The first time Lyell CEO Rick Klausner looked at what PACT Pharma was trying to accomplish with neoantigens, non-viral T cell engineering and cancer, he felt they couldnt get it done. But in the 3 years since theyve launched, Klausner has become a believer.

Now, hes a believer and a partner.

Early Thursday morning, Klausner and PACT CEO Alex Franzusoff announced a plan to jointly pursue one of the Holy Grails of oncology R&D. Blending their technologies and bringing a wide network of leading experts to the table, the two companies are working on a personalized T cell therapy for solid tumors. And an IND is in the offing.

The collaboration joins the Lyell team, which has been concentrating on overcoming the exhaustion that afflicts the first generation of cell therapies, with a PACT group that has developed tech to identify a patients unique signature of cancer mutations and use a non-viral method to engineer their T cells into cancer therapies.

I spent some time on Wednesday talking with Klausner and Franzusoff about the deal, which comes with an undisclosed set of financials as Lyell invests in the alliance.

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A Bay Area upstart with legendary godfathers breaks cover, touting claims of a curative tech, unicorn status and a $300M plan to shoot for an approval...

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Click to Access Sample Pages @https://www.orianresearch.com/request-sample/722408Ethical concerns with the use of embryonic stem cell for r&d, lack of clear regulatory guideline are some of major factors which can hamper the growth of the market.

Rising Demand for Organ Transplantation and Strong Product Pipeline are some of the opportunitites in the forecast period.

Based on therapy the market is segmented into cell therapy, gene therapy, tissue engineering, immunotherapy. The cell-based products is expected to dominate the global Regenerative Medicine market in 2016. Increasing funding from several agencies and private organizations for the research and development of cell therapies, growing inclination of the healthcare industry towards stem cell research, and increasing global awareness about the benefits of stem cell therapies are driving the growth of the cell therapy segment.

Based on application the market is segmented into, Orthopedic & Musculoskeletal Disorders, Dermatology, Oncology, Cardiology

North America dominates the regenerative medicine market due to rapid technological advancements and high investment & funding to support development of regenerative medicine. Asia-Pacific is also expected to propel the regenerative medicine market, owing to factors, such as increasing accessibility to healthcare facilities in the region, and surging economic growth.

Some of the key players operating in this market includeOrganogenesis Inc. (U.S.), Osiris Therapeutics, Inc. (U.S.), Vericel Corporation (U.S.), Stryker Corporation (U.S.), and NuVasive, Inc. (U.S.). The key players in the acellular products segment are Medtronic (Ireland), Acelity (KCI Concepts) (U.S.), Integra LifeSciences (U.S.), Cook Biotech Inc. (U.S.), and C.R. Bard (U.S.).

Key Benefits of the Report:

* Global, Regional, Country, Therapy, and APPLICATION Market Size and Forecast from 2014-2025

* Detailed market dynamics, industry outlook with market specific PESTLE, Value Chain, Supply Chain, and SWOT Analysis to better understand the market and build strategies

* Identification of key companies that can influence this market on a global and regional scale

* Expert interviews and their insights on market shift, current and future outlook and factors impacting vendors short term and long term strategies

* Detailed insights on emerging regions, Therapy& Application, and competitive landscape with qualitative and quantitative information and facts.

Global Regenerative Medicine Industry 2020 Market Research Report is spread across 121 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

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Target Audience:

* Regenerative Medicine providers

* Traders, Importer and Exporter

* Raw material suppliers and distributors

* Research and consulting firms

* Government and research organizations

* Associations and industry bodies.

The Report Covers Exhaustive Analysis on:

The market estimates and forecasts have been verified through exhaustive primary research with the Key Industry Participants (KIPs) which typically include:

* Original Manufacturer,

* Therapy Supplier,

* Distributors,

* Government Body & Associations, and

* Research Institute.

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TABLE OF CONTENT

1 Executive Summary

2 Methodology And Market Scope

3 Regenerative Medicine Market Industry Outlook

4 Regenerative Medicine Market By Product Type

5 Regenerative Medicine Market Application Type

6 Regenerative Medicine Market Regional

7 Competitive Landscape

End Of The Report

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COVID 19 Impact on REGENERATIVE MEDICINE MARKET 2020 GLOBAL INDUSTRY SIZE, ANALYSIS, FUTURE GROWTH, TYPES, END-USERS, KEY PLAYERS AND REGIONAL...

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Carbenicillin is categorized as a semisynthetic penicillin antibiotic which is widely employed in cell culture and molecular biology application due to its ability to inhibit cell wall synthesis by inactivating the transpeptidase present on the inner cell surface of the microbial cell wall.

Cell culture is representing the largest market share in the application segment for the carbenicillin market. Ergonomic features such as very high and improved stability in comparison to ampicillin render it to use in a concentration of 100 g/ml in the cell culture media for the selection of ampr transformed cells. Additionally, features such as high resistance to heat and low pH-induced degradation with respect to different time intervals in the accelerated stability testing studies increase its applicability in liquid culture growth. Molecular biology is going to record rampant market growth during the forecast period on account of the rising prevalence of pandemic infections and chronic diseases worldwide. Carbenicillin is widely used to regulate the bacterial growth in the plants thereby yielding low regeneration frequencies and it is also utilized as a gene selection antibiotic in plant molecular biology to utilize the CRISPR / CAS9 system.

Browse the fullreport Carbenicillin Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2020 2027 athttps://www.atlanticmarketresearch.com/carbenicillin-market

Biopharmaceutical companies are presently leading the end-user segment for the carbenicillin market. Severe adverse side effects associated with chemotherapy has resulted in the increasing demand for gene therapy and immunotherapy for the treatment of metastatic cancer owing to its enhanced therapeutic efficacy and safety. Significant increase in the research and development sector of the life sciences segment for the development of bioengineered molecules utilized in the treatment of rare hereditary diseases. Research academia is expected to register excellent market growth in the near future owing to the increasing funds provided by the government healthcare agencies for novel drug development to curb the mortality rate associated with infectious and chronic diseases across the globe.

North America is presently spearheading the geography segment for thecarbenicillin market. The existence of developed healthcare infrastructure and increasing public health awareness regarding the therapeutic application of biomolecules in the treatment of chronic diseases together steer the market growth in the region. The presence of major players such as Thermo Fisher Scientific, Santa Cruz Biotechnology, Inc., VWR International, LLC, Selleck Chemicals, etc. fortifies the carbenicillin market growth in the region. Europe is placed 2nd in the regional segment for the carbenicillin market. A supportive regulatory environment for the sale and distribution of carbenicillin in the life sciences industry segment provided by the European Medical Agency (EMA), further accentuates the market growth. The Asia Pacific is anticipated to be the fastest-growing regional segment for the carbenicillin market. Developing the life sciences industry and the emergence of local manufacturers together determine the carbenicillin market growth in the Asia Pacific region.

Pharmaceutical manufacturers actively engaged in the production of carbenicillin are Merck KGaA, Thermo Fisher Scientific., Corning, HiMedia Laboratories, VWR International, LLC, Gold Biotechnology, Inc., Selleck Chemicals, Santa Cruz Biotechnology, Inc., Canvax Biotech S.L., and CliniSciences.

Key Market Movements:

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LOS ANGELES, United States: QY Research has recently published a report, titled Global Viral Vector Manufacturing Market Size, Status and Forecast 2020-2026.The market research report is a brilliant, complete, and much-needed resource for companies, stakeholders, and investors interested in the global Viral Vector Manufacturing market. It informs readers about key trends and opportunities in the global Viral Vector Manufacturing market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global Viral Vector Manufacturing market.

Key companies operating in the global Viral Vector Manufacturing market include BioReliance, Cobra Biologics, Oxford BioMedica, UniQure, FinVector, MolMed, MassBiologics, FUJIFILM Diosynth Biotechnologies, Lonza, Biovian, Thermo Fisher Scientific (Brammer Bio) Viral Vector Manufacturing

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

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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 Viral Vector Manufacturing 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 Viral Vector Manufacturing Market Segment By Type:

, Adenoviral Vectors, Adeno-associated Viral Vectors, Retroviral Vectors, Lentiviral Vectors, Other Viral Vector Manufacturing

Global Viral Vector Manufacturing Market Segment By Application:

, Gene Therapy, Vaccinology

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 Viral Vector Manufacturing market.

Key companies operating in the global Viral Vector Manufacturing market include BioReliance, Cobra Biologics, Oxford BioMedica, UniQure, FinVector, MolMed, MassBiologics, FUJIFILM Diosynth Biotechnologies, Lonza, Biovian, Thermo Fisher Scientific (Brammer Bio) Viral Vector Manufacturing

Key questions answered in the report:

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TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Viral Vector Manufacturing Revenue1.4 Market by Type1.4.1 Global Viral Vector Manufacturing Market Size Growth Rate by Type: 2020 VS 20261.4.2 Adenoviral Vectors1.4.3 Adeno-associated Viral Vectors1.4.4 Retroviral Vectors1.4.5 Lentiviral Vectors1.4.6 Other1.5 Market by Application1.5.1 Global Viral Vector Manufacturing Market Share by Application: 2020 VS 20261.5.2 Gene Therapy1.5.3 Vaccinology1.6 Study Objectives1.7 Years Considered 2 Global Growth Trends2.1 Global Viral Vector Manufacturing Market Perspective (2015-2026)2.2 Global Viral Vector Manufacturing Growth Trends by Regions2.2.1 Viral Vector Manufacturing Market Size by Regions: 2015 VS 2020 VS 20262.2.2 Viral Vector Manufacturing Historic Market Share by Regions (2015-2020)2.2.3 Viral Vector Manufacturing Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Challenges2.3.4 Porters Five Forces Analysis2.3.5 Viral Vector Manufacturing Market Growth Strategy2.3.6 Primary Interviews with Key Viral Vector Manufacturing Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Viral Vector Manufacturing Players by Market Size3.1.1 Global Top Viral Vector Manufacturing Players by Revenue (2015-2020)3.1.2 Global Viral Vector Manufacturing Revenue Market Share by Players (2015-2020)3.1.3 Global Viral Vector Manufacturing Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Viral Vector Manufacturing Market Concentration Ratio3.2.1 Global Viral Vector Manufacturing Market Concentration Ratio (CR5 and HHI)3.2.2 Global Top 10 and Top 5 Companies by Viral Vector Manufacturing Revenue in 20193.3 Viral Vector Manufacturing Key Players Head office and Area Served3.4 Key Players Viral Vector Manufacturing Product Solution and Service3.5 Date of Enter into Viral Vector Manufacturing Market3.6 Mergers & Acquisitions, Expansion Plans 4 Market Size by Type (2015-2026)4.1 Global Viral Vector Manufacturing Historic Market Size by Type (2015-2020)4.2 Global Viral Vector Manufacturing Forecasted Market Size by Type (2021-2026) 5 Market Size by Application (2015-2026)5.1 Global Viral Vector Manufacturing Market Size by Application (2015-2020)5.2 Global Viral Vector Manufacturing Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Viral Vector Manufacturing Market Size (2015-2020)6.2 Viral Vector Manufacturing Key Players in North America (2019-2020)6.3 North America Viral Vector Manufacturing Market Size by Type (2015-2020)6.4 North America Viral Vector Manufacturing Market Size by Application (2015-2020) 7 Europe7.1 Europe Viral Vector Manufacturing Market Size (2015-2020)7.2 Viral Vector Manufacturing Key Players in Europe (2019-2020)7.3 Europe Viral Vector Manufacturing Market Size by Type (2015-2020)7.4 Europe Viral Vector Manufacturing Market Size by Application (2015-2020) 8 China8.1 China Viral Vector Manufacturing Market Size (2015-2020)8.2 Viral Vector Manufacturing Key Players in China (2019-2020)8.3 China Viral Vector Manufacturing Market Size by Type (2015-2020)8.4 China Viral Vector Manufacturing Market Size by Application (2015-2020) 9 Japan9.1 Japan Viral Vector Manufacturing Market Size (2015-2020)9.2 Viral Vector Manufacturing Key Players in Japan (2019-2020)9.3 Japan Viral Vector Manufacturing Market Size by Type (2015-2020)9.4 Japan Viral Vector Manufacturing Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Viral Vector Manufacturing Market Size (2015-2020)10.2 Viral Vector Manufacturing Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Viral Vector Manufacturing Market Size by Type (2015-2020)10.4 Southeast Asia Viral Vector Manufacturing Market Size by Application (2015-2020) 11 India11.1 India Viral Vector Manufacturing Market Size (2015-2020)11.2 Viral Vector Manufacturing Key Players in India (2019-2020)11.3 India Viral Vector Manufacturing Market Size by Type (2015-2020)11.4 India Viral Vector Manufacturing Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Viral Vector Manufacturing Market Size (2015-2020)12.2 Viral Vector Manufacturing Key Players in Central & South America (2019-2020)12.3 Central & South America Viral Vector Manufacturing Market Size by Type (2015-2020)12.4 Central & South America Viral Vector Manufacturing Market Size by Application (2015-2020) 13 Key Players Profiles13.1 BioReliance13.1.1 BioReliance Company Details13.1.2 BioReliance Business Overview13.1.3 BioReliance Viral Vector Manufacturing Introduction13.1.4 BioReliance Revenue in Viral Vector Manufacturing Business (2015-2020))13.1.5 BioReliance Recent Development13.2 Cobra Biologics13.2.1 Cobra Biologics Company Details13.2.2 Cobra Biologics Business Overview13.2.3 Cobra Biologics Viral Vector Manufacturing Introduction13.2.4 Cobra Biologics Revenue in Viral Vector Manufacturing Business (2015-2020)13.2.5 Cobra Biologics Recent Development13.3 Oxford BioMedica13.3.1 Oxford BioMedica Company Details13.3.2 Oxford BioMedica Business Overview13.3.3 Oxford BioMedica Viral Vector Manufacturing Introduction13.3.4 Oxford BioMedica Revenue in Viral Vector Manufacturing Business (2015-2020)13.3.5 Oxford BioMedica Recent Development13.4 UniQure13.4.1 UniQure Company Details13.4.2 UniQure Business Overview13.4.3 UniQure Viral Vector Manufacturing Introduction13.4.4 UniQure Revenue in Viral Vector Manufacturing Business (2015-2020)13.4.5 UniQure Recent Development13.5 FinVector13.5.1 FinVector Company Details13.5.2 FinVector Business Overview13.5.3 FinVector Viral Vector Manufacturing Introduction13.5.4 FinVector Revenue in Viral Vector Manufacturing Business (2015-2020)13.5.5 FinVector Recent Development13.6 MolMed13.6.1 MolMed Company Details13.6.2 MolMed Business Overview13.6.3 MolMed Viral Vector Manufacturing Introduction13.6.4 MolMed Revenue in Viral Vector Manufacturing Business (2015-2020)13.6.5 MolMed Recent Development13.7 MassBiologics13.7.1 MassBiologics Company Details13.7.2 MassBiologics Business Overview13.7.3 MassBiologics Viral Vector Manufacturing Introduction13.7.4 MassBiologics Revenue in Viral Vector Manufacturing Business (2015-2020)13.7.5 MassBiologics Recent Development13.8 FUJIFILM Diosynth Biotechnologies13.8.1 FUJIFILM Diosynth Biotechnologies Company Details13.8.2 FUJIFILM Diosynth Biotechnologies Business Overview13.8.3 FUJIFILM Diosynth Biotechnologies Viral Vector Manufacturing Introduction13.8.4 FUJIFILM Diosynth Biotechnologies Revenue in Viral Vector Manufacturing Business (2015-2020)13.8.5 FUJIFILM Diosynth Biotechnologies Recent Development13.9 Lonza13.9.1 Lonza Company Details13.9.2 Lonza Business Overview13.9.3 Lonza Viral Vector Manufacturing Introduction13.9.4 Lonza Revenue in Viral Vector Manufacturing Business (2015-2020)13.9.5 Lonza Recent Development13.10 Biovian13.10.1 Biovian Company Details13.10.2 Biovian Business Overview13.10.3 Biovian Viral Vector Manufacturing Introduction13.10.4 Biovian Revenue in Viral Vector Manufacturing Business (2015-2020)13.10.5 Biovian Recent Development13.11 Thermo Fisher Scientific (Brammer Bio)10.11.1 Thermo Fisher Scientific (Brammer Bio) Company Details10.11.2 Thermo Fisher Scientific (Brammer Bio) Business Overview10.11.3 Thermo Fisher Scientific (Brammer Bio) Viral Vector Manufacturing Introduction10.11.4 Thermo Fisher Scientific (Brammer Bio) Revenue in Viral Vector Manufacturing Business (2015-2020)10.11.5 Thermo Fisher Scientific (Brammer Bio) Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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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 Cell Therapy market.

