Archive for the ‘Gene Therapy Research’ Category
(2020-2026) Biologics Safety Testing Market Research, Growth Opportunities, Analysis and Forecasts Report – 3rd Watch News
Global Biologics Safety Testing Market Growth Projection
The Biologics Safety Testing market report [6 Years Forecast 2020-2026] focuses on the COVID19 Outbreak Impact analysis of key points influencing the growth of the market. The intelligence report prepared contains details on the leading players of the Global Biologics Safety Testing Market, along with various depending aspects related and associated with the market. Profile the Top Key Players of Biologics Safety Testing, with sales, revenue and global market share of Biologics Safety Testing are analyzed emphatically by landscape contrast and speak to info. Upstream raw materials and instrumentation and downstream demand analysis is additionally administrated. The Biologics Safety Testing market business development trends and selling channels square measure analyzed. Biologics Safety Testing industry research report enriched on worldwide competition by topmost prime manufactures which providing information such as Company Profiles, Gross, Gross Margin, Capacity, Product Picture and Specification, Production, Price, Cost, Revenue and contact information.
Biologics Safety Testing Market report provides in-depth review of the Expansion Drivers, Potential Challenges, Distinctive Trends, and Opportunities for market participants equip readers to totally comprehend the landscape of the Biologics Safety Testing market. Major prime key manufactures enclosed within the report alongside Market Share, Stock Determinations and Figures, Contact information, Sales, Capacity, Production, Price, Cost, Revenue and Business Profiles are (Lonza Group, Charles River, Merck, SGS, WuXi AppTec, Thermo Fisher Scientific, Sartorius, Cytovance Biologics, Pace Analytical Services, Toxikon). The main objective of the Biologics Safety Testing industry report is to Supply Key Insights on Competition Positioning, Current Trends, Market Potential, Growth Rates, and Alternative Relevant Statistics.
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There are 10 Chapters to deeply display the Biologics Safety Testing market:
Chapter 1, is executive summary of Biologics Safety Testing Market; Chapter 2, is definition and segment of Biologics Safety Testing; Chapter 3, to show info and data comparison of Biologics Safety Testing Players; Chapter 4, to explain the industry chain of Biologics Safety Testing; Chapter 5, to show comparison of regions and courtiers(or sub-regions); Chapter 6, to show competition and trade situation of Biologics Safety Testing Market; Chapter 7, to show comparison of applications; Chapter 8, to show comparison of types; Chapter 9, to show investment of Biologics Safety Testing Market; Chapter 10, to forecast Biologics Safety Testing market in the next years.
The Biologics Safety Testing market report provides a comprehensive analysis of: Industry overview, cost structure analysis, technical data and competitive analysis, topmost players analysis, development trend analysis, overall market overview, regional market analysis, consumers analysis and marketing type analysis.
Global Biologics Safety Testing Market report focuses on various key parameters that include:
Market concentration ratio Consumption growth rate Growth rate Turnover predictions Industry drivers and major challenges Recent market trends Geographical segmentation Competitive structure Competitive ranking analysis
Scope of Biologics Safety Testing Market:
The global Biologics Safety Testing market is valued at million US$ in 2019 and will reach million US$ by the end of 2026, growing at a CAGR of during 2020-2026. The objectives of this study are to define, segment, and project the size of the Biologics Safety Testing market based on company, product type, application and key regions.
This research report categorizes the global Biologics Safety Testing market by players/brands, region, type and application. This report also studies the global market status, competition landscape, market share, growth rate, future trends, market drivers, opportunities and challenges, sales channels, distributors, customers, research findings & conclusion, appendix & data source and Porters Five Forces Analysis.
On the basis on the end users/applications, this report focuses on the status and outlook for major applications/end users, shipments, revenue (Million USD), price, and market share and growth rate for each application.
Endotoxin Tests, Sterility Tests, Cell Line Authentication and Characterization Tests, Bioburden Tests, Cell Line Authentication, Residual Host Contaminant Detection Tests, Adventitious Agent Detection Tests, Others
On the basis of product type, this report displays the shipments, revenue (Million USD), price, and market share and growth rate of each type.
Vaccine Development, Blood Products Testing, Cellular & Gene Therapy, Tissue and Tissue-Related Products Testing, Stem Cell Research,
Market Size Segmentation by Region & Countries (Customizable):
North America
Europe
Asia-Pacific
South America
Center East and Africa
United States, Canada and Mexico
Germany, France, UK, Russia and Italy
China, Japan, Korea, India and Southeast Asia
Brazil, Argentina, Colombia
Saudi Arabia, UAE, Egypt, Nigeria and South Africa
Our exploration specialists acutely ascertain the significant aspects of the global Biologics Safety Testing market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Biologics Safety Testing market situation. In this Biologics Safety Testing report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Biologics Safety Testing report comprises of primary and secondary data which is exemplified in the form of pie outlines, Biologics Safety Testing tables, analytical figures, and reference diagrams. The Biologics Safety Testing report is presented in an efficient way that involves basic dialect, basic Biologics Safety Testing outline, agreements, and certain facts as per solace and comprehension.
Important Features that are under offering & key highlights of the report:
Detailed overview of Biologics Safety Testing market Changing market dynamics of the industry In-depth market segmentation by Type, Application etc Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape of Biologics Safety Testing market Strategies of key players and product offerings Potential and niche segments/regions exhibiting promising growth A neutral perspective towards Biologics Safety Testing market performance Market players information to sustain and enhance their footprint
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Table of Content
1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered1.4 Market Analysis by Type1.4.1 Global Biologics Safety Testing Market Size Growth Rate by Type (2014-2026)1.4.2 Major-Type1.4.3 Independent-Type1.4.4 Administrator-Type1.5 Market by Application1.5.1 Global Biologics Safety Testing Market Share by Application (2014-2026)1.5.2 Other1.6 Study Objectives1.7 Years Considered
2 Global Growth Trends2.1 Biologics Safety Testing Market Size2.2 Biologics Safety Testing Growth Trends by Regions2.2.1 Biologics Safety Testing Market Size by Regions (2014-2026)2.2.2 Biologics Safety Testing Market Share by Regions (2014-2020)2.3 Industry Trends2.3.1 Market Top Trends2.3.2 Market Drivers2.3.3 Market Opportunities
3 Market Share by Key Players3.1 Biologics Safety Testing Market Size by Manufacturers3.1.1 Global Biologics Safety Testing Revenue by Manufacturers (2014-2020)3.1.2 Global Biologics Safety Testing Revenue Market Share by Manufacturers (2014-2020)3.1.3 Global Biologics Safety Testing Market Concentration Ratio (CR5 and HHI)3.2 Biologics Safety Testing Key Players Head office and Area Served3.3 Key Players Biologics Safety Testing Product/Solution/Service3.4 Date of Enter into Biologics Safety Testing Market3.5 Mergers and Acquisitions, Expansion Plans
4 Breakdown Data by Type and Application4.1 Global Biologics Safety Testing Market Size by Type (2014-2020)4.2 Global Biologics Safety Testing Market Size by Application (2014-2020)
(5, 6, 7, 8, 9, 10, 11) United States, Europe,China,Japan,Southeast Asia,India,Central and South AmericaBiologics Safety Testing Market Size (2014-2020)Key PlayersBiologics Safety Testing Market Size by TypeBiologics Safety Testing Market Size by Application
12 International Players ProfilesCompany DetailsCompany Description and Business OverviewBiologics Safety Testing IntroductionRevenue in Biologics Safety Testing Business (2014-2020)Recent Development
13 Market Forecast 2020-202613.1 Market Size Forecast by Regions13.2 United States13.3 Europe13.4 China13.5 Japan13.6 Southeast Asia13.7 India13.8 Central and South America13.9 Market Size Forecast by Product (2020-2026)13.10 Market Size Forecast by Application (2020-2026)
14 Analysts Viewpoints/Conclusions
15 Appendix15.1 Research Methodology15.1.1 Methodology/Research Approach15.1.1.1 Research Programs/Design15.1.1.2 Market Size Estimation12.1.1.3 Market Breakdown and Data Triangulation15.1.2 Data Source15.1.2.1 Secondary Sources15.1.2.2 Primary Sources15.2 Disclaimer15.3 Author Details
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(2020-2026) Biologics Safety Testing Market Research, Growth Opportunities, Analysis and Forecasts Report - 3rd Watch News
Deep-sea currents are spreading microplastics around the globe – Massive Science
Honey bees have been celebrated by humans since they were first domesticated for pollination and honey production in the earliest days of human civilization. But honey bees are expendable we can purchase them from other countries, ship them overseas, and raise them in a non-native land to pollinate our crops. If all of the honey bees in the U.S. died today, wed buy more tomorrow. This World Bee Day, we should focus our celebration on the lesser-known species of amazing native bees that fill our environment.
Iridescent green sweat bee, called because it is known to be attracted to sweat
Via Wikimedia
World Bee Day was established by the United Nations to recognize the fundamental role of pollinators in pollination services, food production, and to safeguard biodiversity in the face of their many threats. It was not only in recognition of honey bees and the pollination services they provide, but of all bees. The proclamation specifically acknowledged and raised awareness of the urgent need to conserve all of the 20,000 species of native bees worldwide.
The blueberry bee, Osmia ribifloris, a blue-colored bee native to North America.
Via Wikimedia
Native bees are absolutely some of the coolest insects on earth. They come in a huge variety of shapes, sizes, and colors. Social species with a single queen like bumble bees make up about 10% of known bee species. Social bees live in nests and work together like honey bees to raise their young and forage for food. The other 90% are solitary species, meaning they live alone and are solely responsible for finding food and building a nest.
Stelis louisae, a red/orange carder bee
USGS
Native bees come in a variety of colors besides yellow and blackblue, green, orange, and red, to name a few. Some resemble wasps, as a defense mechanism for survival. Others are covered in tiny hairs, resembling giant teddy bears, or almost entirely hairless and smooth. Native bees are responsible for a majority of wild plant and crop pollination worldwide.
There are so many amazing native bees. Unfortunately, the focus generally lands on the domesticated workhorse Apis mellifera, instead of any one of the amazing native species. Native bees face a wide range of threats from lost habitat due to increasing development, lack of flowers for food, agricultural intensification, pesticides, and so much more. Honey bees actually pose a threat to native bees, introducing competition and spillover of diseases and parasites to native bees.
An all black bee, Dufourea monardae
Cole Cheng/USGS
There are a wide variety of studies in native bees, but educating the public is one of the best ways to encourage native bee conservation. So this World Bee Day, take some time to read up on pollinators, and learn what you can do to help our native bees.
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Deep-sea currents are spreading microplastics around the globe - Massive Science
Global Gene Therapy for Ovarian Cancer Market 2020 Significant Growth Prospects and COVID-19 Impact Analysis 2025 – Flagler Times
Global Gene Therapy for Ovarian Cancer Market 2020 by Manufacturers, Countries, Type and Application, Forecast to 2025 is a fundamental and professional analysis of the essential elements driving the market growth rate and the revenue statistic. The report explains the global Gene Therapy for Ovarian Cancer industry growth structure and development trends. The report has administered several comprehensive elements including market share, supply chain, market trends, revenue graph, market size, and application spectrum. The report gives detailed information about major players comprising their name, company profile, product information. The report also highlights an accurate competitive overview of the business-driven outlook elaborating on expansion tactics adopted by major competitors of the industry.
The global Gene Therapy for Ovarian Cancer market is separated by company, by country, and by application/types for the competitive landscape analysis. Some crucial information related to the complete assessment that market retains has been given as well as the availability of several growth opportunities as been underlined. In this report, essential parameters such as development policies as well as plans, cost structures, supply and demand figures, gross margins, import or export consumption, revenue, and price are studied. Additionally, the document highlights the pricing of the product, production and consumption volume, cost analysis, industry value, barriers and growth drivers, major market players, demand and supply ratio of the market, the growth rate of the market and forecast from 2020 to 2025.
