Co-promotion

EISAI PRESENTED NEW ANALYSES OF ARIA AND QOL ON LECANEMAB IN CLARITY AD AT THE AD/PD™ 2023 ANNUAL MEETING

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Disease, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Incidence, QOL, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, 2023 International Conference on Climate Resilient Pakistan, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity, Eisai

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer's disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer's Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Eisai Presented New Analyses of ARIA and QOL on Lecanemab in Clarity AD at the AD/PD™ 2023 Annual Meeting

Retrieved on: 
Friday, March 31, 2023
Amyloid-related imaging abnormalities, Anticoagulant, Apolipoprotein E, Intracerebral hemorrhage, Alzheimer's disease, Clinical trial, The New England Journal of Medicine, Overalls, Edema, BIIB, Quality of life, Horseshoe kidney, Siderosis, Quality, ARIA-H, The Different Forms of Flowers on Plants of the Same Species, Eisai, QOL, Incidence, Dementia, ARIA, International Conference on Population and Development, Patient, Headquarters, Randomness, Corporation, Quality of life (healthcare), Co-promotion, Caregiver burden, Conference, Pharmaceutical industry, Biogen, Lecanemab, Clarity

Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).

Key Points: 
  • Clarity AD was a global confirmatory Phase 3 placebo-controlled, double-blind, parallel-group, randomized study in 1,795 people with early Alzheimer’s disease (AD) (lecanemab group: 10 mg/kg bi-weekly IV treatment: 898, placebo group: 897).
  • Lecanemab Phase 3 Clarity AD Trial: ARIA With the Use of Antiplatelets or Anticoagulants in Early Alzheimer’s Disease
    In the Clarity AD study, ARIA rates were higher for patients receiving lecanemab compared to those on placebo.
  • In Clarity AD, the pattern of occurrence of isolated ARIA-H in lecanemab group was similar to that in placebo group.
  • The results of the Clarity AD Health-related QoL measures presented additional evidence for meaningful benefits of lecanemab treatment to patients and care partners.

Additional Detailed Analyses From Phase 2 Study 201 of Lecanemab Published as Three Papers in Peer-Reviewed Journals

Retrieved on: 
Friday, March 31, 2023
Apolipoprotein E, Alzheimer's disease, Lecanemab, BIIB, PET, Horseshoe kidney, Brain, Cmax, Biomarker, MCI, Dose, Plasma, Eisai, Incidence, ARIA, ARIA-H, Amyloid, Amyloid-related imaging abnormalities, Patient, Headquarters, Corporation, Co-promotion, Intracerebral hemorrhage, ADAS, Research, AD, Phase, OLE, Safety, Medical imaging, Pharmaceutical industry, Biogen, Dementia

Detailed results on biomarker, cognitive, and clinical effects from Study 201.

Key Points: 
  • Detailed results on biomarker, cognitive, and clinical effects from Study 201.
  • The sensitivity analysis showed that 18 months of lecanemab treatment consistently reduced the clinical decline in all statistical models examined.
  • ARIA-H events in the OLE were generally consistent with the rate seen in the lecanemab 10 mg/kg biweekly group in the core study.
  • Based on the fact that lecanemab was generally well tolerated at the highest dose in this study, the Phase 3 Clarity AD study was conducted without dose titration.

NovaBay Pharmaceuticals Reports 2022 Fourth Quarter and Full Year Financial Results

Retrieved on: 
Thursday, March 30, 2023
Medical Supplies, Other Retail, Biotechnology, Health, Cosmetics, Pharmaceutical, General Health, Retail, Optical, Marketing, NBY, G&A, NovaBay Pharmaceuticals, PIN, USDA, Financial result, Co-promotion, OTC, Series, R, Research, NYSE, Cryptocurrency, Pharmaceutical industry, Video game

(NYSE American: NBY) reports financial results for the three and 12 months ended December 31, 2022 and provides a business update.

Key Points: 
  • (NYSE American: NBY) reports financial results for the three and 12 months ended December 31, 2022 and provides a business update.
  • Sales and marketing expenses were $1.9 million for the fourth quarter of 2022, compared with $2.2 million for the fourth quarter of 2021.
  • General and administrative (G&A) expenses for the fourth quarter of 2022 were relatively flat at $2.4 million for the fourth quarter of 2022, compared with $2.7 million for the fourth quarter of 2021.
  • Other expense, net for the fourth quarter of 2022 was $98 thousand, compared with other expense, net for the fourth quarter of 2021 of $1.6 million.

Eisai to Present New Lecanemab Data, Including Research Evaluating Safety Profile, Clinical Outcomes and Quality of Life Measures, as Well as Other Important Alzheimer's Disease Research, at the AD/PD 2023 Annual Meeting

Retrieved on: 
Thursday, March 23, 2023
Amyloid-related imaging abnormalities, Communication, Drug development, Senior, Lecanemab, DSM-IV codes, Research, Clarity, ARIA, International Conference on Emerging Infectious Diseases, Patient, Physician, Clinical research, Quality of life (healthcare), Co-promotion, 2023 International Conference on Climate Resilient Pakistan, AD, Conference, Safety, Disease, Pharmaceutical industry, Medical imaging, Medical device, Alzheimer's disease, Biogen, Eisai

Eisai will present new findings from the company's large, global Phase III confirmatory study of lecanemab, Clarity AD, including research into the management and monitoring of amyloid-related imaging abnormalities (ARIA) and health-related quality of life (HRQoL) measures.

