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Cytovia Therapeutics and Cellectis Partner to Develop TALEN Gene-Edited iPSC-Derived Natural Killer Cells – BioSpace

Posted: February 19, 2021 at 1:46 am

CAMBRIDGE, Mass. and NEW YORK, Feb. 16, 2021 (GLOBE NEWSWIRE) -- Cytovia Therapeutics, Inc., a biopharmaceutical company developing allogeneic off-the-shelf gene-edited Natural Killer (NK) and Chimeric Antigen Receptor (CAR)-NK cells derived from induced pluripotent stem cells (iPSCs), and Cellectis (Euronext Growth: ALCLS - Nasdaq: CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), announced today that they have entered into a strategic research and development collaboration to develop TALEN gene-edited iPSC NK and CAR-NK cells.

The financial terms of the partnership include up to $760 million of development, regulatory, and sales milestones from Cytovia to Cellectis for the first 5 TALEN gene-edited iPSC-derived NK products (partnership products). Cellectis will also receive single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia. Cellectis will receive an equity stake of $15 million in Cytovia stock or an upfront cash payment of $15 million if certain conditions are not met by December 31, 2021, as well as an option to invest in future financing rounds.

We are excited to collaborate with Cellectis, a gene-editing pioneer and leader in the development of gene-edited allogeneic cancer therapies, to further accelerate Cytovias NK cell programs, said Dr. Daniel Teper, Chairman & CEO of Cytovia Therapeutics. Cellectis has a deep understanding and proven expertise in gene-edited cell therapies, and their gene editing technology, TALEN, will yield NK and CAR-NK treatments with improved potency, persistence, and safety for a variety of cancers, including solid tumors. We look forward to leveraging Cellectis insights and experience to help move Cytovias CAR-NKs into clinical trials by 2022.

Cellectis will develop custom TALEN, which Cytovia will use to edit iPSCs. Cytovia will be responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and will conduct the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis is granting Cytovia a worldwide license to its TALEN gene-editing technology, enabling Cytovia to modify NK cells addressing multiple gene targets for therapeutic use in several cancer indications.

We are thrilled to partner with Cytovia, a pioneer in the development of NK cells derived from iPSCs, said Dr. Andr Choulika, CEO of Cellectis. We are looking forward to this collaboration and the opportunity to further expand the potency of our proprietary TALEN gene-editing technology to iPSCs and CAR-NKs. Down the road, this collaboration should allow for NK cell therapies to be made available to cancer patients, which is very much in line with Cellectis mission to provide life-saving product candidates to address unmet patient needs in this field.

About CellectisCellectis is developing the first of its kind allogeneic approach for CAR-T immunotherapies in oncology, pioneering the concept of off-the-shelf and ready-to-use gene-edited CAR T-cells to treat cancer patients. As a clinical-stage biopharmaceutical company with over 20 years of expertise in gene editing, Cellectis is developing life-changing product candidates utilizing TALEN, its gene editing technology, and PulseAgile, its pioneering electroporation system to harness the power of the immune system in order to target and eradicate cancer cells.

As part of its commitment to a cure, Cellectis remains dedicated to its goal of providing lifesaving UCART product candidates to address unmet needs for multiple cancers including acute myeloid leukemia (AML), B-cell acute lymphoblastic leukemia (B-ALL) and multiple myeloma (MM).

Cellectis headquarters are in Paris, France, with additional locations in New York, New York and Raleigh, North Carolina. Cellectis is listed on the Nasdaq Global Market (ticker: CLLS) and on Euronext Growth (ticker: ALCLS). For more information, visit http://www.cellectis.com.

Follow Cellectis on social media: @cellectis, LinkedIn and YouTube.

TALEN is a registered trademark owned by Cellectis.

About Cytovia TherapeuticsCytovia Therapeutics Inc. is a biotechnology company that aims to accelerate patient access to transformational immunotherapies, addressing several of the most challenging unmet medical needs in cancer. Cytovia focuses on Natural Killer (NK) cell biology and is leveraging multiple advanced patented technologies, including an induced pluripotent stem cell (iPSC) platform for CAR (Chimeric Antigen Receptors) NK cell therapy, next-generation precision gene-editing to enhance targeting of NK cells, and NK engager multi-functional antibodies. Our initial product portfolio focuses on both hematological malignancies such as multiple myeloma and solid tumors including hepatocellular carcinoma and glioblastoma. The company is establishing R&D and GMP manufacturing operations in the greater Boston area and partners with the University of California San Francisco (UCSF), the New York Stem Cell Foundation (NYSCF), the Hebrew University of Jerusalem, INSERM, and CytoImmune Therapeutics.Learn more at http://www.cytoviatx.com and follow Cytovia Therapeutics on Social Media (Facebook, LinkedIn, Twitter, and Youtube).

About Gene-Edited, iPSC-derived NK CellsChimeric Antigen Receptors (CAR) are fusion proteins that combine an extracellular antigen recognition domain with an intracellular co-stimulatory signaling domain. Natural Killer (NK) cells are modified genetically to allow insertion of a CAR. CAR-NK cell therapy has demonstrated initial clinical relevance without the limitations of CAR-T, such as Cytokine Release Syndrome, neurotoxicity or Graft vs Host Disease (GVHD). In addition, CAR-NKs are naturally allogeneic, available off-the-shelf and may be able to be administered on an outpatient basis. Recent innovative developments with the induced pluripotent stem cell (iPSC)-derived CAR-NKs, an innovative technology, allow large quantities of true off-the-shelf, homogeneous genetically modified CAR NK cells to be produced from a gene-edited iPSC master cell bank, and thus hold promise to expand access to cell therapy for many patients.

For further information, please contact:

Cellectis Media contacts:Margaret Gandolfo, Communications Manager, 646-628-0300, margaret.gandolfo@cellectis.comConor McGoldrick, Zeno Group, Assistant Account Executive, 914-355-0927, Conor.Mcgoldrick@zenogroup.com

Cellectis IR contact:Simon Harnest, SVP, Corporate Strategy and Finance, 646-385-9008, simon.harnest@cellectis.com

Cytovia Investor Relations contact: Anna Baran-DjokovicVP of Investor Relations646-355-1787anna@cytoviatx.com

Cytovia Media contact: Chris MaggosLifeSci Advisors+41 79 367 6254chris@lifesciadvisors.com

Disclaimer

This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by words such as at this time, believe, expected, forward looking, promising and will, or the negative of these and similar expressions. These forward-looking statements, are based on our managements current expectations and assumptions and on information currently available to management. These forward-looking statements are made in light of information currently available to us and are subject to numerous risks and uncertainties, including with respect to the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation. Furthermore, many other important factors, including those described in our Annual Report on Form 20-F and the financial report (including the management report) for the year ended December 31, 2019 and subsequent filings Cellectis makes with the Securities Exchange Commission from time to time, as well as other known and unknown risks and uncertainties may adversely affect such forward-looking statements and cause our actual results, performance or achievements to be materially different from those expressed or implied by the forward-looking statements. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons why actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

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Cytovia Therapeutics and Cellectis Partner to Develop TALEN Gene-Edited iPSC-Derived Natural Killer Cells - BioSpace

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Recombinant Growth Factors to Account for Over 45% of Overall Demand through 2031: Persistence Market Research – PRNewswire

Posted: February 19, 2021 at 1:46 am

NEW YORK, Feb. 18, 2021 /PRNewswire/ -- Cell culture supplements are the backbone of culturing methods and techniques in mammalian and microbial cell culture. Routinely performed cell-based assays and cell expansion processes require several growth factors to boost cell growth in the culture. Recombinant cell culture supplements serve an array of applications, such as stem cell research, drug discovery, oncology research, and regenerative medicine. Recombinant cell culture supplements and growth factors are used for culturing stem cells for expansion and differentiation into other cell types. Stem cell research is growing and adoption is increasing with time. Recombinant cell culture supplements such as albumin and transferrin are key components of mammalian cell culture. Increasing bioprocessing activities for production of novel biologics are likely to upswing the growth of the recombinant cell culture supplements market over the coming years.