Trusted Business Insights presents an updated and Latest Study on Cell Therapy Market 2019-2026. 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 Cell Therapy 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 @ Cell Therapy Market Size, Share, Market Research and Industry Forecast Report, 2020-2027 (Includes Business Impact of COVID-19)

Industry Insights, Market Size, CAGR, High-Level Analysis: Cell Therapy Market

The global cell therapy market size was valued at USD 5.8 billion in 2019 and is projected to witness a CAGR of 5.4% during the forecast period. The development of precision medicine and advancements in Advanced Therapies Medicinal Products (ATMPS) in context to their efficiency and manufacturing are expected to be the major drivers for the market. In addition, automation in adult stem cell and cord blood processing and storage are the key technological advancements that have supported the growth of the market for cell therapy.The investment in technological advancements for decentralizing manufacturing of this therapy is anticipated to significantly benefit the market. Miltenyi Biotec is one of the companies that has contributed to the decentralization in manufacturing through its CliniMACS Prodigy device. The device is an all-in-one automated manufacturing system that exhibits the capability of manufacturing various cell types.

An increase in financing and investments in the space to support the launch of new companies is expected to boost the organic revenue growth in the market for cell therapy. For instance, in July 2019, Bayer invested USD 215 million for the launch of Century Therapeutics, a U.S.-based biotechnology startup that aimed at developing therapies for solid tumors and blood cancer. Funding was further increased to USD 250 billion by a USD 35 million contribution from Versant Ventures and Fujifilm Cellular Dynamics.The biomanufacturing companies are working in collaboration with customers and other stakeholders to enhance the clinical development and commercial manufacturing of these therapies. Biomanufacturers and OEMs such as GE healthcare are providing end-to-end flexible technology solutions to accelerate the rapid launch of therapies in the market for cell therapy.The expanding stem cells arena has also triggered the entry of new players in the market for cell therapy. Celularity, Century Therapeutics, Rubius Therapeutics, ViaCyte, Fate Therapeutics, ReNeuron, Magenta Therapeutics, Frequency Therapeutics, Promethera Biosciences, and Cellular Dynamics are some startups that have begun their business in this arena lately.Use-type InsightsThe clinical-use segment is expected to grow lucratively during the forecast period owing to the expanding pipeline for therapies. The number of cancer cellular therapies in the pipeline rose from 753 in 2018 to 1,011 in 2019, as per Cancer Research Institute (CRI). The major application of stem cell treatment is hematopoietic stem cell transplantation for the treatment of the immune system and blood disorders for cancer patients.In Europe, blood stem cells are used for the treatment of more than 26,000 patients each year. These factors have driven the revenue for malignancies and autoimmune disorders segment. Currently, most of the stem cells used are derived from bone marrow, blood, and umbilical cord resulting in the larger revenue share in this segment.On the other hand, cell lines, such as Induced Pluripotent Stem Cells (iPSC) and human Embryonic Stem Cells (hESC) are recognized to possess high growth potential. As a result, a several research entities and companies are making significant investments in R&D pertaining to iPSC- and hESC-derived products.TherapyType Insights of Cell Therapy Market

An inclination of physicians towards therapeutic use of autologous and allogeneic cord blood coupled with rising awareness about the use of cord cells and tissues across various therapeutic areas is driving revenue generation. Currently, the allogeneic therapies segment accounted for the largest share in 2019 in the cell therapy market. The presence of a substantial number of approved products for clinical use has led to the large revenue share of this segment.

Furthermore, the practice of autologous tissue transplantation is restricted by the limited availability of healthy tissue in the patient. Moreover, this type of tissue transplantation is not recommended for young patients wherein tissues are in the growth and development phase. Allogeneic tissue transplantation has effectively addressed the above-mentioned challenges associated with the use of autologous transplantation.However, autologous therapies are growing at the fastest growth rate owing to various advantages over allogeneic therapies, which are expected to boost adoption in this segment. Various advantages include easy availability, no need for HLA-matched donor identification, lower risk of life-threatening complications, a rare occurrence of graft failure, and low mortality rate.

Regional Insights of Cell Therapy Market

The presence of leading universities such as the Institute for Stem Cell Biology and Regenerative Medicine, Stanford University, and Yale Stem Cell Center that support research activities in U.S. is one of the key factor driving the market for cell therapy in North America. Moreover, strong regulatory and financing support from the federal bodies for expansion of this arena in U.S. as well as Canada is driving the market.In Asia Pacific, the market is anticipated to emerge as a lucrative source of revenue owing to the availability of therapies at lower prices coupled with growing awareness among the healthcare entities and patients pertaining the potential of these therapies in chronic disease management. Japan is leading the Asian market for cell therapy, which can be attributed to its fast growth as a hub for research on regenerative medicine.Moreover, the Japan government has recognized regenerative medicine and cell therapy as a key contributor to the countrys economic growth. This has positively influenced the attention of global players towards the Asian market, thereby driving marketing operations in the region.

Market Share Insights of Cell Therapy Market

Some key companies operating in this market for cell therapy are Fibrocell Science, Inc.; JCR Pharmaceuticals Co. Ltd.; Kolon TissueGene, Inc.; PHARMICELL Co., Ltd.; Osiris Therapeutics, Inc.; MEDIPOST; Cells for Cells; NuVasive, Inc.; Stemedica Cell Technologies, Inc.; Vericel Corporation; and ANTEROGEN.CO.,LTD. These companies are collaborating with the blood centers and plasma collection centers in order to obtain cells for use in therapeutics development.Several companies have marked their presence in the market by acquiring small and emerging therapy developers. For instance, in August 2019, Bayer acquired BlueRock Therapeutics to establish its position in the market for cell therapy. BlueRock Therapeutics is a U.S. company that relies on a proprietary induced pluripotent stem cell (iPSC) platform for cell therapy development.Several companies are making an entry in the space through the Contract Development and Manufacturing Organization (CDMO) business model. For example, in April 2019, Hitachi Chemical Co. Ltd. acquired apceth Biopharma GmbH to expand its global footprint in the CDMO market for cell and gene therapy manufacturing.

Segmentations, Sub Segmentations, CAGR, & High-Level Analysis overview of Cell Therapy Market Research ReportThis report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2019 to 2030. For the purpose of this study, this market research report has segmented the global cell therapy market on the basis of use-type, therapy-type, and region:

Use-Type Outlook (Revenue, USD Million, 2019 2030)

Clinical-use

By Therapeutic Area

Malignancies

Musculoskeletal Disorders

Autoimmune Disorders

Dermatology

Others

By Cell Type

Stem Cell Therapies

BM, Blood, & Umbilical Cord-derived Stem Cells

Adipose derived cells

Others

Non-stem Cell Therapies

Research-use

Therapy Type Outlook (Revenue, USD Million, 2019 2030)

Allogeneic Therapies

Autologous Therapies

Quick Read Table of Contents of this Report @ Cell Therapy Market Size, Share, Market Research and Industry Forecast Report, 2020-2027 (Includes Business Impact of COVID-19)

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Cell Therapy Market Analysis Of Global Trends, Demand And Competition 2020-2028 - Cole of Duty

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The globalCell Culture Marketis carefully researched in the report while largely concentrating on top players and their business tactics, geographical expansion, market segments, competitive landscape, manufacturing, and pricing and cost structures. Each section of the research study is specially prepared to explore key aspects of the global Cell Culture market. For instance, the market dynamics section digs deep into the drivers, restraints, trends, and opportunities of the global Cell Culture market. With qualitative and quantitative analysis, we help you with thorough and comprehensive research on the global Cell Culture market. We have also focused on SWOT, PESTLE, and Porters Five Forces analyses of the global Cell Culture market.

Leading players of the global Cell Culture market are analyzed taking into account their market share, recent developments, new product launches, partnerships, mergers or acquisitions, and markets served. We also provide an exhaustive analysis of their product portfolios to explore the products and applications they concentrate on when operating in the global Cell Culture market. Furthermore, the report offers two separate market forecasts one for the production side and another for the consumption side of the global Cell Culture market. It also provides useful recommendations for new as well as established players of the global Cell Culture market.

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Major Players:

Thermo FisherMerck MilliporeCorningGE HealthcareBDTakaraLonzaHiMediaCellGenixPromoCell

Segmentation by Product:

CartridgesGlass VialsAmpoules

Segmentation by Application:

Biopharmaceutical ManufacturingTissue Culture & EngineeringGene TherapyOther

Regions and Countries:U.S, Canada, France, Germany, UK, Italy, Rest of Europe, India, China, Japan, Singapore, South Korea, Australia, Rest of APAC, Brazil, Mexico, Argentina, Rest of LATAM, Saudi Arabia, South Africa, UAE.

Report Objectives

Table of Contents

Report Overview:It includes major players of the global Cell Culture market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends:This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Cell Culture market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Cell Culture market are discussed.

Market Share by Manufacturers:Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type:This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application:Besides an overview of the global Cell Culture market by application, it gives a study on the consumption in the global Cell Culture market by application.

Production by Region:Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region:This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles:Almost all leading players of the global Cell Culture market are profiled in this section. The analysts have provided information about their recent developments in the global Cell Culture market, products, revenue, production, business, and company.

Market Forecast by Production:The production and production value forecasts included in this section are for the global Cell Culture market as well as for key regional markets.

Market Forecast by Consumption:The consumption and consumption value forecasts included in this section are for the global Cell Culture market as well as for key regional markets.

Value Chain and Sales Analysis:It deeply analyzes customers, distributors, sales channels, and value chain of the global Cell Culture market.

Key Findings:This section gives a quick look at important findings of the research study.

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Our research base consists of a wide spectrum of premium market research reports. Apart from comprehensive syndicated research reports, our in-house team of research analysts leverages excellent research capabilities to deliver highly customized tailor-made reports. The market entry strategies presented in our reports has helped organizations of all sizes to generate profits by making timely business decisions. The research information including market size, sales, revenue, and competitive analysis offered, is the product of our excellence in the market research domain.

