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NMDP/Be The Match partners with M Health Fairview and Duke University cryopreservation labs to launch Be The Match BioBank – Watauga Democrat

By Gene Therapy Clinics

MINNEAPOLIS, Oct. 6, 2020 /PRNewswire/ --The National Marrow Donor Program (NMDP)/Be The Match today announced a collaboration with the Minnesota health system M Health Fairview and Marcus Center for Cellular Cures (MC3)/Carolinas Cord Blood Bank at Duke University (Duke) to offer cryopreservation services to transplant centers through the Be The Match BioBank. The collaboration brings together industry-leading expertise in cryopreservation and storage of patient-directed donor blood stem cell products to improve donor availability, collection quality, and ultimately, to provide a more reliable path to transplant for patients.

Through the Be The Match BioBank, blood stem cell donors will be able to donate bone marrow or peripheral blood stem cells (PBSC) for an intended patient on a timeline that is convenient for the donor. The cells are then cryopreserved and stored for the transplant center at no cost to them and shipped to coincide with initiation of the patient's conditioning regimen and optimal treatment timeline.

"We're excited to expand our partnership with Duke University by adding the expertise of physicians and researchers at M Health Fairview University of Minnesota Medical Center to continue to overcome logistical barriers to blood and marrow transplantation that might otherwise disrupt optimal patient care. Through the flexibility offered by the Be The Match BioBank, we believe we can provide transplant centers with a well-matched, available donor more often, and allow the transplant to occur at the best time for the patient," explained Steven Devine, MD, Chief Medical Officer, NMDP/Be The Match, and Associate Scientific Director, CIBMTR (Center for International Blood and Marrow Transplant Research). "The team at the Duke University lab was instrumental in the development of the Be The Match BioBank, as well as supporting donor product cryopreservation during the COVID-19 pandemic to ensure patients can continue to receive the transplants they need."

"We are proud to extend our partnership with the NMDP/Be The Match in a new way. Be The Match BioBank is an innovative way to remove barriers that otherwise may stand in the way of a patient's transplant," said Joanne Kurtzberg, MD, who leads the Marcus Center for Cellular Cures (MC3)/Carolinas Cord Blood Bank at Duke University.

"We are thrilled to be working with the NMDP/Be The Match to offer Be The Match BioBank. Through this partnership, transplant physicians can have confidence a high-quality bone marrow or PBSC product will be available from the donor they requested in the timeframe that works best for their patient," said David McKenna, MD, who leads the Molecular and Cellular Therapeutics program at M Health Fairview.

Be The Match BioBank can be used by any transplant center in the NMDP/Be The Match Network of more than 180 transplant centers worldwide. Blood stem cell donors are informed that the transplant center is requesting cryopreservation and provide consent prior to collection. Donors can also consent to having their donated cells made available to other searching patients in the unlikely event the intended patient is unable to proceed to transplant as planned.

To learn more about Be The Match BioBank, visit Network.BeTheMatchClinical.org/BioBank.

About the National Marrow Donor Program/Be The Match The National Marrow Donor Program/Be The Match is the global leader in providing a cure to patients with life-threatening blood and marrow cancers like leukemia and lymphoma, as well as other diseases. The organization manages the world's largest registry of potential blood stem cell donors and cord blood units. The NMDP/Be The Match partners with a global network to connect patients to their donor match for a transplant, and provides education and support for patients. Through Be The Match BioTherapies, the NMDP/Be The Match partners with cell and gene therapy companies to support the development and delivery of new therapies. The organization conducts research through its research program, CIBMTR (Center for International Blood and Marrow Transplant Research), in collaboration with Medical College of Wisconsin.

About M Health Fairview M Health Fairview is the newly expanded collaboration betweenthe University of Minnesota, University of Minnesota Physicians,and Fairview Health Services. The healthcare system combines the best of academic and community medicine expanding access to world-class, breakthrough care through its 10 hospitals and 60 clinics.

