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Everything You Need To Know About Ovarian Cancer Diagnosis – NDTV Doctor

Posted: October 2, 2020 at 12:53 am

Ovarian cancer progression can be controlled if diagnosed early. Symptoms of ovarian cancer should not be ignored. Here's everything you need to know about ovarian cancer diagnosis.

Ovarian cancer: Family history of ovarian cancer can increase your risk

Women have to deal with a complete set of gynaecological cancers unique to their biology. These include cancers of the female reproductive system namely the uterus, cervix and ovaries. Ovarian cancer is the 5th most common cause of cancer deaths in women globally. It also has the highest death rate among all gynaecological cancer. There are various risk factors for ovarian cancer, some of the important ones include family history, 65 years of age, early onset menstrual cycle, late menopause, infertility, obesity, women on hormone replacement therapy and those who have breast care or are above the age of 65 years.

Signs and symptoms of ovarian cancer are frequently absent or very subtle in the early stages. Hence, most women are diagnosed with cancer only at a later stage.

Ovarian cancer may lead to abdominal swellingPhoto Credit: iStock

1. CA-125 is a screening and monitoring test. It should be noted that CA-125 may also be elevated in cancers of pancreas, breast, bladder, lung and in benign conditions like menstruation, pregnancy, fibroids, ovarian cysts, pelvic inflammation and endometriosis. Levels of CA 125 are high in about 85% women with ovarian cancer. If the CA125 value is greater than 200 u/ml and 35 u/ml in premenopausal and postmenopausal women respectively, then the likelihood of the disease is unlikely. CA125 is usually combined with transvaginal sonography or rectovaginal pelvic examination for a more accurate diagnosis.

Also read:How Is Ovarian Cancer Diagnosed? Everything You Need To Know

2. ROMA index: Risk of ovarian malignancy algorithm

It is the most promising marker for ovarian cancer. The ROMA score can be used by a healthcare practitioner prior to surgery to help determine whether a lump in the pelvis (pelvic mass) is likely to be malignant or not. The test is not intended to be used for screening. The test assigns a risk value that is numerical basis the below parameters

A change in HE4 level of less than or equal to 25% is considered significant. Elevated HE4 levels are associated with ovarian cancer but are not disease-specific. It can also rise in healthy women with hypertension and non-cancerous gynaecological diseases.

ROMA is applied for women who meet the following criteria:

The ROMA assessment is to be interpreted in conjunction with clinical and radiological assessment.

3. CA-72.4: It is elevated in cancer of pancreas, stomach, gall bladder, colon, ovaries, cervix and endometrium. It is an independent marker for the therapeutic monitoring and follow up care of ovarian patients and in particular CA125 negative patients.

4 CEA: It is a non-specific marker which is increased in ovarian tumours, along with tumours of lung, breast, and liver.

Also read:Ovarian Cancer Is Deadly, But New Tests, Treatments Start To Emerge

5. Peritoneal wash and histopathological examination of ovarian cancer: Examination of fluid collected in abdominal cavity to look for tumour cells, histopathological examination of tumour mass and immunohistochemistry for staging and grading of tumour for appropriate therapy.

6. NGS for hereditary breast and ovarian cancer syndrome (HBOC):

The syndrome is characterised by early onset cancers of breast, ovary and other organs like pancreas, prostate, melanomas. It is associated with over 2600 mutations in BRCA 1 and 2 genes. It is helpful in early detection and screening of family members of affected individuals, early clinical intervention, and benefits of certain specific treatment modalities. Pre and post-test genetic counselling are very important before and after BRCA analysis.

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(Dr. Kirti Chadha isHistopathologist/Surgical Pathologist andSenior Vice President, Medical Affairs, Metropolis)

Disclaimer: The opinions expressed within this article are the personal opinions of the author. NDTV is not responsible for the accuracy, completeness, suitability, or validity of any information on this article. All information is provided on an as-is basis. The information, facts or opinions appearing in the article do not reflect the views of NDTV and NDTV does not assume any responsibility or liability for the same.

