STOCKHOLM, Oct. 19, 2023 /PRNewswire/ — Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) (“Calliditas”), today announced seven abstract presentations, including a late-breaking poster presentation, highlighting additional analyses of the Phase 3 NefIgArd study at the upcoming American Society of Nephrology (ASN) Kidney Week 2023 in Philadelphia, PA, November 1-5, 2023.
Investigators will be presenting additional analyses of the Phase 3 NefIgArd study’s 2-year data with Nefecon (TARPEYO® (budesonide) delayed-release capsules/Kinpeygo®) for the treatment of Primary IgA nephropathy (IgAN). Presentations will highlight the statistically significant and clinically meaningful treatment benefit of Nefecon, including an oral presentation on the preservation of eGFR in patients with IgAN treated with Nefecon, as well as the Company’s late-breaking poster presentation that will showcase the long-term renal benefit with Nefecon in Chinese patients with primary IgAN. Additionally, pre-clinical data on the treatment of Alport syndrome with setanaxib will be presented following the Company’s recent orphan drug designations granted in the US and receiving a favourable opinion regarding orphan drug classification in Europe.
“We take great pride in the robust clinical evidence we have gathered and look forward to presenting additional findings at ASN from our Phase 3 NefIgArd trial that further establish the beneficial effect of Nefecon on eGFR,” said Richard Philipson, Chief Medical Officer at Calliditas. “These analyses, in addition to a presentation highlighting our new clinical program in the renal space targeting Alport syndrome, reinforce our dedication to expanding treatment options and establishing novel standards of care in rare kidney diseases.”
Poster presentation details are below and will be available on the Presentation and Publication page on the Calliditas’ corporate website following the meeting.
Oral Presentation Details:
Title: eGFR decline in patients with IgAN treated with Nefecon or placebo: Results from the 2-year NefIgArd Phase 3 trialPresenter: Richard Lafayette, M.D., F.A.C.P., Stanford HealthcareDate and Time: Thursday, November 2, 5:15 p.m. – 5:24 p.m. ETSession: Glomerular Diseases: Clinical and Translational Studies [OR1402]Presentation No.: TH-OR26 (Abstract 3938831)Presentation Venue: Room 103 (Pennsylvania Convention Center)
Late-Breaking Poster Presentation Details:
Title: Long-term renal benefit with Nefecon in Chinese patients with primary immunoglobulin A nephropathy: 2-year NefIgArd trial resultsPresenter: Hong ZhangDate and Time: Thursday, November 2, 10:00 a.m. – 12:00 p.m. ETSession: Late-Breaking Posters [LB-PO] Presentation No.: TH-PO1123 (Abstract 3969868)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Poster Presentation Details:
Title: The NOX inhibitor setanaxib combined with ramipril reduces glomerular function decline and fibrosis in a mouse model of Alport syndromePresenter: Thierry ChristopheDate and Time: Thursday, November 2, 10:00 a.m. – 12:00 p.m. ETSession: Genetic Diseases: Glomerulopathies – I [PO1202-1]Presentation No.: TH-PO481 (Abstract 3940209)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: Analysis of the NefIgArd Part A study confirms Nefecon modulated proteins involved in the intestinal immune network for IgA productionPresenter: Roisin ThomasDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO893 (Abstract 3941804)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: Analysis of the NefIgArd Part A study population confirms Nefecon reduces levels of dietary antigen-specific IgA in patients with IgA nephropathyPresenter: Victoria CottonDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO892 (Abstract 3941892)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: Modeling based on NefIgArd 2-year eGFR total slope predicts long-term clinical benefit of Nefecon in a real-world IgAN populationPresenter: Jonathan Barratt, M.B.Ch.B., Ph.D., University of LeicesterDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO886 (Abstract 3943328)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
Title: TRF-budesonide (Nefecon) reduces serum biomarkers of lymphocyte activation in IgA nephropathy, which correlate with changes in serum BAFF levelsPresenter: Nadia Nawaz, University of LeicesterDate and Time: Saturday, November 4, 10:00 a.m. – 12:00 p.m. ETSession: Glomerular Diseases: Therapeutics [PO1402-1]Presentation No.: SA-PO890 (Abstract 3941858)Presentation Venue: Exhibit Halls B-D (Pennsylvania Convention Center)
For more information, visit the American Society of Nephrology (ASN) website here.
