Tag: U.S. Securities
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BitConnect Founder Indicated Over $2.4B Crypto Fraud
The U.S. Department of Justice announced its indictment against Satish Kumbhani, the founder of defunct cryptocurrency platform BitConnect on charges of ‘orchestrating a global Ponzi scheme’ worth $2.4 billion, believed to be the largest cryptocurrency fraud ever. US Justice Department Indicts BitConnect Founder In an official press release, the Justice Department said that Satish Kumbhani had been charged with conspiracy to commit wire fraud, wire fraud, commodity price manipulation, operation of an unlicensed money transmitting business, and committing international money laundering. All the charges have been associated with the operation of BitConnect crypto platform. The service was sold as a lending program that ultimately proved to be a pyramid business of global dimensions, ranking 20th in the list of cryptocurrencies with the most market capitalization. “This indictment alleges a massive cryptocurrency scheme that defrauded investors of more than $2 billion. The U.S. Attorney’s Office and our law enforcement partners are committed to pursuing justice for victims of cryptocurrency fraud,” U.S. Attorney Randy Grossman said in a statement. Crypto Frauds Draw Scrutiny from Regulators The U.S. Securities and Exchange Commission (SEC) and the Department of Justice (DoJ) has been actively hunting down cryptocurrency-related cases recently. Just this week, BitMEX co-founders Delo and Hayes pleaded guilty to violating the U.S Bank Secrecy Act. Under the terms of their plea agreements, the co-founders have agreed to pay a $10 million criminal fine ‘representing pecuniary gain derived from the offense.; Similarly, crypto lending firm BlockFi also paid a $100 million penalty in an SEC settlement this month.
The post BitConnect Founder Indicated Over $2.4B Crypto Fraud appeared first on Cryptoknowmics-Crypto News and Media Platform.
Therapeutic Goods Administration of Australia Authorizes Moderna’s Covid-19 Vaccine in Children (6-11 Years)
"The TGA authorization for the use of our COVID-19 vaccine in children 6-11 years old in Australia is an important milestone for Moderna as it is the first regulatory authorization for the use of our vaccine in this age group. We are grateful to the TGA for their diligence and the Government of Australia for its continued confidence in our mRNA platform," said Stephane Bancel, Chief Executive Officer of Moderna. "We are grateful for the opportunity to provide protection against COVID-19 to this important age group, keeping children safe and able to continue life as normally as possible."
Professor Robert Booy from the Immunisation Coalition commented, "I welcome this decision by the TGA and look forward to the uptake of vaccination in children increasing even more to provide protection of children and maximize school attendance."
Moderna's vaccine was investigated in the ongoing Phase 2 "KidCOVE" study, a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and effectiveness of two 50 ug doses of Spikevax (mRNA-1273) given to healthy children 28 days apart. The study population was divided into three age groups (6 to under 12 years, 2 to under 6 years, and six months to under 2 years).
Data submitted to the TGA demonstrated that vaccination of children 6 to under 12 years of age with a 50 ug mRNA-1273 primary series is associated with non-inferior anti-SARS-CoV-2 neutralizing antibody responses when compared to that in individuals 18-25 years old from the Phase 3 Cove study. The geometric mean ratio (GMR) comparing the response in children to the response in young adults from the Phase 3 COVE study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of 99.3%. Two 50 ug doses of mRNA-1273 were generally well tolerated.
The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). The ClinicalTrials.gov identifier is NCT04796896.
Moderna's vaccine has already received regulatory approval for adults and adolescents in Australia. On 9 August 2021, the TGA granted provisional registration to the Moderna COVID-19 Vaccine for active immunization to prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age and older. On 3 September 2021, the provisional registration was extended to individuals 12 years of age and older.
About Moderna
In 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use and approval of one of the earliest and most-effective vaccines against the COVID-19 pandemic.
Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases, and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past seven years. To learn more, visit www.modernatx.com.
AUTHORIZED USE
The Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six years of age and older.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of a vaccine against COVID-19 (mRNA-1273, or Spikevax); the ability of Spikevax to trigger a neutralizing antibody response in children similar to that in older populations and to protect against COVID-19; and the safety and tolerability profile for Spikevax. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent lings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.
Moderna Contacts:
Media:
Luke Mircea Willats
Director, Corporate Communications
[email protected]
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
[email protected]
SOURCE: Moderna, Inc.
Copyright 2022 ACN Newswire. All rights reserved. www.acnnewswire.comModerna, Inc., (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the Therapeutic Goods Administration (TGA) in Australia has granted provisional registration for the use of Moderna's mRNA COVID-19 vaccine, Spikevax, in a 50 ug dose, two-dose series, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in children aged 6-11 years.
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