These days, a majority of supplements used in research and manufacturing are produced using recombinant technology. Recombinant supplements play an important role in gene and cell therapy. Cell therapy requires to grow the cells outside the human body, i.e. in-vitro, and, recombinant cell culture supplements are inevitable for such applications. Due to rapid development within the biopharmaceutical industry, recombinant cell culture supplements are anticipated to witness significant demand through 2031.

According to a latest report published by Persistence Market Research, the global recombinant cell culture supplements market was valued at US$ 441 Mn in 2020, and is predicted to witness an impressive CAGR of over 6% during the forecast period (2021 2031).

Key Takeaways from Recombinant Cell Culture Supplements Market Study

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"Increasing drug discovery and preference for recombinant technology for bio- production will upswing the global recombinant cell culture supplements market," says an analyst of Persistence Market Research.

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Collaborations & Acquisitions Key Strategies amongst Market Players

Prominent players in the recombinant cell culture supplements market are firming their product ranges through acquisitions and reaching out to emerging markets. Increasing investments and manufacturing capacity expansion are expected to favour the growth the global market over the forecast period

Various players in the recombinant cell culture supplements market are focusing on growth strategies such as acquisitions and collaborations.

What Does the Recombinant cell culture supplements Market Report Cover?

Persistence Market Research offers a unique perspective and actionable insights on the recombinant cell culture supplements market in its latest study, presenting historical demand assessment of 2016 2020 and projections for 2021 2031, on the basis of product (recombinant growth factors, recombinant insulin,recombinant albumin, recombinant transferrin,recombinant trypsin, recombinant aprotinin, recombinant lysozyme, and others), application (stem cell therapy, gene therapy,bioprocess application,vaccine development, and others), source (animals, microorganisms, andhumans), and end user (academic and research institutes,biopharmaceutical companies,cancer research centers, and contract research centers (CROs)), across seven key regions of the world.

Browse Research Release at:https://www.persistencemarketresearch.com/market-research/recombinant-cell-culture-supplements-market.asp

Browse End-to-end Market: IndustrialAutomation

Related Reports:

Cell Culture Media Market:

https://www.persistencemarketresearch.com/market-research/cell-culture-media-market.asp

Cell Culture Freezing Market:

https://www.persistencemarketresearch.com/market-research/cell-culture-freezing-market.asp

About Persistence Market Research

Overview:

Persistence Market Research (PMR)is a third-platform research firm. Our research model is a unique collaboration of data analytics and market research methodology to help businesses achieve optimal performance.

To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At Persistence Market Research, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

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Recombinant Growth Factors to Account for Over 45% of Overall Demand through 2031: Persistence Market Research - PRNewswire

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MIS-C: Cases of rare inflammatory syndrome linked to COVID-19 on the rise among children in US – FOX 32 Chicago

Posted: February 19, 2021 at 1:46 am

COVID-19 and MIS-C: What parents need to know

Most affected children have had current or recent coronavirus infections, the CDC said.

LOS ANGELES - Cases of a rare inflammatory syndrome linked to COVID-19 have been on the rise across the country amid the ongoing coronavirus pandemic, according to the U.S. Centers for Disease Control and Prevention.

In August, The CDC reported that nearly 600 children had been hospitalized in the United States withmultisystem inflammatory syndrome in children, or MIS-C.

MIS-C is a condition that causes various parts of the human body to become inflamed, including the heart, lungs, kidneys, brain, skin, eyes, or gastrointestinal organs, according to the CDC.

The CDC says the number of MIS-C cases in the U.S. surpassed 1,000 as of Oct. 1, 2020. As of Feb. 1, the number had surpassed 2,000.

MIS-C cases have now been reported in 48 states, New York City, Puerto Rico and Washington, D.C.

Most cases have been identified in children and adolescents between the ages of 1 and 14 years, while 69% of reported cases have occurred in children who are Hispanic or Latino, according to the health agency.

There is still limited data about the safety of COVID-19 vaccines for women who are pregnant.

Ninety-nine percent of all identified cases were in children who had tested positive for COVID-19.

Dr. Jean Ballweg, medical director of pediatric heart transplant and advanced heart failure at Childrens Hospital & Medical Center in Omaha, Nebraska, told the New York Times that the hospital was only treating about two cases of MIS-C cases per month from April through October last year.

Ballweg said the number of monthly cases rose to 10 in December and January with 60% requiring intensive care.

The CDC says MIS-C is a new syndrome and questions still remain as to why children and adolescents develop the illness after contracting COVID-19.

The CDC said that the inflammatory condition was first reported in the United Kingdom as early as late April. On May 12 last year, New York City Mayor Bill de Blasio said 100 children in the city had been diagnosed for MIS-C. Of the 100, 55 tested positive for COVID-19 or had antibodies indicating a previous infection.

Medical experts had initially thought the syndrome could be linked to Kawasaki disease, another rare childhood condition that can cause swelling and heart problems, because the symptoms of the two conditions are similar.

More than a year into the pandemic, researchers are still stumped by an array of ever-evolving symptoms and long-term effects that appear in coronavirus patients.

RELATED: Its not just the lungs COVID-19 can affect the brain and heart of those infected, researchers say

A study published on June 25, 2020, in the journal Cell Reports Medicine found that while COVID-19 is commonly known as a respiratory illness, the disease has also been known to instigate inflammatory responses in the body which can negatively affect the function of ones heart and brain.

According to the study, researchers observed SARS-CoV-2 infecting human heart cells that were grown from stem cells in a lab. Within 72 hours of infection, the virus managed to spread and replicate, killing the heart cells.

Another study published last month in the medical journal The Lancet found that some of the first people to be hospitalized for COVID-19 experienced symptoms lasting for up to six months.

Researchers looked at 1,722 coronavirus patients who had been discharged from Jin Yin-tan hospital in Wuhan, China, where the disease was first identified.

The patients were discharged from the hospital between January 7, 2020, and May 29, 2020, and were then interviewed about their symptoms and quality of life pertaining to their health. They were also administered physical examinations and blood tests, as well as a six-minute walking test.

RELATED: COVID-19 symptoms remained for at least 6 months for some Wuhan patients, study finds

Approximately three-quarters of the patients still reported symptoms within six months after contracting the deadly virus.

More than 60% reported still experiencing fatigue or muscle weakness, while 23% reported anxiety and depression."At six months after acute infection, COVID-19 survivors were mainly troubled with fatigue or muscle weakness, sleep difficulties, and anxiety or depression," study authors write. "Patients who were more severely ill during their hospital stay had more severe impaired pulmonary diffusion capacities and abnormal chest imaging manifestations, and are the main target population for intervention of long-term recovery."

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MIS-C: Cases of rare inflammatory syndrome linked to COVID-19 on the rise among children in US - FOX 32 Chicago

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Global Cord Stem Cell Banking Market Positive Outlook, Revenue Generation & Leading Manufacturers, Forecast 2026||Cells4Life Group LLP, Cryo-Cell…

Posted: February 19, 2021 at 1:46 am

Global Cord stem cell banking market is estimated to reach USD 13.8 billion by 2026 registering a healthy CAGR of 22.4%. The increasing number of parents storing their childs cord blood, acceptance of stem cell therapeutics, high applicability of stem cells are key driver to the market.

The worldwide Cord Stem Cell Banking market report gives precise and thorough information about prospective and existing customers, the competition, and the industry in general as it is the foundation of all successful business ventures. A supreme market data and insights allows business owners to determine the feasibility of a business before committing substantial resources to the venture. Market research report encompasses relevant data to help solve marketing challenges that a business will most likely face which is an integral part of the business planning process. By using Cord Stem Cell Banking market document, clients can outperform competitors using accurate and up-to-date demand-side dynamics information.

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Few of the major market competitors currently working in the global cord stem cell banking market are CBR Systems, Inc., Cordlife, Cells4Life Group LLP, Cryo-Cell International, Inc., Cryo-Save AG, Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS PLUS., Cryoviva India, Global Cord Blood Corporation, National Cord Blood Program, Vita 34, ReeLabs Pvt. Ltd., Regrow Biosciences Pvt. Ltd. , ACROBiosystems., Americord Registry LLC., New York Blood Center, Maze Cord Blood, GoodCell., AABB, Stem Cell Cryobank, New England Cryogenic Center, Inc. among others

Cord Stem Cell Banking Market Scenario

According to Data Bridge Market Research the market for cord stem cell banking is booming with the rising expenditure in the healthcare solutions. The increment in the novel advancement for creating good and efficient drugs to cure unmet medical challenges for the betterment of public and patients health will deliver a strategic business growth for cord stem cell banking market globally.