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NMDP/Be The Match partners with M Health Fairview and Duke University cryopreservation labs to launch Be The Match BioBank - Watauga Democrat

What Will Be Driving Growth of Alpha Thalassemia market Near Future By Top Vendors Like | Bluebird Bio, Novartis, Kiadis Pharma, Acceleron Pharma ,…

By Gene Therapy Clinics

Reports Monitor has recently added a new report to its vast depository titledGlobal Alpha Thalassemia Market. The report studies vital factors about theGlobal Alpha Thalassemia Marketthat are essential to be understood by existing as well as new market players. The report highlights the essential elements such as market share, profitability, production, sales, manufacturing, advertising, technological advancements, key market players, regional segmentation, and many more crucial aspects related to theGlobal Alpha Thalassemia Market.

Important factors like strategic developments, government regulations, market analysis, end users, target audience, distribution network, branding, product portfolio, market share, threats and barriers, growth drivers, latest trends in the industry are also mentioned.

The following Top manufacturers are evaluated in this report: Bluebird Bio, Novartis, Kiadis Pharma, Acceleron Pharma & amp; More.

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Product Type Segmentation Iron Chelating Drugs Gene Therapy

Industry Segmentation Hospitals Private clinics

Some of the main geographic regions included in this report are: 1. North America (United States and Canada and rest of North America) 2. Europe (Germany, France, Italy and the rest of Europe) 3. Asia-Pacific (China, Japan, India, South Korea and the rest of Asia-Pacific) 4. LAMEA (Brazil, Turkey, Saudi Arabia, South Africa and the rest of LAMEA)

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The study objectives of this report are:

To study and forecast the market size of the Alpha Thalassemia in the global market.

To analyze the global key players, SWOT analysis, value and global market share for top players.

To define, describe and forecast the market by type, end-use, and region.

To analyze and compare the market status and forecast among global major regions.

To analyze the global key regions market potential and advantage, opportunity and challenge, restraints and risks.

To identify significant trends and factors driving or inhibiting market growth.

To analyze the opportunities in the market for stakeholders by identifying the high growth segments.

To strategically analyze each submarket with respect to individual growth trend and their contribution to the market

To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.

To strategically profile the key players and comprehensively analyze their growth strategies.

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To conclude, the Alpha Thalassemia report mentions the key geographies, the market landscapes as well as the product price, revenues, volume, production, supply, demand, rate of market growth and forecasts etc. This report also provides a SWOT analysis, an investment feasibility analysis and a return on investment. analysis.

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What Will Be Driving Growth of Alpha Thalassemia market Near Future By Top Vendors Like | Bluebird Bio, Novartis, Kiadis Pharma, Acceleron Pharma ,...

Cancer Therapy Market Research by 2020 Top Countries Data, Key Players, Industry Revenue, Demand Status and Investments Plans Forecast to 2024 – The…

By Gene Therapy Clinics

Several big pharmaceutical companies, such as Pfizer and Eli lily, have also started these programs to help uninsured patients who are suffering from chronic diseases. Thus, a large number of uninsured patients, suffering from cancer, can also undergo cancer therapies, which is likely to augment the growth of the market.

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Key Market Trends:

The Target Therapy Segment is Expected to show the Fastest Growth in the Forecast Period

The target therapy segment is expected to show the highest CAGR of 9.68% during the forecast period. The target therapy includes hormone therapies, gene expression modulators, apoptosis inducers, angiogenesis inhibitors, immunotherapies, signal transduction inhibitors, and toxin delivery molecules. Targeted therapy is attaining importance due to its specificity toward cancer cells, while sparing the toxicity to off-target cells.

The breast cancer segment is belived to account for the largest market size over the forecast period. This is majorly attrobuted to the higher and continuously increaisng prevalence of breast cancer acoss the world. As per estimates provided by the Breast Cancer Organization in 2018, it is estimated that over 2,66,120 new cases of invasive breast cancer are expected to be diagnosed in women in the United States, along with 63,960 new cases of non-invasive (in situ) breast cancer.

North America Currently Dominates the Cancer Therapy Market and is Expected to Continue in the Forecast Period

North America currently dominates the market for cancer therapy and is expected to continue its stronghold for a few more years. This region is expected to increase its market share in the future, owing to the increased adoption of cancer therapy. The United States holds majority of the market in the North American region, due to the rising prevalence of cancer in the country. According to the National Cancer Institute (NCI), in 2016, 1.6 million people suffered from cancer, and around 0.5 million people died from cancer. This figure indicates that the prevalence of cancer is rapidly increasing in the United States.

