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Xevudy (Sotrovimab) Granted Marketing Authorization by the European Commission for the Early Treatment of COVID-19

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LONDON and SAN FRANCISCO, Dec. 17, 2021 (GLOBE NEWSWIRE) — GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the European Commission (EC) has granted marketing authorization to Xevudy (sotrovimab) for the early treatment of COVID-19. Sotrovimab is now approved in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

The grant of the marketing authorization in the EU is a result of the positive opinion issued on December 16 by the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).

In July 2021, GSK and Vir announced a Joint Procurement Agreement (JPA) with the EC to supply up to 220,000 doses of sotrovimab. Following the grant of the marketing authorization in the EU, Member States participating in the JPA can now order sotrovimab to support their pandemic responses.

Dr Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “Since the start of the pandemic we have seen an unprecedented effort by governments, academia and industry to find solutions to help as many people as quickly as possible. COVID-19 therapeutics are an important part of the solution. We have already been working to lay the foundation for more patients across Europe to access sotrovimab through the Joint Procurement Agreement with the European Commission. With today’s marketing authorization we are now able to expand access, and we are discussing with governments how we can bring sotrovimab to more patients.”

George Scangos, Ph.D., Chief Executive Officer of Vir, said: “The grant of the marketing authorization in the European Union for sotrovimab marks yet another important milestone in our efforts to combat COVID-19, as it allows us to expand access across multiple countries working to address this challenge. Given recent preclinical data from our own labs, as well as that of other independent labs, demonstrating that sotrovimab retains activity against the rapidly spreading Omicron variant and all other currently tested variants of concern and interest, we remain confident in the critical role of sotrovimab and look forward to further contributing to the fight against this pandemic.”

The grant of the marketing authorization in the EU is based on data from the COMET-ICE Phase 3 trial, demonstrating that intravenous treatment with sotrovimab resulted in a 79% reduction (adjusted relative risk reduction) (p<0.001) in all-cause hospitalizations for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. In absolute numbers, 30 (6%) of the 529 patients in the placebo arm progressed, compared to six (1%) of the 528 patients receiving sotrovimab. In clinical trials conducted to date, sotrovimab has been well-tolerated. The most common adverse reactions are hypersensitivity and infusion-related reactions, seen in approximately 2% and 1% of cases, respectively.

GSK and Vir are committed to the ongoing evaluation of sotrovimab as the COVID-19 landscape continues to evolve at different rates across the globe and new variants of concern and interest emerge. Updated in vitro data, published in bioRxiv, demonstrate that sotrovimab retains activity against all tested variants of concern and interest of the SARS-CoV-2 virus as defined by the World Health Organization, including, but not limited to, Omicron (B.1.1.529), Delta (B.1.617.2), Delta Plus (AY.1 or AY.2) and Mu (B.1.621).

About Xevudy (Sotrovimab)
Xevudy (sotrovimab) is an investigational SARS-CoV-2 neutralizing monoclonal antibody. The antibody binds to an epitope on SARS-CoV-2 shared with SARS-CoV-1 (the virus that causes SARS), indicating that the epitope is highly conserved, which may make it more difficult for resistance to develop. Sotrovimab, which incorporates Xencor, Inc.’s Xtend™ technology, has also been designed to achieve high concentration in the lungs to ensure optimal penetration into airway tissues affected by SARS-CoV-2 and to have an extended half-life.

About Global Access to Sotrovimab

Sotrovimab is authorized for emergency use in the US. Xevudy (sotrovimab) has been granted a Marketing Authorization in the EU, conditional marketing authorization in Great Britain, provisional marketing authorization in Australia, and conditional marketing authorization in Saudi Arabia. It has also been approved via Japan’s Special Approval for Emergency Pathway. Temporary authorizations for sotrovimab have been granted in 12 other countries.

Sotrovimab is supplied in several countries worldwide, including through national agreements in the US, UK, Japan, Australia, Canada, Singapore, Switzerland and the United Arab Emirates. The companies have also announced a JPA with the EC to supply doses of sotrovimab to participating Member States of the EU. Additional agreements are yet to be disclosed due to confidentiality or regulatory requirements.

