FinancialBuzz.com News Commentary
NEW YORK, Jan. 12, 2022 /PRNewswire/ -- The spread of the Omicron variant of COVID-19 continues to break records. U.S. hospitalizations now exceed 140,000 patients for the first time since the start of the pandemic. This is a warning sign, experts say, that the nation's Omicron surge is already more severe than in other countries and will only get worse as it spreads from highly vaccinated cities to less protected parts of the U.S. According to data provided by the New York Times, the country's previous hospitalization peak came on Jan. 6th, 2021, when 139,781 patients were hospitalized nationwide. The country also reported roughly 1.5 million new cases on Monday, according to data compiled by Johns Hopkins University, pushing the seven-day average to 754,000 new cases per day. Todos Medical Ltd. (OTC: TOMDF), Moderna, Inc. (NASDAQ: MRNA), Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN), Merck & Co., Inc. (NYSE: MRK), Atea Pharmaceuticals, Inc. (NASDAQ: AVIR)
As a result of the new wave, testing kits are in short supply. According to Anthony S. Fauci, Chief Medical Adviser to President Biden, it is going to be very important "that we get a greater capability of testing, particularly when the demand for testing is so high, with the combination of the Omicron variant itself, as well as the holiday season, where people want to get that extra level of assuredness that they're protected, even if you are vaccinated and boosted."
Todos Medical Ltd. (OTCQB: TOMDF) announced yesterday breaking news that, "its President & CEO Gerald Commissiong will appear on Fox Business' The Claman Countdown on Tuesday, January 11 during the 3pm Eastern Time hour show to discuss COVID testing in the United States and how it relates to the pending availability of oral antiviral treatments such as the Company's Tollovir™ 3CL protease inhibitor oral antiviral treatment currently preparing to read out on Phase 2 clinical data in hospitalized patients. Mr. Commissiong is also presenting at the Biotech Showcase 2022 to be held virtually from January 10-12th, 2022. Concurrent with this announcement, Mr. Commissiong released a blog entitled "COVID Testing: What Needs to Happen Now to Turn the Corner in 2022" that discusses key points needed to improve the United States COVID testing infrastructure. The blog posting is available online at https://todosmedical.com/blog/covid-testing-what-needs-to-happen-now-to-turn-the-corner-in-2022.
About Todos Medical Ltd.: Founded in Rehovot, Israel with offices in New York City, Todos Medical Ltd. (OTCQB: TOMDF) engineers life-saving diagnostic solutions for the early detection of a variety of cancers. In 2021, Todos completed the acquisition of U.S.-based medical diagnostics company Provista Diagnostics, Inc. to gain rights to its Alpharetta, Georgia-based CLIA/CAP certified lab currently performing PCR COVID testing and Provista's proprietary commercial-stage Videssa® breast cancer blood test. The Company's state-of-the-art and patented Todos Biochemical Infrared Analyses (TBIA) is a proprietary cancer-screening technology using peripheral blood analysis that deploys deep examination into cancer's influence on the immune system, looking for biochemical changes in blood mononuclear cells and plasma. Todos' two internally-developed cancer-screening tests, TMB-1 and TMB-2, have received a CE mark in Europe. Todos is focused on the commercialization of Videssa and will bring the TBIA tests to market thereafter.
Todos has entered into a joint venture with NLC Pharma targeting diagnostic and testing solutions to address the COVID-19 pandemic. The Joint Venture is pursuing the development of diagnostic tests targeting the 3CL protease, as well as 3CL protease inhibitors that target a fundamental reproductive mechanism of coronaviruses. The Company's proprietary therapeutic candidate Tollovir™ is currently in a Phase 2 clinical trial to treat hospitalized COVID-19 patients in Israel, and is preparing to initiate Phase 2/3 clinical trials for both hospitalized and non-hospitalized patients in Israel.
Todos is also developing blood tests for the early detection of neurodegenerative disorders, such as Alzheimer's disease. The Lymphocyte Proliferation Test (LymPro Test™) is a diagnostic blood test that determines the ability of peripheral blood lymphocytes (PBLs) and monocytes to withstand an exogenous mitogenic stimulation that induces them to enter the cell cycle. It is believed that certain diseases, most notably Alzheimer's disease, are the result of compromised cellular machinery that leads to aberrant cell cycle re-entry by neurons, which then leads to apoptosis. LymPro is unique in the use of peripheral blood lymphocytes as a surrogate for neuronal cell function, suggesting a common relationship between PBLs and neurons in the brain.
