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Biobanking Market Is Projected To Grow Vibrantly In The Upcoming Years 2020-2025 (Impact of COVID-19) – Cole of Duty

June 8th, 2020 12:44 am

The global Biobanking Market was valued at USD 1.54 billion in 2016 and is projected to reach USD 2.88billion by 2025, growing at a CAGR of 7.2% from 2017 to 2025.

A biobank is a type of biorepository that stores biological samples (usually human) for use in research. The market for Biobanks has seen a rise in the market values because of increasing awareness amongst young parents regarding storage of stem cells for regenerative purposes. Also, the increased funds of govt. in research and development of Genetically Modified Products is also a key factor in driving the market positively.

The Final Report will cover the impact analysis of COVID-19 on this industry:

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Sample Infographics:

Market Dynamics:1. Market Drivers1.1 More focus on Genetic disease treatment and Research activities1.2 Growing popularity of stem cell banking from placental cord of new born1.3 Demand of regenerative medicines1.4 Cost effective drug discovery researches and project2. Market Restraints2.1 High cost of technical Instruments2.2 Difficulty in procurement of Biological samples

Market Segmentation:1.Global Biobanking Market, by Sample Type:1.1 Blood Products1.2 Human Tissues1.3 Cell Lines1.4 Nucleic Acids1.5 Biological Fluids1.6 Human Waste Products

2. Global Biobanking Market, by Application:2.1 Regenerative Medicine2.2 Life Science Research2.3 Clinical Research

View Source Of Related Reports:

Biobanking MarketViral Inactivation MarketVirus Filtration MarketViral Clearance MarketVeterinary-Animal Vaccines MarketVaccine Adjuvants MarketTerahertz and Infrared Spectroscopy MarketTangential Flow Filtration MarketSterile Filtration MarketStem Cell Banking Market Stem Cell Assay Market

3. Global Biobanking Market, by Products and services:3.1 Equipment3.1.1 Storage3.1.2 Sample analysis3.1.3 Sample Processing3.1.4 Sample Transportation3.2 Consumables3.2.1 Storage3.2.2 Analysis3.2.3 Processing3.2.4 Collection3.3 Services3.3.1 Storage Services3.3.2 Processing Services3.3.3 Transport Services3.3.4 Supply Services3.4 Software

4. Global Biobanking Market, by Application:4.1 Manual4.2 Automated

5. Global Biobanking Market, by Region:5.1 North America (U.S., Canada, Mexico)5.2 Europe (Germany, UK, France, Rest of Europe)5.3 Asia Pacific (China, India, Japan, Rest of Asia Pacific)5.4 Latin America (Brazil, Argentina, Rest of Latin America)5.5 Middle East & Africa

Competitive Landscape:The major players in the market are as follows:1. Thermo Fisher Scientific Inc.2. Panasonic Healthcare Holdings Co., Ltd.3. Becton, Dickinson and Company4. Qiagen N.V.5. Merck KGaA6. VWR Corporation7. Tecan Trading AG8. Brooks Automation, Inc.9. Chart Industries, Inc.10. Hamilton Company11. Greiner Holding AG12. Promega CorporationThese major players have adopted various organic as well as inorganic growth strategies such as mergers & acquisitions, new product launches, expansions, agreements, joint ventures, partnerships, and others to strengthen their position in this market.

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RESEARCH METHODOLOGY OF VERIFIED MARKET RESEARCH:Research study on the Biobanking Marketwas performed in five phases which include Secondary research, Primary research, subject matter expert advice, quality check and final review.The market data was analyzed and forecasted using market statistical and coherent models. Also market shares and key trends were taken into consideration while making the report. Apart from this, other data models include Vendor Positioning Grid, Market Time Line Analysis, Market Overview and Guide, Company Positioning Grid, Company Market Share Analysis, Standards of Measurement, Top to Bottom Analysis and Vendor Share Analysis.

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Biobanking Market Is Projected To Grow Vibrantly In The Upcoming Years 2020-2025 (Impact of COVID-19) - Cole of Duty

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Beware Fraud And Abuse Pitfalls In Precision Medicine – Law360

June 8th, 2020 12:44 am

Law360 (June 4, 2020, 4:18 PM EDT) -- Precision medicine has the potential to transform health care but also presents significant challenges from a regulatory perspective. In this article, we explore the federal fraud and abuse pitfalls inherent in certain precision medicine arrangements, particularly those affecting health systems and hospitals and clinical laboratories with which they routinely partner to perform genomic testing.

Precision medicine, sometimes referred to as personalized medicine, is the future of patient care, and has increasingly become a focal point for hospitals and health systems across the U.S. While the concept of accurate and precise medicine is not new,[1] advances in the fields of regenerative medicine,...

In the legal profession, information is the key to success. You have to know whats happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.

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ImmunoGen Appoints Stacy Coen as Senior Vice President and Chief Business Officer – Business Wire

June 8th, 2020 12:44 am

WALTHAM, Mass.--(BUSINESS WIRE)--ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, today announced that Stacy A. Coen has been appointed Senior Vice President and Chief Business Officer.

We are excited to welcome Stacy to the ImmunoGen leadership team as mirvetuximab soravtansine moves through registration studies and our early-stage pipeline continues to advance, said Mark Enyedy, ImmunoGens President and Chief Executive Officer. Stacy is a proven business leader with broad corporate strategy and business development expertise, and will play an important role in our organization as we continue to execute against our strategy, explore new opportunities for our pipeline, and seek to bring mirvetuximab to patients as quickly as possible.

Ms. Coen brings over 20 years of business and corporate development experience from leading oncology and rare disease companies. She joins ImmunoGen from Editas Medicine, where she served as Vice President, Business Development and was responsible for business development, strategy, transactions, and alliance management. Prior to joining Editas, Ms. Coen served in multiple roles of increasing responsibility at Genzyme Corporation (now known as Sanofi Genzyme), including Vice President, Head of Rare Disease Business Development and Licensing, and Vice President, Global Head of Strategy and Business Development, Multiple Sclerosis, among others. She currently serves on the Board of Trustees of Huntingtons Disease Society of America and is a member of MassBio and the Alliance for Regenerative Medicine (ARM). Ms. Coen received a BS in Finance and Economics from the University of Massachusetts and an MBA from the Darden Graduate School of Business at the University of Virginia.

I am delighted to join ImmunoGen as the Company works to bring its first product to market and advance a portfolio of novel ADCs, said Ms. Coen. I look forward to working with the talented team at ImmunoGen and contributing to the goal of delivering more good days to people living with cancer.

ABOUT IMMUNOGEN

ImmunoGen is developing the next generation of antibody-drug conjugates to improve outcomes for cancer patients. By generating targeted therapies with enhanced anti-tumor activity and favorable tolerability profiles, we aim to disrupt the progression of cancer and offer our patients more good days. We call this our commitment to target a better now.

Learn more about who we are, what we do, and how we do it at http://www.immunogen.com.

FORWARD LOOKING STATEMENTS

This press release includes forward-looking statements based on management's current expectations. These statements include, but are not limited to, ImmunoGens expectations related to the advancement of ImmunoGens research and development programs and Ms. Coens potential contributions to ImmunoGen. For these statements, ImmunoGen claims the protection of the safe harbor for forward-looking statements provided by the Private Securities Litigation Reform Act of 1995. Various factors could cause ImmunoGens actual results to differ materially from those discussed or implied in the forward-looking statements, and you are cautioned not to place undue reliance on these forward-looking statements, which are current only as of the date of this release. Factors that could cause future results to differ materially from such expectations include, but are not limited to: the timing and outcome of ImmunoGens pre-clinical and clinical development processes; the difficulties inherent in the development of novel pharmaceuticals, including uncertainties as to the timing, expense, and results of pre-clinical studies, clinical trials, and regulatory processes; ImmunoGens ability to financially support its product programs; risks and uncertainties associated with the scale and duration of the COVID-19 pandemic and resulting impact on ImmunoGens industry and business; and other factors more fully described in ImmunoGens Annual Report on Form 10-K for the year ended December 31, 2019 and other reports filed with the Securities and Exchange Commission.

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Stem Cell Therapy Seen to Help COPD Patients with Severe Inflammation – COPD News Today

June 6th, 2020 8:53 pm

Remestemcel-L, Mesoblasts lead candidate stem cell therapy for inflammatory diseases, improves lung function and exercise capacity in people with chronic obstructive pulmonary disease (COPD)and a high degree of inflammation, data from a post-hoc analysis of a Phase 2 trial show.

Findings were presented in an oral presentation at the 2020 International Society for Cell & Gene Therapy (ISCT) annual meeting, which took place virtually May 2829.

Remestemcel-L contains around 100 million of adult-derived mesenchymal stem cells (MSCs), cells that are able to give rise to nearly all tissues found in the body, including bones, muscles, and connective tissue.

MSCs are also thought to have strong immunomodulatory and anti-inflammatory properties, able to counteract the overactivation of the immune system and excessive inflammation. For that reason, remestemcel-L is being investigated as a potential therapy for acute graft-versus-host disease (GVHD,a potential life-threatening complication ofbone marrow transplant), and several other autoimmune and inflammatory diseases, including Crohns disease and COPD.

During ISCT, Mesoblast presented a post-hoc analysis of a Phase 2 trial (NCT00683722) that investigated the safety and efficacy of multiple doses of remestemcel-L in patients with moderate-to-severe COPD.

The trial, which concluded in August 2010, enrolled 62 patients who were randomly assigned to either four monthly intravenous infusions of remestemcel-L, containing about 100 million MSCs or to a placebo that lacked MSCs.

Patients were then monitored for two years. During follow-up, they completed several tests designed to assess their lung function and exercise capacity.

Lung function was evaluated based on two parameters: forced vital capacity(FVC), which measures the total amount of air a patient is able to exhale after a deep breath; and forced expiratory volume in one second(FEV1), which measures the total amount of air exhaled in one second after a deep breath.

Exercise capacity was assessed by thesix-minute walk distance (6MWD) test, which looks at total distance a patient is able to cover while walking for six minutes.

The goal of this post-hoc analysis was to compare the effects ofremestemcel-Lrelative to the placebo in patients who had high blood levels of the inflammatory markerC-reactive protein(CRP; 2 mg/mL or more) a protein whose levels rise in the presence of inflammation to patients with low blood levels.

Compared with placebo, remestemcel-L led to significant improvements in both lung function and exercise capacity measures in patients with high C-reactive proteinlevels at day 120 (about four months post-treatment).

Investigators also found these improvements to be more pronounced in those who had the highest blood levels of CRP (4 mg/mL or more), suggesting remestemcel-L is particularly beneficial for those with extensive inflammation. Among these patients, both FVC and FEV1 increased from baseline (study start), while they decreased in the placebo group. 6MWD also rose by a mean of 52 meters (about 171 feet) from baseline, while it dropped by about 3 meters (almost 1 foot) in those given a placebo.

The correlation between highest CRP levels and greatest degree of response to remestemcel-L suggests that the inflammatory component of the lung disease may trigger and be amenable to the immunomodulatory effects of treatment with remestemcel-L in patients with acute inflammatory conditions, Fred Grossman, chief medical officer of Mesoblast, said in a press release.

Since recurrent hospitalization rates and mortality in COPD are associated with both high levels of CRP and progressive decline in the six-minute walk test, these results suggest that remestemcel-L could provide longer-term benefits for COPD patients with high levels of inflammation, Grossman added.

