PayMaya Philippines' Maya Bank will be crypto-ready and crypto-friendly, the firm said.

The post PayMaya Parent Firm’s ‘Crypto-ready’ MayaBank Eyes Q1 Launch appeared first on BitPinas.

Bitcoin prices plummeted on Thursday as global geopolitical tensions escalated to unprecedented levels. On Thursday, there was no agreement reached to end the war during the second round of negotiations between Russian and Ukrainian officials. In response to the impasse, markets were jittery, which pushed prices of conventional safe-haven assets up such as gold and…

The post Bitcoin Prices Dragged Down By Geopolitical Tensions, Ukraine Nuke Plant Bombing appeared first on Bitcoin News Miner.

Customer service has always been important, but as the economy becomes more competitive, it is even more important that clients have a smooth...

    TrustToken, the core team responsible for building the leading unsecured lending protocol TrueFi, as well as popular stablecoins including TrueUSD, unveils its first permissioned single borrower portfolio on TrueFi. Designed specifically for leading digital asset principal trading firm Alameda Research, the portfolio is expected to grant its single borrower as much as $750 million of working capital […]

The post Alameda secures up to $750M credit line from TrueFi’s Single Borrower Pool appeared first on Fintech News.

TOKYO, Mar 4, 2022 - (JCN Newswire) - Eisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401). The lecanemab Clarity AD Phase 3 clinical study for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) and mild AD (collectively known as early AD) is ongoing.

The PMDA's process, known as "prior assessment consultation", is conducted at the development stage before the new drug application submission, which is based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.

Based on discussions with the Ministry of Health, Labour and Welfare (MHLW) and PMDA, Eisai applied to PMDA for permission to utilize the "prior assessment consultation" process for lecanemab with the aim of shortening the review period. The agency approved Eisai's request and Eisai has submitted the non-clinical lecanemab data to PMDA. The additional data of the application package will be submitted hereafter. Eisai plans to obtain the primary endpoint data from Clarity AD study in the fall of 2022, and based on the results of the study, aims to file for the manufacturing and marketing approval in Japan during Eisai's fiscal year 2022.

In September 2021, Eisai initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab, an investigational agent under the Accelerated Approval pathway for the treatment of early AD with confirmed amyloid pathology, and expects to complete this rolling submission in the beginning of Eisai's fiscal year 2022. Based on the results of Clarity AD study as the confirmatory study, Eisai plans to submit for full approval of lecanemab to the U.S. FDA during fiscal year 2022. Eisai and Biogen are committed to providing innovative treatments to persons living with early AD, their families and healthcare professionals who are waiting for new treatment options, as early as possible.

About the Prior Assessment Consultation System

The prior assessment consultation is conducted at the development stage before new drug application submission based on available quality, non-clinical and clinical data. By identifying and resolving any potential issues prior to submission, the aim is to shorten application review time.

About Lecanemab (BAN2401)

Lecanemab is an investigational humanized monoclonal antibody for Alzheimer's disease (AD) that is the result of a strategic research alliance between Eisai and BioArctic. Lecanemab selectively binds to neutralize and eliminate soluble, toxic amyloid-beta (A&#946;) aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in AD. As such, lecanemab may have the potential to have an effect on disease pathology and to slow down the progression of the disease. Currently, lecanemab is being developed as the only anti- A&#946; antibody that can be used for the treatment of early AD without the need for titration. With regard to the results from pre-specified analysis at 18 months of treatment, Study 201 demonstrated reduction of brain Abeta accumulation (P<0.0001) and slowing of disease progression measured by ADCOMS* (P<0.05) in early AD subjects. The study did not achieve its primary outcome measure** at 12 months of treatment. The Study 201 open-label extension was initiated after completion of the Core period and a Gap period off treatment of 9-59 months (average of 24 months, n=180 from core study enrolled) to evaluate safety and efficacy, and is underway.

Currently, lecanemab is being studied in a confirmatory Phase 3 clinical study in symptomatic early AD (Clarity-AD), following the outcome of the Phase 2 clinical study (Study 201). Since July 2020 the Phase 3 clinical study (AHEAD 3-45) for individuals with preclinical AD, meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. AHEAD 3-45 is conducted as a public-private partnership between the Alzheimer's Clinical Trial Consortium that provides the infrastructure for academic clinical trials in Alzheimer's Disease and related dementias in the U.S, funded by the National Institute on Aging, part of the National Institutes of Health, Eisai and Biogen. Furthermore, Eisai has initiated a lecanemab subcutaneous dosing Phase 1 study. Eisai obtained the global rights to study, develop, manufacture and market lecanemab for the treatment of AD pursuant to an agreement concluded with BioArctic in December 2007. In March 2014 Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab and the parties amended that agreement in October 2017.