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CA Prop 14: Stem cell research – CBS News 8

Posted: September 30, 2020 at 9:53 am

Proposition 14 is on the California ballot to continue funding stem cell research by borrowing up to $5.5 billion through bonds.

CALIFORNIA, USA California Proposition 14 is a vote to approve $5.5 billion dollars for stem cell research and research facilities in the state. In 2004, California voters approved Proposition 71. It gave legal protection to stem cell research that was hoping to find new medical treatments or cures for everything from Parkinsons to cancer. Proposition 71 also approved spending more than $3 billion to use for stem cell research and to build research facilities. Since 2004, most of the funding has been spent.

Proposition 14 would help to continue the funding of the existing research program with an additional $5.5 billion. The total estimated cost of the bond is an additional $260 million per year for the next 30 years. The total cost to pay off the bond is estimated to be $7.8 billion ($5.5 billion in bonds + $2.3 billion in interest).

Proposition 14 does offer a chance for the state to make back some money, a unique property compared to most state bonds. If the research leads to new inventions that earn revenue, the state will get a portion of the profits.

So far thats only raised about $350,000 or about 0.01% of the bond money weve already spent on stem cell work since 2004.

Find more background about this proposition as well as opinions from both sides on the California Voter Guide or on your local voter guide.

What is the full name for Prop 14?

The California Stem Cell Research, Treatments, and Cures Initiative of 2020

What does a YES vote on Prop 14 mean?

A yes vote approves $5.5 billion dollars for stem cell research and research facilities. The money will come from a bond.

What does a NO vote on Prop 14 mean?

A no vote means that the states existing stem cell program would start to wind down.

Original filing for Prop 14

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CA Prop 14: Stem cell research - CBS News 8

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Fujifilm Irvine Scientific takes on distribution of substrate that supports cell therapy research – BioPharma-Reporter.com

Posted: September 30, 2020 at 9:53 am

Cellnest was designed and manufactured by Fujifilm Corporation.

Fujifilm sold cellnest through other company channels previously. However, Fujifilm Irvine Scientific is best placed to sell these products since they are complementary to our portfolio of cell culture media for primary cells. We joined Fujifilm in 2018 and synergies such as this are part of the Fujifilm life science strategy, said Lori Serles, spokesperson, Fujifilm Irvine Scientific.

Attachment substrates mimic the extracellular matrix (ECM), a complex and dynamic environment in which cells reside in vivo, in cell culture and allow for the adhesion, expansion, and potential differentiation of stem cells.

Unlike animal-derived components, which can introduce unpredictability in results, the chemically defined, animal component-free formula of cellnest provides consistent results to researchers and can smooth the regulatory path to commercialization, claims Fujifilm Irvine Scientific.

Serles expanded on how those aspects, highlighting that natural and undefined components present regulatory and production concerns.

There is considerable quantitative and qualitative variability in the composition of serum and serumderived products such as HSA. Levels of key growth factors, hormone, etc. can vary widely.

The components in media and the culture system affect attachment, growth, differentiation, phenotype etc. Ultimately that produces variability in in the culture system. While that might not be critical in early research, for translational and clinical research reliable results are necessary.

Regulatory bodies want to mitigate risk. Using a defined substrate in the culture system reduces the risk of variability in the end treatment/efficacy of the therapy. It also reduces risk of adventitious agents entering the process, she told BioPharma-Reporter.

What type of cell or gene therapy research will the use of this substrate help advance?

"Cellnest will contribute to advancing cell therapies involving human mesenchymal stem cells (hMSC).The cell and gene therapy market is maturing and the number of therapies progressing to clinical research phases is increasing rapidly. By providing defined and chemically defined products that can contribute to reliable, consistent results in culture systems, we are supporting this maturation.More therapeutic uses for hMSCs are being discovered, including new clinical trials for the treatment of coronavirus-induced disease, said Serles.

Cellnest is compatible with any adherent cell type that binds to the Arg-Gly-Asp (RGD) domain, an amino acid sequence within the extracellular matrix protein fibronectin that mediates cell attachment, said the producer.