These findings also provide a compelling rationale for the new Phase 3 trial (NCT04371393) assessing remestemcel-Lssafety and efficacy in about 300 people with acute respiratory distress syndrome (ARDS) associated with COVID-19, he said.

Top-line findings from this trial are expected in April 2021.

Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells cells that made up the lining of blood vessels found in the umbilical cord of newborns.

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Patrcia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

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FTC Sends Wave of Warning Letters to Stop Unsupported Claims Products and Therapies Effectively Prevent or Treat COVID-19 – MyChesCo

June 6th, 2020 8:53 pm

WASHINGTON, D.C. The Federal Trade Commission announced it has sent letters warning 35 more marketers nationwide to stop making unsubstantiated claims that their products and therapies can treat or prevent COVID-19, the disease caused by the novel coronavirus.

This is the sixth set of warning letters the FTC has announced as part of its ongoing efforts to protect consumers from health-related COVID-19 scams. In all, the Commission has sent similar letters to more than 160 companies and individuals.

Most of the letters announced this week target treatments offered in clinics or medical offices, including intravenous (IV) Vitamin C and D infusions, supposed stem cell therapy, and vitamin injections that may at first glance appear to be based in medicine or proven effective. However, currently there is no scientific evidence that these, or any, products or services can treat or cure COVID-19.

The FTC sent the letters to the companies and individuals listed below. The recipients are grouped based on the type of therapy, product, or service they pitched as preventing or treating COVID-19.

Intravenous (IV) and Ozone Therapies, Immunity Boosting Injections:

Stem Cell Treatments:

Electromagnetic Field Blocking Patches:

Essential Oils:

Homeopathic Treatments:

Vitamins, Supplements, Silver, and Chinese Herbal Treatments:

In the letters, the FTC states that one or more of the efficacy claims made by the marketers are unsubstantiated because they are not supported by scientific evidence, and therefore violate the FTC Act. The letters advise the recipients to immediately stop making all claims that their products can treat or cure COVID-19, and to notify the Commission within 48 hours about the specific actions they have taken to address the agencys concerns.

The letters also note that if the false claims do not cease, the Commission may seek a federal court injunction and an order requiring money to be refunded to consumers. In April, the FTC announced itsfirst case against a marketer of such products, Marc Ching, doing business as Whole Leaf Organics.

The FTC worked in coordination with the Office of the Texas Attorney General in issuing the warning letter to Hot Springs Biofeedback, and appreciates its assistance.

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Canine Stem Cell Therapy Market 2020 | by Manufacturers | by Countries | by Types and by Applications | by Forecasts to 2026 – 3rd Watch News

June 6th, 2020 8:53 pm

Global Canine Stem Cell Therapy Market Segment Analysis, Opportunity Assessment, Competitive Intelligence, Industry Outlook 2016-2026>This report offers a detailed view of market opportunity by end user segments, product segments, sales channels, key countries, and import / export dynamics. It details market size & forecast, growth drivers, emerging trends, market opportunities, and investment risks in over various segments in Canine Stem Cell Therapy industry. It provides a comprehensive understanding of Canine Stem Cell Therapy market dynamics in both value and volume terms.

New vendors in the market are facing tough competition from established international vendors as they struggle with technological innovations, reliability and quality issues. The report will answer questions about the current market developments and the scope of competition, opportunity cost and more.

The global canine stem cell therapy market was valued USD 118.5 Million in 2018 and is likely to reach USD 240.7 Million by 2026, with a compound annual growth rate of % over the forecast period 2019-2026.

The final report will add the analysis of the Impact of Covid-19 in this report Canine Stem Cell Therapy industry.

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This report focuses on the global Canine Stem Cell Therapy status, future forecast, growth opportunity, key market and key players. The study objectives are to present the Canine Stem Cell Therapy development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.

Table Of Content

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 North America

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendix

This report studies the Canine Stem Cell Therapy market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Canine Stem Cell Therapy market by product type and applications/end industries.

Customization of this Report: This report can be customized to meet the clients requirements. Please connect with our sales team ([emailprotected]), who will ensure that you get a report that suits your needs. For more relevant reports visitwww.reportsandmarkets.com

What to Expect From This Report on Canine Stem Cell Therapy Market:

The developmental plans for your business based on the value of the cost of the production and value of the products, and more for the coming years.

A detailed overview of regional distributions of popular products in the Canine Stem Cell Therapy Market.

How do the major companies and mid-level manufacturers make a profit within the Canine Stem Cell Therapy Market?

Estimate the break-in for new players to enter the Canine Stem Cell Therapy Market.

Comprehensive research on the overall expansion within the Canine Stem Cell Therapy Market for deciding the product launch and asset developments.

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Market research is the new buzzword in the market, which helps in understanding the market potential of any product in the market. Reports And Markets is not just another company in this domain but is a part of a veteran group called Algoro Research Consultants Pvt. Ltd. It offers premium progressive statistical surveying, market research reports, analysis & forecast data for a wide range of sectors both for the government and private agencies all across the world.

For more detailed information please contact us at:

Sanjay Jain

Manager Partner Relations & International Marketing

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Adipose Tissue-derived Stem Cell Therapy Market 2020 | by Manufacturers | by Countries | by Types and by Applications | by Forecasts to 2026 – Farmers…

June 6th, 2020 8:53 pm

The Adipose Tissue-derived Stem Cell Therapy Market report we provide to our readers contains comprehensive data on a specific product/service, available in this industry. We want to perform in-depth analysis, to obtain a comprehensive understanding of the Adipose Tissue-derived Stem Cell Therapy Market. It starts off by going to the basics of the product/service, which is to take a look at the industry definition. The Adipose Tissue-derived Stem Cell Therapy Market report identifies and analyzes the factors which contribute and hamper the growth of this line of business. At the same time, we identify the current value of the Adipose Tissue-derived Stem Cell Therapy Market, with the estimated financial worth, at the end of the forecast period, 2020-2026.

One metric we use to understand the potential growth of the Adipose Tissue-derived Stem Cell Therapy Market is to calculate the CAGR. It helps provide accurate data, improving the quality of the data collected for this report. We make sure to analyze all the information available in this document, to ensure it meets our standards. In this report, the reader will learn which elements are responsible for creating demand for the product/service under observation. At the same time, the reader will also get to know about product/service types that boost the popularity of this industry.

The key players covered in this study > AlloCure, Antria, Celgene Corporation, Cellleris, Corestem, Cytori Therapeutics, Intrexon, Mesoblast, Pluristem Therapeutics, Tissue Genesis, BioRestorative Therapies, Celltex Therapeutics Corporation, iXCells Biotechnologies, Pluristem Therapeutics, Cyagen, Lonza.

The final report will add the analysis of the Impact of Covid-19 in this report Adipose Tissue-derived Stem Cell Therapy industry.

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Market Segmentation

For the purpose of making the information available on Adipose Tissue-derived Stem Cell Therapy Market comprehensive, we segmented the industry. The reason is that it helps our readers learn in-depth about this line of business. The segmentation of the Adipose Tissue-derived Stem Cell Therapy Market is as follows distribution channel, product type, region, and application. When it comes to application, it deals with end-users, who are responsible for generating demand for the product/service. Product type refers to the different variants available in the Adipose Tissue-derived Stem Cell Therapy Market. We use distribution channel, to understand the various sources companies use to supply the product/service to the consumers.

Regional Overview

In the regional overview portion, the Adipose Tissue-derived Stem Cell Therapy Market report has data from countries all over the world. Each region is responsible for contributing to the growth of this industry. From the available data, we will identify which area has the largest share of the market. At the same time, we will compare this data to other regions, to understand the demand in other countries. North and South America, Asia Pacific, Middle East and Africa, and Europe are the areas of interest in this Adipose Tissue-derived Stem Cell Therapy Market report.

Table Of Content

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 North America

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecast 2020-2026

14 Analysts Viewpoints/Conclusions

15 Appendix

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Latest Industry News

We will cover government policies, which favor or go against the Adipose Tissue-derived Stem Cell Therapy Market, as we believe this can change the level of growth. At the same time, technological advancements which have the power to influence the growth will appear in the latest industry news.

Any special requirements about this report, please let us know and we can provide custom report.

About Us:

Market research is the new buzzword in the market, which helps in understanding the market potential of any product in the market. Reports And Markets is not just another company in this domain but is a part of a veteran group called Algoro Research Consultants Pvt. Ltd. It offers premium progressive statistical surveying, market research reports, analysis & forecast data for a wide range of sectors both for the government and private agencies all across the world.

For more detailed information please contact us at:

Sanjay Jain

Manager Partner Relations & International Marketing

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Ph: +1-352-353-0818 (US)

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Global Adipose Tissue-derived Stem Cell Therapy Market 2020 (Coronavirus (COVID-19) Business Impact and Analysis) | Research Industry – SG Research…

June 6th, 2020 8:53 pm

The report study researched by Research Industry US gives comprehensive knowledge and valuable insights about the Global Adipose Tissue-derived Stem Cell Therapy Market. Also, the study attempts to deliver significant and detailed insights into the current market prospect and emerging growth scenarios. The report on the Global Adipose Tissue-derived Stem Cell Therapy Market also emphasizes on market players as well as the new entrants in the market landscape.

Global Adipose Tissue-derived Stem Cell Therapy Market is estimated to reach $XX billion in 2019 with a CAGR of XX% from 2019 to 2025.

Download Free Sample PDF Report (including COVID19 Impact Analysis, full TOC, Tables and Figures) of Global Adipose Tissue-derived Stem Cell Therapy Market @ http://researchindustry.us/report/global-adipose-tissue-derived-stem-cell-therapy-market-rie/347985/request-sample

The Global Adipose Tissue-derived Stem Cell Therapy Market report is a precise and deep-dive study on the current state that aims at the major drivers, market strategies, and imposing growth of the key players. Worldwide Adipose Tissue-derived Stem Cell Therapy Market Industry also offers a granular study of the dynamics, segmentation, revenue, share forecasts, and allows you to make superior business decisions. The report serves imperative statistics on the market stature of the prominent manufacturers and is an important source of guidance and advice for companies and individuals involved in the Adipose Tissue-derived Stem Cell Therapy Market industry.

Impact of Coronavirus (COVID-19) on Global Adipose Tissue-derived Stem Cell Therapy Market.

Coronavirus (COVID-19) is spreading across the world with a serious impact on the economy and the global market. The report considers and accounts for the impact of COVID-19 on Global Adipose Tissue-derived Stem Cell Therapy Market across all the segments, regions, countries, and key players. North America and Europe are worst-hit countries by Coronavirus which are key players in the global economy. The report provides a detailed analysis of the impact on the market, growth strategies, supply china disruption, consumption pattern of the Global Adipose Tissue-derived Stem Cell Therapy Market.

The report provides market size with 2019 as the base year in consideration and a yearly forecast until 2026 in terms of Revenue (USD Million). The estimates for all segments including type and application have been provided on a regional basis for the forecast period mentioned above. We have implemented a mix of top-down and bottom-up approaches for market sizing, analyzing the key regional markets, dynamics, and trends for various applications.

Browse Complete Report Description and Full TOC @ http://researchindustry.us/report/global-adipose-tissue-derived-stem-cell-therapy-market-rie/347985

The Global Adipose Tissue-derived Stem Cell Therapy Market has been estimated by integrating the regional markets.