* Developed by Eisai, ADCOMS (AD Composite Score) combines items from the ADAS-Cog (Alzheimer's Disease Assessment Scale-cognitive subscale), CDR (Clinical Dementia Rating) and the MMSE (Mini-Mental State Examination) scales to enable a sensitive detection of changes in clinical functions of early AD symptoms and changes in memory. The ADCOMS scale ranges from a score of 0.00 to 1.97, with higher score indicating greater impairment.
** An 80% or higher estimated probability of demonstrating 25% or greater slowing in clinical decline at 12 months treatment measured by ADCOMS from baseline compared to placebo.

About the Collaboration between Eisai and Biogen for Alzheimer's Disease

Eisai and Biogen are collaborating on the joint development and commercialization of AD treatments. Eisai serves as the lead in the co-development of lecanemab.

About the Collaboration between Eisai and BioArctic for Alzheimer's Disease

Since 2005, BioArctic has had a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of AD. The commercialization agreement on the lecanemab antibody was signed in December 2007, and the development and commercialization agreement on the antibody lecanemab back-up for AD, which was signed in May 2015. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for AD. BioArctic has no development costs for lecanemab in AD.

About Eisai Co., Ltd.

Eisai Co., Ltd. is a leading global pharmaceutical company headquartered in Japan. Eisai's corporate philosophy is based on the human health care (hhc) concept, which is to give first thought to patients and their families, and to increase the benefits that health care provides to them. With a global network of R&D facilities, manufacturing sites and marketing subsidiaries, we strive to realize our hhc philosophy by delivering innovative products to target diseases with high unmet medical needs, with a particular focus in our strategic areas of Neurology and Oncology.

Leveraging the experience gained from the development and marketing of a treatment for Alzheimer's disease, Eisai aims to establish the "Eisai Dementia Platform." Through this platform, Eisai plans to deliver novel benefits to those living with dementia and their families through constructing a "Dementia Ecosystem," by collaborating with partners such as medical organizations, diagnostic development companies, research organizations, and bio-ventures in addition to private insurance agencies, finance industries, fitness clubs, automobile makers, retailers, and care facilities. For more information about Eisai Co., Ltd., please visit https://www.eisai.com.

About Biogen

As pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. One of the world's first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp. Today, Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer's disease. Biogen is also commercializing biosimilars and focusing on advancing the industry's most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need.

In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Healthy Climate, Healthy Lives aims to eliminate fossil fuels across the company's operations, build collaborations with renowned institutions to advance the science to improve human health outcomes, and support underserved communities.

Biogen Safe Harbor
This news release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, about the potential clinical effects of lecanemab; the potential benefits, safety and efficacy of lecanemab; potential regulatory discussions, submissions and approvals and the timing thereof; the expected data readout for the Clarity AD study; the treatment of Alzheimer's disease; the anticipated benefits and potential of Biogen's collaboration arrangements with Eisai; the potential of Biogen's commercial business and pipeline programs, including lecanemab; and risks and uncertainties associated with drug development and commercialization. These statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical studies may not be indicative of full results or results from later stage or larger scale clinical studies and do not ensure regulatory approval. You should not place undue reliance on these statements or the scientific data presented.

These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation unexpected concerns that may arise from additional data, analysis or results obtained during clinical studies, including the Clarity AD clinical trial and AHEAD 3-45 study; the occurrence of adverse safety events; risks of unexpected costs or delays; the risk of other unexpected hurdles; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of Biogen's drug candidates, including lecanemab; actual timing and content of submissions to and decisions made by the regulatory authorities regarding lecanemab; uncertainty of success in the development and potential commercialization of lecanemab; failure to protect and enforce Biogen's data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; product liability claims; third party collaboration risks; and the direct and indirect impacts of the ongoing COVID-19 pandemic on Biogen's business, results of operations and financial condition. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen's expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen's most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen's current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.


Copyright 2022 JCN Newswire. All rights reserved. www.jcnnewswire.comEisai Co., Ltd. and Biogen Inc. announced today that Eisai has initiated a submission to the Pharmaceuticals and Medical Devices Agency (PMDA) of application data under the prior assessment consultation system in Japan for the investigational anti-amyloid beta (Abeta) protofibril antibody lecanemab (BAN2401).

The deployment of powerful AI systems has enriched our understanding of safety and misuse far more than would have been possible through research alone. Notably:

• API-based language model misuse often comes in different forms than we feared most.
• We have identified limitations in existing language model evaluations that we are

Call for expressions of interest to study the economic impacts of Codex.

American chipmaking company NVIDIA on Tuesday confirmed that its network was breached as a result of a cyber attack, enabling the perpetrators to gain access to sensitive data, including source code purportedly associated with its Deep Learning Super Sampling (DLSS) technology. "We have no evidence of ransomware being deployed on the NVIDIA environment or that this is related to the

NVIDIA this week acknowledged that employee credentials were stolen during a cyberattack on February 23 and confirmed the attackers have started leaking the information online.

