Category Archives: Cell Therapy

A new research study has been presented by Precision Market Reports (PMR) after a comprehensive analysis on AUTOLOGOUS CELL THERAPY Market where user can get benefits from the complete market research report with all required useful information on market. Report discuss all major market aspects with expert opinion on current market status along with historic data as well. Detailed study Price, Share, Size & Growth, Latest News & Developments, Expansion Plan, Current Business Strategy, Top Companies, Sales, Revenue & Competitors Analysis, Production and Consumption, Demand & Supply, Industry and Business Study, Effect of Covid 19 (Buyers & Sellers) and Prediction 2020-2025.

Regions Covered in the AUTOLOGOUS CELL THERAPY Market:

Covid-19 Scenario:

Since the COVID-19 virus outbreak in December 2019, the disease has spread to almost 100 countries around the globe with the World Health Organization declaring it a public health emergency. The global impacts of the corona virus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the market in 2020. COVID-19 can affect the global economy in three main ways: by directly affecting production and demand, by creating supply chain and market disruption, and by its financial impact on firms and financial markets.

Top Players & Competitive Analysis (Benefits) for AUTOLOGOUS CELL THERAPY:

A competitive analysis is a strategy where we identify major competitors and research their products, sales, and marketing strategies. By doing this, you can create solid business strategies that improve upon your competitors. A competitive analysis helps you learn the ins and outs of how your competition works. It also helps you identify what theyre doing right and opportunities where you can easily one-up them by using a strategy they havent taken advantage of.Every brand can benefit from regular competitor analysis. By performing a competitor analysis, youll be able to:

As you can see, learning any of these four components will lead your brand down the path of achievement. But before you get too excited to start, we need to nail down a few important basics.

Once you identify your true competition, youll need to determine what metrics youll be comparing across the board. Below, well give nine specific factors to compare and tips on how to identify this competition in the first place.

AUTOLOGOUS CELL THERAPY Competitors Analysis includes market shares for all the companies listed below, Competitors Analysis revenue chart, Competitive Dashboard, and the competitors latest strategies for overcoming the Covid 19 pandemic situation.

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SEGMENTAL ANALYSIS:

Business segment reporting breaks out a companys financial data by company divisions,subsidiaries, or other kinds of businesssegments. In an annual report, business segment reporting provides an accurate picture of apublic companysperformance to its shareholders. Management uses business segment reporting to evaluate the income, expenses, assets, and liabilities of each business division to assess its general healthincluding profitability and potential pitfalls.

Asegmentis a component of a business that generates its ownrevenuesand creates its own product, product lines, or service offerings.In general, if a unit of a business can be lifted out of the larger company and remain a self-sufficient entity, then it may be classified as a business segment.

By Market Players:BioTime, Pharmicell, BrainStorm Cell Therapeutics, Opexa Therapeutics, Vericel Corporation, Regeneus

By TypeBone Marrow, Epidermis

The prime objective of this report is to help the user understand the market in terms of its definition, segmentation, market potential, influential trends, and the challenges that the market is facing. Deep researches and analysis were done during the preparation of the report. The readers will find this report very helpful in understanding the market in depth. The data and the information regarding the market are taken from reliable sources such as websites, annual reports of the companies, journals, and others and were checked and validated by the industry experts. The facts and data are represented in the report using diagrams, graphs, pie charts, and other pictorial representations. This enhances the visual representation and also helps in understanding the facts much better.

KEY TAKEAWAYS:

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What Reports Provides:

Table of Contents:

