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New Data Presented at ECTRIMS Show Evobrutinib is First BTK Inhibitor to Demonstrate a Significant Reduction in Slowly Expanding Lesions (SEL) in Patients with RMS

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New Data Presented at ECTRIMS Show Evobrutinib is First BTK Inhibitor to Demonstrate a Significant Reduction in Slowly Expanding Lesions (SEL) in Patients with RMS

Business Wire India

Phase II post-hoc data show evobrutinib reduced acute and chronic inflammation processes in the central nervous system that may be early indicators of MS disease progression
Additional data indicate that evobrutinib treatment was associated with reduced MRI and relapse activity in a patient population with more severe prognosis, based on baseline neurofilament levels
The first and only integrated safety analysis of a BTK inhibitor that includes MS patients demonstrated that evobrutinib is well-tolerated across three Phase II trials in more than 1000 patients suffering from autoimmune diseases, including RMS

Not intended for UK and U.S. based media

Merck, a leading science and technology company, today shared data in an oral presentation from a Phase II post-hoc analysis, demonstrating that the oral, central nervous system (CNS)-penetrant, fully covalent Bruton’s tyrosine kinase inhibitor (BTKi) evobrutinib impacted brain lesions associated with chronic inflammation in the CNS, making it the first BTKi to show significant reductions in slowly expanding lesions (SEL). SELs are chronic, active, demyelinated multiple sclerosis (MS) lesions, which are thought to be an early indicator of disease progression in MS. These data were presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) days after the completion of enrolment into the Phase III EVOLUTION RMS program, in which evobrutinib is being investigated, was announced.

 

“The presented analysis is the first to show a BTK inhibitor significantly reducing SEL volume in patients with relapsing MS, providing further evidence to support the mechanism of action of evobrutinib in the treatment of RMS and underscoring the molecule’s potential impact on neurodegeneration and disease progression,” said Dr. Xavier Montalban, Chairman & Director Neurology-Neuroimmunology Department & Neurorehabilitation Unit, Multiple Sclerosis Centre of Catalonia (Cemcat), Vall d’Hebron University Hospital, Barcelona, Spain.

 

The analysis from the Phase II study evaluated the effect of evobrutinib treatment on SEL volume from baseline to Week 48. Evobrutinib reduced SEL volume compared to placebo in a dose-dependent manner with the highest effect with 75mg twice daily (p=0.047). In a subgroup analysis, the effect of evobrutinib on SEL volume was also especially apparent in patients with more advanced disease. SELs are a potential result of accumulating neuronal damage, especially axonal loss, and occur independently of acute inflammation associated with gadolinium-enhancing (Gd+) lesions. These results, combined with the reduction in Gd+ lesions reported previously, suggest that evobrutinib reduces both acute and chronic neuroinflammation that together lead to worsening disability.

 

In addition to SEL volume measurement, assessing blood neurofilament light chain (NfL) levels is another emerging method to evaluate MS disease progression. Previously shared data showed that evobrutinib significantly lowers blood NfL levels as early as week 12, with levels remaining reduced at the last analyses time point at 24 weeks. New data from a second ECTRIMS oral presentation of a post-hoc analysis of the Phase II trial demonstrated that high levels of NfL at baseline were predictive of increased relapse and magnetic resonance imaging (MRI) lesion activity. Evobrutinib 75mg once daily or twice daily reduced MRI and relapse outcomes versus placebo or evobrutinib 25mg once daily over 24 weeks, even in more advanced MS subjects with high baseline NfL levels. These initial findings across NfL data combined with SEL data continue to show evobrutinib’s potential benefit in disease progression.

 

The most extensive integrated safety dataset of a BTKi in autoimmune diseases was also presented. The analysis, which utilized pooled data from three Phase II trials across systemic lupus erythematosus, rheumatoid arthritis and RMS from 1083 patients, included different doses of 25mg or 75mg once daily, or 50mg or 75mg twice daily. Evobrutinib was generally well tolerated with similar rates of adverse events between evobrutinib and placebo by indication and across trials. The most common adverse events reported were urinary tract infections (9.5% versus 8.5% placebo), nasopharyngitis (7.3% versus 5.5% placebo), diarrhea (6.2% versus 4.8% placebo) and alanine aminotransferase (ALT) increase (2.9% versus 1.5% placebo). Liver transaminase elevations were asymptomatic and reversible upon treatment discontinuation.