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Global Regenerative Medicine Partnering Report 2014-2020: Access to Cell Therapy, Organ Regeneration, Stem Cells and Tissue Regeneration Partnering…

Posted: September 30, 2020 at 9:53 am

DUBLIN, Sept. 30, 2020 /PRNewswire/ -- The "Global Regenerative Medicine Partnering Terms and Agreements 2014 to 2020" report has been added to ResearchAndMarkets.com's offering.

The Global Regenerative Medicine Partnering Terms and Agreements 2014-2020 report provides comprehensive understanding and unprecedented access to the regenerative medicine including cell therapy, organ regeneration, stem cells and tissue regeneration partnering deals and agreements entered into by the worlds leading healthcare companies.

The report provides a detailed understanding and analysis of how and why companies enter Regenerative Medicine partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and proceed to commercialization of outcomes.

This report provides details of the latest Regenerative Medicine agreements announced in the life sciences since 2014.

The report takes the reader through a comprehensive review Regenerative Medicine deal trends, key players, top deal values, as well as deal financials, allowing the understanding of how, why and under what terms, companies are entering Regenerative Medicine partnering deals.

The report presents financial deal term values for Regenerative Medicine deals, listing by headline value, upfront payments, milestone payments and royalties, enabling readers to analyse and benchmark the financial value of deals.

The middle section of the report explores the leading dealmakers in the Regenerative Medicine partnering field; both the leading deal values and most active Regenerative Medicine dealmaker companies are reported allowing the reader to see who is succeeding in this dynamic dealmaking market.

One of the key highlights of the report is that over 1100 online deal records of actual Regenerative Medicine deals, as disclosed by the deal parties, are included towards the end of the report in a directory format - by company A-Z, stage of development, deal type, therapy focus, and technology type - that is easy to reference. Each deal record in the report links via Weblink to an online version of the deal.

In addition, where available, records include contract documents as submitted to the Securities Exchange Commission by companies and their partners. Whilst many companies will be seeking details of the payment clauses, the devil is in the detail in terms of how payments are triggered - contract documents provide this insight where press releases and databases do not.

A comprehensive series of appendices is provided organized by Regenerative Medicine partnering company A-Z, stage of development, deal type, and therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each deal on demand.

The report also includes numerous tables and figures that illustrate the trends and activities in Regenerative Medicine partnering and dealmaking since 2014.

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of Regenerative Medicine technologies and products.

Key benefits

Global Regenerative Medicine Partnering Terms and Agreements 2014-2020 provides the reader with the following key benefits:

In Global Regenerative Medicine Partnering Terms and Agreements 2014-2020, the available deals are listed by:

Key Topics Covered:

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in Regenerative Medicine dealmaking2.1. Introduction2.2. Regenerative Medicine partnering over the years2.3. Most active Regenerative Medicine dealmakers2.4. Regenerative Medicine partnering by deal type2.5. Regenerative Medicine partnering by therapy area2.6. Deal terms for Regenerative Medicine partnering2.6.1 Regenerative Medicine partnering headline values2.6.2 Regenerative Medicine deal upfront payments72.6.3 Regenerative Medicine deal milestone payments2.6.4 Regenerative Medicine royalty rates

Chapter 3 - Leading Regenerative Medicine deals3.1. Introduction3.2. Top Regenerative Medicine deals by value

Chapter 4 - Most active Regenerative Medicine dealmakers4.1. Introduction4.2. Most active Regenerative Medicine dealmakers4.3. Most active Regenerative Medicine partnering company profiles

Chapter 5 - Regenerative Medicine contracts dealmaking directory5.1. Introduction5.2. Regenerative Medicine contracts dealmaking directory

Chapter 6 - Regenerative Medicine dealmaking by technology type

Chapter 7 - Partnering resource center7.1. Online partnering7.2. Partnering events7.3. Further reading on dealmaking