Todos is also distributing certain (COVID-19) testing materials and supplies to CLIA-certified labs in the United States. The products cover multiple suppliers of PCR testing kits, extraction kits, automation materials and supplies, as well as COVID-19 antibody and antigen testing kits."
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Moderna, Inc. (NASDAQ: MRNA) announced on December 27th, 2021 a revised supply agreement with the government of South Korea for 20 million doses of Moderna's COVID-19 vaccine or an updated booster vaccine candidate, if authorized. Under the terms of the agreement, Moderna expects to deliver 15 million doses in the third quarter of 2022 and 5 million doses in the fourth quarter of 2022. "We thank the government of South Korea for their planning ahead for the fall 2022 booster season with this supply agreement for our mRNA COVID-19 vaccine and booster," said Stéphane Bancel, Moderna's Chief Executive Officer. "We remain committed to helping to end the COVID-19 pandemic."
Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) announced on November 12th, 2021 that the European Commission (EC) has approved the casirivimab and imdevimab antibody cocktail, known as REGEN-COV® in the U.S. and Ronapreve™ in the European Union (EU) and other countries. The EC granted marketing authorization for the antibody cocktail for people aged 12 years and older for the treatment of non-hospitalized patients (outpatients) with confirmed COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19, and to prevent COVID-19. This decision follows yesterday's positive opinion by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). "This approval adds to the growing number of countries that have recognized our antibody cocktail as an important therapy against COVID-19 to treat non-hospitalized patients already infected with the virus and to prevent infection in the first place," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron. "With today's approval, we hope countries in the European Union will accelerate their adoption of this formidable tool to reduce the burden of COVID-19. For non-hospitalized infected individuals, our antibody cocktail was shown to reduce the risk of hospitalization or death by 70%; and in the prevention setting it reduced the risk of symptomatic infections by 82%. Further, recently released data not yet reviewed by the EMA suggest a single dose provided long-term protection against COVID-19, beyond the currently authorized once-monthly dosing; we will share these new data with regulatory authorities, including the EMA, to better meet the needs of these patients."
Merck & Co., Inc. (NYSE: MRK) known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics announced on December 24th, 2021 that Japan's Ministry of Health, Labor and Welfare has granted Special Approval for Emergency in Japan for molnupiravir, an investigational oral antiviral medicine, for infectious disease caused by SARS-CoV-2. Special Approval for Emergency is the process under Article 14-3 of the Pharmaceuticals and Medical Devices Act to approve a medical product swiftly in an emergency situation to protect public health. Under a previously announced supply agreement, the Japanese government will purchase 1.6 million courses of molnupiravir to accelerate access to patients. "As a single oral medicine that can be taken at home, early treatment with molnupiravir significantly reduced the risk of hospitalization or death in patients at high risk for progressing to severe COVID-19. Importantly for patients, there were markedly fewer deaths among those taking molnupiravir in our clinical study. We believe that molnupiravir will be a critical addition to the measures available to help curb the impact of COVID-19 on patients, healthcare systems and public health in Japan," said Dr. Dean Y. Li, president, Merck Research Laboratories. "All of us at Merck have embraced our responsibility to bring this important medicine forward to patients globally as quickly as possible."
Atea Pharmaceuticals, Inc. (NASDAQ: AVIR) announced on December 14th, 2021 an updated strategy for AT-527 to address the rapidly evolving SARS-CoV-2 and emerging variants by maximizing the compound's unique profile for potential use as both a monotherapy and in combination. Taking into account the changing COVID-19 landscape with the anticipated availability of new antiviral treatment regimens, the global Phase 3 MORNINGSKY trial will be closed out and the ongoing Phase 2 hospitalized trial will be further amended to expand enrollment to unvaccinated, high-risk outpatients. Atea expects to provide a more detailed update on its strategy and new development plan in 2022. "We believe strongly in AT-527's potential to combat the evolving SARS-CoV-2 and emerging variants as a monotherapy and as an important backbone in potential combination therapy," said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea Pharmaceuticals. "Our new strategy enables us to rapidly drive forward a plan to maximize AT-527's unique profile with a development approach designed to meet the current and future needs of COVID-19, which may include the emergence of new variants and drug resistance to other therapies."
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