Latest Research on Autologous Cell Therapy Market 2020 by Application, Industry Share, End User with top players BioTime, Inc., BrainStorm Cell…

Note: Due to the pandemic, we have included a special section on the Impact of COVID 19 on the Autologous Cell TherapyMarket which would mention How the Covid-19 is Affecting the Industry, Market Trends and Potential Opportunities in the COVID-19 Landscape, Key Regions and Proposal for Autologous Cell Therapy Market Players to battle Covid-19 Impact.

The Autologous Cell TherapyMarket report is compilation of intelligent, broad research studies that will help players and stakeholders to make informed business decisions in future. It offers detailed research and analysis of key aspects of the Autologous Cell Therapy market. Readers will be able to gain deeper understanding of the competitive landscape and its future scenarios, crucial dynamics, and leading segments of the global Autologous Cell Therapy market. Buyers of the report will have access to accurate PESTLE, SWOT and other types of analysis on the global Autologous Cell Therapy market. Moreover, it offers highly accurate estimations on the CAGR, market share, and market size of key regions and countries. Players can use this study to explore untapped Autologous Cell Therapy markets to extend their reach and create sales opportunities.

The study encompasses profiles of major Companies/Manufacturers operating in the global Autologous Cell Therapy Market.Key players profiled in the report include:BioTime, Inc., BrainStorm Cell Therapeutics, Caladrius Biosciences, Inc., Fibrocell Science, Inc., Opexa Therapeutics, Inc., Pharmicell Co., Inc., Regeneus Ltd., TiGenix NV, TxCell SA, U.S. Stem Cell, Inc., Vericel Corporation and More

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Market By Product Types:Bone MarrowEpidermis

Market By Applications:NeurologyOrthopedicsCancerWound HealingCVDAutoimmuneOthers

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The authors of the report have analyzed both developing and developed regions considered for the research and analysis of the global Autologous Cell Therapy market. The regional analysis section of the report provides an extensive research study on different regional and country-wise Autologous Cell Therapy industry to help players plan effective expansion strategies.

Regions Covered in the Global Autologous Cell Therapy Market: The Middle East and Africa (GCC Countries and Egypt) North America (the United States, Mexico, and Canada) South America (Brazil etc.) Europe (Turkey, Germany, Russia UK, Italy, France, etc.) Asia-Pacific (Vietnam, China, Malaysia, Japan, Philippines, Korea, Thailand, India, Indonesia, and Australia)

Years Considered to Estimate the Market Size:History Year: 2015-2019Base Year: 2019Estimated Year: 2020Forecast Year: 2020-2025

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Latest Research on Autologous Cell Therapy Market 2020 by Application, Industry Share, End User with top players BioTime, Inc., BrainStorm Cell...

Stem Cell Therapy Market Latest Trends, Development, Revenue, Demand And Forecast To 2022 – Market Research Correspondent

Stem Cell Therapy Market is worth USD 11.99 billion in 2016 and is expected to reach USD 60.94 billion by 2022, growing at a CAGR of 31.1% from 2016 to 2022.

The global stem cell therapy market report offers in-depth analysis of the market size (revenue), market share, major market segments, different geographic regions, forecast for the next five years, key market players, and premium industry trends. It also focuses on the key drivers, restraints, opportunities and challenges in the stem cell therapy market.

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KEY BENEFITS OF THE REPORT:Deeper understanding of the strategies adopted by the key players in this market to stay competitiveGranular analysis about the growth map of the market during the next five yearsComprehensive analysis of the key market players and their market share

KEY PREMIUM INDUSTRY INSIGHTS:The increasing government initiatives and funding from various organizations, the increased spending on research and development, rapid technological advancement in genomics, and the rising awareness about the stem cell therapy are some of the factors fuelling the growth of the stem cell therapy market.

Other factors, such as the robust product pipelines and increasing approval of the new clinical trials are fuelling the growth of the stem cell therapy market further.However, improper infrastructure, insufficient storage systems, and ethical problems are the major restraints for the stem cell therapy market.

MARKET SEGMENTATION:This report analyzes the stem cell therapy market by the following segments:

Stem Cell Therapy Market, by TreatmentsAllogeneic Stem Cell TherapyAutologous Stem Cell TherapyStem Cell Therapy Market, by ApplicationsOncologyCentral Nervous System DiseasesEye DiseasesMusculoskeletal DiseasesWound & InjuriesMetabolic DisordersCardiovascular DisordersImmune System DisordersStem Cell Therapy Market, by End-usersHospitalsAmbulatory Surgical Centers

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KEY MARKET PLAYERS:Key players in the stem cell therapy market include:

Vericel Corporation.Stem Cells, Inc.Mesoblast, Ltd.Gamida CellOsiris Therapeutics, Inc.Chiesi Farmaceutici S.p.AReNeuron Group, plc

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Stem Cell Therapy Market Latest Trends, Development, Revenue, Demand And Forecast To 2022 - Market Research Correspondent

What is Stem Cell Therapy?

HUMAN CELLS AND TISSUE PRODUCTS (HCT/P) REGULATIONS

According to FDA 21 CFR 1271, an HCT/P is regulated solely under section 361 of the PHS Act and the regulations in this part if it meets all of the following criteria:

(1) The HCT/P is minimally manipulated;

(2) The HCT/P is intended for homologous use only, as reflected by the labeling, advertising, or other indications of the manufacturer's objective intent;

(3) The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P; and

(4) Either: (i) The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or (ii) The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and: (a) Is for autologous use; (b) Is for allogeneic use in a first-degree or second-degree blood relative; or (c) Is for reproductive use.

To learn more about FDA Regulations, please visit the following link: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271

More:

What is Stem Cell Therapy?

Nine Things To Know About Stem Cell Treatments A Closer …

It can be hard to tell the difference between doctors conducting responsible clinical trials and clinics selling unproven treatments. One common differentiator is the way a treatment is marketed. Most specialized doctors receive patient referrals, while clinics selling stem cell treatments tend to market directly to patients, often through persuasive language on the Internet, Facebook and in newspaper advertisements.