 

“New treatments are needed that target chronic neuroinflammation early in RMS to effectively prevent progression and accumulation of disability,” said Danny Bar-Zohar, MD, Global Head of Development for the Healthcare business of Merck. “Evobrutinib’s first of its kind BTKi data on both SEL and NfL, which are thought to predict disease progression, further substantiate our belief in evobrutinib’s potential as a best-in-class treatment for people living with relapsing MS.”

 

About Evobrutinib

 

Evobrutinib (M2951) is in clinical development to investigate its potential as a treatment for multiple sclerosis (MS). It is an oral, highly selective inhibitor of Bruton’s tyrosine kinase (BTK) which is important in the development and functioning of various immune cells including B lymphocytes and macrophages. Evobrutinib is designed to inhibit primary B cell responses such as proliferation and antibody and cytokine release, without directly affecting T cells. Evobrutinib is currently under clinical investigation and not approved for any use anywhere in the world.

 

About Multiple Sclerosis

 

Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.8 million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.

 

Merck in Neurology and Immunology

 

Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). The company`s current MS portfolio includes two products for the treatment of relapsing MS – Rebif® (interferon beta-1a) and MAVENCLAD® (cladribine tablets). Merck aims to improve the lives of patients by addressing areas of unmet medical needs. In addition to Merck`s commitment to MS, the company also has a pipeline focusing on discovering new therapies that have the potential in other neuroinflammatory and immune-mediated diseases, including systemic lupus erythematosus (SLE).

 

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

 

About Merck

 

Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2020, Merck generated sales of € 17.5 billion in 66 countries.

 

Scientific exploration and responsible entrepreneurship have been key to Merck’s technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Electronics.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211014005719/en/

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Press Release

Aurora Accelerates Development of the Aurora Driver with AWS

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Aurora Accelerates Development of the Aurora Driver with AWS

Business Wire India

Today, Amazon Web Services, Inc. (AWS), an Amazon.com, Inc. company (NASDAQ: AMZN), announced that Aurora (NASDAQ: AUR), a leader in self-driving vehicle technology, has selected AWS as its preferred cloud provider for machine learning training and cloud-based simulation workloads. Aurora uses AWS’s proven infrastructure and unparalleled portfolio of capabilities to safely accelerate the development of the Aurora Driver, its scalable self-driving vehicle technology. The Aurora Driver consists of sensors that perceive the world, software that plans a safe path through it, and a computer that powers and integrates Aurora’s hardware and software with any vehicle platform. For its machine learning training and cloud-based simulation workloads, Aurora is all-in on AWS, and it uses the cloud to process trillions of data points each day. Now, the company is scaling its training workloads in the cloud to complete up to 12 million physics-based driving simulations per day by the end of the year, building on the petabytes of data it collects during real-world road tests.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211201005041/en/

 

(Image: Aurora)

Autonomous driving is an immensely complex technological challenge that relies heavily on cloud computing to enable breakthroughs in perception, embedded computing, machine learning, motion planning, decision making, and advanced sensor technologies. With AWS’s capabilities in high-performance computing, machine learning, storage, and security, Aurora optimizes and scales its virtual testing efforts to expand the capabilities of the Aurora Driver safely and quickly.

 

“Aurora’s advanced machine learning and simulation at scale are foundational to developing our technology safely and quickly, and AWS delivers the high performance we need to maintain our progress,” said Chris Urmson, CEO of Aurora. “With its virtually unlimited scale, AWS supports millions of virtual tests to validate the capabilities of the Aurora Driver so that it can safely navigate the countless edge cases of real-world driving.”