Competitive Landscape:

Most of the companies present in the market are efficient at the technological front but require significant support for enhancing their services and expanding their businesses. Thus, mergers and acquisitions offer significant opportunities to gain the attention of a large number of providers across developed regions.

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Detailed TOC of Cancer Therapy Market Report 2020-2024:

1 INTRODUCTION 1.1 Study Deliverables 1.2 Study Assumptions 1.3 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS 4.1 Market Overview 4.2 Market Drivers 4.2.1 Increasing Patient Assistance Programs (PAPs) 4.2.2 Growing Government Initiatives for Cancer Awareness 4.2.3 Rising Prevalence of Cancer Worldwide 4.2.4 Strong R&D Initiatives from Key Players 4.3 Market Restraints 4.3.1 Fluctuation in Reimbursement Policies 4.3.2 High Cost of Cancer Therapies 4.4 Porters Five Force Analysis 4.4.1 Threat of New Entrants 4.4.2 Bargaining Power of Buyers/Consumers 4.4.3 Bargaining Power of Suppliers 4.4.4 Threat of Substitute Products 4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION 5.1 By Treatment Type 5.1.1 Chemotherapy 5.1.2 Targeted Therapy 5.1.3 Immunotherapy 5.1.4 Hormonal Therapy 5.1.5 Other Treatment Types 5.2 By Cancer Type 5.2.1 Blood Cancer 5.2.2 Breast Cancer 5.2.3 Prostate Cancer 5.2.4 Gastrointestinal Cancer 5.2.5 Gynecologic Cancer 5.2.6 Respiratory/Lung Cancer 5.2.7 Other Cancer Types 5.3 By End User 5.3.1 Hospitals 5.3.2 Spcialty Clinics 5.3.3 Cancer and Radiation Therapy Centers 5.4 Geography 5.4.1 North America 5.4.1.1 United States 5.4.1.2 Canada 5.4.1.3 Mexico 5.4.2 Europe 5.4.2.1 Germany 5.4.2.2 United Kingdom 5.4.2.3 France 5.4.2.4 Italy 5.4.2.5 Spain 5.4.2.6 Rest of Europe 5.4.3 Asia-Pacific 5.4.3.1 China 5.4.3.2 Japan 5.4.3.3 India 5.4.3.4 South Korea 5.4.3.5 Australia 5.4.3.6 Rest of Asia-Pacific 5.4.4 Middle East & Africa 5.4.4.1 GCC 5.4.4.2 South Africa 5.4.4.3 Rest of Middle East & Africa 5.4.5 South America 5.4.5.1 Brazil 5.4.5.2 Argentina 5.4.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE 6.1 Company Profiles 6.1.1 Amgen Inc. 6.1.2 AstraZeneca PLC 6.1.3 Bayer AG 6.1.4 Johnson and Johnson 6.1.5 Merck & Co. Inc. 6.1.6 F. Hoffmann-La Roche AG 6.1.7 Eli Lilly and Company 6.1.8 Novartis AG 6.1.9 Pfizer Inc.

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

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Cancer Therapy Market Research by 2020 Top Countries Data, Key Players, Industry Revenue, Demand Status and Investments Plans Forecast to 2024 - The...

Global Thalassemia Market 2020: Potential Growth, Challenges, and Know the Companies Listed-Novartis AG; Teva Pharmaceutical Industries Ltd.;…

By Gene Therapy Clinics

Global Thalassemia Marketis expected to rise from its initial estimated value of USD 1.99 billion to a projected value of USD 4.36 billion by 2026, registering a CAGR of 10.29% in the forecast period of 2019-2026. This rise in market value can be attributed to the increasing concern and awareness regarding the disease globally.