By Type:

Autologous Stem CellsAllogeneic Stem Cells

By Application:

Therapeutic ApplicationResearch Application

Competitive Landscape:

Key players profile in the report include

AlloCureMesoblastCelllerisAntriaIntrexonCelgene CorporationTissue GenesisCytori TherapeuticsCorestemPluristem TherapeuticsCyagenBioRestorative TherapiesLonzaPluristem TherapeuticsCelltex Therapeutics CorporationiXCells Biotechnologies

The report of Global Adipose Tissue-derived Stem Cell Therapy Market studies the key players present in the market. The chapter includes the competitive landscape section which provides the full and in-depth analysis of the current market trends, changing technologies, and developments that will be beneficial for the companies, which are competing in the market. The report offers an overview of revenue, demand, and supply of data, futuristic cost, and growth analysis during the projected year. In addition to a brief overview of the company, analysts shed light on their valuation and evolution. It also discusses the list of important products and the ones in the pipeline. The competitive landscape is analyzed by understanding the approaches of the companies and the initiatives they have taken in recent years to triumph over the intensive competition.

A section of the report has given complete information about regional analysis. It provides a market outlook and positions the forecast within the context of the overall Global Adipose Tissue-derived Stem Cell Therapy Market. Research Industry US has segmented the Global Adipose Tissue-derived Stem Cell Therapy Market into major geographical regions such as North America, Europe, Asia Pacific, South America, and the Middle East and Africa. Potential new entrants desiring to target only high growth areas are also incorporated in this informative section of the Global Adipose Tissue-derived Stem Cell Therapy Market.

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Report Objectives:

Get In Touch!Research IndustryNavale ICON IT Park,Office No. 407, 4th Floor, Mumbai Banglore Highway, Narhe, PuneMaharashtra 411041Phone +1 213-275-4706Emailsales@researchindustry.us

David Barstow is a senior editor at SG Research Sphere covering products, apps, services, and consumer tech issues and trends. He is very active in social media and collects regular information for the company. He brings a great vision to the nexus of content and the social, digital, video and pragmatic network. He has eight years of experience with his expertise in conglomerate industries.

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Current and Future Trend of Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market by 2026 – Cole of Duty

June 6th, 2020 8:53 pm

Los Angeles United States: QY Research always aims at offering its clients an in-depth analysis and the best research material of the various market. This new report on the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market is committed to fulfilling the requirements of the clients by giving them thorough insights into the market. An exclusive data offered in this report is collected by research and industry experts.

Key Manufacturers operating in the Report Are: , Orange County Hair Restoration Center, Hair Sciences Center of Colorado, Anderson Center for Hair, Evolution Hair Loss Institute, Savola Aesthetic Dermatology Center, Virginia Surgical Center, Hair Transplant Institute of Miami, Colorado Surgical Center & Hair Institute

The global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market report covers scope and product overview to define the key terms and offers detailed information about market dynamics to the readers. This is followed by the regional outlook and segmental analysis. The report also consists of the facts and key values of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market in terms of sales and volume, revenue, and growth rate.

One of the important factors in the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market report is the competitive analysis. The report covers all the key parameters such as product innovation, market strategies of the key players, market share, revenue generation, latest research and development, and market expert views.

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global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market by Segment Type: Platelet Rich Plasma Injections, Stem Cell Therapy

global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market by Application: Dermatology Clinics, Hospitals

Some of the important factors such as marketing strategy, industrial chain, factor analysis, cost analysis, distributors and sourcing strategy are included in this report which makes it an exclusive one. The aim of QY Research is to offer a comprehensive report. The report on global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market report is compiled by industry experts and properly examined which will highlight the key information required by the clients.

Regional Analysis

A section of the report has given comprehensive information about regional analysis. It provides a market outlook and sets the forecast within the context of the overall global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market. QY Research has segmented the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market into major geographical regions such as North America, South America, Europe, Asia Pacific, and the Middle East and Africa. Potential new entrants wishing to target only high growth areas are also included in this informative section of the global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market.

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Major Points from Table of Content:

Chapter One: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market Overview

Chapter Two: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market Competition by application, by Players/Suppliers, and by Type

Chapter Three: North America Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Four: Europe Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Five: Japan Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Six: China Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Seven: India Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Eight: Southeast Asia Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market (sales price, volume, and value)

Chapter Nine: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market industrial cost analysis

Chapter Ten: Downstream buyers, industrial chain and sourcing strategy

Chapter Eleven: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market Sales data and suppliers profiles/players

Chapter Twelve: Market effect factor analysis

Chapter Thirteen: Traders/Distributors, marketing strategy analysis

Chapter Fourteen: Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies market forecast (2020-2026) analysis

Chapter Fifteen: Conclusion and research findings

Chapter Sixteen: Annexure/Appendix

About Us

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Current and Future Trend of Global Stem Cell and Platelet Rich Plasma (PRP) Alopecia Therapies Market by 2026 - Cole of Duty

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GC027 Shows Promise as Therapy for Adult Relapsed, Refractory T-Cell ALL – Hematology Advisor

June 6th, 2020 8:51 pm

GC027,the first humanized chimeric antigen receptor (CAR)-T cell therapy for relapsed/refractoryT-cell acute lymphoblastic leukemia (T-ALL) in adults, appears to be botheffective and have a manageable safety profile, according to research presentedduring the ASCO20 Virtual Scientific Program.

Mortalityrates are high in relapsed/refractory T-ALL, necessitating novel treatments toimprove survival. CD7, a T-cell antigen expressed in more than 95% of diseasesamples, represents a plausible target in this setting. GC027, which targetsCD7 and was developed using using lentivirus and CRISPR/Cas9, showed promise inmurine models for treating T-ALL.

For this single-arm, open-label study, researchers evaluated the safety and efficacy of GC027 in relapsed/refractory T-ALL. All included patients were between 18 and 70 years old, had a projected survival of more than 3 months, and had a performance status of 0 to 2. Patients with extramedullary disease or central nervous system involvement were not eligible to participate.

Fivemen (median age, 24 years) were enrolled in the trial. The median number ofprior lines of therapy was 5, no patients had undergone prior stem celltransplantation, and the median baseline bone marrow tumor burden was 38.2%.

All5 patients had a complete response or complete response with incomplete hematologicrecovery, and 4 of the 5 patients were minimal residual diseasenegative.

Allpatients also experienced grade 3 (4 patients) or 4 (1 patients) cytokinerelease syndrome; no grade 5 events of any kind were reported.

Witha single infusion of GC027, 80% of the patients had robust CAR-T cell expansionand achieved persistent [minimal residual diseasenegative complete response]without using any biologics as part of the preconditioning therapy or bridgingto [hematopoietic stem cell transplantation], the authors wrote.

Wang X, Li S, Gao L, et al. Safety and efficacy results of GC027: The first-in-human, universal CAR-T cell therapy for adult relapsed/refractory T-cell acute lymphoblastic leukemia (r/r T-ALL). Presented at: ASCO20 Virtual Scientific Program. J Clin Oncol. 2020;38(suppl): abstr 3013.

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GC027 Shows Promise as Therapy for Adult Relapsed, Refractory T-Cell ALL - Hematology Advisor

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Ide-cel Appears Active in Almost Three-Fourths of Heavily Pretreated Patients with Myeloma – Cancer Network

June 6th, 2020 8:51 pm

Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeting CAR T-cell therapy, yielded a response in73% of patients with heavily pretreated relapsed/refractory multiple myeloma, according to topline findings from the pivotal phase 2 KarMMA trial shared during the 2020 ASCO Virtual Scientific Program.

In the study, 33% of patients had a complete response with ide-cel. The median duration of response (DOR) was 10.7 months, and the median progression-free survival (PFS) was 8.8 months (95% CI, 5.6-11.6).

Ide-cel demonstrated frequent, deep, and durable responses in heavily pretreated, highly relapsed/refractory patients with myeloma, said Nikhil C. Munshi, MD, director of Basic and Correlative Science, Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute, professor of Medicine, Harvard Medical School. Overall, ide-cel provides an attractive option for the treatment of patients with triple-class exposed relapsed/refractory myeloma.

In March 2020, Bristol Myers Squibb and bluebird bio, Inc., the codevelopers of ide-cel, submitted a Biologics License Application (BLA) to the FDA for the use of the CAR T-cell therapy as a treatment for adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

However, earlier this month, the FDA issued a Refusal to File letter to the companies regarding the BLA. In its initial review, the agency concluded that additional information was needed for the Chemistry, Manufacturing and Control module of the BLA. The FDA did not ask for any further clinical or nonclinical data according to the companies, which plan to resubmit the application by the end of July of this year.

The phase 2 KarMMA trial (NCT03361748) included 128 patients with relapsed/refractory multiple myeloma who received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

The median age was 61 months (range 33-78), 35% of patients had high-risk cytogenetics, 51% had high tumor burden, 39% had extramedullary disease, and 85% had 50% tumor BCMA expression. ECOG performance status was 0 (45%), 1 (53%), or 2 (2%). R-ISS disease stage was I (11%), 2 (70%), or III (16%). Patients had received a median of 6 (range, 3-16) prior antimyeloma regimens.

Ninety-four percent of patients had received 1 prior autologous stem cell transplant, and 34% had received more than 1. Eighty-eight percent of patients received bridging therapies during CAR T-cell manufacturing; however, only 4% of patients responded to the treatment. Regarding refractory status, 94% of patients were refractory to anti-CD38 antibodies and 84% were triple refractory.

Patients were treated at CAR+ T cell doses of 150 x 106 (n = 4), 300 x 106 (n = 70), or 450 x 106 (n = 54). The median follow-up was 18 months, 15.8 months, and 12.4 months, respectively. Across all patients, the median follow-up was 13.3 months. The primary end point was ORR, with secondary end points including CR, DOR, PFS, overall survival (OS), and quality of life.

Across all patients, the 73% ORR (95% CI, 65.8-81.1; P <.0001) included a 33% CR rate (95% CI, 24.7-40.9; P <.0001), a 20% very good partial response rate, and a 21% partial response rate. The overall CR rate comprised 26% of patients who achieved a CR/stringent CR (sCR) and were minimal residual disease (MRD)-negative, and 7% of patients who achieved a CR/sCR but who did not have MRD data. The median time to first response was 1 month (range, 0.5-8.8) and the median time to CR was 2.8 months (range, 1-11.8).

Durable responses were observed across all doses, said Munshi. At the dose of 450 x 106 CAR+ T cells, the ORR was 82% and the CR/sCR rate was 39%.

Clinically meaningful efficacy in terms of ORR was observed across subgroups, irrespective of age, risk categorization, tumor burden, BCMA expression level, extramedullary disease, triple-refractory status, penta-refractory status, and bridging therapy.

PFS increased as the target dose increased. At the 450 x 106 CAR+ T-cell dose, the median PFS was 12.1 months (95% CI, 8.8-12.3). The median PFS also increased by depth of response with a median of 20.2 months (95% CI, 12.3not evaluable) among patients who achieved a CR/sCR.

Munshi said the survival data are immature. At the time of the analysis, the median OS was 19.4 months (95% CI, 18.2not evaluable) and the 1-year OS rate was 78%.