 

Aurora’s AWS-powered Virtual Testing Suite is a unique accelerator for the development of the Aurora Driver. Aurora can use data from just one testing situation it observes in the real world to inspire hundreds of permutations in the Virtual Testing Suite. That virtual testing helps train the Aurora Driver to more quickly and safely navigate complex situations, such as road construction, jaywalkers, and unprotected left-hand turns. For example, before the Aurora Driver ever attempted an unprotected left-hand turn on a physical road, it completed nearly 2.3 million turns in simulation—estimated to be roughly equal to 20,000 hours of real-world driving practice. Aurora has been running simulations at scale on AWS since 2019, and plans to triple the volume of simulations it runs on AWS to more than 12 million per day by the end of 2021.

 

The offline components of the Aurora Driver software stack all run on AWS, including the Virtual Testing Suite, high-definition road maps (the Aurora “Atlas”), machine learning models, and software development tools. For example, Aurora uses Amazon SageMaker (an AWS service that helps developers and data scientists build, train, and deploy machine learning models quickly) to create, run, and continuously refine the machine learning models that enable its driving simulations. With that service, Aurora accesses Amazon Elastic Compute Cloud (Amazon EC2) instance types like P4d, which deliver the highest performance for machine learning training in the cloud.

 

Before developing simulations, Aurora uses AWS to securely store and process the petabytes of data it logs during real-world testing, and then train its machine learning models on that data. The pre-processing workloads run on Amazon Elastic Kubernetes Service (Amazon EKS) and Amazon EMR, AWS’s service for processing vast amounts of data in the cloud using open-source tools. Aurora’s machine learning training workloads then rely on AWS-optimized deep learning frameworks, such as TensorFlow and PyTorch. Finally, Aurora orchestrates and auto-scales its simulation workflows over hundreds of thousands of concurrent vCPUs and thousands of concurrent GPUs with Amazon EKS and Amazon EC2, which provides accelerated computing instance types like G4dn.

 

“AWS’s highly scalable compute, machine learning, and analytics services are helping Aurora move self-driving vehicle technology forward, toward broad real-world use,” said Swami Sivasubramanian, Vice President of Machine Learning at Amazon Web Services, Inc. “Our reliable infrastructure and comprehensive set of cloud services, including industry-leading machine learning services like Amazon SageMaker, provide the ideal foundation for Aurora to gain insights from the trillions of data points it generates every day to continuously enhance its technology. We are proud to support the acceleration of autonomous vehicle innovation, and look forward to the improved safety and efficiency the transformation of trucking, delivery, and mobility will allow.”

 

About Amazon Web Services

 

For over 15 years, Amazon Web Services has been the world’s most comprehensive and broadly adopted cloud offering. AWS has been continually expanding its services to support virtually any cloud workload, and it now has more than 200 fully featured services for compute, storage, databases, networking, analytics, machine learning and artificial intelligence (AI), Internet of Things (IoT), mobile, security, hybrid, virtual and augmented reality (VR and AR), media, and application development, deployment, and management from 81 Availability Zones within 25 geographic regions, with announced plans for 27 more Availability Zones and nine more AWS Regions in Australia, Canada, India, Indonesia, Israel, New Zealand, Spain, Switzerland, and the United Arab Emirates. Millions of customers—including the fastest-growing startups, largest enterprises, and leading government agencies—trust AWS to power their infrastructure, become more agile, and lower costs. To learn more about AWS, visit aws.amazon.com.

 

About Amazon

 

Amazon is guided by four principles: customer obsession rather than competitor focus, passion for invention, commitment to operational excellence, and long-term thinking. Amazon strives to be Earth’s Most Customer-Centric Company, Earth’s Best Employer, and Earth’s Safest Place to Work. Customer reviews, 1-Click shopping, personalized recommendations, Prime, Fulfillment by Amazon, AWS, Kindle Direct Publishing, Kindle, Career Choice, Fire tablets, Fire TV, Amazon Echo, Alexa, Just Walk Out technology, Amazon Studios, and The Climate Pledge are some of the things pioneered by Amazon. For more information, visit amazon.com/about and follow @AmazonNews.