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Few of the major competitors currently working in the thalassemia market are ApoPharma Inc.; Novartis AG; Teva Pharmaceutical Industries Ltd.; Fresenius Kabi AG; Pfizer Inc.; bluebird bio, Inc.; Acceleron Pharma, Inc.; Incyte Corporation; Kiadis Pharma; Gamida Cell; CELGENE CORPORATION; GlaxoSmithKline plc; Ionis Pharmaceuticals, Inc.; Vifor Pharma; La Jolla Pharmaceutical Company; Lonza and Sangamo Therapeutics.

Major Insights of the Report

Key Developments in the Market:

In April 2019, CELGENE CORPORATION and Acceleron Pharma, Inc. announced that CELGENE had submitted a Biologics License Application (BLA) for luspatercept with the U.S. F.D.A. (United States Food & Drug Administration). This will help in faster commercialization and development of drugs for patients suffering from blood diseases. In January 2019, Vifor Pharma announced positive results from their phase-I trial of VIT-2763 an oral ferroportin inhibitor. The drug being developed for transportation of iron from one cell to another has shown signs in reduction of serum iron in a dose-dependent state. COMPETITIVE ANALYSIS: Global thalassemia 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 thalassemia market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Market Drivers

Increasing prevalence of the disease globally without any viable treatment options available for curing the disease; this factor is expected to drive the market growth Growth in development of pipeline drugs and development of new therapies because of R&D activities and investments by the various authorities; this factor is expected to drive the market growth

Market Restraint

Lack of viable treatment options commercialized for the treatment of disease/disorder rather than the symptoms associated with the disease; this factor is expected to restrain the market growth High cost of treatment for the disorder is expected to act as a restraint to the market growth

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Segmentation: Global Thalassemia Market

By Thalassemia Type

Alpha Thalassemia Beta Thalassemia

By Therapeutic Class

Iron Chelating Drugs Exjade/Jadenu (deferasirox)

By Pipeline

Gene Therapy LentiGlobin

By End-User

Hospitals Clinics Research Institutes Laboratories

By Geography

North America South America Europe Asia-Pacific Middle East & Africa

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Global Thalassemia Market 2020: Potential Growth, Challenges, and Know the Companies Listed-Novartis AG; Teva Pharmaceutical Industries Ltd.;...

Yufan inks deal with Abound to develop antibodies directing CAR T cells against cancer targets – BioWorld Online

By Induced Pluripotent Stem Cells

HONG KONG Xian, China-based Yufan Biotechnologies Co. Ltd. has partnered with Pittsburgh-based Abound Bio Inc. to discover and develop antibodies directing CAR T cells against cancer targets.

The three-year partnership will see the two companies incorporate antibodies for novel cancer targets into the enhanced, HPK1 (hematopoietic progenitor kinase 1)-inhibited CAR T-cell platform, they said. The agreement covers 10 cancer targets, including difficult to treat solid tumors such as liver cancer, Abounds CEO John Mellors told BioWorld.

Although both companies declined to reveal financial details, Mellors said, I calculate that Yufans technology added to Abounds antibodies gives a value greater than two." Yufan declined to comment for the article, but CEO Yan Zhang said, "The partnership with Abound will improve CAR T-cell products for cancer therapy.

The two companies will also share expertise and any potential commercial upside, as well as inventorship and development rights. Yufan definitely benefits, both financially and non-financially, particularly via development rights in China, Mellors said.

The companies will conduct preclinical, then clinical testing of the new CAR T cells against solid tumors, with trials expected to start in the first or second quarter of 2021, Mellors said. They will target the greater China market initially, with the rest of the world to follow. No other firms have been targeted as future partners yet.

Academic roots

The partnership between Yufan and Abound started with an academic collaboration between the National Cancer Institute and Tsinghua University, based on the work led by the universitys professor of pharmaceutical science, Xuebin Liao, who co-founded Yufan along with Zhang. That work demonstrated that HPK1 promotes T-cell exhaustion through NFkB-Blimp1 activation, and that blocking HPK1, via either gene knockout or small-molecule inhibitors, improves CAR T-cell immunotherapy.

Yufan was founded in July 2016 as part of the Xi'an Hi-tech Industries Development Zone Central Organization Departments Thousand Talents program. It focuses on upstream technology development, services and antibody screening for immuno-oncology therapy. The company is developing CAR T cells with a deleted HKP1 gene to prevent cell exhaustion, with a first-in-human clinical study of the XYF-19 HPK1 knockout CD19 CAR T product currently underway in patients with relapsed or refractory CD19+ leukemia or lymphoma.