TARPEYO® (budesonide) delayed release capsules is a corticosteroid indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g.
This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory clinical trial.
Important Safety Information
Contraindications: TARPEYO is contraindicated in patients with hypersensitivity to budesonide or any of the ingredients of TARPEYO. Serious hypersensitivity reactions, including anaphylaxis, have occurred with other budesonide formulations.
Warnings and Precautions
Hypercorticism and adrenal axis suppression: When corticosteroids are used chronically, systemic effects such as hypercorticism and adrenal suppression may occur. Corticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In situations where patients are subject to surgery or other stress situations, supplementation with a systemic corticosteroid is recommended. When discontinuing therapy [see Dosing and Administration] or switching between corticosteroids, monitor for signs of adrenal axis suppression.
Patients with moderate to severe hepatic impairment (Child-Pugh Class B and C, respectively) could be at an increased risk of hypercorticism and adrenal axis suppression due to an increased systemic exposure to oral budesonide. Avoid use in patients with severe hepatic impairment (Child-Pugh Class C). Monitor for increased signs and/or symptoms of hypercorticism in patients with moderate hepatic impairment (Child-Pugh Class B).
Risks of immunosuppression: Patients who are on drugs that suppress the immune system are more susceptible to infection than healthy individuals. Chicken pox and measles, for example, can have a more serious or even fatal course in susceptible patients or patients on immunosuppressive doses of corticosteroids. Avoid corticosteroid therapy in patients with active or quiescent tuberculosis infection; untreated fungal, bacterial, systemic viral, or parasitic infections; or ocular herpes simplex. Avoid exposure to active, easily transmitted infections (eg., chicken pox, measles). Corticosteroid therapy may decrease the immune response to some vaccines.
Other corticosteroid effects: TARPEYO is a systemically available corticosteroid and is expected to cause related adverse reactions. Monitor patients with hypertension, prediabetes, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, cataracts, a family history of diabetes or glaucoma, or with any other condition in which corticosteroids may have unwanted effects.
Adverse reactions: In clinical studies, the most common adverse reactions with TARPEYO (occurring in ≥5% of TARPEYO patients and ≥2% higher than placebo) were hypertension (16%), peripheral edema (14%), muscle spasms (13%), acne (11%), dermatitis (7%), weight increase (7%), dyspnea (6%), face edema (6%), dyspepsia (5%), fatigue (5%), and hirsutism (5%).
Drug interactions: Budesonide is a substrate for CYP3A4. Avoid use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, and cyclosporine. Avoid ingestion of grapefruit juice with TARPEYO. Intake of grapefruit juice, which inhibits CYP3A4 activity, can increase the systemic exposure to budesonide.
Use in specific populations
Pregnancy: The available data from published case series, epidemiological studies, and reviews with oral budesonide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with IgAN. Infants exposed to in utero corticosteroids, including budesonide, are at risk for hypoadrenalism.
Please see Full Prescribing Information.
Calliditas has introduced TARPEYO, the first FDA-approved therapy for the treatment of the autoimmune renal disease primary IgA Nephropathy, or IgAN, to reduce proteinuria in adults with primary IgAN who are at risk of rapid disease progression, generally a UPCR≥1.5g/g. This indication is approved under accelerated approval based on a reduction in proteinuria. It has not been established whether TARPEYO slows kidney function decline in patients with IgAN. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory clinical trial.
TARPEYO is an oral, delayed release formulation of budesonide, a corticosteroid with potent glucocorticoid activity and weak mineralocorticoid activity that undergoes substantial first pass metabolism. TARPEYO is as a 4 mg delayed release capsule and is enteric coated and designed to remain intact until it reaches the ileum. Each capsule contains coated beads of budesonide that target mucosal B-cells present in the ileum, including the Peyer’s patches, which are responsible for the production of galactose-deficient IgA1 antibodies (Gd-Ag1) causing IgA nephropathy. It is unclear to what extent TARPEYO’s efficacy is mediated via local effects in the ileum vs systemic effects.