Key Points: 
  • Eisai will present new findings from the company's large, global Phase III confirmatory study of lecanemab, Clarity AD, including research into the management and monitoring of amyloid-related imaging abnormalities (ARIA) and health-related quality of life (HRQoL) measures.
  • Eisai will also host a symposium, titled "Patient Clinical Care Pathway in Alzheimer's disease: Dialogue Amongst Experts," which will address the evolving landscape in AD.
  • The lecanemab data and additional research findings from Eisai's AD portfolio will be featured in 11 presentations, including seven oral and four poster presentations.
  • "Our latest research examines the real-world outcomes based on lecanemab's impact on clinical results and safety, including its effect on health-related quality of life.

U.S. Veterans' Health Administration (VHA) Provides Coverage of LEQEMBI (lecanemab-Irmb) Two Months After LEQEMBI's FDA Accelerated Approval for Veterans Living with Early Stages of Alzheimer's Disease

Retrieved on: 
Tuesday, March 14, 2023
The New England Journal of Medicine, Tradition, Brain, Veteran, Pathology, Co-promotion, Priority review, VHA, Lecanemab, Patient, Clarity, FDA, Clinical trial, PDUFA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Alzheimer's disease, Biogen, Disease, Eisai

The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.

Key Points: 
  • The VHA's careful consideration and timely action to make LEQEMBI available approximately two months after the FDA approved LEQEMBI under the accelerated approval pathway shows its continued commitment to veterans living with AD.
  • If approved under the traditional pathway, the FDA will update the label for LEQEMBI, which will include new data that has been evaluated by the FDA.
  • The FDA has determined that the results of Clarity AD will serve as the confirmatory study to verify the clinical benefit of LEQEMBI.
  • On the same day that LEQEMBI received its Accelerated approval, Eisai submitted the supplemental Biologics License Application (sBLA) to the FDA for approval under the Traditional pathway.

FDA Accepts Eisai's Filing of a Supplemental Biologics License Application and Grants Priority Review for Traditional Approval of LEQEMBITM (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, March 6, 2023
The New England Journal of Medicine, Brain, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Co-promotion, Pathology, Priority review, BIIB, Lecanemab, Patient, Clarity, FDA, Clinical trial, Oncology Drug Advisory Committee, PDUFA, Prescription Drug User Fee Act, Food, Advisory Committee, AD, Plaque, Immunoglobulin G, Pharmaceutical industry, Medical imaging, Alzheimer's disease, Biogen, Eisai

The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.

Key Points: 
  • The LEQEMBI application has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of July 6, 2023.
  • The FDA is currently planning to hold an Advisory Committee to discuss this application but has not yet publicly announced the date of the meeting.
  • On the same day that LEQEMBI received its accelerated approval, Eisai submitted the sBLA to the FDA for approval under the traditional pathway.
  • The sBLA is based on the findings from Eisai's recently published large, global confirmatory Phase 3 clinical trial, Clarity AD.

Infodriver Capital Launches Fund for DeFi, GameFi, and AI Startups Across UK, UAE, EC, USA.

Retrieved on: 
Friday, March 3, 2023
Metaverse, Investment, Co-promotion, Internet, Digital, Web3, Decentralized finance, IPhone, AMI-audio, Cryptocurrency

The investment strategy charges only 5% investments and diversifies the total portfolio of the startups from Seed to A round with a working revenue model and user base.

Key Points: 
  • The investment strategy charges only 5% investments and diversifies the total portfolio of the startups from Seed to A round with a working revenue model and user base.
  • According to Kirill Mishanin, CEO and Founder of Infodriver Capital, investing in startups in the Web3 space is a wise decision, as it is the future of the internet.
  • Infodriver Capital is committed to shaping that future by supporting innovative startups in this field.
  • Mishanin stated, "We are thrilled to be able to support these innovative startups and help them reach their full potential.

Darolutamide receives EU approval for additional indication in prostate cancer

Retrieved on: 
Wednesday, March 1, 2023
Death, Prostate cancer, European, European Commission, Co-promotion, Disease, Ari, Risk, Darolutamide, Patient, ADT, Orion, Docetaxel, Incidence, Phase, Pharmaceutical industry, Bayer, EU

The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).

Key Points: 
  • The European Commission has granted marketing authorisation in the European Union (EU) for darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC).
  • Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • Additionally, the darolutamide combination showed consistent benefits across clinically relevant secondary endpoints, with the overall incidence of treatment-emergent adverse events being similar between treatment arms.
  • Darolutamide is being investigated in a broad development program with an additional three ongoing or planned large clinical studies, to investigate its potential across prostate cancer patients from the early- to the late-stage of this disease.

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

Retrieved on: 
Tuesday, February 28, 2023
Amyloid beta, Ministry of Health, Labour and Welfare, Lecanemab, Alzheimer's disease, Ministry, Priority review, Ministry of Health (Saudi Arabia), Disease, Biologics license application, European Medicines Agency, BLA, Brain, Research, The New England Journal of Medicine, FDA, Neurotoxicity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, 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

TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.

Key Points: 
  • TOKYO, Feb 28, 2023 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that the Biologics License Application (BLA) for lecanemab (brand name in the U.S.: LEQEMBI), an investigational anti-amyloid beta (Abeta) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.
  • In China, Eisai initiated submission of data for the BLA to the NMPA in December 2022.
  • 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.