Clarity

Eisai: FDA Grants Traditional Approval for LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Friday, July 7, 2023

Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.

Key Points: 
  • Treatment with LEQEMBI should be initiated in patients with MCI or mild dementia stage of disease, (collectively referred to as early AD) the population in which treatment was initiated in clinical trials.
  • LEQEMBI treatment reduced clinical decline on CDR-SB by 27% at 18 months compared to placebo.
  • Importantly, following FDA's traditional approval of LEQEMBI, CMS confirmed that broader coverage of LEQEMBI is now available and released more details on the registry, including the easy-to-use data submission process.
  • "Today, the FDA approved LEQEMBI under the traditional approval pathway, making LEQEMBI the first and only approved anti-amyloid Alzheimer's disease treatment shown to reduce the rate of disease progression and to slow cognitive impairment in the early and mild dementia stages of the disease.

Eisai Files Marketing Authorization Application for Lecanemab as Treatment For Early Alzheimer's Disease in South Korea

Retrieved on: 
Thursday, June 8, 2023

This application is the first application for lecanemab in Asia outside of Japan and China.

Key Points: 
  • This application is the first application for lecanemab in Asia outside of Japan and China.
  • As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease.
  • 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.
  • 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.

Eisai Submits Marketing Authorization Application for Lecanemab as Treatment for Early Alzheimer's Disease in Great Britain

Retrieved on: 
Saturday, May 20, 2023

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).
  • As such, lecanemab may have the potential to have an effect on disease pathology and 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.
  • 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.

FPF Files Comments for the FTC Health Breach Notification Rule Addressing Specific Definitions and Clarity of Scope

Retrieved on: 
Thursday, August 10, 2023

FPF Files Comments for the FTC Health Breach Notification Rule Addressing Specific Definitions and Clarity of Scope

Key Points: 
  • FPF Files Comments for the FTC Health Breach Notification Rule Addressing Specific Definitions and Clarity of Scope
    On August 8th, the Future of Privacy Forum (FPF) filed comments with the U.S. Federal Trade Commission (the Commission) regarding the Notice of Proposed Rulemaking (NPRM) to clarify the scope and application of the Health Breach Notification Rule (HBNR).
  • The HBNR was promulgated in 2009 as part of the American Recovery and Reinvestment Act as a breach of security rule.
  • The cases indicated a shift in the interpretation of “breach of security” by the Commission that drew many proto-typical practices into scope.
  • The NPRM seeks to clarify this broadened scope which has amalgamated traditional breaches of security with nascent breaches of privacy.

Consensus Cloud Solutions Launches AI Technology to Address Healthcare Providers' High Volumes of Unstructured Data

Retrieved on: 
Thursday, August 10, 2023

LOS ANGELES, Aug. 10, 2023 /PRNewswire/ -- Consensus Cloud Solutions, Inc. (NASDAQ: CCSI), the largest provider of digital cloud fax and interoperability solutions, is proud to announce the launch of Clarity Clinical Documentation™ (Clarity CD™), an accessible, cost-effective, and turnkey solution that automatically routes unstructured clinical data from faxes, handwritten notes, and scanned documents into the correct patient record. 

Key Points: 
  • Through a natural language processing and artificial intelligence engine, Clarity CD extracts key patient demographics from unstructured documents and automatically populates that data into a structured Continuity of Care Document (CCD).
  • At least 70% of healthcare providers still exchange medical information by fax, according to federal officials as reported by Bloomberg Law .
  • The launch of this new solution advances the secure exchange of healthcare data while evolving the role digital faxes play in a health system's broader interoperability strategy.
  • Scott Turicchi, CEO of Consensus Cloud Solutions states, "The reality is faxes and handwriting remain prevalent in our day-to-day healthcare system, and many are still years away from eliminating paper.

Clarity AI Announces Partnership With Aspiration to Deliver Data-Led Climate and Impact Solutions for Consumer Platforms, as Consumer Demand for Sustainability Grows

Retrieved on: 
Wednesday, July 26, 2023

Clarity AI , the leading sustainability tech platform announces it has partnered with Aspiration, a top global climate finance company, to launch sustainability assessment solutions for consumer use cases.

Key Points: 
  • Clarity AI , the leading sustainability tech platform announces it has partnered with Aspiration, a top global climate finance company, to launch sustainability assessment solutions for consumer use cases.
  • This unique partnership will deliver effective and accessible solutions to consumer platforms (e.g.
  • Clarity AI’s technology will also provide sustainability insights at the individual retailer level.
  • This solution from Clarity AI and Aspiration aims to empower customers to understand the impact of their purchasing decisions and the opportunity for them to take effective action.

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.

34% of Professional Investors Are Interested in Building Biodiversity-themed Financial Products

Retrieved on: 
Wednesday, July 19, 2023

The virtual event shed light on the substantial commitment of financial institutions to incorporate biodiversity into their decision-making processes .

Key Points: 
  • The virtual event shed light on the substantial commitment of financial institutions to incorporate biodiversity into their decision-making processes .
  • Notably, the 140 signatories of the Finance for Biodiversity initiative collectively manage an impressive $20 trillion in assets.
  • For users managing portfolios composed of multiple companies or funds, technology facilitates data aggregation from asset-level data to portfolio-level data.
  • The company remains dedicated to providing tools, data, and methodologies to empower investors to incorporate biodiversity considerations in a meaningful and impactful manner into portfolios, goal-setting and reporting.

Clarity AI: On average, companies in SDG funds sell less than 1% of their products and/or services in the countries that need them the most

Retrieved on: 
Monday, July 17, 2023

On average, companies in SDG funds sell only 1% of their products and services in these countries.

Key Points: 
  • On average, companies in SDG funds sell only 1% of their products and services in these countries.
  • The SDG Index, a valuable tool for evaluating countries' progress towards the SDGs, demonstrates that different countries are at varying stages of advancement towards achieving the SDG targets.
  • Furthermore, the distribution of revenues generated by companies in SDG funds does not align with the needs of countries lagging in SDG progress.
  • On average, companies in SDG funds receive more than 75% of their revenues from countries in the top quartile of the SDG Index, indicating a flow of funds to already well-performing nations.

Clarity AI: ESG Controversies Led to a 2% to 5% Stock Underperformance after Six Months

Retrieved on: 
Wednesday, July 12, 2023

ESG-related controversial incidents often receive significant attention from the media but the link between these controversies and actual stock performance isn’t always clear.

Key Points: 
  • ESG-related controversial incidents often receive significant attention from the media but the link between these controversies and actual stock performance isn’t always clear.
  • Analysis by Clarity AI , the global sustainability technology platform, tests the hypothesis that involvement in ESG Controversies is a valid predictor of corporate medium-term value loss.
  • The legal and regulatory consequences of such incidents can also be expensive and time-consuming to resolve, further damaging the company's reputation and market value.
  • In general, higher severity incidents led to larger deltas in company value when compared to lower severity cases.