1.1 Research Scope

1.2 Market Segmentation

1.3 Research Objectives

1.4 Research Methodology

1.4.1 Research Process

1.4.2 Data Triangulation

1.4.3 Research Approach

1.4.4 Base Year

1.5 Coronavirus Disease 2019 (Covid-19) Impact Will Have a Severe Impact on Global Growth

1.5.1 Covid-19 Impact: Global GDP Growth, 2019, 2020 and 2021 Projections

1.5.2 Covid-19 Impact: Commodity Prices Indices

1.5.3 Covid-19 Impact: Global Major Government Policy

1.6 The Covid-19 Impact on AUTOLOGOUS CELL THERAPY Industry

1.7 COVID-19 Impact: AUTOLOGOUS CELL THERAPY Market Trends

2 GLOBAL AUTOLOGOUS CELL THERAPY QUARTERLY MARKET SIZE ANALYSIS

2.1 AUTOLOGOUS CELL THERAPY Business Impact Assessment COVID-19

2.1.1 Global AUTOLOGOUS CELL THERAPY Market Size, Pre-COVID-19 and Post- COVID-19 Comparison, 2020-2025

2.2 Global AUTOLOGOUS CELL THERAPY Quarterly Market Size 2020-2021

2.3 COVID-19-Driven Market Dynamics and Factor Analysis

2.3.1 Drivers

2.3.2 Restraints

2.3.3 Opportunities

2.3.4 Challenges

3 QUARTERLY COMPETITIVE ASSESSMENT, 2020

3.1 By Players, Global AUTOLOGOUS CELL THERAPY Quarterly Market Size, 2019 VS 2020

3.2 By Players, AUTOLOGOUS CELL THERAPY Headquarters and Area Served

3.3 Date of Key Players Enter into AUTOLOGOUS CELL THERAPY Market

3.4 Key Players AUTOLOGOUS CELL THERAPY Product Offered

3.5 Mergers & Acquisitions, Expansion Plans

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The study points out the limitations that aim to overcome the challenges to massive success for companies. Through means of this study, customers can conveniently obtain views on the AUTOLOGOUS CELL THERAPY market based on the current scenario.

What is the Impact of Covid-19 Outbreak on the AUTOLOGOUS CELL THERAPY?

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AUTOLOGOUS CELL THERAPY Market 2020 analysis with Key Players, Applications, Trends and Forecasts by 2028|BioTime, Pharmicell, BrainStorm Cell...

The Cell Therapy Manufacturing Market Research Report 2020 published by Prophecy Market Insights is an all-inclusive business research study on the current state of the industry which analyzes innovative strategies for business growth and describes significant factors such as top developers/manufacturers, production value, key regions, and growth rate. Impact of Covid-19 pandemic on the market will be completely analyzed in this report and it will also quantify the impact of this pandemic on the market.

The research study encompasses an evaluation of the market, including growth rate, current scenario, and volume inflation prospects, based on DROT and Porters Five Forces analyses. The market study pitches light on the various factors that are projected to impact the overall market dynamics of the Cell Therapy Manufacturing market over the forecast period (2019-2029).

Regional Overview:

The survey report includes a vast investigation of the geographical scene of the Cell Therapy Manufacturing market, which is manifestly arranged into the localities. The report provides an analysis of regional market players operating in the specific market and outcomes related to the target market for more than 20 countries.

Australia, New Zealand, Rest of Asia-Pacific

The facts and data are represented in the Cell Therapy Manufacturing report using graphs, pie charts, tables, figures and graphical representations helping analyze worldwide key trends & statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

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The research report also focuses on global major leading industry players of Cell Therapy Manufacturing market report providing information such as company profiles, product picture and specification, R&D developments, distribution & production capacity, distribution channels, price, cost, revenue and contact information. The research report examines, legal policies, and competitive analysis between the leading and emerging and upcoming market trends.

Cell Therapy ManufacturingMarket Key Companies:

harmicell, Merck Group, Dickinson and Company, Thermo Fisher, Lonza Group, Miltenyi Biotec GmBH, Takara Bio Group, STEMCELL Technologies, Cellular Dynamics International, Becton, Osiris Therapeutics, Bio-Rad Laboratories, Inc., Anterogen, MEDIPOST, Holostem Terapie Avanazate, Pluristem Therapeutics, Brammer Bio, CELLforCURE, Gene Therapy Catapult EUFETS, MaSTherCell, PharmaCell, Cognate BioServices and WuXi AppTec.

The predictions mentioned in the Cell Therapy Manufacturing market report have been derived using proven research techniques, assumptions and methodologies. This market report states the overview, historical data along with size, share, growth, demand, and revenue of the global industry.

Segmentation Overview:

The report provides an in-depth analysis of the Cell Therapy Manufacturing market segments and highlights the latest trending segment and major innovations in the market. In addition to this, it states the impact of these segments on the growth of the market. Apart from key players analysis provoking business-related decisions that are usually backed by prevalent market conditions, we also do substantial analysis of market based on COVID-19 impact, detailed analysis on economic, health and financial structure.

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Cell Therapy Manufacturing Market: Opportunities Forecast and Value Chain 2020-2030 - 3rd Watch News

Misleading claims of Covid-19 cure

Vincentius Aji Jatikusumo

The Jakarta Post, Indonesia

Researchers at Airlangga University (Unair) and the State Intelligence Agency (BIN) released on June 12 what appeared to be an encouraging statement: the discovery of five combination drug therapies and two stem cell therapies for treating Covid-19.

The joint statement also said that the medicines were ready for distribution to treat Covid-19 patients.

In theory, the drug combinations recommended by Unair and BIN have the potential to inhibit Sars-CoV-2. However, none of the recommended drugs have been proved in any clinical study to be a safe and effective treatment for Covid-19.

In fact, evidence exists that one of the drugs, hydroxychloroquine, may worsen the condition of patients. This led the World Health Organisation to suspend the clinical trial of the drug.

Unair and BIN are correct in conducting in vitro (test tube) experiments to verify the effect and toxicity of the drugs. Unfortunately, they have not communicated in any clear way on how they designed, executed and analysed their experiments.