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Cell Culture MARKET 2020 GLOBAL COMPETITION, SIZE, BUSINESS OUTLOOK, FORECAST TO 2026 | Thermo Fisher, Merck Millipore - Cole of Duty

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The Insight Partners analysts forecast the latest report on Global Primary Immunodeficiency Diseases Treatment Market (Covid-19) Impact and Analysis by 2027, according to report; The Primary Immunodeficiency Diseases Treatment Market report covers the overall and all-inclusive analysis of Market with all its factors that have an impact on market growth. This report is anchored on the thorough qualitative and quantitative assessment of the Primary Immunodeficiency Diseases Treatment Market.

The study provides details such as the market share, Market Insights, Strategic Insights, Segmentation and key playersin the Primary Immunodeficiency Diseases Treatment Market.

MARKET INTRODUCTION

Immunodeficiency disorders prevent a body from fighting infections and diseases. Immunodeficiency disorders are either congenital or acquired. Primary immune-deficiencies are disorders in which part of the bodys immune system is missing or does not function normally, such that it is an inherited defect in the immune system that increases the susceptibility to infections. Fractionation separates the immunoglobulin and blood protein from plasma, which in turn, results in the development of immunoglobulins. Immunoglobulin therapy is useful in reducing the symptoms of the autoimmune disease and a wide range of infections as they easily detect the microorganisms that are entering the body and assist the immune cells in neutralizing them.

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Note The Covid-19 (coronavirus) pandemic is impacting society and the overall economy across the world. The impact of this pandemic is growing day by day as well as affecting the supply chain. The COVID-19 crisis is creating uncertainty in the stock market, massive slowing of supply chain, falling business confidence, and increasing panic among the customer segments. The overall effect of the pandemic is impacting the production process of several industries. This report on Primary Immunodeficiency Diseases Treatment Market provides the analysis on impact on Covid-19 on various business segments and country markets. The reports also showcase market trends and forecast to 2027, factoring the impact of Covid -19 Situation.

Our Sample Report Accommodate a Brief Introduction of the research report, TOC, List of Tables and Figures, Competitive Landscape and Geographic Segmentation, Innovation and Future Developments Based on Research Methodology

The reports cover key developments in the Primary Immunodeficiency Diseases Treatment Market as organic and inorganic growth strategies. Various companies are focusing on organic growth strategies such as product launches, product approvals and others such as patents and events. Inorganic growth strategies activities witnessed in the market were acquisitions, and partnership & collaborations. These activities have paved way for the expansion of business and customer base of market players.

Some of the Major Market Players Are:

MARKET DYNAMICS

The primary immunodeficiency diseases treatment market is driving due to the government approvals and support and increasing awareness regarding primary immunodeficiency diseases treatment. However, poor and critical reimbursement policies and the absence of adequate provision for the diagnosis of primary immunodeficiency are hindering the market growth. Moreover, rising incidences of immune diseases in children and technological advancements in gene therapy are the key driving factors in the primary immunodeficiency therapeutics market.

MARKET SCOPE

The Primary Immunodeficiency Diseases Treatment Market Analysis to 2027 is a specialized and in-depth study of the healthcare industry with a special focus on the global market trend analysis. The report aims to provide an overview of primary immunodeficiency diseases treatment market with detailed market segmentation by disease, test and treatment. The primary immunodeficiency diseases treatment market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading players in primary immunodeficiency diseases treatment market and offers key trends and opportunities in the market.

MARKET SEGMENTATION

The primary immunodeficiency diseases treatment market is segmented on the basis of disease, test and treatment. Based on disease, the market is segmented as innate immune disorders, cellular immunodeficiency, antibody deficiency. On the basis of test, the market is categorized as prenatal testing and blood test. On the basis of treatment, the market is categorized as antibiotic therapy, stem cell and gene therapy, immunoglobulin replacement therapy, and others.

The report analyses factors affecting the Primary Immunodeficiency Diseases Treatment Market from further evaluates market dynamics affecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA, and South America after evaluating political, economic, social and technological factors affecting the Primary Immunodeficiency Diseases Treatment Market in these regions.

Moreover, the report entails the estimate and analysis for the Primary Immunodeficiency Diseases Treatment Market on a global as well as regional level. The study provides historical data as well as the trending features and future predictions of the market growth. Further, the report encompasses drivers and restraints for the Primary Immunodeficiency Diseases Treatment Market growth along with its impact on the overall market development. In addition, the report provides an analysis of the accessible avenues in the market on a global level.

REGIONAL FRAMEWORK

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides an overview and forecast of the global Primary Immunodeficiency Diseases Treatment Market based on various segments. It also provides market size and forecast estimates from the year 2018 to 2027 with respect to five major regions. The Primary Immunodeficiency Diseases Treatment Market by each region is later sub-segmented by respective countries and segments. The report covers the analysis and forecast of 18 countries globally along with the current trend and opportunities prevailing in the region.

Promising Regions & Countries Mentioned in The Primary Immunodeficiency Diseases Treatment Market Report:

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Primary Immunodeficiency Diseases Treatment Market 2020- Technology Growing Rapidly Due to High Quality Standards and Effective Features Till 2027 -...

Recommendation and review posted by Bethany Smith

Gene editing Cas9 protein.

Applied computational biology discoveries vastly expand the range of CRISPRs access to DNA sequences.

In nature, bacteria use CRISPR as an adaptive immune system to protect themselves against viruses. Over the past decade, scientists have been able to successfully build upon that natural phenomenon with the discovery of CRISPR proteins found in bacteria the most widely used of which is the Cas9 enzyme. In combination with a guide RNA, Cas9 is able to target, cut, and degrade specific DNA sequences.

With applications ranging from the treatment of genetic diseases to the nutritional potency of agricultural crops, CRISPR has emerged as one of the most promising tools for genome editing. Cas9 enzymes, however, rely on specific DNA ZIP codes to pinpoint where to cut and edit. The most widely-used Cas9 fromStreptococcus pyogenes bacteria, SpCas9, requires two G nucleotides beside target sites. Less than 10 percent of DNA sequences meet this requirement.

In research published this month in both Nature Biotechnology andNature Communications,a team of computational biologists in the Media Labs Molecular Machines group and the MIT Center for Bits and Atoms have successfully engineered new proteins with enhanced genome editing capabilities, significantly broadening the spectrum of DNA sequences that can be accurately and effectively accessed.

This work was led by Pranam Chatterjee who recently completed his PhD in media arts and sciences; Noah Jakimo PhD 19, a Media Lab affiliate; and Media Lab Associate Professor Joseph Jacobson, in collaboration with lab members and researchers at the University of Massachusetts Medical School.

These new findings stem from the groups earlier breakthrough work in the computational discovery of Cas9 proteins. The teamidentified and experimentally characterized the Cas9 fromStreptococcus canisbacteria (ScCas9), which, while similar to SpCas9, had the ability to target a much broader range of target DNA sequences. That discovery expanded the number of locations that Cas9 enzymes could target from the original 10 percent of sites on the genome to nearly 50 percent. The team first reported those findings in 2018 inScience Advances.

To improve ScCas9 as a genome editing tool, the scientists computationally identified unique parts from similar Cas9 proteins to engineer an optimized version of ScCas9, which the team has named Sc++.Sc++ is the first known enzyme to simultaneously exhibit the three properties deemed essential for effective genome editing: broad targeting capability; robust cutting activity; and minimal errors due to off-targeting, notes Chatterjee.

Concurrently, the team successfully used their previous SPAMALOT algorithm to discoverStreptococcus macacaeCas9 (SmacCas9) that required two A nucleotides, rather than two Gs. Through domain swapping and further engineering, the team presents the newiSpyMac enzyme as one of the first known Cas9 editors not requiring a G, enabling targeting of an additional 20 percent of the genome that was previously inaccessible.To engineer iSpyMac, we simultaneously made hundreds of changes to SpCas9, knowing even a single change can break it,says Jakimo, the senior author on this second study. Our success is a testament to the wealth of microbial genomic data that can provide helpful clues about protein function with tools like SPAMALOT.

Erik Sontheimer, professor and vice chair of the RNA Therapeutics Institute at the University of Massachusetts Medical School, and a collaborator on the research, notes the significance of this work. The fewer targeting limitations we encounter, and the fewer compromises and trade-offs that have to be made between activity and accuracy, the greater the impact that CRISPR genome editing can have on biotechnology and human health. This is why Sc++ and iSpyMac provide such valuable new additions to the CRISPR editing arsenal.

As labs around the world have already begun to use the enzymes to successfully edit the genomes of various organisms, from rice to rabbits, the next goal for this research will be to develop tools to reach the remaining 30 percent of genome sequences. Chatterjee, in collaboration with the University of Zurich, is looking to unlock the final advances that will allow scientists to access any genomic sequence, and to address any type of gene mutation in the treatment of genetic diseases.

For now, however, as in many labs across the MIT campus, work has pivoted to address the Covid-19 pandemic. By applying computational design principles to engineer proteins that can target and bind to the invading SARS-CoV-2 virus, Chatterjee and the research team at the Media Lab are seeking to create enzymes to rapidly halt the virus, and enable cell recovery.

We engineer proteins differently, Chatterjee adds. Our ability to integrate computation and experimentation enables us to refine our algorithms and build impactful tools for a host of applications, from addressing genetic diseases to Covid-19, and beyond.

References:

A Cas9 with PAM recognition for adenine dinucleotides by Pranam Chatterjee, Jooyoung Lee, Lisa Nip, Sabrina R. T. Koseki, Emma Tysinger, Erik J. Sontheimer, Joseph M. Jacobson and Noah Jakimo, 18 May 2020, Nature Communications.DOI: 10.1038/s41467-020-16117-8

An engineered ScCas9 with broad PAM range and high specificity and activity by Pranam Chatterjee, Noah Jakimo, Jooyoung Lee, Nadia Amrani, Toms Rodrguez, Sabrina R. T. Koseki, Emma Tysinger, Rui Qing, Shilei Hao, Erik J. Sontheimer and Joseph Jacobson, 11 May 2020, Nature Biotechnology.DOI: 10.1038/s41587-020-0517-0

Minimal PAM specificity of a highly similar SpCas9 ortholog by Pranam Chatterjee, Noah Jakimo and Joseph M. Jacobson, 24 October 2018, Science Advances.DOI: 10.1126/sciadv.aau0766

See the article here:
Nature-Inspired CRISPR Enzyme Discoveries Vastly Expand Genome Editing - SciTechDaily

Recommendation and review posted by Bethany Smith

-Beta thalassemia: Two patients are transfusion independent at 5 and 15 months after CTX001 infusion; data demonstrate clinical proof-of-concept for CTX001 in transfusion-dependent beta thalassemia-

-Sickle cell disease: Patient is free of vaso-occlusive crises at 9 months after CTX001 infusion-

-Five patients with beta thalassemia and two patients with sickle cell disease have been treated to date with CTX001 and all have successfully engrafted-

ZUG, Switzerland and CAMBRIDGE, Mass. and BOSTON, June 12, 2020 (GLOBE NEWSWIRE) -- CRISPR Therapeutics (Nasdaq: CRSP) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced new clinical data for CTX001, an investigational CRISPR/Cas9 gene-editing therapy, from the CLIMB-111 and CLIMB-121 Phase 1/2 trials in transfusion-dependent beta thalassemia (TDT) and severe sickle cell disease (SCD), and highlighted recent progress in the CTX001 development program. These data were presented during an oral presentation at the European Hematology Association (EHA) virtual congress by Dr. Selim Corbacioglu, Professor of Pediatrics and the Chair of Pediatric Hematology, Oncology, and Stem Cell Transplantation, Regensburg University Hospital, Regensburg, Germany.

CLIMB-111 Trial in Transfusion-Dependent Beta Thalassemia Updated ResultsData presented today at EHA demonstrate clinical proof-of-concept for CTX001 in TDT. Data include longer-duration follow-up data for the first patient with TDT treated with CTX001 and new data for the second TDT patient treated. CRISPR Therapeutics and Vertex announced initial data for the first TDT patient in November of 2019.

Patient 1 with TDT has the 0/IVS-I-110 genotype, which is associated with a severe phenotype similar to 0/0, and had a transfusion requirement of 34 units of packed red blood cells per year (annualized rate during the two years prior to consenting for the trial) before enrolling in the clinical trial. As previously reported, the patient achieved neutrophil engraftment 33 days after CTX001 infusion and platelet engraftment 37 days after infusion. After CTX001 infusion, two serious adverse events (SAEs) occurred, neither of which the principal investigator (PI) considered related to CTX001: pneumonia in the presence of neutropenia, and veno-occlusive liver disease attributed to busulfan conditioning; both subsequently resolved. New data presented today show that at 15 months after CTX001 infusion, the patient was transfusion independent and had total hemoglobin levels of 14.2 g/dL, fetal hemoglobin of 13.5 g/dL, and F-cells (erythrocytes expressing fetal hemoglobin) of 100.0%. Bone marrow allelic editing was 78.1% at 6 months and 76.1% at one year.

Patient 2 with TDT has the 0/IVS-II-745 genotype and had a transfusion requirement of 61 units of packed red blood cells per year (annualized rate during the two years prior to consenting for the trial) before enrolling in the clinical trial. The patient achieved neutrophil engraftment 36 days after CTX001 infusion and platelet engraftment 34 days after infusion. After CTX001 infusion, two SAEs occurred, neither of which the PI considered related to CTX001: pneumonia and an upper respiratory tract infection; both subsequently resolved. At 5 months after CTX001 infusion, the patient was transfusion independent and had total hemoglobin levels of 12.5 g/dL, fetal hemoglobin of 12.2 g/dL, and F-cells (erythrocytes expressing fetal hemoglobin) of 99.4%.