Other projects include CAR T-cell therapy, CAR T-cell GMP production, immune cell gene editing CRISPR/Cas9 technology, a phage antibody library, phage display technology, and the buildout of a human antibody screening platform. The company is currently collaborating with the Air Force Military Medical Universitys Xijing Hospital on an investigational CAR T-cell therapy.

Yufan plans to invest 100 million (US$14.72 million) to build manufacturing facilities for CAR T-cell therapies to treat refractory and relapsed leukemia and lymphoma and expects to generate annual sales of between 200 million to 400 million once those candidates reach market.

Across the Pacific, Abound is an early stage biotechnology company developing antibody-based biological therapeutics for cancer and infectious diseases.

One infectious disease that the company is concentrating on is COVID-19, with the number of global cases topping 35 million as of Oct. 5, according to Johns Hopkins University data. An Abound team led by Mellors and the companys chief scientific officer, Dimiter Dimitrov, discovered human monoclonal antibodies with neutralizing activity in the laboratory against SARS-CoV-2, the virus that causes COVID-19, from antibody libraries.

Although the antibodies have proved effective in low doses in mouse and hamsters, human trials have not yet started. However, the antibodies are ready for testing in CAR T cells in preclinical models, and we hope to rapidly progress to clinical studies, Mellors said.

The company is currently proceeding with production and clinical development for regulatory approval and commercialization in the MENA and ASEAN regions, clinching an agreement with Saudi-U.S. joint venture Saudivax earlier in the year.

The Yufan-Abound partnership also aims to tap the lucrative T-cell market, which was valued at $2.7 billion in 2017 and is expected to reach $8.21 billion in 2025, growing at a compounded annual growth rate (CAGR) of 14.9% between 2017 and 2025, according to Frost & Sullivans report Growth Opportunities in the Global Cell Therapy Market, Forecast to 2025.

Amendments in regulatory and reimbursement policies, as well as the implementation of conditional approval policies for regenerative medicine, will further drive the market by expediting product launches, Aarti Chitale, Frost & Sullivan senior research analyst for transformational health, wrote. Additionally, improvements in cell culturing techniques alongside the use of different stem cells such as adipose-derived stem cells, mesenchymal stem cells, and induced pluripotent stem cells will strengthen the market with superior treatment options for non-oncological conditions such as neurological, musculoskeletal, and dermatological conditions, she added.

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Yufan inks deal with Abound to develop antibodies directing CAR T cells against cancer targets - BioWorld Online

Allele Biotechnology and Pharmaceuticals Files Two Lawsuits for Patent Infringement for the Unauthorized Use of mNeonGreen in Development and Testing…

By Induced Pluripotent Stem Cells

Oct. 6, 2020 01:40 UTC

SAN DIEGO--(BUSINESS WIRE)-- Allele Biotechnology and Pharmaceuticals, Inc. (Allele), a San Diego-based company focused on developing and adapting cutting edge technology for clinical and therapeutic use, filed two patent infringement lawsuits today one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. Both complaints address the infringement of Alleles patented mNeonGreen technology, an important reagent used in the development of therapeutics for COVID-19.

Alleles mNeonGreen protein is considered the worlds brightest monomeric fluorescent protein, and the technology behind that protein was patented in 2019. Prominent scientific journals have touted the use of mNeonGreen as the gold standard for use in assays testing neutralizing antibody and vaccine candidates. Regeneron, Pfizer, and BioNTech used mNeonGreen commercially without authorization from Allele.

I am pleased that mNeonGreen has played a pivotal role in the fight against COVID-19. In no way does Allele want to prohibit, or slow down development of vaccines or therapeutics discovered using this technology, says Dr. Jiwu Wang, Founder and CEO of Allele. Our goal is to have these companies recognize, as many others have before them, the hard work that went in to developing this technology and to respect our intellectual property.