Stem cell therapy is another Covid-19 treatment that Unair and BIN researchers have proposed.

However, stem cell therapy is still considered very risky, expensive and limited to treating a few cancers, such as leukaemia. No evidence exists that stem cell therapy is efficient in treating viral infections in the human body such as the coronavirus.

Unair's and BIN's valiant efforts should still be applauded, as they are committed to treating Covid-19 and ending the pandemic. However, everyone should realise that discovering treatments and developing a potential vaccine for a disease that was virtually unknown six months ago take a lot of time and resources.

Unair and BIN said that they had submitted their research to at least seven peer-reviewed international journals, but this does not mean that their research is validated immediately. It still needs to be reviewed and questioned by their scientific peers.

A policeman standing guard at a barricade at a restricted area sealed by the authorities in Lahore, Pakistan, last Thursday. It is evident that, much like the global trend in countries where Covid-19 cases have soared, Pakistan's daily cases and deaths are growing, says one of the writers. PHOTO: AGENCE FRANCE-PRESSE

Michael Tan

Philippine Daily Inquirer, The Philippines

We are truly fortunate that, in the Philippines, we have adopted masks wholeheartedly, although with some lapses in the way they are used.

We are all right with masks, but with testing, we are pretty much like the United States, with all the well-publicised criticism of our testing continuing to be haphazard and without a sense of direction.

I have written about this several times, as has my fellow columnist Mahar Mangahas: We need random testing or, to use an epidemiological term, sentinel surveillance - looking at all geographical areas and at different population groups, and not just the so-called high-risk ones.

Random (but systematic) testing is not mass testing. We do not need to test all 110 million Filipinos, but we do need to have representative geographical distribution so we can have early detection. Right now, we wait for an outbreak and then rush in to test, and we are often by then overwhelmed by the speed of its spread, as is happening now in Cebu.

What I worry about now is that even while we are improving, ever so slowly, on testing, we do not seem to be doing adequate contact tracing, which must go together with the testing. Contact tracers look at the people behind the numbers. It is through contact tracing that we have obtained some of the very important information on superspreader venues.

Editorial

The Yomiuri Shimbun, Japan

The spread of infections with the coronavirus has directly hit the vulnerabilities in Japan's politics, economy and society. The country must make all-out efforts to restore peace of mind to people's lives.

The Yomiuri Shimbun has compiled a set of proposals to build a society that is resistant to infectious diseases in preparation for the arrival of a second wave of infections.

First, the proposal calls for improving the PCR (polymerase chain reaction) testing system and increasing the number of tests to 100,000 a day. By combining it with antigen tests and other methods appropriately, it is hoped that the reality of the infection situation will be revealed.

A shortage of hospital beds must be avoided. Place people with mild symptoms in accommodation facilities, hospitalise those with moderate symptoms in priority medical institutions and those with severe symptoms in advanced medical institutions.

To increase the speed of implementing measures and delivering clear messages, the creation of a control tower initiated by the prime minister to lead infectious disease measures will be effective.

Second, as for economic stimulus measures, it has taken time to provide cash relief and loans. Efforts must be accelerated to restructure the relevant systems.

There is no point in compiling a budget unless funds are actually distributed. The government must thoroughly reflect on the situation and establish an infrastructure that enables swift budget execution.

Another task is to accelerate digitalisation, which lags behind other countries. Online handling of applications needs to be strengthened, so that people can receive benefits and loans through simple procedures.

Third, international cooperation will be essential to the development of vaccines and therapeutic drugs and the distribution of them. It is proper for Japan, as the host country preparing for the Tokyo Olympics and Paralympics, to take the lead.

Badiuzzaman Bay

The Daily Star, Bangladesh

According to a tell-all report by The Daily Star, a number of professional bodies have secured beds for their members and families at several private hospitals in Dhaka.

On June 11, the Bangladesh Judicial Service Association signed a deal with the Universal Medical College Hospital to provide treatment to lower court judges suffering from Covid-19 and other diseases.

Not to be outdone, the Bangladesh Police on May 5 "hired" an entire hospital (Impulse Hospital) for 2 months to treat its members.

Since when has it been it all right to "book" entire hospitals or hospital beds for certain people? Should we accept this as a new normal where access to treatment for the common people will be contingent on the availability of beds left by the influential?

Since March 8, when the country confirmed its first coronavirus case, there have been multiple reports of ordinary people desperately moving from one hospital to another without receiving treatment. Recently, the nurse of a private hospital in Dhaka died after being denied treatment by the very hospital she worked at.

A common thread running through these heartbreaking episodes is the victims' "ordinariness", their having no power or connections that could qualify them for treatment.