Cytokine release syndrome (CRS) frequency increased with dose but was mostly low-grade, said Munshi. Overall, 84% of patients had 1 CRS event, with the majority (78%) being grade 1/2. There were 5 cases of grade 3 CRS, 1 case of grade 4, and 1 case of grade 5. The median time to onset of CRS was 1 day (range, 1-12), and the median duration of CRS was 5 days (range, 1-63). Fifty-two percent of patients received tocilizumab (Actemra) for CRS management, and 15% of patients received corticosteroids.

Neurotoxicity was mostly low grade and was similar across target doses, said Munshi. Overall, 18% of patients had 1 neurotoxicity event. There were 19 cases of grade 1/2 neurotoxicity and 4 cases of grade 3. There were no grade 4 or 5 incidents. The median time to onset of neurotoxicity was 2 days (range, 1-10), and the median duration was 3 days (range, 1-26). Two percent of patients received tocilizumab for neurotoxicity, and 8% of patients received corticosteroids.

The other significant adverse event, according to Munshi, was cytopenia91% of patients had any grade neutropenia (89% grade 3), and 63% (52% grade 3) had any grade thrombocytopenia. The median time to recovery of grade 3 neutropenia and thrombocytopenia was 2 months and 3 months, respectively, said Munshi.

There were 5 deaths within 8 weeks of ide-cel infusion2 following myeloma progression and 3 from AEs (CRS, aspergillus pneumonia, and GI hemorrhage). There was also 1 other AE-related death (CMV pneumonia) that occurred within 6 months, in the absence of myeloma progression.

Reference:

Munshi NC, Anderson Jr LD, Jagannath S, et al. Idecabtagene vicleucel (ide-cel; bb2121), a BCMA-targeted CAR T-cell therapy, in patients with relapsed and refractory multiple myeloma (RRMM): Initial KarMMa results. Presented at: 2020 ASCO Virtual Scientific Program; May 29-31, 2020. Abstract 8503.

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Experts answer your COVID-19 questions: ‘If two relatives had coronavirus and are now negative, am I safe to be with them if I have not?’ -…

June 6th, 2020 8:51 pm

Have a question about coronavirus, also known as COVID-19?

We will ask the experts.

Send questions to tribdem@tribdem.com.

A reader of The Tribune-Democrat asked:

If you have been around someone with COVID-19 antibodies, do you have to quarantine?

The answer:

SARS-CoV-2 (COVID-19) antibodies include IgM and IgG. IgM is usually the first antibody produced by the immune system when a virus attacks. A positive IgM test indicates that you may have been infected and that your immune system has started responding to the virus.

IgM detection with COVID-19 is a median five days (range three to six days). IgG antibodies are detected in most patients 10 to 21 days (median 14 days) after symptoms of COVID-19 begin. IgG antibodies remain in the blood after the infection has passed.

IgG antibodies also indicate that you may have had COVID-19 in the past, and these antibodies may protect you from future infection. It is unknown at this time how much protection antibodies might provide against reinfection.

If the individual had a positive IgM antibody test, I recommend a molecular Polymerase Chain Reaction (PCR) swab test and quarantine until the PCR test result is available.

If the individual had a positive IgG antibody test and symptoms such as fever, cough and/or shortness of breath 10 to 21 days ago, I also recommend a PCR swab test and quarantine until the PCR result is available.

If the individual has positive IgG antibodies, no recent symptoms and no fever, then no further testing is indicated and quarantine is not necessary.

In summary, it depends on which antibody was detected and if the individual had recent COVID-19 symptoms and/or fever.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If two relatives had coronavirus and are now negative, am I safe to be with them if I have not?

The answer:

A recent study from the Korean Centers for Disease Control and Prevention tracked 285 COVID-19 survivors who had tested positive for the coronavirus after their illness had apparently resolved, as indicated by a previous negative test result. The virus samples collected from them couldnt be grown in culture, indicating the patients were shedding non-infectious or dead virus particles.

So once you recover, and you have no symptoms or fever, its safe to go out in public. However, I would recommend continuing to follow CDC precautions, including social distancing, good hand-washing hygiene, and wearing a face mask.

Since the pandemic was just recently declared on March 11, there is no data on long-term immune response.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

After much concentration with social distancing and staying at home I inadvertently drank from a soda my granddaughter had been drinking from. She is from a family of four with no apparent symptoms. I am 70 years old with Type 2 diabetes. Is there testing we should have done following this incident or any additional measures? Im nervous that after all my efforts the past 2 1/2 months that I will contract the virus.

The answer:

I congratulate you on all your efforts and safe practices. In my opinion, no testing is indicated unless you develop any symptoms or fever, and no additional measures are needed.

I believe your risk is very low concerning the one incident which you described, and I would not worry. I do recommend that you continue social distancing, good hand washing hygiene, and wearing a face mask. Youre doing a great job!

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

My employer has required me to havetwo negative tests before returning to work. How long do I have to wait after my first negative test before I can get my second test?

The answer:

The CDC has placed guidelines concerning returning to work after recovery from COVID-19.

These guidelines state that an individual should havetwo consecutive negative results of an FDA-approved COVID-19 molecular assay for detection of SARS-CoV-2 RNA from at least two consecutive respiratory specimens collected greater than 24 hours apart.

Therefore, the least amount of time between testing that can occur is 25 hours.

It is important to point out that an individual must havetwo consecutive negative tests, and results for these tests can take several days to be returned to the individual.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

I am a personal trainer who has had an 89-year-old client request that I come to her home to train her. Besides being a trainer, I also have a part-time job at a regional airport near my home where I handle bagsand check in passengers, as well as cleaning the plane. I am very careful when I work about wearing a mask, gloves, using social distancing and washing my hands. Is it safe for my client if I train her?

The answer:

Im glad that you are using personal protective equipment (PPE) and practicing good hand-washing hygiene. The question of risk exposure for an 89-year-old individual is not insignificant, even though you are taking appropriate precautions.

In the United States, the highest incidence of severe outcomes with COVID-19 were in patients older than 85. Therefore, visitors other than caregivers are not recommended.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

I am 75 and have Post Polio Syndrome, chronic bronchitis and shingles. My husband is going back to work at an auto glass manufacturer. How can I isolate in my home? We also have three dogs. Could they carry the virus to me if he gets sick?

The answer:

Self-isolate in a private room and use a private bathroom, if possible. Wear a mask when you enter general living areas. Follow other Pennsylvania Department of Health and CDC recommendations and precautions including good hand-washing hygiene and frequently clean with a sanitizer common surfaces you may both touch.

CDC is aware of a small number of pets worldwide, including cats and dogs, reported to be infected with the virus that causes COVID-19, mostly after close contact with people with COVID-19. Based on the limited information available to date, the risk of animals spreading COVID-19 to people is considered to be low.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

I have symptoms of COVID-19 and am scheduled to do my test this morning. It will taketwo days to get results. Is it safe to use my inhaler and nasal spray? And if my test is positive, is it safe to use my inhaler and nasal spray?

The answer:

Im not aware of any inhaler and/or nasal spray contraindications with SARS-CoV-2 (COVID-19). I recommend that you follow-up with your primary care physician.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If the virus has a very short life in/on non-living environments, why is it so important to deep clean spaces that have been vacated for several months?

Wouldnt routine cleaning suffice before the space is occupied again?

The answer:

Cleaning spaces that have been vacant for several months with a deep cleaning is a good idea in general. Many microbes could be present on these surfaces (Staphyloccous and Streptococcus species for example).

There have been news stories circulating that the CDC has changed their guidelines on how SARS CoV-2 spreads. This is untrue. The CDC merely placed the contaminated surfaces under a subcategory stating that the virus does not easily spread via contaminated surfaces. Both the old and new versions of the recommendations state that it is known that the virus can survive on contaminated surfaces for hours to days depending on the surface.

The best way to reduce risk of infection is to wash your hands regularly and clean surfaces with soap and water followed by a disinfectant.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

My husband had COVID-19 symptoms, a sore throat,and because he is 63 years old, we wanted to check to see if he is OK. His results came back positive and he is on a 14-day quarantine. We have now all been tested in the family. So far my youngest daughters results came back negative. Should she move out to be safe?

The answer:

I am assuming the test that all of you received was the genome test. If your husband was positive for the genome, that is indicative of an active infection. This means he is contagious. He needs to quarantine himself and limit the exposure to other family members. It is recommended that high-touch surfaces be cleaned multiple times a day as well.

It is prudent for your daughter (and any other family member who tested negative) to self-isolate in a separate part of the home. Since she is currently living in your home and your husband tested positive, there may have been exposure to SARS CoV-2 since the testing. Testing gives us a snapshot of what is occurring, and since you are all in the same household, there could have been exposure after testing.

If she has a place to go to for 14 days where she is not risking exposure to others, you may want to consider having her go there.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

If I pick up the virus from someone at noon, how soon do I start infecting others?

The answer:

A small number of studies suggest that some people can be contagious during the incubation period, the time between exposure to the virus and the onset of symptoms. The incubation period for SARS-CoV-2 (also known as the COVID-19 virus) is estimated to be between two and 14 days, with a median of five to seven days (possibly longer in children). Greater than 95% of patients develop symptoms within 10-12 days of infection.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

My ex and I have shared custody. She just called to say shes in quarantine waiting for COVID-19 test results. I have the children now, but she had them last week before her quarantine.

Do we need to quarantine now until we hear her results? From a concerned father.

The answer:

Yes, self-isolate to your home while you wait for her results. Whoever else lives in your home should also stay at home. Close contacts are people who have been withinsix feet of you for a period of 10 minutes or more. If you or the children develop symptoms, notify your health-care provider for instructions and testing.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

How can I keep COVID-19 from spreading in my home once I turn on my whole-house air conditioning? My husband works and I am doing my best to isolate him in his room and a bathroom across the hall.

The answer:

There have been two studies that show the airborne droplets containing SARS-CoV2 can spread farther than six feet when the airflow in a room is increased (either from an air conditioner or a heating system). These systems often draw air in from a room and cool it, sending the cool air throughout the home and the heat outside. This type of system has the potential to circulate the virus in a home if someone is infected.

A study out of the University of Oregon together with the University of California-Davis says the best way to reduce the spread of the virus and still ventilate a room is to open a window. Opening a window in the home will reduce the possible virus concentration by increasing the concentration of air from the outside.

If you cant open the window (allergies, asthma, 95-degree heat) and there is concern that someone in the home is infected (showing symptoms, asymptomatic or exposed), you could block the intake vent in the room(s) that individual is isolating in.

Duct tape can cover the vent and help to reduce the spread of the virus through the home.

Jill D. Henning, associate professor of biology, University of Pittsburgh at Johnstown.

Is there a COVID-19 test my 3-year-old grandson can take that would allow him to stay with us for a day or two if he tests negative? I am 71, and would do anything to see him again.

The answer:

Molecular (Polymerase Chain Reaction PCR) swab test detects RNA from SARS-CoV-2, also known as the COVID-19 virus. If the PCR is positive, the patient is considered infected with the COVID-19 virus and presumed to be contagious.

You mention testing your grandson, but also consider testing the grandparents as well. However, it is important to emphasize that a negative PCR does not exclude COVID-19.

Also, realize that the mean incubation period for COVID-19 is five days, and the range can be two to 14 days. This means that a negative result does not rule out infection.

Dr. David Csikos, chief medical officer, Chan Soon-Shiong Medical Center at Windber.

If a persons antibody IgGand IgM came back positive, are they able to spread the virus because of the IGM result?