Clinics peddling unproven stem cell treatments frequently overstate the benefits of their offerings and use patient testimonials to support their claims. These testimonials can be intentionally or unintentionally misleading. For example, a person may feel better immediately after receiving a treatment, but the perceived or actual improvement may be due to other factors, such as an intense belief that the treatment will work, auxiliary treatments accompanying the main treatment, healthy lifestyle changes adapted in conjunction with the treatment and natural fluctuations in the disease or condition. These factors are complex and difficult to measure objectively outside the boundaries of carefully designed clinical trials. Learn more about why we need to perform clinical trials here.

Beware of clinics that use persuasive language, including patient testimonials, on the Internet, Facebook and newspapers, to market their treatments, instead of science-based evidence.

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Nine Things To Know About Stem Cell Treatments A Closer ...

With over 280 therapies under evaluation, the stem cell therapy market is estimated to be worth USD 8.5 Billion by 2030, claims Roots Analysis -…

Roots Analysis has announced the addition of Global Stem Cells Market: Focus on Clinical Therapies, 20202030 (Based on Source (Allogeneic, Autologous); Origin (Adult, Embryonic); Type (Hematopoietic, Mesenchymal, Progenitor); Lineage (Amniotic Fluid, Adipose Tissue, Bone Marrow, Cardiosphere, Chondrocytes, Corneal Tissue, Cord Blood, Dental Pulp, Neural Tissue Placenta, Peripheral Blood, Stromal Cells); and Potency (Multipotent, Pluripotent)) report to its list of offerings.

There is a growing body of evidence supporting the vast applicability and superiority of treatment outcomes of stem cell therapies, compared to conventional treatment options. In fact, the unmet needs within this domain have spurred the establishment of many start-ups in recent years.

To order this 500+ page report, which features 185+ figures and 220+ tables, please visit this link

Key Market Insights

Over 280 stem cell therapies are under development, most of which are allogeneic products

More than 50% of the pipeline candidates are in the mid to late phase trials (phase II and above), and allogenic therapies (majority of which are derived from the bone marrow) make up 65% of the pipeline.

70% of pipeline candidates are based on mesenchymal stem cells

It is worth highlighting that the abovementioned therapies are designed to treat musculoskeletal (22%), neurological (21%) and cardiovascular (15%) disorders. On the other hand, hematopoietic stem cell-based products are mostly being evaluated for the treatment of oncological disorders, primarily hematological malignancies.

Close to 85% stem cell therapy developers are based in North America and Asia-Pacific regions

Within these regions, the US, China, South Korea and Japan, have emerged as key R&D hubs for stem cell therapies. It is worth noting that majority of the initiatives in this domain are driven by small / mid-sized companies

Over 1,500 grants were awarded for stem cell research, since 2015

More than 45% of the total amount was awarded under the R01 mechanism (which supports research projects). The NCI, NHLBI, NICHD, NIDDK, NIGMS and OD emerged as key organizations that have offered financial support for time periods exceeding 25 years as well.

Outsourcing has become indispensable to R&D and manufacturing activity in this domain

Presently, more than 80 industry / non-industry players, based in different regions across the globe, claim to provide contract development and manufacturing services to cater to the unmet needs of therapy developers. Examples include (in alphabetical order) Bio Elpida, Cell and Gene Therapy Catapult, Cell Tech Pharmed, GenCure, KBI Biopharma, Lonza, MEDINET, Nikon CeLL innovation, Roslin Cell Therapies, WuXi Advanced Therapies and YposKesi.

North America and Asia-Pacific markets are anticipated to capture over 80% share by 2030

The stem cell therapies market is anticipated to witness an annualized growth rate of over 30% during the next decade. Interestingly, the market in China / broader Asia-Pacific region is anticipated to grow at a relatively faster rate.

To request a sample copy / brochure of this report, please visit this link

Key Questions Answered

The USD 8.5 billion (by 2030) financial opportunity within the stem cell therapies market has been analyzed across the following segments:

The report features inputs from eminent industry stakeholders, according to whom stem cell therapies are currently considered to be a promising alternatives for the treatment of a myriad of disease indications, with the potential to overcome challenges associated with conventional treatment options. The report includes detailed transcripts of discussions held with the following experts:

The research covers brief profiles of several companies (including those listed below); each profile features an overview of the company, financial information (if available), stem cell therapy portfolio and an informed future outlook.

For additional details, please visit

https://www.rootsanalysis.com/reports/view_document/stem-cells-market/296.html or email [emailprotected]

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With over 280 therapies under evaluation, the stem cell therapy market is estimated to be worth USD 8.5 Billion by 2030, claims Roots Analysis -...

Animal Stem Cell Therapy Market to Reach US$ Million at xx% CAGR During the Forecast Period 2017 2025 – Bulletin Line

With having published myriads of reports, PMR imparts its stalwartness to clients existing all over the globe. Our dedicated team of experts deliver reports with accurate data extracted from trusted sources. We ride the wave of digitalization facilitate clients with the changing trends in various industries, regions and consumers. As customer satisfaction is our top priority, our analysts are available 24/7 to provide tailored business solutions to the clients.

In this new business intelligence report, PMR serves a platter of market forecast, structure, potential, and socioeconomic impacts associated with the global Animal Stem Cell Therapy market. With Porters Five Forces and DROT analyses, the research study incorporates a comprehensive evaluation of the positive and negative factors, as well as the opportunities regarding the Animal Stem Cell Therapy market.

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The Animal Stem Cell Therapy market report has been fragmented into important regions that showcase worthwhile growth to the vendors Region 1 (Country 1, Country 2), region 2 (Country 1, Country 2) and region 3 (Country 1, Country 2). Each geographic segment has been assessed based on supply-demand status, distribution, and pricing. Further, the study provides information about the local distributors with which the market players could create collaborations in a bid to sustain production footprint.

Key Participants

The key participants in the animal stem cell therapy market are Magellan Stem Cells, ANIMAL CELL THERAPIES, Abbott Animal Hospital, VETSTEM BIOPHARMA, Veterinary Hospital and Clinic Frisco, CO, etc. The companies are entering into the collaboration and partnership to keep up the pace of the innovations.