 

About Aurora

 

Founded in 2017 by experts in the self-driving industry, Aurora is on a mission to deliver the benefits of self-driving technology safely, quickly, and broadly. To move both people and goods, the company is building the Aurora Driver, a platform that brings together software, hardware and data services to autonomously operate passenger vehicles, light commercial vehicles, and heavy-duty trucks. Aurora is backed by Sequoia Capital, Baillie Gifford, funds and accounts advised by T. Rowe Price Associates, among others, and is partnered with industry leaders including Toyota, Uber, Volvo, and PACCAR. Aurora tests its vehicles in the Bay Area, Pittsburgh, and Dallas. The company has offices in those areas as well as in Bozeman, MT; Seattle, WA; Louisville, CO; and Wixom, MI. To learn more, visit www.aurora.tech.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211201005041/en/

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Press Release

Square, Inc. Changes Name to Block

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Square, Inc. Changes Name to Block

Business Wire India

Square, Inc. (NYSE: SQ) announced today that it is changing its name to Block. Block will be the name for the company as a corporate entity. The Square name has become synonymous with the company’s Seller business, which provides an integrated ecosystem of commerce solutions, business software, and banking services for sellers, and this move allows the Seller business to own the Square brand it was built for.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211201006139/en/

 

Block logo in white

The change to Block acknowledges the company’s growth. Since its start in 2009, the company has added Cash App, TIDAL, and TBD54566975 as businesses, and the name change creates room for further growth. Block is an overarching ecosystem of many businesses united by their purpose of economic empowerment, and serves many people—individuals, artists, fans, developers, and sellers.

 

“We built the Square brand for our Seller business, which is where it belongs,” said Jack Dorsey, cofounder and CEO of Block. “Block is a new name, but our purpose of economic empowerment remains the same. No matter how we grow or change, we will continue to build tools to help increase access to the economy.”

 

The name change to Block distinguishes the corporate entity from its businesses, or building blocks. There will be no organizational changes, and Square, Cash App, TIDAL, and TBD54566975 will continue to maintain their respective brands. A foundational workforce, which includes teams such as Counsel, People, and Finance, will continue to help guide the ecosystem at the corporate level. As a result of the name change, Square Crypto, a separate initiative of the company dedicated to advancing Bitcoin, will change its name to Spiral.

 

The name has many associated meanings for the company — building blocks, neighborhood blocks and their local businesses, communities coming together at block parties full of music, a blockchain, a section of code, and obstacles to overcome.

 

Square, Inc. is referred to as “Block” in this press release. The legal name “Square, Inc.” is expected to be legally changed to “Block, Inc.” on or about December 10, 2021, upon satisfying all applicable legal requirements. The company’s NYSE ticker symbol “SQ” will not change at this time. Any changes in the future will be publicly disclosed. No action is needed from current stockholders. The Company’s Class A common stock will continue to be listed on NYSE and the CUSIP will not be changing.

 

For more information, please visit www.block.xyz or follow company news via Twitter @blocks and @blockIR. For media assets, go to www.block.xyz/mediakit. We intend to use the Block investor relations website as well as the Twitter accounts @blocks and @blockIR as means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD.

 

About Block

 

Block (NYSE: SQ) is a global technology company with a focus on financial services. Made up of Square, Cash App, Spiral, TIDAL, and TBD54566975, we build tools to help more people access the economy. Square helps sellers run and grow their businesses with its integrated ecosystem of commerce solutions, business software, and banking services. With Cash App, anyone can easily send, spend, or invest their money in stocks or Bitcoin. Spiral (formerly Square Crypto) builds and funds free, open-source Bitcoin projects. Artists use TIDAL to help them succeed as entrepreneurs and connect more deeply with fans. TBD54566975 is building an open developer platform to make it easier to access Bitcoin and other blockchain technologies without having to go through an institution.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211201006139/en/

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Press Release

Bitdeer Black Friday Carnival 2021: Mine Bitcoin at Your Fingertips

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Bitdeer Black Friday Carnival 2021: Mine Bitcoin at Your Fingertips

Business Wire India

Bitdeer, the world’s leading digital assets mining and sharing service platform, commenced its Black Friday consumer campaign that will end on 26 December 2021. In partnership with Bitcoin Magazine, the leading and news site covering Bitcoin and other digital currencies, the Black Friday sale will offer global users with alluring deals. Bitdeer will also join hands with the Texas-based Built With Bitcoin Foundation which is a registered 501(c)3 non-profit organization that is committed to creating equal opportunity and the relief of poverty by providing clean water, access to education, sustainable farming, and humanitarian support, all of which are powered by Bitcoin and other blockchain technologies.