The situation has reached a point where people are simply afraid to have anything to do with sickness lest they need to confront the challenges of hospitalisation.

Editorial

Dawn, Pakistan

On multiple days since the middle of this month, official figures for coronavirus-related deaths in the country have been well over 100. According to press releases issued by the National Command and Operation Centre, 111 people lost their lives to Covid-19 on June 16 and 136 on June 17.

About a week ago, the official death toll in a single day was 153 - the highest in 24 hours since the start of the outbreak in Pakistan at the end of February. As these figures continue to climb, the daily number of tests towards the end of this month stands at an average of 28,500 - far lower than the 100,000 daily testing milestone the government has calculated for next month.

It is evident that, much like the global trend in countries where Covid-19 cases have soared, Pakistan's daily cases and deaths are growing.

Although the authorities may argue that cases and deaths here are still lower than in many of the worst-hit countries, the reality is that Pakistan is still over a month away from what the authorities and think-tanks have estimated to be the "peak phase".

As we approach that dreaded period, testing must be ramped up, and fast, so that we can have a realistic picture of the spread of Covid-19.

The View From Asia is a compilation of articles from The Straits Times' media partner Asia News Network, a grouping of 24 news media titles.

Originally posted here:
Mishandling of the Covid-19 pandemic raises concern, Asia News & Top Stories - straits times

This detailed market study covers Cart Cell Therapy Market growth potentials which can assist the stakeholders to understand key trends and prospects in Cart cell therapy market identifying the growth opportunities and competitive scenarios. The report also focuses on data from different primary and secondary sources, and is analyzed using various tools. It helps to gain insights into the markets growth potential, which can help investors identify scope and opportunities. The analysis also provides details of each segment in the global Cart cell therapy market.

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According to the report, Cart cell therapy market report highlights market opportunities and competitive scenarios for Cart cell therapy on a regional and global basis. Market size estimation and forecasts have been provided based on a unique research design customized to the dynamics of the Cart cell therapy market. The Cart cell therapy market has been segmented by target antigen (cd19, cd22 and others), application (acute lymphoblastic leukemia, diffuse large b-cell lymphoma and others), end user (hospital, pharmaceuticals, clinic and others). Historic back-drop for the Cart cell therapy market has been analyzed according to organic and inorganic developments to provide precise market size estimations. Also, key factors impacting the growth of the Cart cell therapy market have been identified with potential gravity.

Regional segmentation and analysis to understand growth patterns:The market has been segmented in major regions to understand the global development and demand patterns of this market.

North America, Western Europe, Eastern Europe, Asia Pacific, Middle East, & Rest of the World segmented the Cart cell therapy market on a regional basis. Some of the major markets in North America and Western Europe are also typical suppliers of chemicals such as specialty chemicals, bulk chemicals, and so on. The major companies in this market have their headquarters in North and Western Europe.

The Asia Pacific and the Middle East are expected to register substantial growth in the Cart cell therapy market during the forecast period. This demand is with regard to the growth of major end-use industries such as marine, oil & gas, industrial, construction & infrastructure, energy & power, automotive & transportation. Major countries in the Asia Pacific region include China, South Korea, Japan, India, Australia, and so on. Middle East includes the UAE, Saudi Arabia, Iran, Israel, Egypt, and so on.

Eastern Europe has been largely dominated by Russia and Turkey with operations of major chemical giants in the region. Rest the World that includes South America and Africa has a strong potential for the Cart cell therapy market. There have been an increasing number of investments by global companies in these regions to strengthen their presence and tap the potential market. Major economies in these regions for the Cart cell therapy market include Brazil, South Africa, Nigeria, Argentina, Colombia, and others.

This report provides:1) An overview of the global market for Cart cell therapy market and related technologies.2) Analysis of global market trends, yearly estimates and annual growth rate projections for compounds (CAGRs).3) Identification of new market opportunities and targeted consumer marketing strategies for global Cart cell therapy market.4) Analysis of R&D and demand for new technologies and new applications5) Extensive company profiles of key players in industry.

The researchers have studied the market in depth and have developed important segments such as product type, application and region. Each and every segment and its sub-segments are analyzed based on their market share, growth prospects and CAGR. Each market segment offers in-depth, both qualitative and quantitative information on market outlook.

Company profiled in this report based on Business overview, Financial data, Product landscape, Strategic outlook & SWOT analysis:1. Novartis AG2. Kite Pharma3. Mustang Bio4. Sorrento Therapeutics5. CARsgen Therapeutics6. Autolus Therapeutics7. Pfizer Inc.8. Cellectis, Legend Biotech9. Bellicum Pharmaceuticals10. and others.

