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Archive for the ‘Stem Cell Tourism’ Category

Stem Cell Research on the Ballot: A Closer Look at Prop 14 – Fullerton Observer

Thursday, October 15th, 2020

Californians are voting on a number of propositions that deal with a wide variety of issues this election season. Heres a closer look at Proposition 14, which deals with stem cell research. This is a summary of information taken from the official California voters guide and the website Ballotpedia.

Prop 14: Authorizes Bonds Continuing Stem Cell Research. Initiative Statute.

This ballot initiative would issue $5.5 billion in general obligation bonds for the California Institute for Regenerative Medicine (CIRM), which was created to fund stem cell research. In 2004, voters approved Proposition 71, which created CIRM, issued $3.00 billion in bonds to finance CIRM, and established a State constitutional right to conduct stem cell research.

As of October 2019, CIRM had $132 million in funds remaining. On July 1, 2019, CIRM suspended applications for new projects due to depleted funds.

This ballot initiative would require CIRM to spend no more than 7.5% of the bond funds on operation costs. The remaining bond funds would be spent on grants to entities that conduct research, trials, and programs related to stem cells, as well as start-up costs for facilities.

Dedicates $1.5 billion to research and therapy for Alzheimers, Parkinsons, stroke, epilepsy, and other brain and central nervous system diseases and conditions.

An Independent Citizens Oversight Committee (ICOC) is responsible for governing CIRM.

Arguments in Favor

Nearly half of all California families include a child or adult with medical conditions who could benefit from stem cell research, treatments, and cures.

Prop 14 provides continued funding to develop treatments, advance clinical trials, and achieve new scientific breakthroughs for Californias patients with Cancer, Diabetes, Heart Disease, Alzheimers, Parkinsons, HIV/AIDS, ALS, MS, Sickle Cell Disease, Lung Diseases, Kidney Disease, Bubble Baby Disease, Age-Related Blindness and Genetic Blindness, Epilepsy, Stroke, Schizophrenia, Autism, other Mental Health and Brain Conditions, and Infectious Diseases like COVID-19.

Californias original stem cell funding, which runs out this year, has already led to significant progress in the development of treatments and cures, including 92 FDA-approved clinical trials for chronic disease and injuries, over 2,900 medical discoveries, and demonstrated benefits for patients and research on chronic diseases including Cancer, Diabetes, Heart Conditions, Blindness, HIV/AIDS, ALS, Children with Immune Deficiencies, Paralysis, and Kidney Disease.

New revenues, economic activity and jobs are generated by this funding that will contribute to Californias economic recovery.

Chronic diseases, conditions and injuries are cutting lives short and costing Californians billions in healthcare costs. We must continue our investment, developing stem cell treatments to improve the health and reduce the suffering of millions of Californians.

Arguments Against

We cant afford to waste billions. In the middle of an economic crisis, with soaring unemployment and budget shortfalls in the tens of billions of dollars, we dont have money to burn.

And thats on top of the nearly $3 billion this troubled State agency has spent over the past 15 yearswith poor results. After an extensive analysis of spending by the State agency handing out billions in grants, the San Francisco Chronicle concluded that, The predicted financial windfall has not materialized. Only a few federally approved therapies have resulted.

Prop 14 funds a bureaucracy with serious problems. Some have questioned the integrity and independence of the State agency overseeing these funds.

Others can do this job better. The National Institute of Health provides $1.5 billion a year in grants to fund the same type of research. Private investors and companies, including many in California, have made great strides in using stem cells to cure diseasesusing private funds, not tax dollars.

Paying back Prop 14s costs of $7.8 billion could mean huge tax increases at a time when our economy is on its knees. Or laying off thousands of nurses and other heroes who do the real work of keeping California healthy.

Groups supporting Prop 14 include:

California Democratic Party

JDRF (Juvenile Diabetes Research Foundation)

University of California Board of Regents

Top donors to Yes on 14:

Robert N. Klein II ($3,625,000)

Dagmar Dolby ($2,059,000)

Juvenile Diabetes Research Foundation ($1,750,000)

Open Philanthropy Action Fund ($580,000)

Ann S. Tsukamoto ($500,000)

Groups opposed to Prop 14 include:

Editorial boards of The Orange County Register, The Bakersfield Californian, Mercury News & East Bay Times, San Francisco Chronicle, and Los Angeles Times

Top donors to No on 14:

None reported

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Prop. 14: In the COVID age, can California still afford its stem cell research program? – CALmatters

Thursday, October 15th, 2020

In summary

Proposition 14 asks voters to spend nearly $8 billion to continue the stem cell research program at a time when the coronavirus pandemic has decimated the state budget.

For the second time in 16 years, California voters will decide the fate of the states multi-billion dollar stem cell research program that established the state as a worldwide leader.

How the times have changed.

In November, as the pandemic drags on, Proposition 14 asks voters to spend nearly $8 billion to continue the program during a period when the research environment has significantly evolved and coronavirus has battered the states budget.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

At least $1.5 billion would be earmarked for brain and central nervous system diseases like Alzheimers and Parkinsons. The overall cost of the bonds and their interest totals about $7.8 billion, according to the state legislative analyst. The state would pay about $260 million annually for 30 years, or about 1 percent of Californias annual budget.

Proposition 14 is essentially a repeat with a bigger price tag and a few tweaks of Proposition 71, which California voters approved in 2004 after then-President George W. Bush prohibited, on religious grounds, all federal funding of any stem cell research using human embryos.

The bond measure would approve $5.5 billion in bonds to keep the states stem cell research agency running and grants flowing to California universities and companies.

That groundbreaking measure authorized $3 billion in state bonds to create the states stem cell research agency, the California Institute for Regenerative Medicine, and fund grants for research into treatments for Alzheimers disease, cancer, spinal cord injuries and other diseases.

The institute has nearly used up its original funding, so Prop. 71s author, real estate investor and attorney Robert N. Klein II, led a new effort to get Prop. 14 on the November ballot.

This time, embryonic stem cell research is in a much different place, with federal funding no longer blocked and more funding from the biotech industry.

Voters will want to consider what Californias previous investment in stem cell research has accomplished. Its a nuanced track record.

While many scientific experts agree that Prop 71 was a bold social innovation that successfully bolstered emerging stem cell research, some critics argue that the institutes grantmaking was plagued by conflicts of interest and did not live up to the promises of miracle cures that Prop. 71s supporters made years ago. Although the agency is funded with state money, its overseen by its own board and not by the California governor or lawmakers.

The agency had done a very good job of setting priorities for stem cell research, including research using human embryos, and doling out $300 million annually to build up California as a regenerative medicine powerhouse, according to a 2013 evaluation by the National Academies of Science, Engineering and Medicine.

But the report also found that because the institutes board is made up of scientists from universities and biotech firms likely to apply for grants, board members had almost unavoidable conflicts of interest.

Because human stem cells can develop into many types of cells, including blood, brain, nerve and muscle cells, scientists have long looked to them for potential treatments for currently incurable diseases and injuries. Researchers use two types of stem cells: embryonic stem cells, derived from unused human embryos created through in vitro fertilization, and adult stem cells, which are harder to work with but in some cases can be coaxed in a lab into behaving more like embryonic stem cells.

From the start, stem cell research has been ethically charged and politically controversial because human embryos are destroyed in some types of studies. Federal restrictions on the research have waxed and waned, depending on which political party holds power. While former President Bush restricted federal money for embryonic stem cell research, former President Obama removed those restrictions.

The Trump administration has restricted government research involving fetal tissue but not embryonic stem cells. However, anti-abortion lawmakers have called on the President to once again end federal funding for embryonic stem cell research.

California-funded research has led to one stem cell treatment for a form of Severe Combined Immunodeficiency known as the bubble baby disease. Children with the rare disease dont make enough of a key enzyme needed for a normal immune system. Without treatment, they can die from the disease if not kept in a protective environment. The U.S. Food and Drug Administration is now reviewing the treatment but has not yet approved it for widespread use.

Although many of the agencys early grants were for basic science, the institute also has supported 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonlyknown as Lou Gehrigs disease.

A June 2020 analysis by University of Southern California health policy researchers estimated that taxpayers initial $3 billion investment in the research institute helped create more than 50,000 jobs and generated $10 billion for the states economy.

Gov. Gavin Newsom has endorsed Proposition 14, and other supporters include the Regents of the University of California, the California Democratic Party, the Juvenile Diabetes Research Foundation, patient advocacy groups like the March of Dimes, and some local politicians and chambers of commerce.

Supporters have raised more than $8.5 million, including about $2 million from billionaire Dagmar Dolby, to pass the measure, according to California Secretary of State campaign finance reports.

The passage of Proposition 71 helped save my life, Sandra Dillon, a blood cancer patient, wrote in a San Diego Union-Tribune commentary supporting Proposition 14. She wrote that she had benefited from a drug developed with Institute-funded research that has been designated by the FDA as a breakthrough therapy.

It is unimaginable to think that Californians would vote to discontinue this amazing effort I dont know where I would be or what condition I would be in if it wasnt for the investment Californians made nearly two decades ago.

I think the agencys done good work, but this was never planned to be funded forever with debt.

Lawrence Goldstein, a UC San Diego professor of cellular and molecular medicine and stem cell researcher, said the grants were instrumental in furthering his research on treatments for Alzheimers disease and that Prop. 14 will help create new jobs. The agency has funded a great deal of very important stem cell medical research thats already produced terrific results and has the prospect of saving many more lives in the decade to come, he said.

Opponents include one member of the institutes board and a nonprofit that advocates for privacy in genetic research. They contend that the proposition seeks too much money and does not sufficiently address the conflicts of interest that cropped up after Prop. 71 was passed. They also note that private funding, including venture capital, for stem cell research has grown in recent years. Opponents had raised only $250 by late September, from a single contribution by the California Pro Life Council.

The editorial boards of some of Californias biggest newspapers also have opposed the measure, including the Los Angeles Times, the Orange County Register, the San Francisco Chronicle and the San Jose Mercury News/East Bay Times. The Fresno Bee, Modesto Bee, and San Luis Obispo Tribune newspaper editorial boards support Prop 14.