NOTE: Our final report will be revised to address COVID-19 effects on the specific market.
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Leading Players Analysis:
The global Gene Therapy for Ovarian Cancer industry report then covers global major leading industry players, providing information such as company profiles, product picture and specification, capacity, production, price, cost, revenue, and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out.
List of some major players from a wide list of coverage used under the bottom-up approach is: Takara Bio, VBL Therapeutics, CELSION, Targovax,
The product type of market such as: Intravenous, Intratumoral, Intraperitoneal
Applications of the market such as: Ovarian Cancer (unspecified), Recurrent Ovarian Epithelial Cancer, Platinum-Resistant Ovarian Cancer,
Major geographies mentioned in this report are as follows: 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, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)
Moreover, the study report has described the fundamental information about the global Gene Therapy for Ovarian Cancer market such as application, industry outlook, definition, market chain structure, policy analysis, classification and more. It also explains which product has the highest penetration in which market, profit margins, break-even analysis, and R&D status.
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Bicoastal startup Kriya Therapeutics to grow gene therapy manufacturing in NC – WRAL Tech Wire
RESEARCH TRIANGLE PARK Theres a new biotech company setting up shop in the Triangle, and its flush with cash and headed up by some big names in the industry.
MeetKriya Therapeutics the brainchild of Dr. Shankar Ramaswamy, former chief business officer for Axovant Gene Therapies; Fraser Wright, co-founder of Sparks Therapeutics; and Roger Jeffs, the former United Therapeutics CEO who has deep rootsinNorth Carolina.
Launched in 2019, the biotech startup has dual headquarters in Durham and Palo Alto, California, and is billing itself as a next-generation gene therapy company focused on designing and developing treatments for highly prevalent and severe chronic conditions, like diabetes and obesity.
Earlier this month, it arrived in a big way after securing $80.5 million in Series A financing during a pandemic.
Its never easy. But itsa really significant pool of capital for us so were thankful to have been able to get it done,Ramaswamy, Kriyas CEO, told NC Biotech in a video interview this week.[Our] investors have a very long term vision of what a next generation gene therapy company could look like, and were very supportive building towards that vision.
Fraser Wright, PhDScientific Co-Founder and Chief Scientific Advisor; Shankar Ramaswamy, MDCo-Founder, Chairman, and CEO; and Nachi Gupta, MD, PhDChief of Staff.
Among the investors: QVT, Dexcel Pharma, Foresite Capital, Bluebird Ventures (associated with Sutter Hill Ventures), Narya Capital, Amplo,Paul Manning, andAsia Alpha. The round followed an initial seed financing led by Transhuman Capital late last year.
Itsis amilestone for the company andsets us up for success to goout and execute on the things that we really want to get done.
Ramaswamy says the company is now ready to scale, and is focused on building out its teams on both coasts.
We expect to grow very quickly both here in the Bay Area and in North Carolina, he said, emphasizing the Triangles importance as its manufacturing hub. That could be dozens of employees [here] in the not so distant future, if not larger over time.
How it will work: co-founders Ramaswamy and Wright will be based in the Bay area along with finance operations and early-stage research.
Meanwhile, in Durham, co-founder Jeffs will lead a team focused on development and manufacturing. It will include Britt Petty, AveXis former head of global manufacturing and Melissa Rhodes, former chief development officer at Altavant Sciences; and Mitch Lower, another Avexis veteran.
I dont view North Carolina as a satellite office.Thats where well be building our internal manufacturing infrastructure to solve for one of the key bottlenecks in gene therapy,which is manufacturing capacity and quality, saidRamaswamy.
Theres a very strong pool of talent in North Carolina, especially in biologics manufacturing. And [our team] has a very strong track record and history of success with biologics manufacturing, and strong experience there as well. So we think its a great place to be, given the past couple of decades, where there have been so many successful products actually manufactured in North Carolina.
Already, Kriyahas a number of gene therapies in the pipeline.
Among them: KT-A112, an investigational gene therapy administered by intramuscular injection that delivers the genes to produce insulin and glucokinase for type 1 and type 2 diabetes;KT-A522, an investigational gene therapy administered by salivary gland injection that delivers the gene to produce a glucagon-like peptide 1 (GLP-1) receptor agonist for type 2 diabetes and severe obesity; andKT-A83, an investigational gene therapy administered by intrapancreatic injection that delivers the gene to produce modified insulin growth factor 1 (IGF-1) for type 1 diabetes.
The team is currently set up in a temporary office in Durham, but plans to move intoamore permanent space somewhere in the Research Triangle in the near future.
Kriya is building a leading team and cutting-edge infrastructure to engineer best-in-class gene therapies for severe chronic conditions and accelerate their advancement into human clinical trials, saidJeffs, its vice chairman. Through its R&D laboratory capabilities in the Bay Area and in-house process development and manufacturing infrastructure inResearch Triangle Park, I believe that Kriya will be uniquely positioned to become a leader in the gene therapy field.
(c) North Carolina Biotechnology Center
Durhams Kriya Therapuetics lands $80M to advance gene therapies for diabetes, severe obesity
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Bicoastal startup Kriya Therapeutics to grow gene therapy manufacturing in NC - WRAL Tech Wire
EdiGene and Immunochina Announce Research and Development Collaboration to Develop Allogeneic CAR-T Therapy for Cancer – Business Wire
BEIJING, China & CAMBRIDGE, Mass.--(BUSINESS WIRE)--EdiGene, Inc., which develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases, and Immunochinaa company dedicated to innovative gene and cellular technology today announced that they have formed a research and development collaboration to develop allogeneic CAR-T therapy for cancer.
Under this partnership, both companies will combine EdiGenes expertise in genome editing and allogeneic T-cell process with Immunochinas expertise in innovative CAR-T technology to develop potentially best-in-class allogeneic CAR-T therapeutics. Terms are not disclosed.
"EdiGene is a leading gene-editing company with cutting edge technology platform. It is our great pleasure to work with this team," said Ting He, Ph.D.founder and CEO of Immunochina, "Make the Incurable Curable, which is Immunochinas vision. We have accumulated considerable experience in late-stage hematological malignancies, with two IND approvals. Although a number of break throughs have been made by autologous T cells lately, allogeneic T cells could also play an important role in the future. The cooperation is a big step for both teams, and I believe we will make exciting discoveries together."
We are excited to collaborate with Immunochina, one of the leading clinical-stage CAR-T companies, said Dong Wei, Ph.D.CEO of EdiGene, We believe that allogeneic T-cell therapeutics has tremendous potential, by offering innovative T-cell therapies off the shelf with more effective quality control and lower cost. By combining the expertise of EdiGene and Immunochina, we will be well positioned to develop such therapeutics and advance to clinics, one step closer to help the cancer patients in need.
About EdiGene, Inc
EdiGene is a biotechnology company focused on leveraging the cutting-edge genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with subsidiaries in Guangzhou, China and Cambridge, Massachusetts, USA. More information can be found at http://www.edigene.com.
About Immunochina
Immunochina is committed to the application of innovative gene and cellular technology for treatment of lethal diseases. The company owns integrated CAR-T platform, including core technologies such as large-scale viral vector production and primary immune cell processing. The pipeline includes several CAR-T candidates for treatment of advanced cancer, with two IND approvals. Founded in 2015, Immunochina is headquartered in Beijing. More information can be found at http://www.immunochina.com
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EdiGene and Immunochina Announce Research and Development Collaboration to Develop Allogeneic CAR-T Therapy for Cancer - Business Wire
Regenerative Medicine Market to Exhibit a CAGR of 26.1% by 2026; Rising Prevalence of Genetic Disorders to Fuel Demand, states Fortune Business…
Pune, May 27, 2020 (GLOBE NEWSWIRE) -- The global regenerative medicine market size is expected to reach USD 151,949.5 billion by 2026, exhibiting a CAGR of 26.1% during the forecast period. The growing R&D investment by key players for the development of innovative regenerative therapies can be a vital factor enabling the growth of the market during the forecast period, states Fortune Business Insights in a report, titled Regenerative Medicine Market Size, Share and Industry Analysis By Product (Cell Therapy, Gene Therapy, Tissue Engineering, Platelet Rich Plasma), By Application (Orthopaedics, Wound Care, Oncology), By Distribution Channel (Hospitals, Clinics) & Regional Forecast, 2019 2026 the market size stood at USD 23,841.5 Million in 2018. The growing organ transplantation surgeries will spur opportunities for the market during the forecast period.
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Market Driver:
Escalating Cases of Genetic Disorders to Augment Growth
The increasing prevalence of chronic disorders can be an essential factor enabling the growth of the market. Similarly, the growing incidence of genetic disorders will fuel demand for the market. The growing investment in R&D activities by major market players will have a positive impact on the regenerative medicine market growth during the forecast period. For instance, in March 2018, SanBio Group, a leader in regenerative medicine and therapies for neurological disorders announced that it has made a deal with Hitachi Chemical Advanced Therapeutics Solutions, LLC, a cell manufacturing company for the development and manufacturing of innovative regenerative medicines.
Furthermore, the rising cases of neurological disorders will influence the healthy growth of the market. The growing healthcare expenditure in developed and developing countries will boost the market in the forthcoming years. The ongoing clinical trials and robust pipeline products in stem cell andgene therapy will contribute tremendously to the growth of the market. The rising utilization of skin substitutes, grafts, bone matrix, and other tissue-engineered regenerative medicine in orthopedic and neurosurgical applications will augment the growth of the market.
An Overview of the Impact of COVID-19 on this Market:
The emergence of COVID-19 has brought the world to a standstill. We understand that this health crisis has brought an unprecedented impact on businesses across industries. However, this too shall pass. Rising support from governments and several companies can help in the fight against this highly contagious disease. There are some industries that are struggling and some are thriving. Overall, almost every sector is anticipated to be impacted by the pandemic.
We are taking continuous efforts to help your business sustain and grow during COVID-19 pandemics. Based on our experience and expertise, we will offer you an impact analysis of coronavirus outbreak across industries to help you prepare for the future.
To get the short-term and long-term impact of COVID-19 on this Market.
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Regional Analysis:
Development of Novel Therapies to Favor Growth in North America
The market in North America generated a revenue of USD 9,128.2 million in 2018 and is predicted to grow rapidly during the forecast period owing to the presence of major pharmaceutical companies. The growing launch of novel therapeutics and the availability of advanced technologies along with clinical trials will support growth in North America. Asia Pacific is expected to witness a high growth rate during the forecast period owing to the
developing healthcare infrastructure and facilities. The increasing stem cell research in developing countries such as India, Japan China will contribute positively to the growth of the market. For instance, In April 2013, the Japan Ministry of Health, Labor, and Welfare approved Regenerative Medicine law. The growing number of clinical developments of regenerative and cell-based therapies will drive the market in the region. The increasing government initiatives for human embryonic stem cell research and development will further encourage growth in the region. The surge in geriatric patients, the evolving lifestyle of people, and the growing need for novel therapies are factors likely to aid the expansion of the market in Asia Pacific.
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Key Development:
2018: Novartis announced that it has received EUs approval for one-time gene therapy Luxturna, to restore vision in people with rare and genetically-associated retinal disease.
List of the Key Companies Operating in the Regenerative Medicine Market are:
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Detailed Table of Content:
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Induced Pluripotent Stem Cells Market Size, Share and Global Trend By Derived Cell Type (Amniotic cells, Fibroblasts, Keratinocytes, Hepatocytes, Others), By Application (Regenerative medicines, Drug development, Toxicity testing, Reprogramming technology, Academic research, Others), By End-user (Hospitals, Education & research institutes, Biotechnological companies) and Geography Forecast till 2026
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Regenerative Medicine Market to Exhibit a CAGR of 26.1% by 2026; Rising Prevalence of Genetic Disorders to Fuel Demand, states Fortune Business...