Important Information About Sotrovimab in the European Union

For more information on the marketing authorization in the European Union, please review the Summary of Product Characteristics (SmPC). Healthcare professionals should look out for side effects and take appropriate action.

Reporting of Suspected Adverse Reactions

Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Warnings and Precautions

Hypersensitivity Reactions including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, have been reported with administration of sotrovimab (see section 4.8 of the SmPC). If signs or symptoms of a clinically significant hypersensitivity reaction or anaphylaxis occur, administration should be discontinued immediately and appropriate medications and/or supportive care should be given.

Infusion-Related Reactions

Infusion-related reactions (IRRs) have been observed with intravenous administration of monoclonal antibodies (see section 4.8 of the SmPC). These reactions may be severe or life-threatening. If an IRR occurs, the infusion may be interrupted, slowed or stopped.

Adverse Reactions

The most common adverse reactions were hypersensitivity reactions (2%) and infusion-related reactions (1%). The most serious adverse reaction was anaphylaxis (0.05%).

Pregnancy

There are no data from the use of sotrovimab in pregnant women. Animal studies have not been evaluated with respect to reproductive toxicity. In a cross-reactive binding assay using a protein array enriched for human embryofetal proteins, no off-target binding was detected. Since sotrovimab is a human immunoglobulin G (IgG), it has the potential for placental transfer from the mother to the developing fetus. The potential treatment benefit or risk of placental transfer of sotrovimab to the developing fetus is not known.  Sotrovimab should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the fetus.

Lactation

It is not known whether sotrovimab is excreted in human milk or absorbed systemically after ingestion. Administration of sotrovimab while breast-feeding can be considered when clinically indicated.

Sotrovimab in the United States

The following is a summary of information for sotrovimab. Healthcare providers in the US should review the Fact Sheets for information about the authorized use of sotrovimab and mandatory requirements of the Emergency Use Authorization (EUA). Sotrovimab has been authorized by the US FDA for the emergency use described below. Sotrovimab is not FDA-approved for this use.

Sotrovimab is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of sotrovimab under section 564(b)(1) of the Act, 21 USC § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Authorized Use

The US FDA has issued an EUA to permit the emergency use of the unapproved product sotrovimab for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death.

Limitations of Authorized Use

Sotrovimab is not authorized for use in patients:

  • who are hospitalized due to COVID-19, OR
  • who require oxygen therapy due to COVID-19, OR
  • who require an increase in baseline oxygen flow rate due to COVID-19 (in those on chronic oxygen therapy due to underlying non-COVID-19 related comorbidity)

Benefit of treatment with sotrovimab has not been observed in patients hospitalized due to COVID19. SARS-CoV-2 monoclonal antibodies may be associated with worse clinical outcomes when administered to hospitalized patients with COVID19 requiring high flow oxygen or mechanical ventilation.

Please see the Food and Drug Administration (FDA) Letter of Authorization, full Fact Sheet for Healthcare Providers and full Fact Sheet for Patients, Parents, and Caregivers.

About the GSK and Vir Collaboration

In April 2020, GSK and Vir entered into a collaboration to research and develop solutions for coronaviruses, including SARS-CoV-2, the virus that causes COVID-19. The collaboration uses Vir’s proprietary monoclonal antibody platform technology to accelerate existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options to help address the current COVID-19 pandemic and future outbreaks. The companies will leverage GSK’s expertise in functional genomics and combine their capabilities in CRISPR screening and artificial intelligence to identify anti-coronavirus compounds that target cellular host genes. They will also apply their combined expertise to research SARS-CoV-2 and other coronavirus vaccines.

GSK Commitment to Tackling COVID-19

GSK’s response to COVID-19 has been one of the broadest in the industry, with potential treatments in addition to the Company’s vaccine candidates in development with partner organizations.

