Clarity

Clarity AI signs MoU with the Saudi Tadawul Group to Increase Access to Sustainability Assessment, Analysis and Reporting Capabilities for Companies in MENA

Retrieved on: 
Monday, February 13, 2023
Technology, Other Energy, Finance, Consulting, Public Policy, Government, Energy, Professional Services, Artificial Intelligence, Environment, Sustainability, Software, Data Analytics, Data Management, Other Policy Issues, Benchmarking, SAR, Disclosure, Clarity, Saudi Vision 2030, Memorandum of understanding, ESG, Kingdom, Education, Multimedia, Financial sector development, Communication, Arms industry, Cryptocurrency, AI

"This position represents a strong opportunity for us to help bring additional tech-powered sustainability capabilities to these global corporations."

Key Points: 
  • "This position represents a strong opportunity for us to help bring additional tech-powered sustainability capabilities to these global corporations."
  • Khalid Al Hussan, CEO of the Saudi Tadawul Group said: “With investors around the world using ESG metrics to inform their decisions, Saudi Tadawul Group has an important role to play in driving adoption of transparent and purposeful ESG reporting.
  • Clarity AI’s platform will serve both larger companies and support those earlier in their sustainability journey, including small and medium enterprises.
  • Clarity AI's tools and services will help companies enhance their disclosure and understanding of ESG and sustainability, supporting a transition to a more sustainable future for the region and the world.

Mednow Launches New Virtual Diabetes Management Program in Partnership With Dexcom

Retrieved on: 
Thursday, February 2, 2023
Technology, Medical Supplies, Diabetes, Health Technology, Telemedicine, Virtual Medicine, Software, Managed Care, Pharmaceutical, Health, Data Management, Certified diabetes educator, DXCM, Dexcom, Investment, Patient, Clarity, CDE, Partnership, G6, Inc., Pharmaceutical industry

Mednow Inc. (“Mednow” or the “Company”) (TSXV: MNOW) (OTCQX: MDNWF) announced today the launch of its enhanced Virtual Diabetes Management program, an end-to-end digital diabetes management solution, to enable convenient on-demand access to Dexcom G6 (NASDAQ: DXCM) real-time continuous glucose monitoring (rtCGM) supplies and personalized diabetes care services.

Key Points: 
  • Mednow Inc. (“Mednow” or the “Company”) (TSXV: MNOW) (OTCQX: MDNWF) announced today the launch of its enhanced Virtual Diabetes Management program, an end-to-end digital diabetes management solution, to enable convenient on-demand access to Dexcom G6 (NASDAQ: DXCM) real-time continuous glucose monitoring (rtCGM) supplies and personalized diabetes care services.
  • The new integrated Virtual Diabetes Management program combines Mednow virtual pharmacy services with Dexcom rtCGM technology, to provide individuals with a comprehensive diabetes management solution.
  • The Virtual Diabetes Management program will initially be available in Ontario and British Columbia starting in early February.
  • In response, we’ve partnered with Mednow to provide users with a more convenient and coordinated experience, by making Dexcom G6 sensors and transmitters available through the pharmacy combined with enhanced virtual diabetes management support services.”

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Sunday, January 29, 2023
Medicines and Healthcare products Regulatory Agency, Marketing, Disease, MAA, NMPA, Food, Neurotoxicity, Clarity, Pharmaceuticals and Medical Devices Agency, Headquarters, Corporation, National Medical Products Administration, European Medicines Agency, Medication, MHLW, Phase, BLA, Co-promotion, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, FDA, BIIB, AD, The New England Journal of Medicine, Eisai, EMA, PMDA, Priority review, Pharmaceutical industry, Biogen, Health

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Aβ aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

Clarity Files Drill Permit Application for Lithium381 Project

Retrieved on: 
Wednesday, January 18, 2023
Lithium, News, Development, OTC, TSX Venture Exchange, CSE, FSE, National Instrument 43-101, Green, Carbon, Property, SEDAR, Critical, James Bay Road, National instrument, Craton, Clarity

The drill permit includes locations for 27 drill pads.

Key Points: 
  • The drill permit includes locations for 27 drill pads.
  • The Company has begun planning a drilling program which will be further constrained as results of additional geophysical and remote sensing surveys are received.
  • James Rogers CEO of Clarity comments: “We are please to be progressing our exploration efforts and to have filed a permit application that would enable us to drill test the recently identified resistivity target on the Lithium381 project.”
    Figure 1 Preliminary resistivity results on Lithium381 Project and Allkem Limited’s 2008 IP Resistivity survey in the area of their open pit.
  • Figure 2 Location of Lithium381 Project showing nearby properties and total pit outline on Allkem’s James Bay Lithium Project from the Allkem Feasibility Study.

D-Wave Announces New Commercial Customer Engagements, Cross-Platform Product Enhancements at Qubits 2023

Retrieved on: 
Tuesday, January 17, 2023
Software, Technology, Hardware, Gate, Quantum, Mastercard, D-Wave, Architecture, Siemens Healthineers, NYSE, CQM, SDK, Clarity, Frank Recruitment Group, Noise, MIP, Risk management, Renewable energy, Microscope, 3D printing, Toy, Unisys, LEAP, Qubit

D-Wave’s continued commercial customer momentum and product innovations reflect the accelerating adoption of quantum computing solutions and growing recognition of the technology’s ability to unlock business value, today.