The rising demand of cord stem cells by pharmaceuticals enterprises has arranged an ascending array of rise in the cord stem cell banks. This significant germination will be backed by the collection placentas of new born babies after their delivery. The stem cells procured from this source are capable of regenerating advanced cells. They help in transplantation of hematopoietic stem cell, the rate of transplantation is high so thus the requirement. These inputs yields in the graphical success of cord stem cell banking market will be visible in the forthcoming period of 2019 to 2026. Few of the factors will stand in between to hinder the market growth such as high end cost of the preservation and storage of cord stem blood cells, whereas the lower rate of familiarity among the pregnant population will affect its growth.

Now the question is which are the other regions intuitive is targeting? Data Bridge Market Research has forecasted a large growth in North America due to large healthcare infrastructure and leading investment in the cord blood cells research to generate stem cells.

Table of Contents:

1 Introduction

2 Research Methodologies

3 Executive Summary

4 Premium Insights

5 Market Overview

6 Industry Trends

7 Compliance in Cord Stem Cell Banking Market

8 Cord Stem Cell Banking Market, By Service

9 Cord Stem Cell Banking Market, By Deployment Type

10 Cord Stem Cell Banking Market, By Organization Size

11 Cord Stem Cell Banking Market Analyses, By Vertical

12 Geographic Analyses

13 Competitive Landscapes

14 Detailed Company Profiles

15 Related Reports

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Segmentation: Global Cord Stem Cell Banking Market

By Storage Type

By Product Type

By Service Type

By Indication

By Source

By Geography

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Moderna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology – The Advocate

Posted: November 30, 2020 at 2:59 pm

Moderna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology

As laboratories are working hard to develop a vaccine against COVID-19, it emerged that the American pharmaceutical company Moderna took only two days to design its proposal. The speed of response is a result of the use of new mRNA technology, but how does it work?

What could be the greatest scientific advance of the decade was designed in just 48 hours, according to a New York Times report. Mind you, it took them more than three decades of research to come up with a coronavirus vaccine in record time.

Moderna's vaccine is based on messenger RNA, a piece of ribonucleic acid that carries information about the amino acid sequence of a specific protein from the DNA, where all that information is stored, to the ribosome, where in the cell. the different proteins are synthesized. In simple terms, we can view mRNA as a USB device that cells use to pass information from the computer (DNA) to another device, such as the printer (ribosome).

We just announced an amendment to the current supply agreement with the United Kingdom government for an additional 2 million doses of mRNA-1273, our #mRNA vaccine candidate against COVID-19. Read more: https://t.co/w86xN4ckeN pic.twitter.com/rWIVMbSBHN

As they advanced in the production of synthetic RNA, the scientists wondered if they could modify a cell by infiltrating a chain of ribonucleic acid. Thus, they could trick the ribosomes and make them produce the proteins we want.

In 1990, in the laboratories of the University of Wisconsin, it was possible for the first time to "fool" the ribosomes of mice. That opened the door to make "antibodies to vaccinate against infections, enzymes to reverse rare diseases or growth agents to repair damaged heart tissue," the report explains.

Of course, applying it to a human body was more complicated. For one thing, scientists cannot inject synthetic RNA into cells one by one. On the other hand, supplying large amounts of that RNA in the blood could trigger a very dangerous massive immune response.

In 2005, Katalin Karik and Drew Weissman discovered a way to "disguise" synthetic RNA against the immune system. Thus, the infiltrated chain could travel through the body and enter cells without producing immune reactions. This technology is the basis for two of the most advanced vaccines: Moderna's and Pfizer's.

Innovative technologies like mRNA vaccines, currently being investigated, may be critical in the fight against # COVID19 - watch to learn more. pic.twitter.com/UznqUaSq3X

This is how Moderna's vaccine was scheduled in just two days

At first, Moderna researchers were just looking for a quick way to reprogram adult cells and turn them into stem cells. They soon realized that they had something greater: the power to program the molecular system of cells.

The scientists created a kind of "library" with a set of "coded functional implementations" that allowed them to write and design small genomic programs (the synthetic mRNA) quickly and easily.

To do this, they first had to figure out how ribosomes read and synthesize proteins, as well as learn the "machine language" of mRNA. Then we had to find a way to write the instructions we wanted and "compile" it into synthetic RNA. The biggest proof that they succeeded is their coronavirus vaccine.

On January 10, 2020, the first SARS-CoV-2 genome sequencing was made public. There was the description of the spike protein that, due to its particular characteristics, would be the target of the vaccine. The goal is to get the cells to produce this protein, so the immune system could identify it and generate immunity.

A group of Chinese scientists shared the coronavirus genome on this site on January 10. With this gesture, the race for the vaccine began: it allowed EVERYONE who is now developing vaccines to begin designing them. https://t.co/rAgSCRN0Fx pic.twitter.com/OR42Slbfaw

- Federico Kukso (@fedkukso) October 5, 2020

It took Moderna just two days to design the RNA instruction that would make cells produce the coronavirus spike protein. However, the difficult part remained and they are still working on: verifying that this masked synthetic mRNA can be delivered safely and efficiently.

Therefore, if Moderna laboratories or Pfizer are successful, their achievement would be greater than preventing COVID-19, which is enough. They would be testing the power of a technology capable of changing medicine and the pharmaceutical industry as we know it.

Moderna's vaccine was 94.5% effective, while Pfizer's is 95%, according to phase 3 results.

See also: Pfizer has already asked the Ministry of Health for authorization to distribute its vaccine in Mexico, confirmed Marcelo Ebrad

Related:50 mil pesos por ver 25 pelculas en 25 das? Ofrecen este trabajo en EUModerna dise vacuna contra el covid-19 en solo dos das gracias a la tecnologa ARNmModerna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology

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Moderna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology - The Advocate

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Coronavirus Updates: The Latest Treatments and Vaccines – GovTech

Posted: November 30, 2020 at 2:59 pm

(TNS) - Scientists at Bay Area universities, laboratories, biotechnology companies and drug manufacturers are fashioning drug concoctions out of blood plasma, chimpanzee viruses and cells taken from bone marrow in the race to rid the world of COVID-19.

The microbial treasure hunt is not just to find a cure which may not be possible but to control the debilitating health problems caused by the coronavirus.

Major progress has been made this year. The antiviral drug remdesivir, produced in Foster City, has improved recovery times, and the steroid dexamethasone has cut the number of deaths in severely ill patients.

What follows is a list of some of the most promising medications and vaccines with ties to the Bay Area:

Antibodies

and Immunity

Mesenchymal stem cells / UCSF and UC Davis Medical Center:

UCSF Dr. Michael Matthay is leading a study of whether a kind of stem cell found in bone marrow can help critically ill patients with severe respiratory failure, known as ARDS. Matthay hopes the stem cells can help reduce the inflammation associated with some of ARDS' most dire respiratory symptoms, and help patients' lungs recover.

In all, 120 patients are being enrolled at UCSF Medical Center, Zuckerberg San Francisco General Hospital, the UC Davis Medical Center in Sacramento and hospitals in Oregon and Texas. He said the trial, which includes a small number of ARDS patients who don't have COVID-19, should have results by summer or fall 2021. So far, 28 patients are enrolled in San Francisco.

Lambda-interferon / Stanford University:

Lambda-interferon is a manufactured version of a naturally occurring protein that had been used to treat hepatitis, and researchers hoped it would help patients in the early stages of COVID-19.

Stanford researchers completed their trial of lambda-interferon and found that it did not boost the immune system response to coronavirus infections.

"That trial did not find any difference in outcomes between the treatment and placebo," said Yvonne Maldonado, chief of pediatric infectious diseases at Lucile Packard Children's Hospital at Stanford, where 120 patients were enrolled in the trial. "It didn't work."

Antiviral drugs

Remdesivir / Gilead Sciences ( Foster City):

Remdesivir, once conceived as a potential treatment for Ebola, was approved by the Food and Drug Administration in October for use on hospitalized COVID-19 patients.