Hemoglobin data over time are presented for Patient 1 and Patient 2 below.

Figure 1accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/35581299-d683-44b0-a75e-7a1a9b9fe9eb

CLIMB-121 Trial in Severe Sickle Cell Disease Updated Results Data presented today at EHA reflect longer-duration follow-up data for the first patient with SCD treated with CTX001. CRISPR Therapeutics and Vertex announced initial data for this first SCD patient in November of 2019.

Patient 1 with SCD experienced seven vaso-occlusive crises (VOCs) and five packed red blood cell transfusions per year (annualized rate during the two years prior to consenting for the trial) before enrolling in the clinical trial. As previously reported, the patient achieved neutrophil and platelet engraftment 30 days after CTX001 infusion. After CTX001 infusion, three SAEs occurred, none of which the PI considered related to CTX001: sepsis in the presence of neutropenia, cholelithiasis and abdominal pain; all subsequently resolved. New data presented today show that at 9 months after CTX001 infusion, the patient was free of VOCs, was transfusion independent and had total hemoglobin levels of 11.8 g/dL, 46.1% fetal hemoglobin, and F-cells (erythrocytes expressing fetal hemoglobin) of 99.7%. Bone marrow allelic editing was 81.4% at 6 months. Figure 2 presents the hemoglobin data over time for this patient.

Figure 2 accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7610c5bd-25c8-4f5b-be86-8bc16ed57eb1

With these new data, we are beginning to see early evidence of the potential durability of benefit from treatment with CTX001, as well as consistency of the therapeutic effect across patients, said Samarth Kulkarni, Ph.D., Chief Executive Officer of CRISPR Therapeutics. These highly encouraging early data represent one more step toward delivering on the promise and potential of CRISPR/Cas9 therapies as a new class of potentially transformative medicines to treat serious diseases.

The data announced today are remarkable, including the demonstration of clinical proof-of-concept in TDT, said Reshma Kewalramani, M.D., Chief Executive Officer and President of Vertex. While these are still early days, these data mark another important milestone for this program and for the field of gene editing. The results presented at this medical conference add to results previously shared demonstrating that CRISPR/Cas9 gene editing has the potential to be a curative therapy for severe genetic diseases like sickle cell and beta thalassemia.

In my 25 years of caring for children and young adults facing both sickle cell disease and beta thalassemia, I have seen how these diseases can adversely affect patients lives in very significant ways, said Dr. Haydar Frangoul, Medical Director of Pediatric Hematology and Oncology at Sarah Cannon Research Institute, HCA Healthcares TriStar Centennial Medical Center and senior author of the abstract presented at the EHA virtual congress. I am encouraged by the preliminary results, which demonstrate, in essence, a functional cure for patients with beta thalassemia and sickle cell disease.

Recent Progress in the Phase 1/2 Clinical TrialsCLIMB-111 for TDT has dosed a total of 5 patients, and all patients have successfully engrafted. The trial is also now open for concurrent dosing after successful dosing and engraftment of the first two patients. Additionally, CLIMB-111 has been expanded to allow enrollment of 0/0 patients and is in the process of being expanded to allow enrollment of pediatric patients ages 12 years or older.

CLIMB-121 for SCD has dosed a total of 2 patients and both patients have successfully engrafted. The trial is also now open for concurrent dosing after successful dosing and engraftment of these first two patients.

The initial safety profile in these trials appears to be consistent with myeloablative busulfan conditioning and an autologous hematopoietic stem cell transplant.

In March 2020, clinical trial sites in the U.S. and Europe temporarily paused their elective hematopoietic stem cell transplant programs due to the COVID-19 pandemic, and as a result, CRISPR and Vertex temporarily paused conditioning and dosing in these trials. Enrollment, mobilization and drug product manufacturing in each trial remains ongoing. The companies are now in the process of re-initiating dosing with CTX001 at certain clinical trial sites. The CLIMB-111 and CLIMB-121 clinical trials are ongoing, and patients will be followed for 2 years following CTX001 infusion. The companies expect to provide additional data in the second half of 2020.

About CTX001CTX001 is an investigational ex vivo CRISPR gene-edited therapy that is being evaluated for patients suffering from TDT or severe SCD in which a patients hematopoietic stem cells are engineered to produce high levels of fetal hemoglobin (HbF; hemoglobin F) in red blood cells. HbF is a form of the oxygen-carrying hemoglobin that is naturally present at birth, which then switches to the adult form of hemoglobin. The elevation of HbF by CTX001 has the potential to alleviate transfusion requirements for TDT patients and reduce painful and debilitating sickle crises for SCD patients.

Based on progress in this program to date, CTX001 has been granted Regenerative Medicine Advanced Therapy (RMAT) from the U.S. FDA, Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA), and Fast Track Designation from the FDA for both SCD and TDT.

CTX001 is being developed under a co-development and co-commercialization agreement between CRISPR Therapeutics and Vertex. CTX001 is the most advanced gene-editing approach in development for TDT and SCD.

About CLIMB-111The ongoing Phase 1/2 open-label trial, CLIMB-Thal-111, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with TDT. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About CLIMB-121The ongoing Phase 1/2 open-label trial, CLIMB-SCD-121, is designed to assess the safety and efficacy of a single dose of CTX001 in patients ages 18 to 35 with severe SCD. The trial will enroll up to 45 patients and follow patients for approximately two years after infusion. Each patient will be asked to participate in a long-term follow-up trial.

About the Gene-Editing Process in These TrialsPatients who enroll in these trials will have their own hematopoietic stem and progenitor cells collected from peripheral blood. The patients cells will be edited using the CRISPR/Cas9 technology. The edited cells, CTX001, will then be infused back into the patient as part of a stem cell transplant, a process which involves, among other things, a patient being treated with myeloablative busulfan conditioning. Patients undergoing stem cell transplants may also encounter side effects (ranging from mild to severe) that are unrelated to the administration of CTX001. Patients will initially be monitored to determine when the edited cells begin to produce mature blood cells, a process known as engraftment. After engraftment, patients will continue to be monitored to track the impact of CTX001 on multiple measures of disease and for safety.

About the CRISPR-Vertex Collaboration CRISPR Therapeutics and Vertex entered into a strategic research collaboration in 2015 focused on the use of CRISPR/Cas9 to discover and develop potential new treatments aimed at the underlying genetic causes of human disease. CTX001 represents the first treatment to emerge from the joint research program. CRISPR Therapeutics and Vertex will jointly develop and commercialize CTX001 and equally share all research and development costs and profits worldwide.

About CRISPR TherapeuticsCRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic collaborations with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations based in Cambridge, Massachusetts, and business offices in San Francisco, California and London, United Kingdom. For more information, please visit http://www.crisprtx.com.

CRISPR Therapeutics Forward-Looking StatementThis press release may contain a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements made by Dr. Kulkarni, Dr. Kewalramani and Dr. Frangoul in this press release, as well as statements regarding CRISPR Therapeutics expectations about any or all of the following: (i) the status of clinical trials (including, without limitation, the expected timing of data releases and activities at clinical trial sites) related to product candidates under development by CRISPR Therapeutics and its collaborators, including expectations regarding the data that is being presented at the European Hematology Associations virtual congress; (ii) the expected benefits of CRISPR Therapeutics collaborations; and (iii) the therapeutic value, development, and commercial potential of CRISPR/Cas9 gene editing technologies and therapies. Without limiting the foregoing, the words believes, anticipates, plans, expects and similar expressions are intended to identify forward-looking statements. You are cautioned that forward-looking statements are inherently uncertain. Although CRISPR Therapeutics believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those projected or suggested in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: potential impacts due to the coronavirus pandemic, such as the timing and progress of clinical trials; the potential for initial and preliminary data from any clinical trial and initial data from a limited number of patients (as is the case with CTX001 at this time) not to be indicative of final trial results; the potential that CTX001 clinical trial results may not be favorable; that future competitive or other market factors may adversely affect the commercial potential for CTX001; uncertainties regarding the intellectual property protection for CRISPR Therapeutics technology and intellectual property belonging to third parties, and the outcome of proceedings (such as an interference, an opposition or a similar proceeding) involving all or any portion of such intellectual property; and those risks and uncertainties described under the heading "Risk Factors" in CRISPR Therapeutics most recent annual report on Form 10-K, and in any other subsequent filings made by CRISPR Therapeutics with the U.S. Securities and Exchange Commission, which are available on the SEC's website at http://www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. CRISPR Therapeutics disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release, other than to the extent required by law.

About VertexVertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Vertex Special Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Dr. Kulkarni, Dr. Kewalramani and Dr. Frangoul in this press release, and statements regarding our plans and expectations for our clinical trials and clinical trial sites, and our expectations regarding future data announcements. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration or further development of its compounds due to safety, efficacy or other reasons, and other risks listed under Risk Factors in Vertex's annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

CRISPR Therapeutics Investor Contact:Susan Kim, +1 617-307-7503susan.kim@crisprtx.com

CRISPR Therapeutics Media Contact:Rachel EidesWCG on behalf of CRISPR+1 617-337-4167reides@wcgworld.com

Vertex Pharmaceuticals IncorporatedInvestors:Michael Partridge, +1 617-341-6108orZach Barber, +1 617-341-6470orBrenda Eustace, +1 617-341-6187

Media:mediainfo@vrtx.comorU.S.: +1 617-341-6992orHeather Nichols: +1 617-839-3607orInternational: +44 20 3204 5275

Continued here:
CRISPR Therapeutics and Vertex Announce New Clinical Data for Investigational Gene-Editing Therapy CTX001 in Severe Hemoglobinopathies at the 25th...

Recommendation and review posted by Bethany Smith

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The report offers a systematic presentation of the existing trends, growth opportunities, market dynamics that are expected to shape the growth of the CRISPR and CAS Gene market. The various research methods and tools were involved in the market analysis, to uncover crucial information about the market such as current & future trends, opportunities, business strategies and more, which in turn will aid the business decision-makers to make the right decision in future.

This Report Covers Leading Companies Associated in Worldwide CRISPR and CAS Gene Market: Caribou Biosciences Inc., CRISPR Therapeutics, Mirus Bio LLC, Editas Medicine, Takara Bio Inc., Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

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The report begins with a brief introduction and market overview of the CRISPR and CAS Gene industry followed by its market scope and size. Next, the report provides an overview of market segmentation such as type, application, and region. The drivers, limitations, and opportunities for the market are also listed along with current trends and policies in the industry.

The key players profiled in this report include: Caribou Biosciences Inc., CRISPR Therapeutics, Mirus Bio LLC, Editas Medicine, Takara Bio Inc., Synthego, Thermo Fisher Scientific, Inc., GenScript, Addgene, Merck KGaA (Sigma-Aldrich), Integrated DNA Technologies, Inc., Transposagen Biopharmaceuticals, Inc., OriGene Technologies, Inc., New England Biolabs, Dharmacon, Cellecta, Inc., Agilent Technologies, and Applied StemCell, Inc.

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o North America (United States, Canada, and Mexico)

o Europe (Germany, France, UK, Russia, and Italy)

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o South America (Brazil, Argentina, Colombia)

o Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

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Impact of COVID-19 on CRISPR and CAS Gene Market Potential Growth and Forecast Period 2020-2027 | By Leading Players Caribou Biosciences Inc., CRISPR...

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Global Gene Editing Tools market report gives a top to bottom investigation of the general market over a period from 2020-2027. The Gene Editing Tools Market report additionally gives the market sway and new open doors made because of the COVID19 fiasco.

As a training, this research report consolidating the effect of COVID19 available in each report as a worth included segment. Report incorporate income Impact investigation, interruptions and new open doors in the gracefully chain, overhauled merchant scene blend, new open doors mapping, and then some. Report resolved to rise triumphant against this COVID-19 pandemic and to guarantee that customers have zero to least disturbance in business results.

The global Gene Editing Tools market report covers major market players such as

Thermofisher ScientificCRISPR TherapeuticsEditas MedicineNHGRIIntellia TherapeuticsMerck KGaAHorizon

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The Gene Editing Tools market report next half moreover sheds investigate on the hole among flexibly and utilization. Aside from the referenced business development pace of market in 2027 is additionally clarified. Moreover, type and application insightful utilization tables and figures of Gene Editing Tools market are given.

Execution examination of Gene Editing Tools industry 2020 featuring ongoing business sector development, patterns and advancement 2027 figure report. The global Gene Editing Tools market report additionally contemplates the assembling cost structure and presents the different subtleties, for example, crude material, the general creation process, and the business chain structure.

Global Gene Editing Tools Market Segmentation By Type:

Zinc finger nucleases (ZFNs)Transcription Activator-Like Effector-based Nucleases (TALENs)CRISPR-Cas system

Global Gene Editing Tools Market Segmentation By Applications:

Sickle Cell DiseaseHeart DiseaseDiabetesAlzheimers DiseaseObesityOthers

Global Gene Editing Tools Market Segmentation By Regions:

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Furthermore, the Gene Editing Tools report consists of the important information related to the growth rate, top players of the parent market, product development, and others also by considering the past and present values of the market report predicting the forecasting values of the Gene Editing Tools market. Along with these things report selected the appropriate SWOT analysis which guides the various opportunities and growth scope for the Gene Editing Tools market.

The research report Gene Editing Tools market consist the in-depth information about the data analysis by using the figures, graphs, pie charts, tables and bar graphs. With the help of these users easily understand the analyzed data in a better and easy way. Also, the report provides the different business challenges which are impacting market growth in a positive and negative direction.