Jeff Sheehy, the only institute board member not to support Proposition 14, told CalMatters that the research environment has changed since voters initially approved state funding for stem cell research in 2004 and that California should prioritize other needs like education, health care, and housing.

I think the agencys done good work, but this was never planned to be funded forever with debt, Sheehy said. At this point the state cant afford it; were looking at a huge deficit.

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Sorrento Adds Mesenchymal Stem Cell Program (MSC) That Has Been Cleared for a Phase 1 Trial by the FDA to the Pipeline of COVID-19 Focused Rescue…

Thursday, October 15th, 2020

SAN DIEGO, Oct. 12, 2020 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") announced today that it has entered into an exclusive license agreement with Personalized Stem Cells, Inc. (PSC) to acquire global rights to its adipose derived mesenchymal stem cells (MSCs) for patients suffering from acute respiratory distress syndrome (ARDS) associated with COVID-19, which have been cleared for a Phase 1 clinical trial by the FDA.

The study is a single arm, non-randomized Phase 1 study of the safety and preliminary efficacy of an adipose-derived allogeneic MSC product candidate. The outcome data will be compared to contemporaneous non-enrolled patients at the same clinical site(s) as the enrolled patients. The primary objective is to evaluate the safety of intravenous infusion of allogeneic adipose stem cells in patients with COVID-19 and in respiratory distress. The secondary objective is to evaluate a set of safety and efficacy outcome variables to give guidance regarding the risk/benefit ratio in patients with COVID-19 respiratory distress.

More information on the Phase 1 trial can be found at:

https://clinicaltrials.gov/ct2/show/NCT04486001?term=coronastem&draw=2&rank=1

Sorrento will be assuming responsibility for executing the Phase 1 trial, which is targeted to enroll about 20 hospitalized COVID-19 patients in California. Pending the results of the Phase 1 trial, Sorrento expects to expand into Phase 2 trials in multiple relevant geographies as may be determined in consultation with applicable regulatory authorities.

Stem cells have been demonstrated to support resolution of symptoms in multiple disease settings and have the potential to reduce the long-term effects associated with pulmonary tissue damage for these patients. More information on the potential use and benefits of MSCs for patients with COVID-19 can be found in the recently published review at:

https://translational-medicine.biomedcentral.com/articles/10.1186/s12967-020-02380-2

Stem cells represent a treatment modality with high potential to help in the fight against COVID-19 as a stand-alone therapy or in synergy with other product candidates in Sorrentos pipeline, including small molecules (abivertinib or salicyn-30) and neutralizing antibodies (STI-1499 or STI 2020).

Until a time where early treatments are more readily available, it is important to provide patients severely afflicted with COVID-19 multimodal solutions that can help increase survival, reduce the time spent in the hospital and reduce long-term sequelae. The long-term lingering effects of COVID-19 on the body can persist for months after patients leave the hospital, especially for patients that received ventilator support. Shortness of breath, difficulty doing simple tasks and pulmonary fibrosis are among the common complaints of long-term effects of the disease on COVID-19 patients leaving the ICU.

Dr. Robert Harman, CEO of PSC stated, We are delighted to be working with a company such as Sorrento, that has the vision and expertise to take our program through the next steps in the clinical development process. Sorrento saw the translational value of our decades of work in animal health and has acknowledged the extensive manufacturing and regulatory work we have done in bringing human cell lines to a Phase 1 FDA clearance. We are looking forward to collaborating on this initiative and beyond.

Dr. Henry Ji, Chairman and CEO of Sorrento stated, Stem cells were a missing piece in our comprehensive portfolio of potential solutions against COVID-19. We now cover multiple stages of the continuum of care from prevention to potential therapeutic solutions for the most advanced stages of the disease. With PSCs Phase 1 product candidate, we hope to move quickly through the next clinical trials, and, if successful, be able to provide a supportive therapy that may save the lives of the most advanced patients and may also ensure patients who have to undergo intensive care can benefit from a therapy with the potential to minimize the long-term effects of the disease due to the lung damage created by the virus early in the infection.

About Sorrento Therapeutics, Inc.

Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. Sorrentos multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (G-MAB library), clinical stage immuno-cellular therapies (CAR-T, DAR-T), antibody-drug conjugates (ADCs), and clinical stage oncolytic virus (Seprehvir, Seprehvec). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIDTRAP, ACE-MAB, COVI-MAB, COVI-GUARD, COVI-SHIELD, COVI-AMG and T-VIVA-19; and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRACE.

Sorrentos commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (RTX), and ZTlido (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a phase IB trial for intractable pain associated with cancer and a phase 1B trial in osteoarthritis patients. ZTlido was approved by the FDA on February 28, 2018.

For more information visit http://www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding the safety and efficacy of an adipose-derived allogeneic MSC product in patients with COVID-19 and in respiratory distress; the clinical testing of an adipose-derived allogeneic MSC product; the expected enrollment of the Phase 1 trial; the potential commencement of any future clinical trials for an adipose-derived allogeneic MSC product; the ability of an adipose-derived allogeneic MSC product to work as a stand-alone therapy or in synergy with our other product candidates; the ability of an adipose-derived allogeneic MSC product to support healing and reduce the long-term effects associated with pulmonary tissue damage for COVID-19 patients; our ability to provide a supportive therapy for COVID-19 patents using an adipose-derived allogeneic MSC product; the ability of an adipose-derived allogeneic MSC product to potentially save lives of COVID-19 patients and to potentially minimize the long-term effects of COVID-19; our ability to cover all stages of the continuum of care for COVID-19; and our potential position in the antiviral industry. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's and its subsidiaries', affiliates and partners technologies and prospects and collaborations with partners, including, but not limited to risks related to seeking regulatory approval for any adipose-derived allogeneic MSC product; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its COVID-19 therapeutic product candidate strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2019, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Media and Investor Relations

Alexis Nahama, DVM (SVP Corporate Development)

Telephone: 1.858.203.4120

Email: mediarelations@sorrentotherapeutics.com

Sorrento and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.G-MAB, COVI-GUARDTM, COVI-SHIELD, COVI-AMG, COVIDTRAP, T-VIVA-19, COVI-MAB, ACE-MAB, COVI-TRACK, COVI-STIX and COVI-TRACE are trademarks of Sorrento Therapeutics, Inc.

ZTlido is a trademark owned by Scilex Pharmaceuticals Inc.All other trademarks are the property of their respective owners. 2020 Sorrento Therapeutics, Inc. All Rights Reserved.

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AIVITA Biomedical’s Stem Cell Therapeutic in Vision Loss Published in Investigative Ophthalmology & Vision Science – PRNewswire

Thursday, October 15th, 2020

IRVINE, Calif., Oct. 9, 2020 /PRNewswire/ --AIVITA Biomedical, Inc., a private biotechnology company developing personalized vaccines for the treatment of cancer and COVID-19, announced today the publication of the peer-reviewed manuscript, "Retina organoid transplants develop photoreceptors and improve visual function in RCS rats with RPE dysfunction,"in the journal Investigative Ophthalmology & Visual Science. The study, led by researchers at AIVITA Biomedical and the Sue & Bill Gross Stem Cell Research Center of the University of California, Irvine, used 3D-retina organoids generated from human stem cells developed by AIVITA to provide insight into the potential use of transplanted retina organoids as a therapeutic option for blinding diseases.

In the study, transplanted retina organoid sheets were examined to determine if human stem cell-derived photoreceptors coulddevelop, survive and function in vivo without the support of healthy retina pigment epithelium (RPE). Visual function was examined through a variety of tests, including optokinetic testing (OKT), electroretinogram (ERG), and superior colliculus (SC) brain recording. These tests concluded that retina organoid transplantations demonstrated significant improvement in visual function compared to non-surgery and sham surgery controls, supporting the application of AIVITA's stem cell technologies in visual disease therapeutics.

"Leveraging our expertise in stem cell growth and differentiation, I'm excited to see the promise of our technology platform in potential therapeutics for vision loss," said Hans Keirstead, Ph.D., chief executive officer of AIVITA and a contributing author to the paper. "To our knowledge, this study is the first to show that it's possible for photoreceptors derived from stem cells to survive and function after transplantation when a host has a dysfunctional RPE."

This work is supported by funding from the California Institute for Regenerative Medicine (CIRM) and National Institutes of Health (NIH).

About AIVITA Biomedical AIVITA Biomedical is a privately held company engaged in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. Founded in 2016 by pioneers in the stem cell industry, AIVITA Biomedical utilizes its expertise in stem cell growth and directed, high-purity differentiation to enable safe, efficient and economical manufacturing systems which support its therapeutic pipeline and commercial line of skin care products. All proceeds from the sale of AIVITA's skin care products support the treatment of people with cancer.

SOURCE AIVITA Biomedical, Inc.

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AIVITA Biomedical's Stem Cell Therapeutic in Vision Loss Published in Investigative Ophthalmology & Vision Science - PRNewswire

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Was Trump’s Regeneron ‘Cure’ Developed Using Stem Cells and Fetal Tissues? – Snopes.com

Thursday, October 15th, 2020

As governments fight the COVID-19 pandemic, Snopes is fighting an infodemic of rumors and misinformation, and you can help. Read our coronavirus fact checks. Submit any questionable rumors and advice you encounter. Become a Founding Member to help us hire more fact-checkers. And, please, follow the CDC or WHO for guidance on protecting your community from the disease.

As the world raced to find a treatment that would alleviate the global pressure of the coronavirus pandemic, U.S. President Donald Trump contracted the virus in early October 2020 and developed COVID-19, the respiratory disease caused by SARS-CoV-2. In the days following his diagnosis and public release from Walter Reed Hospital, where he received world-class treatment, Trump touted the powers of a miracle drug called Regeneron, which he promised to make available to the American people.

A video shared in tweet by the president on Oct. 7 claimed that Regeneron was a cure.

I spent four days there [at Walter Reed] and I went in, I wasnt feeling so hot. And within a very short period of time, they gave me Regeneron. Its called Regeneron. And other things too but I think this was the key. But they gave me Regeneron, and it was like, unbelievable. I felt good immediately. I felt as good three days ago as I do now.

So, I just want to say, we have Regeneron. We have a very similar drug from Eli Lilly, and theyre coming out and were trying to get them on an emergency basis. Weve authorized it. Ive authorized it. And if youre in the hospital and youre feeling really bad, I think were going to work it so that you get them and youre going to get them free.