AppendicesAppendix 1 - Regenerative Medicine deals by company A-ZAppendix 2 - Regenerative Medicine deals by stage of developmentAppendix 3 - Regenerative Medicine deals by deal typeAppendix 4 - Regenerative Medicine deals by therapy area

For more information about this report visit https://www.researchandmarkets.com/r/dcq9uu

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Research and Markets Laura Wood, Senior Manager [emailprotected]

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Global Adipose Derived Stem Cell Therapy Market 2020 Industry Analysis, Growth Factors, Share, Opportunities and Forecast to 2025 – The Daily…

Posted: September 30, 2020 at 9:52 am

Global Adipose Derived Stem Cell Therapy Market 2020 by Company, Type and Application, Forecast to 2025 is the latest addition to the database of MarketsandResearch.biz which exhibits an easily comprehensible description of the global market. The report provides proficient and in-depth research on the market, focusing on the market landscape and its growth prospects over the coming years from 2020 to 2025. The report emphasizes market share, market demographics, size as well as valuation and voluminous growth rate. The research also includes a discussion of the key vendors operating in this global Adipose Derived Stem Cell Therapy market. The study shares details such as current trends of the market in conjunction with the geographical landscape, demand scope, remuneration scale, and growth graph of this vertical have also been included in this report.

The report covers an in-depth analysis of the key trends and emerging drivers of the market as well as market characteristics, competitive landscape, market size and growth, regional breakdown, and strategies for this market. The research analyzes revenue growth, product range, and pricing factors related to the global Adipose Derived Stem Cell Therapy market. The report sheds light on the competition matrix and shares a versatile understanding of various vital details comprising new product related developments that are adequately addressed and invested by leading players in the global market. Details about the competitive landscape, ensuring robust growth in the global market has been given in the report.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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The major players covered in the market are: AlloCure, Mesoblast, Cellleris, Antria, Intrexon, Celgene Corporation, Tissue Genesis, Cytori Therapeutics, Corestem, Pluristem Therapeutics, Cyagen, BioRestorative Therapies, Lonza, Pluristem Therapeutics, Celltex Therapeutics Corporation, iXCells Biotechnologies

Scope of Market Report:

This report provides an analysis of the supply chain, import, and export control, and future influence on the industry. Detailed analysis of the market status, competition pattern, advantages, and disadvantages of enterprise products, industry development trends (2020-2025), regional industrial layout characteristics, industrial policy has also been included. From raw materials to end-users of this industry are analyzed, as well as the trends of product circulation and sales channels are presented.

On the basis of regional segmentation, the market is bifurcated into major regions of North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India and Southeast Asia), South America (Brazil, Argentina, etc.), Middle East & Africa (Saudi Arabia, Egypt, Nigeria and South Africa). The regional analysis further covers country-wise bifurcation of the market and key players.

On the basis of product type, we research the production, revenue, price, market share, and growth rate, primarily split into: Autologous Stem Cells, Allogeneic Stem Cells

For the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate of Adipose Derived Stem Cell Therapy market report for each application, including: Therapeutic Application, Research Application

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Global Adipose Derived Stem Cell Therapy Market 2020 Industry Analysis, Growth Factors, Share, Opportunities and Forecast to 2025 - The Daily...

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Researchers Discover Cells That Heal Cardiac Damage After Infarction – Technology Networks

Posted: September 30, 2020 at 9:52 am

Researchers at Cima and the Clinica Universidad de Navarra (Spain) have led an international study identifying the cardiac cells responsible for repairing the damage to this organ after infarction. These "restorative" cells are a subpopulation of cardiac fibroblasts that play a fundamental role in the creation of the collagen scar needed to avoid the rupture of the ventricular wall. The research also reveals the molecular mechanisms involved in the activation of these cells and the regulation of their function.

This finding, in which basic and clinical researchers have participated, will permit the identification of new therapeutic targets and the development of targeted therapies which will control the healing process of the heart after infarction.

