Japan – U.S. FDA Accepts and Grants Priority Review for Eisai’s Biologics License Application of Lecanemab

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.

Copyright ©2022 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

CaixaBank grants FRV a line of green guarantees amounting to €40 million

-This line of guarantees will enable FRV to develop projects with a positive impact on the environment.


-The funding reinforces CaixaBank’s credentials as a leader in the innovation and service diversification to advance sustainable financing solutions.

WEBWIRE



CaixaBank has granted Fotowatio Renewable Ventures (FRV), the world’s leading developer of sustainable energy solutions, part of Abdul Latif Jameel Energy, a line of green guarantees amounting to €40 million. This green facility will be available for one year, with an option for renewal, and will enable FRV to develop projects with a positive impact on the environment, as well as improve its financial flexibility.


This financing operation further highlights FRV’s commitment towards advancing the sustainability of its business. Javier Huergo, Chief Investment Officer at FRV, stated, “This agreement will allow us to continue to promote access to renewable energies through solutions that contribute to the sustainable development of the communities in which we operate. This is an important development which will contribute to improving the energy system’s performance with a significantly cleaner and more competitive energy supply.”


FRV plans to invest $1.5 billion in doubling its total installed capacity and thus substantially exceed 4 GW by 2024. It will do so through employing new business models and leveraging innovative technologies, such as green hydrogen and batteries.


This operation is another example of CaixaBank’s innovation and is underpinned by its diversification plan, under which the bank seeks to adapt sustainable financing solutions to transaction banking products most used by companies. In 2021, CaixaBank completed 15 sustainable  transaction banking operations, distributing €4.2 billion to companies in various sectors through pioneering solutions in reverse factoring, factoring, guarantee lines, and others.


CaixaBank, committed to sustainability


CaixaBank has a steadfast  commitment to sustainability. Through its activities, the Bank is supporting environmentally friendly initiatives and projects that contribute to preventing and mitigating climate change and encourage the transition to a low-carbon economy and social development.


In 2021, the bank mobilised €31.4 billion in sustainable financing, representing a 150% increase in the volume of sustainable financing year on year. 


At the end of Q1 2022, CaixaBank was the 6th European bank  and the number one Spanish bank in green and sustainable loans according to Refinitiv’s League Tables Top Tier by volume.


FRV, from developer to independent power producer


FRV, part of Abdul Latif Jameel Energy, is a global leader in the development of renewable energy. Seeking to continue to lead the global transition towards a more sustainable energy future, FRV has evolved from being a pure developer to an independent power producer.


FRV aims to become one of the main green energy and infrastructure platforms worldwide. To achieve this, the company plans to invest more than $1.5 billion in doubling its total installed capacity from 2 GW in 2021 to 4 GW by 2024.

Japan – Eisai: MHLW Grants Orphan Drug Designation in Japan to Mecobalamin Ultrahigh-Dose Formulation with Prospective Indication for Delaying the Progression of Disease and Functional Impairment of ALS

Eisai Co., Ltd. announced today that it has received orphan drug designation for ultrahigh-dose mecobalamin, with a prospective indication for delaying the progression of disease and functional impairment of amyotrophic lateral sclerosis (ALS), by the Ministry of Health, Labour and Welfare (MHLW).

ALS is an intractable, progressive, neurodegenerative disease with significant unmet medical needs. In Japan, the estimated number of ALS patients is approximately 10,000.

Based on a favorable clinical results of the JETALS (The Japan Early-Stage Trial of Ultrahigh-Dose Methylcobalamin for ALS), an investigator-initiated Phase III trial to evaluate efficacy and safety of ultrahigh- dose methylcobalamin (mecobalamin) in early onset ALS patients, led by a research team with Extraordinary Professor Ryuji Kaji (Principal Investigator), Tokushima University and Professor Yuishin Izumi (Coordinating Investigator), the Department of Neurology, Tokushima University Graduate School of Biomedical Sciences, Eisai has initiated preparation on a new drug application (NDA) of ultrahigh-dose mecobalamin for ALS, and plans to submit a NDA during the fiscal year 2023 in Japan.

Eisai considers neurology a therapeutic area of focus and is committed to new drug development in this field in order to fulfill unmet medical needs, and ultimately further its contribution to improving the benefit of patients and their families.

Media Inquiries:
Public Relations Department, Eisai Co., Ltd.
+81-(0)3-3817-5120

Copyright ©2022 JCN Newswire. All rights reserved. A division of Japan Corporate News Network.

Rs. 21,741 Crore Tied Grants For Drinking Water & Sanitation Sector Under 15th Finance Commission Released To States In 2021-22


The 15th Finance Commission (FC) has recommended a total of Rs. 2,36,805 Crore for duly constituted Rural Local Bodies (RLBs) in 28 States for the period 2021-22 to 2025-26. The commission has recommended a total of Rs. 1,42,083 Crore as tied grant for the period 2021-22 to 2025-26, for maintenance of ODF status, supply of drinking water, rainwater harvesting and water recycling. For FY 2020-21, 15th FC had recommended Rs. 30,375 Crore as Tied Grant to RLBs of 28 States and for FY 2021-22, Rs. 26,941 Crore was recommended.