There are 13 Chapters to display the Global Gene Editing Tools market:

Chapter 1: Market Overview, Drivers, Restraints and Opportunities, Segmentation overviewChapter 2: Market Competition by ManufacturersChapter 3: Production by RegionsChapter 4: Consumption by RegionsChapter 5: Production, By Types, Revenue and Market share by TypesChapter 6: Consumption, By Applications, Market share (%) and Growth Rate by ApplicationsChapter 7: Complete profiling and analysis of ManufacturersChapter 8: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expenses.Chapter 9: Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10: Marketing Strategy Analysis, Distributors/TradersChapter 11: Market Effect Factors AnalysisChapter 12: Market ForecastChapter 13: Gene Editing Tools Research Findings and Conclusion, Appendix, methodology and data source.

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Global Gene Editing Tools Market 2020 Impact of COVID-19, Future Growth Analysis and Challenges | Thermofisher Scientific, CRISPR Therapeutics,...

Recommendation and review posted by Bethany Smith

Also known as genome editing with engineered nucleases (GEEN), genome editing is a method of altering DNA within a cell in a safe manner. The technique is also used for removing, adding, or modifying DNA in the genome. By thus editing the genome, it is possible to change the primary characteristic features of an organism or a cell.

The global genome editing market can be segmented on the basis of delivery method, technology, application, and geography. By technology, the global genome editing market can be segmented into Flp-In, CRISPR, PiggyBac, and ZFN. Based on delivery method, in vivo and ex vivo can be the two broad segments of the global genome editing market. By application, the global genome editing market can be categorized into medicine, academic research, and biotechnology.

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Global Genome Editing Market: Key Trends

Since genome editing is gaining rising adoption in the domain of scientific research for attaining a better understanding of biological aspects of organisms and how they work, the global genome editing market is likely to promise considerable growth over the forthcoming years. More importantly, genome editing is being used by medical technologies, where it can be used for modifying human blood cells which can then be placed back in the body for treating conditions such as AIDS and leukemia. The technology can also be potentially utilized to combat infections such as MRSA as well as simple genetic disorders including hemophilia and muscular dystrophy.

Global Genome Editing Market: Market Potential

As more easy-to-use and flexible genome technologies are being developed, greater potential of genome editing is being recognized across bioprocessing and treatment modalities. For instance, in May 2017, MilliporeSigma announced that it successfully developed a novel genome editing tool which can make the CRISPR system more productive, specific, and flexible. The researchers thus have a more number of experimental options along with faster results.

All this can lead to a growing rate of drug development, enabling access to more advanced therapies. Proxy-CRISPR, the new technique, makes access to earlier inaccessible aspects of the genome possible. As most of the existing CRISPR systems cannot manage without re-engineering of human cells, the new method is expected to gain more popularity by virtue of the elimination of the need for re-engineering, simplifying the procedures.

Several other market players are focusing on clinical studies with a view to produce effective treatments for different health conditions. For example, another major genome editing firm, Editas Medicine, Inc. announced the results of its pre-clinical study displaying the success of the CEP290 gene present in the retina of primates in the same month. With the positive results of the study, the companys belief in the vast potential of its candidate in the treatment of a genetically inherited retinal degenerative disease, Leber congenital amaurosis type 10, affecting childrens eyesight has been reinforced.

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Global Genome Editing Market: Regional Outlook

By geography, the global genome editing market can be segmented into Latin America, Europe, Asia Pacific, the Middle East and Africa, and North America. North America registered the highest growth in the past, and has been claiming the largest portion of the global genome editing market presently. The extraordinary growth of this region can be attributed to greater adoption of cutting edge technologies across several research organizations. The U.S., being the hub of research activities, is expected to emerge as the leading contributor. Asia Pacific is also likely to witness tremendous demand for genome editing over the forthcoming period, assisting the expansion of the global genome editing market.

Global Genome Editing Market: Competitive Analysis

CRISPR THERAPEUTICS, Caribou Biosciences, Inc., Sigma Aldrich Corporation, Sangamo, Intellia Therapeutics, Inc., Editas Medicine, Thermo Fisher Scientific, Inc., and Recombinetics, Inc are some of the key firms operating in the global genome editing market.

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Genome Editing Market Predicted to Accelerate the Growth by 2017-2025 - Owned

Recommendation and review posted by Bethany Smith

The Global Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology Market report offers users the detailed study of the market and its main aspects. There are different marketing strategies that every marketer looks up to in order to ace the competition in the Global market. Some of the primary marketing strategies that is needed for every business to be successful are Passion, Focus, Watching the Data, Communicating the value To Your Customers, Your Understanding of Your Target Market. There is a target set in market that every marketing strategy has to reach. Some of the important aspects analyzed in the report includes market share, production, key regions, revenue rate as well as key players. This Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology report also provides the readers with detailed figures at which the Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology Market was valued in the historical year and its expected growth in upcoming years. Besides, analysis also forecasts the CAGR at which the Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology is expected to mount and major factors driving markets growth.

This study covers following key players:Thermo Fisher ScientificMerckGenScriptIntegrated DNA TechnologiesHorizon Discovery GroupAgilent TechnologiesCellectaGeneCopoeiaNew England BiolabsOrigene TechnologiesSynthego CorporationToolgen

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A significant development has been recorded by the market of Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology, in past few years. It is also for it to grow further. To analyze the Global Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology Market, the analysis methods used are SWOT analysis and PESTEL analysis. To identify what makes the business stand out and to take the chance to gain advantage from these findings, SWOT analysis is used by marketers. Whereas PESTEL analysis is the study concerning Economic, Technological, legal political, social, environmental matters. For the analysis of market on the terms of research strategies, these techniques are helpful. Various important factors such as market trends, revenue growth patterns market shares and demand and supply are included in almost all the market research report for every industry.

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Market segment by Type, the product can be split intoProductsServices

Market segment by Application, split intoBiomedical ApplicationsAgricultural ApplicationsIndustrial ApplicationsBiological Research

A systematized methodology is used to make a Report on the Global Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology Market. For the analysis of market on the terms of research strategies, these techniques are helpful. All the information about the Products, manufacturers, vendors, customers and much more is covered in research reports. The market tends to be highly competitive in nature as the number of vendors present in the market is too high.

The Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology market has its impact all over the globe. On Global Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology industry is segmented on the basis of product type, applications, and regions. It also focusses on market dynamics, Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology growth drivers, developing market segments and the market growth curve is offered based on past, present and future market data. The industry plans, news, and policies are presented at a Global and regional level.

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Global Clustered Regularly Interspaced Short Palindromic Repeats(CRISPR) Technology Market 2020 By Size, Share, Trend, Production, High Demand,...

Recommendation and review posted by Bethany Smith

As businesses and schools seek to reopen, most public health experts agree that Covid-19 testing is needed more than ever.

The team behind Ginkgo Bioworks, a genetic engineering start-up, is going all in.

Using equipment from Illumina, a maker of DNA sequencing machines, the company which made CNBC's 2020 Disruptor 50 list is working on technology to run a half million tests per day, said Jason Kelly, Ginkgo's co-founder and CEO.The technology, if approved by federal regulators, will be saliva-based, which in theory would make it easier for consumers to get tested than using the nasal swabs most tests employ today.

Jason Kelly, Founder, Ginkgo Bioworks

Scott Mlyn | CNBC

"We didn't initially have enough tests, but now we've ramped up to about 400,000 per day," he said. "That's enough for our clinical diagnostics needs. ... However, we are now entering phase 2 of this thing."

Ginkgo, a darling of the burgeoning synthetic biology sector, got its start in 2009 when a group of MIT scientists got together to develop biotechnology tools for industries including agriculture, pharmaceuticals and cosmetics. In essence, it develops custom microorganisms that aim to replace technology with biology. Think of it as a way to program cells, a bit like you'd program computers.

"We program DNA and cells to make them do new things," said Kelly, who describes the company as the largest designers of "printing DNA" in the world.

The Boston-based company has raised close to $1 billion to date, as investors clamor to throw money into companies at the intersection of health care and technology. Kelly maintains that enthusiasm is warranted. The cost of sequencing DNA data is coming down faster than the cost of processing data on computers,outpacingMoore's law.

As Kelly puts it, "the chips aren't getting that much faster," but in biology things are "exponentially improving."

Right now Kelly believes Ginkgo can best apply its technology to help ramp up coronavirus testing in the U.S.

As the CEO explained, the initial crop of tests were primarily used to determine if people experiencing Covid-19 symptoms did, in fact, have the virus. But now, as people are going back to their lives, there will be an increasing need for regular testing of people who don't have symptoms.

For instance, Amazon plans to test its fulfillment center workers every two weeks, as well as monitor outbreaks in the community.

That means the country is going to need a lot more coronavirus tests.

Ginkgo started surveyingthe various techniques to scale up testing back in the spring, including antigen (a technology that looks for viral surface proteins), CRISPR-based (a genome editing technique) and next-generation sequencing approaches. Companies have only recently been granted emergency-use authorizations from the U.S. Food and Drug Administration for these types of tests. All of them, if ramped up, could theoretically augment the polymerase chain reaction tests that are currently the gold standard for Covid-19.

Ginkgo has decided to focus on next-generation sequencing with Illumina, which has already been granted an emergency-use approvalfor its Covid-19 test that is designed to sequence the full genome of the virus.

"Beyond diagnostic testing, Illumina and a number of our customers are exploring NGS-based workflows to enable high-volume screening to support a return to work and school," Illumina CEO Francis deSouza said in a statement.

In May Ginkgo announced it had raised another $70 million, including from Illumina, to fund its expansion in the diagnostics field. It is also using the money tobuild out its own testing facility in its highly automated Boston Seaport labs.

More from Disruptor 50:Moderna CEO sees success with Covid-19 vaccineThe technology that will dominate daily life on the other side of coronavirusCLEAR poised to lead in biometric screening for Covid

Kelly can't predict exactly when the company will be rolling out its tests, but it hopes to get FDA approval this summer. He said the company is already starting to work with businesses to help advise them as they determine how to safely get employees back to work. Many are concerned about a potential second shutdown if there's another outbreak in their area.

He believes that testing and contact tracing, where government officials track down and warn people who might have been exposed to Covid-19, are key to reopening the economy.

"I'm also sensing that a lot of people don't have a ton of hope," Kelly said. "Now we have to really try. If we try, we can win."

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Ginkgo Bioworks CEO on scaling up Covid-19 testing: 'If we try, we can win' - CNBC

Recommendation and review posted by Bethany Smith

Pituitary incidentaloma is defined as a previously unsuspected pituitary lesion that is discovered on imaging study performed for an unrelated reason in a patient with no obvious symptoms to suggest pituitary disease.1,2 The incidence of these lesions is between 10% and 20% of the population and the prevalence can approach 1 in 1000 people.3,4

Pituitary adenoma is the most common incidentally found pituitary lesion, but the differential diagnosis of a pituitary lesion identified on imaging also includes Rathke cleft cyst, craniopharyngioma, meningioma, hypophysitis, or metastasis.2,5

Pituitary adenomas can be either functioning or nonfunctioning, the latter being the most common.2 Although functional tumors can be associated with significant symptoms secondary to the hormone excess, cases of nonfunctional pituitary tumors may present with symptoms related to the mass effect on surrounding structures, such as headache, visual defects, and hypopituitarism.6

The natural history of pituitary incidentalomas is not fully understood, but data suggest that most microincidentalomas (lesions <10 mm) have a benign course, whereas macroincidentalomas (10 mm) require more attention as the risk for hormone abnormalities and mass effects is higher.5

In the largest series of pituitary incidentalomas published in 2016,7 including 328 patients diagnosed with these tumors, researchers reported that most incidentalomas were pituitary adenomas (73%) and that approximately one-quarter (27%) of cases were nonpituitary sellar masses. There was no sex difference in the prevalence of these tumors. Most tumors were macroadenomas at presentation, likely because they were detected on imaging of the brain and not that of the sella, which may have missed smaller lesions.7

The most common indication for imaging in the case series was headache, which relates one of the controversial topics regarding the association between headaches and pituitary incidentalomas: considering the fact that headache may be one of the symptoms of pituitary tumors and that in some patients the headache resolves following removal of the tumor, would it be correct to classify these tumors as incidental?

