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GMP Cell Banking Services Gain Momentum among Stem Cell Research Institutes Due to Cost-effectiveness and Quality They Offer – TMR Research Blog

The global GMP cell banking services marketis expected to gain stupendous demand avenues in the forthcoming years. This growth is attributed to increasing demand for GMP Cell banking services from the enterprises engaged in the pharmaceutical and stem cell research industries. Cell banks use a conventional technique named cryopreservation to keep the cells materials preserved. At the same time, cell banks also prevent the natural cell division process; thereby improve the shelf life of products preserved in the cell banks.

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One of the important factors owing to which GMP cell banking services are gaining momentum among scientists and research institutes is the cost-effectiveness of these services. In recent years, there is remarkable growth in the use of GMP cell banking services among gamut of research institutes from all across the world. This scenario depicts that the vendors working in the global GMP cell banking services market will witness stupendous demand opportunities in the forthcoming period.

Government Bodies Increase Flow of Funding to Discover Treatment Options for Rare Diseases

In recent years, there is noteworthy increase in the number of people living with various rare diseases. This situation has compelled scientists working in all worldwide locations to focus on the discovery of novel options to treat these health issues. To accelerate these research activities, government bodies of many countries from all over the world are financially supporting these research projects. This factor is positively impacting on the development of the global GMP cell banking services market.

On regional front, players working in the GMP cell banking services market are projected to gain fantastic development opportunities in North America and Asia Pacific. Presence of substantial mammalian cell is said to be one of the key reasons driving the growth of GMP cell banking services market in North America.

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GMP Cell Banking Services Gain Momentum among Stem Cell Research Institutes Due to Cost-effectiveness and Quality They Offer - TMR Research Blog

US FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus…

NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast Chief Medical Officer Dr Fred Grossman said: Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by todays outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.

The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made solely by the FDA, and the recommendations by the panel are non-binding. RYONCIL has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.

Pediatric transplant physician Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, said: This devastating condition has an extremely poor prognosis and there are no FDA-approved options for children under the age of 12. The clinical studies I have directed have demonstrated the potential for this treatment to fill a significant unmet medical need.

Conference Call An audio webcast can be accessed via https://webcast.boardroom.media/mesoblast-limited/20200813/NaN5f3237e85300840019de909d

The archived webcast is also available on the Investor page of the Companys website http://www.mesoblast.com

About Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3 There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85. 2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953. 3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814

About Mesoblast Mesoblast Limited (Nasdaq:MESO; ASX:MSB) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Companys proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking Statements This announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any decision that the FDA may make based upon the recommendation of the ODAC in relation to the efficacy of remestemcel-L), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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US FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus...

Growing R&D Activities to Push the Global Protein Expression Market to Garner $2491.67 Million by 2028 – marketscreener.com

According to an analysis by Triton Market Research on the global protein expression market, the industry, which generated $950.67 million in the year 2019, will grow with a CAGR of 11.30% by 2028.

A study by Triton Market Research with the title 'Global Protein Expression Market,' covers the Global Analysis and Forecast for 2019-2028 by Application (Industrial, Research, Therapeutic), by Product Type (Instruments, Reagents, Services, Expression Vectors, Competent Cells), by End-user (Pharmaceutical & Biotechnology Companies, Contract Research Organizations, Academic Research Institutes, Other End-users), by Geographical Region (Asia-Pacific, Latin America, North America, Middle East and Africa, Europe).

Protein expression refers to the manufacturing of proteins through the manipulation of the gene expression. It is used in the fields of genetic engineering and recombinant technologies.

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As per the report, the global protein expression market is anticipated to reach $2491.67 million by 2028, showcasing a CAGR of 11.30% over the projected years between 2019 and 2028.

The increasing prevalence of chronic diseases like diabetes and cardiovascular disorders is instigating demand for better treatment options, thereby driving the growth of the protein expression market. Protein expression systems are majorly used in therapeutic applications. Besides, the growing R&D activities in the field of genomics and proteomics are also favoring the market growth. However, the huge cost of the protein expression and reagents is impeding the growth of the protein expression market.

The protein expression market is segmented into three parts, application, product type and end-user. The first segment, application, includes industrial, research and therapeutic. The second segment, product type, is divided into instruments, reagents, services, expression vectors and competent cells. The last segment, end-user, divides into pharmaceutical & biotechnology companies, contract research organizations, academic research institutes and other end-users.

Considering the regional landscape, Asia-Pacific is predicted to be the fastest-growing market for protein expression over the projected period. There are several research organizations engaged in the fields of genomics and proteomics in countries like South Korea and India. The government of these countries are implementing various initiatives to develop R&D activities. Huge investments have also been made by the government towards the development of the proteomics market in South Korea. Besides, protein expression has immense potential to solve issues pertaining to medicine, food and fuel needs. This is likely to increase the adoption of protein expression in the region. Further, many public and private organizations in this market are increasingly engaging in collaborations, which is influencing the market positively.

Major companies in the protein expression market are Thermo Fisher Scientific Inc, GenScript, Takara Holdings Inc, Bio-Rad Laboratories Inc, Lonza, Biotechrabbit, Merck KGaA, Agilent Technologies Inc, Qiagen, Promega Corporation, New England Biolabs, BD (Becton, Dickinson and Company), LifeSensors, Peak Proteins Ltd and ProMab.

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Question & Answer: Protein Expression Market

Question 1: Which are the factors driving the growth of the protein expression market?

Answer: The increasing prevalence of chronic diseases like diabetes and cardiovascular disorders is instigating demand for better treatment options, thereby driving the growth of the protein expression market. Protein expression systems are majorly used in therapeutic applications. Besides, the growing R&D activities in the field of genomics and proteomics is also favoring the market growth.

Question 2: What factor is impeding the growth of the protein expression market?

Answer: The huge cost of the protein expression and reagents is impeding the growth of the protein expression market.

Question 3: How is Asia-Pacific impacting the protein expression market outlook?

Answer: Considering the regional landscape, Asia-Pacific is predicted to be the fastest-growing region for protein expression over the projected period. There are several research organizations engaged in the fields of genomics and proteomics in countries like South Korea and India. The government of these countries is implementing various initiatives to develop R&D activities.

Huge investments have also been made by the government towards the development of the proteomics market in South Korea. Besides, protein expression has immense potential to solve issues pertaining to medicine, food and fuel needs. This is likely to increase the adoption of protein expression in the region. Further, many public and private organizations in this market are increasingly engaging in collaborations, which is influencing the market positively.

Question 4: Which are the major companies in the protein expression market?

Answer: Major companies in the protein expression market are Thermo Fisher Scientific Inc, GenScript, Takara Holdings Inc, Bio-Rad Laboratories Inc, Lonza, Biotechrabbit, Merck KGaA, Agilent Technologies Inc, Qiagen, Promega Corporation, New England Biolabs, BD (Becton, Dickinson and Company), LifeSensors, Peak Proteins Ltd and ProMab.