Shortly after the president praised what he deemed a cure for his COVID-19 infection, some social media users pushed the claim that the drug Trump was given was developed using fetal tissue a practice in direct conflict with the administrations pro-life platform.

To clarify, Trump was treated with REGN-COV2, a novel anti-viral antibody cocktail created by Regeneron Pharmaceuticals, a New York-based company that has openly stated it uses stem cell and fetal tissues as part of its research and development on new pharmaceutical treatments. This knowledge, and open support from a pro-life president, incited social media pushback from users who argued that the companys use of stem cells and fetal tissues for scientific research goes against pro-life platforms and policies.

REGN-COV2 is a combination of two human-made proteins, or monoclonal antibodies, known as REGN10933 and REGN10987. These two monoclonal antibodies were specifically designed to block the ability of SARs-CoV-2 to infect human cells. The biotechnology company further went on to describe the development of REGN-COV2 as follows:

To develop REGN-COV2, Regeneron scientists evaluated thousands of fully-human antibodies produced by the companys VelocImmune mice, which have been genetically modified to have a human immune system, as well as antibodies identified from humans who have recovered from COVID-19. The two potent, virus-neutralizing antibodies that form REGN-COV2 bind non-competitively to the critical receptor binding domain of the viruss spike protein, which diminishes the ability of mutant viruses to escape treatment and protects against spike variants that have arisen in the human population.

While it is true that Regeneron has used stem cells for some of its research, no human stem cells or human embryonic stem cells were used in the development of REGN-COV2, according to Alexandria Bowie, a spokesperson for the company. An April 2020 statement issued by Regeneron confirmed that research using stem cells helps its scientists model complex diseases, test new drug candidates, and lead to scientific insights that may help spur the creation of new medicines but the company contends that embryonic cells were not used in the production of REGN-CO2.

In short: we did not use human stem cells or human embryonic stem cells in the development of REGN-COV2, Bowie told Snopes in an email.

But its not quite that cut and dried.

In the research and development of pharmaceutical therapeutics, many companies turn to what is known as a cell line. These are cultures of human or animal cells that are derived from a living organism and cultured and propagated repeatedly, and, in some cases, used indefinitely. The development of REGN-COV2 utilized HEK293T a cell line that is derived from human fetal embryonic kidney tissues to create a pseudovirus that mimics a spike Protein found in SARS-CoV-2 in order to test the drugs ability to neutralize and ultimately treat the novel coronavirus.

HEK293s are considered immortalized cells (not stem cells) and are a common and widespread tool in research labs. This cell line was originally derived by adenovirus transformation of human embryonic kidney cells in 1977, explained Bowie, adding that HEK293 were further transformed at Stanford in the 1980s with SV40 large T antigen, a solution that is used by researchers to initiate and maintain DNA replication necessary for creating cell lines.

Fetal tissues were not directly used n the development of REGN-COV2, but cell lines from decades-old embryonic kidney tissues were. Fetal tissues are used to develop cell lines. Embryonic stem cells, on the other hand, are different than adult stem cells in that they are undifferentiated and regenerative cells, which means that they have not been assigned a key task in the human body. As such, researchers have uncovered ways to direct their use in creating human tissues that allow for a variety of uses, including testing new pharmaceuticals.

Opposition to the use of fetal tissue and embryonic stem cell research has been at the heart of the pro-life platform due to the way in which these cells are obtained and its association with using living fetuses either inside (in utero) or outside of the uterus (ex utero). Pro-life groups like March for Life have even gone so far as to pressure the Trump administration to halt funding for research that requires aborted fetal organs and tissues. In summer 2019, the president required any federally funded research using fetal tissue to undergo an ethics review, and has since stocked his cabinet with other similarly-minded officials.

REGN-COV2 is currently in late-stage clinical trials for various populations, including non-hospitalized and hospitalized patients as well as for the potential prevention in individuals who may have had close household exposure to COVID-19. According to a news release published on Sept. 29, the company announced that the antibody cocktail was shown to reduce the viral load and alleviate symptoms in non-hospitalized patients with COVID-19. REGN-COV2 also showed positive trends in reducing medical visits. However, it is important to note that the research included a relatively small sample size of just 275 patients.

The greatest treatment benefit was in patients who had not mounted their own effective immune response, suggesting that REGN-COV2 could provide a therapeutic substitute for the naturally-occurring immune response. These patients were less likely to clear the virus on their own and were at greater risk for prolonged symptoms, said Regeneron President and Chief Scientific Officer Dr. George D. Yancopoulos in a statement.

As of Oct. 12, Regeneron had submitted an emergency use authorization (EUA) to the U.S. Food and Drug Administration in early October, and noted REGN-COV2s early, promising clinical data paired with the continued, pressing unmet need of COVID-19 meets the FDA standard for emergency use authorization.

Regeneron told Snopes that it cant speculate on potential timing for an EUA. We will update when such is available.

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UofL-born company secures an additional $115 million to advance cell therapy – uoflnews.com

Thursday, October 15th, 2020

A company born at the University of Louisville has raised an additional $115 million to further develop a therapy that could improve the lives of kidney transplant recipients.

The company, Talaris Therapeutics Inc., plans to use the series B funding to support a Phase 3 clinical trial the last step before applying for FDA approval. This follows a $100 million series A funding round announced last year to hire staff and initiate the trial.

Talaris recently began dosing patients in that trial of the unique cell therapy, called FCR001, which allows living-donor kidney transplant recipients to stay off immunosuppression drugs they would otherwise need for the rest of their lives.

Immunosuppressants help prevent rejection of the transplanted organ, but can cause side effects, including high blood pressure, diabetes, high cholesterol, neurological effects, increased risk of infection and decline in kidney function over time.

This technology could help transplant patients live fuller, healthier lives,said UofL Executive Vice President for Research and Innovation, Kevin Gardner.This UofL research, in the hands of strong industry partners and backed by investors, is a big step in advancing our health.

FCR001 consists of stem cells taken from the organ donor and processed at the Talaris facility, then infused into the organ transplant recipient. The goal is to create a durable dual immune system (part donor-derived and part recipient) in the transplant recipient. These two immune systems coexist, recognizing both the recipients own body as well as the donated organ as self.

The new funding also will advance aplanned Phase 2 trial of FCR001 in diffuse systemic sclerosis, a severe form of the rare autoimmune disease scleroderma.

Talaris, formerly known as Regenerex LLC, was founded by UofL researcher and innovator Suzanne Ildstad to commercialize the pioneering work of her team at the university. She now serves as Talaris chief scientific officer.

This financing moves us one step closer to helping organ transplant recipients no longer be dependent on immunosuppressive drugs, resulting in a greatly improved quality of life, Ildstad said of the earlier Phase 3 trial financing. The support and research infrastructure at UofL have been invaluable in our journey to this important juncture.

In an earlier Phase 2 trial, FCR001 allowed 70% of living donor kidney transplant patients durably to be weaned off all of their immunosuppression treatments.

The Phase 3 trial is expected to enroll 120 adult living donor kidney transplant recipients at multiple sites across the U.S. To date, the trial has been initiated at five clinical sites around the country.

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UofL-born company secures an additional $115 million to advance cell therapy - uoflnews.com

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Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for COVID-19 Related Acute Respiratory Distress Syndrome…

Thursday, October 15th, 2020

Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite

"Novellus's iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of their high potency as demonstrated in our pre-clinical studies, as well as our ability to cost-effectively provide high doses and repeat doses." said Myron Holubiak, CEO of Citius.

"We are excited to be developing iMSCs because of their promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Matt Angel, Chief Science Officer of Novellus. He continued, "Our iMSCs have multimodal immunomodulatory mechanisms of action that make them promising for treatment of acute respiratory diseases."

About Novellus Therapeutics LimitedNovellus is a pre-clinical stage biotechnology company developing engineered cellular medicines using its patented non-immunogenic mRNA, high-specificity gene editing, mutation-free & footprint-free cell reprogramming and serum-insensitive mRNA lipid delivery technologies. Novellus is privately held and is headquartered in Cambridge, MA. For more information, please visit http://www.novellustx.com.

About NoveCite, Inc.NoveCite, Inc. is a newly formed subsidiary of Citius Pharmaceuticals, a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care. For more information, please visit http://www.citiuspharma.com.

Contact: [emailprotected]

SOURCE Novellus Therapeutics

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Bone Therapeutics’ allogeneic cell therapy product, ALLOB, shows 90% fusion rate at 24 months in Phase IIa study in lumbar spinal fusion -…

Thursday, October 15th, 2020

Gosselies, Belgium, 14 October 2020, 7am CEST BONE THERAPEUTICS(Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces positive 24-month follow-up results for the Phase IIa study with the allogeneic cell therapy product, ALLOB, in patients undergoing lumbar spinal fusion procedures.

The 24-month data show a high percentage of successful lumbar vertebrae fusion of 90%. Patients also continue to experience important clinical improvements in function and pain, from as early as six months after treatment, up to the 24-month follow-up period.

Degenerative spine disorders have a major impact on the quality of life of patients. These impacts include decreases in the stability of the spine and pain in motion,said Dr. Alphonse Lubansu, M.D., Head of the Spinal Clinic, Erasme University Hospital, Universit libre de Bruxelles. The 24 month follow-up data of this Phase IIa clinical trial have demonstrated that patients treated with ALLOB in spinal fusion procedure show a high incidence in fusion, and benefit from a sustained, clinically meaningful improvement in function and pain throughout the 24 months following treatment together with a good safety profile. These results show that ALLOB in combination with the standard spine fusion surgery could be a promising treatment option to address the currently unmet needs of these patients.

This positive data forlumbar spinal fusion complementsthe strong Phase I/IIa results from ALLOB in patients with delayed union fractures,said Miguel Forte, MD, PhD, Chief Executive Officer of Bone Therapeutics. These studies provide promising clinical evidence for the potential ofBone Therapeuticsunique allogeneic cell therapy platform to address high unmet medical needs in orthopaedics and bone related disorders. We will now hold discussions with global regulators and our partners to explore a variety of options for the next stages of clinical development for ALLOB in different orthopedic indications, while pursuing the phase IIb study of ALLOB in difficult tibial fractures.In addition, theclinical results provide further evidence for the expansion of ALLOB and our platform of differentiated MSCs to other indications.