Takara Bio Announces the Completion of a New GMP Facility for Manufacturing Gene and Cell Therapy Products – Business Wire
MOUNTAIN VIEW, Calif.--(BUSINESS WIRE)--Takara Bio USA, Inc. (TBUSA) announced that its parent company, Takara Bio Inc., has completed the construction of a new facility, the Center for Gene and Cell Therapy Processing II (CGCPII) in Shiga, Japan. The CGCPII has been operational since January 2020.
The CGCPII is an expansion of the Center for Gene and Cell Processing (CGCP), which was established in 2014 and designed specifically for the safe, efficient manufacture of gene and cell therapy products. Both facilities have received ISO 9001 certification. The CGCPII provides additional capacity for Good Manufacturing Practice (GMP) viral vector production, process development, aseptic filling, and quality-testing facilities, as well as room for future expansion.
With the addition of the CGCPII, Takara Bio is able to accommodate the growing demand for gene and cell therapies and will continue to enhance its services for biopharmaceuticals and regenerative medicine products under GMP and Good Gene, Cellular, and Tissue-based Products Manufacturing Practice (GCTP).
"Takara Bio is excited to increase our capacity to provide even more support to customers worldwide in the development of their regenerative medicine products. We have a history of developing products like RetroNectin reagent for regenerative medicine research, and we are building on that history with our expanded facility and service offerings," said Junichi Mineno, Chief Operating Officer, Takara Bio Inc.
With our state-of-the-art GMP manufacturing facilities in Japan and Europe, Takara Bio provides services for viral vector production, cell processing, clinical-grade human embryonic stem cell line derivation, quality testing, and cell banking. These gene and cell therapy manufacturing services, carried out by a global team of seasoned experts, provide support throughout the entire process of developing vital regenerative medicine products.
About Takara Bio
Takara Bio USA, Inc. (TBUSA) is a wholly owned subsidiary of Takara Bio Inc. that manufactures and distributes kits, reagents, and instruments for the life sciences, including NGS, PCR, gene delivery, genome editing, stem cell research, nucleic acid and protein purification, and automated sample preparation.
Takara Bio Inc., a world leader in biotechnology research and development, offers a host of life science research solutions, from enzymes and GMP reagents to contracted cell and gene therapy manufacturing services and is the developer of the RetroNectin reagent, a world standard in gene therapy protocols. Takara Bio is committed to preventing disease and improving the quality of life for all people through the use of biotechnology.
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Takara Bio Announces the Completion of a New GMP Facility for Manufacturing Gene and Cell Therapy Products - Business Wire
Double Trouble: Researchers Find Many Cancers Carry Two Mutations in the Same Gene – On Cancer – Memorial Sloan Kettering
Summary
It turns out that finding driver mutations may be more complicated than previously thought: Nearly a quarter of all tumors have two different mutations in the same gene.
A major effort in cancer research is the search for driver mutations in tumors. These mutations are changes in a genes DNA that play a direct role in the growth of cancer. They are different from passenger mutations, which are genetic changes found in tumors that dont have anything to do with the cancer: Those are just along for the ride.
Figuring out which tumor mutations are drivers is important because they help provide an understanding of how and why tumors grow. Identifying driver mutations also helps researchers design treatments and helps doctors predict how a persons cancer is likely to behave.
But according to a studypublished by Memorial Sloan Kettering researchers in Nature on May 27, the strategy of focusing on driver mutations may be more complicated than previously thought. It turns out that nearly a quarter of all tumors have two different mutations in the same gene that are contributing to the formation of an individual cancer.
Weve seen this phenomenon here and there before, but until now we had no idea how common it was, says MSK computational oncologist Barry Taylor, one of the studys two senior authors. The harder we looked, the more clearly we saw it.
MSK-IMPACT: A Targeted Test for Mutations in Both Rare and Common Cancers
MSK-IMPACT stands for integrated mutation profiling of actionable cancer targets. It is a targeted tumor-sequencing test available to MSK patients.
In every cell of our bodies, we have two copies of each gene. One comes from our mother and the other from our father. When one copy of a gene develops a mutation either by chance or due to exposure to something harmful like UV light, radiation, or tobacco smoke the other copy is there to potentially make up for the loss. If there is a mutation in the second copy, thats when trouble can start: If both copies of a gene are mutated, it can send the cell down the road toward becoming cancerous. These multiple mutations, also called composite mutations,were known to occur with a class of genes called tumor suppressors, where the double mutation effectively cripples the function of both copies of a gene and can lead to cancer.
But it turns out that another type of composite mutation that hasnt been well understood is much more common than expected: It occurs when two different mutations affect the same copy of a gene. Here, the two mutations work together to produce a mutant protein with new, unexpected functions. This situation can lead to the formation of oncogenic proteins those that drive cancer growth.
[MSK-IMPACT data is] well suited to doing this kind of detailed analysis.
In a way, were looking at a phenomenon thats been staring people in the face for a long time, says MSK computational oncologist Ed Reznik, the papers other senior author. I credit graduate student Alex Gorelick, who was working in both my and Barrys labs, with coming up with the idea to look at how common composite mutations are and what they may mean. Mr. Gorelick is first author on the Nature paper.
The team was able to make this discovery thanks to data from MSK-IMPACT, a diagnostic test that helps match people with cancer to the best treatment based on the genetic changes in their tumors. This test, which has been used since 2014, has now analyzed more than 50,000 tumors, giving researchers a lot of data to work with.
One special thing about MSK-IMPACT data is that its very deep and contains a lot more information than other sequencing platforms, Dr. Reznik says. That makes it well suited to doing this kind of detailed analysis.
Now that the researchers know about composite mutations, the next step is to determine what they might mean for individual cancers. One study that came out last year in Science, published by MSK cancer biologist Maurizio Scaltriti and colleagues, found that breast cancers with composite mutations in the gene PIK3CA may respond better to targeted therapy than breast cancers in which only one PIK3CA mutation is present.
However, with other cancers and other mutations, its possible that composite mutations may make them harder to treat.
This gives us a tremendous opportunity to look at the function of these mutations in a different way.
Theres still so much we dont understand about composite mutations. Rather than creating frustration, knowing of their existence leads to new opportunities, concludes Dr. Taylor, who is an Associate Director of the Marie-Jose & Henry R. Kravis Center for Molecular Oncology. This gives us a tremendous opportunity to look at the function of these mutations in a different way and learn something fundamental about cancer genes that we may not have appreciated before.
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Double Trouble: Researchers Find Many Cancers Carry Two Mutations in the Same Gene - On Cancer - Memorial Sloan Kettering
Troubleshooting the Development of New Gene Therapies – Technology Networks
Gene therapy does more than treat genetic diseases it can cure them. A one-time dose of a non-replicative viral vector, such as commonly used recombinant adeno-associated virus (AAV), delivers a functional gene to replace or compensate for a dysfunctional version that is causing a patients disease (Figure 1). As a cutting-edge biopharmaceutical technology, there are multiple gene therapies now FDA approved; with hundreds more in clinical trials, were likely to see many more of these therapies on the market soon.1 However, to keep up with the rapid pace of clinical research, developers are working to streamline the manufacturing and quality control process to improve quality and lower the cost of bringing these important drugs to market.Developers use a multitude of analytical tests to develop gene therapies and optimize their manufacturing process. When developers get aberrant test results, they must be able to interpret where the problem lies. Did the manufacturing process produce an undesirable product, or is the analytical testing method unreliable? Analytical testing companies that have the infrastructure, personnel, and experience often partner with developers to tighten up analytical variability so that results of tests clearly indicate where there are opportunities to increase efficiency and product quality.
Figure 1. Gene delivery by recombinant viral vector.During gene therapy, viral capsids containing the therapeutic gene are taken up by the patients cells and the genetic material is delivered to the nucleus. There, the gene gets expressed as a protein necessary for the patients health. Credit: Avomeen.
Figure 2. A full AAV capsid and associated capsid impurities. Complete viral capsids have AAV are assembled from 60 capsid proteins, with a defined stoichiometry and shape and contain a therapeutic gene. AAV vector impurities include capsids that contain too many copies of the gene (overfilled), those that contain lower copy numbers or truncations of the gene (partially full), or empty capsids that contain no genetic material. Credit:Avomeen.
There are several ways to measure the empty/full capsid ratio, and as developers are establishing their chemistry, manufacturing and control (CMC) protocol, it is important that they choose an optimized method, as they must use that method for effective quality control from early process development to lot release and stability.3 Gene therapy developers may choose analytical ultracentrifugation to evaluate capsids, but while highly effective, this method is not as quantitative, robust or efficient as some newer methods. High-performance liquid chromatography (HPLC) using AAV full/empty analytical columns have been demonstrated to be highly effective at separating full, empty, and improperly filled capsids for robust quantification. Additionally, this method is higher throughput than ultracentrifugation, and requires less precious AAV sample to run.
Cellular potency is evaluated by transducing cells with the AAV product and then measuring a phenotypic or functional outcome due to the transduction. Developing these tests can be challenging because there is no one-size-fits-all test that will give developers the answers they need. Developers often draw on the experience of analytical labs to determine how to best evaluate their AAV products transduction efficiency.A gene therapy in development must also be tested to ensure that it is free of residual, process-related impurities such as polyethylenimine, iodixanol, poloxamer, and other excipients that must be removed in the final product to ensure safety. Few research and manufacturing facilities have the equipment and expertise necessary to perform this kind of testing, and it is advisable to find one that has experience testing polymers, extractables and leachables to examine if components of the manufacturing equipment or drugs packaging are not contaminating the final product.
As fast-paced as the gene therapy field is now, it stands to become a true race to the finish line to bring new gene therapies to market in the near future. Regulatory bodies are becoming more familiar with reviewing gene therapies, and the road to commercialization will move more quickly. There is no denying that gene therapies will bring incredible benefits to patients, but it will be crucial to improve manufacturing efficiency and lower costs to make gene therapies more accessible to the patients who need them.References
1. Colasante, W., Diesel, P., and Gerlovin, Lev. (2018). New Approaches To Market Access And Reimbursement For Gene And Cell Therapies. Cell & Gene. Retrieved from: https://www.cellandgene.com/doc/new-approaches-to-market-access-and-reimbursement-for-gene-and-cell-therapies-0001
2. Fraser Wright, J. (2014). Product-Related Impurities in Clinical-Grade Recombinant AAV Vectors: Characterization and Risk Assessment. Biomedicines, 2, 80-97; doi:10.3390/biomedicines2010080
3. U.S. Food & Drug Administration (2019). Guidance for Human Somatic Cell Therapy and Gene Therapy. Retrieved from: https://www.fda.gov/animal-veterinary/guidance-industry/chemistry-manufacturing-and-controls-cmc-guidances-industry-gfis
4. Stein, R. (2019). At $2.1 Million, New Gene Therapy Is The Most Expensive Drug Ever. NPR. Retrieved from: https://www.npr.org/sections/health-shots/2019/05/24/725404168/at-2-125-million-new-gene-therapy-is-the-most-expensive-drug-ever
5. Cohen, J.T, Chambers, J. D., Silver, M. C., Lin, P., Neumann, P.J. (2019). Putting The Costs And Benefits Of New Gene Therapies Into Perspective. Health Affairs. Retrieved from: https://www.healthaffairs.org/do/10.1377/hblog20190827.553404/full/
6. ATCC (accessed May, 2020) ATCC Virus Reference Materials. Retrieved from: https://www.atcc.org/en/Standards/Standards_Programs/ATCC_Virus_Reference_Materials.aspx#
7. U.S. FDA (2020). FDA Details Policies on Gene Therapies in Seven Guidances. Retrieved from: https://www.fdanews.com/articles/195767-fda-details-policies-on-gene-therapies-in-seven-guidances
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Troubleshooting the Development of New Gene Therapies - Technology Networks
What Sanofi Might Buy With Its Regeneron Windfall – Barron’s
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Sanofi is about to have $11.7 billion burning a hole in its pocket. What might it buy?