Trademarked under the name Veklury, the drug interferes with the process through which the virus replicates itself. It was one of the drugs given to President Trump and has been used regularly in hospitals under what is known as an emergency use authorization.

It was approved after three clinical trials showed hospitalized coronavirus patients who received remdesivir recovered five days faster on average than those who received a placebo. Patients who required oxygen recovered seven days faster, according to the studies.

Gilead now plans to conduct clinical trials to see how remdesivir works on pediatric patients, from newborns to teenagers, with moderate to severe COVID-19 symptoms. Remdesivir is also being studied with steroids and other drugs to see if it works better as part of a medicinal cocktail. An inhalable form of the drug is also being developed.

Favipiravir / Fujifilm Toyama Chemical ( Stanford University):

This antiviral drug, developed in 2014 by a subsidiary of the Japanese film company to treat influenza, is undergoing numerous clinical studies worldwide, including a trial involving 180 patients at Stanford University.

Stanford epidemiologists are testing favipiravir to see if it prevents the coronavirus from replicating in human cells, halts the shedding of the virus and reduces the severity of infection. Unlike remdesivir, it can be administered orally, so it can be used to treat patients early in the disease, before hospitalization is necessary.

The Stanford study has so far enrolled about 90 patients, who are given the drug within 72 hours of when they were first diagnosed with COVID-19. Half of them get a placebo. People can enroll by emailing treatcovid@stanford.edu.

Monoclonal antibodies

REGN-COV2 / Regeneron Pharmaceuticals / Stanford School of Medicine:

The REGN-COV2 cocktail is the same one Trump received, and Stanford is one of dozens of locations nationwide where clinical trials are being held. Two separate trials are under way at Stanford one for hospitalized patients, the other for outpatients. A third trial is about to begin for people who aren't sick but are in contact with carriers of the virus.

Regeneron halted testing on severely ill patients requiring high-flow oxygen or mechanical ventilation after the independent Data and Safety Monitoring Board determined that the drug was unlikely to help them.

The drug is a combination of two monoclonal antibodies lab-made clones of the antibodies produced naturally in people who have recovered from COVID-19. The antibodies bind to the virus' spike protein and block the virus' ability to enter cells.

Dr. Aruna Subramanian, professor of infectious diseases at Stanford and lead investigator for the inpatient trial, said the 21 hospitalized patients in the study receive a high dose like Trump, a lower dose or a placebo. Subramanian plans to expand the inpatient trial to 45 patients. The outpatient study has enrolled a little more than 40 of the 60 patients researchers intend to sign up.

"There's enough promising evidence that it helps people early in the infection," Subramanian said. "What we don't know is whether it helps people who are pretty sick but not critically ill."

Bamlanivimab / Eli Lilly / Stanford and UCSF:

Stanford and UCSF are testing the Eli Lilly monoclonal antibodies on outpatients after the pharmaceutical company halted trials on hospitalized COVID-19 patients because of adverse results.

Dr. Andra Blomkalns, chair of emergency medicine at Stanford and the lead in the Eli Lilly outpatient trial, said she is now enrolling older people with comorbidities like heart disease, chronic lung disease, a history of strokes and severe obesity shortly after they test positive.

The hypothesis is that the bamlanivimab monotherapy, which is very similar to the Regeneron monoclonals, might work best early in the infection. Although about 400 patients have been enrolled in the Lilly phase 3 trials nationwide, to date fewer than 10 have been enrolled at Stanford and UCSF.

Matthay, who headed up the Lilly monoclonal study with LY-CoV555 at UCSF, said the cancellation of this inpatient trial was disappointing, but "just because this one did not work, doesn't mean another one won't work for hospitalized patients."

Blomkalns said the testing criteria has been changing. She expects the outpatient trial to open soon to adolescents ages 12 and up to determine whether the drug can be used as a preventive.

Designer monoclonal antibodies / Vir Biotechnology, San Francisco:

Scientists at Vir are studying several types of monoclonal antibodies, including a type engineered to activate T cells, which can search out and destroy cells infected with the coronavirus. A study published in the journal Nature in October found that monoclonals, modified to bind with certain receptors, stimulated T cells and improved the human immune response.

"By observing and learning from our body's powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases," said Herbert Virgin, the chief scientific officer at Vir and co-author of the study.

A similarly modified monoclonal antibody, leronlimab, is being studied in coronavirus clinical trials by its Washington state drugmaker, CytoDyn, which has developed drugs to treat HIV. The company's chief medical officer is in San Francisco, and the company that does laboratory tests of leronlimab is in San Carlos.

Anti-inflammatory drugs

Colchicine / UCSF ( San Francisco and New York):

The anti-inflammatory drug commonly used to treat gout flare-ups is being studied by scientists at UCSF and New York University. The drug short-circuits inflammation by decreasing the body's production of certain proteins, and researchers hope that it will reduce lung complications and prevent deaths from COVID-19.

Preliminary results from a clinical trial found that "Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers."

Selinexor / Kaiser Permanente:

Kaiser hospitals in San Francisco, Oakland and Sacramento are studying selinexor, an anticancer drug that blocks a key protein in the cellular machinery for DNA processing. Preliminary findings during the trials indicated that low doses of selinexor helped hospitalized patients with severe COVID-19. The drug has both antiviral and anti-inflammatory properties, and it's administered orally, according to Kaiser's Dr. Jacek Skarbinski.

Vaccines

VXA-COV2-1 / Vaxart, South San Francisco:

The biotechnology company Vaxart is testing VXA-COV2-1, the only potential vaccine in pill form. It uses the genetic code of the coronavirus to trigger a defensive response in mucous membranes. The hope is that the newly fortified membranes will prevent the virus from entering the body.

"It's the only vaccine (candidate) that activates the first line of defense, which is the mucosa," said Andrei Floroiu, Vaxart's chief executive. He said intravenous vaccines kill the virus after it is inside the body, but this one stops it beforehand.

Continued here:
Coronavirus Updates: The Latest Treatments and Vaccines - GovTech

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Here are the latest updates on coronavirus treatments and the Moderna, Pfizer and other vaccines – San Francisco Chronicle

Posted: November 30, 2020 at 2:59 pm

Scientists at Bay Area universities, laboratories, biotechnology companies and drug manufacturers are fashioning drug concoctions out of blood plasma, chimpanzee viruses and cells taken from bone marrow in the race to rid the world of COVID-19.

The microbial treasure hunt is not just to find a cure which may not be possible but to control the debilitating health problems caused by the coronavirus.

What follows is a list of some of the most promising medications and vaccines with ties to the Bay Area:

Antibodies

and Immunity

Mesenchymal stem cells / UCSF and UC Davis Medical Center:

UCSF Dr. Michael Matthay is leading a study of whether a kind of stem cell found in bone marrow can help critically ill patients with severe respiratory failure, known as ARDS. Matthay hopes the stem cells can help reduce the inflammation associated with some of ARDS most dire respiratory symptoms, and help patients lungs recover.

In all, 120 patients are being enrolled at UCSF Medical Center, Zuckerberg San Francisco General Hospital, the UC Davis Medical Center in Sacramento and hospitals in Oregon and Texas. He said the trial, which includes a small number of ARDS patients who dont have COVID-19, should have results by summer or fall 2021. So far, 28 patients are enrolled in San Francisco.

Lambda-interferon / Stanford University:

Lambda-interferon is a manufactured version of a naturally occurring protein that had been used to treat hepatitis, and researchers hoped it would help patients in the early stages of COVID-19.

Stanford researchers completed their trial of lambda-interferon and found that it did not boost the immune system response to coronavirus infections.

That trial did not find any difference in outcomes between the treatment and placebo, said Yvonne Maldonado, chief of pediatric infectious diseases at Lucile Packard Childrens Hospital at Stanford, where 120 patients were enrolled in the trial. It didnt work.

Antiviral drugs

Remdesivir / Gilead Sciences (Foster City):

Remdesivir, once conceived as a potential treatment for Ebola, was approved by the Food and Drug Administration in October for use on hospitalized COVID-19 patients.