The answer:

Testing shows us a snapshot of what is happening with a person andhis/her course of disease. The two types of antibody tests are looking for a particular type of immune response.

When we are exposed to a pathogenic microbe, our immune system has two ways to defeat it.

The first is called the innate response. This response is encoded in our DNA as a human.

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Genetically modified mosquitoes could be released in Florida and Texas beginning this summer silver bullet or jumping the gun? – The Conversation US

June 6th, 2020 8:50 pm

This summer, for the first time, genetically modified mosquitoes could be released in the U.S.

On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population.

However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Coral reefs that can withstand rising sea temperatures, American chestnut trees that can survive blight and mosquitoes that cant spread disease are examples of how genetic engineering may transform the natural world.

Genetic engineering offers an unprecedented opportunity for humans to reshape the fundamental structure of the biological world. Yet, as new advances in genetic decoding and gene editing emerge with speed and enthusiasm, the ecological systems they could alter remain enormously complex and understudied.

Recently, no group of organisms has received more attention for genetic modification than mosquitoes to yield inviable offspring or make them unsuitable for disease transmission. These strategies hold considerable potential benefits for the hundreds of millions of people impacted by mosquito-borne diseases each year.

Although the EPA approved the permit for Oxitec, state approval is still required. A previously planned release in the Florida Keys of an earlier version of Oxitecs GM mosquito (OX513) was withdrawn in 2018 after a referendum in 2016 indicated significant opposition from local residents. Oxitec has field-trialed their GM mosquitoes in Brazil, the Cayman Islands, Malaysia and Panama.

The public forum on Oxitecs recent permit application garnered 31,174 comments opposing release and 56 in support. The EPA considered these during their review process.

However, it is difficult to assess how EPA regulators weighed and considered public comments and how much of the evidence used in final risk determinations was provided solely by the technology developers.

The closed nature of this risk assessment process is concerning to us.

There is a potential bias and conflict of interest when experimental trials and assessments of ecological risk lack political accountability and are performed by, or in close collaboration with, the technology developers.

This scenario becomes more troubling with a for-profit technology company when cost- and risk-benefit analyses comparing GM mosquitoes to other approaches arent being conducted.

Another concern is that risk assessments tend to focus on only a narrow set of biological parameters such as the potential for the GM mosquito to transmit disease or the potential of the mosquitoes new proteins to trigger an allergic response in people and neglect other important biological, ethical and social considerations.

To address these shortcomings, the Institute for Sustainability, Energy and Environment at University of Illinois Urbana-Champaign convened a Critical Conversation on GM mosquitoes. The discussion involved 35 participants from academic, government and nonprofit organizations from around the world with expertise in mosquito biology, community engagement and risk assessment.

A primary takeaway from this conversation was an urgent need to make regulatory procedures more transparent, comprehensive and protected from biases and conflicts of interest. In short, we believe it is time to reassess risk assessment for GM mosquitoes. Here are some of the key elements we recommend.

First, an official, government-funded registry for GM organisms specifically designed to reproduce in the wild and intended for release in the U.S. would make risk assessments more transparent and accountable. Similar to the U.S. database that lists all human clinical trials, this field trial registry would require all technology developers to disclose intentions to release, information on their GM strategy, scale and location of release and intentions for data collection.

This registry could be presented in a way that protects intellectual property rights, just as therapies entering clinical trials are patent-protected in their registry. The GM organism registry would be updated in real time and made fully available to the public.

Second, a broader set of risks needs to be assessed and an evidence base needs to be generated by third-party researchers. Because each GM mosquito is released into a unique environment, risk assessments and experiments prior to and during trial releases should address local effects on the ecosystem and food webs. They should also probe the disease transmission potential of the mosquitos wild counterparts and ecological competitors, examine evolutionary pressures on disease agents in the mosquito community and track the gene flow between GM and wild mosquitoes.

To identify and assess risks, a commitment of funding is necessary. The U.S. EPAs recent announcement that it would improve general risk assessment analysis for biotechnology products is a good start. But regulatory and funding support for an external advisory committee to review assessments for GM organisms released in the wild is also needed; diverse expertise and local community representation would secure a more fair and comprehensive assessment.

Furthermore, independent researchers and advisers could help guide what data are collected during trials to reduce uncertainty and inform future large-scale releases and risk assessments.

The objective to reduce or even eliminate mosquito-borne disease is laudable. GM mosquitoes could prove to be an important tool in alleviating global health burdens. However, to ensure their success, we believe that regulatory frameworks for open, comprehensive and participatory decision-making are urgently needed.

This article was updated to correct the date that Oxitec withdrew its OX513 trial application to 2018.

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Viewpoint: News or propaganda? UK newspaper the Guardian paid over $800k to publish anti-farming ‘investigation’ – Genetic Literacy Project

June 6th, 2020 8:50 pm

We grew up in an era when the mainstream media reported the news straightforwardly, but now much of it is bought and paid for. In other words, it is propaganda defined as information, especially of a biased or misleading nature, used to promote or publicize a particular political cause or point of view.

The British Guardian newspaper is Exhibit A, or maybe, as members of the scientific community, we should say Public Enemy No. 1. The paper sought and received a grant$886,600from an advocacy group, the Open Philanthropy Project (OPP), to publish a series titled Animals farmed. The grant spurred a succession of articles that paint animal husbandry variously as inhumane, unhealthy, or dangerous to the environment:

To put it bluntly, the transactional arrangement between The Guardian and OPP has yielded propaganda, not news.

The Guardians hypocrisy is prominently on display in view of its stated commitments: We will inform our readers about threats to the environment based on scientific facts, not driven by commercial or political interests, and The Guardians editorial independence means we set our own agenda and voice our own opinions. Our journalism is free from commercial and political influence.

We can cite 886,600 rebuttals to those hollow promises.

What motivates the Open Philanthropy Project? It supports animal welfare, as do we, but the group has a conflict of interest from a financial interest in a competitor of animal husbandry. That is revealedhereby University of California Davis Professor of animal science Frank Mitloehner:

The Guardian was a likely candidate for such a shady arrangement, in any case. For decades, it has been a predictable source of disinformation and fear-mongering about molecular genetic engineering in agriculture, including asympathetic descriptionof Greenpeaces rationale for the wanton destruction of genetically engineered crop research, and stories supportingcritics of genetic engineering. The Guardian even had the audacity to run astoryclaiming that Father of the Green Revolution Dr. Norman Borlaug, killed millions, when in fact his research arguablysaveda billion people from starvation.

The reality is that four decades of research and development on genetically engineered food crops has confirmed what theory predicted from the outset, and what data have reinforced repeatedly that the use of the technology confers no incremental risk and is essentially an extension, or refinement, of earlier, less precise techniques for genetic improvement, and that it could yield monumental commercial and humanitarian successes.

The Guardian frequently propagates the myth that the terms genetic modification and the common shorthand GMO (for genetically modified organism) represent a meaningful grouping of things that is, a genuine category. In fact, organisms improved with the newest molecular genetic engineering techniques and the foods derived from them do not in any way constitute meaningful groupings, which makes any choice of what to include in them wholly arbitrary and misleading. Nor have they been shown to be lesssafeor, given the pedigree of the foods in our diet, in any way less natural than thousands of other common foods.

Genetic modification by means of selection and hybridization to say nothing of the natural movement of genes, as part of Darwinian natural selection has been with us for millennia, and the techniques employed along the way, including the newest ones, are part of a seamless continuum. For more than a century, plant breeders routinely have used radiation or chemical mutagens on seeds to scramble a plants DNA to generate new traits.

Since the 1930s, wide cross hybridizations, which involve the movement of genes from one species or one genus to another, have given rise to plants thatdo not exist in nature; they include the varieties of corn, oats, pumpkin, wheat, rice, tomatoes and potatoes we buy and consume routinely. (Yes, even heirloom varieties and the overpriced, often inferiororganicstuff at Whole Foods.) With the exception of wild berries, wild game, wild mushrooms and fish and shellfish, virtually everything in North American and European diets has been genetically improved in some way.

The erroneous assumption that genetic modification is a meaningful category has led to various kinds of mischief, including the vandalization of field trials and the destruction of laboratories; local bans or restrictions; and a spate of spurious lawsuits of various kinds.

The Guardian has published a few accurate news articles about genetic engineering, such asoneabout Nobel Laureatesstatingthere are no unique health risks from GE crops, andanotherthat reported positive attributes about GE crops. The paper also ran anarticleby a British farmer that paints an accurate picture of animal agriculture.

But fear sells far better and can be more persuasive than facts and it gets more prominent presentation; recall the old adage about media, If it bleeds, it leads. In any case, those few do not undo the litany of misrepresentation and bias. Responsible journalism is not served by a false equivalence between inaccurate, scurrilous, hit-pieces whether paid for or not and accurate news or opinion articles, especially when the former have predominated for decades. The Guardians fear-mongering is part of a calculated information cascade that has stigmatized andstymiedthe adoption of this safe effective technology in many parts of the world.

In democracies, freedom of the press includes the right to be biased and dishonest. The Guardian invokes that right repeatedly and, thereby, lets down its readers.

Rob Wager is a researcher in the department of biology at Vancouver Island University. Follow him on Twitter @RobertWager1. Henry Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the U.S. FDAs Office of Biotechnology. Follow him on Twitter @henryimiller

This article was originally published at the American Council on Science and Health (ACSH) and has been republished here with permission. Follow ACSH on Twitter @ACSHorg

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Genetically Modified Mosquitoes Could be Released in Florida and Texas This Summer – The Daily Beast

June 6th, 2020 8:50 pm

This article originally appeared on The Conversation.

This summer, for the first time, genetically modified mosquitoes could be released in the U.S.

On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population.

However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.

Coral reefs that can withstand rising sea temperatures, American chestnut trees that can survive blight and mosquitoes that cant spread disease are examples of how genetic engineering may transform the natural world.

Genetic engineering offers an unprecedented opportunity for humans to reshape the fundamental structure of the biological world. Yet, as new advances in genetic decoding and gene editing emerge with speed and enthusiasm, the ecological systems they could alter remain enormously complex and understudied.

Recently, no group of organisms has received more attention for genetic modification than mosquitoesto yield inviable offspring or make them unsuitable for disease transmission. These strategies hold considerable potential benefits for the hundreds of millions of people impacted by mosquito-borne diseases each year.

Although the EPA approved the permit for Oxitec, state approval is still required. A previously planned release in the Florida Keys of an earlier version of Oxitecs GM mosquito (OX513) was withdrawn in 2016 after a referendum indicated significant opposition from local residents. Oxitec has field-trialed their GM mosquitoes in Brazil, the Cayman Islands, Malaysia and Panama.

The public forum on Oxitecs recent permit application garnered 31,174 comments opposing release and 56 in support. The EPA considered these during their review process.

However, it is difficult to assess how EPA regulators weighed and considered public comments and how much of the evidence used in final risk determinations was provided solely by the technology developers.

The closed nature of this risk assessment process is concerning to us.

There is a potential bias and conflict of interest when experimental trials and assessments of ecological risk lack political accountability and are performed by, or in close collaboration with, the technology developers.

This scenario becomes more troubling with a for-profit technology company when cost- and risk-benefit analyses comparing GM mosquitoes to other approaches arent being conducted.

Another concern is that risk assessments tend to focus on only a narrow set of biological parameterssuch as the potential for the GM mosquito to transmit disease or the potential of the mosquitoes new proteins to trigger an allergic response in peopleand neglect other important biological, ethical and social considerations.