Interestingly, pituitary incidentalomas in children have different patterns than those detected in the adulthood with a high prevalence of physiologic pituitary hypertrophy.8 As most incidentalomas in pediatric patients are not associated with hormonal hypersecretion or hypopiuitarism and structural progression is not common, it is believed that the extensive follow-up assessment recommended for adults might not be necessary for children.8

The Endocrine Society clinical practice guidelines for management of pituitary incidentaloma recommend completing a thorough history and physical examination, as well as laboratory evaluation for pituitary hormone excess or deficiency.1 Magnetic resonance imaging (MRI) should be completed in all cases that were initially diagnosed by computed tomography and visual field assessment is recommended in the presence of a tumor abutting the optic nerves or chiasm on MRI.1

There are different opinions on how to screen for pituitary hormone deficiencies, but as a general rule, the investigation should include measurements of total or free thyroxine, thyrotropin, cortisol, insulinlike growth factor-1 (IGF-1), luteinizing hormone and follicular-stimulating hormone (FSH) in men and postmenopausal women, and total testosterone in men.5 Stimulation tests should be performed for adrenocorticotropic hormone (ACTH) and growth hormone (GH) deficiency when baseline test results are not confirmatory.1,5 The most common deficits are GH deficiency and hypogonadism, followed by central hypothyroidism and secondary adrenal insufficiency.6

Significant hypopituitarism is not commonly seen with microincidentaloms.2 The Endocrine Society clinical practice guidelines strongly favor routine testing for hypopituitarism in macroincidentalomas and larger microincidentalomas measuring 6 to 9 mm, as asymptomatic pituitary hormone deficits are more likely to occur with larger lesions.1

As for hormone hypersecretion, it is recommended to include an assessment for prolactin, GH, and possibly ACTH hypersecretion.1 Although approximately half of pituitary incidentalomas are nonfunctional, prolactin-secreting pituitary tumors are the most common functional type.7 Elevated prolactin can indicate either direct tumor secretion or disconnection of the hypothalamus and normal pituitary gland by a large nonfunctioning pituitary mass.2 Silent somatotroph-secreting tumors are rare, but evaluation for GH excess is recommended by measurement of IGF-1 level, as treatment could reduce long-term morbidity. When clinically suspected, laboratory screening for glucocorticoid excess and Cushing syndrome is suggested.1

The available natural history data on pituitary incidentalomas are mostly derived from small-scale studies with relatively limited follow-up and the risk of developing hormonal dysfunction over longer follow-up is unknown.7 A systematic review and meta-analysis to assess the natural history of nonfunctioning pituitary adenomas revealed that tumor growth was more common in macroadenomas (12.5 per 100 person-years) and solid lesions (5.7 per 100 person-years) compared with the incidence of tumor growth in microadenomas (3.3 per 100 person-years) and cystic lesions (0.05 per 100 person-years).9

The follow-up testing of a pituitary incidentaloma is different for microincidentaloma and macroincidentaloma. For macroincidentaloma, pituitary MRI with clinical and biochemical testing for hypopituitarism should be completed at 6 months after the initial diagnosis and then yearly for several years, with visual field assessment if the tumor enlarges to abut or compress the optic nerves or chiasm. For microincidentaloma, MRI should be performed at 12 months after the initial diagnosis, but there is no need to test for hypopituitarism if there was no change in the clinical and radiographic features.1

Surgical intervention should be recommended for cases of hypersecreting tumors other than prolactinomas, pituitary apoplexy with visual disturbances, lesions abutting or compressing the optic nerves or chiasm on MRI, or in the presence of visual field deficit or other visual abnormalities due to the lesion.1 Surgical resection of nonfunctioning microadenomas is not indicated as tumor growth is rare, with less than 5% growing significantly during long-term follow-up.6

Medical treatment for pituitary incidentaloma may include dopamine agonist therapy for patients with prolactinoma. In some cases of pituitary incidentaloma, somatostatin analogues may be used, but there are limited data on the use of medical therapy for these tumors.1

References

1. Freda PU, Beckers AM, Katznelson L, et al. Pituitary incidentaloma: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2011;96(4):894-904.

2. Bevan JS. Pituitary incidentaloma. Clin Med J R Coll Physicians London. 2013;13(3):296-298.

3. Ezzat S, Asa SL, Couldwell WT, et al. The prevalence of pituitary adenomas: a systematic review. Cancer. 2004;101(3):613-619.

4. Scangas GA, Laws ER. Pituitary incidentalomas. Pituitary. 2014;17(5):486-491.

5. Boguszewski CL, de Castro Musolino NR, Kasuki L. Management of pituitary incidentaloma. Best Pract Res Clin Endocrinol Metab. 2019;33(2):101268.

6. Esposito D, Olsson DS, Ragnarsson O, Buchfelder M, Skoglund T, Johannsson G. Non-functioning pituitary adenomas: indications for pituitary surgery and post-surgical management. Pituitary. 2019;22(4):422-434.

7. Imran SA, Yip C-E, Papneja N, et al. Analysis and natural history of pituitary incidentalomas. Eur J Endocrinol. 2016;175(1):1-9.

8. Souteiro P, Maia R, Santos-Silva R, et al. Pituitary incidentalomas in paediatric age are different from those described in adulthood. Pituitary. 2019;22(2):124-128.

9. Fernndez-Balsells MM, Murad MH, Barwise A, et al. Natural history of nonfunctioning pituitary adenomas and incidentalomas: a systematic review and metaanalysis. J Clin Endocrinol Metab. 2011;96(4):905-912.

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Diagnosis and Management of Pituitary Incidentaloma - Endocrinology Advisor

Recommendation and review posted by Bethany Smith

Ancient remains of a suspected Amazon warrior have been identified as a girl no older than 13 years old.

The 2,600-year-old teenager is also said to have a visible wart and a range of war-like grave goods.

The grave was first discovered in 1988 in Siberias modern-day Tuva republic.

However, the mummified remains were labeled as female.

A new study used modern techniques to reassess the discovery and found the body belonged to a young girl.

The researchers think this stunning discovery is further confirmation of a female warrior tribe, known as Amazons, living among the Scythians of central Asia.

The Amazons were a tribe mentioned in Greek mythology and numerous archaeologists have worked to try to prove they existed.

According to the Siberian Times, researcher Dr. Kilunovskaya said: It was so stunning when we just opened the lid and I saw the face there, with that wart, looking so impressive.

The girl is said to have a rough seam on the skin of her abdomen, implying that mummification was attempted.

She was buried in a leather cap and next to a complete set of weapons.

These included an ax, a bow and a selection of arrows made of bronze, bone and wood.

The remains were initially identified as a boy because no beads or grave goods usually associated with a girl were found.

Today we have modern technology that can look at genetics rather than just items.

Kilunovskaya said: We were recently offered the chance to undertake tests to determine the sex, age, and genetic affiliation of the buried warrior.

We agreed with pleasure and got such a stunning result.

These tests were conducted at the Moscow Institute of Physics and Technology.

Kilunovskaya told the Siberian Times: The burial of the child with weapons introduces a new touch to the social structure of early nomadic society.

This discrepancy in the norms of the funeral rite received an unexpected explanation: Firstly, the young man turned out to be a girl, and this young Amazon had not yet reached the age of 14 years.

The results of genome-wide sequencing, which showed that a girl was buried in a wooden coffin, were unexpected.

This opens up a new aspect in the study of the social history of Scythian society and involuntarily returns us to the myth of the Amazons that survived thanks to Herodotus.

The researchers also think she was wearing a shirt and beige trousers or a skirt but a lot of evidence for this has decayed.

Her coffin was hollowed from a single piece of wood and she was only buried 3 feet underground.

Greek physician Hippocrates wrote about female warriors in his famous texts.

One example reads: Their women, so long as they are virgins, ride, shoot, throw the javelin while mounted, and fight with their enemies.

They do not lay aside their virginity until they have killed three of their enemies, and they do not marry before they have performed the traditional sacred rites.

A woman who takes to herself a husband no longer rides, unless she is compelled to do so by a general expedition.

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Mummified Amazon warrior girl, 13, found buried with ax, bow and a wart still visible on face - New York Post

Recommendation and review posted by Bethany Smith

The platypus, liberated from the pillowcase in which it had been traveling, headed straight for water.

Sarah May, watching, marveled at its glossy coat and the smoothness of its movement. It was like a Slinky, she said: It almost poured over the ground. The platypus reached the still pond, slid in, and was gone. Dr. May had been anticipating this moment for months, but now that it had arrived, she found herself surprised at just how deeply moved she felt.

The glossy platypus, along with two others, arrived at Tidbinbilla Nature Reserve, a 45-minute drive from the Australian capital of Canberra, on April 30. They had been away for four months, sheltering at a zoo in Sydney. The cold, wet and windy day of their release could not have been more different from the day in late December when they had left the reserve.

Back then, Tidbinbilla was parched from extreme heat and drought and menaced by an approaching bush fire. Dr. May, the wildlife team leader for the reserve, and her crew were working long hours in thick smoke, trying to protect their lungs with face masks, their eyes red and burning. It was a grim and apocalyptic-feeling time, she said: Fires had taken over everybodys psyche. But the team worried most about their animal charges, the rare, endangered and iconic wildlife that make the reserve their home.

Tidbinbilla encompasses a eucalyptus forest, a broad valley full of emus and kangaroos, and a large wetland of ponds protected by a predator-proof fence. But in December the wetland, known as the Sanctuary, no longer resembled its name. Animals came to drink and forage from shrinking, muddy ponds, which were surrounded by large areas of dried, cracked earth. Dr. May watched as water birds tried to swim through mud but ended up walking: The ponds were shallower than their legs were long. She feared that only a few days or weeks of water remained.

The reserve contacted Taronga Zoo, in Sydney, asking if it had space to shelter its platypus population, aware that the animals would be unable to survive without their ponds. Taronga, which lists the platypus as one of the legacy species it considers crucial to protect, was fielding similar requests from other conservation agencies, as well as farmers and landowners who saw platypuses struggling in drying creeks and ponds. We were inundated, Phoebe Meagher, the zoos wildlife conservation officer, said but unfortunately, there was only so much space to house them.

The zoo agreed to send a rescue mission to Tidbinbilla. Because platypuses are active at dusk and at night, the team worked in darkness; the smoke was so thick that it was hard to breathe and the beams from flashlights looked like lightsabers. After hours of trapping, they had caught seven platypuses. The rest would have to take their chances, Dr. May said.

In the following weeks, as the fires moved toward Tidbinbilla, the reserve looked for other temporary refuges to which it could evacuate its animals. Eventually, it moved six koalas; nearly 1,000 endangered northern corroboree frogs; 22 especially precious brush-tailed rock wallabies, whose genetics are key to a breeding program meant to reestablish a population that is nearing extinction in the wild, and 26 endangered eastern bettongs, which already went extinct on the mainland but are being reintroduced. (In the end, the reserve did not burn). At Taronga Zoo, keepers were careful to keep the relocated platypuses wild: limiting their interactions with people, making sure they still had to burrow and catch their own food. The zoo also began to make plans for housing larger numbers of platypuses, should the need for evacuation arise again soon something that climate projections suggest is likely.

And then, at last, rains returned, although they came so heavily that flash floods tore through fencing at the top of the Sanctuary. The ponds of Tidbinbilla refilled. The reserve tested the quality of the water to make sure it was not contaminated with fire retardants, and did surveys to make sure the ponds still held enough food. Finally, it was time to release the first round of platypuses and watch how they fared.

The platypuses arrived in a van and were checked by a vet. Then the zoo keepers who had taken care of them for the months of their exile released them into full ponds, edged with greenery, that looked little like the ones they had left. Just before the release, the rain and wind stopped and the clouds parted to let sun shine on the water.

The returned platypuses were plumper, and different in another way as well: Theyd been implanted with tracking devices as part of an ongoing study to better understand how platypuses behave, how they respond to changes in their habitats, and how they are faring in Australia which is still a very open question, explained Gilad Bino, a researcher at the University of New South Wales who will be monitoring the Tidbinbilla platypuses. Everyone seems to assume that if its out of sight its probably doing OK, he said. But his research suggests that platypuses, thanks to unsustainable water use and climate-driven drought, are actually in considerable trouble: extinct in 40 percent of their historical range, with bigger losses coming as climate change intensifies.

Tahneal Hawke, another University of New South Wales researcher, recently analyzed nearly 26,000 records of interactions with platypuses, going back to 1760: newspaper articles, explorers journals, books of natural history. The results, for modern platypus researchers, make for surreal reading. Dr. Bino was struck to read about people seeing (or shooting) platypuses by the dozen, or using terms like mob or migration. I would never, in our years of studying platypuses, describe them that way, he said.

The final four platypuses returned to Tidbinbilla on June 5. Their receivers, Dr. Meagher reported, are tracking them happily moving about the ponds. People who saw the platypuses slip into their recovered habitats described doing so with a feeling of relief, even of magic, after a painful summer. But Dr. May cant shake the memory of those desperate days in December, when the air was orange and the bush crackled with dryness. And Dr. Bino warns that the story of happy news disguises a more alarming larger picture. Rescuing platypuses from drying ponds is not really a viable strategy for the survival of the species, he said. But the way things are going, he is sure that more rescues will be necessary.

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The Return of the Platypuses - The New York Times

Recommendation and review posted by Bethany Smith

The new government commission on racial inequalities, set up by the Head of the Number 10 Policy Unit, Munira Mirza, is coming under fire from progressive anti-racists who are interested in neither social progress nor fighting all forms of racism.

Mirza has previously criticised the politics of grievance, which acts as a barrier to meaningful policy change on issues of race and ethnicity. Radical leftist figures, in predictable fashion, have wasted little time in directing racially charged slurs towards her. Novara Medias Ash Sarkar has labelled Mirza as a racial gatekeeper a term used for non-white people who supposedly provide political cover for perceived injustices based on race.

Arguably one of the most toxic voices in Britains race relations debate, Dr. Shola Mos-Shogbamimu, has called Mirza a brown executioner of white supremacy. The acceptance and normalisation of the most egregious forms of racism from Left-wing social activists, reinforced by identitarian academics operating in Britains universities, is a worrying development to say the least.

Debates on race-related matters and ethnic inequalities are being infected by the virus of tribal identity politics. Radical Leftist figures in the spheres of politics, academic, media, and policy are intent on framing every single racial inequality as a direct outcome of structural racism. This includes the disproportionate impact of the COVID-19 pandemic on the UKs ethnic minorities, where myriad potential factors may be at play including lifestyle choices and genetics.