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Market Segmentation:By Target Antigeno CD19o CD22o Others

By Applicationo Acute Lymphoblastic Leukemiao Diffuse Large B-Cell Lymphomao Others

By End-Usero Pharmaceuticals Companieso Hospitalo Clinico Other

By Region:North Americao By Country (US, Canada, Mexico)o By Target Antigeno By Applicationo By End User

Western Europeo By Country (Germany, UK, France, Italy, Spain, Rest of Western Europe)o By Target Antigeno By Applicationo By End User

Eastern Europeo By Country (Russia, Turkey, Rest of Eastern Europe)o By Target Antigeno By Applicationo By End User

Asia Pacifico By Country (China, Japan, India, South Korea, Australia, Rest of Asia Pacific)o By Target Antigeno By Applicationo By End User

Middle Easto By Country (UAE, Saudi Arabia, Qatar, Iran, Rest of Middle East)o By Target Antigeno By Applicationo By End User

Rest of the Worldo By Region (South America, Africa)o By Target Antigeno By Applicationo By End User

Reasons to Buy This Report:o Market size estimation of the cart cell therapy market on a regional and global basiso Unique research usage for market size estimation and forecast

o Profiling of major companies operating in the market with key developmentso Broad scope to cover all the possible segments helping every stakeholder in the market

Customization:We provide customization of the study to meet specific requirements:o By Segmento By Sub-segmento By Region/Country

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Cart Cell Therapy Market 2020 By Players, Type, Application, Marketing Channel and Region - Owned

CRANFORD, N.J., June 26, 2020 /PRNewswire/ --Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of acute respiratory distress syndrome (ARDS) in patients with COVID-19.

The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials. The Company plans to initiate actions on the FDA's recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the Coronavirus Treatment Acceleration Program (CTAP).

Myron Holubiak, Chief Executive Officer of Citius, commented, "We appreciate the FDA's thoughtful guidance on our unique, allogenic mesenchymal stem cells derived from induced pluripotent stem cells (iPSCs). We understand that iPSC-derived stem cells are not the same as adult-donor derived cells and, therefore, would require different proof of concept studies. Since we believe in the advantages of iPSC MSCs over donor-derived cells, we intend to develop assays recommended by the FDA and demonstrate the safety of these MSCs in our preclinical studies. We are committed to the successful completion of the required clinical trials to provide an effective and safe therapy for ARDS due to COVID-19."

About Citius Pharmaceuticals, Inc.Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visitwww.citiuspharma.com.

About Citius iMSCCitius's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The iMSCs produced from this clonal technique are differentiated from adult donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, iMSCs exhibit superior potency and high cell viability. The iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. The Citius iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

About Acute Respiratory Distress Syndrome (ARDS)ARDS is a type of respiratory failure characterized by rapid onset of widespread inflammation in the lungs. ARDS is a rapidly progressive disease that occurs in critically ill patients most notably now in those diagnosed with COVID-19. ARDS affects approximately 200,000 patients per year in the U.S., exclusive of the current COVID-19 pandemic, and has a 30% to 50% mortality rate. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

About Coronavirus Treatment Acceleration Program (CTAP)In response to the pandemic, the FDA has created an emergency program called the Coronavirus Treatment Acceleration Program (CTAP) to accelerate the development of treatments for COVID-19. By redeploying staff, the FDA is responding to COVID-19-related requests and reviewing protocols within 24 hours of receipt. The FDA said CTAP "uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful." In practice, that means developers of potential treatments for COVID-19 would benefit from an unusually faster track at the FDA to shorten wait times at multiple steps of the process.

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risk of successfully negotiating a license agreement for a potential ARDS therapy with Novellus, Inc. within the option period; the ability to access the FDA's CTAP program for our planned ARDS therapy; risks associated with developing our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; risks associated with conducting our Phase 3 trial for Mino-Lok, including completing patient enrollment, opening study sites and achieving the required number of catheter failure events; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:

Andrew Scott Vice President, Corporate Development (O) 908-967-6677 x105[emailprotected]

SOURCE Citius Pharmaceuticals, Inc.

http://www.citiuspharma.com

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Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute...

A week after updating their S-1 in search of at least $115 million on the hot biotech IPO market, Poseida Therapeutics says its also raised a fresh venture round a little more than a year after its last.

The first time around, after Poseida delayed its IPO during a government shutdown, the biotech reported a $150 million C round. This time around, its adding $110 million more from Fidelity Management Research Company and others.

Theres no word in the biotechs statement on Novartis, which bought up half of the equity for the Series C cash with a $75 million investment.

According to the SEC filing, Novartis which fielded the first, somewhat troubled CAR-T owns 14.9% of the company, with Malin in for 23.2%, though those numbers may have changed now.

The big beneficiary is CEO Eric Ostertag, who controls 12.6 million shares 25.4% through various family trusts.

Poseidas big idea involves the use of a non-viral DNA tech that they say can be used to gather a bigger concentration of stem cell memory T cells that can avoid the exhaustion that limits the efficacy of the pioneers a central theme in cell therapy 2.0.

