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Vitamin D Supplementation May Lead to Small Risk Reduction for Acute Respiratory Infections




Vitamin D supplementation may safely reduce the overall risk for acute respiratory infection compared with placebo, but the risk reduction is small and the relevance of these findings to coronavirus disease 2019 (COVID-19) is unknown and requires additional investigation. This is according to research published in Lancet Diabetes Endocrinology.

Since the COVID-19 pandemic began, interest in the role of vitamin D in reducing acute respiratory infections has increased. Results of randomized controlled trials, though, have been heterogenous and variable, with some demonstrating protection and others reporting findings that are null. Results of a 2017 meta-analysis indicated the potential protective effect of vitamin D supplementation. Researchers sought to build on those results by conducting a new systematic review and meta-analysis of studies conducted since December 31, 2015.

The primary study outcome was the proportion of patients who had one or more acute respiratory infection (upper, lower, or location unclassified). Secondary outcomes included the proportion of participants who experienced one or more upper or lower respiratory infection, emergency department visit, hospitalization, or both for an acute respiratory infection, death due to acute respiratory infection or respiratory failure, antibiotic use, absence from school or work, serious adverse events, death, and potential adverse reactions to vitamin D.

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The analysis included 46 studies representing 75,541 patients. Thirty-five studies compared the effects of vitamin D regimen with placebo, 5 compared higher- and lower-dose vitamin D with placebo groups, and 6 compared the effects of higher dose vitamin D with lower-dose vitamin D regimens.

Primary outcome data were obtained for 98.1% of 49,419 available participants.

In the 35 studies that measured baseline 25(OH)D concentrations, mean levels ranged from 18.9 to 90.9 nmol/L. Across studies, vitamin D was administered through variable routes, including oral dosing, weekly dosing, bolus dosing once every month to once every 3 months, and combination bolus and daily dosing.

A significantly lower proportion of participants who were taking vitamin D supplements had 1 or more acute respiratory infections compared with those taking placebos (61.3% vs 62.3%; odds ratio [OR], 0.92; 95% CI, 0.86-0.99). The heterogeneity effect for these data was moderate (I2=35.6%).

For secondary comparisons of high vs low dose vitamin D supplementation, no significant differences in the proportion of at least one acute respiratory infection was noted between participant groups (68.2% vs 64.6%; OR, 0.87; 95% CI, 0.73-1.04; I2=0.0%).

In order to investigate the reasons for the heterogeneity of the effect for the primary comparison (vitamin D vs placebo), researchers conducted an analysis stratified by 2 participant level factors (baseline 25(OH)D concentration and age) and 4 trial-level factors (dose, dose frequency, trial duration, and presence or absence of airway disease). Four of these factors—baseline 25(OH)D concentration, dose, dose frequency, and trial duration—were prespecified in study protocols and two—age and presence or absence of airway infections—were exploratory analyses.

Compared with placebo groups, there was no significant effect of vitamin D supplementation on the risk of having 1 or more acute respiratory infection in participants with baseline 25(OH)D concentrations of less than 25 nmol/L, 25 to 49.9 nmol/L, 50 to 74.9 nmol/L, or greater than 75 nmol/L (ORs, 0.81, 1.04, 0.88, 0.76, and 1.00, respectively).

A significant protective effect of vitamin D supplementation was seen on the risk for developing one or more acute respiratory infection compared with placebo, particularly in trials where vitamin D was given daily (OR 0.78) compared with weekly dosing or bolus dosing once a month or once every 3 months (ORs, 0.97 and 0.98).

Significant protective effects were also noted against the risk of having one or more acute respiratory infection vs placebo in trials that were not restricted only to participants with asthma or chronic obstructive pulmonary disease (COPD).

The meta-analysis for secondary outcomes included only the results of placebo-controlled trials. Without considering participant- or trial-level factors, vitamin D supplementation did not demonstrate a significant effect on the proportion of participants who experienced 1 or more upper or lower respiratory infection, used antibiotics to treat an infection, reported absence from school or work, or had been admitted to the hospital, or who went to the emergency department.

Study limitations include the analysis of aggregate trial-level, rather than individual participant-level data due to the need for results in the face of the COVID-19 pandemic, a lack of participant-level data on race, ethnicity, or obesity as potential effect-modifiers, and an inability to account for other factors that might influence the protective effect of supplementation.

“This updated meta-analysis…showed a significant overall protective effect of this intervention compared with a placebo control,” the researchers wrote. “In contrast to findings of our previous meta-analysis of individual participant-level data, we did not see a protective effect…among participants with the lowest baseline 25(OH)D concentrations.”