The compromise occured on February 23 and impacted certain "IT resources," an NVIDIA spokesperson told SecurityWeek.

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SANTA MONICA, CA, Feb 28, 2022 - (ACN Newswire) - Power of One Foundation ("POOF") has entered into a partnership with Legacy Block (BLCK:Pancakeswap). BLCK is an operating division of Peerless Exponential Partners, LLC (PXP). By way of the partnership POOF will use Legacy Block's BLCK governance token as the governance token for a series of new blockchain based projects targeted at ending hunger in the United States. These projects will materially increase POOF's reach and efficiency in addressing its goal that aligns with the United Nations Sustainable Development Goal (SDG) - Zero Hunger.
Legacy Block ("BLCK") is the governance token of several protocols seeking to address some of the world's greatest challenges. "We believe we can use our token to solve some of the world's pressing challenges," says Joel Plasco, Co-Founder of Legacy Block. "When we set out to do this in Nigeria we were met with pessimism, what we now know is people will invest their time in what we call Personal Natural Resources ("PNR") to help themselves and their community. Blockchain and tokens are a very helpful tool for documenting and rewarding people for their participation."

Through the partnership POOF will work with Legacy Block to create new food security solutions leveraging the power of Blockchain. POOF's expertise and capabilities have been tested and honed over the duration of the Covid Pandemic. In 2020, as the effects of Covid halted the economy and devastated the income for tens of millions of Americans, POOF stepped up to feed over 3 million people in California and distributed over 10 million lbs of food earning it 2020 California Nonprofit of the Year.

"We learned during the height of the pandemic that new blockchain based tools could have possibly helped us increase the number of people we fed and could have helped people in need get other vital services. We believe we can use PNR to convert time and other intangible assets into tokenized monetizable assets," says Andre Roberson, CEO of Power of One Foundation.

By working with POOF, Legacy Block believes in the acquisition and utility of cryptographic assets available to everyone on the planet. Legacy Block has signed up 100,000 members in Africa who have pledged more than 5 million hours of their time to help social innovators who solve real world problems. These members are using PNR to eliminate extreme poverty. Legacy Block has agreed as part of this partnership to provide training and start-up capital to 50,000 POOF members which will allow those members to use PNR to reduce food insecurity.

"Applying PNR to food securities issues in the USA is the next step in creating a global PNR ecosystem capable of reducing financial inequalities," says Master Node Holder Lou Zant.

"We are excited to work with Legacy Block to help 50,000 of our community members activate their Personal Natural Resources ("PNR") to achieve permanent food security and to have access to the Legacy Block BLCK governance token and the great minds gathering to solve real life problems using blockchain," says Andre Roberson.

About Legacy Block

Legacy Block is an operating subsidiary of Peerless Exponential Partners, LLC, a company headquartered in the USA. Its purpose is to provide a framework for governance and coordinate the Legacy Block Initiative. This will foster transformative social impact through decentralized technologies in support of financial inclusion. The goal is the elimination of extreme poverty to ensure universal basic opportunities exist for every citizen on the planet.

For more information visit https://blckcoin.org

Contact: [email protected].


Forward-Looking Statements
This press release may contain "forward-looking statements." Forward-looking statements reflect the current view about future events. When used in this presentation, the words "anticipate," "believe," "estimate," "expect," "future," "intend," "plan," or the negative of these terms and similar expressions, as they relate to us or our management, identify forward-looking statements. Such statements include, but are not limited to, statements contained in this presentation relating to the view of management of any company mentioned in this press release. (the "Company") concerning its business strategy, future operating results, and liquidity and capital resources outlook. Forward-looking statements are based on the Company's current expectations and assumptions regarding its business, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. The Company's actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. We caution you therefore against relying on any of these forward-looking statements. Factors or events that could cause the Company's actual results to differ may emerge from time to time, and the Company can't predict all of them. The Company cannot guarantee future results, levels of activity, performance, or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comPower of One Foundation ("POOF") has entered into a partnership with Legacy Block (BLCK:Pancakeswap). BLCK is an operating division of Peerless Exponential Partners, LLC (PXP).

Shibainfinity NFT project, a collection of 10000 NFT artistic designs inspired by shiba Inu. Shiba NFT is the new kid on the NFT block set. The NFT artistic designs are inspired by space and astronauts. With a set whose theme is centered around the dog metaverse sitting in outer space, shiba NFT public minting was [...]

The post Shibainfinity Begins Public Minting of Shiba NFTs, Join Now And Become a Holder appeared first on Blockonomi.

In December 2021, Polkadot achieved something it had been working on for a long time:  Parachains from its first round of auctions went live.  This was years in the making, and with all roadmaps that reach a major milestone, it was a big win for Polkadot, the parachains, and the blockchain industry as a whole. […]