The multi-center, open-label proof-of-concept Phase IIa study was designed to evaluate the safety and efficacy of ALLOB administered, procedure in which an interbody cage with bioceramic granules mixed with ALLOB is implanted into the spine to achieve fusion of the lumbar vertebrae. The main endpoints of the 24-month follow-up analysis included safety and radiological assessments to evaluate vertebrae fusion (continuous bone bridges) and clinical assessments to evaluate improvement in patients functional disability as well as reduction in back and leg pain. The study evaluated 30 patients treated with ALLOB, 29 patients attended the 24-month visit.

Radiological data was collected from CT-scans at 24 months and assessed by three external readers. It showed a successful fusion of the lumbar vertebrae in 27 out of 30 patients (90%). In addition, the remaining 3 patients showed radiological evidence of bone formation. Treatment with ALLOB also resulted in a clear and statistically significant clinical improvement in function and reduction in pain over the 24-month follow-up period. Functional disability improved from the pre-treatment baseline to 24-month by a mean score of 60% (p<0.001) on the Oswestry Disability Index(1). Back and leg pain were strongly reduced by 57 to 62% (p<0.001) and 68 to 70% (p<0.001) respectively compared to pre-treatment baseline. Treatment with ALLOB was generally well-tolerated by the patients, consistent with previous reported results.

(1)The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to measure a patients permanent functional disability. This validated questionnaire was first published by Jeremy Fairbank et al. in Physiotherapy in 1980. ODI score of 0%-20%: minimal disability; 21%-40%: moderate disability; 41%-60%: severe disability; 61%-80%: crippled; 81%-100%: bed bound.

About Spinal Fusion

Due to ageing populations and sedentary lifestyles, the number of people suffering from degenerative spine disorders continues to increase. Today, spinal fusion procedures are performed to relieve pain and improve patient daily functioning in a broad spectrum of degenerative spine disorders. Spinal fusion consists of bridging two or more vertebrae with the use of a cage and graft material, traditionally autologous bone graft or demineralised bone matrix placed into the intervertebral space for fusing an unstable portion of the spine and immobilizing a painful intervertebral motion segment. Over 1,000,000 spinal fusion procedures are performed annually in the US and EU, of which half at lumbar level and the market is growing at a rate of 5% per year. Although spinal fusion surgery is routine, non-fusion, slow progression to fusion and failure to eliminate pain are still frequent with up to 35% of patients not being satisfied with their surgery.

About ALLOB

ALLOB is the Companys off-the-shelf allogeneic cell therapy platform consisting of human allogeneic bone-forming cells derived from cultured bone marrow mesenchymal stem cells (MSC) from healthy adult donors, offering numerous advantages in product quality, injectable quantity, production, logistics and cost as compared to an autologous approach. To address critical factors for the development and commercialisation of cell therapy products, Bone Therapeutics has established a proprietary, optimised production process that improves consistency, scalability, cost effectiveness and ease of use of ALLOB. This optimized production process significantly increases the production yield, generating 100,000 of doses of ALLOB per bone marrow donation. Additionally, the final ALLOB product will be cryopreserved, enabling easy shipment and the capability to be stored in a frozen form at the hospital level. The process will therefore substantially reduce overall production costs, simplify supply chain logistics, improve patient accessibility and facilitate global commercialisation. The Company will implement the optimized production process for all future clinical trials with ALLOB.

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company is ready to start the phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available atwww.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

For US Media and Investor Enquiries:LHA Investor RelationsYvonne BriggsTel: +1 310 691 7100ybriggs@lhai.com

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

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Thalassemia Treatment Market projected to expand at a CAGR of 7.9% from 2018 to 2026 – The Daily Chronicle

Wednesday, September 30th, 2020

Transparency Market Research (TMR)has published a new report titled, Thalassemia Treatment Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20182026.According to the report, theglobal thalassemia treatment marketwas valued at US$ 842.0 Mn in 2017 and is projected to expand at a CAGR of 7.9% from 2018 to 2026. Increase in R&D investment by key players for developing new drugs for treating thalassemia and rise in demand for chelating therapy are anticipated to fuel the growth of the global market from 2018 to 2026. Asia Pacific and Middle East & Africa are expected to dominate the global market owing to increase in prevalence of thalassemia disorder and high adoption of chelation therapy & blood transfusion for treatment by doctors as well as patients. The market in Asia Pacific is projected to expand at the fastest CAGR during the forecast period. Growth of the market in the region is attributed to large base of private clinics and hospitals, rise in number of thalassemia population requiring chelation therapy services after spleen surgery, and surge in adoption of blood transfusion among patients. The thalassemia treatment market in Latin America is likely to expand at a moderate growth rate during the forecast period.

Request Brochure for Report https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=44462

Value Added Features in Thalassemia Treatments to Propel Global Market

The global thalassemia treatment market is projected to be driven by value added features offered by various thalassemia drug manufacturing companies in order to streamline the day to day work flow and increase revenue. The thalassemia treatment provides limited range of features and benefits ranging from patient pain heeling remedies to treatment procedures. For instance, very less number of people go for the much beneficial chelation therapy. These features help physicians and nurses to streamline the chelation therapy required for patients to maintain their daily workflow efficiently and effectively. Key players offering thalassemia treatment are coming up with value added features such as bone marrow transplantation, stem cell regeneration, gene editing methodologies, and effective modality features used for drug manufacturing along with creating a prominent candidate molecule for drugs. These features can reduce the overall operating cost and improve the overall effectiveness and efficiency of treatment practices. Companies are focusing on the development of combined drug therapy in their system to effectively integrate chelating therapy or other treatment procedure at an affordable cost. These value added features save time for physicians and help improve thalassemia patient survival performance.

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Chelation Therapy to be Highly Lucrative Segment

Traditionally, blood transfusion based on type of thalassemia treatment was the most commonly used procedure among thalassemia patients. This treatment type was associated with availability of donor and cost of treatment procedure. Moreover, chelation therapy based on thalassemia treatment are priced on perpetual license model and are expensive. Chelation therapy treatment enables patients to practice intensive therapy to treat acute iron overload leading to 90% recovery among thalassemia patients. These chelation therapy based treatments address specific challenges faced during the treatment procedure. The chelation therapy treatment facilitates benefits such as pain relief, and increase in motion of blood flow among patients.

Asia Pacific Presents Significant Opportunities

North America and Europe accounted for major share of the global thalassemia treatment market in 2017 and are likely to gain market shares by 2026. High rate of immigration from tropical regions, increasing health care budgets by governments, and government initiatives to promote thalassemia treatment technique contributed to the leading share of these regions. Asia Pacific is projected to be the most attractive market for thalassemia treatment, with highest attractiveness index. The market in Asia Pacific is expected to expand at a high CAGR of 9% during the forecast period due to large number of thalassemia patients opting for chelation therapy in developing countries such as India and China. Well-established health care facilities, medical tourism for treatment of thalassemia, and high adoption of blood transfusion safety technique in countries such as Turkey and GCC Countries are likely to drive the market in Middle East & Africa. The market in Latin America is poised to expand at a moderate growth rate during the forecast period.

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Trend of R&D among Leading Players to Increase Geographic Presence

The report also provides profiles of leading players operating in the global thalassemia treatment market. bluebird bio, Inc., Acceleron Pharma, Inc., Novartis AG, Celgene Corporation, and Shire plc (Takeda Pharmaceuticals) are the leading players operating in the global market. Companies operating in the thalassemia treatment market aim to increase geographic presence and research & development through strategic acquisitions and collaborations with leading players in respective domains and region. In December 2017, Shire plc committed to pay approximately US$ 1,409.9 Mn to contract vendors for administering and executing clinical trials. Other prominent players operating in the global thalassemia treatment include Incyte Corporation, Kiadis Pharma, Gamida Cell, Celgene Corporation, and Bellicum Pharmaceuticals.

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Indian Biotechnology Market Market scrutinized in the new analysis – WhaTech

Tuesday, September 22nd, 2020

Indian Biotechnology Market Size, Share & Trends Analysis Report by Type (Healthcare, Crop Production and Agriculture, Industrial, Natural Resources & Environment, and Others) and Forecast 2020-2026

Indian biotechnology market is estimated to grow significantly at a CAGR of 8.1% during the forecast period. The increasing healthcare expenditure and increasing funding in cell-based research in the country are further supporting the biotechnology market in the country. The Government of India has taken some steps to promote cell harvesting techniques in the country and have set up numbers of stem cell banks throughout the country.

Report: http://www.omrglobal.com/requestogy-market

According to International Brand Equity Foundation (IBEF), the Indian healthcare market can increase three-fold to nearly $133.4 billion in 2022. The country is experiencing growth of around 22-25% in medical tourism. Various hospital chains such as Apollo Hospitals and Global Healthcare Enterprise are growing significantly in India due to a huge prevalence of cancer and related diseases. Private hospitals are expanding their business to provide a wide range of diagnostic tests and applications to a massive pool of cancer patients including foreign patients during medical tourism.

Browse for Full Report Description atwww.omrglobal.com/industrogy-market

The Indian biotechnology market is classified on the basis of type.

Based on type, the market is segmented into healthcare, crop production and agriculture, industrial, natural resources & environment, and others. The companies which are contributing to the growth of the Indian biotechnology market include Amgen Inc., Novo Nordisk A/S, CSL Ltd., Bristol-Myers Squibb Co., AstraZeneca PLC, Merck & Co., Inc., Johnson & Johnson Services Inc., and Pfizer Inc. The market players are considerably contributing to the market growth by the adoption of various strategies including new product launch, merger, and acquisition, collaborations with government, funding to the start-ups, and technological advancements to stay competitive in the market.

Market Segmentation

Indian Biotechnology Market by Type

Company Profiles

Report: http://www.omrglobal.com/report-ogy-market

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Why Are There Only 10 Cell and Gene Therapies in… – Labiotech.eu

Tuesday, September 22nd, 2020

There is a lot of talk about how cell and gene therapy are going to change medicine, so why have only a few of them reached the market?