Favipiravir / Fujifilm Toyama Chemical (Stanford University):

Monoclonal antibodies

REGN-COV2 / Regeneron Pharmaceuticals / Stanford School of Medicine:

The REGN-COV2 cocktail is the same one Trump received, and Stanford is one of dozens of locations nationwide where clinical trials are being held. Two separate trials are under way at Stanford one for hospitalized patients, the other for outpatients. A third trial is about to begin for people who arent sick but are in contact with carriers of the virus.

The drug is a combination of two monoclonal antibodies lab-made clones of the antibodies produced naturally in people who have recovered from COVID-19. The antibodies bind to the virus spike protein and block the virus ability to enter cells.

Theres enough promising evidence that it helps people early in the infection, Subramanian said. What we dont know is whether it helps people who are pretty sick but not critically ill.

Bamlanivimab / Eli Lilly / Stanford and UCSF:

Stanford and UCSF are testing the Eli Lilly monoclonal antibodies on outpatients after the pharmaceutical company halted trials on hospitalized COVID-19 patients because of adverse results.

Matthay, who headed up the Lilly monoclonal study with LY-CoV555 at UCSF, said the cancellation of this inpatient trial was disappointing, but just because this one did not work, doesnt mean another one wont work for hospitalized patients.

Blomkalns said the testing criteria has been changing. She expects the outpatient trial to open soon to adolescents ages 12 and up to determine whether the drug can be used as a preventive.

Designer monoclonal antibodies / Vir Biotechnology, San Francisco:

By observing and learning from our bodys powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases, said Herbert Virgin, the chief scientific officer at Vir and co-author of the study.

A similarly modified monoclonal antibody, leronlimab, is being studied in coronavirus clinical trials by its Washington state drugmaker, CytoDyn, which has developed drugs to treat HIV. The companys chief medical officer is in San Francisco, and the company that does laboratory tests of leronlimab is in San Carlos.

Anti-inflammatory drugs

Colchicine / UCSF (San Francisco and New York):

The anti-inflammatory drug commonly used to treat gout flare-ups is being studied by scientists at UCSF and New York University. The drug short-circuits inflammation by decreasing the bodys production of certain proteins, and researchers hope that it will reduce lung complications and prevent deaths from COVID-19.

Preliminary results from a clinical trial found that Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers.

Selinexor / Kaiser Permanente:

Kaiser hospitals in San Francisco, Oakland and Sacramento are studying selinexor, an anticancer drug that blocks a key protein in the cellular machinery for DNA processing. Preliminary findings during the trials indicated that low doses of selinexor helped hospitalized patients with severe COVID-19. The drug has both antiviral and anti-inflammatory properties, and its administered orally, according to Kaisers Dr. Jacek Skarbinski.

Vaccines

VXA-COV2-1 / Vaxart, South San Francisco:

Its the only vaccine (candidate) that activates the first line of defense, which is the mucosa, said Andrei Floroiu, Vaxarts chief executive. He said intravenous vaccines kill the virus after it is inside the body, but this one stops it beforehand.

The drug, which is effective against influenza and norovirus, induced both neutralizing antibodies and T cells during coronavirus drug trials, according to preliminary trial results published in September.

VaxiPatch / Verndari (Napa and UC Davis Medical Center):

A Napa company, Verndari, is studying vaccines for COVID-19 that can be delivered using an adhesive patch. Researchers at UC Davis Medical Center in Sacramento said the patch caused an immune response in preclinical tests.

An October report in the online journal ScienceDirect touted the system, saying it could serve as a shelter in place vaccination strategy, in which vulnerable populations receive delivery at home without needing to engage an already-overtaxed health care infrastructure.

If the vaccine is proven effective and safe, patients could receive it through the mail, according to Dr. Daniel Henderson, Verndaris chief executive officer.

ChAdOx1 / AstraZeneca (UCSF, San Francisco General Hospital, Bridge HIV):

Enrollment is under way at 80 sites in the United States, including three in the Bay Area, for the phase 3 trial of AstraZenecas vaccine, developed by Oxford University from an adenovirus, which typically causes colds in chimpanzees.

At least 1,000 of the 40,000 participants in the phase 3 AstraZeneca trial will be from the Bay Area, including 500 at Sutter Healths East Bay AIDS Center in Oakland, 250 at Zuckerberg San Francisco General Hospital and another 250 at Bridge HIV San Francisco.

An interim analysis of trials in Britain and Brazil showed the vaccine was 90% effective in preventing COVID-19 in 131 patients who got a half-dose of the vaccine by mistake. The vaccine was only 62% effective in people who got a full dose, leading to major questions about the results and how the trial was conducted.

Bay Area trial leaders Dr. Annie Luetkemeyer of UCSF and Dr. Susan Buchbinder, director of Bridge HIV and a UCSF professor of medicine and epidemiology, are hoping future trial results are more clear. Thats because AstraZenecas vaccine is cheaper than those made by its rivals Pfizer and Moderna, whose vaccines were 95% and 94.5% effective in preliminary tests.

The AstraZeneca candidate can also be stored at temperatures between 36 and 46 degrees Fahrenheit, which is orders of magnitude higher than the Pfizer and Moderna vaccines. The Pfizer and Moderna vaccines must be kept at 94 degrees below zero Fahrenheit, colder than many storage facilities can manage.

Johnson & Johnson (Stanford University)

The Johnson & Johnson clinical trials have enrolled 20,000 of the 60,000 volunteers worldwide that officials expect to have signed up by Christmas. That includes 70 people at Stanford.

The vaccine is, like the AstraZeneca version, a chimpanzee adenovirus that was genetically altered so that it carries the RNA of the coronavirus spike protein. The technique inspires the body to produce antibodies that block the protein without causing people to get sick.

Phase 2 studies show that it produces a good immune response and the early results of phase 3 show that its safe, said Dr. Philip Grant, assistant professor of infectious disease at Stanford and leader of the trial.

Grant, who is enrolling about 15 people a day for the trial, said he doesnt expect results on the vaccines effectiveness until sometime in March.

Peter Fimrite is a San Francisco Chronicle staff writer. Email: pfimrite@sfchronicle.com Twitter: @pfimrite

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Here are the latest updates on coronavirus treatments and the Moderna, Pfizer and other vaccines - San Francisco Chronicle

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Global Cell Harvesting Market to Reach US$381,4 Million by the Year 2027 – Salamanca Press

Posted: November 30, 2020 at 2:59 pm

NEW YORK, Nov. 25, 2020 /PRNewswire/ --Amid the COVID-19 crisis, the global market for Cell Harvesting estimated at US$233.2 Million in the year 2020, is projected to reach a revised size of US$381.4 Million by 2027, growing at a CAGR of 7.3% over the period 2020-2027.Manual, one of the segments analyzed in the report, is projected to grow at a 7.9% CAGR to reach US$284.4 Million by the end of the analysis period. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the Automated segment is readjusted to a revised 5.6% CAGR for the next 7-year period. This segment currently accounts for a 28.3% share of the global Cell Harvesting market.

Read the full report: https://www.reportlinker.com/p05798117/?utm_source=PRN

The U.S. Accounts for Over 30.9% of Global Market Size in 2020, While China is Forecast to Grow at a 10.4% CAGR for the Period of 2020-2027

The Cell Harvesting market in the U.S. is estimated at US$72 Million in the year 2020. The country currently accounts for a 30.86% share in the global market. China, the world second largest economy, is forecast to reach an estimated market size of US$34.9 Million in the year 2027 trailing a CAGR of 10.4% through 2027. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 6.1% and 7% respectively over the 2020-2027 period. Within Europe, Germany is forecast to grow at approximately 6.6% CAGR while Rest of European market (as defined in the study) will reach US$34.9 Million by the year 2027.We bring years of research experience to this 5th edition of our report. The 226-page report presents concise insights into how the pandemic has impacted production and the buy side for 2020 and 2021. A short-term phased recovery by key geography is also addressed.