“The vitamin D dosing regimen of most benefit was daily and used standard doses (400-1000 IU) for up to 12 months. The relevance of these findings to COVID-19 is not known and requires further investigation,” they concluded.

Disclosure: Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of authors’ disclosures.


Jolliffe DA, Camargo Jr CA, Sluyter JD, et al. Vitamin D supplementation to prevent acute respiratory infections: A systematic review and meta-analysis of aggregate data from randomized controlled trials. Published online March 30, 2021. Lancet Diabetes Endocrinol. doi: 10.1016/S2213-8587(21)00051-6.

This article originally appeared on Endocrinology Advisor

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New Approaches to Covid-19 Treatment Enter the Picture




The Covid-19 treatment response process includes a number of different major players, including Pfizer Inc (NYSE: PFE), BioNTech SE – ADR (NASDAQ: BNTX), Moderna Inc (NASDAQ: MRNA), AstraZeneca plc (NASDAQ: AZN), Novavax Inc (NASDAQ: NVAX), Halberd Corp (OTC US: HALB), and Johnson & Johnson (NYSE: JNJ).

The pandemic is under control. Or is it? In much of the developing world, this is far from the case. Only about 12% of people in the world have had access to vaccines. And new mutated variants are popping up all around the world every day.

Sooner or later, those mutated variants will start to fall outside the efficacy boundaries of our current vaccine solutions, and we will have to start working on vaccine 2.0. Then vaccine 3.0. On and on it will go.

Suffice it to say, the effort needs to be comprehensive and multifaceted if we are to be successful over the long term in this battle. And that process may need to include some different approaches.

With that in mind, we take a look a few of the more interesting stocks in the Covid-19 space.

Novavax Inc (NASDAQ: NVAX) bills itself as a clinical-stage biotechnology company that focuses on the discovery, development, and commercialization of recombinant nanoparticle vaccines and adjuvants.

Its lead adjuvant is Matrix-M that is used to enable a vaccine to enhance the amplitude of the immune response and qualitatively change it, enhance its specificity to provide protection against related microorganisms, as well as allows immunization with much lower doses of antigen.

Novavax Inc (NASDAQ: NVAX) most recently announced that it has finalized an advance purchase agreement (APA) with Gavi, the Vaccine Alliance (Gavi) for supply of its recombinant protein-based COVID-19 vaccine candidate to the COVAX Facility. Under the APA, Novavax is expected to manufacture and distribute 350 million doses of NVX-CoV2373 to countries participating under the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. Under a separate purchase agreement with Gavi, the Serum Institute of India (Serum Institute) is expected to manufacture and deliver the balance of the 1.1 billion doses of Novavax’ vaccine.

“This is a tremendous opportunity to partner with global organizations focused on accelerating equitable access to safe and effective COVID-19 vaccines, particularly in countries where vaccination rates are currently low,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “This arrangement is the culmination of a collaboration among CEPI, Gavi, Serum Institute and Novavax, who are partnering in our urgent mission to deliver significant amounts of vaccines to all countries, regardless of income level. Novavax thanks CEPI for its longstanding support and tireless work with Gavi as the curators of the COVAX Facility.”

Even in light of this news, NVAX has had a rough past week of trading action, with shares sinking something like -26% in that time. That said, chart support is nearby and we may be in the process of constructing a nice setup for some movement back the other way. NVAX shares have been relatively flat over the past month of action, with very little net movement during that period.

Novavax Inc (NASDAQ: NVAX) managed to rope in revenues totaling $279.7M in overall sales during the company’s most recently reported quarterly financial data — a figure that represents a rate of top line growth of 3072.2%, as compared to year-ago data in comparable terms. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($804.9M against $579.7M).

Halberd Corp (OTCMKTS: HALB) is another interesting play on the coronavirus theme, albeit with an alternative direction from the vaccine producers. The company recently announced the appointment of Dr. Mitchell S. Felder, previously a consultant to Halberd Corporation, to the position of Chief Technical Officer. Dr. Patricio Reyes, former Chief Technical Officer, has requested reduced duties due to pressing other outside commitments, but will continue to serve as a valuable contributor to the company moving forward, as a consultant.

According to the release, Dr. Felder is a Board-Certified Neurologist and is the author of numerous patents, including critical patents on the development of radio frequency and laser emissive energy in the extracorporeal eradication of disease. Dr. Felder, in his new role, will oversee the coordination of testing in these fields at three university-affiliated organizations.