Over the last decade, only 14 advanced therapy medicinal products (ATMPs) that is, cell and gene therapies have received approval in Europe. With four withdrawals, only 10 of them still have a valid marketing authorization.

That is a stark contrast with the fact that there have been over 500 clinical trials using ATMPs in the EU since 2009. But the reality is that its a bit too soon to be expecting results many of these technologies are brand new and decades-old discoveries are only just reaching the market. For example, the development of Strimvelis, approved in 2016, took more than 20 years. The approval of Chondrocelect in 2009 took nine years since its developer, TiGenix, was founded.

Holoclar initially seemed like an exceptional case: research and development started around 1996 and the first clinical results were published just a year later. But one of its developers, Graziella Pellegrini, reported the product was under development for a total of 25 years. So those excited about CRISPR therapies, based on a gene-editing technology that was only developed in 2012, will still have to wait.

If the time scale wasnt daunting enough, research and development also burns cash quickly.A big chunk of the total money invested goes into meeting the quality, safety, and efficacy standards set by the regulatory authorities. This step seems to represent one of the biggest challenges for developers.

In fact, when regulations for ATMPs were first released in Europe, it appeared that authorities and researchers were on different wavelengths. In 2007, new European Union (EU) regulations on advanced therapies came in, which added more, very frustrating years to the development, said Pellegrini. It seemed that we had to start from scratch.

Thanks to frequent stakeholder consultations, these requirements are constantly being simplified, following the EMAs goal of fostering development and expanding patient access. But even with dynamic regulations, some products may only be authorized at thenational level and not for the whole continent.

For example, there is a dedicated pathway to exceptionally approve and commercialize ATMPs only locally as hospital exemptions. This status includes several limitations: this designation is only for non-routine products and those custom-made for individual patients, and importing or exporting them is illegal which can lead to the dangerous practice of stem cell tourism.

It seems complicated enough to reach the market with a cell or gene therapy, but the struggle isnt over at that point. The EMA can still withdraw a marketing application due to safety issues or if the company doesnt apply (and pay) for a renewal of the marketing authorization after five years.

That was the case of Glybera, the first gene therapy to receive approval in Europe. Its developers decided to not renew its market authorization after the therapys commercial failure in Europe and difficulties reaching the US market. With a very small target market and a price of one million euros, it was the most expensive treatment back in 2012, making it hard to convince governments and private insurance companies to pay for it.

In fact, only one person was treated with Glybera after its approval. Elisabeth Steinhagen-Thiessen, the doctor who prescribed it, had a lengthy fight with the German authorities and the insurance company to make them pay for the treatment. After the withdrawal, three doses left were given to patients for one euro each.

A big challenge for cell and gene therapies is that they often target conditions that affect a very small number of patients. Pharmaceutical companies are not much interested in unprofitable rare disease, commented Pellegrini.

In the case of Strimvelis, there are only about 14 people per year in Europe and 12 in the US diagnosed with its target disease, a rare form of genetic immune deficiency called ADA-SCID. The numbers are better for Holoclar, with around 1,000 people annually in Europe being eligible burn victims who have become blind but whose eyes have not been too extensively destroyed. Still,it is far short of a blockbuster.

There are exceptions, such as Imlygic, a therapy from Amgen approved in 2015 for the treatment of late-stage melanoma, with over 56,000 new cases across the EU each year.

Its fair to say that the majority of withdrawals have been made for business reasons, not safety issues. This highlights the fact that receiving EMA approval does not guarantee commercial viability the product can still be an economic failure.

Clearly, we have a lot of lessons to learn from past failure and success stories. As regulators and insurance companies become more familiar with cell and gene therapies, and developers avoid the mistakes made by others in the past, we can expect a future where cell and gene therapies become commonplace and no longer a futuristic hope.

Cover illustration by Elena Resko, images via Pharma Boardroom and the author. This article was published in April 2018 and has since been updated to reflect the latest EMA approvals.

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Colorado woman arrested for Assault in the Second Degree and Resisting Arrest – Maui Time

Sunday, September 13th, 2020

On September 11, 2020 at about 5:07 a.m., Tara Trunfio (24), from Colorado, was arrested for Assault in the Second Degree and Resisting Arrest.

Investigation reveals that on September 11, 2020 at about 3:46 a.m., Hana Patrol officers were assigned to the 4590 Hana Highway, regarding a female with a stab wound. It was alleged that Trunfio had earlier stabbed the victim while at the end of Ulaino Road.

Trunfio was located at the very end of Uluino Road. After advisement of her Constitutional Rights and being told she was under arrest, Trunfio physically and verbally resisted. A struggle ensued. Trunfio was taken into custody and transported to the Hana Police Station. She was assessed by Medic 6. Neither Trunfio nor Officers sustained or reported any injuries as a result of this incident.

Trunfio was later transported to the Wailuku Receiving Desk for processing.

On September 11, 2020 at about 11:01 a.m., Trunfio was formally charged for Assault in the Second Degree and Resisting Arrest. Her bail is set at $7,000. As of 12:15 p.m., she remains in Police Custody.

Press Release 9-120-20 Maui Police Department

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County seeking broadband need response – Mount Airy News

Sunday, September 13th, 2020

September 06, 2020

Doug McDaniel has spent much of his life sifting through decades worth of data online, scouring old newspapers and tracking down primary sources in hopes of documenting the athletic history of Mount Airy City Schools.

McDaniels meticulous research has connected Granite City student-athletes, coaches and fans of today with those of the past century. His work began primarily in football, but has since spread to sports across the board.

In all his trips down the rabbit hole, McDaniel has unearthed some of the most successful athletes in state history that also called Mount Airy home.

The 1973 graduate of Mount Airy High thought hed discovered the best athletes from the citys history, especially in football and basketball, by now. If someone told McDaniel there was someone he missed in his research, McDaniel would be skeptical to say the least.

Never in his life was McDaniel so elated to recently learn he was wrong.

As it turns out, a world class athlete named Ted McBride sat just a few pews away from McDaniel at Fellowship Missionary Baptist Church. The two knew each other for the better part of 50 years.

McDaniel just happened to run across an old article about McBride within the past year. McDaniel considered McBride a dear friend, but he had no clue McBride possessed such an incomparable resume. It included state championships, a few All-American selections and a pair of Olympic medals.

There was no question then that McBride deserved to be known as a true legend.

I think hes the best athlete that Surry County has ever known and maybe will know, McDaniel said.

McDaniel isnt the first to believe this, either. In a 1957 article from The Mount Airy News, author Joe Griffin said the following:

When one surveys the historical annals in search of who was probably the best athlete ever to emerge from the Granite City, he can hardly overlook the performances of a young deaf athlete by the name Ted McBride.

You name it, he did it

Ted Lee McBride was born Nov. 29, 1934, to parents Benson Boss and Kate McBride.

He grew up in a big, white frame house across from the old Flat Rock High School. According to McBrides widow, Eugenia, he attended school at Flat Rock until his mother realized he was not progressing.

As a result, his mother decided the best thing to do was to send McBride to the North Carolina School for the Deaf in Morganton.

She told me, That was the hardest thing I ever had to do, to leave my son; and I couldnt go back for two weeks, Eugenia McBride said, stressing how beneficial the move was to her sons life. Ted credits that to his success. He had good parents and good teachers that influenced him a whole lot.

McBride started attending the school in 1946. Because he wasnt fluent in sign language, McBride had a lot of catching up to do in school. As a result, he didnt enter high school until 1950, just a few months shy of 16.

School officials learned very quickly they had a star in the making. Griffins article stated that McBride was tall, fast and, most importantly, humble.

You name it, he did it, Eugenia said.

McBride morphed into an all-time great in football, basketball and track.

As a tight end and defensive end, McBride helped the school record three perfect seasons in 1951, 1953 and 1954. McBride earned All-American honors in three straight seasons from 1952-54. The school had an overall record of 22-2 during that three-season span.

The schools undefeated season in 1954 was good enough to rank them third in the nation. In addition to being named an All-American for a third time, McBride was named National Player of the Year by Silent Workers, a national magazine popular with the deaf population.

McBride also served as the schools basketball center during his high school years. He led the team in rebounding for most of his high school career and was named a member of the All-American Second Team by Silent Workers.

Track and Field was the latest of McBrides sporting endeavors, picking it up in 1953. It went on to be the sport in which he experienced the most success after high school.

While at the North Carolina School for the Deaf, McBride set numerous school records in hurdles as well as the pole vault. He led the team to a national championship and was named the top individual performer in the Asheville Relays the top state event in track.

McBride captured three state championships in the Western North Carolina High School Activities Association, which didnt merge with the N.C. High School Athletic Association until 1977.

Olympic Medalist

McBride aged out of high school sports in 1955. As he finished school, McBride played basketball in an industrial league in Morganton. He led the team to a 13-2 record and was named to the all-league team.

He later represented South Carolina in the National Deaf Tournament that year. Teams from across the country convened in Washington, D.C. McBride helped South Carolina finish second in the tournament.

Graduation came in 1956. He ended up staying in Morganton to work in the maintenance department.

The completion of high school did not mark the end of McBrides athletic career. In fact, he arguably made the biggest impact after school.

The United States was tasked with assembling a team for the 1957 Deaflympics in Milan, Italy.

From Griffins article: He was so well liked and respected that, when NCSD was given an invitation to enter an athlete for competition in the Deaf Olympics [sic], Ted was the unanimous choice.

Fundraisers in both Morganton and Mount Airy helped raise the $1,200 necessary to send McBride to Italy. He was set to compete in the 110-meter hurdles and 400-meter hurdles.

McBride stood tall at the international competition just as he had at every other level.

The 110-hurdles was McBrides specialty. He finished the race in 16.2 seconds to earn the gold medal. This was 0.8 seconds faster than the previous Deaflympics world record.

Competing in the 400-hurdles was new to McBride, as schools in the states only went up to 300 meters at the time. This was the first time hed competed in such a race competitively, and he still managed to grab a medal. He earned a bronze medal with a time of 56.7 seconds, just 0.2 seconds behind the silver medalist.

McBrides two medals helped Team USA win the overall track and field event. He was featured in publications such as The New York Times and in stories by the United Press.