About the NeflgArd Study
The global clinical trial NefIgArd is a Phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN (N=364), as an addition to optimized RAS inhibitor therapy. Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period. The primary endpoint was UPCR, and eGFR was a secondary endpoint. Part B included a 12-month observational period off drug and assessed eGFR over the entire 2-year period for patients who were treated with the TARPEYO or placebo regimen in Part A. The full NefIgArd trial met its primary endpoint. Topline data from the full NefIgArd study were reported on March 12, 2023.
About Primary Immunoglobulin A Nephropathy
Primary immunoglobulin A nephropathy (IgA nephropathy or IgAN or Berger’s Disease) is a rare, progressive, chronic autoimmune disease that attacks the kidneys and occurs when galactose-deficient IgA1 is recognized by autoantibodies, creating IgA1 immune complexes that become deposited in the glomerular mesangium of the kidney.2,3 This deposition in the kidney can lead to progressive kidney damage and potentially a clinical course resulting in end- stage renal disease. IgAN most often develops between late teens and late 30s.3,4
1 TARPEYO® (budesonide) [prescribing information]. Stockholm, SE: Calliditas Therapeutics AB; 20212 Barratt, J., & Feehally, J. (2005). IgA nephropathy. J Am Soc Nephrol, 16(7), 2088-2097. https://doi.org/10.1681/ASN.20050201343 Barratt, J., Rovin, B. H., Cattran, D., et al. (2020). Why Target the Gut to Treat IgA Nephropathy? Kidney Int Rep, 5(10), 1620-1624. https://doi.org/10.1016/j.ekir.2020.08.0094 Jarrick, S., Lundberg, S., Welander, A., et al. (2019). Mortality in IgA Nephropathy: A Nationwide Population-Based Cohort Study. J Am Soc Nephrol, 30(5), 866-876. https://doi.org/10.1681/ASN.2018101017
For further information, please contact:
Åsa Hillsten, Head of IR, CalliditasTel.: +46 76 403 35 43, E-Mail: [email protected]
The information was sent for publication, through the agency of the contact persons set out above, on October 19 at 8.00 a.m. CET.
The following files are available for download:
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Zetrix and Beitou Launch Digital ID & Driver’s Licence Services on Blockchain
Service is the first global W3C-compliant Verifiable Credential implementation and will be initially used by China domestic users travelling abroad
KUALA LUMPUR, Malaysia, Dec. 10, 2023 /PRNewswire/ — Zetrix, a layer 1 public blockchain platform, today announced the launch of its groundbreaking Digital Credentials platform, ushering in a new era of secure, convenient, and interoperable credentials verification. This innovative solution addresses the challenges of traditional paper-based credentials, offering a range of benefits that will transform the way individuals, organisations, and governments interact in the digital realm.
The launch marks the commercialisation of the collaboration announced on 18th September 2023 between Malaysia’s MY E.G. Services Berhad and China’s state-owned Guangxi Beitou IT Innovation Technology Investment Group Co Ltd (“Beitou”), the IT arm of Guangxi Beibu Gulf Investment Group listed as one of China’s Top 500 enterprises.
The launch was held on 9th December 2023 at Ritz-Carlton Hotel Kuala Lumpur and officiated by Malaysia’s Deputy Prime Minister, Datuk Seri Dr Ahmad Zahid Hamidi.
The service initially will be offered to domestic China nationals who can choose to digitise their National ID or driving licence as a Verifiable Credential (“VC”) on Xinghuo International, the international gateway for China’s national Public Blockchain. Through Zetrix, which is integrated with Xinghuo, the National ID or driving licence VC can then be presented abroad to be authenticated by any verifier wishing to verify the relevant identity or driving licence data according to their needs.
Beitou IT’s integration to China’s nationwide police and transport department databases ensures seamless authentication and digitisation of the documents into VCs.
Furthermore, in view of the immutability of blockchain, verifiers will have the assurance of knowing that the VCs and all data contained in the document are true and genuine.
It is foreseen that besides IDs and driving licences, other important credential documents held by individuals or businesses would also be digitised as VCs in the near future.
Enhancing Security and Combating Breach of Data
The use of digital credentials, with the initial pilot of driving licences based on blockchain technology will significantly enhance security and combat counterfeiting of electronic licences. By leveraging on the Self Sovereign Identity (“SSI”) framework, Zetrix’s Digital Credentials platform enables the real time verification of documents digitised as Verifiable Credentials, providing a robust defence against fraud and forgery.