The report covers exhaustive analysis on:

Regional analysis for Market includes

Report Highlights:

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What does the Animal Stem Cell Therapy market report contain?

Readers can get the answers of the following questions while going through the Animal Stem Cell Therapy market report:

And many more

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Animal Stem Cell Therapy Market to Reach US$ Million at xx% CAGR During the Forecast Period 2017 2025 - Bulletin Line

Good-Risk Group of Patients With Myeloma Saw Better Outcomes – Cancer Therapy Advisor

Researchers have used deep whole-genome sequencing (WGS) to identify genomic markers of a good-risk group of patients with multiple myeloma with prolonged survival. Specifically, patients found to have a low genomic scar score and chromosome 9 gain had superior outcomes.

In the study, researchers analyzed WGS data from a 2009 study from 183 patients with newly diagnosed myeloma who had been treated with lenalidomide, bortezomib, and dexamethasone alone or in combination with autologous stem cell transplant. These data were then integrated with clinical data.

The researchers calculated a genomic scar score (GSS) using allele-specific copy-number alterations. Patients with a total score of 5 or less were considered to have a low GSS.

On average, WGS identified 7343 single nucleotide variants, 235 small insertions, and 376 deletions per patient. Significant variations in mutational load were found, with hyperdiploid myeloma having the lowest and t(14;16) myeloma having the highest load (P =.004).

In all, patients with a low GSS had significantly longer median progression-free survival and overall survival than other patients. The researchers identified a genomically defined subgroup of patients accounting for about 17% of patients with low DNA damage (a low genomic scar score with chromosome 9 gain) and a superior outcome. These patients had 100% overall survival at 69 months.

Other characteristics of this subgroup included lower mutational load with significant contribution from age-related mutations and NRAS mutation. Specifically, patients with low GSS and chromosome 9 gain had significantly lower mutational load compared with other groups (P =.0002).

Interestingly, the superior outcome group identified here was independent of traditional clinical risk factors, such as ISS, response to treatment, and achievement of [minimal residual disease] negativity, the researchers wrote. Importantly, our study shows that, in addition to traditional risk markers, we can use genomic markers such as low GSS and gain9 to identify true low-risk groups.

Reference

Samur MK, Samur AA, Fulciniti M, et al. Genome-wide somatic alterations in multiple myeloma reveal a superior outcome group [published online July 20, 2020]. J Clin Oncol. doi: 10.1200/jco.20.00461

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Good-Risk Group of Patients With Myeloma Saw Better Outcomes - Cancer Therapy Advisor

‘Year of Preparations for the Next Fifty Years’ will contribute to country’s development process – Emirates News Agency

ABU DHABI, 3rd August, 2020 (WAM) -- In 2020, the UAEs achievements, most notably the launch of the Hope Probe to Mars and the operation of Unit 1 of the Barakah Nuclear Power Plant, have proven that the "Year of Preparations for the Next Fifty Years" will significantly contribute to the countrys development process.

Despite the difficult circumstances facing the world caused by the coronavirus, COVID-19, pandemic, the UAE has succeeded in turning challenges into opportunities for innovation and development, which is reflected in its approach to limiting the spread of the virus through a range of creative measures, such as developing technology to discover the virus using lasers that generate results in a record time, using stem cell therapy for patients, and participating in global efforts to find a vaccine.

In 2020, the UAEs achievements reflect the national ambitions and wisdom of its leadership. The Hope Probe project involved nearly 200 Emirati engineers and researchers, who worked hard for six years to fulfil the UAE's dream to reach the Red Planet.

The Barakah Nuclear Power Plant also highlights the UAEs efforts to build the capacities of national cadres in this sector. Nearly 244 employees work for the Federal Authority for Nuclear Regulation, FANR, with 67 percent being Emiratis, of which 45 percent are in leading and managerial positions. Women also account for over 40 percent of the Authoritys employees.

Once all four units of the plant are commercially operating, the UAE's Barakah Nuclear Energy Plant will produce up to 25 percent of the country's electricity requirements while in parallel preventing the release of 21 million tons of carbon emissions each year.

On the level of combating COVID-19, Emirati national cadres and institutions joined the front line since the first day to discover the first case in the country, and contributed to achieving milestones at the global level.

In May, a patent was granted by the Ministry of Economy for the development of an innovative and promising treatment for COVID-19 infections using stem cells. The treatment was developed by a team of doctors and researchers at the Abu Dhabi Stem Cell Center, ADSCC, and involves extracting stem cells from the patients own blood and reintroducing them after activating them.

QuantLase Imaging Lab, the medical-research arm of the Abu Dhabi Stock Exchange-listed International Holdings Company, IHC, announced that it has developed novel equipment which enables for much faster mass screenings, with test results available in seconds and allowing testing on a wider scale.

The technology will reinforce the UAEs position as a hub of research and innovation, as scientists around the world scramble to devise a faster method of testing for patients suspected to have been infected with the coronavirus and potentially identifying carriers before they become infectious.

The first World Health Organisation, WHO, enlisted global clinical Phase III trial of Sinopharm CNBGs inactivated vaccine to combat COVID-19 started in Abu Dhabi.

The worlds first Phase III trial is the result of a cooperation partnership between Abu Dhabi based G42 Healthcare, currently at the forefront of the battle against COVID-19 in the UAE, and Sinopharm CNBG, the worlds sixth-largest vaccine manufacturer, ranked 169th on the Fortune Global 500 list of 2018.

The trials are being operated by health practitioners from Abu Dhabi Health Services, SEHA, who are providing facilities at five of their clinics in Abu Dhabi and Al Ain in addition to a mobile clinic to ensure the trials are readily accessible to volunteers participating in the programme.

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'Year of Preparations for the Next Fifty Years' will contribute to country's development process - Emirates News Agency

Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 – Bulletin Line

Insights on the Global Stem Cell-Derived Cells Market

PMR is one of the leading market research companies in India. Our team of research analysts have a deep understanding and knowledge related to the latest market research techniques and use their analytical skills to curate insightful and high-quality market reports. The presented data is collected from credible primary sources including marketing heads, sales managers, product managers, industry experts, and more.