His athletic career slowed following the Deaflympics. McBride earned an All-District award from the National Basketball Congress of America in 1959. He was later inducted into the North Carolina School for the Deaf Athletic Hall of Fame in 1979 and then the Southeast Athletic Association of the Deaf Hall of Fame in 2012.

Ted McBride is right up there with anybody as far as greatness goes, McDaniel said. I challenge anybody to have his credentials of athletic achievement. Not just countywide, not just statewide and not just nationwidebut internationally.

He was just Ted

Given McBrides incredible athletic past, its almost unfathomable to think most people never had a clue about it.

Eugenia McBride explained her husband was always humble and more interested in other peoples lives and stories. In fact, she said when they got married all of his medals and awards were in a shoebox in the trunk of his car.

He didnt brag about this, Eugenia McBride said. He was just Ted; a Mount Airy boy. If someone asked, he would tell you about it, but he never brought it up. Thats about the only way I know to describe it.

When he looked at you and he smiled I dont know how to explain it, McDaniel said. Its like a smile of caring and of love. Like saying, When Im looking at you, youre the most important person on earth.

Eugenia and Ted met through the Fellowship Missionary Baptist Church. A couple in the congregation had a daughter that was about to graduate from Ted McBrides old school and wanted to attend a church in Mount Airy that had an interpreter.

We had a missionary come to the church and God just called me, she said. I got a call to go to that alter at the end of the service to commit to learning sign language. I couldnt have done it without God.

The first teacher Eugenia McBride had left the church when she had been learning for a while, saying now was the time to immerse herself in sign language. So, she and a few women from church went to beg her future husband to teach them and he agreed.

Shortly after they began dating and eventually married in 1970.

I tell everybody I married the teacher, Eugenia said.

Together, the two had a daughter, Rebecca, that is now married to Brad Calloway. Rebecca and Brad have two children in college: Hayden and Haley.

Ted McBride went on to work at Pike Electric and was well respected as a master electrician, McDaniel said. He attended church every week he was able and always cared for his friends and family.

Eugenia McBride said that being deaf did not bother Ted, and that he didnt see it as a handicap. Rather, it was just the way life was. Whether in athletics or when raising a family, McBride worked hard and never took shortcuts. It he was going to do something, it was going to get done right, Eugenia McBride said.

I get a little emotional about Ted McBride because he was such a dear friend of ours, McDaniel said. He would kind of get you started about what youre doing and never wanted to talk about himself. He just kind of deferred everything away from him. To be more like Ted McBride is what we should all strive for.

Up here we didnt even know about his past, and down there in Morganton hes a legend. He needs to be a legend up here, and he needs to be talked about.

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ProgenCell – Stem Cell Therapies announces new facilities – PR Web

Friday, August 28th, 2020

Our patients will have access to even more services and extraordinary specialists available at the medical tourism complex, in a convenient and strategic location.

SAN DIEGO (PRWEB) August 25, 2020

ProgenCell - Stem Cell Therapies is announcing the opening of its brand new Stem Cell Treatment Center to give international and local patients a more comprehensive medical treatment in a luxury and stress free environment. With this announcement, ProgenCell establishes its leadership in the field of regenerative medicine and medical tourism. ProgenCells New Clinic is part of the one of a kind all-in-house medical tourism complex: NewCity Medical Plaza.

A great deal of planning went into making this stem cell treatment right for the wide range of medical conditions we deal with, said Dr Jorge Gavino, president of ProgenCell Scientific Committee. Our patients will have access to even more services and extraordinary specialists available at the medical tourism complex, in a convenient and strategic location. Im excited to welcome patients at this new facility.

It has been a long journey. Time had given lot of experience since 2008, when the clinic was found, said Elias Bemaras, CEO. Stem cell therapy has evolved, has improved in many ways, getting better results, learning from long term treated patients. We understand the need for a new facility, more convenient for patients with equipment renovation, better distribution, and a better location. Although a high investment is required, we believe it is worth it because our patients will receive better service, easier logistics, more time with the doctor, better follow up, and that translates to 360 degrees patient satisfaction.

With this new facility, ProgenCell establishes its commitment to offer the most advanced technology in modern and comfortable facilities and in a fully licensed, government regulated and certified facility, overseen by an independent ethics and scientific committee.

About ProgenCell - Stem Cell TherapiesProgenCell - Stem Cell Therapies is a leading stem cell treatmentcenter that offers individualized stem cell therapies for patients with chronic-degenerative diseases with more than 10 years of experience. ProgenCell also provides assistance with lodging, traveling and logistics to provide a comprehensive and safe medical tourism experience.ProgenCell is now part of the Health System of NewCity Medical Plaza, a modern and innovative Medical Tourism Center in Tijuana, Mexico. NewCity Medical Plaza is a 30-story tower, with doctors offices, hospital, medical lab, imaging center, commercial plaza, gastronomic center and a 140-room five star hotel.

To learn more about ProgenCell new facilities or scheduling inquiries contact ProgenCell directly at 1 888 443 6235 or email info@progencell.com

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Autologous Cell Therapy Market Along With Covid-19 Impact Analysis and Business Opportunities Outlook 2027 – Scientect

Tuesday, August 25th, 2020

Transparency Market Research (TMR)has published a new report titled, Autologous cell therapy Market Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 20192027. According to the report, the globalautologous cell therapy marketwas valued atUS$ 7.5 Bnin2018and is projected to expand at a CAGR of18.1%from2019to2027.

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Overview

Rise in Prevalence of Neurological Disorders & Cancer and Others to Drive Market

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Bone Marrow Segment to Dominate Market

Neurology Segment to be Highly Lucrative Segment

Hospitals Segment to be Highly Lucrative Segment

North America to Dominate Global Market

Competitive Landscape

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The global autologous cell therapy market has been segmented as follows:

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Candle Lit Tour and New Outdoor Exhibits Coming to the Baldwin Home Museum – Maui Time

Saturday, August 22nd, 2020

The new sports exhibit shows off some of Lahainas Pioneer Mill era sports teams.

Come take a step back into Lahainas past as Candle Lit Tours return to the Baldwin Home Museum starting Friday, Sept. 4 from 5 8 pm, alongside a new, free Pioneer Mill era sports exhibit. The tours and exhibits will be held weekly in conjunction with Friday Night is Art Night.

The Candle Lit Tour explores the fully furnished 19thcentury Baldwin Home which will be illuminated by dozens of candles. Tours are $5 per person with children 12 and under free. Each 20 minute tour is limited to 5 people. Signups will be taken on site. Docents will walk each group through the home, and once they are back outside, questions will be taken. The docents of the popular tour are excited for a return to educating the public, and invite the community to take a step back into time.

A free exhibit featuring photographs of a variety of sports teams from the Pioneer Mill era will be on display on the Baldwin Home lawn. The exhibit shows off the many memories of youth, club and community sports from the 1930s to the 1970s.

The public is invited to stroll through Historic Lahaina Town for the festive Friday Night is Art Night. Visitwww.LahainaRestoration.org for a list of participating galleries.

In conformance with Maui County regulations, masks must be worn on the candle lit tour and while looking at the outdoor exhibits. Single use masks, and hand sanitizer will be available on site and social distancing will be enforced. Please be conscious of the safety and comfort of yourself and others when attending.

Contactevents@lahainarestoration.orgfor more information

Press Release and Image courtesy Lahaina Restoration Foundation

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Deals Under the Radar: These Are the Israeli Tech Companies Already Operating in the UAE – Algemeiner

Saturday, August 22nd, 2020

A general view of ADNOC headquarters in Abu Dhabi, United Arab Emirates May 29, 2019. Photo: REUTERS/Christopher Pike/File Photo.

CTech Im very active on LinkedIn, I have tens of thousands of contacts and I receive around 10 new requests a day, but something weird happened last Friday. I was swamped with new follower requests. I thought my account was hacked, but when I began looking through the names and the accounts analytics I saw that they were all businessmen and senior executives from insurance companies in the United Arab Emirates, Yariv Yanay, Director of Business Development and Innovation at Hachshara Insurance Company, told Calcalist.

Yanay is one of the founders of the go Digital Insurance application developed by Hachshara for digital car insurance. I approved all the requests and already set Zoom meetings with them. They ask serious questions that show that they know what they need from us. A representative from a big insurance company there asked me a very specific question about one of our developments in UBI (usage-based insurance) while someone else was interested in learning about dealing with claims digitally, and another inquired if the product suits a B2C market. It was apparent that they had done their homework.

Israel has become an insurtech powerhouse in recent years, even though local consumers arent aware of the services being offered by many of the companies.

Right now, I feel like they are checking us out because they have heard that Israel is an insurtech superpower, noted Yanay. The potential isnt just in the possible sale of products to the UAE, but that this can also lay the infrastructure for entering the rest of the Arab world and places like Jordan and Egypt. I take part in many international conferences and until now it was very obvious we were outcasts.

August 22, 2020 10:39 am

By complete coincidence, Yarivs brother, the CEO and President of biomed company Pluristem, announced on Monday that the regenerative medicine company developing a platform of novel biological therapeutic products has signed a non-binding Memorandum of Understanding (MOU) with the UAE-based Abu Dhabi Stem Cells Center (ADSCC), a specialist healthcare center focused on cell therapy and regenerative medicine.

Alongside insurtech and biomedicine, the fintech sector has also generated plenty of interest in the UAE. The Israeli fintech sector, which includes 530 startups, attracted record funding of $2 billion during 2019. This looks like a match made in heaven, said Shmulik Ben-Tovim, president of the Fintech Community of Israel. While Israel is regarded as a tech powerhouse, but an undeveloped financial center, in Dubai there is the exact opposite situation. Israeli fintech companies will literally be entering a desert.

Israel nowadays is mainly known in the Gulf states for its aesthetics medical innovation as Dubai and Abu Dhabi have a young and rich population, noted Adi Nov, deputy manager at ICIC-Israel Credit Insurance Company. Another strong sector is agtech, specifically irrigation technology. There is also business in the plastic industry and some fashion, mainly swimwear and underwear.

According to Paris-based insurance company Euler Hermes, which holds shares in ICIC, Israels areas of expertise are similar to those of the US which is the third-largest exporter to the UAE after China and India and is responsible for 10% of the imports in the weapons and tech sectors.