Competitors identified in this market include, among others,

Read the full report: https://www.reportlinker.com/p05798117/?utm_source=PRN

I. INTRODUCTION, METHODOLOGY & REPORT SCOPE I-1

II. EXECUTIVE SUMMARY II-1

1. MARKET OVERVIEW II-1Cell Harvesting - A Prelude II-1Impact of Covid-19 and a Looming Global Recession II-1With Stem Cells Holding Potential to Emerge as Savior forHealthcare System Struggling with COVID-19 Crisis, Demand forCell Harvesting to Grow II-1Select Clinical Trials in Progress for MSCs in the Treatment ofCOVID-19 II-2Lack of Antiviral Therapy Brings Spotlight on MSCs as PotentialOption to Treat Severe Cases of COVID-19 II-3Stem Cells Garner Significant Attention amid COVID-19 Crisis II-3Growing R&D Investments & Rising Incidence of Chronic Diseasesto Drive the Global Cell Harvesting Market over the Long-term II-3US Dominates the Global Market, Asia-Pacific to ExperienceLucrative Growth Rate II-4Biopharmaceutical & Biotechnology Firms to Remain Key End-User II-4Remarkable Progress in Stem Cell Research Unleashes UnlimitedAvenues for Regenerative Medicine and Drug Development II-4Drug Development II-5Therapeutic Potential II-5

2. FOCUS ON SELECT PLAYERS II-6Recent Market Activity II-7Innovations and Advancements II-7

3. MARKET TRENDS & DRIVERS II-8Development of Regenerative Medicine Accelerates Demand forCell Harvesting II-8The Use of Mesenchymal Stem Cells in Regenerative Medicine toDrive the Cell Harvesting Market II-8Rise in Volume of Orthopedic Procedures Boosts Prospects forStem Cell, Driving the Cell Harvesting II-9Exhibit 1: Global Orthopedic Surgical Procedure Volume (2010-2020) (in Million) II-11Increasing Demand for Stem Cell Based Bone Grafts: PromisingGrowth Ahead for Cell Harvesting II-11Spectacular Advances in Stem Cell R&D Open New Horizons forRegenerative Medicine II-12Exhibit 2: Global Regenerative Medicines Market by Category(2019): Percentage Breakdown for Biomaterials, Stem CellTherapies and Tissue Engineering II-13Stem Cell Transplants Drive the Demand for Cell Harvesting II-13Rise in Number of Hematopoietic Stem Cell TransplantationProcedures Propels Market Expansion II-15Growing Incidence of Chronic Diseases to Boost the Demand forCell Harvesting II-16Exhibit 3: Global Cancer Incidence: Number of New Cancer Casesin Million for the Years 2018, 2020, 2025, 2030, 2035 and 2040 II-17Exhibit 4: Global Number of New Cancer Cases and Cancer-relatedDeaths by Cancer Site for 2018 II-18Exhibit 5: Number of New Cancer Cases and Deaths (in Million)by Region for 2018 II-19Exhibit 6: Fatalities by Heart Conditions: Estimated PercentageBreakdown for Cardiovascular Disease, Ischemic Heart Disease,Stroke, and Others II-19Exhibit 7: Rising Diabetes Prevalence Presents Opportunity forCell Harvesting: Number of Adults (20-79) with Diabetes (inMillions) by Region for 2017 and 2045 II-20Ageing Demographics to Drive Demand for Stem Cell Banking II-20Global Aging Population Statistics - Opportunity Indicators II-21Exhibit 8: Expanding Elderly Population Worldwide: Breakdown ofNumber of People Aged 65+ Years in Million by GeographicRegion for the Years 2019 and 2030 II-21Exhibit 9: Life Expectancy for Select Countries in Number ofYears: 2019 II-22High Cell Density as Major Bottleneck Leads to Innovative CellHarvesting Methods II-22Advanced Harvesting Systems to Overcome Centrifugation Issues II-23Sophisticated Filters for Filtration Challenges II-23Innovations in Closed Systems Boost Efficiency & Productivityof Cell Harvesting II-23Enhanced Harvesting and Separation of Micro-Carrier Beads II-24

4. GLOBAL MARKET PERSPECTIVE II-25Table 1: World Current & Future Analysis for Cell Harvesting byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-25

Table 2: World Historic Review for Cell Harvesting byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-26

Table 3: World 15-Year Perspective for Cell Harvesting byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld Markets for Years 2012, 2020 & 2027 II-27

Table 4: World Current & Future Analysis for Manual byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-28

Table 5: World Historic Review for Manual by Geographic Region- USA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 II-29

Table 6: World 15-Year Perspective for Manual by GeographicRegion - Percentage Breakdown of Value Sales for USA, Canada,Japan, China, Europe, Asia-Pacific and Rest of World for Years2012, 2020 & 2027 II-30

Table 7: World Current & Future Analysis for Automated byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-31

Table 8: World Historic Review for Automated by GeographicRegion - USA, Canada, Japan, China, Europe, Asia-Pacific andRest of World Markets - Independent Analysis of Annual Sales inUS$ Thousand for Years 2012 through 2019 II-32

Table 9: World 15-Year Perspective for Automated by GeographicRegion - Percentage Breakdown of Value Sales for USA, Canada,Japan, China, Europe, Asia-Pacific and Rest of World for Years2012, 2020 & 2027 II-33

Table 10: World Current & Future Analysis for Peripheral Bloodby Geographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-34

Table 11: World Historic Review for Peripheral Blood byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-35

Table 12: World 15-Year Perspective for Peripheral Blood byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-36

Table 13: World Current & Future Analysis for Bone Marrow byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-37

Table 14: World Historic Review for Bone Marrow by GeographicRegion - USA, Canada, Japan, China, Europe, Asia-Pacific andRest of World Markets - Independent Analysis of Annual Sales inUS$ Thousand for Years 2012 through 2019 II-38

Table 15: World 15-Year Perspective for Bone Marrow byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-39

Table 16: World Current & Future Analysis for Umbilical Cord byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-40

Table 17: World Historic Review for Umbilical Cord byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-41

Table 18: World 15-Year Perspective for Umbilical Cord byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-42

Table 19: World Current & Future Analysis for Adipose Tissue byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-43

Table 20: World Historic Review for Adipose Tissue byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-44

Table 21: World 15-Year Perspective for Adipose Tissue byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-45

Table 22: World Current & Future Analysis for OtherApplications by Geographic Region - USA, Canada, Japan, China,Europe, Asia-Pacific and Rest of World Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2020 through2027 II-46

Table 23: World Historic Review for Other Applications byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-47

Table 24: World 15-Year Perspective for Other Applications byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-48

Table 25: World Current & Future Analysis for Biotech &Biopharma Companies by Geographic Region - USA, Canada, Japan,China, Europe, Asia-Pacific and Rest of World Markets -Independent Analysis of Annual Sales in US$ Thousand for Years2020 through 2027 II-49

Table 26: World Historic Review for Biotech & BiopharmaCompanies by Geographic Region - USA, Canada, Japan, China,Europe, Asia-Pacific and Rest of World Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 II-50

Table 27: World 15-Year Perspective for Biotech & BiopharmaCompanies by Geographic Region - Percentage Breakdown of ValueSales for USA, Canada, Japan, China, Europe, Asia-Pacific andRest of World for Years 2012, 2020 & 2027 II-51

Table 28: World Current & Future Analysis for ResearchInstitutes by Geographic Region - USA, Canada, Japan, China,Europe, Asia-Pacific and Rest of World Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2020 through2027 II-52

Table 29: World Historic Review for Research Institutes byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-53

Table 30: World 15-Year Perspective for Research Institutes byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-54

Table 31: World Current & Future Analysis for Other End-Uses byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-55

Table 32: World Historic Review for Other End-Uses byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-56

Table 33: World 15-Year Perspective for Other End-Uses byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-57