To address these shortcomings, the Institute for Sustainability, Energy and Environment at University of Illinois Urbana-Champaign convened a Critical Conversation on GM mosquitoes. The discussion involved 35 participants from academic, government and nonprofit organizations from around the world with expertise in mosquito biology, community engagement and risk assessment.

A primary takeaway from this conversation was an urgent need to make regulatory procedures more transparent, comprehensive and protected from biases and conflicts of interest. In short, we believe it is time to reassess risk assessment for GM mosquitoes. Here are some of the key elements we recommend.

First, an official, government-funded registry for GM organisms specifically designed to reproduce in the wild and intended for release in the U.S. would make risk assessments more transparent and accountable. Similar to the U.S. database that lists all human clinical trials, this field trial registry would require all technology developers to disclose intentions to release, information on their GM strategy, scale and location of release and intentions for data collection.

This registry could be presented in a way that protects intellectual property rights, just as therapies entering clinical trials are patent-protected in their registry. The GM organism registry would be updated in real time and made fully available to the public.

Second, a broader set of risks needs to be assessed and an evidence base needs to be generated by third-party researchers. Because each GM mosquito is released into a unique environment, risk assessments and experiments prior to and during trial releases should address local effects on the ecosystem and food webs. They should also probe the disease transmission potential of the mosquitos wild counterparts and ecological competitors, examine evolutionary pressures on disease agents in the mosquito community and track the gene flow between GM and wild mosquitoes.

To identify and assess risks, a commitment of funding is necessary. The U.S. EPAs recent announcement that it would improve general risk assessment analysis for biotechnology products is a good start. But regulatory and funding support for an external advisory committee to review assessments for GM organisms released in the wild is also needed; diverse expertise and local community representation would secure a more fair and comprehensive assessment.

Furthermore, independent researchers and advisers could help guide what data are collected during trials to reduce uncertainty and inform future large-scale releases and risk assessments.

The objective to reduce or even eliminate mosquito-borne disease is laudable. GM mosquitoes could prove to be an important tool in alleviating global health burdens. However, to ensure their success, we believe that regulatory frameworks for open, comprehensive and participatory decision-making are urgently needed.

Written by Brian Allan, Associate Professor of Entomology, University of Illinois at Urbana-Champaign; Chris Stone, Medical Entomologist, University of Illinois at Urbana-Champaign; Holly Tuten, Vector Ecologist, University of Illinois at Urbana-Champaign; Jennifer Kuzma, Goodnight-NCGSK Distinguished Professor, North Carolina State University; Natalie Kofler, Levenick Resident Scholar in Sustainability, University of Illinois at Urbana-Champaign.

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How a new biotech rule will foster distrust with the public and impede progress in science – The Conversation US

June 6th, 2020 8:50 pm

In May, federal regulators finalized a new biotechnology policy that will bring sweeping changes to the U.S. food system. Dubbed SECURE, the rule revises U.S. Department of Agriculture regulations over genetically engineered plants, automatically exempting many gene-edited crops from government oversight. Companies and labs will be allowed to self-determine whether or not a crop should undergo regulatory review or environmental risk assessment.

Initial responses to this new policy have followed familiar fault lines in the food community. Seed industry trade groups and biotech firms hailed the rule as important to support continuing innovation. Environmental and small farmer NGOs called the USDAs decision shameful and less attentive to public well-being than to agribusinesss bottom line.

But the gene-editing tool CRISPR was supposed to break the impasse in old GM wars by making biotechnology more widely affordable, accessible and thus democratic.

In my research, I study how biotechnology affects transitions to sustainable food systems. Its clear that since 2012 the swelling R&D pipeline of gene-edited grains, fruits and vegetables, fish and livestock has forced U.S. agencies to respond to the so-called CRISPR revolution.

Yet this rule change has a number of people in the food and scientific communities concerned. To me, it reflects the lack of accountability and trust between the public and government agencies setting policies.

The USDA Animal and Plant Health Inspection Service, or APHIS, serves as the dominant U.S. regulator for plant health. Since the mid-1990s, genetically modified crops have typically fallen under APHIS oversight because Agrobacterium, a plant pest, is commonly used as a tool to engineer GM products. Using a plant pest did not prevent many GM crops from being approved. But it did mean that if APHIS suspected a plant pest or noxious weed had been created through genetic engineering, the agency would regulate the biotech product, including its release into the environment, and its import, handling, and interstate movement.

Changes to APHIS regulations began during the Obama administration. In January 2017, the agency released new draft rules. However, the Trump administration withdrew these nine months later after pushback from industry and biotech developers which argued that the rules would stifle innovation.

Last summer, USDA released a revised rule for public comment, which it finalized on May 18, 2020. Most changes go into effect in April 2021.

Hints to how USDA intended to treat gene-edited crops came early on, when Penn States nonbrowning mushrooms and DuPonts waxy corn were approved by APHIS in 2015 and 2016, respectively.

Then in March 2018, USDA Secretary Perdue clarified the agencys stance. USDA does not currently regulate, or have any plans to regulate, plants that could otherwise have been developed through traditional breeding techniques as long as they are developed without the use of a plant pest as the donor or vector and they are not themselves plant pests.

The new SECURE rule establishes several ways for developers to qualify for deregulated status. Included are CRISPR modifications like deletions of sections of the genetic code, tiny substitutions, and introductions of DNA from related species. So, for example, a CRISPRd cauliflower would not be regulated if a chunk of DNA was deleted. But it would still be regulated if CRISPR introduced foreign DNA into cauliflower in a way that USDA believes could turn the product into a plant pest.

Another significant change is that companies and scientists will get to decide for themselves if a new product qualifies for exemption from oversight. APHIS says that developers may consult regulators if at any point they arent sure if a new crop is exempt. However, the agency has already expressed confidence that only about 1% of plants might not qualify for an exemption or for deregulation after an initial review.

Ironically, this policy has begun aligning communities typically at loggerheads in the polarized GM conversation. For example, the UC-based Innovative Genomics Institute, founded by CRISPR co-inventor Jennifer Doudna, wrote in its public comments to APHIS: While we recognize the agencys rationale behind self-determination and desire to provide regulatory relief in order to spur innovation, we are concerned that rather than stimulating innovation, such an undisclosed step may have the effect of dampening trust through the loss of transparency in the development and oversight process.

Meanwhile, GM-watchdog organizations including the National Family Farmers Coalition, Pesticide Action Network and Friends of the Earth issued a joint press statement criticizing a rule that allows industry to self-determine its regulatory status. The new framework, they said, has dealt a devastating blow to the security of farmers livelihoods, the health of their farms and communities, and their ability to build the biodiverse, climate-resilient, and economically robust farming systems that we so urgently need.

My research on democratizing biotechnology has helped me unpack the problematic ways in which democracy is being hitched to technological innovation. When it comes to CRISPR, the public has been told that being cheap, easy to use and free from regulation is a powerful cocktail that makes gene editing intrinsically more democratic.

Like many convenient narratives, there are certain truths to this story. But just as clearly, cheapness is not equivalent to democratic. According to USDA, some 6,150 comments were received on the draft rule during the three-month public feedback period, a window designed to give citizens a say in government policy.

The agency admitted that most letters expressed general opposition to GE products. Of the comments that specifically addressed provisions of the rule, approximately 25 expressed some support for the rule. This means a vast majority of the comments did not. Yet, the USDA disregarded this feedback. Such a lack of civic input can lead to environmental and health concerns being sidelined.

Thoughtful scientists, social movements and governments are now asking if there is an alternative way to regulate engineered food. For example, the Norwegian Biotechnology Advisory Board has set out an ethics-based regulatory framework aimed at advancing genetic technology, while protecting community and environmental health and promoting societal welfare.

In the academic sphere, colleagues in Europe have proposed a framework for responsible innovation. I have developed a set of principles and practices for governing CRISPR based on dialogue with front-line communities who are most affected by the technologies others usher in. Communities dont just have to adopt or refuse technology they can co-create it.

One way to move forward in the U.S. is to take advantage of common ground between sustainable agriculture movements and CRISPR scientists. The struggle over USDA rules suggests that few outside of industry believe self-regulation is fair, wise or scientific.

At present, companies dont even have to notify the USDA of biotech crops they will commercialize. The result, as Greg Jaffe of the Center for Science in the Public Interest told Science, is that government regulators and the public will have no idea what products will enter the market. Farmers and everyone else will pay the price,said Jim Goodman, dairy farmer and board president of the National Family Farm Coalition.

Reclaiming a baseline of accountability, then, is the first step in building public confidence in regulatory systems that work for people as well as science that the public believes in.

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The pandemic, the environment and Cuba – OnCubaNews

June 6th, 2020 8:50 pm

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Perhaps it is difficult to find a moment in the history of humanity in which, in such a short time, such an enormous volume of information (and disinformation) has been generated about a problem that affects the entire human species, as what has happened with the COVID-19 pandemic. Nor has humanity faced such an uncertain near future.

In addition to the global health emergency, which has caused hundreds of thousands of deaths and more than 2 million infected people worldwide, this pandemic has put on the political table the unsustainability of the capitalist system worldwide, the paradigm of unlimited growth and the culture of growing consumer.

On Earth Day Coronavirus, a pollution hiccup?

Suddenly, the reality that we live on a limited planet, with increasingly scarce resources, and that in the biosphere all existence is interconnected, has unquestionably emerged. The zoonotic nature of the COVID-19 itself tells us of the direct transmission of the virus to humans, most likely due to the contact or consumption of wild species and even due to the natural boundaries being displaced and the loss of biodiversity. The fact that it expands globally also alerts us to the profound environmental changes caused by human action and its techno-industrial culture developed on the basis of fossil energy. We have to think about what can happen when, as a result of climate change, the thaws continue and the paleo viruses frozen thousands of years ago are released, in a period too fast for existing species, and especially humans, to adapt to that change. If we add to the above the unsustainability of production systems and value chains (think of stabled livestock, large extensions of monocultures, the application to these systems of agrochemicals, hormones, antivirals and genetic manipulation), we will have an approximate picture of the world that will emerge after the pandemic

This will be a challenge not only for science, which will have to rethink a series of paradigms, but also for world politics that has taken too long to have global agreements to slow down or minimize these processes; hence, one of the elements that should emerge from this experience at the global level is a more direct relationship between science and political decision-making at the country level.

After this pandemic, there will be no new normal, another world will have to be built and that construction will be carried out by all, with greater solidarity and conscious citizen participation, or it will be exercised through increasingly more authoritarian mechanisms of power; we can already see these trends in some governments.

The world as we have known it was structured from obtaining cheap fossil energy, which allowed a techno-industrial culture to develop in the last 200 years that led to the emergence of large human concentrations in megacities. The United Nations has predicted that the urban population will increase to 6.7 billion; that is, 68% of humanity by 2050. In that decade, if the current rhythm continues, there will be 43 megacities with more than 10 million inhabitants each, really something unsustainable for the planet. Current and future generations will be forced to rethink their lifestyles or be willing to live in a dystopian world of isolation, in which relationships must be mediated by technology.

The advances in technoscience in the last 20 years already present us with a new ethics, in which each human being is aware of their limits of all kinds.

Genetic engineering, with all its potential, implies the application of the precautionary principle for the introduction of each technological advance. We are still unaware of the many effects of new technologies on our health and the global environment, yet we continue to use them too frequently.

