Category Archives: Stell Cell Research


Cell Separation Technologies Market Research Report by Technology, by Application, by End User – Global Forecast to 2025 – Cumulative Impact of…

August 13, 2020 04:36 ET | Source: ReportLinker

New York, Aug. 13, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Cell Separation Technologies Market Research Report by Technology, by Application, by End User - Global Forecast to 2025 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p05913778/?utm_source=GNW

The Global Cell Separation Technologies Market is expected to grow from USD 5,347.52 Million in 2019 to USD 12,724.42 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 15.54%.

Market Segmentation & Coverage: This research report categorizes the Cell Separation Technologies to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Technology, the Cell Separation Technologies Market studied across Fluorescence-activated Cell Sorting, Immunomagnetic Cell Separation, and Microfluidic Cell Separation.

Based on Application, the Cell Separation Technologies Market studied across Cancer Research, Immunology, and Stem Cell Research.

Based on End User, the Cell Separation Technologies Market studied across Biotechnology and Pharmaceutical Companies and Hospitals and Diagnostic Laboratories.

Based on Geography, the Cell Separation Technologies Market studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region surveyed across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region surveyed across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region surveyed across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Company Usability Profiles: The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Cell Separation Technologies Market including BD Biosciences, Life Technologies Corporation, Merck Millipore, Miltenyi Biotec GmbH, STEMCELL Technologies, Inc., and Terumo BCT, Inc..

FPNV Positioning Matrix: The FPNV Positioning Matrix evaluates and categorizes the vendors in the Cell Separation Technologies Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window: The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

Cumulative Impact of COVID-19: COVID-19 is an incomparable global public health emergency that has affected almost every industry, so for and, the long-term effects projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlaying COVID-19 issues and potential paths forward. The report is delivering insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecast, considering the COVID-19 impact on the market.

The report provides insights on the following pointers: 1. Market Penetration: Provides comprehensive information on the market offered by the key players 2. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets 3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments 4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players 5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments

The report answers questions such as: 1. What is the market size and forecast of the Global Cell Separation Technologies Market? 2. What are the inhibiting factors and impact of COVID-19 shaping the Global Cell Separation Technologies Market during the forecast period? 3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Cell Separation Technologies Market? 4. What is the competitive strategic window for opportunities in the Global Cell Separation Technologies Market? 5. What are the technology trends and regulatory frameworks in the Global Cell Separation Technologies Market? 6. What are the modes and strategic moves considered suitable for entering the Global Cell Separation Technologies Market? Read the full report: https://www.reportlinker.com/p05913778/?utm_source=GNW

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Cell Separation Technologies Market Research Report by Technology, by Application, by End User - Global Forecast to 2025 - Cumulative Impact of...

Humanigen Expands Phase III Study of Lenzilumab in COVID-19 to Brazil – Business Wire

BURLINGAME, Calif.--(BUSINESS WIRE)--Humanigen, Inc., (HGEN) (Humanigen), a clinical stage biopharmaceutical company focused on preventing and treating cytokine storm with lenzilumab, the companys proprietary Humaneered anti-human granulocyte macrophage-colony stimulating factor (GM-CSF) monoclonal antibody, announced that the Brazilian regulatory agency, Anvisa, has granted permission to commence a Phase III study of lenzilumab in patients with COVID-19 in Brazil.

This study, now set to begin recruiting patients in Brazil, follows the same protocol approved by the US Food and Drug Administration in April a multicenter, randomized, placebo-controlled, double-blinded clinical trial focused on hospitalized severe and critical adult COVID-19 patients at high risk of disease progression. Humanigen is working with Clinical Trial & Consulting (CTI), recently named the top global contract research organization, to conduct this trial in Brazil.

Cameron Durrant, MD, MBA, chief executive officer of Humanigen, said, COVID-19 is a global crisis and we are committed to offering assistance to patients across the world that are impacted by the pandemic. We hope that expanding the study of lenzilumab to research centers in Brazil, a country with surging rates of COVID-19, will offer patients much needed access to a leading COVID-19 therapeutic candidate.

Currently, Brazil has the second highest reported rates of COVID-19 infection in the world, second only to the US.

Access to clinical trials is critical for healthcare providers in the fight against COVID-19, remarked Timothy Schroeder, chief executive officer of CTI. We are proud to collaborate with our colleagues at Humanigen to extend the reach of the Phase III study of lenzilumab and bring a potential treatment option to those in need.