Days after the French drug giant announced that it would sell its stake in the biotech company Regeneron Pharmaceuticals (ticker: REGN), speculation is growing on whether the company might pursue an acquisition or two in the coming months.
Sanofi (SNY) has not said what it plans to do with the proceeds of its sale of 21.6 million shares of Regeneron. In a statement, the company said it would use the proceeds to further execute on its strategy to drive innovation and growth.
Still, Sanofis new CEO, Paul Hudson, said in December that the company would consider future deals: We are open-minded and interested, he said at the time. In January, Sanofi completed the acquisition of the cancer drug developer Synthorx for $2.5 billion.
Sanofi appears to be taking advantage of the strong liquidity in biotech equity markets, and in REGN in particular, to accelerate the implementation of their strategy, and we do not expect them to sit on their new capital, SVB Leerink analyst Geoffrey Porges wrote in a note on Tuesday.
Porges suggested that the company could be looking for a gene therapy company to acquire.
We certainly expect a M&A deal of decent size ($5bn) in the coming months for Sanofi, he wrote.
In another note Tuesday, Citi Research analyst Mohit Bansal wrote that the gene therapy company BioMarin Pharmaceutical (BMRN) was an unlikely target for Sanofi. Bansal said that BioMarin does not fit with previous comments from Sanofi about their acquisition interests, noting that the company has indicated a preference toward smaller companies, and away from the crowded hemophilia gene therapy race in which BioMarin is a lead contender. BioMarins market value is $18.8 billion.
Gene therapy companies with market value closer to the $5 billion range include bluebird bio (BLUE), which has a market value of $3.6 billion, and Ultragenyx Pharmaceutical (RARE), which has a market value of $4.4 billion.
Sanofi had some $10.3 billion in cash and cash equivalents on hand as of the end of 2019. The company did not immediately respond to a request for comment.
Shares of Sanofi are down 6.8% so far this year, and on Wednesday morning were trading down 1%. The stock trades at 13.4 times earnings projected over the next 12 months, close to its five-year average of 13.5 times earnings.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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What Sanofi Might Buy With Its Regeneron Windfall - Barron's
Benchling, BERG, Thermo Fisher Scientific, And More: News From May 2020 – Bio-IT World
May 27, 2020 |May featured exciting new, products, and partnerships from around the bio-IT community from innovating companies, organizations, and universities, including Benchling, BERG, Thermo Fisher Scientific, and more.
Benchlingannounced the launch ofBenchling Insights, a new solution that gives life sciences companies the ability to query, visualize and collaborate around high quality, structured data that resides on the platform. While the biotech industry continues to grow, companies are faced with increased competition, patent expirations and increased scrutiny over pricing and efficacy. Biotech companies are under immense pressure to deliver new products into clinical evaluation faster than ever, which requires disciplined execution, a high degree of collaboration and unfettered access to data across the R&D lifecycle, saidSaji Wickramasekara, CEO and Co-Founder of Benchling, in a press release. We launched Benchling Insights so that our customers can make intelligent decisions with a complete view of their experimental and operational data. Analyses and dashboards can be rapidly created and shared across programs, teams, and leadership so companies can reach breakthroughs faster. Benchling Insights extends the Benchling Life Sciences R&D Cloudwith an integrated solution for data querying, visualization, and collaboration. Scientists can tailor advanced queries to visualize scientific and operational metrics, and use these to quickly answer key questions about their programs. For example, they can assess which cell lines generate the best assay performance, or which process variants lead to optimal outputs. R&D leaders can use centralized data to track overall pipeline performance and remove operational bottlenecks, while IT leaders can track product utilization and compliance. Press release
BERGannounced a new collaboration with Boehringer Ingelheimaround understanding the multifaceted nature of the spectrum of inflammatory diseases and seeks to unravel the associated biological drivers. The pilot program with Boehringer Ingelheim will work to reveal novel insights into the complexities of various inflammatory diseases. The potential outcomes of this partnership could lead to a broader understanding of the etiology of potential candidate biomarkers. BERG has previously collaborated with multiple pharmaceutical companies and applied its Interrogative Biologyplatform to diverse datasets to address major clinical unmet needs. Were excited to partner with Boehringer Ingelheim, which will combine Boehringer Ingelheim's translational medicine and biomarker expertise with BERGs next generation AI-driven, patient-biology capability, Niven R. Narain, BERG Co-founder, President and Chief Executive Officer, said in a press release. Our intent is for BERGs Interrogative Biology platform to enable the discoveryofbiomarkersthat willrevolutionize how to diagnose and treat patients with inflammatory diseases. Press release
Thermo Fisher Scientificreleased the Thermo Scientific Helios 5 Laser PFIBsystem, an advanced focused ion beam scanning electron microscope (FIB-SEM) with a fully integrated femtosecond laser that quickly characterizes millimeter-scale volumes of material in 3D with nanometer resolution. The Helios 5 Laser PFIB combines the best-in-class Thermo Scientific Elstar SEM Columnfor ultra-high-resolution imaging and advanced analytical capabilities with a plasma FIB column for top performance at all operating conditions, and a femtosecond laser that enables in-situ ablation at material removal rates not previously obtained by a commercially available product. The Helios 5 Laser PFIB is part of the fifth generation of the industry-leading Helios family. The Helios 5 Laser PFIB dramatically accelerates the pace of research for both academic and industrial users, allowing them to characterize materials in a matter of minutes versus the days it took before,Rosy Lee, vice president of materials science at Thermo Fisher, said in a press release. Not only can researchers quickly and accurately image statistically relevant, site-specific, millimeter-size cross-sections at nanoscale resolution, they can also set up large-volume 3D analyses to be automatically completed overnight, freeing up the microscope for other uses. The Helios 5 Laser PFIB allows researchers to obtain accurate large-volume 3D and sub-surface data up to 15,000 times faster than a typical Gallium ion source focused ion beam (Ga-FIB). For many materials, a large cross-section of hundreds of microns can be milled by the Helios 5 Laser PFIB in less than 5 minutes. Serial-section tomography is now possible with this combination of Laser and Plasma FIB, and when combined with EDS and EBSD detectors, can be extended to 3D elemental and grain orientation analysis at the millimeter scale. Press release
Following the recent launch of NVIDIAs new DGX A100system, NetApp ONTAP AIannounced it will be among the first converged AI stacks to incorporate the DGX A100 and NVIDIA Mellanox networking. NetApp and NVIDIA have been collaborating for several years to deliver AI solutions that help enterprises accelerate AI adoption. Both companies are working on eliminating AI bottlenecks and advancing the realm of possibilities, Kim Stevenson, Sr. Vice President and General Manager, Foundational Data Services Business Unit, NetApp, said in an official statement. NetApps full stack AI/ML/DL platforms delivered at the edge, core and cloud with ONTAP AI complements NVIDIAs rapidly expanding ecosystem of AI hardware, software, and development toolkits. Blog post
Advanced Biological Laboratories (ABL)announced the CE-IVDmarking of its DeepChek-HIVAssays is now available for in-vitro diagnostics. Intended to be used on HIV-1 Group M viruses from patients diagnosed with HIV infection, the assays deliver standardized, open and flexible solution suited to clinical settings performing sequencing through Capillary Electrophoresis and Next Generation Sequencing (NGS) systems. The DeepChek-HIV CE IVD Assays are covering respectively the Protease / Reverse Transcriptase and the Integrase regions of the virus and are intended to be used from input RNA extracted from plasma, serum or whole blood samples. Both assays are highly sensitive and have been validated to process clinical samples as low as 1,000 copies/mL with outstanding performances (100% agreement of analytical reproducibility and repeatability, 100% clinical reproducibility, 99% clinical sensitivity) in all three regions. Open and flexible, the DeepChek-HIV CE IVD Assays is a unique and versatile system that can be used under a large variety of laboratory throughput configurations. Obtaining CE IVD marking for our DeepChek-HIV assays will allow virology labs to access a unique and innovative technology, for HIV genotyping diagnostics. ABL will keep standardizing its entire portfolio of applications in virology and microbiology following European and International guidelines to improve the management of patients suffering from chronic diseases on a worldwide basis, Chalom Sayada, CEO of ABL, said in an official statement. Press release
Cardinal Healthand Vinetiannounced a collaboration to support cell and gene therapy manufacturers with a fully integrated solution that aligns logistics and commercialization services with digital Chain of Identityand Chain of Custodythroughout the treatment journey. Cardinal Healthsupports the cell and gene therapy market with a robust suite of services that includes end-to-end logistics, regulatory strategy, order-to-cash management and patient access and support services. Vineti offers a digital platform of record to integrate logistics, manufacturing and clinical data for cell and gene therapies. The Vineti platform delivers digital Chain of Identity and Chain of Custody, providing essential patient safety and regulatory compliance across the value chain.Together, Cardinal Health and Vineti will develop best-in-class solutions to support the distribution of transformative, personalized therapies for cancer and other serious diseases.Specifically, Cardinal Health and Vineti will focus on integrated solutions that enable cell and gene therapy manufacturers to accelerate the commercialization of their products, while delivering a more simple, seamless and secure experience to hospitals and patients, from initial patient enrollment through delivery of the final dose of therapy and beyond. Press release
Immunailaunched out of stealth to map the entire immune system for better detection, diagnosis, and treatment of disease. Leveraging single-cell technologies and machine learning algorithms, Immunai has mapped out millions of immune cells and their functions, building the largest proprietary data set in the world for clinical immunological data. The company is also announcing $20M in seed funding, which will be used to further the development of its technology and business functions while expanding its team of scientists, engineers, and machine learning experts. Cell therapies and cancer immunotherapies have revolutionized medicine in the last few years and are expected to continue for the near future. However, due to the incredible complexity of the immune systemits trillions of cells partitioned into hundreds of cell types and states and how they interplay with other cells and proteinsit is prohibitively hard to predict how drugs will affect immune cells. For cell therapies with high manufacturing costs, a slight variation in cell therapy products can have a significant influence on a patients response to the therapy.Immunai has developed a vertically-integrated platform for multi-omic single-cell profiling that offers a broader view of the immune system in states of health, disease, and treatment to examine the bodys response to stimulus. With Immunais platform, pharmaceutical companies can identify more subtle nuances in cell abundances and cell function and mechanisms of action and biomarkers for toxicity response to accurately measure the efficacy of immunotherapies. For cell therapies, in particular, Immunai partners with cell therapy companies to understand cellular products sub-populations in unprecedented detail before and after infusion.Press release
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Benchling, BERG, Thermo Fisher Scientific, And More: News From May 2020 - Bio-IT World
ElevateBio to Present at the Jefferies Virtual Healthcare Conference – Business Wire
CAMBRIDGE, Mass.--(BUSINESS WIRE)--ElevateBio, LLC, a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies, announced that the company will present at the Jefferies Virtual Healthcare Conference on Thursday, June 4, 2020 at 8:30 a.m. ET.
About ElevateBio
ElevateBio, LLC, is a Cambridge-based creator and operator of a portfolio of innovative cell and gene therapy companies. It begins with an environment where scientific inventors can transform their visions for cell and gene therapies into reality for patients with devastating and life-threatening diseases. Working with leading academic researchers, medical centers, and corporate partners, ElevateBios team of scientists, drug developers, and company builders are creating a portfolio of therapeutics companies that are changing the face of cell and gene therapy and regenerative medicine. Core to ElevateBios vision is BaseCamp, a centralized state-of-the-art innovation and manufacturing center, providing fully integrated capabilities, including basic and transitional research, process development, clinical development, cGMP manufacturing, and regulatory affairs across multiple cell and gene therapy and regenerative medicine technology platforms. ElevateBio portfolio companies, as well as select strategic partners are supported by ElevateBio BaseCamp in the advancement of novel cell and gene therapies.