GSK is collaborating with several organizations on COVID-19 vaccines by providing access to its adjuvant technology. The Company is working with Sanofi SA, Medicago Inc. and SK bioscience Co., Ltd. to develop adjuvanted, protein-based vaccine candidates, and all are now in Phase 3 clinical trials. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protecting more people in need.

GSK is also working with mRNA specialist CureVac NV to jointly develop next-generation, optimized mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine.

GSK is also exploring treatments for COVID-19 patients, collaborating with Vir Biotechnology to investigate monoclonal antibodies that could be used as therapeutic or preventive options for COVID-19.

Vir’s Commitment to COVID-19

Vir was founded with the mission of addressing the world’s most serious infectious diseases. In 2020, Vir responded rapidly to the COVID-19 pandemic by leveraging our unique scientific insights and industry-leading antibody platform to explore multiple monoclonal antibodies as potential therapeutic or preventive options for COVID-19. Sotrovimab is the first SARS-CoV-2-targeting antibody Vir advanced into the clinic. It was carefully selected for its demonstrated promise in preclinical research, including an anticipated high barrier to resistance and potential ability to both block the virus from entering healthy cells and clear infected cells. Vir is continuing to pursue novel therapeutic and prophylactic solutions to combat SARS-CoV-2 and future coronavirus pandemics, both independently and in collaboration with its partners.

About GSK

GSK is a science-led global healthcare company. For further information please visit www.gsk.com/aboutus.

About Vir Biotechnology

Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. Its current development pipeline consists of product candidates targeting COVID-19, hepatitis B virus, influenza A and human immunodeficiency virus. For more information, please visit www.vir.bio.

GSK Cautionary Statement Regarding Forward-Looking Statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the Company’s Annual Report on Form 20-F for 2020, GSK’s 2021 Q3 Results and any impacts of the COVID-19 pandemic.

Vir Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding the ability of sotrovimab to treat and/or prevent COVID-19 either through IV or IM administration, Vir’s collaboration with GSK, plans to progress regulatory submissions globally, including with the FDA regarding the existing EUA for sotrovimab, planned discussions with other global regulatory agencies, the timing of availability of clinical data, program updates and data disclosures, the clinical development program for sotrovimab, and the ability of sotrovimab to maintain activity against circulating variants of concern and interest, including Omicron. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, challenges in the treatment of hospitalized patients, difficulties in collaborating with other companies or government agencies, challenges in accessing manufacturing capacity, successful development and/or commercialization of alternative product candidates by Vir’s competitors, changes in expected or existing competition, delays in or disruptions to Vir’s business or clinical trials due to the COVID-19 pandemic, geopolitical changes or other external factors, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

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TW8 9GS

GSK inquiries:

 

     
Media Inquiries: Tim Foley +44 (0) 20 8047 5502 (London)
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Automotive Digital Cockpit Domain Controller Power Expected to Double by 2030

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NEW YORK, March 28, 2024 /PRNewswire/ — The lengthening lifecycle of vehicles is driving automotive Original Equipment Manufacturers (OEMs) to plan several years of customer support through regular Over-the-Air (OTA) updates. Achieving this requires a digital Cockpit Domain Controller (CDC) with an architecture that supports long-term updating and maintenance. According to a new report from global technology intelligence firm ABI Research, the computing power of the CDC will increase significantly over the next few years, with graphical computing power and deep-learning processing power (for AI-powered functions) expected to double by 2030 for an average mid-market CDC.