Related Report:

Global Biotechnology Reagents Market

The Global Biotechnology Reagents Market is likely to generate $144.74 billion by the year 2028, with a CAGR of 9.54% in the forthcoming years between 2019 and 2028.

Protein profiling is used to diagnose specific illnesses like cancer or infectious diseases like hepatitis and malaria, where particular proteins are released in the serum. Biotechnology reagents are used as a substrate in protein profiling in the diagnosis of cancer. Besides, there has been an alarming increase in the occurrence of cancer across the world. All these factors indicate an increased adoption of biotechnology reagents in the market.

There is an increase in research activities in environmental biotechnology across the world. Environmental biotecnology is used to detect & prevent the emission of pollutants in the environment. The rising R&D in this sector is likely to create business opportunities for the biotechnology reagents market. Stem cell research is another potential application of the studied market. In recent times, increasing expenditure has been witnessed in this sector, leading to an increase in the number of discoveries in stem cell research. This is likely to push the demand for the biotechnology reagents market over the coming years.

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Growing R&D Activities to Push the Global Protein Expression Market to Garner $2491.67 Million by 2028 - marketscreener.com

‘We want to be everywhere.’ Mission Bio raises $70M behind resistance-hunting sequencing platform – Endpoints News

Charlie Silver wants to look really, really closely at a lot of your cells. And he just got a lot of money to do so.

Silvers startup, Mission Bio, raised $70 million in a Series C round Thursday led by Novo Holdings. The money, which brings Mission Bio to $120 million raised since its 2012 founding, will be used to advance the single-cell sequencing platform they built to detectearly response or resistance to new cancer therapies.

We want this everywhere, Silver toldEndpoints News. Everywhere where therapy resistance is important and its important for most of oncology.

In the last few years, single-cell sequencing technology has become ubiquitous in biomedical research. Its allowed researchers to zoom into whats unfolding in an individual cell, as opposed to blending multiple cells together and getting an average, as previous sequencing methods have required.

Much of that work, though, has been through RNA sequencing, also known as RNA-Seq. A quick PubMed for RNA-Seq search turns up over 10,000 papers since the start of 2019. This year alone, its been used to profile the human antibody response, compare mouse and human brains, and even tosee if you can get a portrait of someones microbiome out of their sperm.

Much of the work, though, has come in cancer, where cell heterogeneity or the variety of different cells and mutations can offer key clues about how cancer arises, develops, responds to and resists therapy. There, Silver said, Mission Bio has an advantage by focusing on DNA rather than RNA. Theyre not the only DNA-Seq platform, but he claims we are the only ones that do single-cell DNA at every scale, from single mutation, copy number through the whole chromosome and the only ones that can link that DNA snapshot to the proteins on the cells.

We took our platform and basically purpose-built it for pharma, Silver said. The combination of DNA and protein together tends to be exactly what pharma needs for drug development, because you can link together the mutation youre trying to drug, along with the pathway that you can now link together with protein.

So far, Mission Bio has tested the platform with a handful of small biotechs, such as Agios and Agilent Technologies, and cancer centers such as MD Anderson. They claim to have unnamed partnerships with Big Pharma as well.

The idea, Silver said, is to give researchers tools to see earlier whether a patient is responding to a therapy or evolving resistance to a therapy. That could in theory then shorten development time, allowing companies to abort doomed trials or weed people with the wrong molecular profile out, making sure only those most likely to respond to the therapy are studied.

In a paper inBloodin March, MD Anderson researchers used the platform to discover tiny pockets of cancer cells with rare mutations that limited patients response to the acute myeloid leukemia drug Venclexta. In May, in Blood Advances, researchers at Agios used it to find new resistance mechanisms to their AML drug Tibsovo.

Thorough cataloging of resistance mechanisms to targeted therapies has proven invaluable in the development of next-generation therapies, such as second- and third-generation inhibitors of BCR-ABL, EGFR, and ALK, the researchers noted, and in the development of efficacious combination therapies such as BRAF-MEK dual inhibition in melanoma.

In addition to finding new cancer partners for their platform, Silver said they were also going to use the Series C funding to push into gene and cell therapy. Missions platform, he said, could help characterize how successfully cells have been edited.

Were really expanding, he said.

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'We want to be everywhere.' Mission Bio raises $70M behind resistance-hunting sequencing platform - Endpoints News

Current and Future Trend of Global and United States TNF & IL Cytokines Market 2020-2026 | , AbbVie, Johnson & Johnson – The Daily Chronicle

LOS ANGELES, United States: QY Research has recently published a report, titled Global and United States TNF & IL Cytokines Market Insights, Forecast to 2026. The research report gives the potential headway openings that prevails in the global market. The report is amalgamated depending on research procured from primary and secondary information. The global Global and United States TNF & IL Cytokines market is relied upon to develop generously and succeed in volume and value during the predicted time period. Moreover, the report gives nitty gritty data on different manufacturers, region, and products which are important to totally understanding the market.

Key Companies/Manufacturers operating in the global Global and United States TNF & IL Cytokines market include: , AbbVie, Johnson & Johnson, GlaxoSmithKline, Novartis, Roche, Pfizer, Sanofi, Bayer HealthCare Pharmaceuticals, Thermo Fisher Scientific, Biocon, Biotechne, Peprotech, STEMCELL Technologies

Get PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

https://www.qyresearch.com/sample-form/form/2071012/global-and-united-states-tnf-amp-il-cytokines-market

Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Global and United States TNF & IL Cytokines market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Global and United States TNF & IL Cytokines Market Segment By Type:

TNF IL Cytokines

Global Global and United States TNF & IL Cytokines Market Segment By Application:

Cancer and Malignancy Arthritis Asthma / Airway Inflammation Others

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Global and United States TNF & IL Cytokines market.