ElevateBios investors include F2 Ventures, MPM Capital, EcoR1 Capital, Redmile Group, Samsara BioCapital, The Invus Group, Surveyor Capital (A Citadel company), EDBI, and Vertex Ventures HC.
ElevateBio is headquartered in Cambridge, Mass, with ElevateBio BaseCamp located in Waltham, Mass. For more information, please visit http://www.elevate.bio.
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ElevateBio to Present at the Jefferies Virtual Healthcare Conference - Business Wire
European regulators accept FibroGen’s anemia drug for review; Passage Bio’s lead gene therapy gets more love from the FDA – Endpoints News
Gilead CEO Dan ODay has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosens Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..
Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. ODay also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. Theres $500 million in potential TIGIT milestones on US regulatory events likely capped by an approval if Gilead partners on it and the stars align on the data. And theres another $150 million opt-in payments for the rest of the Arcus pipeline.
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European regulators accept FibroGen's anemia drug for review; Passage Bio's lead gene therapy gets more love from the FDA - Endpoints News
TCR Therapeutics Hires Key Business Development and Regulatory Affairs Cell Therapy Experts to Support Strategic Objectives – GlobeNewswire
CAMBRIDGE, Mass., May 27, 2020 (GLOBE NEWSWIRE) -- TCR2 Therapeutics Inc. (Nasdaq: TCRR), a clinical-stage immunotherapy company developing the next generation of novel T cell therapies for patients suffering from cancer, today announced an expansion of its leadership team to strengthen expertise in business development and regulatory affairs as the Company advances the development of TRuC-T cells addressing solid tumors and hematological malignancies.
As we position TCR2 for our next phase of growth and value creation, we are pleased to announce the addition of experienced leaders in two key competencies business development and regulatory affairs, said Garry Menzel, Ph.D., President and Chief Executive Officer of TCR2 Therapeutics. Clinical progress and the execution of strategic partnerships are important priorities for the Company and having the right expertise in both domains is critical for our success.
Gregg McConnell brings considerable experience to the business development role after his successful tenures at Pfizer and BlueRock Therapeutics, an engineered cell therapy company purchased by Bayer AG for $1.0 billion. He will lead our effort to deliver significant value from the innovation and progress of our TRuC-T cells through deals with strategic partners, added Dr. Menzel.
Viera Muzithras brings very specific cell therapy experience to TCR2, from leading the development of multiple myeloma assets at Bristol Myers Squibb to the global regulatory strategy for Kymriah while at Novartis, ultimately leading to its approval by the FDA, said Alfonso Quints, M.D., Chief Medical Officer of TCR2 Therapeutics. Her deep expertise will be critical as we advance our two current TRuC-T cell programs in the clinic, TC-210 and TC-110, and file an IND for our third CD70-targeted mono TRuC program.
Gregg McConnell joins TCR2 as Head of Business Development. Most recently, he served as Vice President and Head of Business Development at BlueRock Therapeutics, a leading engineered cell therapy company which was acquired by Bayer AG for an implied value of up to $1.0 billion. At BlueRock, he held numerous responsibilities including leading business development and partnering activities for a pipeline of allogeneic cell therapy programs in neurology, cardiology and immunology. Prior to BlueRock, Gregg held several business development and corporate strategy roles at Pfizer, including Senior Director of Worldwide Business Development, where he led and co-managed the execution of buy- and sell-side transactions across multiple structures, development stages and therapeutic areas, including oncology, immunology and gene therapy.
Viera Muzithras joins TCR2 as Vice President of Regulatory Affairs. With over 25 years of global regulatory experience focusing on cell and gene therapy, oncology and vaccines, she most recently served as Executive Director of Global Regulatory Affairs at Bristol Myers Squibb (formerly Celgene Corporation), where she oversaw the development of novel cell and gene therapy products, biologicals such as T-cell engagers and antibody drug conjugates, and small molecules for hematologic diseases in multiple myeloma. Prior to Bristol Myers Squibb, Viera worked at Novartis Pharmaceuticals as Senior Director of Regulatory Affairs and Global Regulatory Director, where she was responsible for leading the global regulatory strategy and preparation and submission of the New Biologics License Application for Kymriah, a genetically modified autologous T cell immunotherapy targeting CD19. Earlier in her career, Viera served in various regulatory affairs roles at Bayer AG, Sanofi S.A., and Pfizer.
About TCR2 Therapeutics
TCR2Therapeutics Inc.is a clinical-stage immunotherapy company developing the next generation of novel Tcell therapies for patients suffering from cancer.TCR2sproprietary T cell receptor (TCR) Fusion Construct Tcells (TRuC-T cells) specifically recognize and kill cancer cells by harnessing signaling from the entire TCR, independent ofhuman leukocyte antigens (HLA). In preclinical studies, TRuC-T cells have demonstrated superior anti-tumor activity compared to chimeric antigen receptor T cells (CAR-T cells), while exhibiting lower levels of cytokine release. The Companys lead TRuC-T cell product candidate targeting solid tumors, TC-210, is currently being studied in a Phase 1/2 clinical trial to treat patients with mesothelin-positive non-small cell lung cancer (NSCLC), ovarian cancer, malignant pleural/peritoneal mesothelioma, and cholangiocarcinoma. The Companys lead TRuC-T cell product candidate targeting hematological malignancies, TC-110, is currently being studied in a Phase 1/2 clinical trial to treat patients with CD19-positive adult acute lymphoblastic leukemia (aALL) and with aggressive or indolent non-Hodgkin lymphoma (NHL). For more information about TCR2, please visitwww.tcr2.com.
Forward-looking Statements
This press release contains forward-looking statements and information within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. These forward-looking statements include, but are not limited to, express or implied statements regarding the pre-clinical and clinical development of the Companys TRuC-T cells, potential collaborations and strategic partnerships, the future value of the Companys TRuC-T cell platform, the Companys pre-clinical and clinical regulatory strategy and planned IND filings for the Companys third mono TRuC-T cell program.
The expressed or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities, including review under accelerated approval processes; orphan drug designation eligibility; regulatory approvals to conduct trials or to market products; TCR2s ability to maintain sufficient manufacturing capabilities to support its research, development and commercialization efforts, whether TCR2's cash resources will be sufficient to fund TCR2's foreseeable and unforeseeable operating expenses and capital expenditure requirements, the impact of the COVID-19 pandemic on TCR2s ongoing operations; and other risks set forth under the caption "Risk Factors" in TCR2s most recent Annual Report on Form 10-K, most recent Quarterly Report on Form 10-Q and its other filings with theSecurities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although TCR2believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur.
Moreover, except as required by law, neither TCR2nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.
Investor and Media Contact:
Carl MauchDirector, Investor Relations and Corporate CommunicationsTCR2 Therapeutics Inc.(617) 949-5667carl.mauch@tcr2.com
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TCR Therapeutics Hires Key Business Development and Regulatory Affairs Cell Therapy Experts to Support Strategic Objectives - GlobeNewswire
Poietis Announces Formation of Scientific Advisory Board and Appoints Two First Prominent Regenerative Medicine Experts – BioSpace
Pessac, France Poietis, 4D Bioprinting company, announces formation of Scientific Advisory Board (SAB) and appointment of two first prominent Scientists in Regenerative Medicine. The SAB will serve as a key strategic resource to Poietis as the company expands capabilities of NextGeneration Bioprinting (NGB) platform to therapeutic applications and develops first implantable tissues such as a bioprinted skin substitute in collaboration with the Assistance Publique Hpitaux de Marseille. Poietis appoints Dr. Geoffrey Gurtner, MD, Johnson and Johnson Professor of Surgery, Professor of Materials Science and Engineering at Stanford University and Vice-Chairman of Surgery for Innovation at Stanford University School of Medicine (California, United States) and Dr. Michael H. May, President & CEO of the Center for Commercialization of Regenerative Medicine (CCRM) at Toronto (Canada).
The formation of Poietis SAB is a very important step towards company global deployment in the clinical area says Bruno Brisson, Poietis co-founder and VP Business Development. We are delighted to welcome Dr. Gurtner and Dr. May to our SAB, where they will be key contributors in further enhancing our efforts to bring bioprinting solutions to clinicians and patients with high unmet needs.
To have Dr. Gurtner, a world-renowned expert in tissue-engineering therapies for skin wound healing, join our SAB will enrich our R&D efforts to achieve the first-in-human of a bioprinted skin substitute in the coming years adds Dr. Fabien Guillemot, CEO and Poietis founder. We also believe Dr. May will prove invaluable to Poietis leadership team, and we look forward to his insights and guidance to accelerate the advancement of our bioprinting platform technology to address the key challenges in tissue manufacturing and regenerative medicine.
3D bioprinting is a once-in-a-generation transformative technology. By focusing its 3D printing platform on a clinical application of high unmet need, Poietis is leading the adoption of 3D printing in cell therapy and tissue engineering comments Dr. Michael H. May, PhD, President & CEO of the CCRM.
Dr. Geoffrey Gurtner, MD, is Johnson and Johnson Professor of Surgery and Professor of Materials Science and Engineering at Stanford University, California; USA. He currently serves as the Associate Chairman for Research in the Department of Surgery and is the Executive Director of the Stanford Wound Care Center.
Geoff is a magna cum laude graduate of Dartmouth College and an AOA graduate of the University of California-San Francisco School of Medicine. He completed a general surgery residency at Massachusetts General Hospital, a plastic surgery residency at NYU School of Medicine and received advanced training in microsurgery at the University of Texas-MD Anderson Cancer Center. He is board certified in both general surgery and plastic surgery. He is the author of over 180 peer-reviewed publications in both scientific and surgical literature and editor for two major textbooks in the field: Grabb & Smiths Plastic Surgery and Plastic Surgery. Geoff was awarded the James Barrett Brown Award (for best paper in plastic surgery) in both 2009 and 2010, and has been named Researcher of the Year by the American Society of Plastic Surgeons and the American Association of Plastic Surgeons. His research has led to the development of several novel biomedical technologies. Geoff has co-founded several start-ups focused on wound healing, aesthetics and cardiovascular health.
Dr. Michael May completed his PhD in Chemical Engineering at the University of Toronto in 1998 as an NSERC Scholar and was awarded the Martin Walmsley Fellowship for Technological Entrepreneurship. He is President and Chief Executive Officer of the Center for Commercialization of Regenerative Medicine (CCRM) a Canadian public-private partnership supporting the translation and commercialization of cell & gene therapies and associated enabling technologies through stakeholder networks and with specialized teams, infrastructure and funding. He is also CEO of CCRM Enterprises, the venture creation and investment arm of CCRM.
Prior to CCRM, Michael was the President and co-founder of Rimon Therapeutics Ltd., a Toronto-based tissue engineering company developing novel medical polymers that possess drug-like activity. Rimons initial focus was on advanced wound healing. Michael sits on a number of boards and advisory committees, including: the Entrepreneurship Leadership Council at the University of Toronto; the Commercialization Committee of the International Society for Cell and Gene Therapy, the Alliance for Regenerative Medicine Foundation, CellCan and AgeX Inc. He is Chair of ExcellThera and co-moderates sessions in the health streams of the Creative Destruction Labs.