OEMs are beginning to plan for several years of support, both in software patches and bug fixes, and for delivering new added value features to the driving experience. “This support and feature roadmap requires a hardware and software architecture that supports the continuous updating of vehicles over time. OEMs need a system that accommodates quick, targeted updates by shipping vehicles with planned overhead in computing power, software containerization, and robust hypervisors. These can be accommodated by silicon vendors such as NVIDIA or Qualcomm with their suite of high-powered System-on-Chips (SoCs), along with hypervisor and software specialists such as Blackberry QNX. The ecosystem hasn’t fully adjusted to OTA updates in mixed-criticality systems like the digital cockpit domain controller yet, with most OEMs speculating about the level of computing power that is needed for several years of support and few going to their silicon and tier-one partners with roadmaps of planned features,” explains Abu Miah, Smart Mobility and Automotive Analyst at ABI Research.
The computing power of the CDC will increase significantly over time. The Tera Floating-Point Operations per Second (TFLOPS) of an average mid-market CDC is expected to rise from 1 TFLOPS in 2023 to 2.5 TFLOPS by 2030. Miah adds, “One of the primary drivers of this increase is the implementation of a larger number of higher resolution screens in the vehicle to accommodate new high-end gaming and video-on-demand features.”
Building a ‘future-proofed’ CDC is not as simple as throwing compute power at the vehicle. “OEMs, tier ones, and silicon vendors must all work toward an ecosystem of hardware and software agnosticism, modular architecture, and collaborative software development if they are to match customers’ expectations of updates, patches, and bug fixes from the consumer electronics space,” Miah concludes.
These findings are from ABI Research’s Future-Proofing Digital Cockpit Domain Controllers application analysis report. This report is part of the company’s Smart Mobility and Automotive research service, which includes research, data, and ABI Insights. Based on extensive primary interviews, Application Analysis reports present an in-depth analysis of key market trends and factors for a specific technology.
About ABI Research
ABI Research is a global technology intelligence firm uniquely positioned at the intersection of technology solution providers and end-market companies. We serve as the bridge that seamlessly connects these two segments by providing exclusive research and expert guidance to drive successful technology implementations and deliver strategies proven to attract and retain customers.
ABI Research是一家全球性的技术情报公司,拥有得天独厚的优势,充当终端市场公司和技术解决方案提供商之间的桥梁,通过提供独家研究和专业性指导,推动成功的技术实施和提供经证明可吸引和留住客户的战略,无缝连接这两大主体。
For more information about ABI Research’s services, contact us at +1.516.624.2500 in the Americas, +44.203.326.0140 in Europe, +65.6592.0290 in Asia-Pacific, or visit www.abiresearch.com.
Contact Info: 
GlobalDeborah Petrara Tel: +1.516.624.2558 [email protected] 
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ACL Digital in Collaboration with AWS and Infineon to Participate at Embedded World 2024

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SAN JOSE, Calif., March 28, 2024  /PRNewswire/ — ACL Digital, an ALTEN group company, is a pioneer in design-led digital experience, innovation, enterprise IT modernization, and product engineering services, announced that ACL Digital, in collaboration with AWS and Infineon, is going to showcase its AWS IoT & Cloud capabilities at Embedded World 2024, Hall 4 (Booth #4-552) from April 9 to April 11 in Nuremberg, Germany.

