Nov 09, 2021 (Financial News Media via COMTEX) -- Palm Beach, FL - November 9, 2021 – FinancialNewsMedia.com News Commentary – The increasing outbreak of covid-19 is increasing the demand for coronavirus vaccines or therapies, which will result in the expansion of the COVID-19 therapeutics market during the forecast period. COVID-19 virus causes respiratory illness in humans. It may cause severe disease in the geriatric population (Mainly those with diabetes, chronic respiratory disease, cardiovascular disease, and cancer). According to the World Health Organization (WHO), globally, 175,847,347 confirmed cases of COVID-19, including 3,807,276 deaths, were reported to WHO as of 15 June 2021. Covid-19 cases are increasing day by day, and there is no officially approved drug for COVID-19. Many countries are facing a shortage of drugs likely to offer growth opportunities for pharmaceutical drug manufacturers. Leading market players are also developing innovative and efficient covid-19 drug therapies, resulting in overall market growth. According to the latest market intelligence report by InsightAce Analytic, the global COVID-19 therapeutics market size, which was valued at US$ 5.26 Billion in 2020, is expected to reach US$ 25.6 Billion in 2030, recording a promising CAGR of 10.7% from 2021 to 2030. The report said: "Major factors responsible for the growth of the COVID 19 therapeutic market are the fast adoption of advanced technologies, the growing number of corona patients, increasing healthcare expenditures, rising awareness about coronavirus, and increasing efforts by the pharmaceutical companies to develop covid-19 therapeutic drugs. For instance, Eli Lilly and Company is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 treatments at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic. Furthermore, increasing research investments for the R&D of covid-19 therapeutic drugs is anticipated to drive market growth in the future. However, the high cost required to validate therapies, and long-term clinical trials limit the COVID-19 therapeutics market growth." Active biotech companies in the market this week include BioVaxys Technology Corp. (otcqb:BVAXF) /zigman2/quotes/209221990/delayed CA:BIOV +5.41% , Merck /zigman2/quotes/209956077/composite MRK -0.95% , Moderna, Inc. /zigman2/quotes/205619834/composite MRNA -4.45% , Sorrento Therapeutics, Inc. /zigman2/quotes/205669265/composite SRNE -8.75% , Pfizer Inc. /zigman2/quotes/202877789/composite PFE -2.33% .
InsightAce Analytic concluded: "During the forecast period 2020-2030, North America COVID-19 therapeutic market is expected to dominate the COVID-19 therapeutics market, owing to advancement of technologies, growing awareness about coronavirus, rising government initiatives for R&D of covid-19 vaccines, and an increasing number of market players in this Region. On the other hand, the European region will also hold the largest share of this market during the forecast years due to rising government initiatives in R&D and increasing demand for covid-19 treatment options. Furthermore, Asia Pacific COVID-19 therapeutic market is estimated to be the fastest-growing regional market in the future, attributed to the increasing number of corona patients, rising awareness about the covid treatment options and healthcare facilities, and entry of new players in the market."
BioVaxys Technology Corp. (otcqb:BVAXF) BREAKING NEWS: BioVaxys announces that CoviDTH Demonstrates Safety and Tolerability in Broad Ranging In Vivo Clinical Pathology, Immunology, and Histopathology Evaluation, Supporting Planned Clinical Development of CoviDTH – BioVaxys Technology Corp. ("BioVaxys") announced today that results from its in vivo animal research study support the safety and tolerability of CoviDTH at two intradermal dose levels across a battery of clinical pathology, immunology, and histopathology evaluations.
The objective of the study was to determine the potential toxicity and toxicokinetic profile of SARS-CoV-2 Spike Protein when administered two times via intradermal injection in a rabbit model, and to determine the persistence or reversibility of any toxic effects over a one-week recovery period.
Conducted together with global contract research organization Inotiv, Inc. ("Inotiv"), the Good Laboratory Practice ("GLP") study successfully met all objectives and demonstrated the safety, tolerability, and lack of toxicity of the purified recombinant SARS-CoV-2 s-protein that is a principal constituent of CoviDTH. The highest dose tested in the study was 5x-10x higher than the probable dose in humans, with no adverse effects except some mild localized redness.
In its Written Response this summer to BioVaxys on the Company's request for a Pre-IND Type B review of CoviDTH as a diagnostic for evaluating T-cell immune response to SARS-CoV-2, the US Food and Drug Administration ("FDA") indicated that animal toxicity studies for CoviDTH were not required and that the Company could start its clinical development program with a combined Phase I/II study. "The battery of analyses provides further evidence of the safety and tolerability of CoviDTH," stated BioVaxys President and Chief Operating Officer Ken Kovan, adding that "Although the animal tox study is deemed discretionary by the FDA, we believe the data will be very supportive of our IND. Preparation of the IND is ongoing as we finalize GMP production plans."