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About Poietis: Bioprinting company specializing in the development of new biomanufacturing solutions, based on Laser-Assisted Bioprinting, for human tissues. Poietis mission is to provide clinicians and patients with tissue engineering therapies thanks to its innovative, proprietary Next-Generation Bioprinting platform (NGB). The multimodal NGB platform is declined in two versions: one for in vitro tissue engineering research (NGB-R) and a clinical version (NGB-C) for the production of implantable bioprinted tissues. This multi-modal, automated biomanufacturing platform enables researchers to achieve superior tissue through high resolution, and enables the fabrication of complex tissues with repeatability and reproducibility. Poietis bioprinting technology is the result of innovative research carried out over ten years at Inserm and the University of Bordeaux. Poietis won the iLab competition in 2014, the World Innovation Challenge Phase II in 2017 and recently the EY Disruptive Strategy Award. The company currently employs 35 people. More information: http://www.poietis.com Contact : bruno.brisson@poietis.com
Covid-19 Impact On Global Gene Therapy Products Market 2020 : Industry Trends, Size, Growth, Swot Analysis By Top Key Players And Forecast Report To…
The chapter of global growth trends of this Gene Therapy Products Market business report includes industry tendencies, the growth proportion of major producers, and production analysis while studying market size by application. It covers market consumption analysis by application and studies market size by type, analysis of value, product utility, market percentage & production market share by type. Analysis of profiles of manufacturers or commanding players of the global market is performed based on sales area, key products, gross margin, revenue, price, and production. Market value chain and sales channel analysis of this market document includes details of customer, distributor, market value chain, and sales channel analysis.
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Global gene therapy products market is set to witness a substantial CAGR in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. Rising cancer cases and unused potential for emerging markets are the major factors for the growth of this market.
Few of the major competitors currently working in the globalgene therapy products marketareAdaptimmune., Anchiano Therapeutics, bluebird bio, Inc., CELGENE CORPORATION, GlaxoSmithKline plc., Merck KGaA, Novartis AG, Achieve Life Sciences, Inc., Spark Therapeutics, Inc., Abeona Therapeutics, Inc, Adverum, agtc, Arbutus Biopharma, Audentes Therapeutics, AveXis, Inc., CRISPR Therapeutics, Intellia Therapeutics, Inc and Gilead Sciences,Inc. among others.
Market Definition:Global Gene Therapy Products Market
Gene therapy or human gene therapy is a process which is used to modify gene for the treatment of any disease. Plasmid DNA, bacterial vector, human gene editing technology and viral vectors are some of the most common type of gene therapy products. The main aim of the gene therapy is to replace the dysfunctional genes. Somatic and germline are some of the most common type of the gene therapy.
Complete report on Global Gene Therapy Product Market Research Report 2019-2026 spread across 350 Pages, profiling Top companies and supports with tables and figures
Segmentation: Global Gene Therapy Products Market
Gene Therapy Products Market : By Product
Gene Therapy Products Market : By Application
Gene Therapy Products Market : ByGeography
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Key Developments in the Gene Therapy Products Market:
Gene Therapy Products Market Drivers
Gene Therapy Products Market Restraints
Competitive Analysis: Gene Therapy Products Market
Global gene therapy products market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of gene therapy products market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.
Key questions answered in the report :-
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COVID-19 Impact on GENE THERAPY MARKET EXPECTED 2020 WITNESS A SUSTAINABLE GROWTH OVER 2027 WITH SANGAMO THERAPEUTICS, INC., BLUEBIRD BIO, UNIQURE NV,…
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MARKET INTRODUCTION
Gene therapy is the introduction of DNA into a patient to treat a genetic disease or a disorder. The newly inserted DNA contains a correcting gene to correct the effects of a disease, causing mutations. Gene therapy is a promising treatment for genetic diseases and also includes cystic fibrosis and muscular dystrophy. Gene therapy is a suitable treatment for infectious diseases, inherited disease and cancer.
MARKET DYNAMICSThe growth of the gene therapy market is regulated due to various reason which includes the rapid involvement of synthetically modified gene to treat various diseases, it helps in designing the personalized medicine, rise in the research and development of the gene therapy among the others. The gene therapy requires less doses of medicines and is one time treatment, this factor is likely to show growth opportunity for gene therapy market in coming near future.
The report also includes the profiles of key gene therapy market companies along with their SWOT analysis and market strategies. In addition, the report focuses on leading industry players with information such as company profiles, components and services offered, financial information of last 3 years, key development in past five years.
Key Competitors In Market areSangamo Therapeutics, Inc., bluebird bio, Inc., uniQure N.V., AveXis, Inc., Vineti, Solid Biosciences., Spark Therapeutics, Inc., CHIMERON BIO, RENOVA THERAPEUTICS, HORAMA S.A.
TOC of Market Report Contains:
MARKET SCOPE
The Global Gene Therapy Market Analysis to 2027 is a specialized and in-depth study of the biotechnology industry with a special focus on the global market trend analysis. The report aims to provide an overview of gene therapy market with detailed market segmentation by cell type, application and geography. The global gene therapy market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading gene therapy market players and offers key trends and opportunities in the market.
Market segmentation:
Gene Therapy Market to 2027 Global Analysis and Forecasts by Cell Type (Somatic Gene Therapy, Germline Gene Therapy); By Application (Genetic Disorder, Cancer, Neurological Disorder, and Others)
By Geography North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. And 13 countries globally along with current trend and opportunities prevailing in the region.
Points Covered in The Report:
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COVID-19 Impact on GENE THERAPY MARKET EXPECTED 2020 WITNESS A SUSTAINABLE GROWTH OVER 2027 WITH SANGAMO THERAPEUTICS, INC., BLUEBIRD BIO, UNIQURE NV,...
The Economic Impact of Coronavirus on Gene Therapy for CNS Disorders Market : In-depth study on Industry Size and Analysis on Emerging Growth Factors…
Gene Therapy for CNS Disorders Market Insights 2018, is a professional and in-depth study on the current state of the global Gene Therapy for CNS Disorders industry with a focus on the Global market. The report provides key statistics on the market status of the Gene Therapy for CNS Disorders manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. Overall, the report provides an in-depth insight of 2018-2025 global Gene Therapy for CNS Disorders market covering all important parameters.
The report on the Gene Therapy for CNS Disorders market provides a birds eye view of the current proceeding within the Gene Therapy for CNS Disorders market. Further, the report also takes into account the impact of the novel COVID-19 pandemic on the Gene Therapy for CNS Disorders market and offers a clear assessment of the projected market fluctuations during the forecast period. The different factors that are likely to impact the overall dynamics of the Gene Therapy for CNS Disorders market over the forecast period (2019-2029) including the current trends, growth opportunities, restraining factors, and more are discussed in detail in the market study.
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The key points of the Gene Therapy for CNS Disorders Market report:
The report provides a basic overview of the Gene Therapy for CNS Disorders industry including its definition, applications and manufacturing technology.
The report explores the international and Chinese major industry players in detail. In this part, the report presents the company profile, product specifications, capacity, production value, and 2018-2025 market shares for each company.
Through the statistical analysis, the report depicts the global total market of Gene Therapy for CNS Disorders industry including capacity, production, production value, cost/profit, supply/demand and Chinese import/export.
The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.
The report then estimates 2018-2025 market development trends of Gene Therapy for CNS Disorders industry. Analysis of upstream raw materials, downstream demand, and current market dynamics is also carried out.
The report makes some important proposals for a new project of Gene Therapy for CNS Disorders Industry before evaluating its feasibility.
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There are 3 key segments covered in this report: competitor segment, product type segment, end use/application segment.
For competitor segment, the report includes global key players of Gene Therapy for CNS Disorders are included:
The key players covered in this studyGilead (Kite Pharma)Amgen (BioVex)NovartisRoche (Spark Therapeutics)Bluebird Bio
Market segment by Type, the product can be split intoEx VivoIn VivoMarket segment by Application, split intoHospitalsClinicsOthers
Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaJapanSoutheast AsiaIndiaCentral & South America
The study objectives of this report are:To analyze global Gene Therapy for CNS Disorders status, future forecast, growth opportunity, key market and key players.To present the Gene Therapy for CNS Disorders development in North America, Europe, China, Japan, Southeast Asia, India and Central & South America.To strategically profile the key players and comprehensively analyze their development plan and strategies.To define, describe and forecast the market by type, market and key regions.
In this study, the years considered to estimate the market size of Gene Therapy for CNS Disorders are as follows:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year 2020 to 2026For the data information by region, company, type and application, 2019 is considered as the base year. Whenever data information was unavailable for the base year, the prior year has been considered.
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Reasons to Purchase this Report:
* Estimates 2018-2025 Gene Therapy for CNS Disorders market development trends with the recent trends and SWOT analysis
* Market dynamics scenario, along with growth opportunities of the market in the years to come
* Market segmentation analysis including qualitative and quantitative research incorporating the impact of economic and policy aspects
* Regional and country level analysis integrating the demand and supply forces that are influencing the growth of the market.
* Competitive landscape involving the market share of major players, along with the new projects and strategies adopted by players in the past five years
* Comprehensive company profiles covering the product offerings, key financial information, recent developments, SWOT analysis, and strategies employed by the major market players
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The Economic Impact of Coronavirus on Gene Therapy for CNS Disorders Market : In-depth study on Industry Size and Analysis on Emerging Growth Factors...
MiNA Therapeutics Announces Publication of Phase I Liver Cancer Data in Clinical Cancer Research and Provides Update on Clinical Development and Drug…
LONDON--(BUSINESS WIRE)-- MiNA Therapeutics, the pioneer in RNA activation therapeutics, announced today the publication of data from its Phase I liver cancer trial, OUTREACH, in Clinical Cancer Research. It is the first publication in which a small activating RNA treatment (MTL-CEBPA) demonstrated clinical benefit. In addition, the Company provided an update on its ongoing clinical trials for lead program MTL-CEBPA and its drug discovery programs.
This landmark publication in Clinical Cancer Research details for the first time that RNA medicines can activate gene expression, providing clinical benefit to patients, commented Robert Habib, CEO of MiNA Therapeutics. As we enter into the second half of 2020, we continue to advance our clinical development objectives and uncover the vast opportunities inherent in our unique drug discovery pipeline.
Publication and OUTREACH Study Update
The publication in Clinical Cancer Research summarizes the results from MiNAs Phase I, open-label, dose escalation and dose expansion trial of MTL-CEBPA, OUTREACH, in adults with advanced Hepatocellular Carcinoma (HCC). Overall, MTL-CEBPA was well-tolerated and demonstrated pharmacodynamic target engagement, meeting the primary endpoint of the study. Furthermore, a reduction of suppressive immune cells in the tumour microenvironment as well as initial signs of potential synergistic efficacy when combined with standard of care tyrosine kinase inhibitors in HCC could be observed. These encouraging Phase I data validate the targeting of C/EBP- as a novel therapeutic strategy in cancer and prompted a Phase Ib study further evaluating MTL-CEBPA in combination with sorafenib in HCC. Enrolment for the Phase Ib part of the OUTREACH trial was completed in Q1 2020 and initial results will be presented during a poster session at the forthcoming American Society of Clinical Oncology (ASCO) on Friday, May 29, 2020. The framework for a subsequent Phase II clinical trial is currently being designed with the objective of initiating this next stage of clinical development in the second half of 2020.
The full Clinical Cancer Research publication is available on the Publications page of MiNAs website. A similar overview of the Phase I data was most recently presented at the European Society for Medical Oncology (ESMO) in September 2019.
TIMEPOINT Update
In March 2020, TIMEPOINT, a global Phase I/Ib clinical study of MTL-CEBPA in combination with anti-PD1 checkpoint inhibitor pembrolizumab in patients with advanced solid tumours was initiated and the first patient was treated. The study is designed to assess the safety, tolerability, pharmacology and clinical activity of MTL-CEBPA in combination with pembrolizumab in these patients. Recruitment for the study is expected to continue through 2021.