As per the report, the global Stem Cell-Derived Cells market reached a value of ~US$ XX in 2018 and is likely to surpass a market value of ~US$XX by the end of 2029. Further, the report reveals that the Stem Cell-Derived Cells market is set to grow at a CAGR of ~XX% during the forecast period (2019-2029)

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Critical doubts related to the Stem Cell-Derived Cells market addressed in the report:

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Segmentation of the Stem Cell-Derived Cells market

The report bifurcates the Stem Cell-Derived Cells market into different segments to provide a clear understanding of the various aspects of the market.

Regional Outlook

The regional outlook section of the report includes vital data such as the current trends, regulatory framework, The Stem Cell-Derived Cells market study offers critical data including, the sales volume, sales growth, and pricing analysis of the different products in the Stem Cell-Derived Cells market.

key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

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Stem Cell-Derived Cells Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2019 2029 - Bulletin Line

UAE’s first bone marrow transplant patient tells of life-saving treatment – The National

The first patient to undergo a bone marrow transplant in the UAE has told of how the stem cell treatment saved his life.

Abdullah Muhammad had blood cancer diagnosed in 2018 after he began to vomit blood.

Doctors said the health of the 49-year-old electrician from Pakistan had begun to rapidly deteriorate and his only option was to undergo an expensive bone marrow transplant.

I didnt have money to get a transplant and the UAE sponsored my treatment.

"I am happy to be first one to undergo this transplant in the UAE. It wouldnt have been able to afford it in Pakistan, said Mr Muhammad, whose family live in Khanewal District. The father of four received his transplant on July 18 at Sheikh Khalifa Medical City, with the involvement of Abu Dhabi Stem Cell Centre, which is also developing a treatment for Covid-19 patients.

I didnt have money to get a transplant and the UAE sponsored my treatment. I am happy to be first one to undergo this transplant in the UAE

Abdullah Nazir Ahmad Muhammad

The transplant procedure will bring hope to cancer patients in the UAE, who can now seek treatment closer to home.

Known as regenerative medicine, stem cell therapy promotes the repair of abnormal or injured tissue.

Doctors can manipulate the cells into the type the patient needs and inject them where repair is necessary. The cells can be taken from a matching donor or harvested from the patient, treated, and then reintroduced to the body.

The UAE has begun to harness stem cell therapy in recent months to fight the coronavirus, but this was the first time it was used in a transplant in the Emirates.

In Mr Muhammads case, stem cells were harvested from his own blood and were injected back into him after he underwent a short course of chemotherapy. This is called an autologous bone marrow transplant.

Dr Fatima Al Kaabi, executive director of Abu Dhabi Bone Marrow Transplant Programme, said the treatment was a milestone for the UAE.

Most of these cases travel abroad so, in the near future, we will be self-sufficient and efficient to take care of our own with the highest calibre of medical care and international standards," she said.

Dr Al Kaabi said that to harvest the cells, Mr Muhammad was injected with a stimulant that prompted the stem cells to leave his bone marrow and enter his bloodstream.

His blood was drawn using a machine similar to one used in kidney dialysis to separate the plasma containing the stem cells from the blood.

The plasma was safely stored while Mr Muhammad underwent chemotherapy to wipe out the bone marrow and give way to the new cells, she said.

Mr Muhammad was kept in a sterile area for 10 to 15 days to prevent him from catching infections until the stem cells were returned to his body. The reintroduction of cells to his body took about 20 minutes.

After the successful autologous bone marrow transplant, Abu Dhabi Stem Cells Centre aims to begin carrying out transplants from related donors.

For now only we are doing autologous transplants, where the patient and donor are the same person, but in the near future we will not only do related transplantation but more complicated ones where donors are not related to the patient, said Dr Yendry Ventura, general manager of the stem cell centre and director of Abu Dhabi Bone Marrow Transplant Programme.

Sheikh Khalifa Medical City and the Department of Health Abu Dhabi are working on a stem cell donor registry.

The next transplant is scheduled for a few weeks' time, with the centre aiming to perform 10 transplants before the related transplant programme. It also plans to begin a transplant programme for children.

We want to provide the people of UAE a programme that is not only comparable with any other programme in the rest of the world but also offers customised and personalised treatment, Dr Ventura said.

Mr Muhammad, who has been in hospital since July 8, will be released in a few days and plans to return to Pakistan in October to see his family.

Updated: July 29, 2020 03:10 PM

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UAE's first bone marrow transplant patient tells of life-saving treatment - The National

Cell Therapy Manufacturing Market is estimated to reach close to USD 11 Billion by 2030, predicts Roots Analysis – Market Research Posts

Manufacturing cell therapies is technically and financially demanding; as a result, despite therapy developers gradually strengthening their in-house expertise, they are also becoming increasingly reliant on contract service providers

Roots Analysis is pleased to announce the publication of its recent study, titled, Cell Therapy Manufacturing Market (3rd Edition), 2019 2030.

The report features an extensive study of the current market landscape and future opportunities associated with cell therapy manufacturing. It focuses on both contract manufacturers, as well as developers with in-house manufacturing facilities, offering in-depth analyses of the various business entities that are engaged in this domain, across different global regions. Amongst other elements, the report includes:

Read Detailed Analysis: https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html

A detailed market forecast, featuring analysis of the current and projected future opportunity across key market segments (listed below)

Type of therapy

Source of cells

Scale of operation

Purpose of manufacturing

Key geographical regions

Key companies covered in the report

For more information, please click on the following link:

https://www.rootsanalysis.com/reports/view_document/cell-therapy-manufacturing/285.html

About Roots Analysis

Roots Analysis is one of the fastest growing market research companies, sharing fresh and independent perspectives in the bio-pharmaceutical industry. The in-depth research, analysis and insights are driven by an experienced leadership team which has gained many years of significant experience in this sector. If youd like help with your growing business needs, get in touch at [emailprotected]

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Cell Therapy Manufacturing Market is estimated to reach close to USD 11 Billion by 2030, predicts Roots Analysis - Market Research Posts

Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with…

DetailsCategory: AntibodiesPublished on Sunday, 02 August 2020 16:34Hits: 922

COPENHAGEN, Denmark I July 31, 2020 I Genmab A/S (Nasdaq: GMAB) announced today that the European Myeloma Network (EMN) in collaboration with Janssen Research & Development, LLC (Janssen) reported positive results from the Phase 3 APOLLO (MMY3013) study of the subcutaneous (SC) formulation of daratumumab in combination with pomalidomide and dexamethasone (Pd) versus Pd alone as treatment for patients with relapsed or refractory multiple myeloma who have previously been treated with lenalidomide (an immunomodulatory drug) and a proteasome inhibitor (PI). The study met the primary endpoint of improving progression-free survival (PFS). Overall, the safety profile of daratumumab SC in combination with Pd was consistent with the safety profile for each therapy separately.