The study has been published in the latest issue of the journal Circulation, the leading scientific journal of the American Heart Association.Characterization of the reparative cardiac fibroblasts

Cardiac fibroblasts are one of the fundamental components of the heart. These cells play an essential role in maintaining the structure and mechanism of this vital organ. "Recent studies have shown that fibroblasts do not respond homogeneously to heart injury. Therefore the object of our study was to determine their heterogeneity during the remodeling of the injured ventricle and to understand the mechanisms that regulate the function of these cells", said Dr Felipe Prsper, a researcher at Cima and the Clinica Universidad de Navarra, the leader of the study.

"Using single-cell transcription analysis techniques (single-cell RNA-seq), we identified a subpopulation within the cardiac fibroblasts, which we have named Reparative Cardiac Fibroblasts (RCF) due to their role after the cardiac injury. We have found that, when a patient has a heart attack, these RCF are activated and offer a fibrotic response due to which a collagen scar is generated to avoid the rupture of the cardiac tissue", stated Dr Prsper, who is also a member of the Red de Terapia Celular (TerCel) and the Instituto de Investigacin Sanitaria de Navarra (IdiSNA).

CTHRC1, a protein related to collagen and essential for the regenerative process

In the detailed molecular study, the researchers have found that the RCF have a unique transcriptional profile, that is to say, a specific information pattern for the expression of the genes involved in their cardiac function. "Among the main differential markers of the transcriptome of these cells, we have identified the CTHRC1 protein (Collagen Triple Helix Repeat Containing 1), a molecule with a fundamental role in the fibrotic response after myocardial infarction. Specifically, this protein participates in the collagen synthesis of the extracellular cardiac matrix and is crucial for the process of ventricular remodeling", in the words of Adrin Ruiz-Villalba, a researcher on the Regenerative Medicine Program at Cima and first author of the article.

These results "suggest that the RCF activates the healing scar process of the cardiac lesion by secreting the CTHRC1 protein. Thus, this molecule may be considered as a biomarker associated with the physiological condition of the injured heart and a potential therapeutic target for patients who have suffered a heart attack or have dilated cardiomyopathy", stated Ruiz-Villalba, who is also a researcher at IdiSNA. In addition to Cima and the Clinica Universidad de Navarra, basic and clinical researchers from the United States, Belgium and Austria have taken part in this research.

This work falls within the framework of the Cell Therapy and Regenerative Medicine research line being carried out at Cima and the Clinica Universidad de Navarra, aimed at understanding the regenerative potential of stem cells and their therapeutic application in different diseases such as cardiovascular ones. Specifically, this study is linked to the BRAV? project, an international research project combining bioengineering and cardiac stem cells to restore the function of an infarcted heart. BRAV? is an H2020 funded program by the European Union (H2020-SC1-BHC-07-2019-874827).

Reference: Ruiz-Villalba A, Romero JP, Hernandez SC, et al.Single-Cell RNA-seq Analysis Reveals a Crucial Role for Collagen Triple Helix Repeat Containing 1 (CTHRC1) Cardiac Fibroblasts after Myocardial Infarction. Circ, 2020. doi:10.1161/CIRCULATIONAHA.119.044557

This article has been republished from the following materials. Note: material may have been edited for length and content. For further information, please contact the cited source.

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STEM CELL BANKING Market Potential Growth, Size, Share, Demand and Analysis of Key Players Research Forecasts to 2027 – The Daily Chronicle

Posted: September 30, 2020 at 9:52 am

Fort Collins, Colorado The STEM CELL BANKING Market is growing at a rapid pace and contributes significantly to the global economy in terms of turnover, growth rate, sales, market share and size. The STEM CELL BANKING Market Report is a comprehensive research paper that provides readers with valuable information to understand the basics of the STEM CELL BANKING Report. The report describes business strategies, market needs, dominant market players and a futuristic view of the market.

The report has been updated to reflect the most recent economic scenario and market size regarding the ongoing COVID-19 pandemic. The report looks at the growth outlook as well as current and futuristic earnings expectations in a post-COVID scenario. The report also covers changing market trends and dynamics as a result of the pandemic and provides an accurate analysis of the impact of the crisis on the market as a whole.