Israels tech companies werent waiting around for Donald Trumps announcement that Israel and the UAE had agreed to normalize ties, with many companies doing business in the region for several years. Most of them do so via a local distributor, but companies like Cybereason, which is based out of the US, have offices in the UAE.

The UAE is a very special and significant market, said Shai Horovitz, Chief Revenue Officer at Cybereason. The leading investor in Cybereason is the Vision Fund, with half of its $100 billion under management coming in from the Persian Gulf and Saudi Arabia. As a result, the Israeli cyber company has relationships in the region dating back many years.

There are several Israeli cybersecurity companies currently operating successfully in the UAE, including Check Point, which states on its website that it has representation in Dubai; CyberArk, which works with a local distributor; and IntSights, which has significant sales in the region.

There is a clear need for cybersecurity products due to geopolitical reasons. The Emirates encounter the same threats that our western clients are facing. The same actors that threaten large financial institutions and government agencies in Europe and the US are also acting against the UAEs interests, explained Horovitz.

Guy Nizan, co-founder and CEO of IntSights, said that Israeli tech is received very well in the region. It is an advantage because the client recognizes Israeli tech as a brand. Moreover, they understand the importance of security and are willing to invest a lot in the sector.

And it isnt just Israeli cybersecurity that is prospering in Dubai. There are several other Israeli tech companies that have made a name for themselves, including Cato Networks, whose core product is a cloud service and operates a server farm in Dubai. Israeli giant Monday.com has also become well known in the UAE over the past three years and is partnering with several companies in the region.

We have over 700 clients in the Persian Gulf and over the last year the company increased its sales in the region by 300% and is planning on reaching sales of $5 million by the end of 2021, said Barak Zigdon, partnerships and global resellers manager at Monday.com. Software company JFron is also selling to clients in the UAE.

One sector with great potential in the area is agtech, mainly due to the dry climate in both Israel and the UAE.

We have been talking to different actors in the UAE about promoting desert agriculture projects, said Or Haviv, partner and head of ventures at Arieli Capital. There is no done deal, but we were already discussing it prior to last weeks announcement. The UAE wants to learn how to do agriculture in the desert and gain produce which is at the level of that grown in Israel. There is a plan to send a delegation from the UAE to Israel so that they can undergo training at Ramat Negev.

Alan Feld, co-founder and managing partner at Vintage Investment Partners, believes that the UAE is open to investing in Israeli tech in addition to purchasing its products. I believe that we will very soon see investments in VCs and Israeli companies. They have a VC industry and they also want us to invest in their companies.

The entire region is a desert and in the middle of it they built an amazing airport and one of the best tourism systems Ive seen, added Feld, who was in the UAE in February. They want to diversify their sources of income and not be so dependent on the price of oil. They see themselves as a regional technology center and Israel is a good source of technology for them.

Boaz Dinte, managing general partner at Qumra Capital, added: Over the past two years we have received more and more approaches from people in the region who are interested in investing in Israeli funds and Israel in general. From a personal standpoint, I was a little wary as I didnt know what the consequences would be for the fund if we received money from the Gulf. I was uncertain what it would mean and if it would put constraints on the fund, but now it has clearly become legitimate.

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Deals Under the Radar: These Are the Israeli Tech Companies Already Operating in the UAE - Algemeiner

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Cell Separation Technology Market is Anticipated to Expand at a CAGR of ~ 12% during 2019 2027 – Press Release – Digital Journal

Saturday, July 11th, 2020

Cell Separation Technology Market is boosted by advancements in technology, increase in the geriatric population, surge in investments in research & development.

Transparency Market Research (TMR) has published a new report on the global cell separation technology market for the forecast period of 20192027. According to the report, the global cell separation technology market was valued at ~ US$ 5 Bn in 2018, and is projected to expand at a double-digit CAGR during the forecast period.

Overview

Cell separation, also known as cell sorting or cell isolation, is the process of removing cells from biological samples such as tissue or whole blood. Cell separation is a powerful technology that assists biological research. Rising incidences of chronic illnesses across the globe are likely to boost the development of regenerative medicines or tissue engineering, which further boosts the adoption of cell separation technologies by researchers.

Expansion of the global cell separation technology market is attributed to an increase in technological advancements and surge in investments in research & development, such as stem cell research and cancer research. The rising geriatric population is another factor boosting the need for cell separation technologies Moreover, the geriatric population, globally, is more prone to long-term neurological and other chronic illnesses, which, in turn, is driving research to develop treatment for chronic illnesses. Furthermore, increase in the awareness about innovative technologies, such as microfluidics, fluorescent-activated cells sorting, and magnetic activated cells sorting is expected to propel the global cell separation technology market.

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North America dominated the global cell separation technology market in 2018, and the trend is anticipated to continue during the forecast period. This is attributed to technological advancements in offering cell separation solutions, presence of key players, and increased initiatives by governments for advancing the cell separation process. However, insufficient funding for the development of cell separation technologies is likely to hamper the global cell separation technology market during the forecast period. Asia Pacific is expected to be a highly lucrative market for cell separation technology during the forecast period, owing to improving healthcare infrastructure along with rising investments in research & development in the region.

Rising Incidences of Chronic Diseases, Worldwide, Boosting the Demand for Cell Therapy

Incidences of chronic diseases such as diabetes, obesity, arthritis, cardiac diseases, and cancer are increasing due to sedentary lifestyles, aging population, and increased alcohol consumption and cigarette smoking. According to the World Health Organization (WHO), by 2020, the mortality rate from chronic diseases is expected to reach 73%, and in developing counties, 70% deaths are estimated to be caused by chronic diseases. Southeast Asia, Eastern Mediterranean, and Africa are expected to be greatly affected by chronic diseases. Thus, the increasing burden of chronic diseases around the world is fuelling the demand for cellular therapies to treat chronic diseases. This, in turn, is driving focus and investments on research to develop effective treatments. Thus, increase in cellular research activities is boosting the global cell separation technology market.

Increase in Geriatric Population Boosting the Demand for Surgeries

The geriatric population is likely to suffer from chronic diseases such as cancer and neurological disorders more than the younger population. Moreover, the geriatric population is increasing at a rapid pace as compared to that of the younger population. Increase in the geriatric population aged above 65 years is projected to drive the incidences of Alzheimers, dementia, cancer, and immune diseases, which, in turn, is anticipated to boost the need for corrective treatment of these disorders. This is estimated to further drive the demand for clinical trials and research that require cell separation products. These factors are likely to boost the global cell separation technology market.

According to the United Nations, the geriatric population aged above 60 is expected to double by 2050 and triple by 2100, an increase from 962 million in 2017 to 2.1 billion in 2050 and 3.1 billion by 2100.

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Productive Partnerships in Microfluidics Likely to Boost the Cell Separation Technology Market

Technological advancements are prompting companies to innovate in microfluidics cell separation technology. Strategic partnerships and collaborations is an ongoing trend, which is boosting the innovation and development of microfluidics-based products. Governments and stakeholders look upon the potential in single cell separation technology and its analysis, which drives them to invest in the development of microfluidics. Companies are striving to build a platform by utilizing their expertise and experience to further offer enhanced solutions to end users.

Stem Cell Research to Account for a Prominent Share

Stem cell is a prominent cell therapy utilized in the development of regenerative medicine, which is employed in the replacement of tissues or organs, rather than treating them. Thus, stem cell accounted for a prominent share of the global market. The geriatric population is likely to increase at a rapid pace as compared to the adult population, by 2030, which is likely to attract the use of stem cell therapy for treatment. Stem cells require considerably higher number of clinical trials, which is likely to drive the demand for cell separation technology, globally. Rising stem cell research is likely to attract government and private funding, which, in turn, is estimated to offer significant opportunity for stem cell therapies.

Biotechnology & Pharmaceuticals Companies to Dominate the Market

The number of biotechnology companies operating across the globe is rising, especially in developing countries. Pharmaceutical companies are likely to use cells separation techniques to develop drugs and continue contributing through innovation. Growing research in stem cell has prompted companies to own large separate units to boost the same. Thus, advancements in developing drugs and treatments, such as CAR-T through cell separation technologies, are likely to drive the segment.

As per research, 449 public biotech companies operate in the U.S., which is expected to boost the biotechnology & pharmaceutical companies segment. In developing countries such as China, China Food and Drug Administration (CFDA) reforms pave the way for innovation to further boost biotechnology & pharmaceutical companies in the country.

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Global Cell Separation Technology Market: Prominent Regions

North America to Dominate Global Market, While Asia Pacific to Offer Significant Opportunity

In terms of region, the global cell separation technology market has been segmented into five major regions: North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. North America dominated the global market in 2018, followed by Europe. North America accounted for a major share of the global cell separation technology market in 2018, owing to the development of cell separation advanced technologies, well-defined regulatory framework, and initiatives by governments in the region to further encourage the research industry. The U.S. is a major investor in stem cell research, which accelerates the development of regenerative medicines for the treatment of various long-term illnesses.

The cell separation technology market in Asia Pacific is projected to expand at a high CAGR from 2019 to 2027. This can be attributed to an increase in healthcare expenditure and large patient population, especially in countries such as India and China. Rising medical tourism in the region and technological advancements are likely to drive the cell separation technology market in the region.

Launching Innovative Products, and Acquisitions & Collaborations by Key Players Driving Global Cell Separation Technology Market

The global cell separation technology market is highly competitive in terms of number of players. Key players operating in the global cell separation technology market include Akadeum Life Sciences, STEMCELL Technologies, Inc., BD, Bio-Rad Laboratories, Inc., Miltenyi Biotech, 10X Genomics, Thermo Fisher Scientific, Inc., Zeiss, GE Healthcare Life Sciences, PerkinElmer, Inc., and QIAGEN.

These players have adopted various strategies such as expanding their product portfolios by launching new cell separation kits and devices, and participation in acquisitions, establishing strong distribution networks. Companies are expanding their geographic presence in order sustain in the global cell separation technology market. For instance, in May 2019, Akadeum Life Sciences launched seven new microbubble-based products at a conference. In July 2017, BD received the U.S. FDAs clearance for its BD FACS Lyric flow cytometer system, which is used in the diagnosis of immunological disorders.