While there is a serious discussion to be had on enduring forms of racial discrimination in the UKs labour market, the creation of socio-economic ethnic inequalities is a complex phenomenon. Mirzas role has ruffled feathers because she will not shy away from delving into politically sensitive territory. This includes exploring the role of internal religio-cultural norms and social behaviours in the production of socio-economic disparities between British ethnic groups.

This is deeply unsettling for Leftist ideologues who refuse to acknowledge the possibility that family dynamics, lack of female empowerment, and a general failure to cultivate aspirational attitudes in the household may be holding back the progress of certain non-white communities in the UK.The debate on race relations and ethnic inequalities must not be hijacked by extreme-Left ideologues who are not only uninterested in holding level-headed discussions, but are directly complicit in one of the most dehumanising forms of racism: that an individual must think a certain way on a range of social, economic, and cultural issues, purely on the grounds of their racial identity.

A notable number of self-labelled anti-racists do not truly prioritise ethnic-minority advancement, nor the empowerment of marginalised sections within non-white communities. Unfortunately, a growing number on the Left are ultimately obsessed with framing British society as a white-supremacist superstructure, and locking non-white people under a perpetual state of victimhood. There really is no surprise that Mirza is being subjected to racially motivated attacks from this dangerous political cult. A successful working-class Northern woman of Pakistani Muslim origin, who refuses to tow the identitarian line, is the radical Lefts worst nightmare.

Dr Rakib Ehsan is a research fellow at the Henry Jackson Society. Twitter: @rakibehsan

Read the rest here:
Munira Mirza is the bigoted Left's worst nightmare - Telegraph.co.uk

Recommendation and review posted by Bethany Smith

The Origin of species by natural selection, Charles Darwins (1809-1882) masterpiece, was published in Nov 1859- all twelve hundred and fifty copies were sold out on the first day. Since then Darwins ideas have revolutionised the entire premise of evolutionary biology and superseded the concept of naturalism as an explanation of human evolution.

In this article, however, we will discuss the social, economic and cultural impact of Darwins theory. Social Darwinism, as it is called, has an impact in shaping the current geopolitical environment of the world. The current riots in the Unites States and the United Kingdom motivated by racial inequality have deep seated roots. There is no denying the fact that racism has existed since time immemorial, but in this article, we will review the history and impact of social Darwinism on modern day racism.

Thomas H Huxley (1825-1895) also known as Darwins bulldog, coined the phrase Social Darwinism in 1861. However, the first use of the term Social Darwinism in Europe is attributed to a French journalist called Emile Gautier (1853-1937). The concept of social Darwinism borrowed the idea of survival of the fittest and natural selection from Darwins biological theory of evolution and applied this to economics, sociology and politics. It is a mishmash of ideologies that was and still is used to justify colonisation, imperialism, racism, social inequality and eugenics.

Thomas Malthus (1766-1834) was an English economist and an influential scholar. Malthusianism is atheoryof exponentialpopulationgrowth in comparison to the linear growth of food supply and other resources. In his book An essay on the Principle of population Malthus describes this apparent disparity between population growth and food supply. Malthusbelieved that through preventative and positive checks, thepopulation could be controlled to balance the food supply with thepopulationlevel. The Malthusian catastrophe is described as a population, when unchecked, goes on doubling itself every twenty-five years, or increases in a geometrical ratio,so that population soon exceeds its food supply.

Darwin was familiar with Malthuss concepts and was influenced by his ideas. He made the Malthusian struggle for existence the basis of his natural selection. He saw a similarity between farmers picking the best stock inselective breeding, and a Malthusian philosophy. The very extended wording on the title page of his book, by Means of Natural Selection, or the Preservation of Favoured Races in the Struggle for Life, are suggestive of his views on race superiority. In The Descent of Man, he wrote We civilised men. do our utmost to check the process of elimination, we build asylums for the imbecile, the maimed and the sick. Thus, the weak members of society propagate their kind.

Herbert Spencer (1820-1903) an English polymath and a sociologist was the first one to describe the term survival of the fittest. A very big proponent of utilitarian philosophy, Spenser believed that a social system that provides for the poor and needy is eventually detrimental to the overall growth of the society as it promotes the survival of the weak and the infirm leading to an overall retardation of growth. His concept of survival of the fittest implied that nature eliminates inefficiency- any efforts to slow this process will impair the overall benefits to the strong races. In his work,Social Statics (1850), he argued that imperialism had served civilization by clearing the inferior races off the earth.

Francis Galton (1822-1911) was an English polymath and Darwins half cousin, fascinated by Darwins work, he made it his lifes mission to study variations in human population and its implication. Galton published his book the Hereditary Genius in 1869- he extensively studied the physical traits of eminent men and the inheritance of physical as well as intellectual attributes. Galton wrote in this book: Let us do what we can to encourage the multiplication of the races best fitted to invent, and conform to, a high and generous civilisation, and not, out of mistaken instinct of giving support to the weak, prevent the incoming of strong and hearty individuals.

Eugenics promotes the exclusion or elimination of human races deemed to be inferior with the preservation of superior races eventually leading to the overall improvement in genetic quality

It was Galton who championed the concept of eugenics (meaning well born). Eugenics promotes the exclusion or elimination of human races deemed to be inferior with the preservation of superior races eventually leading to the overall improvement in genetic quality. Eugenics gained momentum in the early 1900s with the formation of British and American Eugenics societies. Winston Churchill supported the British Eugenics Society and was an honorary vice president for the organization. Churchill believed that eugenics could solve race deterioration and reduce crime and poverty. Eugenics promoted practices such as genetic screening, birth control, marriage restrictions, bothracial segregationand sequestering the mentally ill,compulsory sterilization,forced abortions and pregnancies. Theodore Roosevelt, Alexander Graham Bell, John D. Rockefeller, Jr., and many other prominent citizens were outspoken supporters. George Bernard Shaw (1856-1950) wrote: The only fundamental and possible socialism is the socialisation of the selective breeding of man. He proposed that the state should issue colour-coded procreation tickets to prevent the gene pool of the elite being diluted by inferior human beings. Those who decided to have children with holders of a different-coloured ticket would be punished with a heavy fine.In the United States, scientific racism was used to justify African slavery. Samuel Cartwright (1793-1863) coined the term drapetomania which was descried as a mental disorder of slaves who had tried to run away from their captives- the condition was deemed treatable. Negroes, with their smaller brains and blood vessels, and their tendency toward indolence and barbarism, had only to be kept benevolently in the state of submission, awe and reverence that God had ordained. The Negro is [then] spellbound, and cannot run away, he said.

The ethos of eugenics was incorporated into Nazi Germanys racial policies. Hitler justified the policies of sterilization of defectives, involuntary euthanasia and the holocaust based on racial hygiene, a term that gained tremendous popularity in the Nazi Germany. After the second world war, due to Hitlers adaptation of eugenics, there has been a sharp decline in the popularity of this policy, at least at a state level.

The roots of the idea that the white races are superior, more intelligent, stronger and higher on the evolutionary ladder, are varied and multifactorial.

The age of European enlightenment, followed by imperialism compounded by social Darwinism, has reinforced the concept over centuries. In Sweden, the practice of forced sterilisation was continued till 1970. In the US, involuntary sterilisation of female prisoners occurred as late as 2010.

Modern day evolutionary scientists and molecular biologists dismiss the idea of race superiority based on hereditary genetics. The superiority of a human over another, based on race, colour, creed and sex are morally and ethically wrong. A better world would be world without prejudice and racism.

The writer is a surgeon with an interest in theology and history

Read more:
Social Darwinism and the origins of scientific racism - Daily Times

Recommendation and review posted by Bethany Smith

A recent market intelligence study titled Global Autologous Stem Cell Based Therapies Market 2020 by Company, Type and Application, Forecast to 2025 integrated from various professional and trusted sources include a detailed examination of this vertical that is anticipated to accrue substantial proceeds during the predicted timeline from 2020 to 2025. The report provides valuable insights concerning the market size, share, and growth rate of the global Autologous Stem Cell Based Therapies market. The report delivers creditable perceptions with respect to industry size, revenue approximations, sales volume, and more. The research gives knowledge about market players, segments, revenue, profit, restrain, share, size, etc.

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Global Autologous Stem Cell Based Therapies Market 2020 Growth, Industry Trends, Sales Revenue, Size by Regional Forecast to 2025 - 3rd Watch News

Recommendation and review posted by Bethany Smith

KENILWORTH, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Mercks anti-PD-1 therapy, as monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation (HSCT). Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate. KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. For more information, see Selected Important Safety Information below.

For the second time, KEYTRUDA monotherapy is now approved based on a biomarker rather than the location in the body where the tumor originated, said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. TMB-H, defined as 10 mutations per megabase or more, can help identify patients most likely to benefit from KEYTRUDA. Were pleased that our collaborative efforts to advance biomarker research have resulted in our ability to provide a new treatment option that addresses a high unmet medical need for these patients with cancer.

As physicians, we are always looking to find new options for patients, especially in the second-line or higher treatment setting, said Roy S. Herbst, M.D., Ph.D., ensign professor of medicine (medical oncology) and professor of pharmacology, Yale School of Medicine; chief of medical oncology, Yale Cancer Center and Smilow Cancer Hospital; and associate cancer center director for translational research, Yale Cancer Center. Its great to see the use of innovative biomarkers and immunotherapy come together with this approval and encouraging that we now have an option for patients with TMB-H tumors across cancer types, including rare cancers.

The FDA also approved FoundationOne CDx test as the companion diagnostic to identify patients with solid tumors that are TMB-H (10 mutations/ megabase) who may benefit from immunotherapy treatment with KEYTRUDA monotherapy.

These approvals stem from years of research into how TMB levels may influence a patients response to immunotherapy, said Brian Alexander, M.D., M.P.H., chief medical officer, Foundation Medicine. Its critical that healthcare professionals have access to a validated genomic test to measure TMB in clinical tumor assessments and pinpoint those who are more likely to respond. Were proud to be collaborating with Merck to help match appropriate patients to this important treatment.

Data Supporting the Approval

The accelerated approval was based on data from a prospectively-planned retrospective analysis of 10 cohorts (A through J) of patients with various previously treated unresectable or metastatic solid tumors with TMB-H, who were enrolled in KEYNOTE-158 (NCT02628067), a multicenter, non-randomized, open-label trial evaluating KEYTRUDA (200 mg every three weeks). The trial excluded patients who previously received an anti-PD-1 or other immune-modulating monoclonal antibody, or who had an autoimmune disease, or a medical condition that required immunosuppression. TMB status was assessed using the FoundationOne CDx assay and pre-specified cutpoints of 10 and 13 mut/Mb, and testing was blinded with respect to clinical outcomes. Tumor response was assessed every nine weeks for the first 12 months and every 12 weeks thereafter. The major efficacy outcome measures were objective response rate (ORR) and duration of response (DOR) in the patients who received at least one dose of KEYTRUDA as assessed by blinded independent central review (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, modified to follow a maximum of 10 target lesions and a maximum of five target lesions per organ.

In KEYNOTE-158, 1,050 patients were included in the efficacy analysis population. TMB was analyzed in the subset of 790 patients with sufficient tissue for testing based on protocol-specified testing requirements. Of the 790 patients, 102 (13%) had tumors identified as TMB-H, defined as TMB 10 mut/Mb. The study population characteristics of these 102 patients were: median age of 61 years (range, 27 to 80); 34% age 65 or older; 34% male; 81% White; and 41% Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 and 58% ECOG PS of 1. Fifty-six percent of patients had at least two prior lines of therapy.

In the 102 patients whose tumors were TMB-H, KEYTRUDA demonstrated an ORR of 29% (95% CI, 21-39), with a complete response rate of 4% and a partial response rate of 25%. After a median follow-up time of 11.1 months, the median DOR had not been reached (range, 2.2+ to 34.8+ months). Among the 30 responding patients, 57% had ongoing responses of 12 months or longer, and 50% had ongoing responses of 24 months or longer.

In a pre-specified analysis of patients with TMB 13 mut/Mb (n=70), KEYTRUDA demonstrated an ORR of 37% (95% CI, 26-50), with a complete response rate of 3% and a partial response rate of 34%. After a median follow-up time of 11.1 months, the median DOR had not been reached (range, 2.2+ to 34.8+ months). Among the 26 responding patients, 58% had ongoing responses of 12 months or longer, and 50% had ongoing responses of 24 months or longer. In an exploratory analysis in 32 patients whose cancer had TMB 10 mut/Mb and <13 mut/Mb, the ORR was 13% (95% CI, 4-29), including two complete responses and two partial responses.

The median duration of exposure to KEYTRUDA was 4.9 months (range, 0.03 to 35.2 months). The most common adverse reactions for KEYTRUDA (reported in 20% of patients) were fatigue, musculoskeletal pain, decreased appetite, pruritus, diarrhea, nausea, rash, pyrexia, cough, dyspnea, constipation, pain and abdominal pain.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

See more here:
FDA Approves Second Biomarker-Based Indication for Merck's KEYTRUDA (pembrolizumab), Regardless of Tumor Type - BioSpace

Recommendation and review posted by Bethany Smith

The Exosome Therapeutic Market study analyzes the market status, market share, growth rate, future trends, market drivers, opportunities, challenges, risks, entry barriers, sales channels, distributors & Porters Five Forces Analysis. This market report performs geographical analysis for the major areas such as North America, China, Europe, Southeast Asia, Japan, and India, with respect to the production, price, revenue and market share for top manufacturers. Moreover, businesses can gain insights into profit growth and sustainability program with this report. The Exosome Therapeutic Market report also consists detailed profiles of markets major manufacturers and importers who are dominating the market.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in the Exosome Therapeutic Market report are evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global. Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Get Full TOC, Tables and Figures of Market Report @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&rp

Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

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Exosome Therapeutic Market 2020 Global Industry Growth, Size, Demand, Trends, Insights | Leading Players evox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE...