Global STEM CELL BANKING Market to reach USD 11.2 billion by 2025. Global STEM CELL BANKING Market valued approximately USD 5.4 billion in 2016 is anticipated to grow with a healthy growth rate of more than 8.4% over the forecast period 2017-2025.

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Industry STEM CELL BANKING Study provides an in-depth analysis of key market drivers, opportunities, challenges and their impact on market performance. The report also highlights technological advancements and product developments that drive market needs.

The report contains a detailed analysis of the major players in the market, as well as their business overview, expansion plans and strategies. Key players explored in the report include:

The report provides comprehensive analysis in an organized manner in the form of tables, graphs, charts, pictures and diagrams. Organized data paves the way for research and exploration of current and future market outlooks.

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The report provides comprehensive data on the STEM CELL BANKING market and its trends to help the reader formulate solutions to accelerate business growth. The report provides a comprehensive overview of the economic scenario of the market, as well as its benefits and limitations.

The STEM CELL BANKING Market Report includes production chain analysis and value chain analysis to provide a comprehensive picture of the STEM CELL BANKING market. The research consists of market analysis and detailed analysis of application segments, product types, market size, growth rates, and current and emerging industry trends.

By Application:

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The market is geographically spread across several key geographic regions and the report includes regional analysis as well as production, consumption, revenue and market share in these regions for the 2020-2027 forecast period. Regions include North America, Latin America, Europe, Asia Pacific, the Middle East, and Africa.

Radical Coverage of the STEM CELL BANKING Market:

Key Questions Addressed in the Report:

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Stem Cell Therapy Market Size, Analytical Overview, Key Players, Growth Factors, Demand, Trends And Forecast to 2027 – thedailychronicle.in

Posted: September 30, 2020 at 9:52 am

Fort Collins, Colorado Reports Globe recently added the Stem Cell Therapy Market Research Report that provides a thorough investigation of the market scenario of the market size, share, demand, growth, trends, and forecast from 2020-2027. The report covers the impact analysis of the COVID-19 pandemic. COVID-19 pandemic has affected the export-import, demands, and trends of the industry and is expected to have some economic impact on the market. The report provides a comprehensive analysis of the impact of the pandemic on the overall industry and offers insights into a post-COVID-19 market scenario.

The report primarily mentions definitions, classifications, applications, and market overview of the Stem Cell Therapy industry. It also covers product portfolios, manufacturing processes, cost analysis, structures, and gross margin of the industry. It also provides a comprehensive analysis of the key competitors and their regional spread and market size.

Global Stem Cell TherapyMarketwas valued at 117.66 million in 2019 and is projected to reach USD255.37 million by 2027, growing at a CAGR of 10.97% from 2020 to 2027.

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Competitive Analysis:

The report provides a comprehensive analysis of the companies operating in the Stem Cell Therapy market, along with their overview, business plans, strengths, and weaknesses to provide a substantial analysis of the growth through the forecast period. The evaluation provides a competitive edge and understanding of their market position and strategies undertaken by them to gain a substantial market size in the global market.

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The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

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Additionally, the report is furnished by the advanced analytical data from SWOT analysis, Porters Five Forces Analysis, Feasibility Analysis, and Investment Return Analysis. The report also provides a detailed analysis of the mergers, consolidations, acquisitions, partnerships, and government deals. Along with this, an in-depth analysis of current and emerging trends, opportunities, threats, limitations, entry-level barriers, restraints and drivers, and estimated market growth throughout the forecast period are offered in the report.

Market Breakdown:

The market breakdown provides market segmentation data based on the availability of the data and information. The market is segmented on the basis of types and applications.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

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The report provides additional analysis about the key geographical segments of the Stem Cell Therapy Market and provides analysis about their current and previous share. Current and emerging trends, challenges, opportunities, and other influencing factors are presented in the report.

Regional analysis includes an in-depth study of the key geographical regions to gain a better understanding of the market and provide an accurate analysis. The regional analysis coversNorth America, Latin America, Europe, Asia-Pacific, and the Middle East & Africa.