More details on Humanigens programs in COVID-19 can be found on the companys website at http://www.humanigen.com under the COVID-19 tab, and details of the US Phase III potential registration study can be found at clinicaltrials.gov using ClinicalTrials.gov Identifier NCT04351152.

About Humanigen, Inc.

Humanigen, Inc. is developing its portfolio of clinical and pre-clinical therapies for the treatment of cancers and infectious diseases via its novel, cutting-edge GM-CSF neutralization and gene-knockout platforms. We believe that our GM-CSF neutralization and gene-editing platform technologies have the potential to reduce the inflammatory cascade associated with coronavirus infection. The companys immediate focus is to prevent or minimize the cytokine release syndrome that precedes severe lung dysfunction and ARDS in serious cases of SARS-CoV-2 infection. The company is also focused on creating next-generation combinatory gene-edited CAR-T therapies using strategies to improve efficacy while employing GM-CSF gene knockout technologies to control toxicity. In addition, the company is developing its own portfolio of proprietary first-in-class EphA3-CAR-T for various solid cancers and EMR1-CAR-T for various eosinophilic disorders. The company is also exploring the effectiveness of its GM-CSF neutralization technologies (either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout) in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments to break the efficacy/toxicity linkage, including to prevent and/or treat graft-versus-host disease (GvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT). Additionally, Humanigen and Kite, a Gilead Company, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration. For more information, visit http://www.humanigen.com.

About CTI Clinical Trial and Consulting Services

CTI Clinical Trial and Consulting Services is a global, privately held, full-service contract research organization (CRO) recently named #1 CRO in the world for quality, delivering a complete spectrum of clinical trial and consulting services throughout the lifecycle of development, from concept to commercialization. CTIs focused therapeutic approach provides pharmaceutical, biotechnology, and medical device firms with clinical and disease area expertise in rare diseases, regenerative medicine/gene therapy, immunology, transplantation, nephrology, hematology/oncology, neurology, infectious diseases, hepatology, cardiopulmonary, and pediatric populations. CTI also offers a fully integrated multi-specialty clinical research site that conducts phase I-IV trials. CTI has a passion for helping life-changing therapies succeed in chronically and critically ill patient populations. With clinical trial experience across 6 continents, CTI partners with research sites, patients, and sponsors to fulfill unmet medical needs. CTI is headquartered in the Greater Cincinnati, OH area, with operations across North America, Europe, Latin America, and Asia-Pacific. For more information visit http://www.ctifacts.com.

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual events or results may differ materially from those contained in the forward-looking statements. Words such as "will," "expect," "intend," "plan," "potential," "possible," "goals," "accelerate," "continue," and similar expressions identify forward-looking statements, including, without limitation, statements regarding our expectations surrounding our ongoing and anticipated clinical trial activities in the United States and Brazil and our operational, research, development or commercialization activities for lenzilumab and the other product candidates in our current pipeline. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the risks inherent in our lack of profitability and need for additional capital to conduct the Phase III study and grow our business; our dependence on partners to further the development of our product candidates; the uncertainties inherent in the development and launch of any new pharmaceutical product; the outcome of pending or future litigation; and the various risks and uncertainties described in the "Risk Factors" sections and elsewhere in the Company's periodic and other filings with the Securities and Exchange Commission.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You should not place undue reliance on any forward-looking statements, which speak only as of the date of this release. We undertake no obligation to revise or update any forward-looking statements made in this press release to reflect events or circumstances after the date hereof or to reflect new information or the occurrence of unanticipated events, except as required by law.

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Humanigen Expands Phase III Study of Lenzilumab in COVID-19 to Brazil - Business Wire

Global Hunter Syndrome Treatment Market was valued at approximately USD 927.9 million in 2019, and is expected to generate revenue of around USD…

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Hunter Syndrome Treatment market.

Trusted Business Insights presents an updated and Latest Study on Hunter Syndrome Treatment Market 2019-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Hunter Syndrome Treatment market during the forecast period (2019-2029). It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Hunter Syndrome Treatment Market by Treatment (Hematopoietic Stem Cell Transplant (HSCT), Enzyme Replacement Therapy (ERT), and Others)-Global Industry Analytics, COVID-19 Business Impact, and Trends, 2020 2029

Abstract

The report covers forecast and analysis for the hunter syndrome treatment market on a global and regional level. The study provides historic data from 2016 to 2019 along with forecast from 2020 to 2026 based on revenue (USD Million). The study includes drivers and restraints for the hunter syndrome treatment market along with the impact they have on the demand over the forecast period. Additionally, the report includes the study of opportunities available in the hunter syndrome treatment market on a global as well as regional level.