Ostertag picked up his PhD in molecular biology at Penn and went on to a career that included a variety of biotech startups.

Link:
Novartis-backed Poseida is packing in the cash for its next-gen CAR-T work, adding a $110M venture raise on top of its newly-refiled IPO - Endpoints...

Theglobal CAR T cell therapy marketwas estimated to be valued at USD XX million in 2018 and is projected to reach USD XX million by 2026, at a CAGR of XX% during 2019 to 2026.

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Chimeric Antigen Receptor(CAR) T celltherapy is an immunotherapy used for cancer treatment. In this therapy, T cells from patient body are isolated and inserted in the CAR gene so that the gene for the specific receptor binds to a certain protein on the patients cancer cells.

The growing prevalence of cancer across the world, technological advancement & reliable treatment for cancer, growing pharmaceutical industry, and rise in the number of cell therapy clinical studies are driving the growth of the market globally.

However, side-effects of CAR T-cell therapy and high cost of treatment are the major factors expected to hamper the growth of the global market.

Theglobal CAR T cell therapy marketis primarily segmented based on different target antigen, application, and regions. On the basis of target antigen, the market is divided into CD19, CD22, and others. The applications covered in the study include acute lymphoblastic leukemia, diffuse large B-cell lymphoma, and others.

CAR T Cell Therapy Industry report offers a comprehensive insight into the development policies and plans in addition to manufacturing processes and cost structures. On the basis of product, this report displays the cost structure, sales revenue, sales volume, gross margin, market share and growth rate.

Report Covers Market Segment by Manufacturers:

Novartis AG Kite Pharma Pfizer, Inc. Cellectis Autolus Therapeutics PLC CARsgen Therapeutics

Report Covers Market Segment by Types:

CD19 CD22 Others

Global CAR T Cell Therapy Industry 2019 Market Research Report is spread across 121 pages and provides exclusive vital statistics, data, information, trends and competitive landscape details in this niche sector.

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Report Covers Market Segment by Applications:

Acute Lymphoblastic Leukemia Diffuse Large B-Cell Lymphoma Other Applications

Key Benefits of the Report:

Global, and regional, product type & application market size and their forecast from 2019-2026 Identification and detailed analysis on key market dynamics, such as, drivers, restraints, opportunities, and challenges influencing the growth of the market

Detailed analysis on industry outlook with market specific PEST analysis, and Supply Chain to better understand the market and build expansion strategies Identification of key market players and comprehensively analyze their market share and core competencies, detailed financial positions, key products, and unique selling points Analysis on key players strategic initiatives and competitive developments, such as agreements & joint ventures, mergers & acquisitions, expansion, and new product launches in the market Expert interviews and their insights on market trends, market shift, current and future outlook, and factors impacting vendors short term & long term strategies Detailed insights on emerging regions, product type and application with qualitative and quantitative information and facts Identification of the key patents filed in the field of CAR T Cell Therapy equipment and other related technologies.

Target Audience:

CAR T Cell Therapy providers Traders, Importer and Exporter Raw material suppliers and distributors Research and consulting firms Government and research organizations Associations and industry bodies

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Research Methodology

The market is derived through extensive use of secondary, primary, in-house research followed by expert validation and third party perspective like analyst report of investment banks. The secondary research forms the base of our study where we conducted extensive data mining, referring to verified data sources such as white papers government and regulatory published materials, technical journals, trade magazines, and paid data sources.

For forecasting, regional demand & supply factor, investment, market dynamics including technical scenario, consumer behavior, and end use industry trends and dynamics, capacity Types, spending were taken into consideration.

We have assigned weights to these parameters and quantified their market impacts using the weighted average analysis to derive the expected market growth rate.

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

Original Equipment Manufacturer Component Supplier Distributors Government Body & Associations Research Institute

Table of Content

1 Executive Summary2 Methodology And Market Scope3 CAR T Cell Therapy Market Industry Outlook4 CAR T Cell Therapy Market By End User5 CAR T Cell Therapy Market Type6 CAR T Cell Therapy Market Regional Outlook7 Competitive LandscapeEnd of the reportDisclaimer

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COVID-19 Impact on Global CAR T Cell Therapy Market 2020: Industry Trends, Size, Share, SWOT Analysis by Top Key Players and Forecast Report to 2026 -...

In recent months, even as our attention has been focused on the coronavirus outbreak, there have been a slew of scientific breakthroughs in treating diseases that cause blindness.

Researchers at U.S.-based Editas Medicine and Ireland-based Allergan have administered CRISPR for the first time to a person with a genetic disease. This landmark treatment uses the CRISPR approach to a specific mutation in a gene linked to childhood blindness. The mutation affects the functioning of the light-sensing compartment of the eye, called the retina, and leads to loss of the light-sensing cells.