Key Points: 
  • D-Wave’s continued commercial customer momentum and product innovations reflect the accelerating adoption of quantum computing solutions and growing recognition of the technology’s ability to unlock business value, today.
  • In addition to showcasing commercial quantum applications at Qubits, D-Wave today announced that it has recently added a number of customers to its portfolio, representing a diverse set of potential use cases.
  • New and renewing commercial customers working with D-Wave on quantum-hybrid use cases include Siemens Healthineers, Unisys, and Davidson Technologies.
  • “As we gather at our annual Qubits user conference in Miami this week, the commercialization of quantum is on full display.

Pimax Shows the Future of VR at CES2023 with New VR Products for Consumers

Retrieved on: 
Thursday, January 12, 2023
CES, Las Vegas Convention Center, Face, Central Hall, VR, Hand, PPD, Methodist Central Hall, Westminster, Lens, Crystal, Clarity, Android, Eye, Video game console, Inverse

The Pimax Crystal is Pimax's third generation VR headset, after Pimax's 5K in 2017, and the 8K in 2018.

Key Points: 
  • The Pimax Crystal is Pimax's third generation VR headset, after Pimax's 5K in 2017, and the 8K in 2018.
  • With no image distortion, the maximum pixel density can be 42PPD, which is the highest PPD known in VR headsets.
  • In recent years, VR games have become popular, but none of the products can really meet the needs of users for multi-scenario applications.
  • Harry (Skeeva) Skigis: "The Pimax Crystal had the clearest picture I've seen in VR to date!

Lecanemab Receives Priority Review Status in Japan

Retrieved on: 
Monday, January 30, 2023
Disease, The New England Journal of Medicine, Alzheimer's disease, European Medicines Agency, PMDA, National Medical Products Administration, Amyloid beta, Priority review, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, MHLW, FDA, AD, Medication, Marketing, Pharmaceuticals and Medical Devices Agency, Food, Neurotoxicity, Medicines and Healthcare products Regulatory Agency, Eisai, BLA, Co-promotion, NMPA, Clarity, Phase, MAA, EMA, Pharmaceutical industry, Health, Biogen

Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.

Key Points: 
  • Priority Review in Japan is granted to new medicines recognized as having high medical utility for serious diseases, and once designated for Priority Review, the target total review period is shortened.
  • In Japan, Eisai submitted the manufacturing and marketing approval for lecanemab to the Pharmaceuticals and Medical Devices Agency (PMDA) on January 16, 2023.
  • Lecanemab selectively binds and eliminates soluble, toxic Abeta aggregates (protofibrils) that are thought to contribute to the neurotoxicity in AD.
  • The Clarity AD study of lecanemab met its primary endpoint and all key secondary endpoints with highly statistically significant results.

Eisai Files Marketing Authorization Application for Anti-Amyloid-Beta Protofibril Antibody Lecanemab for Early Alzheimer's Disease in Japan

Retrieved on: 
Monday, January 16, 2023
PET, Brain, Brand, European Medicines Agency, PMDA, Headache, National Medical Products Administration, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Safety, FDA, Superficial siderosis, AD, Siderosis, Medication, Pharmaceuticals and Medical Devices Agency, Food, Medicines and Healthcare products Regulatory Agency, BLA, Eisai, Co-promotion, NMPA, MCI, Clarity, ADCS, Phase, Alzheimer's disease, EMA, MAA, Medical imaging, Medical device, Pharmaceutical industry, Biogen

Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.

Key Points: 
  • Prior to submitting this application, Eisai utilized the prior assessment consultation system of PMDA, with the aim of shortening the review period for lecanemab.
  • On the same day, Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway.
  • In Europe, Eisai submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) on January 9, 2023.
  • 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.

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

Retrieved on: 
Wednesday, January 11, 2023
Memory, Problem solving, The New England Journal of Medicine, Alzheimer's disease, Brand, European Medicines Agency, Judgement, Headache, National Medical Products Administration, Amyloid beta, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, BIIB, Hobby, FDA, Superficial siderosis, AD, Food, BLA, Co-promotion, NMPA, Clarity, Dementia, Phase, MAA, EMA, Orientation, Medical device, Pharmaceutical industry, Biogen, Eisai

In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.

Key Points: 
  • In the U.S., lecanemab was granted accelerated approval as a treatment for AD by the U.S. Food and Drug Administration (FDA) on January 6, 2023.
  • Eisai submitted a Supplemental Biologics License Application (sBLA) to the FDA for approval under the traditional pathway on the same day.
  • In Japan, Eisai plans to submit a marketing authorization application by the end of Eisai's fiscal year 2022, which ends March 31, 2023.
  • 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.

Eisai Submits Supplemental Biologics License Application to FDA for Traditional Approval of LEQEMBI (lecanemab-irmb) for the Treatment of Alzheimer's Disease

Retrieved on: 
Monday, January 9, 2023
Disease, The New England Journal of Medicine, Brain, National Medical Products Administration, Amyloid beta, Trial of the century, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Pathology, FDA, AD, Accelerated approval (FDA), Marketing, Food, BLA, Plaque, Patient, File, Amyloid-related imaging abnormalities, ARIA, Co-promotion, NMPA, Immunoglobulin G, Medicine, Clarity, Incidence, Pharmaceutical industry, Biogen, Eisai, Alzheimer's disease, EU

This sBLA is subject to validation of whether the FDA accepts the application for review.

Key Points: 
  • This sBLA is subject to validation of whether the FDA accepts the application for review.
  • Treatment with LEQEMBI should only be initiated in patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of Aβ pathology.
  • Accelerated Approval of LEQEMBI was based on Phase 2 data that demonstrated LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD.
  • The sBLA for LEQEMBI is based on the data from the Phase 3 confirmatory Clarity AD clinical trial.