Discovery Programs
In parallel to the clinical trial developments, MiNA is further expanding its drug discovery pipeline with a focus on developing new drug candidates that can address a range of indications including genetic and metabolic diseases. Most recently in January 2020, MiNA validated its metabolic disease capabilities through the entry into a research collaboration with AstraZeneca, a global leader in the discovery and development of prescription medicines to treat metabolic diseases. MiNA remains well-positioned to build out its early-stage pipeline based on its saRNA approach which, through transcriptional activation, enables the modulation of previously undruggable targets.
About MTL-CEBPA
MTL-CEBPA is the first therapy to specifically up-regulate CCAAT/enhancer binding protein alpha (C/EBP-), a transcription factor that acts as a master regulator of myeloid cell lineage determination and differentiation. Dysregulated myeloid cells have been implicated in several diseases and identified as a critical barrier for many therapies to induce clinical responses in solid tumour cancers. In pre-clinical studies MTL-CEBPA has been shown to improve the anti-tumour activity of cancer therapies by targeting dysregulated myeloid cells and reducing their suppression in the tumour microenvironment.
About MiNA Therapeutics
Harnessing an innate mechanism of gene activation, MiNA Therapeutics' platform enables the development of new medicines that restore normal function to patients cells. We are applying our technology and clinical know-how to transform the therapy landscape of cancer and other severe diseases. http://www.minatx.com
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US Food and Drug Administration Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of…
DetailsCategory: AntibodiesPublished on Wednesday, 27 May 2020 10:34Hits: 305
In CheckMate -9LA, Opdivo + Yervoy combined with two cycles of chemotherapy demonstrated superior overall survival versus chemotherapy, regardless of PD-L1 expression or tumor histology1
Approval marks sixth indication for Opdivo + Yervoy-based combinations across five types of cancer
Two Opdivo + Yervoy-based combinations are now approved in first-line lung cancer
PRINCETON, NJ, USA I May 26, 2020 IBristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.1 The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.1 This application was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.2 On May 15, the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L11% as determined by an FDA-approved test.
Approval for Opdivo + Yervoy with limited chemotherapy is based on the pre-specified interim analysis from the Phase 3 CheckMate -9LA trial in which Opdivo + Yervoy combined with two cycles of platinum-doublet chemotherapy demonstrated superior overall survival (OS) versus chemotherapy (hazard ratio [HR] 0.69; 96.71% confidence interval [CI]: 0.55 to 0.87; P=0.0006) regardless of PD-L1 expression or tumor histology (minimum 8.1 months follow up).1,3 Median overall survival (mOS) was 14.1 months (95% CI: 13.2 to 16.2) versus 10.7 months (95% CI: 9.5 to 12.5), respectively.1 In a follow-up analysis at 12.7 months, the hazard ratio improved numerically to 0.66 (95% CI: 0.55 to 0.80), with mOS of 15.6 months (95% CI: 13.9 to 20.0) and 10.9 months (95% CI: 9.5 to 12.5).1,3 At one year, 63% of patients treated with Opdivo + Yervoy with limited chemotherapy and 47% of those treated with chemotherapy were still alive.3
Opdivo is associated with the following Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion-related reactions; embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1,4 Please see the Important Safety Information section below, including Boxed WARNING for Yervoy regarding immune-mediated adverse reactions.4
We have come a long way in understanding the role of dual immunotherapy-based approaches in cancer and the potential impact on patients long-term outcomes, said David P. Carbone, MD, PhD, CheckMate -9LA investigator and Director of the James Thoracic Oncology Center at The Ohio State University. The positive findings from CheckMate -9LA demonstrate the benefit of combining dual immunotherapy with limited chemotherapy for NSCLC patients regardless of PD-L1 status. With todays approval, more patients now have access to an Opdivo + Yervoy-based option and a chance at a longer life.1
In the trial, the overall response rate (ORR) per Blinded Independent Central Review (BICR) was 38% (95% CI: 33 to 43) for patients treated with Opdivo + Yervoy with limited chemotherapy and 25% (95% CI: 21 to 30) for patients treated with chemotherapy.
Non-small cell lung cancer is a complex disease that requires multiple treatment options to address the needs of different patient populations,5 said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb. This second approval of an Opdivo + Yervoy-based combination for the first-line treatment of advanced NSCLC now gives more patients access to a dual immunotherapy approach that can be administered with or without limited chemotherapy, depending on the patient and their PD-L1 status, and the possibility of a chance to live longer.1
Opdivo + Yervoy is a unique combination of immune checkpoint inhibitors, featuring a potentially synergistic mechanism of action that targets two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.1,4,6 Some of the T cells stimulated by Yervoy can become memory T cells, which may allow for a long-term immune response.6,7,8,9,10,11 Targeting of normal cells can also occur and result in immune-mediated adverse reactions, which can be severe and potentially fatal.1 Please see the Important Safety Information section, including Boxed WARNING for Yervoy (ipilimumab) regarding immune-mediated adverse reactions.4
Receiving a diagnosis of advanced lung cancer is devastating,12 said Andrea Ferris, president and chief executive officer, LUNGevity. Todays announcement is welcome news as it provides a new dual immunotherapy-based option for previously untreated patients searching for a treatment that may help extend their lives.1
This application is part of the FDAs Project Orbis initiative, enabling concurrent review by the FDA and the health authorities in Australia, Canada and Singapore.
About CheckMate -9LA
CheckMate -9LA (NCT03215706) is a Phase 3, randomized open-label, multi-center study evaluating Opdivo + Yervoy combined with two cycles of platinum-doublet chemotherapy versus platinum-doublet chemotherapy (four cycles followed by optional pemetrexed maintenance therapy if eligible) as a first-line treatment in patients with metastatic or recurrent NSCLC regardless of PD-L1 expression and histology.1 A total of 361 patients were treated with Opdivo + Yervoy with platinum-doublet chemotherapy until disease progression, unacceptable toxicity or for up to two years.1 A total of 358 patients were treated with platinum-doublet chemotherapy for four cycles and optional pemetrexed maintenance for non-squamous patients (if eligible) until disease progression or toxicity.1 The primary efficacy outcome measure of the trial was OS.1 Additional efficacy outcome measures included progression-free survival, ORR and duration of response as assessed by BICR.1
Select Safety Profile from CheckMate -9LA Study
Serious adverse reactions occurred in 57% of patients.1 Opdivo + Yervoy in combination with platinum-doublet chemotherapy were discontinued for adverse reactions in 24% of patients and 56% had at least one treatment withheld for an adverse reaction.1 The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis and respiratory failure.1 Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia and massive hemoptysis in the setting of thrombocytopenia.1 The most common (>20%) adverse reactions were fatigue (49%), musculoskeletal pain (39%), nausea (32%), diarrhea (31%), rash (30%), decreased appetite (28%), constipation (21%) and pruritus (21%).1
About Lung Cancer
Lung cancer is the leading cause of cancer death in the United States.12 The two main types of lung cancer are non-small cell and small cell.13 Non-small cell lung cancer is one of the most common types of lung cancer, and accounts for approximately 84% of diagnoses.13 Survival rates vary depending on the stage and type of the cancer when diagnosed.12
INDICATIONS
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations. For this indication, OPDIVO 3 mg/kg is administered every 2 weeks with YERVOY 1 mg/kg every 6 weeks.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), 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 overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING regarding immune-mediated adverse reactions for YERVOY.
Bristol Myers Squibb: Advancing Cancer Research
At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.
Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.
About Bristol Myers Squibbs Patient Access Support
Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.
BMS Access Support, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Support at 1-800-861-0048 or by visiting http://www.bmsaccesssupport.com.
About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.
Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.
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US Food and Drug Administration Approves Opdivo (nivolumab) + Yervoy (ipilimumab) Combined with Limited Chemotherapy as First-Line Treatment of...
COVID-19 Impact on Global Canavan Disease Market 2020: Industry Share, Size, Applications, Top Key Players and Forecast Research to 2026 – 3rd Watch…
TheGlobal Canavan Disease Marketwas estimated to be valued at USD XX million in 2019 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2019 to 2026.
Canavan disease is an autosomal recessive degenerative disorder that causes progressive damage to nerve cells in the brain. The market is primarily driven by increasing prevalence of life threatening cerebral diseases. However, lack of awareness and lack of skilled neurologist might impede the market growth.
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Development policies and plans are discussed as well as manufacturing processes and cost structures are also analyzed. This report also states import/export consumption, supply and demand Figures, cost, price, revenue and gross margins.
The key players profiled in the market include:Johnson & Johnson, GlaxoSmithKline plc., Novartis AG, Sanofi, F. Hoffmann-La Roche Ltd., Amgen, Inc., Turing Pharmaceuticals AG, Pfizer Inc., Aspa Therapeutics and BridgeBio
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Global Canavan DiseaseMarket is spread across 121 pages
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On the basis of types, the market is split into:
Based on applications, the market is divided into:
Moreover, the market is classified based on regions and countries as follows:
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Table Of Content
1 Introduction
2 Research Methodology
3 Executive Summary
4 Global Canavan Disease Market Overview
5 Global Canavan Disease Market, by Product Type
6 Global Canavan Disease Market, by Application
7 Global Canavan Disease Market by Region
8 Competitive Landscape
9 Company Profiles
10 Key Insights
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COVID-19 Impact on Global Canavan Disease Market 2020: Industry Share, Size, Applications, Top Key Players and Forecast Research to 2026 - 3rd Watch...
Hemophilia Gene Therapy Market 2020 by Global Industry Trends, Sales Revenue, Industry Growth, Development Status, Top Leaders, Future Plans and…
Magarpatta SEZ, Pune, ReportsnReportsprovides in depth study ofHemophilia Gene Therapy Marketusing SWOT analysis i.e. Strength, Weakness, Opportunities and Threat to the organisation. The Hemophilia Gene Therapy Market report also provides an in-depth survey of key players in the market which is based on the various objectives of an organisation such as profiling, the product outline, the quantity of production, required raw material, and the financial health of the organisation.
The global Hemophilia Gene Therapy Market is expected to witness a promising growth in the next few years. The rising level of competition among the leading players and the rising focus on the development of new products are likely to offer promising growth opportunities throughout the forecast period. The research study on the global Hemophilia Gene Therapy Market offers a detailed overview, highlighting the key aspects that are expected to enhance the growth of the market in the near future. The key segmentation and the competitive landscape of the market have also been mentioned at length in the research study.
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The global Hemophilia Gene Therapy Market is highly fragmented. Small market players operating at regional and local levels are challenging the market shares of the leading players (on the basis of cost differentiation and technical support services). In order to maintain their market shares, leading players are continuously developing new technologies and upgrading their existing products and services to enhance their product portfolios. Increasing competition is expected to drive innovation in the market, thereby helping the industry to overcome existing challenges in the field of healthcare mobility and at the same time address user compliance issues and unmet needs of the market.
Analysis on Strategies of Leading Players: Market players can use this evaluation to gain competitive advantage over their competition inside the global Hemophilia Gene Therapy Market.
Summary
Market OverviewThe global Hemophilia Gene Therapy market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.The Hemophilia Gene Therapy market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.
Market segmentationHemophilia Gene Therapy market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.By Type, Hemophilia Gene Therapy market has been segmented into Hemophilia A, Hemophilia B, etc.By Application, Hemophilia Gene Therapy has been segmented into Hemophilia A Gene Therapy, Hemophilia B Gene Therapy, etc.
Regions and Countries Level AnalysisRegional analysis is another highly comprehensive part of the research and analysis study of the global Hemophilia Gene Therapy market presented in the report. This section sheds light on the sales growth of different regional and country-level Hemophilia Gene Therapy markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Hemophilia Gene Therapy market.The report offers in-depth assessment of the growth and other aspects of the Hemophilia Gene Therapy market in important countries (regions), including United States, Canada, Mexico, Germany, France, United Kingdom, Russia, Italy, China, Japan, Korea, India, Southeast Asia, Australia, Brazil and Saudi Arabia, etc. It also throws light on the progress of key regional Hemophilia Gene Therapy markets such as North America, Europe, Asia-Pacific, South America and Middle East & Africa.