According to the World Health Organization, at least 2.2 billion people in the world have some form of visual impairment. In the United States, approximately 200,000 people suffer from inherited forms of retinal disease for which there is no cure. But things have started to change for good. We can now see light at the end of the tunnel.

I am an ophthalmology and visual sciences researcher, and am particularly interested in these advances because my laboratory is focusing on designing new and improved gene therapy approaches to treat inherited forms of blindness.

Gene therapy involves inserting the correct copy of a gene into cells that have a mistake in the genetic sequence of that gene, recovering the normal function of the protein in the cell. The eye is an ideal organ for testing new therapeutic approaches, including CRISPR. That is because the eye is the most exposed part of our brain and thus is easily accessible.

The second reason is that retinal tissue in the eye is shielded from the bodys defense mechanism, which would otherwise consider the injected material used in gene therapy as foreign and mount a defensive attack response. Such a response would destroy the benefits associated with the treatment.

In recent years, breakthrough gene therapy studies paved the way to the first ever Food and Drug Administration-approved gene therapy drug, Luxturna TM, for a devastating childhood blindness disease, Leber congenital amaurosis Type 2.

This form of Leber congenital amaurosis is caused by mutations in a gene that codes for a protein called RPE65. The protein participates in chemical reactions that are needed to detect light. The mutations lessen or eliminate the function of RPE65, which leads to our inability to detect light blindness.

The treatment method developed simultaneously by groups at University of Pennsylvania and at University College London and Moorefields Eye Hospital involved inserting a healthy copy of the mutated gene directly into the space between the retina and the retinal pigmented epithelium, the tissue located behind the retina where the chemical reactions takes place. This gene helped the retinal pigmented epithelium cell produce the missing protein that is dysfunctional in patients.

Although the treated eyes showed vision improvement, as measured by the patients ability to navigate an obstacle course at differing light levels, it is not a permanent fix. This is due to the lack of technologies that can fix the mutated genetic code in the DNA of the cells of the patient.

Lately, scientists have been developing a powerful new tool that is shifting biology and genetic engineering into the next phase. This breakthrough gene editing technology, which is called CRISPR, enables researchers to directly edit the genetic code of cells in the eye and correct the mutation causing the disease.

Children suffering from the disease Leber congenital amaurosis Type 10 endure progressive vision loss beginning as early as one year old. This specific form of Leber congenital amaurosis is caused by a change to the DNA that affects the ability of the gene called CEP290 to make the complete protein. The loss of the CEP290 protein affects the survival and function of our light-sensing cells, called photoreceptors.

One treatment strategy is to deliver the full form of the CEP290 gene using a virus as the delivery vehicle. But the CEP290 gene is too big to be cargo for viruses. So another approach was needed. One strategy was to fix the mutation by using CRISPR.

The scientists at Editas Medicine first showed safety and proof of the concept of the CRISPR strategy in cells extracted from patient skin biopsy and in nonhuman primate animals.

These studies led to the formulation of the first ever in human CRISPR gene therapeutic clinical trial. This Phase 1 and Phase 2 trial will eventually assess the safety and efficacy of the CRISPR therapy in 18 Leber congenital amaurosis Type 10 patients. The patients receive a dose of the therapy while under anesthesia when the retina surgeon uses a scope, needle and syringe to inject the CRISPR enzyme and nucleic acids into the back of the eye near the photoreceptors.

To make sure that the experiment is working and safe for the patients, the clinical trial has recruited people with late-stage disease and no hope of recovering their vision. The doctors are also injecting the CRISPR editing tools into only one eye.

An ongoing project in my laboratory focuses on designing a gene therapy approach for the same gene CEP290. Contrary to the CRISPR approach, which can target only a specific mutation at one time, my team is developing an approach that would work for all CEP290 mutations in Leber congenital amaurosis Type 10.

This approach involves using shorter yet functional forms of the CEP290 protein that can be delivered to the photoreceptors using the viruses approved for clinical use.

Gene therapy that involves CRISPR promises a permanent fix and a significantly reduced recovery period. A downside of the CRISPR approach is the possibility of an off-target effect in which another region of the cells DNA is edited, which could cause undesirable side effects, such as cancer. However, new and improved strategies have made such likelihood very low.

Although the CRISPR study is for a specific mutation in CEP290, I believe the use of CRISPR technology in the body to be exciting and a giant leap. I know this treatment is in an early phase, but it shows clear promise. In my mind, as well as the minds of many other scientists, CRISPR-mediated therapeutic innovation absolutely holds immense promise.

In another study just reported in the journal Science, German and Swiss scientists have developed a revolutionary technology, which enables mice and human retinas to detect infrared radiation. This ability could be useful for patients suffering from loss of photoreceptors and sight.