Key companies operating in the global Global and United States TNF & IL Cytokines market include , AbbVie, Johnson & Johnson, GlaxoSmithKline, Novartis, Roche, Pfizer, Sanofi, Bayer HealthCare Pharmaceuticals, Thermo Fisher Scientific, Biocon, Biotechne, Peprotech, STEMCELL Technologies

Key questions answered in the report:

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TOC

1 Study Coverage 1.1 TNF & IL Cytokines Product Introduction 1.2 Market Segments 1.3 Key TNF & IL Cytokines Manufacturers Covered: Ranking by Revenue 1.4 Market by Type 1.4.1 Global TNF & IL Cytokines Market Size Growth Rate by Type 1.4.2 TNF 1.4.3 IL Cytokines 1.5 Market by Application 1.5.1 Global TNF & IL Cytokines Market Size Growth Rate by Application 1.5.2 Cancer and Malignancy 1.5.3 Arthritis 1.5.4 Asthma / Airway Inflammation 1.5.5 Others 1.6 Study Objectives 1.7 Years Considered 2 Executive Summary 2.1 Global TNF & IL Cytokines Market Size, Estimates and Forecasts 2.1.1 Global TNF & IL Cytokines Revenue 2015-2026 2.1.2 Global TNF & IL Cytokines Sales 2015-2026 2.2 Global TNF & IL Cytokines, Market Size by Producing Regions: 2015 VS 2020 VS 2026 2.3 TNF & IL Cytokines Historical Market Size by Region (2015-2020) 2.3.1 Global TNF & IL Cytokines Retrospective Market Scenario in Sales by Region: 2015-2020 2.3.2 Global TNF & IL Cytokines Retrospective Market Scenario in Revenue by Region: 2015-2020 2.4 TNF & IL Cytokines Market Estimates and Projections by Region (2021-2026) 2.4.1 Global TNF & IL Cytokines Sales Forecast by Region (2021-2026) 2.4.2 Global TNF & IL Cytokines Revenue Forecast by Region (2021-2026) 3 Global TNF & IL Cytokines Competitor Landscape by Players 3.1 Global Top TNF & IL Cytokines Sales by Manufacturers 3.1.1 Global TNF & IL Cytokines Sales by Manufacturers (2015-2020) 3.1.2 Global TNF & IL Cytokines Sales Market Share by Manufacturers (2015-2020) 3.2 Global TNF & IL Cytokines Manufacturers by Revenue 3.2.1 Global TNF & IL Cytokines Revenue by Manufacturers (2015-2020) 3.2.2 Global TNF & IL Cytokines Revenue Share by Manufacturers (2015-2020) 3.2.3 Global TNF & IL Cytokines Market Concentration Ratio (CR5 and HHI) (2015-2020) 3.2.4 Global Top 10 and Top 5 Companies by TNF & IL Cytokines Revenue in 2019 3.2.5 Global TNF & IL Cytokines Market Share by Company Type (Tier 1, Tier 2 and Tier 3) 3.3 Global TNF & IL Cytokines Price by Manufacturers 3.4 Global TNF & IL Cytokines Manufacturing Base Distribution, Product Types 3.4.1 TNF & IL Cytokines Manufacturers Manufacturing Base Distribution, Headquarters 3.4.2 Manufacturers TNF & IL Cytokines Product Type 3.4.3 Date of International Manufacturers Enter into TNF & IL Cytokines Market 3.5 Manufacturers Mergers & Acquisitions, Expansion Plans 4 Market Size by Type (2015-2026) 4.1 Global TNF & IL Cytokines Market Size by Type (2015-2020) 4.1.1 Global TNF & IL Cytokines Sales by Type (2015-2020) 4.1.2 Global TNF & IL Cytokines Revenue by Type (2015-2020) 4.1.3 TNF & IL Cytokines Average Selling Price (ASP) by Type (2015-2026) 4.2 Global TNF & IL Cytokines Market Size Forecast by Type (2021-2026) 4.2.1 Global TNF & IL Cytokines Sales Forecast by Type (2021-2026) 4.2.2 Global TNF & IL Cytokines Revenue Forecast by Type (2021-2026) 4.2.3 TNF & IL Cytokines Average Selling Price (ASP) Forecast by Type (2021-2026) 4.3 Global TNF & IL Cytokines Market Share by Price Tier (2015-2020): Low-End, Mid-Range and High-End 5 Market Size by Application (2015-2026) 5.1 Global TNF & IL Cytokines Market Size by Application (2015-2020) 5.1.1 Global TNF & IL Cytokines Sales by Application (2015-2020) 5.1.2 Global TNF & IL Cytokines Revenue by Application (2015-2020) 5.1.3 TNF & IL Cytokines Price by Application (2015-2020) 5.2 TNF & IL Cytokines Market Size Forecast by Application (2021-2026) 5.2.1 Global TNF & IL Cytokines Sales Forecast by Application (2021-2026) 5.2.2 Global TNF & IL Cytokines Revenue Forecast by Application (2021-2026) 5.2.3 Global TNF & IL Cytokines Price Forecast by Application (2021-2026) 6 United States by Players, Type and Application 6.1 United States TNF & IL Cytokines Market Size YoY Growth 2015-2026 6.1.1 United States TNF & IL Cytokines Sales YoY Growth 2015-2026 6.1.2 United States TNF & IL Cytokines Revenue YoY Growth 2015-2026 6.1.3 United States TNF & IL Cytokines Market Share in Global Market 2015-2026 6.2 United States TNF & IL Cytokines Market Size by Players (International and Local Players) 6.2.1 United States Top TNF & IL Cytokines Players by Sales (2015-2020) 6.2.2 United States Top TNF & IL Cytokines Players by Revenue (2015-2020) 6.3 United States TNF & IL Cytokines Historic Market Review by Type (2015-2020) 6.3.1 United States TNF & IL Cytokines Sales Market Share by Type (2015-2020) 6.3.2 United States TNF & IL Cytokines Revenue Market Share by Type (2015-2020) 6.3.3 United States TNF & IL Cytokines Price by Type (2015-2020) 6.4 United States TNF & IL Cytokines Market Estimates and Forecasts by Type (2021-2026) 6.4.1 United States TNF & IL Cytokines Sales Forecast by Type (2021-2026) 6.4.2 United States TNF & IL Cytokines Revenue Forecast by Type (2021-2026) 6.4.3 United States TNF & IL Cytokines Price Forecast by Type (2021-2026) 6.5 United States TNF & IL Cytokines Historic Market Review by Application (2015-2020) 6.5.1 United States TNF & IL Cytokines Sales Market Share by Application (2015-2020) 6.5.2 United States TNF & IL Cytokines Revenue Market Share by Application (2015-2020) 6.5.3 United States TNF & IL Cytokines Price by Application (2015-2020) 6.6 United States TNF & IL Cytokines Market Estimates and Forecasts by Application (2021-2026) 6.6.1 United States TNF & IL Cytokines Sales Forecast by Application (2021-2026) 6.6.2 United States TNF & IL Cytokines Revenue Forecast by Application (2021-2026) 6.6.3 United States TNF & IL Cytokines Price Forecast by Application (2021-2026) 7 North America 7.1 North America TNF & IL Cytokines