ottesen is a highly accomplished drug developer with extensive global clinical development experience across oncology and immune-oncology with a track record of more than 20 years in both early- and late-phase clinical development.

Key Points: 
  • Dr. Ottesen is a highly accomplished drug developer with extensive global clinical development experience across oncology and immune-oncology with a track record of more than 20 years in both early- and late-phase clinical development.
  • Dr. Ottesen held roles of increasing seniority in Global Oncology Development at GSK, Eisai and most recently at AstraZeneca, where
    she was Global Clinical Head in Late-Stage Clinical Development.
  • She joins Adcendo from Circio, formerly known as Targovax, where she was Chief Medical Officer and previously Chief Development Officer.
  • Lone Ottesen, incoming Chief Medical Officer at Adcendo, said "ADCs are at the forefront of a paradigm shift in cancer chemotherapy, and I am excited to join Adcendo to shape its IND-enabling activities and clinical plans.

FDA Accepts Application for Merck’s KEYTRUDA® (pembrolizumab) Plus Chemotherapy as Treatment for Advanced or Unresectable Biliary Tract Cancer

Retrieved on: 
Thursday, June 8, 2023

The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.

Key Points: 
  • The sBLA is based on data from the KEYNOTE-966 trial, in which KEYTRUDA plus chemotherapy demonstrated a statistically significant improvement in overall survival (OS) compared to chemotherapy alone.
  • Results from KEYNOTE-966 were presented at the American Association for Cancer Research (AACR) 2023 Annual Meeting.
  • The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of February 7, 2024.
  • “Most biliary tract cancers go undetected until an advanced stage, at which point many patients are ineligible for surgery and have few treatment options,” said Dr. Scot Ebbinghaus, vice president, global clinical development, Merck Research Laboratories.