 

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20211201005613/en/

 

Bitdeer Black Friday Carnival 2021: Mine Bitcoin at Your Fingertips (Graphic: Business Wire)

Extending Bitdeer’s philosophy of ‘Customer Obsession’ – a customer-centric approach in its business developments – the Black Friday campaign is aimed giving back and rewarding the Bitdeer community and customers with deals and discounts, thanking them for their long-term support and trust in Bitdeer. At the same time, Bitdeer recognized that in the spirit of thanksgiving, it is a good time to also give back to communities in need.

 

Bitdeer as the Exclusive Crypto Mining Partner on BitcoinBlackFriday.com

 

Being the exclusive crypto mining sponsor to Bitcoin Magazine’s subsidiary BitcoinBlackFriday, Bitdeer is also introducing flash sale promotions that will offer a better deals for global miners and cryptocurrency enthusiasts who are keen to try out its top-notch Bitcoin mining model and service packages.

 

The promotion will encompass a wide range of service package offerings both on Bitdeer.com and the campaign website with up to 13% discounts. In addition, a shortest 5-day trial of the powerful Antminer S17 with total costs starting at $8.10 only. A variety of other discounted offers and plans are also available for fans to choose from.*

 

Celebrate with Purpose – Auction and Donation to Charity

 

Bitdeer is not only eyeing on the development of a more sustainable business and economic future, but also committed to the public welfare. Giving back to the society plays a critical part in Bitdeer’s philosophy.

 

As a result, part of the revenue generated during the Black Friday promotional sales will be allocated for charitable purposes, with 1% of the hashrate fees generated from the sharing service packages to be donated. Bitdeer will also be donating $1 for each 5-day trial sold during the promotional period.

 

In addition, a 3D-printed Bitdeer mining facility miniature will be available for auction at the campaign platform. A joyful display and a collector’s item for those who love Bitcoin or crypto mining, this 3D-printed model is made from resin and contains multiple ANTBOX units. It is designed and printed based on the structure and appearance of Bitdeer’s state of the art mining facilities in Norway. Fans and enthusiasts can start collecting and combining parts of various model series and finally recreate their own dream mining facility.*

 

All proceeds from the above mentioned activities will be donated to Built With Bitcoin Foundation in the form of cryptocurrency to support the foundation’s operations and projects in underdeveloped and poverty stricken regions and countries.

 

*Terms and conditions apply, for more details, please visit bitcoinblackfriday.com.

 

About Bitdeer

 

Bitdeer is the world’s leading digital assets mining and sharing service platform, enabling global users to mine cryptocurrencies in a transparent, reliable, and convenient way. It saves users from the complicated process of purchasing, installing, and hosting mining machines. Individual miners can enjoy the service with just one click.

 

For more information, please get in touch with Bitdeer:

 

Website: https://www.Bitdeer.com
Facebook: https://www.facebook.com/BitDeerplatform
Twitter: https://twitter.com/BitDeerOfficial

 

*Information provided in this article is for general information and reference only and does not constitute nor is intended to be construed as any advertisement, professional advice, offer, solicitation, or recommendation to deal in any product. No guarantee, representation, warranty or undertaking, express or implied, is made as to the fairness, accuracy, timeliness, completeness or correctness of any information, or the future returns, performance or outcome of any product. Bitdeer expressly excludes any and all liability (to the extent permitted by applicable law) in respect of the information provided in this article, and in no event shall Bitdeer be liable to any person for any losses incurred or damages suffered as a result of any reliance on any information in this article.

 

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20211201005613/en/

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