“In addition to ensuring authenticity, documents digitised as Verifiable Credentials offer the ability for selective disclosure or confirmation of data. For instance, document holders can have their age or their home location verified without actually having to provide their date of birth or full address. This is extremely useful as it protects raw user data from being shared unless absolutely necessary, thus reducing the possibilities of cyber attacks,” explained TS Wong, founder of Zetrix.
Lai Shuiping, Chairman of the Board of Guangxi Beitou IT Innovation Investment Group Co.,Ltd, Lai Shuiping, said: “The China-ASEAN digital driving license cross-border verification platform is jointly developed by Beitou IT and MYEG. The platform will continue to expand into providing more convenient services for communication between citizens of China and ASEAN countries, and promote economic development across the entire region.”
“In future, Beitou IT will further strengthen cooperation with Malaysian enterprises in the field of transportation digitalisation, and promote continuous improvement of intelligent transportation in ASEAN countries,” Lai added.
Multi-Chain e-Wallet for International Travelers
Zetrix’s Digital Credentials platform also leverages a multi-chain e-wallet that is able to store Zetrix’s native tokens as well as VCs from Xinghuo International and Ethereum. This feature facilitates seamless cross chain transactions and simplifies identity and document verification across multiple scenarios, enhancing the experience for travelling individuals.
The digital credentials service exemplifies the World Wide Web Consortium (W3C) standards of Verifiable Credentials and Decentralised Identifiers as Self-Sovereign Identity. This will be a key catalyst to enable a greater interoperability across blockchains and decentralised applications.
Zetrix is a layer-1 public blockchain that facilitates smart contracts and delivers privacy, security and scalability. Zetrix’s cryptographic infrastructure can be introduced to multiple industries to connect governments, businesses and their citizens to a global blockchain-based economy. Developed by MY E.G. Services Bhd, the cross-border and cross-chain integration with China enables Zetrix to serve as a blockchain gateway that facilitates global trade by deploying critical building blocks for Web3 services such as Blockchain-based Identifiers (BID) and Verifiable Credentials (VC).
About Guangxi Beitou IT Innovation Technology Investment Group Co Ltd
Guangxi Beitou IT Innovation Investment Group Co. (Beitou IT) stands as a wholly owned subsidiary of Beibu Gulf Investment Group (Beitou Group), boasting total assets exceeding 300 billion RMB. Established in October 2020 with a registered capital of 1 billion RMB, Beitou IT has emerged as the foremost digital company in Southwest China. Beitou IT strategically concentrates on four primary business domains: ITAI project implementation and operation, IT product R&D, integration and sales, and the development of New Infrastructure. Over the past three years, Beitou IT has successfully undertaken numerous government and enterprise-level projects encompassing digital government, digital transportation, digital port, smart court, and enterprise digitalization.
With a workforce exceeding 400 employees, Beitou IT houses a team of hardware and software engineers, where over 50% hold master’s degrees from esteemed universities. The team includes 2 State Council-subsidized experts, numerous district industrial authorized experts, and a Fin-Tech expert from the ‘Hong Kong, Macao, and Taiwan Talent Project.’ This robust talent pool positions Beitou IT as one of the rare state-owned digital companies capable of independent R&D.
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Sustainability Empowerment, Brand Upgrade VIVOTEK among Taiwan’s Best Global Brands
TAIPEI, Dec. 10, 2023 /PRNewswire/ — VIVOTEK (3454TW), the global leading IP surveillance solution provider, has been selected to the Best Taiwan Global Brands, and consistently earned market recognition. The three development engines of operational excellence, comprehensive brand management, and active promotion of sustainable actions, have elevated the brand above competition to display outstanding brand value.
Best Taiwan Global Brands is organized by the Industrial Development Bureau, MOEA, and valuation is carried out by Interbrand, a global authority on brand valuation; this year, ESG was also included as key standards of valuation. In 2022, VIVOTEK set a record high in revenue with annual consolidated revenue reaching USD $332 million, achieving a growth rate of 82% compared to the same period in 2021. In addition to displaying operational strengths, VIVOTEK also advocated several sustainable actions, while also encouraging its employees to practice environmental protection both at work and in daily life, further earning the approval of the organizer.