Recommendation and review posted by Bethany Smith

Beijing-based Sinovac has posted a positive preliminary snapshot of human data from the Phase I/II study of their vaccine for coronavirus, showing that the jab was able to safely spur protective antibodies in more than 90% of the volunteers involved.

The biotech reported Saturday that they had recruited 743 patients for the two-step trial, with 143 in Phase I and the rest in Phase II.

The neutralizing antibody seroconversion rate is above 90%, the company states, which concludes the vaccine candidate can induce positive immune response. Thats about all youre getting at this stage of the process, though, with little hard data in their statement to decipher.

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Eyeing a hot IPO market, 4DMT tops up its cash reserves and preps a leap into the clinic with bespoke gene therapy vectors - Endpoints News

Recommendation and review posted by Bethany Smith

(Representative image) by Dr. Indumathi MariappanResearch Scientist, LV Prasad Eye Institute, Hyderabad

Retinal Blindness

Millions of people the world over suffer visual disability as a result of retinal dystrophy that involves the death of retinal cells that are important for the light sensing function of the eye. Enormous progress has been made in other blinding conditions involving the cornea, lens, among others. However, the retinal dystrophies and optic nerve atrophies do not have any proven therapy till date. The major forms of retinal dystrophies such as Age-related macular degeneration (AMD), retinitis pigmentosa (RP), Lebers congenital amaurosis (LCA), Stargardts disease etc. are either inherited disorders or developed with aging. In most cases, the retinal cells are present at birth, but undergo gradual death during the later stages of life. It is typically characterized by initial symptoms of low vision and night blindness during early childhood, which progresses to severe visual impairment and total blindness at different stages of adulthood. Inherited defects in many genes involved in retina-specific functions and vitamin A metabolism are linked to various forms of retinal dystrophies. These genetic defects affect the normal cellular functions of the retina, leading to gradual cell death and ultimately the patient becomes legally blind.

Recent Technologies and Novel Treatment Options

The current modalities for the treatment of such patients mainly include dietary supplements, visual aids and rehabilitation support. However, a radical approach is required either to preserve or to restore visual function in these patients. Some of them include the replacement of either the lost retinal cells or the defective genes within the surviving, but non-functional retinal cells. This has been the principle behind the massive efforts involved in the development of cell and gene-based therapies. They are currently at different stages of product development and clinical trial evaluation. In cell therapy, normal retinal cells are prepared from specialized stem cells and are injected into the eye to replace the lost cells and to restore retinal functions. Clinical safety trials using cell therapy are ongoing in many countries such as USA, Japan, UK and others (Weblinks 1-4). In gene therapy, the prime strategy is to introduce a normal copy of the affected gene into the surviving retinal cells of the patient, to restore normal cellular functions and improvements in vision. This is achieved by engineering safe viral vectors to carry a normal copy of the desired gene as their cargo. When injected into the eye, the viruses can infect the retinal cells once and deliver the normal gene to restore cellular functions (Weblinks 5-7). A step further is an advanced method of DNA microsurgery, wherein, the defective part of the retinal cell DNA is precisely edited to correct the genetic defect and to restore cellular functions. This could be achieved using the latest gene editing tools such as ZFNs, TALENs, CRISPR/Cas systems etc. These are naturally occurring molecular scissors, employed as host defense mechanism and immune memory to combat viral infections in different species of bacteria. These systems are now engineered to enable DNA and RNA editing in almost any living cells. Such tools are now combined with either cell therapy or gene therapy to develop novel drugs for the treatment of various inherited genetic diseases (Weblink 8).

Gene therapy products approved for clinical use:

LUXTURNATM (Weblink 5)

This is the first commercial gene therapy drug approved by the US-FDA and European Commission for the treatment of an early childhood retinal dystrophic condition called the Leber Congenital Amaurosis 2 (LCA2). This disease is caused due to genetic defects in the gene called RPE65. LUXTURNA (AAV2-hRPE65v2 or Voretigene neparovec-rzyl) is an engineered adeno-associated virus 2 (AAV2) vector carrying a normal copy of the human RPE65 gene. This product was developed and marketed by Spark Therapeutics, a US-based startup now owned by Roche, a Swiss pharma company.

This drug has been tested on 20 patients, aged 3 years or older, in a randomized, controlled, open label, phase 3 interventional clinical trial at two sites in the US from June 2015. All treated individuals showed significantly improved functional vision, with no product-related serious adverse events or deleterious immune responses. The treated patient will be followed for further 15 years until March 2030 to assess the long-term retinal gene expression and stable maintenance of functional vision. It is administered as a onetime injection behind the retina of an eye of patients genetically diagnosed to carry mutations in RPE65 gene and also have sufficient viable retinal cells. It is priced at $850,000 for two eyes in the US and UK, which translates to about 6.5 crores in Indian rupees.

Many such gene therapy vectors are currently under clinical trial evaluation for the delivery of other retinal gene such as REP1, PDE6B, RPGR, OAT (Ornithine aminotransferase), MERTK, sFLT1etc.

EDIT101 (Weblink 8)

This is the first gene editing based drug approved by US-FDA, for the treatment of another early childhood retinal dystrophic condition called LCA10, caused by defects in the CEP290 gene. Here, it is important to understand that a gene editing approach is different from a gene therapy. In gene therapy, a normal copy of entire gene is delivered to the retina to complement the defective gene. In CRISPR/Cas9 based gene editing, only the mutated region of the gene is edited/corrected in situ inside the target cells. This is an attractive approach for correcting a variety of gene mutations, especially those in large genes which exceed the cargo capacity of the commonly used AAV-based gene therapy vectors.

EDIT101 (AGN-151587) is an engineered adeno-associated virus 5 (AAV5) vector carrying a CRISPR/Cas9 based DNA editing machinery to locate and remove a specific mutation hotspot within the intron 26 of human CEP290 gene. When injected behind the retina, the virus will infect the surviving photoreceptor cells and deliver the CRISPRs to enable mutation editing. Successful DNA edits in photoreceptor cells would inactivate a spurious splice site created by the mutation and restore normal protein expression and retinal function.

Preclinical testing in mice and monkey eyes has proved significant edit efficiency of up to 28%, which was above the expected 10% threshold required for clinical efficacy in human trials. This drug was developed by the gene editing company, Editas Medicine, Inc. and is being tested in 18 participants in a Phase 1/2 clinical trial sponsored by Allergan, at four sites in the US from March 2019 and the outcomes are awaited.

Similar gene editing strategy is being explored at different centers for mutation correction in other retinal genes such as KCNJ13, RP1, USH2A, MYO7A, RDH12 etc.

Who can benefit?

Both gene therapy and gene editing approaches have opened up newer hopes for the treatment of various genetic condition affecting different cell types of the body. However, only a small subset of patients can benefit from such therapies at the moment. Such treatment considerations require a thorough genetic screening/genotyping to confirm the identity of the gene affected in a specific patient. Further, the patients should retain some viable cells in the retina for the treatment to be clinically effective.

Research efforts in India

Many labs in the country are developing gene therapies and gene editing based therapeutics for the treatment of various diseases affecting the blood, retina, liveretc. Researchers at the CMC, Vellore, CSIR-IGIB, Delhi, CSIR-CCMB, Hyderabad are developing gene therapeutics for the treatment of different forms of blood disorders. Narayana Nethralaya, Bangalore is engaged in developing AAV-based gene therapies for various retinal dystrophies. Our lab at the LV Prasad Eye Institute is collaborating with the research teams at IIT-Kanpur and CSIR-IGIB, Delhi to develop modified gene therapy vectors for retinal gene delivery and cell-based therapies using CRISPR edited stem cells and retinal cells respectively.

The way forward

As of May 2020, the RetNet database lists about 271 genes to be associated with different forms of retinal dystrophies. This requires a larger library of gene delivery vectors to be developed and made available at affordable costs for the treatment of a large number of patients. This mandates the need for developing indigenous and cost-effective therapeutics and ICMR has set up a dedicated task force on gene therapy research, to identify and support promising research ideas in this newly emerging area of biomedical research. A national guideline for gene therapy product development and clinical trials has been jointly formulated and released by the DBT and ICMR in 2019. It is hoped that the streamlined regulatory framework would fast track our basic and translational research efforts into developing novel and cost-effective treatment options in the near future.

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Gene Therapy and Editing : Novel options for inherited retinal blindness - ETHealthworld.com

Recommendation and review posted by Bethany Smith

The Gene Therapy for Age-related Macular Degeneration Market research report added by Report Ocean, is an in-depth analysis of the latest developments, market size, status, upcoming technologies, industry drivers, challenges, regulatory policies, with key company profiles and strategies of players. The research report compiled by Report Ocean offers the study of market opportunities and market impact that are created due to the COVID-19 pandemic. The overall market impact of COVID-19 can be witnessed in the Q1 2020 but is anticipated to be highly impacted in subsequent quarters in the whole year.

In addition to enlightens the current competitive putting and growth plans enforced with the aid of the Gene Therapy for Age-related Macular Degeneration Market players. Comprehensive secondary research was done to collect information on the market and its parent and ancillary markets. Further, primary research was performed to validate the assumptions and findings obtained from secondary research with key opinion leaders (KOL) and industry experts.

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Gene Therapy for Age-related Macular Degeneration Market Forecast Under COVID-19

Under the public background of the COVID-19 crisis, the industry is being affected by COVID-19. It is currently impossible to accurately predict the degree of control of this epidemic in various countries, and it is impossible to predict whether it will function normally for long-term economic activities.

However, historical data shows that the impact of natural disasters on the macro economy is usually short-term, and the economy often shows a V-shaped trend. Affected by the disaster and market sentiment, the economic growth rate usually drops sharply in a short period of time, but as the disaster is gradually controlled, the market sentiment returns to stability, and the temporarily suppressed consumption and investment needs will be released, resulting in Economic rebound.

Competitive Landscape:

The competitive analysis of major market players is another notable feature of the Gene Therapy for Age-related Macular Degeneration Market report; it identifies direct or indirect competitors in the market.

Key parameters which define the competitive landscape of the Gene Therapy for Age-related Macular Degeneration Market:

Revenue and Market Share by Player

Production and Share by Player

Average Price by Player

Base Distribution, Sales Area and Product Type by Player

Concentration Rate

Mergers & Acquisitions, Expansion

Manufacturing Base

Major players in the global Gene Therapy for Age-related Macular Degeneration market include:RetroSense TherapeuticsAGTCREGENXBIO

Market Segmentation:

Gene Therapy for Age-related Macular Degeneration Market is segmented on the basis of types, on the basis of applications and regions.

Geographical Analysis

Gene Therapy for Age-related Macular Degeneration Market Segment by Regions Consists:

North America (U.S. and Canada)

Europe (UK, Germany, France, Russia, Italy and Rest of Europe)

Asia-Pacific (China, Japan, India, Malaysia, Singapore, Philippines, Indonesia, Thailand, Vietnam)

South America (Brazil, Argentina, Mexico, and Rest of South America)

The Middle East and Africa (Saudi Arabia, United Arab Emirates, Turkey, Egypt, South Africa, Nigeria)

Some of the Major Highlights of TOC covers:

Gene Therapy for Age-related Macular Degeneration Market Production, Revenue (Value), Price Trend by Type

Production and Market Share by Type

Revenue and Market Share by Type

Price by Type

Gene Therapy for Age-related Macular Degeneration Market Analysis by Application

Consumption and Market Share by Application

Gene Therapy for Age-related Macular Degeneration Market Production, Consumption, Export, Import by Region

Production, Consumption, Export, Import by Region

Production, Consumption, Export, Import by Country

Production, Revenue, Price and Gross Margin

Gene Therapy for Age-related Macular Degeneration Market Manufacturing Analysis

Key Raw Materials Analysis

Market Concentration Rate of Raw Materials

Manufacturing Cost Analysis

Labor Cost Analysis

Manufacturing Cost Structure Analysis

Manufacturing Process Analysis of Gene Therapy for Age-related Macular Degeneration Market

Industrial Chain, Sourcing Strategy and Downstream Buyers

Gene Therapy for Age-related Macular Degeneration Market Chain Analysis

Raw Materials Sources of Gene Therapy for Age-related Macular Degeneration Market Major Players in 2020

Downstream Buyers

Market Dynamics

Market Drivers

Restraints

Opportunities

Increased Demand in Emerging Markets

Challenges

Porters Five Forces Analysis

Gene Therapy for Age-related Macular Degeneration Market Forecast (2020-2027)

Gene Therapy for Age-related Macular Degeneration Market Production, Revenue Forecast

Gene Therapy for Age-related Macular Degeneration Market Production, Consumption, Export and Import Forecast by Region

Gene Therapy for Age-related Macular Degeneration Market Production, Revenue and Price Forecast by Type

Gene Therapy for Age-related Macular Degeneration Market Consumption Forecast by Application

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Gene Therapy for Age-related Macular Degeneration Market by global COVID-19 impact analysis, industry trends, business strategies, opportunities and...

Recommendation and review posted by Bethany Smith