Objectives of the Report:

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Stem Cell Therapy Market Size, Analytical Overview, Key Players, Growth Factors, Demand, Trends And Forecast to 2027 - thedailychronicle.in

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Genetic Engineering Drug Market 2020 | What Is The Estimated Market Size In The Upcoming Years? – The Daily Chronicle

Posted: September 30, 2020 at 9:51 am

The Global Marketers provides you regional research analysis on Genetic Engineering Drug Market and forecast to 2026. The global Genetic Engineering Drug Market report comprises a valuable bunch of information that enlightens the most imperative sectors of the Genetic Engineering Drug market. The global Genetic Engineering Drug market report provides information regarding all the aspects associated with the market, which includes reviews of the final product, and the key factors influencing or hampering the market growth.

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Main players in the Genetic Engineering Drug Market:

GeneScience Pharmaceuticals Co., LtdBeijing SL Pharmaceutical Co., LtdBiotech Pharmaceutical Co., LtdShenzhen Neptunus Interlong Bio-Technique Co., LtdJiangsu Sihuan Bioengineering Co., LtdTonghua Dongbao Pharmaceutical Co., LtdAnhui Anke Biotechnology (Group) Co., Ltd3SBio Inc.Shanghai Lansheng Guojian Pharmaceutical Co., Ltd

Some of the geographic regions examined in the overall Genetic Engineering Drug Market are:

In addition, the global Genetic Engineering Drug market report delivers brief information about federal regulations and policies that may ultimately affect market growth as well as the financial state. The situation of the global market at the global and regional levels is also described in the global Genetic Engineering Drug market report through geographical segmentation. The Genetic Engineering Drug report introduces speculation attainability evaluation, a task SWOT investigation, and venture yield evaluation.

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Global Genetic Engineering Drug Market Segmentation:

On the Basis of The Application:

30 Years Old30 Years Old-60 Years Old60 Years Old

On the Basis of Type:

Monoclonal AntibodyRecombinant Human ErythropoietinRecombinant Human InterferonRecombinant Human Growth HormoneRecombinant Human Insulin

Moreover, the report comprises the main developments made in the Genetic Engineering Drug market. Porters five force analysis is used to conclude the competition in the Genetic Engineering Drug market along with new entrants and their strategies & tactics. The report involves the value chain analysis which denotes workflow in the Genetic Engineering Drug market. Also, the market has been classified on the basis of category, processes, end-use industry, and region. On the basis of geography, the report Genetic Engineering Drug the market.

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The Genetic Engineering Drug Market research report presents a comprehensive analysis of the market and contains attentive insights, facts, past data, and statistical support, and industry-validated market data. It furthermore contains projections applying a suitable set of assumptions and methodologies. The research Genetic Engineering Drug report provides examination and information according to market segments such as geographies, applications, and industry by considering major players.

Key questions answered in this report

Highlights of the TOC of the Genetic Engineering Drug Report:

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Genetic Engineering Drug Market 2020 | What Is The Estimated Market Size In The Upcoming Years? - The Daily Chronicle

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Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics – JD Supra

Posted: September 30, 2020 at 9:51 am

The prospect of genetic engineering using CRISPR (clustered regularly interspaced short palindromic repeats) and CRISPR-associated nucleases (Cas) has long been hailed as a revolutionary development in medicine.

This technology is rapidly advancing, and several CRISPR/Cas-based drugs have entered clinical trials over the past several years. One kind of product in clinical trials is CRISPR-modified cells, such as CTX001 (CRISPR-Cas9-modified autologous hematopoietic stem cells), currently under study for the treatment of b-thalassemia and severe sickle cell anemia. Another CRISPR-based product, AGN-151587, is injected into the eye with the goal of eliminating a genetic mutation in patients with Leber congenital amaurosis 10, a leading cause of childhood blindness. In parallel, others are working to harness the CRISPR/Cas system to develop drugs for rare diseases, including bespoke therapies tailored to an individual patients needs.