Competitive Landscape and Hemophilia Gene Therapy Market Share AnalysisHemophilia Gene Therapy competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Hemophilia Gene Therapy sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Hemophilia Gene Therapy sales, revenue and market share for each player covered in this report.The major players covered in Hemophilia Gene Therapy are: Spark Therapeutics, Freeline Therapeutics, Sangamo Therapeutics, Ultragenyx, uniQure, Shire PLC, BioMarin, Bioverativ, etc. Among other players domestic and global, Hemophilia Gene Therapy market share data is available for global, North America, Europe, Asia-Pacific, Middle East & Africa and South America separately. Global Info Research analysts understand competitive strengths and provide competitive analysis for each competitor separately.
The Hemophilia Gene Therapy Market industry development trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed, and overall research conclusions offered.
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This report studies the Hemophilia Gene Therapy Marketstatus and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Hemophilia Gene Therapy Marketby product type and applications/end industries. These details further contain a basic summary of the company, merchant profile, and the product range of the company in question. The report analyzes data regarding the proceeds accrued, product sales, gross margins, price patterns, and news updates relating to the company.
Other than the aforementioned parameters which Hemophilia Gene Therapy Market report focuses on, another imperative objective of the report is to present the Hemophilia Gene Therapy Market development across the globe especially in North America, Europe, China, Japan, Southeast Asia, India and Central and South America. In the report, the market has been categorized into manufacturers, type, application and regions.
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The report helps to identify the main Hemophilia Gene Therapy Marketplayers. It assists in analyzing Hemophilia Gene Therapy Market competitive environment, including company overview, company total revenue, market opportunities, value, production sites and facilities, SWOT analysis, product details. The study also reveals the sales, revenue and market share for each market player included in this report for the period of 2015-2020. It also helps to ascertain the growth drivers and future prospects for the forecast timeline.
Conclusively, this report is a one stop reference point for the industrial stakeholders to get Hemophilia Gene Therapy Marketforecast of till 2025. This report helps to know the estimated market size, market status, future development, growth opportunity, challenges, growth drivers of by analyzing the historical overall data of the considered market segments.
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Hemophilia Gene Therapy Market 2020 by Global Industry Trends, Sales Revenue, Industry Growth, Development Status, Top Leaders, Future Plans and...
Impact COVID-19 on Viral Vector & Plasmid DNA Manufacturing Market Along with Major Market Players | Merck, uniQure, The Cell and Gene Therapy…
Global Viral Vector & Plasmid DNA Manufacturing Market Report is a finished appraisal of current market Status, Opportunities, Trends, and individual pieces of the pie of the absolute most conspicuous players in this scene. The investigation contains mindful experiences, realities, chronicled information, and factually bolstered and industry-approved market information. This examination additionally investigates Business models, Key techniques, and Growth openings in the up and coming years.
The catchphrase showcase report looks at the financial status and anticipation of worldwide and significant areas, in the possibility all things considered, types and end-client application/ventures; this report analyzes the most striking players in major and worldwide locales, likewise partitions the Viral Vector & Plasmid DNA Manufacturing advertise by portions and applications/end organizations.
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Worldwide Viral Vector & Plasmid DNA Manufacturing Market bits of knowledge spread qualities, development, and size, division, provincial retreats, serious scene, pieces of the pie, patterns, and plans. The qualities part of this catchphrase report characterizes and clarifies the development. The Viral Vector & Plasmid DNA Manufacturing showcase size office gives industry income, covering the verifiable development of this and foreseeing the since quite a while ago run. Viral Vector & Plasmid DNA Manufacturing Drivers and limitations with the factors influencing the development of this market. The division isolate the fundamental catchphrase sub-businesses that structure the market.
Types are separated into:
Applications are separated into:
Noteworthy areas shrouded in this report:
North America, China, Rest of Asia-Pacific, UK, Europe, Central South America, Middle East Africa
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The Viral Vector & Plasmid DNA Manufacturing investigation consolidates authentic information from 2014 to 2019 and forecasts until 2025 assisting with making the reports an important asset for industry administrators, advancement, item and project leads, counselors, experts, and various individuals attempting to discover essential catchphrase industry information in promptly available records with unmistakably showed tables and diagrams.
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Impact COVID-19 on Viral Vector & Plasmid DNA Manufacturing Market Along with Major Market Players | Merck, uniQure, The Cell and Gene Therapy...
Cell and Gene Therapy Market Segmentation By Qualitative And Quantitative Research Incorporating Impact Of Economic And Non-Economic Aspects By 2027 |…
Global Cell and Gene Therapy Market
The Global Cell and Gene Therapy Market report consists of the latest discoveries and technological advancements recorded in the industry, along with an analysis of the factors and their effect on the markets future development. The report focuses on the current businesses and the present-day headways, and the future growth prospects for the Cell and Gene Therapy market.
This report covers the current COVID-19 effects on the economy. This outbreak has brought along drastic changes in world economic situations. The current scenario of the ever-evolving business sector and present and future appraisal of the effects are covered in the report as well.
The Global Cell and Gene Therapy market size will reach XX Million USD by 2027, from XX Million USD in 2019, at a CAGR of XX% during the forecast period.
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The global Cell and Gene Therapy marketreport gives a 360 approach for a holistic understanding of the market scenario. It relies on authentically-sourced information and an industry-wide analysis to predict the future growth of the sector. The study gives a comprehensive assessment of the global Cell and Gene Therapy industry, along with market segmentation, product types, applications, and value chain.
The study also delivers accurate insights into the market in the forecast duration and other key facts and figures pertaining to the global Cell and Gene Therapy market.
Leading Cell and Gene Therapy manufacturers/companies operating at both regional and global levels:
Amgen Inc., bluebird bio, Inc. Dendreon Pharmaceuticals LLC., Fibrocell Science, Inc., Human Stem Cell Institute, Kite Pharma, Inc., Kolon TissueGene, Inc., Novartis AG, Orchard Therapeutics plc., Organogenesis Holdings Inc., Pfizer, Inc., Spark Therapeutics, Inc., Vericel Corporation, and ViroMed Co., Ltd., among others.
The report also inspects the financial standing of the leading companies, which includes gross profit, revenue generation, sales volume, sales revenue, manufacturing cost, individual growth rate, and other financial ratios.
Research Objective:
Our panel of trade analysts has taken immense efforts in doing this group action in order to produce relevant and reliable primary & secondary data regarding the global Cell and Gene Therapy market. Also, the report delivers inputs from the trade consultants that will help the key players in saving their time from the internal analysis. Readers of this report are going to be profited with the inferences delivered in the report. The report gives an in-depth and extensive analysis of the Cell and Gene Therapy market.
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Cell and Gene Therapy Market has maintained a steady growth rate in the past decade and is predicted to grow at a higher growth rate during the forecast period. The analysis offers an industry-wide evaluation of the market by looking at vital aspects like growth trends, drivers, constraints, opinions of industry experts, facts and figures, historical information, and statistically-backed and trade valid market information to predict the future market growth.
The Global Cell and Gene Therapy Market is segmented:
In market segmentation by types of Cell and Gene Therapy, the report covers-
ell and gene therapy manufacturing landscape:
upstream manufacturing, and downstream manufacturing.
product landscape:
therapeutic market and pipeline analysis.
In market segmentation by applications of the Cell and Gene Therapy, the report covers the following uses-
oncology, hematology, cardiovascular, ophthalmology, neurology
This Cell and Gene Therapy report umbrellas vital elements such as market trends, share, size, and aspects that facilitate the growth of the companies operating in the market to help readers implement profitable strategies to boost the growth of their business. This report also analyses the expansion, market size, key segments, market share, application, key drivers, and restraints.
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Cell and Gene Therapy Market Regional Analysis:
Geographically, the Cell and Gene Therapy market is segmented across the following regions: North America, Europe, Latin America, Asia Pacific, and Middle East & Africa.
Key Coverage of Report:
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In conclusion, the Global Cell and Gene Therapy Market report provides a detailed study of the market by taking into account leading companies, present market status, and historical data to for accurate market estimations, which will serve as an industry-wide database for both the established players and the new entrants in the market.
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Cell and Gene Therapy Market Segmentation By Qualitative And Quantitative Research Incorporating Impact Of Economic And Non-Economic Aspects By 2027 |...
Research Report with COVID-19 Forecasts – Regenerative Medicine Market 2020-2024 | Increasing Prevalence of Chronic Diseases to Boost Growth |…
LONDON--(BUSINESS WIRE)--Technavio has been monitoring the regenerative medicine market and it is poised to grow by USD 9.55 billion during 2020-2024, progressing at a CAGR of over 20% during the forecast period. The report offers an up-to-date analysis regarding the current market scenario, latest trends and drivers, and the overall market environment.
Technavio suggests three forecast scenarios (optimistic, probable, and pessimistic) considering the impact of COVID-19. Please Request Free Sample Report on COVID-19 Impact
The market is fragmented, and the degree of fragmentation will accelerate during the forecast period. Allergan Plc, Amgen Inc., Hitachi Chemical Co. Ltd., Integra LifeSciences Holdings Corp., Medtronic Plc, MiMedx Group Inc., Organogenesis Holdings Inc., Smith & Nephew Plc, Takeda Pharmaceutical Co. Ltd., and Zimmer Biomet Holdings Inc. are some of the major market participants. The increasing prevalence of chronic diseases will offer immense growth opportunities. To make the most of the opportunities, market vendors should focus more on the growth prospects in the fast-growing segments, while maintaining their positions in the slow-growing segments.
Increasing prevalence of chronic diseases has been instrumental in driving the growth of the market.
Regenerative Medicine Market 2020-2024: Segmentation
Regenerative Medicine Market is segmented as below:
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Regenerative Medicine Market 2020-2024: Scope
Technavio presents a detailed picture of the market by the way of study, synthesis, and summation of data from multiple sources. Our regenerative medicine market report covers the following areas:
This study identifies the increasing number of clinical trials as one of the prime reasons driving the regenerative medicine market growth during the next few years.
Regenerative Medicine Market 2020-2024: Vendor Analysis
We provide a detailed analysis of vendors operating in the regenerative medicine market, including some of the vendors such as Allergan Plc, Amgen Inc., Hitachi Chemical Co. Ltd., Integra LifeSciences Holdings Corp., Medtronic Plc, MiMedx Group Inc., Organogenesis Holdings Inc., Smith & Nephew Plc, Takeda Pharmaceutical Co. Ltd., and Zimmer Biomet Holdings Inc. Backed with competitive intelligence and benchmarking, our research reports on the regenerative medicine market are designed to provide entry support, customer profile and M&As as well as go-to-market strategy support.
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Regenerative Medicine Market 2020-2024: Key Highlights
Table Of Contents:
Executive Summary
Market Landscape
Market Sizing
Five Forces Analysis
Market Segmentation by Technology
Customer Landscape
Geographic Landscape
Drivers, Challenges, and Trends
Vendor Landscape
Vendor Analysis
Appendix
About Us
Technavio is a leading global technology research and advisory company. Their research and analysis focus on emerging market trends and provides actionable insights to help businesses identify market opportunities and develop effective strategies to optimize their market positions. With over 500 specialized analysts, Technavios report library consists of more than 17,000 reports and counting, covering 800 technologies, spanning across 50 countries. Their client base consists of enterprises of all sizes, including more than 100 Fortune 500 companies. This growing client base relies on Technavios comprehensive coverage, extensive research, and actionable market insights to identify opportunities in existing and potential markets and assess their competitive positions within changing market scenarios.
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Research Report with COVID-19 Forecasts - Regenerative Medicine Market 2020-2024 | Increasing Prevalence of Chronic Diseases to Boost Growth |...