Hundreds of organizations and universities have active licenses to use Alleles mNeonGreen technology. According to the complaint, Allele reached out to Regeneron on multiple occasions to negotiate a license on reasonable terms, but all of its requests went unanswered. In fact, no defendant sought any permission in advance of using mNeonGreen to obtain breakthrough successes in developing and testing their vaccines.

The purpose of these lawsuits is to maintain Allele's patent rights and to ensure that an agreement can be put in place to protect the rights of current and future licensees, says Dan Catron, Executive Director, Licensing and Business Development for Allele.

Perkins Coie LLP is representing Allele in the New York filing. Troutman Pepper Hamilton Sanders LLP is representing Allele in the California lawsuits.

About Allele Biotechnology and Pharmaceuticals Inc.

Established in 1999, Allele Biotechnology has focused on developing and adapting cutting edge technology for clinical and therapeutic use. Allele has worked on biological advancements that have been at the forefront of molecular biology research, including RNA interference, fluorescent proteins, induced Pluripotent Stem Cells (iPSCs), and camelid-derived, single-domain nanoantibodies. With the advent of the global pandemic, Allele initiated the development of a series of llama nanoantibodies against SARS-CoV-2, the virus responsible for COVID-19. To learn more, go to https://www.allelebiotech.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201005005984/en/

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Allele Biotechnology and Pharmaceuticals Files Two Lawsuits for Patent Infringement for the Unauthorized Use of mNeonGreen in Development and Testing...

Antibody cocktail given to Trump is controversial, and not only because its still under trial – ThePrint

By Stem Cell Treatment

Text Size: A- A+

New Delhi: US President Donald Trump was given an array of drugs to treat his Covid-19 symptoms. These included remdesivir, steroid dexamethasone, and an experimental cocktail of antibodies by biotech major Regeneron Pharmaceuticals.

While remdesivir and dexamethasone have been known to be used for mild and severe cases of Covid, the eight grams of experimental cocktail Trump was given generated controversy partly because it is still under trial, but also because it uses a method of research that has stirred Trumps voter base in the past: embryonic stem cell research.

In a statement on the research in April, the company said: Regeneron uses a wide variety of research tools and technologies to help discover and develop new therapeutics. Stem cells are one such tool. It added that there are limited research efforts employinghuman embryonic stem cells.

Trump has repeatedly identified himself as pro-life, a belief that nothing should harm life once it has been conceived. This is in line with the conservatives, who are often anti-abortion because of their Christian beliefs and make up a chunk of the Republican vote. In 2019, Trump even clamped down on the use of foetal tissue in scientific research.

In March this year, the Washington Post reported that a scientist was forced to abandon his research into a coronavirus treatment because of Trumps foetal tissue laws.

Also read:Trump leaves hospital but White House to restrict access to him during recovery

Embryonic stem cell research involves using cells at the embryo stage, when the human egg has been fertilised by sperm. The fertilised egg is referred to as an embryo till the 9th week, after which it is called a foetus.

Embryonic stem cells are sought after in scientific research because they can develop into all cell types of the body. While embryonic cells from abortions are commonly used, Regeneron clarified that it uses embryos that have been created solely through in vitro fertilization.

In 2001, the George Bush administration restricted federal funding for embryonic stem cell research. Bush, a conservative and Christian, said at the time, At its core, this issue forces us to confront fundamental questions about the beginnings of life and the ends of science.

This was changed only after Barack Obama came to power in 2008.

After Trump took the Oval Office in 2016, a ban or restriction on the use of embryonic and foetal tissue research was always on the cards. In 2019, the government officially imposed restrictions on the federal funding of research requiring foetal tissue.

According to the new rules, scientists must detail why exactly they require fetal tissue and how it will be obtained.

In its statement, Regeneron said it uses embryonic cells that are approved for research use by the National Institutes of Health and adheres to federal and state laws and regulations.

The cocktail given to Trump includes a mix of two potent antibodies directed against a spike protein found on the novel coronavirus surface. The therapy is still under trial. Regeneron released preliminary results last month saying it was safe, reduces viral load, and eases symptoms.

While recovering this week, Trump put out a spate of Tweets about the therapy. One of them said, PRO LIFE! VOTE!.