III. MARKET ANALYSIS III-1

GEOGRAPHIC MARKET ANALYSIS III-1

UNITED STATES III-1Increasing Research on Stem Cells for Treating COVID-19 todrive the Cell Harvesting Market III-1Rising Investments in Stem Cell-based Research Favors CellHarvesting Market III-1Exhibit 10: Stem Cell Research Funding in the US (in US$Million) for the Years 2011 through 2017 III-2A Strong Regenerative Medicine Market Drives Cell HarvestingDemand III-2Arthritis III-3Exhibit 11: Percentage of Population Diagnosed with Arthritisby Age Group III-3Rapidly Ageing Population: A Major Driving Demand for CellHarvesting Market III-4Exhibit 12: North American Elderly Population by Age Group(1975-2050) III-4Increasing Incidence of Chronic Diseases Drives Focus onto CellHarvesting III-5Exhibit 13: CVD in the US: Cardiovascular Disease* Prevalencein Adults by Gender & Age Group III-5Rising Cancer Cases Spur Growth in Cell Harvesting Market III-5Exhibit 14: Estimated Number of New Cancer Cases and Deaths inthe US (2019) III-6Exhibit 15: Estimated New Cases of Blood Cancers in the US(2020) - Lymphoma, Leukemia, Myeloma III-7Exhibit 16: Estimated New Cases of Leukemia in the US: 2020 III-7Market Analytics III-8Table 34: USA Current & Future Analysis for Cell Harvesting byType - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-8

Table 35: USA Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-9

Table 36: USA 15-Year Perspective for Cell Harvesting by Type -Percentage Breakdown of Value Sales for Manual and Automatedfor the Years 2012, 2020 & 2027 III-10

Table 37: USA Current & Future Analysis for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-11

Table 38: USA Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-12

Table 39: USA 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-13

Table 40: USA Current & Future Analysis for Cell Harvesting byEnd-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-14

Table 41: USA Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-15

Table 42: USA 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-16

CANADA III-17Market Overview III-17Exhibit 17: Number of New Cancer Cases in Canada: 2019 III-17Market Analytics III-18Table 43: Canada Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-18

Table 44: Canada Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-19

Table 45: Canada 15-Year Perspective for Cell Harvesting byType - Percentage Breakdown of Value Sales for Manual andAutomated for the Years 2012, 2020 & 2027 III-20

Table 46: Canada Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-21

Table 47: Canada Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-22

Table 48: Canada 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-23

Table 49: Canada Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-24

Table 50: Canada Historic Review for Cell Harvesting by End-Use- Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-25

Table 51: Canada 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-26

JAPAN III-27Increasing Demand for Regenerative Medicine in GeriatricHealthcare and Cancer Care to Drive Demand for Cell Harvesting III-27Exhibit 18: Japanese Population by Age Group (2015 & 2040):Percentage Share Breakdown of Population for 0-14, 15-64 and65 & Above Age Groups III-27Exhibit 19: Cancer Related Incidence and Deaths by Site inJapan: 2018 III-28Market Analytics III-29Table 52: Japan Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-29

Table 53: Japan Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-30

Table 54: Japan 15-Year Perspective for Cell Harvesting by Type- Percentage Breakdown of Value Sales for Manual and Automatedfor the Years 2012, 2020 & 2027 III-31

Table 55: Japan Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-32

Table 56: Japan Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-33

Table 57: Japan 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-34

Table 58: Japan Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-35

Table 59: Japan Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-36

Table 60: Japan 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-37

CHINA III-38Rising Incidence of Cancer Drives Cell Harvesting Market III-38Exhibit 20: Number of New Cancer Cases Diagnosed (in Thousands)in China: 2018 III-38Market Analytics III-39Table 61: China Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-39

Table 62: China Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-40

Table 63: China 15-Year Perspective for Cell Harvesting by Type -Percentage Breakdown of Value Sales for Manual and Automatedfor the Years 2012, 2020 & 2027 III-41

Table 64: China Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-42

Table 65: China Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-43

Table 66: China 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-44

Table 67: China Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-45

Table 68: China Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-46

Table 69: China 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-47

EUROPE III-48Cancer in Europe: Key Statistics III-48Exhibit 21: Cancer Incidence in Europe: Number of New CancerCases (in Thousands) by Site for 2018 III-48Ageing Population to Drive Demand for Cell Harvesting Market III-49Exhibit 22: European Population by Age Group (2016, 2030 &2050): Percentage Share Breakdown by Age Group for 0-14, 15-64, and 65 & Above III-49Market Analytics III-50Table 70: Europe Current & Future Analysis for Cell Harvestingby Geographic Region - France, Germany, Italy, UK and Rest ofEurope Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2020 through 2027 III-50

Table 71: Europe Historic Review for Cell Harvesting byGeographic Region - France, Germany, Italy, UK and Rest ofEurope Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-51

Table 72: Europe 15-Year Perspective for Cell Harvesting byGeographic Region - Percentage Breakdown of Value Sales forFrance, Germany, Italy, UK and Rest of Europe Markets for Years2012, 2020 & 2027 III-52

Table 73: Europe Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-53

Table 74: Europe Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-54

Table 75: Europe 15-Year Perspective for Cell Harvesting byType - Percentage Breakdown of Value Sales for Manual andAutomated for the Years 2012, 2020 & 2027 III-55

Table 76: Europe Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-56

Table 77: Europe Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-57

Table 78: Europe 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-58

Table 79: Europe Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-59

Table 80: Europe Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-60

Table 81: Europe 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-61

FRANCE III-62Table 82: France Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-62

Table 83: France Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-63

Table 84: France 15-Year Perspective for Cell Harvesting byType - Percentage Breakdown of Value Sales for Manual andAutomated for the Years 2012, 2020 & 2027 III-64

Table 85: France Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-65

Table 86: France Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-66

Table 87: France 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-67

The rest is here:
Global Cell Harvesting Market to Reach US$381,4 Million by the Year 2027 - Salamanca Press

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Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Royal Caribbean, Mesoblast, Loop Industries, and…

Posted: November 30, 2020 at 2:59 pm

NEW YORK, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Royal Caribbean Group (NYSE: RCL), Mesoblast Limited (NASDAQ: MESO), Loop Industries, Inc. (NASDAQ: LOOP), and Turquoise Hill Resources Ltd. (NYSE: TRQ). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link

Royal Caribbean Group (NYSE: RCL)

Class Period: February 4, 2020 to March 17, 2020

Lead Plaintiff Deadline: December 7, 2020

The complaint, filed on October 7, 2020, alleges that throughout the Class Period defendants failed to disclose material facts about the Companys decrease in bookings outside China, instead maintaining that it was only experiencing a slowdown in bookings from China. The Action further alleges that defendants failed to disclose material facts about the Companys inadequate policies and procedures to prevent the spread of COVID-19 on its ships. The truth about the scope of the impact that COVID-19 had on the Companys overall bookings and the inability of Royal Caribbean to prevent the virus spread on its ships was revealed through a series of disclosures.

First, on February 13, 2020, Royal Caribbean issued a press release stating that it had canceled 18 voyages in Southeast Asia due to recent travel restrictions and further warning that recent bookings had been softer for its broader business.

On this news, Royal Caribbean shares fell over 3 percent.

Second, on February 25, 2020, Royal Caribbean filed its 2019 Form 10-K, indicating that COVID-19 concerns were negatively impacting its overall business.

On this news, Royal Caribbean shares fell over 14 percent.

Third, on March 10, 2020, Royal Caribbean withdrew its 2020 financial guidance, increased its revolving credit facility by $550 million, and announced that it would take cost-cutting actions due to the proliferation of COVID-19, further revealing that COVID-19 was severely impacting Royal Caribbeans 2020 customer booking and that its safety measures were inadequate to prevent the spread of the virus on its ships.

On this news, Royal Caribbean shares fell over 14 percent.

Fourth, on March 11, 2020, Royal Caribbeans largest competitor, Carnival, announced a 60-day suspension of all operations, prompting concern that Royal Caribbean would follow suit. At the same time, Royal Caribbean also cancelled two cruises, beginning a series of cancellations and suspensions to follow.

On this news, Royal Caribbean shares fell almost 32 percent.

Fifth, on March 14, 2020, Royal Caribbean announced a suspension of all global cruises for 30 days.

On this news, Royal Caribbean stock fell over 7 percent.

Sixth, on March 16, 2020, the Company revealed that global operations could be suspended longer than anticipated, announcing the cancellations of two additional cruises throughout April and into May.

On this news, Royal Caribbean shares fell over 7 percent.

Finally, on March 18, 2020, analysts downgraded Royal Caribbeans stock and slashed their price targets.

On this news, Royal Caribbean shares fell more than 19 percent.

For more information on the Royal Caribbean class action go to: https://bespc.com/cases/RCL

Mesoblast Limited (NASDAQ: MESO)

Class Period: April 16, 2019 to October 1, 2020

Lead Plaintiff Deadline: December 7, 2020

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.