We are pleased with these positive results for daratumumab, administered as a subcutaneous formulation, in combination with pomalidomide and dexamethasone. The corresponding intravenous regimen was previously approved by the U.S. FDA based on the Phase1 single-arm EQUULEUS study, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Janssen Biotech, Inc., which obtained an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab in 2012, intends to discuss the data with health authorities in preparation for regulatory submissions and plans to submit the data for presentation at an upcoming medical conference.

The APOLLO study was designed to confirm the results from the Phase 1 EQUULEUS (MMY1001) study, which investigated intravenous (IV) daratumumab plus Pd in the same indication. In June 2017, the U.S. Food and Drug Administration (U.S. FDA) approved the use of DARZALEX in combination with Pd for the treatment of patients with multiple myeloma who have received at least two prior therapies including lenalidomide and aPI based on the results of the EQUULEUS study.

About the APOLLO (MMY3013) studyThis Phase 3 (NCT03180736), randomized, open-label, multicenter study included 304 patients with multiple myeloma who have previously been treated with lenalidomide and a PI. Patients were randomized 1:1 to either receive daratumumab in combination with Pd or Pd alone. In the original design of the study, patients in the daratumumab plus Pd arm were treated with the IV formulation of daratumumab. As of Amendment 1, all new subjects in the experimental arm were dosed with the SC formulation of daratumumab and patients who had already begun treatment with IV daratumumab had the option to switch to the SC formulation. The primary endpoint of the study was PFS. The study was conducted in Europe under an agreement between Janssen, EMN and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).

About multiple myelomaMultiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,000 new patients were estimated diagnosed with multiple myeloma and approximately 13,650 people were expected to have died from the disease in the U.S. in 2018.3 Globally, it was estimated that 160,000 people were diagnosed and 106,000 died from the disease in 2018.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5

About DARZALEX (daratumumab)DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients in the United States: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent.6 DARZALEX is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration (U.S. FDA) approval to treat multiple myeloma.

DARZALEX is indicated for the treatment of adult patients in Europe via intravenous infusion or subcutaneous administration: in combination with bortezomib, thalidomide and dexamethasone as treatment for patients newly diagnosed with multiple myeloma who are eligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy7. Daratumumab is the first subcutaneous CD38-directed antibody approved in Europe for the treatment of multiple myeloma. The option to split the first infusion of DARZALEX over two consecutive days has been approved in both Europe and the U.S.

In Japan, DARZALEX intravenous infusion is approved for the treatment of adult patients: in combination with lenalidomide and dexamethasone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant; in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for the treatment of relapsed or refractory multiple myeloma. DARZALEX is the first human CD38 monoclonal antibody to reach the market in the United States, Europe and Japan. For more information, visit http://www.DARZALEX.com.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, is approved in the United States for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for ASCT; in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a PI and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.8 DARZALEX FASPRO is the first subcutaneous CD38-directed antibody approved in the U.S. for the treatment of multiple myeloma.

Daratumumab is a human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab triggers a persons own immune system to attack the cancer cells, resulting in rapid tumor cell death through multiple immune-mediated mechanisms of action and through immunomodulatory effects, in addition to direct tumor cell death, via apoptosis (programmed cell death).6,9,10,11,12

Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. A comprehensive clinical development program for daratumumab is ongoing, including multiple Phase III studies in smoldering, relapsed and refractory and frontline multiple myeloma settings. Additional studies are ongoing or planned to assess the potential of daratumumab in other malignant and pre-malignant diseases in which CD38 is expressed, such as amyloidosis and T-cell acute lymphocytic leukemia (ALL). Daratumumab has received two Breakthrough Therapy Designations from the U.S. FDA for certain indications of multiple myeloma, including as a monotherapy for heavily pretreated multiple myeloma and in combination with certain other therapies for second-line treatment of multiple myeloma.

About Genmab Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX (daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra (ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S., has been approved in the U.S. and Europe for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody platform for generation of bispecific antibodies, the HexaBody platform, which creates effector function enhanced antibodies, the HexElect platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.

1 American Cancer Society. "Multiple Myeloma Overview." Available at http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed June 2016.2 National Cancer Institute. "A Snapshot of Myeloma." Available at http://www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016. 3 Globocan 2018. United States of America Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4 Globocan 2018. World Fact Sheet. Available at http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.5 American Cancer Society. "How is Multiple Myeloma Diagnosed?" http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 20166 DARZALEX Prescribing information, September 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf Last accessed September 20197 DARZALEX Summary of Product Characteristics, available at https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last accessed June 20208 DARZALEX FASPRO Prescribing information, May 2020. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf Last accessed May 20209 De Weers, M et al. Daratumumab, a Novel Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of Multiple Myeloma and Other Hematological Tumors. The Journal of Immunology. 2011; 186: 1840-1848.10 Overdijk, MB, et al. Antibody-mediated phagocytosis contributes to the anti-tumor activity of the therapeutic antibody daratumumab in lymphoma and multiple myeloma. MAbs. 2015; 7: 311-21.11 Krejcik, MD et al. Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood. 2016; 128: 384-94.12 Jansen, JH et al. Daratumumab, a human CD38 antibody induces apoptosis of myeloma tumor cells via Fc receptor-mediated crosslinking.Blood. 2012; 120(21): abstract 2974.

SOURCE: Genmab

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Genmab Announces European Myeloma Network and Janssen Achieve Positive Topline Results from Phase 3 APOLLO Study of Daratumumab in Combination with...