But Twitter users were quick to point out the hypocrisy.

Also read:Trump intends to be ready to debate Biden next week but will oppose a mute button

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Antibody cocktail given to Trump is controversial, and not only because its still under trial - ThePrint

Stem cell therapy for blood cancer patients at NIMS – The Hindu

By Stem Cell Treatment

In a big blessing for blood cancer patients requiring stem cell therapy, the State government has established a Centre for Stem Cell and Regenerative Medicine in the Nizams Institute of Medical Sciences (NIMS). The facility will particularly help those from the lower strata of the society who cannot afford corporate medical care.

The centre was inaugurated on Friday by Health Minister Eatala Rajender in the presence of NIMS Director K. Manohar and Superintendent N. Satyanarayana. The centre will provide a ray of hope to blood cancer patients from poor families, those covered under Aarogyashri scheme, requiring stem cell therapy as they would be treated at the centre free of cost, the Minister saidafter dedicating the stem cell and molecular lab as part of the centre to the people.

With the opening of the stem cell therapy centre, NIMS has grown into one of the major hospitals in the country, Mr Rajender stated samples of blood cancer patients which were sent to Delhi for diagnosis earlier can now be done here itself. The success rate of NIMS in stem cell therapy among kidney and heart transplantation patients was very high, he said, but some services were stopped due to rise in COVID-19 cases. However, all services would be resumed within a week with the COVID spread now under control.

Stating that living with COVID-19 would be a new norm as the society was doing with dengue, viral fever, swine flu and malaria, the Minister said and asserted that as per ICMR statistics, about 40 lakh people in Telangana had developed antibodies to COVID and the fleecing of patients families by corporate hospitals in the name of plasma therapy and some costly injections was wrong.

Mr Rajender admitted that COVID treatment in NIMS had impacted the treatment of other patients, particularly those coming in emergency health conditions, and made it clear that outpatient services would be scaled up soon with OP and Critical Care blocks being set up with an investment of 250 crore. Chief Minister K. Chandrasekhar Rao would lay the foundation stone for the new blocks soon to scale up the outpatient services from 2,500 a day in the past to 5,000 a day.

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Stem cell therapy for blood cancer patients at NIMS - The Hindu

The Global Stem Cell Therapy Market Growth To 2023 Will Be Driven By Increasing Prevalence Of Chronic Diseases – Press Release – Digital Journal

By Stem Cell Treatment

"Global Stem Cell Therapy Market, Forecast Market Size, 2019 2023, $ Billion"

The Business Research Companys Global Stem Cell Therapy Market Report 2020-30: Covid 19 Growth And Change; Segments Covered: 1) By Type: Allogeneic Stem Cell Therapy, Autologous Stem Cell Therapy 2) By Cell Source: Adult Stem Cells, Induced Pluripotent Stem Cells, Embryonic Stem Cells 3) By Application: Musculoskeletal Disorders, Wounds and Injuries, Cancer, Autoimmune Disorders, Others 4) By End-User: Hospitals, Clinics

The global stem cell therapy market is expected to decline from $8.73 billion in 2019 to $8.62 billion in 2020 at a compound annual growth rate (CAGR) of -1.24%. The decline is mainly due to the COVID-19 outbreak that has led to restrictive containment measures involving social distancing, remote working, and the closure of industries and other commercial activities resulting in operational challenges. The global stem cell therapy market is then expected to recover and reach $14.76 billion in 2023 at a CAGR of 19.62%.

The rising prevalence of chronic diseases contributed to the stem cell therapy market growth. Long working hours, limited physical activity, and unhealthy eating and drinking habits contribute to the prevalence of chronic diseases among people, thus driving the need for stem cell therapy. According to a United Nations article, by 2030, the proportion of global deaths due to chronic diseases is expected to increase to 70% of total deaths. The global burden of chronic diseases is expected to reach about 60%. The rising prevalence of chronic diseases is expected to drive the global stem cell therapy market growth.