Halberd Corp (OTCMKTS: HALB) president and CEO, William A. Hartman, stated, “This move will not only fill the spot vacated by Dr. Reyes, but is intended to maximize the benefits of our R&D tests at Youngstown State University, where we intend to conduct simultaneous experimentations on both radio frequency and laser methods to eradicate E. coli bacteria from water, as a prelude to eradicating disease from bodily fluids. Most of the required equipment and supplies have either been recently secured or are already on hand, and the start of testing is imminent and may have already begun. Tests on other pathogens, including Covid-19 will be conducted after demonstrating success in eliminating E. coli bacteria from distilled water, initially, and subsequently from human bodily fluids. Halberd’s technology is protected via two existing patents on the requisite extra-corporeal (outside the body) process and eight related provisional patent applications filed in the last year.”

Hartman added, “Our scientists believe that the advantage of radio frequency and lasers to eradicate disease antigens is that virtually no disease would be immune from these processes, and there would be virtually none of the side effects associated with the application of conventional internal medications for disease treatment. We are exploring both radio frequency and lasers to eradicate disease so that the most appropriate methodology can be applied to each specific disease. If successful, these processes could revolutionize the worldwide medical industry.”

HALB shares have been rising over the past 8 months, pushing about 500% higher in that time. Over that period, the stock’s upward trend has held firm, and it has seen numerous rallies spurred by successive tests of the trendline. Here we are again, as the stock is testing the trendline support for the umpteenth time since last November. It may represent yet another trend test opportunity for new investors. Keep it on the radar.

Halberd Corp (OTCMKTS: HALB) with vaccine solutions against COVID-19 already receiving some cultural pushback, demand for alternative solution(s) may be a big story in the weeks and months ahead. The company may be one of the few that has the capacity to offer something materially different to the established paradigm.

Moderna Inc (NASDAQ: MRNA) promulgates itself as a clinical stage biotechnology company that develops therapeutics and vaccines based on messenger RNA for the treatment of infectious diseases, immuno-oncology, rare diseases, and autoimmune and cardiovascular diseases. It has a leading approved COVID-19 vaccine now in distribution around the world.

It has strategic alliances with AstraZeneca, Merck & Co., Vertex Pharmaceuticals, Biomedical Advanced Research and Development Authority, Defense Advanced Research Projects Agency, and Bill & Melinda Gates Foundation, as well as the Coalition for Epidemic Preparedness Innovations.

Moderna Inc (NASDAQ: MRNA) just reported financial results and provided business updates for the first quarter 2021 and highlighted pipeline progress, including increased 2021 supply forecast to between 800 million and 1 billion doses; making additional investments to increase global supply for COVID-19 Vaccine to up to 3 billion doses in 2022 (depending on the mix); the company recently announced data supporting 3-month refrigerated (2-8°C) stable formulation; and new data shows a single booster dose of 50 µg of mRNA-1273 or mRNA-1273.351 increased neutralizing titers against SARS-CoV-2 and two variants of concern (B.1.351, P.1) in previously vaccinated clinical trial participants.

“In the first quarter, the Moderna team delivered on its supply commitments to many governments and helped protect more than 100 million people. This accomplishment translated into our first profitable quarter in the company’s history, after 10 years of scientific innovation and several billion dollars invested to make our mRNA platform a reality,” said Stéphane Bancel, Chief Executive Officer of Moderna. “Based on these first quarter accomplishments and our current manufacturing scale-up trajectory, we were pleased to again increase our base plan for 2021 to 800 million doses. The Moderna team and our manufacturing partners are working hard to get as close to 1 billion doses in 2021 as we can. The feedback from governments around the world requesting high-efficacy mRNA vaccines and variant boosters is overwhelming. We are now actively engaged in discussions and agreements for 2022 with all of the governments we are currently supplying for 2021. On top of that, new partnerships, like COVAX, for up to 466 million doses in 2022 and discussions with new governments in Asia, Middle East, Africa, and Latin America, make us believe that our total advance purchase agreements for 2022 should be higher than those in 2021.”

The stock has suffered a bit of late, with shares of MRNA taking a hit in recent action, down about -9% over the past week.

Moderna Inc (NASDAQ: MRNA) pulled in sales of $570.7M in its last reported quarterly financials, representing top-line growth of 3960.8%. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($4.6B against $4.4B).