Boehringer Ingelheim acquires GST to strengthen its stem cell capabilities in Animal Health – Business Wire

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim, a market leader in animal health, has acquired Global Stem cell Technology (GST), a Belgian veterinary biotech company. GST is dedicated to the research, development and production of evidence-based, regenerative medicines (stem cell therapies) used to treat orthopedic and metabolic diseases in animals. Boehringer Ingelheim already entered into a partnership with GST in 2018; in 2019, the companies launched Arti-Cell Forte in Europe.

Arti-Cell Forte is testimony to the innovation strength that lies within both companies. It is the first-ever stem cell product in the veterinary world granted marketing authorization by the European Commission. The acquisition and integration of GST will accelerate the development pipeline of Boehringer Ingelheim while maintaining its focus on setting new standards of care for animals.

Collaboration with external partners plays an essential role in helping us expand our portfolio. After two years of a very successful partnership, we have decided to acquire GST. We are convinced that its expertise in the field of state-of-the art stem cell products will help us bring even more innovative solutions to our customers, shares Jean-Luc Michel, Head of Global Strategic Marketing, Boehringer Ingelheim Animal Health.

Boehringer Ingelheim wants to lead a new wave of innovation in the veterinary field. This ambition is a natural fit with GSTs management, staff and vision. From the very beginning we aimed to change the veterinary field, a role we will continue to play as a new R&D division within Boehringer Ingelheim, says Jan Spaas, CEO of GST.

This decision is fully aligned with our recently refocused strategic direction. Stem cell research areas and regenerative medicine offer an exciting potential for the next wave of innovation we are actively pursuing. In addition, strengthening external partnerships to accelerate our innovative efforts and growth is one of the key elements of our strategy, adds Eric Haaksma, Head of Global Innovation at Boehringer Ingelheim Animal Health.

The companies did not disclose the financial terms of the deal.

For references and notes to editors, please visit:

http://www.boehringer-ingelheim.com/press-release/boehringer-ingelheim-acquires-global-stem-cell-technology

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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Boehringer Ingelheim acquires GST to strengthen its stem cell capabilities in Animal Health - Business Wire

Animal Stem Cell Therapy Market Growth, Trends and Value Chain 2019-2025 – Owned

Animal Stem Cell Therapy Market 2018: Global Industry Insights by Global Players, Regional Segmentation, Growth, Applications, Major Drivers, Value and Foreseen till 2024

The report provides both quantitative and qualitative information of global Animal Stem Cell Therapy market for period of 2018 to 2025. As per the analysis provided in the report, the global market of Animal Stem Cell Therapy is estimated to growth at a CAGR of _% during the forecast period 2018 to 2025 and is expected to rise to USD _ million/billion by the end of year 2025. In the year 2016, the global Animal Stem Cell Therapy market was valued at USD _ million/billion.

This research report based on Animal Stem Cell Therapy market and available with Market Study Report includes latest and upcoming industry trends in addition to the global spectrum of the Animal Stem Cell Therapy market that includes numerous regions. Likewise, the report also expands on intricate details pertaining to contributions by key players, demand and supply analysis as well as market share growth of the Animal Stem Cell Therapy industry.

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The Research projects that the Animal Stem Cell Therapy market size will grow from in 2018 to by 2024, at an estimated CAGR of XX%. The base year considered for the study is 2018, and the market size is projected from 2018 to 2024.

Segment by Type, the Animal Stem Cell Therapy market is segmented intoDogsHorsesOthers

Segment by Application, the Animal Stem Cell Therapy market is segmented intoVeterinary HospitalsResearch Organizations

Regional and Country-level AnalysisThe Animal Stem Cell Therapy market is analysed and market size information is provided by regions (countries).The key regions covered in the Animal Stem Cell Therapy market report are North America, Europe, Asia Pacific, Latin America, Middle East and Africa. It also covers key regions (countries), viz, U.S., Canada, Germany, France, U.K., Italy, Russia, China, Japan, South Korea, India, Australia, Taiwan, Indonesia, Thailand, Malaysia, Philippines, Vietnam, Mexico, Brazil, Turkey, Saudi Arabia, UAE, etc.The report includes country-wise and region-wise market size for the period 2015-2026. It also includes market size and forecast by Type, and by Application segment in terms of sales and revenue for the period 2015-2026.Competitive Landscape and Animal Stem Cell Therapy Market Share AnalysisAnimal Stem Cell Therapy market competitive landscape provides details and data information by players. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on revenue (global and regional level) by players for the period 2015-2020. Details included are company description, major business, company total revenue and the sales, revenue generated in Animal Stem Cell Therapy business, the date to enter into the Animal Stem Cell Therapy market, Animal Stem Cell Therapy product introduction, recent developments, etc.The major vendors covered:Medivet Biologics LLCVETSTEM BIOPHARMAJ-ARMU.S. Stem Cell, IncVetCell TherapeuticsCelavet Inc.Magellan Stem CellsKintaro Cells PowerAnimal Stem CareAnimal Cell TherapiesCell Therapy SciencesAnimacel

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Animal Stem Cell Therapy Market Growth, Trends and Value Chain 2019-2025 - Owned

Rheumatoid Arthritis Stem Cell Therapy Market Shares, Strategies and Forecast Worldwide, 2018 to 2028 Bulletin Line – Bulletin Line

Fact.MR, in its recently published market research report, provides an in-depth analysis of the Rheumatoid Arthritis Stem Cell Therapy market included the anticipated growth pattern of the market over the forecast period (2019-2029). A detailed assessment of the various micro and macro-economic factors that are likely to shape the course of the Rheumatoid Arthritis Stem Cell Therapy market over the next decade is enclosed in the report. The study suggests that the Rheumatoid Arthritis Stem Cell Therapy market is expected to register a CAGR growth of XX% over the forecast period primarily driven by factors including factor 1, factor 2, factor 3, and factor 4.

Further, the methodical and systematic approach adopted by the analysts while curating the report ensures that the data in the report is insightful, relevant, and a valuable tool for our clients to gain a competitive advantage in the current and future market landscape.

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Competitive assessment

The competitive assessment included in the report throws light on the business strategies incorporated by leading market players operating in the Rheumatoid Arthritis Stem Cell Therapy market. The comprehensive study provides a birds eye view of the business operations of top-tier market players along with relevant graphs, figures, and tables.