The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Mesoblast class action go to: https://bespc.com/cases/MESO

Loop Industries, Inc. (NASDAQ: LOOP)

Class Period: September 24, 2018 to October 12, 2020

Lead Plaintiff Deadline: December 14, 2020

On October 13, 2020, Hindenburg Research published a report alleging, among other things, that Loops scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the companys process internally. The report also stated that Loops previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were technically and industrially impossible, according to a former employee. Moreover, the report alleged that Executives from a division of key partner Thyssenkrupp, who Loop entered into a global alliance agreement with in December 2018, told us their partnership is on indefinite hold and that Loop underestimated both costs and complexities of its process.

On this news, the Companys share price fell $3.78, or over 32%, to close at $7.83 per share on October 13, 2020.

The complaint, filed on October 13, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Loop scientists were encouraged to misrepresent the results of Loops purportedly proprietary process; (2) that Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) that, as a result, the Company was unlikely to realize the purported benefits of Loops announced partnerships with Indorama and Thyssenkrupp; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Loop class action go to: https://bespc.com/cases/Loop

Turquoise Hill Resources Ltd. (NYSE: TRQ)

Class Period: July 17, 2018 to July 31, 2019

Lead Plaintiff Deadline: December 14, 2020

Turquoise Hill is an international mining company focused on the operation and development of the Oyu Tolgoi copper-gold mine in Southern Mongolia (Oyu Tolgoi), which is the Companys principal and only material resource property. Turquoise Hills subsidiary, Oyu Tolgoi LLC, holds a 66% interest in Oyu Tolgoi, and the remainder is held by the Government of Mongolia.

Rio Tinto plc and Rio Tinto Limited are operated and managed together as single economic unit and engage in mining and metals operations in approximately 35 countries. Through their subsidiaries, Rio Tinto owns 50.8% of Turquoise Hill. A Rio Tinto subsidiary, Rio Tinto International Holdings, Inc. (Rio Tinto International or RTIH; and collectively with Rio Tinto plc and Rio Tinto Limited, Rio Tinto), is also the manager of the Oyu Tolgoi project, including having responsibility for its development and construction.

On July 31, 2019, Turquoise Hill issued a press release and Management Discussion & Analysis (MD&A) making further disclosures about the status of the project, including that Turquoise Hill took a $600 million impairment charge and a substantial deferred income tax recognition adjustment tied to the Oyu Tolgoi project, and that it suffered a loss in the second quarter. The next day, before the market open, Rio Tinto issued a release concerning in part the project status, including that it had also taken an impairment charge related to the Oyu Tolgoi project, of $800 million.

Following this news, on August 1, 2019, Turquoise Hills common stock price closed at $0.53 per share, down 8.62% from the prior days closing price of $0.58 per share.

The complaint, filed on October 15, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements and omitted to disclose material facts regarding the Companys business and operations. Specifically, defendants made false and or misleading statements and/or failed to disclose that: (i) the progress of underground development of Oyu Tolgoi was not proceeding as planned; (ii) there were significant undisclosed underground stability issues that called into question the design of the mine, the projected cost and timing of production; (iii) the Companys publicly disclosed estimates of the cost, date of completion and dates for production from the underground mine were not achievable; (iv) the development capital required for the underground development of Oyu Tolgoi would cost substantially more than a billion dollars over what the Company had represented; and (v) Turquoise Hill would require additional financing and/or equity to complete the project.

For more information on the Turquoise Hill class action go to: https://bespc.com/cases/TRQ

About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq. Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com

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Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Royal Caribbean, Mesoblast, Loop Industries, and...

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Mesoblast Receives Complete Response Letter From the FDA for Biologics License Application for Steroid-Refractory Acute Graft Versus Host Disease in…

Posted: October 2, 2020 at 12:58 am

NEW YORK, Oct. 01, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (NASDAQ:MESO, ASX:MSB)), global leader in allogeneic cellular medicines for inflammatory diseases, announced today that the US Food and Drug Administration (FDA) has issued a Complete Response Letter to its Biologics License Application (BLA) for remestemcel-L for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). While the Oncologic Drugs Advisory Committee (ODAC)1 of the FDA voted 9:1 that the available data support the efficacy of remestemcel-L in pediatric patients with SR-aGVHD, the FDA recommended that Mesoblast conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. As there are currently no approved treatments for this life-threatening condition in children under 12, Mesoblast will urgently request a Type A meeting with the FDA, expected within 30 days, to discuss a potential accelerated approval with a post-approval condition for an additional study.

Joanne Kurtzberg, MD, Jerome Harris Distinguished Professor of Pediatrics, Director, Pediatric Blood and Marrow Transplant Program, and Co-Director, Stem Cell Transplant Laboratory Duke University Medical Center, said: "The Phase 3 trial results showed that remestemcel-L provides a meaningful treatment for children with SR-aGVHD who have a very dismal prognosis. I look forward to having this much-needed therapy available to our patients."

Mesoblast is currently conducting a randomized, controlled Phase 3 trial evaluating remestemcel-L in up to 300 ventilator-dependent adults with moderate to severe acute respiratory distress syndrome (ARDS) due to COVID-19. A second interim analysis by the trial's independent Data Safety Monitoring Board is expected in early November, with completion of patient enrollment expected in December. COVID-19 ARDS is an inflammatory disease with a similar profile of damaging inflammatory cytokines as is seen in children with SR-aGVHD, and is the primary cause of death in COVID-19 infection. The trial's primary endpoint is reduction of all-cause mortality within 30 days of randomization.

The FDA also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the product's biologic activity. 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, such as SR-aGVHD and COVID-19 ARDS.

Mesoblast Chief Executive Dr Silviu Itescu stated: "We are working tirelessly to bring remestemcel-L to patients with life threatening inflammatory conditions, including SR-aGVHD and COVID-19 ARDS."

About Acute Graft Versus Host DiseaseAcute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.2In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.3,4There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

About Remestemcel-LMesoblast's lead allogeneic cell therapy product candidate, remestemcel-L, is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. Remestemcel-L is thought to have immunomodulatory properties to counteract the cytokine storms that are implicated in various inflammatory conditions by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

References1. This vote includes a change to the original vote by one of the ODAC panel members after electronic voting closed.2. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85.3. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953.4. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814

Conference CallAn audio webcast will begin at 9.15am Friday, October 2 AEST / 7.15pm Thursday, October 1, 2020 EDT. The audio webcast can be accessed viahttps://webcast.boardroom.media/mesoblast-limited/20200930/NaN5f7147e5581a8100190f7687orWebcast link

The archived webcast will be available on the Investor page of the Company's website http://www.mesoblast.com

About MesoblastMesoblast Limited (NASDAQ:MESO, ASX:MSB)) is a world leader in developing allogeneic (off-the-shelf) cellular medicines. The Company has leveraged its proprietary mesenchymal lineage cell therapy technology platform to establish a broad portfolio of commercial products and late-stage product candidates. Mesoblast has a strong and extensive global intellectual property (IP) portfolio with protection extending through to at least 2040 in all major markets. The Company's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Remestemcel-L is being developed for inflammatory diseases in children and adults including steroid-refractory acute graft versus host disease and moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblast's licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see http://www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as "anticipate," "believe," "could," "estimate," "expect," "goal," "intend," "likely," "look forward to," "may," "plan," "potential," "predict," "project," "should," "will," "would" and similar expressions and variations thereof. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. The risks, uncertainties and other factors that may impact our forward-looking statements include, but are not limited to: the timing, progress and results of Mesoblast's preclinical and clinical studies; Mesoblast's ability to advance product candidates into, enroll and successfully complete, clinical studies; the timing or likelihood of regulatory filings and approvals (including our request to have a Type A meeting with the FDA, the outcome of such a meeting, and any future decision that the FDA may make on the BLA for remestemcel-L for pediatric patients with SR-aGVHD); and the pricing and reimbursement of Mesoblast's product candidates, if approved; Mesoblast's ability to establish and maintain intellectual property on its product candidates and Mesoblast's ability to successfully defend these in cases of alleged infringement. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast's actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. Unless required by law, we do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorizedby the Board.

For further information, please contact:

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