CoviDTH is the world's first and only low cost, disposable, point-of-care diagnostic tool that screens for a T-cell response to SARS-CoV-2, the virus that causes Covid-19. Recent published clinical studies have validated the use of the delayed-type hypersensitivity (DTH) cutaneous test behind CoviDTH as a feasible and safe in vivo method to assess cellular immune responses in both natural and vaccinated SARS-CoV-2 exposed individuals and also that the DTH response is highly durable and persists for at least one year after COVID-19 exposure or vaccine administration. CONTINUED...Read this full release and more news for BioVaxys Technology at: https://www.financialnewsmedia.com/news-biov/
Other recent covid-19 developments in the biotech industry include:
Moderna Inc. /zigman2/quotes/205619834/composite MRNA -4.45% , a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines and Metagenomi, Inc., a genetic medicines company with a versatile portfolio of next-generation gene editing tools, recently announced that the two companies have entered into a strategic research and development collaboration focused on advancing new gene editing systems for in vivo human therapeutic applications. The collaboration will utilize Metagenomi's novel gene editing tools and leverage Moderna's mRNA platform, as well as lipid nanoparticle (LNP) delivery technologies, with the goal of developing curative therapies for patients with serious genetic diseases.
“Metagenomi has demonstrated the power of its proprietary metagenomics approach that mines the Earth's natural environment to discover next-generation gene editing tools and has developed discovery capabilities with the potential to address multiple diseases,” said Eric Huang, PhD, General Manager & Chief Scientific Officer, Moderna Genomics (mGx). “Their discovery platform and expertise will expand Moderna Genomics' ongoing efforts to develop innovative in vivo gene editing therapies to address a significant unmet medical need. This collaboration represents another milestone on our journey to create transformational genome-engineering based medicines.”
Pfizer Inc. /zigman2/quotes/202877789/composite PFE -2.33% recently announced its investigational novel COVID-19 oral antiviral candidate, PAXLOVID(TM), significantly reduced hospitalization and death, based on an interim analysis of the Phase 2/3 EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) randomized, double-blind study of non-hospitalized adult patients with COVID-19, who are at high risk of progressing to severe illness.
The scheduled interim analysis showed an 89% reduction in risk of COVID-19-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset (primary endpoint); 0.8% of patients who received PAXLOVID(TM) were hospitalized through Day 28 following randomization (3/389 hospitalized with no deaths), compared to 7.0% of patients who received placebo and were hospitalized or died (27/385 hospitalized with 7 subsequent deaths). The statistical significance of these results was high (p<0.0001). Similar reductions in COVID-19-related hospitalization or death were observed in patients treated within five days of symptom onset; 1.0% of patients who received PAXLOVID(TM) were hospitalized through Day 28 following randomization (6/607 hospitalized, with no deaths), compared to 6.7% of patients who received a placebo (41/612 hospitalized with 10 subsequent deaths), with high statistical significance (p<0.0001). In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID(TM) as compared to 10 (1.6%) deaths in patients who received placebo.
Merck /zigman2/quotes/209956077/composite MRK -0.95% , known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics recently announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral medicine authorized for the treatment of mild-to-moderate COVID-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing severe illness. In the U.K., LAGEVRIO [(R)] (lah-GEV-ree-oh) is the planned trademark for molnupiravir; the trademark for molnupiravir in other countries has not been approved. Merck announced its application with the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of molnupiravir is under review and recently announced the European Medicines Agency has initiated a rolling review of the company's Marketing Authorization Application. Merck is actively working to submit applications to other regulatory agencies around the world.
“The first global authorization of molnupiravir is a major achievement in Merck's singular legacy of bringing forward breakthrough medicines and vaccines to address the world's greatest health challenges. In pursuit of Merck's unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” said Robert M. Davis, chief executive officer and president, Merck.
Sorrento Therapeutics, Inc. /zigman2/quotes/205669265/composite SRNE -8.75% recently announced receipt of approval from the Brazilian regulatory agency (ANVISA) for COVISTIX in Brazil.
COVISTIX manufacturing approval (for good manufacturing practices) from ANVISA was published in the Brazilian government official journal on October 18 [th] under registration CNPJ 17700763/0001-48, resolution #3951.
COVISTIX marketing authorization from ANVISA was published in the Brazilian government official journal on November 3 [rd] under the same registration, with reference # 25351.041767/2021-72 / 80961800001.
The registration will be held for Sorrento by FUTURA Ltd, a highly respected local partner for hospitals and direct point of care distribution of prescription drugs and health products, while SYNOVA Ltd will distribute the test among their client network of diagnostic laboratories.
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