Regional analysis

The regional analysis section touches upon the market scenario in the various geographies worldwide and the factors that are projected to influence the market dynamics in each region. The impact of the economic and political policies of different countries in each region is discussed in the report in detail.

End Use study

The report bifurcates the Rheumatoid Arthritis Stem Cell Therapy market on the basis of end-use and tracks the Y-o-Y growth of each end use segment.

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Rheumatoid Arthritis Stem Cell Therapy Market Shares, Strategies and Forecast Worldwide, 2018 to 2028 Bulletin Line - Bulletin Line

FDA Approves Tafasitamab-cxix in Combination With Lenalidomide for the Treatment of DLBCL – Pharmacy Times

FDA Approves Tafasitamab-cxix in Combination With Lenalidomide for the Treatment of DLBCL

A humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, tafasitamab-cxix received accelerated approval based on overall response rate (ORR). Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Globally, DLBCL is the most common type of non-Hodgkin lymphoma in adults. The aggressive disease is characterized by rapidly growing masses of malignant B-cells in the lymph nodes, spleen, liver, bone marrow or other organs, and about 1 in 3 patients do not respond to initial therapy or relapsing thereafter.In the United States, approximately 10,000 patients are diagnosed with relapsed or refractory DLBCL who are not eligible for ASCT, each year.

The FDA approval was based on data from the MorphoSys-sponsored Phase 2 L-MIND study, an open label, multicenter, single arm trial of tafasitamab-cxix in combination with lenalidomide as a treatment for adult patients with relapsed or refractory DLBCL. Results from the study showed an ORR of 55% (primary endpoint), including a complete response (CR) rate of 37%, and a partial response rate (PR) of 18%. The median duration of response (mDOR) was 21.7 months (key secondary endpoint).

Warnings and precautions for tafasitamab-cxix included infusion-related reactions (6%), serious or severe myelosuppression including neutropenia (50%), thrombocytopenia (18%), and anemia (7%); infections (73%), and embryo-fetal toxicity. Neutropenia led to treatment discontinuation in 3.7% of patients. The most common adverse reactions ( 20%) were neutropenia, fatigue, anemia, diarrhea, thrombocytopenia, cough, pyrexia, peripheral edema, respiratory tract infection, and decreased appetite.

The FDA previously granted Fast Track and Breakthrough Therapy Designation for the tafasitamab-cxix and lenalidomide combination in treatment of relapsed or refractory DLBCL. FDA.

Tafasitamab-cxix is expected to be commercially available in the United States shortly, according to MorphoSys and Incyte, which plan to co-commercialize this therapy in the US. Incyte has exclusive commercialization rights outside the US.

REFERENCE

FDA Approves Monjuvi(tafasitamab-cxix) in Combination With Lenalidomide for the Treatment of Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) [news release]. Planegg & Munich, Germany, and Wilmington, DE; July 31, 2020: MorphoSys and Incyte.https://www.businesswire.com/news/home/20200731005497/en.

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FDA Approves Tafasitamab-cxix in Combination With Lenalidomide for the Treatment of DLBCL - Pharmacy Times

Ozzy Osbourne: I was convinced I was dying during nightmare health year – Martinsville Bulletin

Ozzy Osbourne was "convinced" he was dying amid his year plagued with health setbacks.

The 'Crazy Train' hitmaker suffered a nightmare year in 2019 which saw him endure several medical issues including a fall, neck surgery, an infection in his hand, and hospitalization for the flu.

And at the start of 2020, he revealed he had been diagnosed with Parkinson's - which is a brain disorder that leads to shaking, stiffness, and difficulty with walking, balance, and coordination - for which he later had stem cell treatment to try and ease the symptoms.

Discussing his year of ill health, Ozzy said: "I'm not back to 100 percent. I'm about 75 percent there, but it's such a slow recovery. Spine surgery is bad news, man. I've been in such a bad state with pain; I'm still having a lot of pain.

"There was a point I was convinced that I was dying. I was in that much discomfort and pain and misery. I thought they were all hiding it from me. I remember saying to Sharon, 'You've gotta level with me. Is it worse than you're making it out [to be]?' She says, 'No.' ... I've dropped all the medication for pain now."

And despite his health woes, the 71-year-old rocker is itching to get back on stage as soon as the coronavirus pandemic - which has forced all concerts to be cancelled - has passed.

He added in an interview for SiriusXM: "I cannot wait [to get on stage], but I was talking to Tony Iommi the other day, and he was saying with the way it's going with this coronavirus, indoor shows will be a thing of the past."

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Ozzy Osbourne: I was convinced I was dying during nightmare health year - Martinsville Bulletin

Amniotic Fluid Stem Cell Therapy Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2018 – 2026 – Market Research Correspondent

With having published myriads of reports, PMR imparts its stalwartness to clients existing all over the globe. Our dedicated team of experts deliver reports with accurate data extracted from trusted sources. We ride the wave of digitalization facilitate clients with the changing trends in various industries, regions and consumers. As customer satisfaction is our top priority, our analysts are available 24/7 to provide tailored business solutions to the clients.

In this new business intelligence report, PMR serves a platter of market forecast, structure, potential, and socioeconomic impacts associated with the global Amniotic Fluid Stem Cell Therapy market. With Porters Five Forces and DROT analyses, the research study incorporates a comprehensive evaluation of the positive and negative factors, as well as the opportunities regarding the Amniotic Fluid Stem Cell Therapy market.

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Amniotic Fluid Stem Cell Therapy Market Forecasted To Surpass The Value Of US$ XX Mn/Bn By 2018 - 2026 - Market Research Correspondent

Mesoblast sees lasting need for COVID treatment beyond a vaccine – Sydney Morning Herald

Mesoblast is hoping its flagship product remestemcel-L will be shown to relieve acute respiratory distress syndrome (ARDS) in COVID-19 patients. The company is running a phase 3 trial of the product in US hospitals, but the research is still in its early stages, with a pilot study of the project looking at only 12 patients.