Over the past few months we have often seen on social media claims about the short-term recovery of natural spaces and wildlife activity in urban areas, dolphins swimming placidly in Venices canals, goats visiting Scottish historical sites, wild boars rummaging through the garbage in Paris and Barcelona. We have been glad that our brothers of other species recover their ancestral spaces even when it was our presence that expelled them; but this is all a fallacy. The processes of environmental deterioration at the planetary level continue, and their resilience, if they can start being reversed, will take years, but we have to start. Just think about these figures: in 2018, the burning of fossil fuels pumped 37.1 billion tons of carbon dioxide into the atmosphere. If we add to this the net carbon emissions caused by soil oxidation and the most vigorous forest fires, we can see why atmospheric concentrations of carbon dioxide reached an all-time high of 415 parts per million in early 2019.

Cubas challenges

Cuba has a different but contradictory panorama. A poor country, blocked for 60 years by the worlds greatest power and with a frankly deteriorating open economy (it is estimated that its GDP will decrease between 4 and 7% in 2020), with a large debt, without external financing, with a high rate of illiquidity, with a country risk like never before, perhaps it is the deepest point of the systemic crisis of its economy. This really places it in a very critical situation, above all due to the enormous supply crisis that threatens to become a food crisis as acute as that of the early 1990s. From the economic point of view, the only alternative is unblocking the mechanisms and to rapidly start applying the agreements contained in the Guidelines discussed massively 10 years ago and which inexplicably have not been applied.

I think that all Cubans could agree on the urgency of doing away with obstacles to agricultural production, the inefficiency of this sector and the dreadful methods of administration and management, which contrast with the statistics that show that most of the national food production is generated by small producers, then the assessment still has blank questions. Advancing towards an agriculture with low energy inputs, sustainable management of the soil and crops, rational use of water, that is, organic agriculture will benefit everyone, there are examples and very successful at that.

Cuba has potentialities that must be taken into account from an environmental point of view and that have been gradually implemented. Its energy dependence constitutes an Achilles heel for its economy and attempts are being made, with a very successful intensive policy, to decrease it with an accelerated increase in clean energy; the Cuban aquifer stock is limited, but the country has a very intelligent and well-structured water policy.

The development of the Cuban health policy with the pandemic has been successful so far and there is no indication that wont continue like this; the Cuban experience in the detection and control of epidemics has made it possible to establish mechanisms of local control and primary care that other countries have not been able to implement, just remember that Cuban doctors have participated in the control and treatment of epidemics such as Ebola in Africa and cholera in Haiti, in addition to the epidemics that for decades have been introduced in Cuba by foreign aggressions (swine fever, dengue, etc.). It is possible to think, unlike other countries, that the island will emerge from the pandemic in a relatively short period of time and with minimal impact on its population. For this reason, the greatest complexity will not be precisely the epidemic, but rather the food supply, and in this direction all the nations efforts must be applied; I say the nation, and not only the state. For its part, the government must open the floodgates to diverse productive forces, the effort is everyones.

On June 2, in commemoration of World Environment Day, the director general of the Environment Agency of the Cuban Ministry of Science, Technology and Environment (CITMA) expressed in a television appearance in Holgun a principle that will have to be present in the next designs of Cuban domestic policies, the interconnection of the natural world with society, or what is the same as the eco-social relationship of all the elements that make up and determine our environment. The relationship of science and politics must recognize that the Cuban territory is limited and all relationship we establish on it has a finite character and has a load capacity that cannot be exceeded. The celebration of June 5 this year is curious, because as always, it is a date in which the environmental work carried out for twelve months by each province and municipality is recognized, but now, in 2020 it will have to be done almost virtually due to the epidemic.

Thinking of Pinar del Ro, a province that this year was the best in its environmental work (the parameters established for the evaluation cover all the activities in the province of the different sectors that tend towards environmental sustainability), brings to mind the need to transfer the financing dedicated to the expansion of tourism to the reactivation and development of agriculture. Tourism is recognized in the world as the smokeless industry, but it is still an industry, it requires the import of all kinds of inputs, as well as being an eminently extractive activity. Today Cuba has a capacity per rooms that is far from the market demand for the island, the existing statistics do not exceed more than 30% of linear occupancy in the various destinations of the archipelago. If we add to this the globalized nature of tourism (it arises precisely with the development of capitalism in its last phase) and the physical interconnections that are established with visitors, even immunologically, we approach a portrait of an activity that is very profitable but that creates links of dependency on a specific and very fragile world market.

According to the activitys development plans in the near future, if the developmentalist vision continues to be applied in the tourism sector, Pinar del Ro will have a huge megaproject called Punta Colorada, which will cost billions of dollars and will have an impact, undoubtedly, on the marine-coastal ecosystems of the northwest of the province and in the Guanahacabibes and Viales biosphere reserves.

The COVID-19 epidemic in the world has put the neoliberal capitalist system in check. It will remain to be seen if it is able to resist this onslaught.

For Cuba it means the need and the urgency to consolidate what exists and works well and transform the inefficient, because for Cuba once again the possibility of creating an eco-socialist alternative with citizen participation is opening.

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Can Operation Warp Speed deliver a COVID-19 vaccine by the end of the year? – The Daily World

June 6th, 2020 8:50 pm

By Melissa Healy

Los Angeles Times

To capture the speed and audacity of its plan to field a coronavirus vaccine, the Trump administration reached into science fictions vault for an inspiring moniker: Operation Warp Speed.

The vaccine initiatives name challenges a mantra penned by an actual science fiction writer, Arthur C. Clarke: Science demands patience.

Patience is essential for those who ply the science of vaccines. But in that field, challenging economic conditions and a forbidding regulatory system converge with the immune systems complexity and the resilience of microscopic pathogens. Add in drug companies preference for big profits and the result is a trash heap of failed and abandoned efforts.

In the last 25 years, the U.S. Food and Drug Administration has approved new vaccines for only seven diseases. A vaccine to protect against the Ebola virus won approval just last year, three years after the epidemic in West Africa ended.

But in the midst of a COVID-19 pandemic that has killed more than 100,000 Americans and cratered the U.S. economy, Trump has shown little tolerance for sciences deliberate pace. And scientists, with fingers crossed, are falling in line.

The president declared that he wants 300 million doses enough to protect as many as 90% of Americans developed, manufactured and delivered by January 2021. He has ordered academics, government officials, private companies and the U.S. military to work together to make it so.

That means big and it means fast, Trump said. A massive scientific, industrial and logistical endeavor unlike anything our country has seen since the Manhattan Project.

The new effort will demand the support, development, testing and assessment of several promising vaccine candidates by scientists at the National Institutes of Health, the FDA and companies and academic institutions across the world.

It will require the manufacture, procurement and storage of complex biologic medicines, as well as the vials, needles, syringes and storage equipment needed to deliver them. All will be needed on a massive scale.

And all that materiel will need to be transported, distributed and possibly administered by an army of logistics specialists.

Wherever possible, Operation Warp Speed envisions that many steps that have always followed each other in strict sequence clinical trials and production, for instance, or government approval and supply-chain development be done in parallel.

The program has awarded a total of $2.16 billion so far to five companies with vaccine candidates at different stages of development.

To lead the effort, Trump tapped immunologist Moncef Slaoui, a pharmaceutical venture capitalist and former chairman of vaccines at the drug giant GlaxoSmithKline. The U.S. Armys most senior logistics and procurement specialist, Gen. Gustave Perna, will be the operations chief operating officer. Both expressed confidence in the operations success.

Pena called the project herculean. Slaoui, who has been criticized for holding a major stake in at least one of the vaccine makers that stands to benefit from Operation Warp Speed, told Trump we will do the best we can.

The time is short and the stakes are high. Just over four months after the coronavirus announced its presence inside the United States, President Trump is determined to send the country back to work.

With no effective treatment in sight, and no indication that the coronavirus would magically disappear, as Trump has frequently predicted, a vaccine will be the ultimate game changer in the pandemic, according Dr. Anthony Fauci, the nations leading expert on the outbreak.

Theres never a guarantee of success, Fauci said. But he added that he was cautiously optimistic that by winter, at least one of nearly a dozen promising vaccine candidates would have shown itself to be safe and effective in inducing immunity in humans.

Vaccine scientists are similarly cautious, especially of a testing schedule that will compress both the size and duration of safety and effectiveness trials and even overlap them in a bid to save time.

Its fine for politicians to say were going to have a vaccine next month, said Mayo Clinic immunologist Dr. Gregory Poland. But the literature is littered with false starts and unanticipated safety effects in vaccines.

Poland noted that a vaccines rarer side effects are often not recognized until its put into broad use. To ferret out an adverse outcome that only occurs in one person in 100,000, for instance, a company would need to test it in 384,250 people from broad backgrounds and with a variety of medical conditions, he said.

Such large trials are unlikely in the rush to field a vaccine, Poland said, and he fears the result could be a dangerous erosion of public trust. The yearly flu shot carries a risk of less than 1 in 1 million cases of the neurological complication Guillain-Barre syndrome, he said. And even with that low a risk, close to half of Americans refuse to get it.

You have a whole spectrum of people out there who wont be reassured by any amount of information, Poland said. If we dont pay strict attention to safety, this is going to backfire.

Money may help. Congress approved $8.3 billion in early March to fund federal agencies pandemic response. And scientists across the world have been scrambling to design vaccines to protect a population with no immunity to the deadly new pathogen.

Scientists in China, Kazakhstan, India, Russia, Germany, Sweden and the United States have brought 10 potential COVID-19 vaccines to the point where they are being evaluated in humans in some form. Another 115 are considered by the World Health Organization to be in the preclinical stage of development.

In some cases, these preclinical vaccine candidates are scarcely off the drawing board. In others, they are still being tweaked or tested in cells. Some are being tried in lab animals.

The prospective vaccines range widely in their design and novelty. There are those that challenge a persons immune system with a killed or attenuated virus, the traditional approach used by the polio vaccine and other immunizations. Others are products of genetic engineering and have never been tried in a vaccine before.

The vaccine candidates also vary in their ease of manufacture, the number of doses a patient needs to gain lasting immunity, and the way they are administered.

FDA Commissioner Dr. Stephen Hahn has said his agency evaluated about 10 vaccine candidates in early studies. By late May, it had narrowed its focus to five candidates that will begin a rapid and sometimes overlapping progression through human studies of safety and effectiveness.

Meanwhile, the groundwork for large-scale production is already being laid. Trump has said that the U.S. military may aid in the manufacture, and companies with the capability to produce vaccines will be recruited to do so.

Given the pressing urgency of the administrations deadline, vaccine candidates that can be produced fastest, transported most easily and administered to patients most efficiently will likely win the most and earliest support, experts said.

The redundancy built into Operation Warp Speed may also prove a vital safeguard against failure.

If the coronavirus shows signs that it is mutating in ways that could make one vaccine candidate ineffective, the scientific judges could swiftly shift their preferences toward a competitor that can be adapted more readily to changes in the virus. If rare but untoward effects show up with broader use, back-up vaccines could be brought on line. Some vaccines will be found to work better or worse in specific populations, and can be used accordingly.

The result will be an evolving panoply of vaccine choices, not only because some will be ready earlier than others, but because some will be more effective than others in certain populations.

There will be of necessity multiple types of vaccines, Poland said.