Market Size YoY Growth 2015-2026 7.2 North America TNF & IL Cytokines Market Facts & Figures by Country 7.2.1 North America TNF & IL Cytokines Sales by Country (2015-2020) 7.2.2 North America TNF & IL Cytokines Revenue by Country (2015-2020) 7.2.3 U.S. 7.2.4 Canada 8 Europe 8.1 Europe TNF & IL Cytokines Market Size YoY Growth 2015-2026 8.2 Europe TNF & IL Cytokines Market Facts & Figures by Country 8.2.1 Europe TNF & IL Cytokines Sales by Country 8.2.2 Europe TNF & IL Cytokines Revenue by Country 8.2.3 Germany 8.2.4 France 8.2.5 U.K. 8.2.6 Italy 8.2.7 Russia 9 Asia Pacific 9.1 Asia Pacific TNF & IL Cytokines Market Size YoY Growth 2015-2026 9.2 Asia Pacific TNF & IL Cytokines Market Facts & Figures by Country 9.2.1 Asia Pacific TNF & IL Cytokines Sales by Region (2015-2020) 9.2.2 Asia Pacific TNF & IL Cytokines Revenue by Region 9.2.3 China 9.2.4 Japan 9.2.5 South Korea 9.2.6 India 9.2.7 Australia 9.2.8 Taiwan 9.2.9 Indonesia 9.2.10 Thailand 9.2.11 Malaysia 9.2.12 Philippines 9.2.13 Vietnam 10 Latin America 10.1 Latin America TNF & IL Cytokines Market Size YoY Growth 2015-2026 10.2 Latin America TNF & IL Cytokines Market Facts & Figures by Country 10.2.1 Latin America TNF & IL Cytokines Sales by Country 10.2.2 Latin America TNF & IL Cytokines Revenue by Country 10.2.3 Mexico 10.2.4 Brazil 10.2.5 Argentina 11 Middle East and Africa 11.1 Middle East and Africa TNF & IL Cytokines Market Size YoY Growth 2015-2026 11.2 Middle East and Africa TNF & IL Cytokines Market Facts & Figures by Country 11.2.1 Middle East and Africa TNF & IL Cytokines Sales by Country 11.2.2 Middle East and Africa TNF & IL Cytokines Revenue by Country 11.2.3 Turkey 11.2.4 Saudi Arabia 11.2.5 U.A.E 12 Company Profiles 12.1 AbbVie 12.1.1 AbbVie Corporation Information 12.1.2 AbbVie Description and Business Overview 12.1.3 AbbVie Sales, Revenue and Gross Margin (2015-2020) 12.1.4 AbbVie TNF & IL Cytokines Products Offered 12.1.5 AbbVie Recent Development 12.2 Johnson & Johnson 12.2.1 Johnson & Johnson Corporation Information 12.2.2 Johnson & Johnson Description and Business Overview 12.2.3 Johnson & Johnson Sales, Revenue and Gross Margin (2015-2020) 12.2.4 Johnson & Johnson TNF & IL Cytokines Products Offered 12.2.5 Johnson & Johnson Recent Development 12.3 GlaxoSmithKline 12.3.1 GlaxoSmithKline Corporation Information 12.3.2 GlaxoSmithKline Description and Business Overview 12.3.3 GlaxoSmithKline Sales, Revenue and Gross Margin (2015-2020) 12.3.4 GlaxoSmithKline TNF & IL Cytokines Products Offered 12.3.5 GlaxoSmithKline Recent Development 12.4 Novartis 12.4.1 Novartis Corporation Information 12.4.2 Novartis Description and Business Overview 12.4.3 Novartis Sales, Revenue and Gross Margin (2015-2020) 12.4.4 Novartis TNF & IL Cytokines Products Offered 12.4.5 Novartis Recent Development 12.5 Roche 12.5.1 Roche Corporation Information 12.5.2 Roche Description and Business Overview 12.5.3 Roche Sales, Revenue and Gross Margin (2015-2020) 12.5.4 Roche TNF & IL Cytokines Products Offered 12.5.5 Roche Recent Development 12.6 Pfizer 12.6.1 Pfizer Corporation Information 12.6.2 Pfizer Description and Business Overview 12.6.3 Pfizer Sales, Revenue and Gross Margin (2015-2020) 12.6.4 Pfizer TNF & IL Cytokines Products Offered 12.6.5 Pfizer Recent Development 12.7 Sanofi 12.7.1 Sanofi Corporation Information 12.7.2 Sanofi Description and Business Overview 12.7.3 Sanofi Sales, Revenue and Gross Margin (2015-2020) 12.7.4 Sanofi TNF & IL Cytokines Products Offered 12.7.5 Sanofi Recent Development 12.8 Bayer HealthCare Pharmaceuticals 12.8.1 Bayer HealthCare Pharmaceuticals Corporation Information 12.8.2 Bayer HealthCare Pharmaceuticals Description and Business Overview 12.8.3 Bayer HealthCare Pharmaceuticals Sales, Revenue and Gross Margin (2015-2020) 12.8.4 Bayer HealthCare Pharmaceuticals TNF & IL Cytokines Products Offered 12.8.5 Bayer HealthCare Pharmaceuticals Recent Development 12.9 Thermo Fisher Scientific 12.9.1 Thermo Fisher Scientific Corporation Information 12.9.2 Thermo Fisher Scientific Description and Business Overview 12.9.3 Thermo Fisher Scientific Sales, Revenue and Gross Margin (2015-2020) 12.9.4 Thermo Fisher Scientific TNF & IL Cytokines Products Offered 12.9.5 Thermo Fisher Scientific Recent Development 12.10 Biocon 12.10.1 Biocon Corporation Information 12.10.2 Biocon Description and Business Overview 12.10.3 Biocon Sales, Revenue and Gross Margin (2015-2020) 12.10.4 Biocon TNF & IL Cytokines Products Offered 12.10.5 Biocon Recent Development 12.11 AbbVie 12.11.1 AbbVie Corporation Information 12.11.2 AbbVie Description and Business Overview 12.11.3 AbbVie Sales, Revenue and Gross Margin (2015-2020) 12.11.4 AbbVie TNF & IL Cytokines Products Offered 12.11.5 AbbVie Recent Development 12.12 Peprotech 12.12.1 Peprotech Corporation Information 12.12.2 Peprotech Description and Business Overview 12.12.3 Peprotech Sales, Revenue and Gross Margin (2015-2020) 12.12.4 Peprotech Products Offered 12.12.5 Peprotech Recent Development 12.13 STEMCELL Technologies 12.13.1 STEMCELL Technologies Corporation Information 12.13.2 STEMCELL Technologies Description and Business Overview 12.13.3 STEMCELL Technologies Sales, Revenue and Gross Margin (2015-2020) 12.13.4 STEMCELL Technologies Products Offered 12.13.5 STEMCELL Technologies Recent Development 13 Market Opportunities, Challenges, Risks and Influences Factors Analysis 13.1 Market Opportunities and Drivers 13.2 Market Challenges 13.3 Market Risks/Restraints 13.4 Porters Five Forces Analysis 13.5 Primary Interviews with Key TNF & IL Cytokines Players (Opinion Leaders) 14 Value Chain and Sales Channels Analysis 14.1 Value Chain Analysis 14.2 TNF & IL Cytokines Customers 14.3 Sales Channels Analysis 14.3.1 Sales Channels 14.3.2 Distributors 15 Research Findings and Conclusion 16 Appendix 16.1 Research Methodology 16.1.1 Methodology/Research Approach 16.1.2 Data Source 16.2 Author Details 16.3 Disclaimer