DISCLAIMER:  EDM Media LLC (EDM), is a third-party publisher and news dissemination service provider, which disseminates electronic information through multiple online media channels.  EDM is NOT affiliated in any manner with any company mentioned herein.  EDM and its affiliated companies are a news dissemination solutions provider and are NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security.  EDM’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities.  The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material.  All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks.  All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release.  EDM is not liable for any investment decisions by its readers or subscribers.  Investors are cautioned that they may lose all or a portion of their investment when investing in stocks.  For current services performed EDM has NOT been compensated for news coverage of the current press releases issued by Halberd Corp (OTCMKTS: HALB).


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Brazilian President Allocates More Than $1 Billion To Produce COVID-19 Vaccines




President of Brazil Jair Bolsonaro announced Monday that the country is directing more than $1 billion toward the production and distribution of COVID-19 vaccines. Andressa Anholete/Getty Images hide caption

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Andressa Anholete/Getty Images

Brazil, one of the worst-hit countries in the world by the pandemic, is directing more than $1 billion toward the production and distribution of COVID-19 vaccines, the country’s far-right president announced Monday, Reuters reported.

President Jair Bolsonaro, who has criticized lockdown measures and has told Brazilians to “stop whining” about the deadly virus, said about $1.05 billion will be spent on the inoculation effort.

The announcement comes amid an investigation into Bolsonaro’s role in his government’s handling of the coronavirus crisis, which has killed more than 421,000 people to date — the second highest number of fatalities in the world.

During the first day of testimony last week, the country’s former health minister Luiz Henrique Mandetta told the Senate committee investigating Bolsonaro’s actions that the president “went against science-based Ministry of Health guidelines for fighting the coronavirus pandemic,” Folha de S. Paolo reported.

Mandetta was sacked by Bolsonaro in April 2020.

According to the Brazilian newspaper, Mandetta told officials that before getting fired, he wrote a letter to the president saying social distancing could help contain the spread of the virus. “It was very embarrassing for a health minister to explain that the health minister was going one way and the president the other,” he said

Since the start of the pandemic, Bolsonaro has consistently downplayed the global health crisis and contradicted expert advice on how to slow its spread.

“Enough fussing and whining. How much longer will the crying go on?” Bolsonaro told a crowd at an event in March. “How much longer will you stay at home and close everything? No one can stand it anymore. We regret the deaths, again, but we need a solution.”

The president led hundreds of motorcyclists in a rally celebrating Mother’s Day in the capital around Brasilia on Sunday. He took advantage of the demonstration to once again ridicule health officials who advocate for social distancing measures.

“Let all those who want to see the people far from me, or who hope to see me far from the people, give up,” Bolsonaro wrote in a tweet.

As of May 9, more than 46.8 million doses of the COVID-19 vaccine have been distributed, the government reported.

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FDA OKs Pfizer COVID-19 Vaccine For 12-15 Age Group




A doctor prepares to administer a vaccine injection at New York-Presbyterian Lawrence Hospital in Bronxville, N.Y., in January. The Food and Drug Administration has approved emergency use authorization of the Pfizer/BioNTech vaccine for patients ages 12 to 15. Kevin Hagen/AP hide caption

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Kevin Hagen/AP

The Food and Drug Administration said Monday that children 12 to 15 years old are now eligible to receive a key COVID-19 vaccine as the agency expanded its emergency use authorization for the Pfizer/BioNTech vaccine.

Dr. Janet Woodcock, the acting FDA commissioner, said the expansion “brings us closer to returning to a sense of normalcy.”

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations,” Woodcock said.

Until now, the Pfizer vaccine had been authorized only for people age 16 and older. Pfizer asked the FDA to broaden its emergency use authorization for the vaccine after announcing in late March that clinical trials found “100% efficacy and robust antibody responses” in study participants who were 12 to 15.

The FDA first granted Pfizer’s request for an emergency use authorization for its COVID-19 vaccine in December. It got federal approval to include children as young as 12 in its vaccine trial in October.

All three makers of U.S.-authorized vaccines — Pfizer, Moderna and Johnson & Johnson — are studying the safety and effectiveness of their vaccines in children, including as young as 6 months.

Johnson & Johnson said last week that its vaccine “will initially be tested in a small number of adolescents, which will be expanded to a larger group in a step-wise approach, if initial data shows an acceptable safety profile.”

Those expanded trials started last month when J&J vaccine shots were given to teens from 16 to 17. If all goes well, the trial will include kids as young as 12, the company said.