ACL Digital, a top-tier AWS Services partner, propels organizations of all sizes to navigate digital transformation to accelerate time-to-market. The company provides comprehensive support, from adopting to modernizing IT infrastructure on AWS. By leveraging expertise in architecture, security, migration, and operations, ACL Digital unlocks the full potential of AWS, streamlining IoT and cloud journeys and fast-tracking business growth and innovation.
The AWS Advanced Tier partnership enables ACL Digital to leverage AWS expertise, its robust support ecosystem and best practices to deliver customer delight.
ACL Digital offers visitors at Embedded World 2024 a chance to experience the exclusive demo of a Smart Stove Solution, built by leveraging the AWS Cloud and Infineon platform and how it has added value to our customers.
With over 100 AWS-certified experts, ACL Digital empowers clients to achieve breakthrough results in their digital transformation. Also, the leading digital transformation company supports global clients in navigating the complexities of cloud implementation, migration and digital transformation with ease and helping them unlock new growth opportunities.
About AWS
Since 2006, Amazon Web Services has been the world’s most comprehensive and broadly adopted cloud. AWS has been continually expanding its services to support virtually any workload, and it now has more than 240 fully featured services for compute, storage, databases, networking, analytics, machine learning and artificial intelligence (AI), Internet of Things (IoT), mobile, security, hybrid, media, and application development, deployment, and management from 105 Availability Zones within 33 geographic regions, with announced plans for 12 more Availability Zones and four more AWS Regions in Malaysia, New Zealand, Thailand, and the AWS European Sovereign Cloud. 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 https://aws.amazon.com .
About Infineon
Infineon Technologies AG is a global semiconductor leader in power systems and IoT. Infineon drives decarbonization and digitalization with its products and solutions. The company has around 58,600 employees worldwide and generated revenue of about €16.3 billion in the 2023 fiscal year (ending 30 September). Infineon is listed on the Frankfurt Stock Exchange (ticker symbol: IFX) and in the USA on the OTCQX International over-the-counter market (ticker symbol: IFNNY). To learn more about Infineon, visit https://www.infineon.com/
About ACL Digital
ACL Digital an ALTEN Group Company, is a digital product innovation and engineering leader. We help our clients design and build innovative products (AI, Cloud, and Mobile ready), content and commerce-driven platforms, and connected, converged digital experiences for the modern world through a design-led Digital Transformation framework.
Headquartered in Silicon Valley, ACL Digital is a leader in design-led digital experience, innovation, enterprise modernization, and product engineering services converging to Technology, Media & Telecom. The company has a workforce of 57,000+ spread across more than 30+ countries.

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Gilbarco Veeder-Root champions fuel efficiency, clean fuels and diesel rebate solutions in mining

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JOHANNESBURG, March 28, 2024 /PRNewswire/ — Global leader in technology solutions OEM Gilbarco Veeder-Root (GVR) is dedicated to enhancing operational performance by delivering comprehensive end-to-end wetstock, industrial, mining, and business-to-business solutions, all tailored to meet the specific needs of the customer.

 
 
By encompassing every aspect of mining operations, GVR commercial and industrial Middle East and Africa director Westtar Kapito says, “the company is setting new benchmarks for fuel efficiency, safety and sustainability within the mining industry”.
As part of a holistic approach to mining excellence, Kapito explains that Gilbarco’s integrated fuel and fleet management technology solutions are designed to address the multifaceted challenges of the mining industry.
Some of these facets include wetstock control, equipment maintenance and management, fleet management and automation, compliance monitoring and environmental sustainability, as well as driving productivity and profitability through innovation.
In addition, the introduction of Gilbarco’s clean fuel solution exemplifies the company’s commitment to maintaining equipment integrity and performance.
This technology, GVR says, monitors in real-time the status of up to 16 “clean fuels” key performance matrices, thereby ensuring that dirty fuel is flagged and not transferred into mining equipment which would affect engines and injectors and thus lower productivity.
Gilbarco’s comprehensive site automation solutions empower mining companies with critical data analytic insights, facilitating efficient monitoring and management of fleet and fuel inventory. Gilbarco’s dataFLEX360 platform plays a pivotal role, offering near real-time reporting and analytics to drive informed decision-making and operational agility.
dataFLEX360 is a Web-based, cloud-hosted strategic operational insights platform. The system ensures accurate, reliable and relevant reporting of all fuel, fleet and asset transactions, and provides for proactive corrective measures to reduce complex reporting and gives a consolidated and comprehensive view across all sites and assets.
With reconciliations at its core, dataFLEX360 provides solution accuracy on operational data.
Integral to the company’s solutions is compliance with Global Industry Standards and environmental stewardship, from leak detection to vapour recovery and clean fuel technologies. Gilbarco’s products are designed to ensure compliance and minimise the carbon footprint of mining operations.
Additionally, through the company’s innovative telematics technology and the data generated, it can systematically and seamlessly generate South African Revenue Services- (SARS-) compliant fuel rebate reports for any selected tax period.  
GVR’s technology provides a full audit trail required for eligibility for SARS rebates, and its reporting platform simplifies logbook and data gathering required, enabling successful rebate claims and return on investment.
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