May 9, 2023 | Business
DENSO Corporation accepted the IEEE Corporate Innovation Award during a May 5 ceremony in Atlanta. IEEE,(1) the largest international association for electrical and electronic engineering, awarded DENSO for developing the QR Code(2) and spreading its use globally, enabling the world to benefit from its numerous capabilities.
From left, IEEE President-Elect Thomas Coughlin, DENSO President and CEO Koji Arima, IEEE President Saifur Rahman
The IEEE Corporate Innovation Award, one of the most prestigious technical awards in the world, is presented to organizations that have made a significant global impact with innovative technologies and products and contributed to the development of electrical and electronic engineering.
The QR Code was developed in 1994 by DENSO’s applied equipment engineering group (currently DENSO WAVE) as an easy-to-read code that can store large amounts of information. The innovative two-dimensional code can store about 200 times more information than barcodes and can be read at high speed. DENSO started to use the code mainly for inventory management at its manufacturing plants, and later made the patent available free of charge, allowing it to spread globally. In the early 2000s, the QR Code became more familiar to the general public as the use of mobile phones with cameras grew. Today, it is widely used in many daily life applications, including electronic tickets and cashless payments. In 2020, the QR Code was recognized as an IEEE Milestone(3) for its outstanding contribution to the world.
To help commemorate that the company invented the QR Code nearly 30 years ago, DENSO recently launched a free online game – DENSO QR Code Maze – and created a new webpage on its North America website detailing the QR Code’s history and the IEEE honor.
Guided by its Two Great Causes – Green and Peace of Mind – DENSO remains committed to developing innovative technologies that contribute to society and industry, making for a future that’s green, safe and seamless for all.
*Please refer to the December 2, 2022, press release for award details.
www.denso.com/global/en/news/newsroom/2022/20221202-g01
(1) The Institute of Electrical and Electronics Engineers, Inc.
Headquartered in the United States, it is the world’s largest engineering academy with more than 400,000 members in more than 160 countries.
(2) QR Code is registered trademarks of DENSO WAVE Incorporated.
(3) An IEEE Milestone commends a historic achievement which has greatly assisted the development of society and industry in electrical and electronic engineering.
2020/10/07 DENSO receives IEEE Milestone for QR Code
www.denso.com/global/en/news/newsroom/2020/201007-g01/
– 2023 IEEE Award Recipients
https://corporate-awards.ieee.org/recipients/current-recipients/#recognition-awards
– IEEE Corporate Innovation Award Recipients
https://www.ieee.org/content/dam/ieee-org/ieee/web/org/about/awards/recipients/corp-inn-rl.pdf
– Details of the QR Code
Video featuring the QR Code https://youtu.be/ieAYPNJq1bA
About the QR Code: QR Code.com https://www.qrcode.com/en/
QR Code development story https://www.denso-wave.com/en/technology/vol1.html
Website commemorating the 25th anniversary of the development of the QR Code (released in 2019)
www.denso-wave.com/qr2019/en/
Proposal for recognition of the QR Code as an IEEE Milestone
http://ieeemilestones.ethw.org/Milestone-Proposal:QR_Code
About DENSO CORPORATION
DENSO is a $47.9 billion global mobility supplier that develops advanced technology and components for nearly every vehicle make and model on the road today. With manufacturing at its core, DENSO invests in its around 200 facilities to produce electrification, powertrain, thermal, mobility electronics, advanced devices to create jobs that directly change how the world moves. The company’s around 165,000 employees are paving the way to a mobility future that improves lives, eliminates traffic accidents, and preserves the environment. Globally headquartered in Kariya, Japan, DENSO spent around 9.0 percent of its global consolidated sales on research and development in the fiscal year ending March 31, 2023. For more information about global DENSO, visit www.denso.com/global.
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Mar 6, 2023 | Business
Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) announced today that the U.S. Food and Drug Administration (FDA) has accepted Eisai’s supplemental Biologics License Application (sBLA) for LEQEMBITM (lecanemab-irmb) 100 mg/mL injection for intravenous use, supporting the conversion of the accelerated approval of LEQEMBI to a traditional approval. 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.