“Being selected to Taiwan’s Best Global Brands is a recognition of the company’s strengths,” pointed out Allen Hsieh, VIVOTEK Spokesperson and Director of Global Marketing Division. “Brand power is not just manifested through the technical aspect of products, but also through the CSR aspect. By embedding ESG into our brand’s DNA, we not only adopt sustainable thinking, but also create a differentiated brand image. In the future, VIVOTEK will continue to empower our brand through ESG, while also constantly promoting smart and green innovations of security and protection technology, steering the brand towards greater value of sustainable development.”
Evolution of the brand is the firm starting point of VIVOTEK’s brand management. Through redefining identity and slogan, “We Get The Picture,” VIVOTEK breaks the limitations of the industry to redefine its brand value, establishing its unique status within the security and protection industry. By grasping the opportunity of technical innovation, VIVOTEK combines its hardware advantage and software capability to expand its deployment of security and protection solutions, becoming a leading solution provider, while also actively exploring the market of AI security and protection, such as: successfully launching innovative VORTEX smart cloud surveillance service that focuses on customer needs and accumulating many successful cases around the world. Recently, VIVOTEK was ranked number 12 among a&s Security 50, reaching the highest spot ever, and this is the very manifestation of the brand’s continued improvement of brand competitiveness.
VIVOTEK is a leading surveillance brand that strives for sustainability and began deploying ESG strategy many years ago. Key measures include voluntary publication of sustainability report for six consecutive years, participation in the RE100 global corporate renewable energy initiative, and promotion of renewable energy applications. More recently, VIVOTEK has incorporated the principle of sustainability into its product box design, reutilizing packaging of its products to create eco-friendly smartphone holders. This marks the first time the brand’s innovative sustainability principle has been extended through its products. VIVOTEK also plans to launch a product carbon footprint project in 2024 to facilitate formulation of comprehensive carbon reduction strategy, further strengthening brand development and upgrading sustainable operations.
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Belgian Commitment to Partnership Supports a New Frontier of Europe-US Space Research
BRUSSELS, Dec. 10, 2023 /PRNewswire/ — Belgian Prime Minister Alexander De Croo has travelled to Houston, United States, to meet Raphaël Liégeois, the Belgian career astronaut selected as part of the European Space Agency (ESA) astronaut class of 2022. De Croo’s visit coincides with the ESA cohort’s familiarisation trip to NASA’s Johnson Space Centre, which is the precursor to a further two years of training, delivered in Houston, to prepare the astronauts for their respective missions on the International Space Station. The visit signals a new phase of the long-standing collaboration between Europe and the United States on space research and exemplifies Belgium’s commitment to partnerships in facing global challenges.
Belgium’s expertise in aerospace, and in science more generally, is internationally recognised – in terms of both training and industry. Belgium is a founding member of the ESA and its fifth-largest funder. The country’s support of the ESA shows its commitment to shaping the development of Europe’s space capability and ensuring that investment in space continues to deliver benefits to the citizens of Europe and the world.
“For Belgians, the sky isn’t the limit, the universe is,” said De Croo. “Today, we are very proud to see Raphaël take this important step in his career as an astronaut. He will be an important role model for many generations of STEM students to come. Space research and innovation hold particular importance for Belgium; they are powerful economic drivers which foster the growth of high-tech industries and create jobs – as evidenced by the number of Belgian companies on the cutting edge of aeronautics.”
The 17 members of the ESA astronaut class of 2022 were selected from a pool of over 23,000 applicants. The process, designed to bring together the finest scientific minds that Europe has to offer, took place over a period lasting 18 months.
The selection of Raphaël Liégeois is testament to Belgium’s focus on embracing openness, driven by innovation, partnerships, and diversity, to create solutions that drive progress for all.
Located in the heart of Europe, Belgium is one of the most open economies in the world, counting 11.5 million people with a reputation for innovation, hard work, partnership, and multilingualism. Strategically located between Germany, the Netherlands, France, and Luxembourg, and only a stone’s throw from the UK, it lies at the centre of the richest and most densely populated area in Europe. A member of the European Union, Belgium enjoys full access to the world’s most advanced single market and customs zone which ensures extensive frictionless trade.
Belgium boasts a highly developed transport infrastructure, including the second largest seaport in Europe (Antwerp). Belgium is home to world-leading research and innovation facilities, multinational corporations, and artisanal businesses supported by the investor-centric approach of public services.
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