Given CRISPR/Cas-based drugs potential to treat rare diseases, issues relating to orphan drug exclusivity will arise as these products are developed. In May 2020, for example, CTX001 received an orphan drug designation for transfusion-dependent b-thalassemia.

In January 2020, the FDA provided draft guidance regarding orphan drug exclusivity for gene therapy products, which includes CRISPR/Cas gene editing (Draft Guidance). This guidance focuses on the analysis of whether two gene therapy products are the same under the Orphan Drug Act. Although informative, the limited scope of the Draft Guidance invites more questions than it answers.

Same Drugs Under the Orphan Drug Act

Obtaining orphan drug exclusivity involves a two-step process. First, a sponsor requests designation of a drug for a particular rare disease or condition. See 21 C.F.R. 316.20. If this drug is the same drug as a drug already approved to treat the same rare disease or condition, the sponsor must provide a plausible hypothesis that the new drug is clinically superior to the previously-approved drug. Id. Whether two drugs are the same depends on consideration of structural features relevant to that type of drug. See id. 316.3(b)(14).

If the new drug later obtains marketing approval for a use or indication within the rare disease or condition for which it received orphan drug designation, the FDA will determine if the drug is eligible for orphan drug exclusivity. See 21 C.F.R. 316.31(a). In this situation, to receive exclusivity, the sponsor of the new drug must show that its drug is clinically superior to the same previously-approved drug for the same rare disease or condition. See id. 316.34(c). A clinical superiority determination is based on the new drugs greater efficacy, greater safety, or a major contribution to patient care. See id. 316.3(b)(3).

Highlights from Draft FDA Guidance

To determine whether one gene therapy product is the same as another, per 316.3(b)(14)(ii), the FDA will evaluate the principal molecular structural features of the two products, particularly transgenes (e.g., transgenes that encode different enzymes for treatment of the same rare disease) and vectors. For example:

Additionally, [w]hen applicable, the FDA generally intends to consider additional features of the final gene therapy product, such as regulatory elements or, in the case of genetically-modified cells, the type of cell that is transduced. It generally intends to consider requests for designation and exclusivity of gene therapy products to evaluate whether such additional features may also be considered to be principal molecular structural features.

Implications for CRISPR/Cas Therapy Exclusivity

The Draft Guidance helps answer certain high-level questions relating to whether two gene therapy products would be considered the same under the Orphan Drug Act. As various stakeholders have recognized, however, it is short on the details that meaningfully aid the process of drug research and development.

It is clear from the Draft Guidance that a new product can be considered the same as a previously-approved product even if the two products are not perfectly identical, but the guidance does not explain what would constitute a minor difference between such products, or what the scope of additional features would be.

For example, the Draft Guidance does not clarify what makes two transgenes the same. Nor does it cite to prior guidance or regulations that may answer this question. The question is significant because Cas nucleases and other parts of the CRISPR/Cas system may be modified in various ways. To address whether these modifications bar a finding of same-ness, the FDA could potentially import the kinds of considerations that govern same-ness of other kinds of large-molecule products, such as polynucleotide drugs or closely related, complex partly definable drugs with similar therapeutic intent (e.g., viral vaccines). See 21 C.F.R. 316.3(b)(14)(ii)(C), (D). However, this is not clear from the Draft Guidance.

The Draft Guidance also does not explain what will factor into the case-by-case basis assessment of whether viral vectors from the same viral class are the same. In the case of AAV2 and AAV5the two viruses identified in the guidanceresearchers have found that these viruses differ with respect to sequence analysis, tissue tropism, and heparin sensitivity. It is not clear from the guidance, however, whether a plausible hypothesis of clinical superiority will be required to seek orphan drug designation for a drug based on AAV2 if the previously-approved drug expresses the same transgene(s) but is based on AAV5.

It would be beneficial to sponsors and other stakeholders if these aspects of gene therapy drugs sameness are clarified further before they invest significant resources into the design and development of these therapeutics.

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Orphan Drug Exclusivity for CRISPR/Cas-Based Therapeutics - JD Supra

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