In order to give the users of this report a comprehensive view on the hunter syndrome treatment market we have included competitive landscape and analysis of Porters Five Forces model for the market. The study encompasses a market attractiveness analysis, wherein all segments are benchmarked based on their market size, growth rate and general attractiveness.

The report provides company market share analysis in order to give a broader overview of the key players in the hunter syndrome treatment market. In addition, the report also covers key strategic developments of the market including acquisitions & mergers, new indication launch, agreements, partnerships, collaborations & joint ventures, research & development, regional expansion of major participants involved in the hunter syndrome treatment market on global and regional basis.

The study provides a crucial view on the hunter syndrome treatment by segmenting the market based on treatment and region. All the segments of hunter syndrome treatment market have been analyzed based on present and future trends and the market is estimated from 2016 to 2026.

The global demand for hunter syndrome treatment market is driven by expected approval of new therapies, growing research and development activities, and extended life expectancy. However, lack of awareness and high cost may act as restraining factors for the market growth in the coming years. Increasing collaboration and technological advancements are projected to bring new growth avenues for market players during the forecast timeframe.

The hunter syndrome treatment market has been divided into treatment and region. Based on treatment, global hunter syndrome treatment market is segmented into Hematopoietic Stem Cell Transplant (HSCT), Enzyme Replacement Therapy (ERT), and others. Market was dominated by Enzyme Replacement Therapy (ERT) segment in 2019 and is projected to retain its dominance over the forecast timeframe.

North America held largest revenue share of the global hunter syndrome treatment market in 2018. This large share is attributed to government funding, growing awareness and presence of key players in this region. Europe was second leading regional market in terms of revenue. Availability of developed infrastructure, increasing geriatric population, and growing awareness are major factors that support market growth in this region. Asia Pacific region is projected to be rapidly growing regional market for hunter syndrome treatment. Increasing chronic disease prevalence and geriatric population base, economic development, improvement of healthcare infrastructure, growing awareness are major factors attributing to the swift growth in this region. Moderate growth is projected in Latin America region over the forecast period. Middle East and Africa will witness sluggish growth in the coming years.

Major players in hunter syndrome treatment market are GC Pharma, Takeda Pharmaceutical Company, RegenxBio Inc., JCR Pharmaceuticals Co Ltd., Sangamo Therapeutics, Inc., Inventiva S.A., ArmaGen Inc, Esteve, Bioasis Technologies Inc., and Denali Therapeutics Inc among others.

The report segment of global hunter syndrome treatment market as follows:

Global Hunter Syndrome Treatment Market: Treatment

Hematopoietic Stem Cell Transplant (HSCT) Enzyme Replacement Therapy (ERT) Others

Global Hunter Syndrome Treatment Market: By Region

North America

The U.S. Canada

Europe

France The UK Spain Germany Italy Rest of Europe

Asia Pacific

China Japan India South Korea Southeast Asia Rest of Asia Pacific

Latin America

Brazil Mexico Rest of Latin America

Middle East & Africa

GCC South Africa Rest of Middle East & Africa

Looking for more? Check out our repository for all available reports on Hunter Syndrome Treatment in related sectors.

Quick Read Table of Contents of this Report @ Hunter Syndrome Treatment Market by Treatment (Hematopoietic Stem Cell Transplant (HSCT), Enzyme Replacement Therapy (ERT), and Others)-Global Industry Analytics, COVID-19 Business Impact, and Trends, 2020 2029

Trusted Business Insights Shelly Arnold Media & Marketing Executive Email Me For Any Clarifications Connect on LinkedIn Click to follow Trusted Business Insights LinkedIn for Market Data and Updates. US: +1 646 568 9797 UK: +44 330 808 0580

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Global Hunter Syndrome Treatment Market was valued at approximately USD 927.9 million in 2019, and is expected to generate revenue of around USD...

Global Cancer Stem Cell Therapeutics Market Growth Factors, CAGR of 8.79% , Price, Share , Size and Current Industry Trends After Covid 19 Pandemic -…

Global Cancer Stem Cell Therapeutics Market is expected to grow at a CAGR of 8.79% from 2020 to 2023 and Cancer Stem Cell Therapeutics Market report explains why and how it is going to achieve this growth. It provides vital information on every parameter which is required for making strategic decisions and development of every business in Cancer Stem Cell Therapeutics industry. It would come handy to understand market situations, top competitors with their focused segments, regions etc.