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Focus on the United Kingdom | 2020-06-01 – World Grain

June 6th, 2020 8:50 pm

The UK grains sector faces enormous change after almost five decades operating under the European Unions Common Agricultural Policy. It also faces enormous potential disruption following the UK exit from the EU on Jan. 31, unless a new trade deal with the EU can be made by the end of the year. At the same time, the sector is coping with the problems caused by the coronavirus (COVID-19) pandemic, with supply chains disrupted and new challenges from the need to feed a population in lockdown.

The International Grains Council (IGC) projects the UKs 2020-21 grains production at a total of 19.7 million tonnes, down from 25.7 million the year before. The countrys wheat production is put at 10 million tonnes, down from 16.3 million in 2019-20. Barley production is forecast to rise to 8.4 million tonnes, up from 8.2 million.

The UKs rapeseed crop is forecast at 1.3 million tonnes in 2020-21, compared with 1.8 million in 2019-20.

The Agriculture and Horticulture Development Board (AHDB) on Feb. 27 published a forecast putting 2019-20 wheat imports at 1.050 million tonnes, down 808,000 on the year before because of greater supply.

It is worth noting that the fall in imported demand is expected to be driven by the animal feed and bioethanol sectors, the AHDB commented. Imported wheat usage by flour millers is expected to be marginally higher year on year.

The AHDB forecast barley imports at 52,000 tonnes, down 18,000 on larger domestic supply. Maize imports in 2019-20 are put at 2.3 million tonnes. While the pace of maize imports is expected to slow somewhat over the next few months, imports may begin to increase again at the end of this season and into the 2020-21 season, due to its relative price compared with domestic grains.

Trade sources put likely imports of wheat at 2.6 million tonnes in 2020-21, with barley imports at 60,000 tonnes. Imports of rapeseed are forecast at 600,000 tonnes.

According to the National Association of British and Irish Millers (nabim), there are 32 companies, with a total of 51 milling sites in the countrys flour milling sector. Thirty-one are members of nabim, with 50 sites between them accounting for 99% of UK flour production. The association puts the industrys annual consumption of wheat to produce flour at 5 million tonnes, with some 1.3 million to 1.5 million tonnes used by starch and bioethanol producers.

The COVID-19 pandemic and the lockdown that has accompanied it has forced the industry to change. Following representations from nabim, the government decided to relax working time rules to help ensure deliveries. It also recognized food industry workers as key, giving them access to childcare and education support, the association said in an April 3 statement. British schools are closed but remain open to care for children of key workers.

An early warning system also has been set up by nabim to give notice of problems before they become critical.

The grain supply and delivery sector, including nabim members, has agreed small changes in working practice that will help the flow of goods and accompanying documentation while respecting social distancing and the difficulty of distributing documentation while so many administrative staff are working from home, nabim said. The government has allowed extra time for some tests to be undertaken and, wherever possible, auditing is being conducted remotely.

One feature of the lockdown has been increased demand from consumers for bagged flour for home baking. A website has been set up by nabim to let consumers know where they can buy the size of bags normally only sold to catering outlets, which are now closed.

The UK left the EU on Jan.31. The country is currently in a transition phase, in which trade continues under the same terms as before, while a future relationship between the two is negotiated. The advent of the COVID-19 crisis means that the transition period, due to last until the end of 2020, is widely expected to be extended, although the British government, which would have to ask for an extension, is still, at the time of writing, insisting that it will stick to the planned timetable.

One aspect of the future that is causing particular concern for the milling industry is the arrangements for trade between the islands of Britain and Ireland. Although the northern part of Ireland is part of the UK, under the 1998 Good Friday Agreement, which brought piece to Northern Ireland after many years of turmoil, there must be no hard border between the UK and the Republic of Ireland on the island of Ireland. That means that a customs barrier is planned, within the UK. The government of Prime Minister Boris Johnson is pretending that the problem does not exist, and no checks will be necessary, ignoring an explicit reference in the UKs Withdrawal Agreement with the EU. The high level of integration between the food sectors in the two countries, particularly in milling, means controls, with a potential need for sanitary and phytosanitary checks, could be highly onerous.

Leaving the EU takes British agriculture out of the EUs Common Agricultural Policy, with its system of direct payments to support farming. Instead, in a bill introduced to parliament on Jan. 16, the government plans to create a system under which farmers are rewarded for providing public goods such as improved air and water quality, higher animal welfare standards, improved access to the countryside or measures to reduce flooding.

In England, direct payments will be phased out over a seven-year period, starting in 2021.

BIOFUELS and GMOs

The UK is currently using E5 gasoline, but the government has announced a move to E10, beginning in 2021. The country has two large ethanol plants, Ensus and Vivergo, both in the northeast. Only Ensus is currently operating, using wheat and maize.

In an April 9 report, the USDA attach in London explained how the British government appears to want to expand the use of GM crops in the country, but the continuing close trading relationship between the UK and the remaining EU countries makes a big change unlikely.

The report cites the July 2019 inaugural speech of Prime Minister Johnson who said: Lets liberate the UKs extraordinary bioscience sector from anti-genetic modification rules.

Under any scenario, the UKs departure from the EU will not change policy or trade in genetically engineered plants or animals in the short to medium term, the attach commented. The EU is the UKs largest trading partner and the UK will retain much EU food law for many years to come.

For most of the British public, genetic engineering in food is irrelevant. There are very few mainstream grocery products that contain GE as an outright ingredient and, with this invisibility, UK consumers consider the GM problem to have gone away.

Follow our breaking news coverage of the coronavirus/COVID-19 situation.

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Focus on the United Kingdom | 2020-06-01 - World Grain

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22nd Century Group Appoints James A. Mish as Chief Executive Officer and John Franzino as Chief Financial Officer – GlobeNewswire

June 6th, 2020 8:50 pm

Mish brings extensive global executive leadership experience in the development, manufacturing and commercialization of active pharmaceutical ingredients, including cannabinoids, and related consumer products

Franzino brings extensive strategic financial leadership experience in tobacco and alcoholic beverage industries

WILLIAMSVILLE, N.Y., June 03, 2020 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. (NYSE American: XXII) (22nd Century or the Company), a leading plant biotechnology company primarily focused on reduced nicotine tobacco and also hemp/cannabis plant genetics research and development, announced today that James A. Mish has been appointed Chief Executive Officer, effective June 22, 2020. The Company also announced that John Franzino has been appointed Chief Financial Officer, effective immediately.

Mish brings extensive global executive leadership experience in science-driven organizations with a recent focus on the development, manufacturing and commercialization of active pharmaceutical ingredients (API), including cannabinoids, and related consumer products. He has an outstanding track record of delivering profitable growth at both privately held and publicly traded companies. Prior to joining 22nd Century, Mish served as Chief Executive Officer of Noramco, a global leader in the production of controlled substances for the pharmaceutical industry, and Purisys, a synthetic cannabinoid API, ingredients and solutions provider to pharmaceutical and consumer products companies. Mish led the creation and spinoff of Purisys from Noramco during his tenure.

We are very pleased to welcome Jim as our new Chief Executive Officer at this critical juncture in our Companys history, said Nora B. Sullivan, Chairperson of the Board of Directors of 22nd Century. Jims extensive and proven executive leadership capabilities, substantial science-based industry background and deep experience with pharmaceutical and consumer products make him an outstanding candidate to successfully execute on the Companys initiatives and strategic plan going forward. We are confident that under Jims demonstrated leadership capabilities, 22nd Century will continue to build its portfolio of assets and create value for the benefit of our shareholders. We expect that with Jims direction and guidance, 22nd Century will achieve meaningful growth as the Company looks towards the anticipated authorization of our MRTP application for our proprietary, reduced nicotine cigarettes, and as we work to develop new hemp/cannabis intellectual property and proprietary plants with valuable cannabinoid profiles.

I am delighted to join 22nd Century Group at this pivotal time in the Companys growth as it looks to deliver on its primary mission to reduce smoking-related harm and also bring new and valuable hemp-derived cannabinoid products to market, said Mish. 22nd Century is an innovative, plant-based biotech company with an extensive and growing intellectual property portfolio that is poised to disrupt both the tobacco and hemp/cannabis industries. I look forward to partnering with 22nd Centurys Board and management team to drive the business forward to deliver value to our customers and shareholders.

Sullivan continued, We are also pleased to welcome John Franzino into the role of Chief Financial Officer. John is an accomplished strategic financial executive with a track record of successful leadership in high-growth, highly regulated, consumer-facing industries including tobacco and alcoholic beverages. We are excited to have a CFO of his caliber on the executive management team to help lead the Company through the next chapter of its growth.

Prior to joining 22nd Century Group, Franzino served as Chief Financial Officer of the West Point Association of Graduates. Additionally, he has extensive strategic financial leadership experience serving as Vice President of Finance and Controller at Bard College; as Chief Financial Officer of Santa Fe Natural Tobacco Company, a subsidiary of Reynolds American, Inc.; and as Chief Financial Officer of Labatt USA. Franzino is a Certified Public Accountant (CPA) and holds a Master of Business Administration degree from Farleigh Dickinson University.

Also, on behalf of the Companys Board of Directors, I would like to thank Andrea Jentsch, who has resigned as Chief Financial Officer due to personal reasons, for her service and significant contributions to the Company. Despite the challenges presented by COVID-19, Andrea has built a very strong team critical to advancing the Companys accounting, finance, information technology and human resources activities, and she has made a number of significant improvements to the Companys processes, internal reporting and IT resources that will be important enablers for the commercialization of the Companys proprietary plants and products. We wish Andrea the best in her future endeavors, Sullivan added.

About 22nd Century Group, Inc.22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing and modern plant breeding. The Companys primary mission in tobacco is to reduce the harm caused by smoking by bringing its proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes to adult smokers in the U.S. and international markets. The Companys primary mission in hemp/cannabis is to develop proprietary hemp/cannabis plants with valuable cannabinoid profiles and agronomic traits and to commercialize those plants through a synergistic portfolio of strategic partnerships in the hemp/cannabis industry.

Learn more atxxiicentury.com, on Twitter@_xxiicenturyand onLinkedIn.

Cautionary Note Regarding Forward Looking StatementsThis press release contains forward-looking statements concerning our business, operations and financial performance and condition as well as our plans, objectives and expectations for our business operations and financial performance and condition that are subject to risks and uncertainties. All statements other than statements of historical fact included in this press release are forward-looking statements. You can identify these statements by words such as aim, anticipate, assume, believe, could, due, estimate, expect, goal, intend, may, objective, plan, potential, positioned, predict, should, target, will, would and other similar expressions that are predictions of or indicate future events and future trends. These forward-looking statements are based on current expectations, estimates, forecasts and projections about our business and the industry in which we operate and our management's beliefs and assumptions. These statements are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. All forward-looking statements are subject to risks and uncertainties and others that could cause actual results to differ materially from those contained in our forward-looking statements. Please refer to the Risk Factors in our Annual Report on Form 10-K filed on March 11, 2020 and in our subsequently filed Quarterly Report on Form 10-Q. We undertake no obligation to publicly update or revise any forward-looking statement as a result of new information, future events or otherwise, except as otherwise required by law.

Contacts:Mei Kuo22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com

Cory ZiskindICR(646) 277-1232cory.ziskind@icrinc.com

See the article here:
22nd Century Group Appoints James A. Mish as Chief Executive Officer and John Franzino as Chief Financial Officer - GlobeNewswire

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