During 2021-22 out of total Rs. 26,941 Crore, Rs. 21,741.03 Crore has been released as tied grants till 31st March 2022, out of which Rs. 13,429.70 Crore has been released as 1st installment to 27 States and Rs. 8,311.33 Crore as 2nd installment to 13 States.


Out of the total grant earmarked for Panchayati Raj institutions, 60 percent is earmarked for drinking water & sanitation sector as tied grant and 40 percent as untied grant and is to be utilized at the discretion of the Panchayati Raj institutions for improving basic services in the panchayats.


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University Grants Commission organises a webinar on


The Government of India has launched a 75-week long campaign Azadi ka Amrit Mahotsav; to celebrate the achievements of the country and its people. The University Grants Commission (UGC) as part of  this campaign  is conducting a series of activities beginning with the a sensitisation webinar on “Cyber security Empowerment of Higher Education Institutions (HEIs)”an effort towards making cyber security more accessible, available, and adaptable for HEIs.


Delivering the welcome address, Prof. Rajnish Jain, Secretary, UGC welcomed and introduced all panelists. He set the context for the webinar, stressing on the need for cybersecurity awareness with the increased dependence on IT post pandemic. He emphasised on the fact that the pandemic has put Higher Education in the cyber space which has led HEIs to be subject to increased cybersecurity issues. He said that there is a need to understand how cyber security issues may be addressed and how cyber hygiene may be managed.


The keynote address was delivered by Lt. Gen. (Dr.) Rajesh Pant, Chief (retd.), National Cyber Security Coordinator, National Cyber Coordination Centre, PMO. He emphasized and reiterated the threat cybercrime poses to economy and national security. He focused on cybersecurity for HEIs that are base of personal information and intellectual property. He highlighted the structure of institutions that make them susceptible to cybercrimes and the measures to be taken to address these issues. He shared the ongoing and proposed government initiatives of cyber swacchta kendra and the malware posh and national blockchain project given to IIT Kanpur.  He concluded with two mantras for survival in the new normal: personal hygiene and cyber hygiene. 


Shri Abhishek Singh, CEO, My Gov and President & CEO NeGD, Ministry of Electronics & Information Technology delivering his address emphasised on the importance of cyber security due to the increased dependency and use of the cyber space. He focused on the issues of cybersecurity; cyberattacks, frauds and use of cyber warfare, further emphasising the steps and measures to be taken by HEIs to stay safe. He touched upon the various aspects of cybercrimes and measures to be taken and the processes for reporting cybersecurity issues. He spoke of Cyber Surakshit Bharat of Government of India aimed at educating people on cybersecurity.


Shri Deepak Virmani, Deputy Secretary, Indian Cyber Crime Coordination Centre (I4C) , Cyber & Information Security, Division, Ministry of Home Affairs spoke about the initiatives of Ministry of Home Affairs’ CIS and its efforts in controlling Cybercrimes. He shed light on the Indian Cyber Crime Coordination Centre schemes (I4C) of MHA that aims to prevent cybercrimes. He discussed in detail the 7 verticals of the scheme that also involve the training of police personnel and government functionaries. He further shared about the various portals and helpline numbers that can be availed by the citizens and the initiative Cyber Jaagrookta Diwas, celebrated every month since October 2021. Further delivering his address, he hailed UGC for its initiatives for promoting and sensitizing HEIs regarding Cyber security through the proposed handbook on cyber hygiene and cybersafe curriculum. 


Dr. Charru Malhotra , Coordinator, Centre of e-Governance, Indian Institute of Planning and Administration, New Delhi  brought out the findings on Cybersecurity through analysis of a pre webinar questionnaire which had been shared with HEIs. She highlighted the current status amongst HEIs about cyber security and their preparedness.


Prof. Naveen Chowdhary, National Forensic Science University, Gandhinagar through his address shared the cybersecurity threat landscape highlighting cases of compromises on cybersecurity in Educational Institutions, research facilities.  He provided a detailed outlook and a framework for cybersecurity.


Dr. Atul Kumar Pandey, Chairperson , Rajiv Gandhi National Cyber Law Centre, NLIU, Bhopal spoke about the threat landscape in HEIs and the importance of cybersecurity in HEIs. In his address he shed light on various components like content protection and privacy and capacity building for addressing cybersecurity.


The address by the panelists was followed by a Question and Answer session from the faculty members from HEIs.


The webinar discussed pertinent issues of cyber security with prioritizing its impact on HEIs and the necessary. The Webinar was the first step towards Cyber security empowerment of HEIs and provided an opportunity for sensitization and awareness on cyber security.  


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MJPS/AK




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