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QYResearch always pursuits high product quality with the belief that quality is the soul of business. Through years of effort and supports from huge number of customer supports, QYResearch consulting group has accumulated creative design methods on many high-quality markets investigation and research team with rich experience. Today, QYResearch has become the brand of quality assurance in consulting industry.

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Current and Future Trend of Global and United States TNF & IL Cytokines Market 2020-2026 | , AbbVie, Johnson & Johnson - The Daily Chronicle

Health and Fitness: Hip replacement surgery: getting back to what you love – taosnews

More than 300,000 total hip replacement surgeries are performed annually in the United States.

Awhile back, I helped develop a hiking plan for a friend who had hip replacement surgery and wanted to return to hiking gradually as part of her physical therapy. It didn't occur to me that I would need the same type of plan one day.

I have had the opportunity to hike many of the beautiful trails near Taos over the last 30 years. I began to write about hiking for the Taos News in 2011 and wrote the "Taos Hiking Guide" in 2015.

Up until about two years ago, I was hiking 14 miles round trip to places like Las Trampas Lakes near the Truchas Peaks, sometimes backpacking with no problem and little pain. Then that winter, I started to experience a lot of discomfort in my right hip and leg; occasionally my leg would just collapse and refuse to work.

I had seen Dr. Keith Christian, DOM, of Taos Chiropractic Health Center over time whenever I had a little twinge of pain in my knee or hip and for awhile, he was able to straighten out my body and reduce the pain.

But there came a time when no amount of adjusting reduced the pain or improved function. We both realized that something new was going on and Christian suggested that there was some significant deterioration in my hips.

When I got an X-ray at Holy Cross Hospital last summer, it showed that I had worn out all the cartilage in my right hip and had only a bit remaining in my left hip. I made an appointment with Dr. Sean Marvil at Taos Orthopaedic Institute to talk about options for treatment.

It turns out there aren't many options: steroid shots can help with pain for a period of months and stem cell therapy is an emerging approach that has promise for the future, but the proposed solution from Marvil was hip replacement surgery, technically known as total hip arthroplasty, at least for my right hip.

The number of hip replacement surgeries in the U.S. is projected to grow over time. The average age for hip replacement is 67 years old, according to the American Joint Replacement Registry. In addition to improving the quality of life for patients, one study in Sweden showed that hip replacement surgery also may add years to a person's life.

According to the two surgeons I consulted, the reason I needed the procedure is osteoarthritis: a condition that damages the cartilage covering the end of the bones where they come together in the hip socket. This condition arises from a combination of wear and tear and genetics.

Although hip surgery is generally classified as elective surgery, doctors may recommend it if the condition is causing a lot of pain and interfering with the ability to do basic tasks like getting dressed and walking.

Although I had two other friends who have had hip replacement surgery and I was beginning to wonder if my pain was the result of arthritis l, I was still surprised and a little angry at the diagnosis. I had somehow assumed that being active and fit would protect me from needing this kind of surgery. And I am younger than the average age for the surgery by a number of years.

After I had a chance to reflect on the situation a bit, I was relieved that at least there was something that could be done about the pain and dysfunction and that I could again be hiking longer distances. I made the decision to have the surgery and planned for it sometime in the spring of 2020.

Then life intervened. With the coming of the COVID-19 virus, elective surgeries were delayed. My mom who had been diagnosed with ovarian cancer at Christmas passed away in April and during that time all my priorities changed.

Finally in early June, I was able to see a surgeon in Colorado. Due to the requirements of my insurance plan, I had to have the procedure done in Colorado from a preapproved list of doctors in order to have it covered. This was a difficult decision, as I would have been happy to work with Marvil at Taos Orthopaedic Institute.

After reading reviews of all the approved physicians, I chose Dr. Joseph Assini at OrthoOne at Swedish Medical Center in Denver, due to his favorable reviews by past patients.

When asked about the benefits of hip replacement surgery, Assini said, "It is always great to see the amazing pain relief patients get after a total hip replacement. While the path for each patient is variable in terms of time and discomfort, patients will end up happy and generally back to most activities six to 12 weeks from surgery. Being able to help patients get back their quality of life is very rewarding."

Before the surgery in June, I had a variety of exams and tests, including a screening for the COVID virus. All the test results looked good.

Early on the morning of June 24, my sister Brenda Staab picked me up and we went across town to the Rocky Mountain Surgery Center. I had spoken to the anesthesiologist the night before, who advised I have no food for eight hours and no liquids four hours before.

When I arrived, I checked in and was taken back to the preoperative area where an IV was started and I was given some painkillers. Assini stopped by and marked the right hip where the incision would be.

The anesthesiologist discussed the options with me. The two primary options were general anesthetic or a spinal block with additional medication that made sure the patient was asleep for the operation. We agreed on the spinal block as it is less impactful to the body and less likely to cause nausea and other side effects. He explained that he would put some cold gel on my back before giving me the injection. The cold gel was the last thing I remember until waking up a short time later.

What was amazing to me was that the actual hip replacement took under an hour. After demonstrating I could walk with crutches and perform certain other bodily functions to ensure that the spinal block had worn off, I was able to go home later the same day as the procedure.

I came back home to Taos the Sunday after my surgery to settle into the recovery process.

Recovery and physical therapy

Right after the surgery, I had nausea and a fair amount of pain. I was surprised by the extent of the swelling and bruising I experienced, not only in my hip, but also all the way down my leg to my foot, although Assini and staff reassured me that what I was experiencing was in the normal range.

For the first two weeks after surgery, I had to wear compression stockings which were hot and uncomfortable, but reduced the risk of a blood clot, one of the major risks of surgery. I've been taking two aspirin per day as a blood thinner to prevent clots and will need to continue to do so for a total of six weeks.

The pain medication that was prescribed to me was oxycodone - a narcotic drug with many side effects. It carries with it the risk of addiction. For the first few days, I took it every four to six hours and found it made me lightheaded and added to my nausea. Since then, I have been taking only one per day to help me sleep at night and am ready to begin to end that use as well.

In order to get back into shape for hiking and gardening, I have had the pleasure of working with Amryn Ayres of Physical Therapy and Rehab, a program of Holy Cross Hospital. Ayres received her doctorate in physical therapy just over two years ago and has worked at Physical Therapy and Rehab since the beginning of April.

She said, "The goal for physical therapy is to get people back to what they love. Surgery in general has widespread effects on the body in regard to motion, strength and overall function. As physical therapists, we are trained to identify specific impairments and guide you back to feeling better and living your life."

I first saw Ayres five days after surgery. She assessed my mobility and put together a series of exercises for me to do at home. She's also looked at my incision and helped determine it was ready to have the stitches removed.

I have been going to physical therapy one to two times a week since returning home and can feel that my hip and leg are becoming stronger.