LEQEMBI is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibrils*) and insoluble forms of amyloid beta (Aβ), approved under the Accelerated Approval Pathway for the treatment of Alzheimer’s Disease (AD) on January 6, 2023.
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. LEQEMBI met the primary endpoint and all key secondary endpoints with highly statistically significant results. In November 2022, results of the Clarity AD study were presented at the Clinical Trials on Alzheimer’s Disease (CTAD) conference and simultaneously published in the peer-reviewed medical journal, The New England Journal of Medicine.
LEQEMBI was approved under accelerated approval in the U.S. and was launched in the U.S. on January 18, 2023. The accelerated approval was based on Phase 2 data that demonstrated that LEQEMBI reduced the accumulation of Aβ plaque in the brain, a defining feature of AD, and its continued approval may be contingent upon verification of LEQEMBI’s clinical benefit in a confirmatory trial. The FDA has determined that the results of Clarity AD can serve as the confirmatory study to verify the clinical benefit of lecanemab.
Eisai serves as the lead of LEQEMBI development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product and Eisai having final decision-making authority.
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.
* Protofibrils are large Aβ aggregated soluble species of 75-500 Kd.1 To learn more, visit www.LEQEMBI.com.
For more information, visit www.eisai.com/news/2023/pdf/enews202316pdf.pdf.
Copyright ©2023 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.
Jul 6, 2022 | Business
Eisai Co., Ltd. and Biogen Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) under the accelerated approval pathway for lecanemab (development code: BAN2401), an investigational anti-amyloid beta (Abeta) protofibril antibody for the treatment of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) and mild AD (collectively known as early AD) with confirmed presence of amyloid pathology in the brain. Eisai’s application, which was completed in early May 2022, has been granted Priority Review, with a Prescription Drug User Fee Act (PDUFA) action date of January 6, 2023.
“Alzheimer’s disease is a serious disease that causes significant disability and burden to the people living with Alzheimer’s disease and their families. Treatment options for Alzheimer’s disease are limited and creation of new treatment options is strongly encouraged. Eisai employees have spent time with people living with Alzheimer’s disease to truly understand their feelings and challenges and have been working to create new treatments for many years,” said Haruo Naito, Chief Executive Officer at Eisai. “The acceptance of lecanemab’s BLA with priority review is an important milestone in serving people living with Alzheimer’s disease who have been waiting for new treatment options to address an underlying pathology of Alzheimer’s disease. We will continue to actively cooperate with the FDA’s review in an effort to bring this new treatment option to people living with Alzheimer’s disease and their families as soon as possible.”
“We believe in a future where people living with Alzheimer’s disease will have different treatment options to address this complex disease, and today’s BLA acceptance with priority review by FDA is an important step towards this vision,” said Michel Vounatsos, Chief Executive Officer at Biogen. “Together with Eisai, we are committed to continuing our work to address the tremendous unmet need for these patients and their families.”
The Clarity AD Phase 3 clinical study for lecanemab in early AD is ongoing and Eisai completed enrollment in March 2021 with 1,795 patients. The readout of the primary endpoint data of Clarity AD will occur in the Fall of 2022. The FDA has agreed that the results of Clarity AD, when completed, can serve as the confirmatory study to verify the clinical benefit of lecanemab. Eisai utilized the FDA’s Accelerated Approval Pathway in an effort to streamline the submission process for the potential traditional approval of lecanemab in order to expedite patients’ access to lecanemab. Dependent upon the results of the Clarity AD clinical trial, Eisai will submit for traditional approval of lecanemab to the FDA during Eisai’s fiscal year 2022, which ends on March 31, 2023.
In Japan, in March 2022, Eisai initiated the submission of application data to the Pharmaceuticals and Medical Devices Agency (PMDA) under the prior assessment consultation system with the aim of obtaining early approval for lecanemab. Eisai aims to file for the manufacturing and marketing approval based on the results of Clarity AD during Eisai’s fiscal year 2022. Also, in Europe, based on the results of the Clarity AD study, Eisai plans to submit a new drug application in fiscal year 2022.
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.
For more information, visit www.eisai.com/news/2022/pdf/enews202254pdf.pdf.
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