Moderna said in mid-April that its vaccine study in adolescents is now fully enrolled, with around 3,000 people ages 12 to 17 slated to receive doses. A second phase of the study will follow, including children who are from 6 months to 11 years old.

Pfizer said it won’t be ready to ask the FDA for new emergency use authorization expansions for kids younger than 12 until September. One such request would cover children from 2 to 5 years old; a second would apply to ages 5 to 11. A third request, aimed at protecting infants and toddlers, isn’t expected until the fourth quarter of this year.

Pfizer and BioNTech said they have the capacity to manufacture up to 2.5 billion vaccine doses in 2021, and to produce at least 3 billion doses in 2022.

In another move that could boost COVID-19 vaccine availability, Pfizer recently asked the FDA to approve a change that would allow its vaccine to be stored at common refrigerator temperatures of 2 to 8 degrees Celsius (roughly 36 to 46 degrees Fahrenheit) for up to four weeks. The company said it submitted data about the vaccine’s stability at those temperatures on April 30.

In general, Pfizer’s vaccine must be stored at ultra-cold temperatures of around -70 degrees Celsius (-94 degrees Fahrenheit). The company loosened that requirement a bit in February, however, saying the shots, which use messenger RNA, could safely be kept at typical home freezer temperatures, -25 to -15 degrees Celsius (-13 to 5 degrees Fahrenheit), for up to two weeks.

The COVID-19 vaccine’s success has brought billions of dollars to Pfizer. In the first quarter of 2021 alone, the vaccine added $3.5 billion in global revenue, Pfizer Chairman and CEO Albert Bourla told investors in a conference call last week. Over the entire year, Pfizer could bring in around $26 billion based on the vaccine, Bourla said.

The company and BioNTech, its development and revenue-sharing partner, have shipped some 430 million doses to 91 countries and territories, Bourla said last week.

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China To Set Up ‘Line Of Separation’ On Mount Everest, Citing Nepal COVID-19 Outbreak




China will set up a “line of separation” at Mount Everest’s summit, as Nepal struggles to control a COVID-19 outbreak. In this photograph, on May 2, 2021 mountaineers trek along the Khumbu glacier near Everest base camp in the Mount Everest region of Solukhumbu district, some 140 km northeast of Nepal’s capital Kathmandu. Prakash Mathema/AFP via Getty Images hide caption

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Prakash Mathema/AFP via Getty Images

China will set up a “line of separation” on one side of Mount Everest’s peak, saying the measure is needed to keep Nepal’s COVID-19 outbreak from crossing the border, according to state media.

The plan is part of China’s “zero contact strategy” to keep climbers from the Chinese and Nepalese sides of Everest from mixing if they reach the summit on the same day, said Nyima Tsering, head of the Tibetan Sports Bureau, according to the state-run Xinhua news outlet.

Everest straddles the border between Nepal and the Tibetan region of China — where the world’s highest mountain is known as Mount Qomolangma. The separation line will be erected by guides who are climbing alongside rope-fixing teams who are readying paths for the looming season.

Officials say the line will cordon off the northern side of the peak, starting from one of the highest Tibetan camps at 8,300 meters (about 27,230 feet), from which mountaineers leave to reach the summit.

China has barred foreigners from visiting Everest since last year, due to the pandemic. But for the 2021 mountaineering season, Chinese nationals have been granted 21 expedition permits for the north side of the mountain, Xinhua reports.

News of China’s plan comes after a coronavirus outbreak made headlines at Nepal’s Everest Base Camp, which is situated at 17,598 feet. Some climbers were evacuated to the capital, Kathmandu, for further tests and treatment for COVID-19. Last week, Nepalese officials reportedly confirmed around 17 cases, but anecdotal reports have put the number much higher, with more than 30 mountaineers said to be infected.

In addition to the separation line at the summit, the China Tibet Mountaineering Association has set up a checkpoint 300 meters from the base camp where climbers adjust to the high altitude’s low oxygen levels, Xinhua said.

Nepal’s health ministry has reported more than 403,000 COVID-19 cases, including more than 9,100 new infections on Monday. Nearly 3,900 Nepalese have died from the disease. There are currently more than 93,000 actives cases in Nepal, whose population tops 28 million people.

The rush of new COVID-19 cases has put Nepal’s public health system on the brink of disaster, according to Human Rights Watch.

“Large volumes of oxygen equipment and other medical supplies are urgently needed to avert a Covid-19 catastrophe in the country,” said Meenakshi Ganguly, HRW’s South Asia director.

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