After hip replacement on the right side, the patient is not able to drive for several weeks. I found Michelle Chandler, who in addition to being a musician and executive director of the Taos Youth Music School, offers various services to individuals and couples, including ministerial counseling and practical support. Chandler took me to physical therapy and also grocery shopping. Without her assistance, I would not have been able to navigate the first few weeks after surgery.

Also, 10,000 Wags Pet Resort was helpful. They picked up my dog twice a week and took him to play group so he got some exercise when I couldn't walk him.

Although I am not done recovering, I can feel that I'm stronger every day and have been returning to some of my regular activities slowly. I was cleared to drive at about four weeks after surgery and am slowly returning to short hikes with my dog, while continuing my physical therapy appointments and exercises at home.

At five weeks after surgery, I have much better mobility in my hip and the remaining muscle pain from the surgery is gradually decreasing.

Not surprisingly, another thing I observed is having medical insurance is important. The total bill covered by insurance was more than $73,000, with my portion totaling around $3,000.

I may need to have my left hip replaced at some point. But for now, I am going to focus on healing and becoming stronger, so that by the time fall is here, I will be once again hiking high in the mountains around Taos watching the leaves turn to gold.

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Health and Fitness: Hip replacement surgery: getting back to what you love - taosnews

This revolutionary new coronavirus cure is already saving lives – BGR

The novel coronavirus is an incredibly scary illness given the complex way it operates. Its incredibly infectious and it can cause severe complications that can lead to death. It even kills younger patients and people who have no other underlying conditions. And some of the people who manage to recover after what could be a months-long battle with COVID-19 will have to deal with secondary health problems that could last a lifetime. Thats why you should avoid other people as much as possible, wash your hands often, and wear face masks until treatments and vaccines become available and even after that. The good news is that doctors and researchers have not run out of ideas in their quest to beat the novel virus. Plenty of promising therapies are in clinical trials right alongside vaccines, as the world will need therapeutics that can cure the infection as well as drugs that can prevent it. Not all of them are miracle drugs, and remdesivir and dexamethasone are the best examples of that. Theyre drugs that work and can save lives, but they wont save everyone. And weve often told you that we dont even need a single miracle drug. Instead, combinations of effective medicines could reduce complications and the risk of death. But it turns out there may be a drug that does qualify as a miracle COVID-19 cure, one that might save plenty of severe COVID-19 patients.

The promising therapy uses medicinal signaling cells or MSCs, which are found on blood vessels throughout the body, explained Kevin Kimberlin in a Wall Street Journal op-ed. These MSCs pack a powerful 1-2-3 punch, according to the piece. These cells eliminate the virus, calm the immune overreaction known as a cytokine storm, and repair damaged lung tissue, Kimberlin wrote.

Thats the kind of combination we havent seen from other drugs, and it could save lives of patients experiencing serious COVID-19 complications. In fact, its already saving lives right now. The report mentions two pilot studies, one from Mount Sinai Hosptial in March and one published in The Lancet in July. MSCs were used to treat 25 critically ill COVID-19 cases between the two studies. 10 people our of 12 survived in the March trial, and 11 people out of 13 lived in the July pilot.

While Kimberlin calls these drugs MSCs in his article, Mesoblast actually has a name for the drug: Remestemcel-L, which is based on mesenchymal lineage adult stem cells. The July study calls them adipose-tissue derived mesenchymal stromal cells (AT-MSC). In other words, were looking at stem cell therapy and weve already reported on the Mount Sinai pilot months ago. Doctors involved with that project said at the time that vaccines will be the miracle drug everyone is waiting for, not stem cell therapy.

Mount Sinai and Mesoblast won FDA clearance and National Institutes of Health funding for a randomized trial on 300 patients that started in May. Researchers found that MSCs can increase the number of T cells and reduce inflammation at the same time. Furthermore, chest X-rays showed that the drugs helped to repair lung tissue, sometimes as soon as 48 hours after therapies began.

MSCs were identified some 30 years ago by Prof. Arnold Caplan and colleagues at Case Western Reserve University, explains Kimberlin, who co-founded Osiris Therapeutics together with Caplan in 1993. These MSCs sound very promising, at least on paper:

When a MSC detects an infection or an injury to those vessels, it transforms into a factory to recruit and pump out immune-modulating and vessel-repair agents. These cells ameliorate crippling and deadly conditions when traditional chemical or biochemical drugs fail.

According to Kimberlin, MSCs therapy also worked in a Mesoblast study on graft-versus-host disease. Up to 80% of affected children can die if steroids dont stop the inflammation. But in an MSCs trial, 160 of 239 patients who did not respond to steroids survived after infusions with MSCs. Their cytokine storm disappeared. Injured tissues normalized, Kimberlin wrote.

Results from the May COVID-19 trial should be available before the end of September. Its unclear how much treatments like this would cost, however, or whether theyre scalable to meet demand. Still, if MSCs are found to be as effective as they were in the early trials, we may soon have the first drugs that can really crush COVID, as Kimberlin puts it.

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

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This revolutionary new coronavirus cure is already saving lives - BGR

Survivors of Pediatric Cancers May Experience Lasting Impact on Heart, Metabolic Health Following Radiation Therapy – Pharmacy Times

Survivors of Pediatric Cancers May Experience Lasting Impact on Heart, Metabolic Health Following Radiation Therapy

Previous reports had been made regarding the impact of radiation therapy on the metabolic health of survivors of pediatric leukemia, brain tumors, and hematopoietic stem cell transplants. However, the radiation therapys effect on survivors of pediatric abdominal and pelvic tumors had not yet been assessed.

"Body composition abnormalities and cardiometabolic impairments are of concern among survivors given that in the general population, these conditions increase the risk of developing life-threatening diseases including cardiovascular disease and type 2 diabetes," said Carmen Wilson, PhD, assistant member in the Epidemiology and Cancer Control Department at St. Jude Children's Research Hospital, in a press release.

Specifically, the analyses showed that survivors of abdominal and pelvic solid tumors had low lean body mass, which is the measurement of the non-fat content of the body. The researchers found that survivors lean body mass was lower than the general population and that the lower relative lean body mass was connected with the prior abdominal or pelvic radiation. Those individuals with lower lean body mass burn fewer calories while resting than those with higher lean body mass, Wilson explained.

In conducting the study, the researchers assessed 431 adult survivors of pediatric abdominal or pelvic solid tumors who were treated at St. Jude Children's Research Hospital. At the time of the study, the median age of the participants was 29.9 years.

Of the childhood diagnoses, the most frequent were neuroblastoma, Wilms tumor, and germ cell tumor, with a median age of 3.6 years at diagnosis. Approximately 37% of participants had received abdominal radiation therapy and 36% had received pelvic radiation therapy during their treatment.