The US Data Safety Monitoring board, which reviews clinical data, had selected a date in early September to complete an initial review of Mesoblast's phase 3 trial, the company said. There are no approved treatments for this kind of respiratory distress, and it is not yet known whether its product will prove safe and effective in a large group of patients.

Dr Itescu said the company would know the results by the end of this calendar year. If the project is successful, the product could be manufactured in Australia for export into global markets to treat COVID patients around the world.

"We're tracking pretty much as expected," Dr Itescu said.

The company has also been working on getting the same product approved in the US for use in children who have graft-vs-host disease, a complication from bone marrow transplants.

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The Food and Drug Administration will review data about the effectiveness of the treatment on August 13. Dr Itescu said the regulator would advise whether the product has received approval before September 30.

Reviews of these two projects could have large implications for Mesoblast's future.

The company, which has been backed by high-profile investors including billionaire Alex Waislitz, has seen its shares turbocharged by updates on its COVID research in recent months. They jumped more than 5 per cent again on Thursday, trading at $3.84 by mid-afternoon.

The business generated $US2.1 million from customers in the June quarter and had $19.6 million in operating expenses.

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Mesoblast sees lasting need for COVID treatment beyond a vaccine - Sydney Morning Herald

Limited Reporting of Adverse Events Tied to Regenerative Treatments Leaves Consumers Vulnerable – The Pew Charitable Trusts

Editor's note: This was updated on July 31, 2020 to clarify when FDAs regulatory framework for regenerative medicine products takes effect.

The Food and Drug Administration (FDA) has taken a series of actions in recent years to crack down on businesses marketing high-risk, unapproved regenerative medicine interventions, including unproven stem cell treatments, but more needs to be done to ensure consumers are protected.

The proliferation of clinics offering these interventionsmore than 700 in the United Statesposes a significant risk to public health and has led to multiple instances of patient harm, including blindness and life-threatening infections. Although FDAs efforts so far are encouraging, additional steps can be taken to fully address the risks posed by businesses marketing these products.

In particular, better reporting by patients and physicians of adverse events caused by unapproved stem cell interventions will help FDA and other regulatory authorities identify the riskiest practices and take targeted action to protect patients.

In June, FDA sent a warning letter to Las Vegas-based EUCYT Laboratories LLC for marketing a range of unapproved regenerative products derived from umbilical cord blood, amniotic fluid, and other human cells and tissues. The company said the products could treat or prevent various diseases and conditions, including COVID-19.

According to the letter, one of the companys exosome products caused multiple serious adverse events in patients in Nebraska late last year, including severe infections requiring hospitalization. Exosomes are small, membrane-enclosed vesicles, or packages, of materials released by individual cells. They are thought to play a role in cell communication or molecule transmission. Researchers are studying them for a variety of potential clinical applications, but FDA has not yet approved any exosome products.

Other companies also have marketed unapproved exosomes to patients. Last December, the agency issued a general safety alert, noting that multiple clinics that manufactured or marketed illegal stem cell products had begun offering exosome treatments and warning the public that these approaches had not been evaluated for safety or efficacy. FDA then wrote to another firm, Kimera Labs in Miramar, Florida, noting that the company had been marketing exosomes to treat diseases or conditions such as Parkinsons, multiple sclerosis, brain injuries, diabetes, stroke, and spinal cord injuries.

Such efforts to enforce regulations for businesses marketing potentially dangerous interventions will likely expand significantly next year, when the agencys regulatory framework for regenerative medicine products takes full effect. In 2017, FDA released four guidance documents to clarify how it would regulate this burgeoning field and more clearly delineate which products must be reviewed before they go on the market.

At the same time, the agency granted businesses three years of enforcement discretion to give manufacturers time to comply with the new regulatory policy and begin moving their products through the review process. During this periodwhich was slated to end in November but has been extended for six months because of the COVID-19 pandemicFDA has taken a risk-based approach to enforcement, acting only against those products that pose a significant safety concern. Since 2017, the agency has filed injunctions against two companies and issued at least 35 regulatory letters to businesses marketing unapproved regenerative products.

Reports of patients being harmed prompted the agencys early actions. For example, in 2019, FDA and the Department of Justice sought and won a permanent injunction against a clinic that injected unproven stem cell products into three women suffering from age-related macular degeneration. The products blinded one and severely damaged the vision of the others.

Reports of such adverse events reach the agency through a variety of channels, including FDAs MedWatch database, which includes mandatory reports from manufacturers, suppliers, and distributors, as well as voluntary reports from physicians and consumers. Because many regenerative medicine products on the market are not FDA-approved, adverse events related to their use are likely to be reported only by patients and their physicians, and even then, only when those individuals know about the database.

This means that adverse events linked to unapproved regenerative products are underreported, perhaps significantly, making it difficult to know how widespread the harm is, or which businesses may be driving the problems. In general, adverse events for all medical products are underreported.

FDA acknowledged this challenge with regenerative therapies in a recent article in the Journal of the American Medical Association and encouraged more thorough reporting by patients and their clinicians. Improved reporting would allow the agency to target enforcement activities more effectively and reinforce the case for tighter regulation of this market. As awareness of the harms grows, fewer patients may be willing to undergo these treatments in the first place.

The agency should consider additional steps to encourage reporting. For example, although the number of consumer reports to the MedWatch database has increased in recent years, patient knowledge of the database appears to be limited. Targeted public awareness campaigns could help boost that knowledge and encourage broader use. The agency also could consider updating the instructions for patients in the MedWatch online reporting system to facilitate easier and more complete reporting of adverse events related to unapproved stem cell productsincluding essential information on where patients receive these treatments.

Most important, however, will be how effectively FDAand potentially otherregulatory authoritiesuse adverse event information to target enforcement activities. Once the period of enforcement discretion ends, the agency will need to take aggressive action against possibly hundreds of businesses across the countryincluding issuing warning letters and, where necessary, seizing products, filing injunctions or pursuing criminal prosecutions to stop the spread of these interventions and protect patients from harm.

Liz Richardson directs The Pew Charitable Trusts health care products project.

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Limited Reporting of Adverse Events Tied to Regenerative Treatments Leaves Consumers Vulnerable - The Pew Charitable Trusts