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Transparency Market Research is a global market intelligence company providing global business information reports and services. Our exclusive blend of quantitative forecasting and trends analysis provides forward-looking insight for several decision makers. Our experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

Our data repository is continuously updated and revised by a team of research experts so that it always reflects latest trends and information. With a broad research and analysis capability, Transparency Market Research employs rigorous primary and secondary research techniques in developing distinctive data sets and research material for business reports.

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Impact Analysis of COVID-19 on Stem Cells Market Study 2018-2028 Segmented On The Basis of Product Type, Geographical Analysis, Future Forecast,…

Saturday, July 11th, 2020

The global stem cells market is driven by various factors which include increasing prevalence and incidence rate of cancer and cancer-related diseases. Rising research and development programs, increasing awareness related to regenerative treatment, increasing the use of biomarkers and growth in biopsy market are also driving the market. The high prevalence of cancer in children is also a key driving factor for stem cell study. The number of stem cell banks has increased exponentially.

The Final Report will cover the impact analysis of COVID-19 on this industry (Global and Regional Market).

The number of hospitals and research centers in developed countries is capable of storing stem cells. Even in countries such as China and India, the growing awareness amongst the professionals and masses is the key driver for the market. India, China, and other emerging nations are also offering stem cell therapies and services and lower cost which is leading to the emergence of medical tourism in the stem cells market.

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The market is segmented on the basis of product type, applications, and technology. The product types consist of adult stem cells, human embryonic stem cells market, induced pluripotent stem cells market, and very small embryonic-like cells market. Applications include regenerative medicines market which is further segmented as cancer regenerative medicines market, orthopedics regenerative medicines market, hematological regenerative medicines market, neurological regenerative medicines market, cardiovascular regenerative medicines market, regenerative medicines market, injuries regenerative medicines market and others regenerative medicines market.

Drug discovery is also a major application. Stem cells market by technology includes bone marrow harvest, apheresis, umbilical blood cord, therapeutic cloning, in vitro fertilization, isolation, cell culture, cryopreservation, and expansion and subculture.

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Geographically, the market is a segment as North America, Europe, Asia Pacific and the rest of the world. North America has the highest market share followed by Europe and the Asia Pacific. The Asia Pacific is expected to report the highest growth rate for the forecasted period. Key companies in the market include STEMCELL technologies, Millipore, Corning, BioTime Inc, Advanced Cell technology Inc, Cellular engineering technologies and other major companies.

How does the report examine the growth drivers and restraints of the Stem Cells Market?

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Company profiles

1. STEMCELL technologies2. Millipore3. Corning4. BioTime Inc5. Advanced Cell Technology Inc6. Cellular engineering technologies7. Cellartis AB8. Angel Biotechnology9. Bioheart Inc10. Cellgene corporation11. Brainstorm cell therapeutics12. Osiris therapeutics13. BD biosciences14. Lonza15. ATCC16. Allcells17. Miltenyi biotec GmBH18. QIAGEN19. Novocell20. Stemgent21. Sigma Aldrich22. Invitrogen23. Nunc24. Peprotec25. R&D systems26. Cellular dynamics international27. ChanTest corporation28. Wiicell research institute29. Hybrid Organ GmBH30. BIOE31. Aastrom Biosciences32. California Stem Cells33. International Stem Cell Corporation34. NeoStem35. NeuralStem36. Medistem37. Apceth38. Cardio3 BioSciences39. TiGenix

This Research Report covers

1. Historical data2. Revenue forecasts, growth rates and CAGR up to 20283. Industry Analysis4. Competitive Analysis5. Key geographic growth data

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About Kenneth Research:

Kenneth Research provides market research reports to different individuals, industries, associations, and organizations with the aim of helping them to take prominent decisions. Our research library comprises more than 10,000 research reports provided by more than 15 market research publishers across different industries. Our collection of market research solutions covers both the macro level as well as micro-level categories with relevant and suitable market research titles. As a global market research reselling firm, Kenneth Research provides a significant analysis of various markets with pure business intelligence and consulting services on different industries across the globe. In addition to that, our internal research team always keeps a track of the international and domestic market for any economic changes impacting the products demand, growth, and opportunities for new and existing players.

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Facial Injectable Market Growth Analysis, Size Projection, Key Insights, COVID-19 Impact Analysis and Future Trends By 2025 – Cole of Duty

Friday, July 10th, 2020

Global Facial Injectable Market Share, Growth and Trends Analysis by Type (Botulinum Toxin, Hyaluronic Acid, Polymers and Particles and Collagen), Application (Facial Line Correction Treatment, Face Lift and Lip Treatments), End User (Hospitals, Specialty Clinics and Spa & Beauty Clinic) and Region (North America, Europe, Asia-Pacific and Middle East & Africa) Forecast till 2025

Anti-ageing, face rejuvenation and cosmetic treatments have changed the rules of engagement and reinvention. Today, its possible to change the basic elements of yourself to fulfil the basic desire of humans to be young.

Thefacial injectable marketis been driven by numerous factors. However rising proportion and absolute numbers of older people led by baby boomers generation with good incomes are the critical driving factor for the global facial injectable market. According to the World Health Organization estimates between 2015 and 2050, the proportion of the worlds population over 60 years will double from 12% to 22% which will be a positive development for the market.

Another critical driver and the motive behind the market is the primal desire to remain young. The extension of life has been a primal desire of humanity and a mainstay motif in the history of scientific pursuits and ideas throughout history, from the Egyptian Smith medical papyrus, Ayurveda practitioners, alchemists, etc. This primal desire for youth has driven the market for anti-ageing drugs since time immemorial.

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The growing influence of lifestyle, fashion and film industry have led to rising demand of medications to slow the ageing and its signs. Health and youth wellness have become a status symbol and youthful appearance is penetrating peoples life and there is increasing consumerization of youth. The growth of media such as television and lifestyle magazines have led to a craze for youthful appearance.

Other driving factors are primal desire of humans to remain young, influence of lifestyle industry and rising awareness about wellbeing, high levels of disposable incomes etc. The market restraints are skepticism and concerns of safety regarding the unrestricted use of anti-ageing drugs without greater and clearer experimental validation. Ambiguity of the definition of anti-ageing drugs is also a cause of concern. For example, numerous cosmetics have been included or claimed to have anti-aging effects and have been termed as Cosmeceuticals. Cosmeceutical is defined by the cosmetic industry as cosmetic products that have medicinal or drug like effects which is not supported by the U.S. Food and Drug Administration (FDA) or the Food, Drug and Cosmetic Act.

The facial injectable market is a technological oriented market having a high research and development potential due to advancement in technologies and cellular understanding which are keys to unravel the exact mechanism of ageing. Gene therapy, stem cell technology and targeted delivery of nutrients using biotechnology are expected to open the gates for anti-ageing drugs. The development of biomarkers for physiochemical modifications in the body such as alteration of concentration of an enzyme or hormone provides another exiting avenue for the future market. For example, levels of homocysteine has been proposed as a marker of age related changes in the body so as to compensate the change by drugs.

From a market perspective the facial injectable market is ripe with mergers, acquisitions and partnerships. For example, in 2017, cosmetic giant LOral acquired skincare brands such as CeraVe, AcneFree and Ambi from Valeant Pharmaceuticals at ~ $1.25 billion. In 2016, Johnson & Johnson acquired Vogue International LLC, for greater than $3 billion to strengthen its consumer segment. Thus, partnerships seem to be a good strategy to curtail the developmental cost of any new facial injectable drug. Acquisition of other companies also leads to expansion of product lines which improves market penetration and exposure.

The global market for facial injectable is expected to reach USD 9.04 billion by the end of the forecasted period 2023 and is expected to grow at a CAGR of 13.2%

Global facial injectable market is segment by types and applications. Based on types the market is sub-segmented as botulinum toxin, hyaluronic acid, polymers & particles, and collagen. On the basis of application, the market is sub-segmented into facial line correction treatment, face-lift, lip treatments and others.

The key players in his market are Allergan, Galderma, Integra Lifesciences, Merz Pharma, Sanofi, SciVision Biotech Inc, Sinclair. Suneva Medical and Valeant Pharmaceuticals.

Regional outlook for the facial injectable market

The facial injectable market is dominated by North America. The U.S. is the prime mover of the facial injectable market. However, it has to be noted that Latin America despite its lower per capita income has a disproportionate share of the market. It is estimated that Latin America will be the fastest in the future. As of the present the European regions is expected to be the second largest market globally, with countries like Germany, UK and France playing a prominent role in the market. Germany accounts for both the largest and the fastest growing nation in the European region facial injectable market, followed by France.

Asia Pacific market is expected to be the fastest future growing market during the forecast period 2016-2023. The Asia Pacific region will be led by countries such as China and India. However the greatest hindering reasons for the Asia pacific region market is the poor per capita income and the high cost of treatment. Nations such as Thailand etc. have a disproportionate share of Asia Pacific market considering their low income as compared to the U.S. The market of these nations is influenced to a considerable degree by the tourism and fashion industry. Advertisement and greater exposure seems to be the best strategy to be a market leader along with product development. The return on investment for advertisement and publicity is very high for the cosmetic surgery market.

There has been a definite shift of the cosmetic surgery market from the developed regions to the developing ones particularly Latin America and Asia Pacific countries such as Thailand. The market represents a clustered outlook with urban metropolitan cities especially with adjoining tourism and fashion industry having an extreme lead over the rural areas. Large tourism clusters such as Miami, Bangkok, Bali etc. have a disproportionate share of the market due to the large volume of cosmetic surgeries.

The porn industry also is affecting the market and it has been seen that the rise of cosmetic surgeries has a linear relationship with the quality and bandwidth of the internet. Thus cities such as Los Angeles, Las Vegas etc. are the leading clusters of cosmetic surgery market.

Browse Complete Research Report with COVID-19 Impact Analysis at:https://www.marketresearchfuture.com/reports/facial-injectable-market-1527

NOTE: Our team of researchers are studying Covid19 and its impact on various industry verticals and wherever required we will be considering covid19 footprints for a better analysis of markets and industries. Cordially get in touch for more details.

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Facial Injectable Market Growth Analysis, Size Projection, Key Insights, COVID-19 Impact Analysis and Future Trends By 2025 - Cole of Duty

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