In order to assess the participants' body composition, metabolic abnormalities, and physical function in relation to the general population, the researchers used data from the 2013 to 2014 National Health and Nutrition Examination Survey (NHANES) that matched the age, sex, and ethnicity of the patients in the study.

The researchers found that compared with individuals from NHANES, the survivors of abdominal and pelvic solid tumors had a significantly higher likelihood of having insulin resistance (33.8% vs. 40.6%), high triglycerides (10.02% vs. 18.4%), and low levels of high-density lipoproteins (28.9% vs. 33.5%), which are commonly referred to as good cholesterol. However, the levels of low-density lipoproteins (bad cholesterol) between survivors and individuals from NHANES showed no significant differences.

"It is possible that abdominal and pelvic-directed radiation therapy damages postural muscles or subtly impairs sex hormone production, ultimately affecting muscle mass," Wilson said in the press release.

Radiation therapy has been previously shown to cause muscle injury, resulting in the loss of muscle fiber and muscle regenerative cells in animal studies, Wilson explained. She noted that lifestyle choices could potentially affect relative lean mass and cardiometabolic health as well.

The researchers said that it would be beneficial for future research on the topic to examine the effect of radiation therapy and other cancer treatments in relation to fat distribution in the body. This is of particular interest because increased abdominal obesity can be a stronger predictor of adverse effects than overall obesity, according to the study.

Additionally, Wilson noted that she is interested in investigating how lifestyle behaviors might influence lean mass among survivors of pediatric cancers.

"While it may not be possible to avoid radiation therapy as a key treatment for many solid tumors, early research suggests that resistance training interventions in survivors increase lean mass," Wilson said. "Further work is needed to see if training would also impact cardiometabolic impairments in this population."

REFERENCE Radiation to treat pediatric cancers may have lasting impact on heart and metabolic health. American Association for Cancer Research; August 13, 2020. eurekalert.org/pub_releases/2020-08/aafc-rtt081020.php. Accessed August 14, 2020.

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Survivors of Pediatric Cancers May Experience Lasting Impact on Heart, Metabolic Health Following Radiation Therapy - Pharmacy Times

TG Therapeutics Umbralisib Development, And Other News: The Good, Bad And Ugly Of Biopharma – Seeking Alpha

TG Therapeutics reports development for Umbralisib

TG Therapeutics Inc. (TGTX) reported that the FDA has accepted its New Drug Application for umbralisib. The drug candidate will be reviewed under the Priority Review pathway. It had been granted Breakthrough Therapy tag for treating marginal zone lymphoma condition. Its Prescription Drug User Fee Act (PDUFA) goal date has been set at February 15, 2021. For follicular lymphoma, the drug candidate will undergo standard review and the PDUFA goal date of June 15, 2021, has been set.

TG Therapeutics has used data from the umbralisib monotherapy MZL and FL cohorts of the UNITY-NHL Phase 2b trial for supporting its NDA. The trial was set to assess the potential of umbralisib in treating patients suffering from marginal zone lymphoma or follicular lymphoma. Michael S. Weiss of TG Therapeutics said:

If approved, we believe umbralisib could become an important treatment option for patients with previously treated MZL and FL. We look forward to presenting the data from the UNITY-NHL trial that supported this NDA submission by year end."

TG Therapeutics had earlier reported that each cohort of the trial had met its primary endpoint pertaining overall response rate. The company's target guidance was pegged at 40 to 50 percent ORR and its achievement was confirmed by an Independent Review Committee. The drug candidate was tagged as an orphan drug for both the indications of MZL and FL.

The UNITY-NHL trial is a global multicenter, open-label Phase 2b trial. Its MZL cohort aimed to assess the safety and efficacy of single-agent umbralisib in patients with MZL who have been administered at least one prior anti-CD20 regimen. All treated MZL patients met the primary endpoint of overall response rate.

The follicular Lymphoma cohort aimed to assess the safety and efficacy of single-agent umbralisib in patients with FL who were relapsed or refractory following at least two prior lines of therapy, including an anti-CD20 regimen and an alkylating agent. All treated FL patients also met the primary endpoint of ORR. The results were also in line with the company's pre-decided response target of 40 to 50 percent ORR.

On June 15, 2020, TG Therapeutics reported that it has completed the rolling submission of an NDA to the FDA. The company had requested the FDA for accelerated approval of the drug candidate for treating patients with previously treated MZL and FL. The company's request has now been accepted by the FDA.

TG Therapeutics is mainly invested in acquiring, developing, and commercializing treatments for various autoimmune diseases and B-cell malignancies. The company currently has two investigational compounds in late-stage clinical development phase. These two compounds are ublituximab and umbralisib and they target autoimmune ailments and hematological malignancies.

Ublituximab is a glycoengineered monoclonal antibody and works by targeting a particular epitope on the CD20 antigen found on mature B-lymphocytes. Umbralisib is an oral dual inhibitor and is designed to be taken once a day daily. TG Therapeutics has a robust development pipeline with two fully enrolled identical Phase 3 trials evaluating ublituximab monotherapy in patients with relapsing forms of multiple sclerosis.

Mesoblast Limited (MESO) announced that the Oncologic Drugs Advisory Committee of the FDA has voted in favor of Ryoncil in pediatric patients with steroid-refractory acute graft versus host disease. The ODAC is an independent panel of experts that assesses the efficacy and safety of data for the purpose of making appropriate recommendations to the FDA.

The news has come as a surprise to many industry experts as the company had been marred with several issues pertaining to the drug candidate. It has been noted that the review team had raised concerns regarding the data presented by the company with its application. The committee had raised concerns that the main pediatric study, MSB-GVHD001, allowed the use of other agents, which might have compromised the outcomes.

While the FDA takes committee recommendation into account while delivering the final verdict, it has no obligation to follow such recommendation. Dr. Fred Grossman of Mesoblast said:

We are very encouraged by today's outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant."

The drug candidate has been given an action date of September 30, 2020, under the Prescription Drug User Fee Act.

Ryoncil is the lead drug candidate for Mesoblast. It is an investigational therapy comprising culture-expanded mesenchymal stem cells. These cells are taken from the bone marrow of an unrelated donor. The drug candidate is deemed to have immunomodulatory properties for counteracting the inflammatory processes. These processes may down regulate the production of pro-inflammatory cytokines and thus may expand the production of anti-inflammatory cytokines and allowing recruitment of naturally occurring anti-inflammatory cells to involved tissues.

Imara Inc. (IMRA) announced the dosing of the first patient for the company's Ardent Phase 2b clinical trial of IMR-687 for adult patients with sickle cell disease. The company had earlier reported the data from the second planned interim analysis of Phase 2a clinical trial of IMR-687. The company is looking to report top-line data from this Phase 2a clinical trial in the fourth quarter of 2020.