Request a Sample Copy of the Report For COVID-19 Impact Analysis onCancer Stem Cell Therapeutics Market

About Cancer Stem Cell Therapeutics market

Cancer is one of the most common causes of deaths across the world. The high prevalence of various types of cancer, such as breast cancer, bladder cancer, lung cancer, leukemia, pancreatic cancer, and prostate cancer, has increased the mortality rate across the world. Countries such as Hungary, Netherlands, Denmark, and Croatia have witnessed an increase in the number of cancer cases over the past few years. The growing instances of cancer-related morbidity across the world will fuel the demand for cancer stem cell therapeutics and drive the growth of the global cancer stem cell therapy market size at a CAGR of over 11% during the forecast period.

TheTop Manufacturers/playersincluding:-

Cellerant Therapeutics Inc., Celularity Inc., Gamida Cell Ltd., Nohla Therapeutics Inc., Sumitomo Dainippon Pharma Co. Ltd.

Get a Sample PDF of report https://www.360marketupdates.com/enquiry/request-sample/14115476

Market Segment of Cancer Stem Cell Therapeutics Industry:

Market Overview

Competitive Landscape

Feel Free to Ask Question Before Purchasing the Report at https://www.360marketupdates.com/enquiry/pre-order-enquiry/14115476

Cancer Stem Cell Therapeutics Market Report provides comprehensive analysis of-

Key Summary of Cancer Stem Cell Therapeutics Market Growth Report:

In our market size and forecast determination efforts, in-depth secondary research was initially completed to realize an honest perspective of the market in each region. Extensive primary research was also administered by interviewing key executives from the industry. These interviews helped us to fill-in the info gaps after secondary research. Several secondary sources like encyclopedia, directories, and databases are wont to identify and collect information useful for this extensive techno-commercial study.

Key Questions Answered in ROY Cancer Stem Cell Therapeutics Market Report:

Purchase this report (Price2500 USD for a single-user license)@ https://www.360marketupdates.com/purchase/14115476

In the end, the Cancer Stem Cell Therapeutics Market report makes some important proposals for a new project of the Cancer Stem Cell Therapeutics Industry before evaluating its feasibility. Overall, the report provides an in-depth insight of Global Cancer Stem Cell Therapeutics Industry covering all important parameters.

Table of Contents included in Cancer Stem Cell Therapeutics Market ROY Report

PART 01: Executive summary

PART 02: Scope of the report

PART 03: Research Methodology

PART 04: Introduction

PART 05: Market landscape

PART 06: Market segmentation by end-user industry

PART 07: Market segmentation by application

PART 08: Geographical Segmentation

PART 09: A Decision framework

PART 10: Impact of drivers and challengesAnd Many More Parts Covered.

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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.

Get SampleCopy of this Report @ https://www.tmrresearch.com/sample/sample?flag=B&rep_id=6584

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.

Check Table of Contents of this Report @ https://www.tmrresearch.com/sample/sample?flag=T&rep_id=6584

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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.

Release authorized by the Chief Executive.

For further information, please contact:

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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

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

RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device, Enabling Clinical Study for Safety and Feasibility – BioSpace

ROSELAND, N.J., Aug. 11, 2020 (GLOBE NEWSWIRE) -- Renovacare, Inc. (Symbol: RCAR; http://www.renovacareinc.com), developer of patented technologies for spraying self-donated stem cells for the regeneration of skin and other organs and tissues, today announced that the US Food and Drug Administration (FDA)conditionally approved the Companys Investigational Device Exemption (IDE) application to conduct a clinical trial to evaluate the safety and feasibility of autologous stem cells rendered by its CellMist System from donor skin and applied topically with the SkinGun spray device for treatment of burn wounds.

"The FDA conditional approval marks a significant milestone for RenovaCare and our technology for spraying an ultra-gentle mist of a patients own skin cells for the healing of burns and wounds. We are working to complete the FDA's technical requirements so that we may move forward with the next phase of development," stated Alan L. Rubino, the Company's President and Chief Executive Officer.

The clinical trial protocol, conditionally approved on August 5, 2020 by the FDA is an open-label single-arm clinical study that will enroll 14 human burn subjects with partial-thickness second- or- third degree thermal burn wounds. The Company expects to conduct the clinical study at multiple U.S. burn centers.