Companies in the stem cell therapy market are increasingly investing in strategic partnerships. The strategic partnership is a mutually beneficial agreement between two companies that do not compete directly with each other. For instance, in September 2018, CRISPR Therapeutics, a biotechnology company that develops transformative medicine using the gene-editing platform for serious diseases, and ViaCyte, a California-based regenerative medicine company, collaborated for the development and commercialization of allogeneic stem cell therapies for diabetes treatment.

The high cost of stem cell therapy is expected to limit the growth of the stem cell therapy market. The pressure to contain costs and demonstrate value is widespread. Political uncertainty and persistent economic stress in numerous countries are calling into question the sustainability of public health care funding. In less wealthy countries, the lack of cost-effective therapies for chronic diseases has impacted the health conditions of the population and has led to a low average life expectancy. According to the DVCSTEM, the average cost of stem cell therapy in the USA is between $20,000 to $25,000, in Mexico, it is $33,000, in Central America, it is $30,000, and in Asia, it is $50,000, thus restraining the growth of the market.

The stem cell therapy market consists of the sales of stem cell therapy and related services by entities (organizations, sole traders, and partnerships) that provide stem cell therapy. Stem cell therapy, also known as regenerative medicine, promotes the repair response of a diseased patient, or a dysfunctional or injured tissue using stem cells or their derivatives.

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The Global Stem Cell Therapy Market Growth To 2023 Will Be Driven By Increasing Prevalence Of Chronic Diseases - Press Release - Digital Journal

Mesoblast hit by FDA rejection, request to run another trial – FierceBiotech

By Stem Cell Treatment

The FDA has issued (PDF) a complete response letter to Mesoblasts request for approval of allogeneic cell therapy remestemcel-L in children with steroid-resistant graft-versus-host disease. FDA officials want to see data from at least one additional clinical trial before granting full authorization, but Mesoblast is still hoping to snag an accelerated approval using its existing data.

Evidence of the FDAs concerns with Mesoblasts remestemcel-L filing emerged in August when the agency released a briefing document to inform a discussion of the application by the Oncologic Drugs Advisory Committee (ODAC). The FDA cited multiple perceived shortcomings of the filing, arguing for example that the ability of the mesenchymal stem cell therapy to reduce inflammation as measured by inflammatory biomarkers in humans receiving the product has not been demonstrated.

Despite the FDAs concerns, ODAC members voted nine to one that the data support the efficacy of remestemcel-L in children with steroid-resistant graft-versus-host disease. The positive ODAC vote sent shares in Mesoblast, which had been depressed by the briefing document, up 50%.

Join a panel of experts as they discuss the rigor involved in optimizing and scaling a reproducible serological assay for COVID-19.

However, the ODAC vote was advisory, and the FDA, in a rare but far from unprecedented action, has chosen to go against the recommendation of the committee. Shares in Mesoblast fell 37% in response to the rejection, sinking back to the low they hit in the wake of the briefing document.

Mesoblast said the FDA has recommended it runs at least one additional randomized clinical trial in adults or children with steroid-resistant graft-versus-host disease before refiling for approval. The recommendation suggests Mesoblast will need to expend time and money to get remestemcel-L to market. The phase 3 trial cited in the briefing document lasted almost three years.

However, Mesoblast is holding out hope that it can get remestemcel-L to some patients without the extra data requested by the FDA. In light of the unmet medical need, Mesoblast plans to request a Type A meeting with FDA to discuss the possibility of an accelerated approval. Mesoblast is hoping the FDA will agree to authorize remestemcel-L on the proviso that it runs a study post-approval.

If Mesoblast is to persuade the FDA to grant remestemcel-L accelerated approval, it may need to address some of the agencys other concerns. Mesoblast said the FDAs response letter identified the need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

The comment reflects sections of the briefing document in which the FDA said the quality attributes lack a demonstrated relationship to the clinical performance of specific [drug product] lots. In the absence of evidence of that relationship, the FDA said the attributes may not be sufficient to ensure the manufacturing process consistently produces remestemcel-L lots of acceptable quality.

In disclosing the response letter, Mesoblast said assays measuring the potency of remestemcel-L will continue to be refined to provide further scientific rationale for its use in severe inflammatory diseases with high mortality risk.

See more here:
Mesoblast hit by FDA rejection, request to run another trial - FierceBiotech

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