The researchers demonstrated this approach, inspired by the ability of snakes and bats to see heat, by endowing mice and postmortem human retinas with a protein that becomes active in response to heat. Infrared light is light emitted by warm objects that is beyond the visible spectrum.

The heat warms a specially engineered gold particle that the researchers introduced into the retina. This particle binds to the protein and helps it convert the heat signal into electrical signals that are then sent to the brain.

In the future, more research is needed to tweak the ability of the infrared sensitive proteins to different wave lengths of light that will also enhance the remaining vision.

This approach is still being tested in animals and in retinal tissue in the lab. But all approaches suggest that it might be possible to either restore, enhance or provide patients with forms of vision used by other species.

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Gene therapy and CRISPR strategies for curing blindness (Yes, you read that right) - The Conversation US

An area where stem cell biology and medicine are combining effectively is the establishment of new cell therapies. However, current therapies are limited to a narrow set of cell types that can be isolated or created and expanded in vitro. Dr Owen Rackham discusses how utilising computational approaches will further enhance applications of stem-cell-derived therapies in the future.

For decades (or perhaps centuries) the approach in cell biology has remained relatively unchanged. We isolate cells and with our confined knowledge of their endogenous conditions, begin to experiment until we can sustain them in vitro. Once established, we can conduct further investigation to assess a cells response to different conditions, changes over time or response to manipulation. This is especially true of stem cell biology, established from tireless efforts to incrementally improve culture conditions or differentiation protocols based on fragmented knowledge of developmental processes. Despite this, the promise of stem-cell therapies is already being realised in the clinic, but the breadth of cell types being used is still relatively narrow. Recent technological advances in the field have been focused on the safe and scalable manufacture of therapies. While these are revolutionary breakthroughs, the applications are largely limited to T cells, haematopoietic- and pluripotent-stem cells (HSCs and PSCs), a small fraction in the grand heterogeneity of cell types. Consequently, the lack of cell source diversity prevents cell therapy from fulfilling its clinical potential, pointing to the need for new means to isolate or generate source cells.

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Using big data approaches to develop cell therapies - Drug Target Review

Cell therapy manufacturing costs could be reduced dramatically using immobilized growth factors in culture according to research.

Industry interest in cell therapies has increased significantly in recent years. According to a report by US industry group PhRMA, there are 362 cell and gene therapies in clinical development, up from 289 in 2018.

The surge in cell therapies entering the clinic is the result of years of pioneering research by Americas biopharmaceutical research companies, according to PhRMA.

Image: iStock/Sviatlana Zyhmantovich

It also reflects the potential revenue cell therapies can generate. According to analysis by market research firm Bioinformant while prices vary, all cell therapies are expensive.

For example, cell therapies for wound care cost between $1,500 and $2,500 per administration, while those delivered via injection can cost up to $200,000 per shot. Cell-based gene therapies are valued in the $500,000 to $1 million range.

But revenue is not the only factor. The prices also reflect the high cost of goods sold (COGS) for a cell therapy according to Bioinformant.

The cost of manufacturing a cell product cannot be compared with small molecule products manufactured by pharmaceutical companies or biomolecules produced by biotechnology companies. Cell therapies are costlier to develop, with autologous cell products commanding the highest price tags.

In general, the manufacturing cost of autologous cell product is many times higher than that of an allogeneic product and this is reflected in the market pricing the authors wrote.

Growth factors as the name suggests are proteins that stimulate cell growth. They are one of the most costly components of the cell therapy manufacturing process according to a 2018 study published in Frontiers in Medicine.

The authors who looked at production strategies for allogenic therapies said Identifying mimetic-based alternatives to costly growth factors or leaner media alternatives would help to substantially reduce cost of goods.

Another approach is to immobilize growth factors used in cell culture according to the team behind a study due to be published in Frontiers in Bioengineering and Biotechnology.

Author Marion Brunck, associate professor at the Monterrey Institute of Technology and Higher Education (ITESM), told Bioprocess Insider Immobilizing growth factors is a good idea in general, as the process stabilizes the protein and prevents its degradation, internalization, i.e. bioactivity does not decrease at the same rate as with soluble proteins.

However, some growth factors must be internalized for the transduction cascade to occur appropriately, in these situations, a different approach may be sought out, for example immobilizing the growth factor by physical entrapment which allow a gradual release in culture media.

The take home message is that it may be a very good idea to decrease production cost but the biology of the growth factor (GF) and its signaling mechanistics must be well known.

Brunck added that, The impact of GF immobilization on cost will definitely vary depending on each individual process. In some cases, culture media accounts for more than half of the cost of goods, and within the cost of culture media, GF is again a big contributor.

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growth factors to cut cell therapy COGS - Bioprocess Insider - BioProcess Insider