"This achievement marks the culmination of our innovative stem cell and spray technologies coupled to applied research and development resulting in a formal clinical evaluation of skin stem cells as a therapeutic to facilitate burn wound healing," stated RenovaCare Chief Scientific Officer, Dr. Robin A. Robinson. "I am proud of our RenovaCare Team and their dedication to our mission and commitment to provide effective and expedited patient healing and look forward to commencing this study as quickly as possible."

About RenovaCare RenovaCare, Inc. is developing new generation autologous stem cell therapies for the regeneration of human organs and tissues. The Company's initial product under development targets the bodys largest organ, the skin. The Companys flagship technology, the CellMist System, renders single-cell suspensions of tissue-specific pluripotent cells from donor tissues through sequential protease digestions. The RenovaCare CellMist System facilitates rapid healing of wounds or other afflicted tissues when applied topically as a gentle cell mist using the patented RenovaCare SkinGun. The Companys SkinGun is used to spray a liquid suspension of a patients stem cells the CellMist Solution on to wounds.

RenovaCare is developing its CellMist System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars. In the US alone, this $45 billion market is greater than the spending on high-blood pressure management, cholesterol treatments, and back pain therapeutics.

Development for next-generation biomedical technologies and devices for addressing unmet medical needs and commercialization is taking place at the RenovaCare R&D Innovation Center, located at StemCell Systems in Berlin, Germany. The Innovation Center houses dedicated RenovaCare cell biology laboratories; additional engineering, fabrication, prototyping and performance testing facilities; and product design studios for medical devices and biomedical products. Experienced contract bioengineers, cell biologists, and support staff work under the direction of a team of MD-PhDs who are experts in regenerative medicine, new product development, and clinical translation.

RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the Companys planned or filed submissions to the U.S. Food and Drug Administration will be accepted or cleared by the FDA.

For additional information, please call Amit Singh at: 1-888-398-0202 or visit:https://renovacareinc.com

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Social Media Disclaimer Investors and others should note that we announce material financial information to our investors using SEC filings and press releases. We use our website and social media to communicate with our subscribers, shareholders and the public about the company, RenovaCare, Inc. development, and other corporate matters that are in the public domain. At this time, the company will not post information on social media that could be deemed to be material information unless that information was distributed to public distribution channels first.

We encourage investors, the media, and others interested in the company to review the information we post on the companys website and the social media channels listed below:

* This list may be updated from time to time.

Legal Notice Regarding Forward-Looking Statements No statement herein should be considered an offer or a solicitation of an offer for the purchase or sale of any securities. This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although RenovaCare, Inc. (the Company) believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words may, will, should, could, expect, anticipate, estimate, believe, intend, or project or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties, including but not limited to: the timing and success of clinical and preclinical studies of product candidates, the potential timing and success of the Companys product programs through their individual product development and regulatory approval processes, adverse economic conditions, intense competition, lack of meaningful research results, entry of new competitors and products, inadequate capital, unexpected costs and operating deficits, increases in general and administrative costs, termination of contracts or agreements, obsolescence of the Companys technologies, technical problems with the Companys research, price increases for supplies and components, litigation and administrative proceedings involving the Company, the possible acquisition of new businesses or technologies that result in operating losses or that do not perform as anticipated, unanticipated losses, the possible fluctuation and volatility of the Companys operating results, financial condition and stock price, losses incurred in litigating and settling cases, dilution in the Companys ownership of its business, adverse publicity and news coverage, inability to carry out research, development and commercialization plans, loss or retirement of key executives and research scientists, and other risks. There can be no assurance that further research and development will validate and support the results of our preliminary research and studies. Further, there can be no assurance that the necessary regulatory approvals will be obtained or that the Company will be able to develop commercially viable products on the basis of its technologies. In addition, other factors that could cause actual results to differ materially are discussed in the Companys most recent Form 10-Q and Form 10-K filings with the Securities and Exchange Commission. These reports and filings may be inspected and copied at the Public Reference Room maintained by the U.S. Securities & Exchange Commission at 100 F Street, N.E., Washington, D.C. 20549. You can obtain information about operation of the Public Reference Room by calling the U.S. Securities & Exchange Commission at 1-800-SEC-0330. The U.S. Securities & Exchange Commission also maintains an Internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the U.S. Securities & Exchange Commission athttp://www.sec.gov. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

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RenovaCare Receives FDA Conditional IDE Approval of CellMist System and SkinGun Device, Enabling Clinical Study for Safety and Feasibility - BioSpace