IMR-687 Phase 2b Clinical Trial is a global, randomized, double-blind, placebo-controlled, multicenter study under the name of Ardent. The study will have nearly 99 adult patients suffering from sickle cell disease and will be randomized using hydroxyurea and the region. Doses will be based on weight to optimize tolerability and drug exposure.

The primary efficacy objective of the trial is to assess the proportion of all patients with fetal hemoglobin (HbF) response. The endpoint has been defined as an increase of 3% in HbF from baseline to week 24, compared to placebo. Rahul Ballal, CEO of Imara said:

Dosing of the first patient in the Ardent clinical trial represents a critical step forward as we advance IMR-687 into Phase 2b testing, a clinical trial that will test higher doses and longer durations of IMR-687."

During the trial, the patients will be kept on treatment through 52 weeks to gather data for planned secondary and additional exploratory endpoints. Some of these endpoints are indices of red cell hemolysis, quality of life measures, and HbF-associated biomarkers. Once the period of 52 weeks of treatment is over, patients will be entitled to be enrolled in an open-label extension study.

IMR-687 is a highly selective and potent small-molecule inhibitor of PDE9. People suffering from SCD and beta-thalassemia generally have lower levels of cGMP and may experience greater cell adhesion and reduced blood flow in addition to the decline in nitric oxide-mediated vasodilation.

Thanks for reading. At the Total Pharma Tracker, we do more than follow biotech news. Using our IOMachine, our team of analysts work to be ahead of the curve.

That means that when the catalyst comes that will make or break a stock, we've positioned ourselves for success. And we share that positioning and all the analysis behind it with our members.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

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TG Therapeutics Umbralisib Development, And Other News: The Good, Bad And Ugly Of Biopharma - Seeking Alpha

AgeX Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update – Business Wire

ALAMEDA, Calif.--(BUSINESS WIRE)--AgeX Therapeutics, Inc. (AgeX; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the second quarter ended June 30, 2020.

AgeX made strides with respect to its newly established licensing and collaboration model, which aims to embed its technology platforms across the cell therapy industry. AgeX has entered into a research license for the use of its immunotolerance UniverCyteTM technology by Sernova Corp. (Sernova), a publicly-listed Canadian regenerative medicine therapeutics company. It also entered a Manufacturing, Marketing, and Distribution Agreement with Pluristyx, Inc. (Pluristyx), an advanced therapy tools and services company serving customers in the fields of regenerative medicine and cellular and gene therapies. In addition, AgeX signed a letter of intent with ImStem Biotechnology (ImStem), for ImStem to utilize AgeXs ESI-brand pluripotent stem cells to derive a cell therapy product for potential use in the treatment of COVID-19 and as well acute respiratory distress syndrome (ARDS) from non-COVID-19 causes.

We are working diligently to position our subsidiary Reverse Bioengineering to optimize the potential of induced tissue regeneration (iTR) technology, said Michael West, CEO of AgeX. We believe this technology offers a powerful new modality to treat age-related degenerative diseases by reversing developmental aging in a tissue, thereby unlocking an innate capacity of tissues to regenerate scarlessly.

AgeX completed its restructuring to streamline its operations to allow efficient usage of capital in the current pandemic environment as well to meet near-term strategic company priorities of deriving value and generating preclinical and ultimately clinical data from our technology platforms through external licensing and collaboration agreements. In the longer-term, AgeX remains committed to in-house product development of AgeX-BAT1 and AgeX-VASC1. AgeX is considering options to bring capital into the company.

AgeX has made excellent progress in terms of its collaboration and licensing model, closing five deals since the beginning of the year so far, said Greg Bailey M.D., Chairman of AgeX. The deals have spanned all three of our technology platforms of UniverCyte for the generation of universal cells, PureStem for the derivation and manufacturing of therapeutic cells, and AgeX ESI pluripotent stem cells to act as a source material for cellular therapies. All these deals show the value industry and academia see in our offerings.

Q2 Highlights

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the New Loan Agreement) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. As of August 14, 2020, AgeX has borrowed $3.5 million and may draw additional funds from time to time subject to Juvenescences discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1.0 million in any single draw. More information about the New Loan Agreement can be found in AgeXs Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for the periods ended March 31, 2020 and June 30, 2020 filed with the Securities and Exchange Commission on March 30, 2020, May 14, 2020, and August 14, 2020 respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the PPP Loan). The PPP Loan bears interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the Paycheck Protection Program (PPP) to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, Qualifying Expenses), during the time frame permitted by the PPP. AgeX believes that it has used the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

In May 2020, AgeX laid off 11 research and development personnel and consequently paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and recognized approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which have been settled in cash. The staff reductions followed AgeXs strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeXs most recent projected cash flows, and considering that loans from Juvenescence under the New Loan Agreement will be subject to Juvenescences discretion, AgeX believes that its cash and cash equivalents, the remaining $5.5 million available under the New Loan Agreement and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeXs Quarterly Report on Form 10-Q for the three and six months ended June 30, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Second Quarter 2020 Operating Results

Revenues: Total revenues for the second quarter of 2020 were $414,000 as compared with $380,000 for the second quarter of 2019. AgeX revenues are primarily generated from subscription and advertising revenues from the GeneCards online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $36,000 of allowable expenses under its research grant from the NIH as compared with $47,000 in the same period in 2019.

Operating expenses: Operating expenses for the three months ended June 30, 2020 were $3.0 million as compared to $3.8 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended June 30, 2020 were $2.5 million as compared to $3.1 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses decreased by $0.3 million to $1.4 million during the three months ended June 30, 2020 from $1.7 million during the same period in 2019. The decrease was primarily attributable to the layoff of 11 research and development personnel in May 2020 and decrease in shared services from Lineage Cell Therapeutics, Inc. (Lineage) with the termination of our Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses decreased by $0.4 million to $1.7 million during the three months ended June 30, 2020 from $2.1 million during the same period in 2019 despite an increase in head count with the employment of AgeXs own finance team since October 1, 2019. These increases were offset by a decrease in travel and related expenses with the shelter in place mandates since March 15, 2020 resulting from the COVID-19 pandemic, and the elimination of shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem and UniverCyte manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeXs revolutionary longevity platform induced Tissue Regeneration (iTR) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem is AgeXs delivery technology to stably engraft PureStem cell therapies in the body. AgeXs core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit http://www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the Risk Factors section of AgeXs most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at http://www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. In addition, with respect to AgeXs Manufacturing, Marketing and Distribution Agreement with Pluristyx there is no assurance that (i) Pluristyx will generate significant sales of AgeX ESI hESC lines, or (ii) AgeX will derive significant revenue from sales of ESI hESC lines by Pluristyx. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

June 30, 2020

December 31, 2019

(Unaudited)

ASSETS

CURRENT ASSETS

Cash and cash equivalents

$

1,033

$

2,352

Accounts and grants receivable, net

235

363

Prepaid expenses and other current assets

836

1,339

Total current assets

2,104

4,054

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AgeX Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update - Business Wire