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Global Dermal Regeneration Matrix Device Market to Witness Stellar CAGR During the Forecast Period – The News Brok

By daniellenierenberg

Skin is the largest organ of the human body. It is composed of three layers: epidermis-the outermost layer; dermis-contains sweat glands, hair follicles and connective tissue and hypodermis-made up of fat and connective tissue. The main functions of the skin includes protection, sensation and regulation. The skin acts as a barrier and provides protection against harmful chemicals, radiation, microorganism and changing environmental conditions. It also helps regulate body temperature and maintain fluid balance. Skin is an extensive network of nerve cells and contains various receptors to detect changes in the environment such as touch, pain, heat and cold. Damage to skin due to burn or trauma can disrupt all the vital functions performed by the skin.

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Currently, topical antibiotics, skin grafting, wound dressings and tissue-engineered substitutes are available in the market that are used to treat skin-related disorders. A skin graft can be done by natural substitute such as amniotic membrane, potato peel or artificial material that includes synthetic polymer sheet, polymer foam or spray. These substitute helps in the healing process. Skin regeneration refers to the regrowth of the damaged skin from the remaining tissue. Stem cell therapy has a vital application in skin regeneration.

Dermal regeneration matrix device provides an appropriate environment that is necessary for the proliferation and differentiation of skin cells. It helps in triggering the bodys own repair mechanism by cell signaling, that drive the matrix environment in wound healing process. Dermal regeneration matrix device is used to treat skin burns and is also finds application in reconstructive surgery for contractures (scars). The dermal regeneration matrix device is placed over the damaged skin which provides an environment for regeneration of new skin and tissue. The matrix is made of cow collagen, silicone and shark cartilage.

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In 1996, the U.S. Food and Drug Administration (FDA) first approved integra dermal regeneration matrix device for treatment of burn injuries. In 2002, dermal regeneration matrix device was approved for use in reconstructive surgery for burn scars. About 30 million people in the U.S. are suffering from diabetes, of which 15% experience a diabetic foot ulcer in their lifetime. In January 2016, FDA approved the use of dermal regeneration matrix for treatment of chronic diabetic foot ulcers (DFU). The usage of dermal regeneration matrix device is expected to expand the growth of dermal regeneration matrix device owing to increase usage in chronic foot ulcer.

Technological advancement and continued research in the development of artificial skin promises to bring more products to the marketplace. Increasing adoption of the device and long-term benefits associated with its application are some of the factors expected to fuel growth of the global dermal regeneration matrix device market over the forecast period. However, less awareness among the consumers and high cost of device are some of the key factors that could hamper growth of the market.

The global dermal regeneration matrix device is segmented on the basis of source, application, end user and geography.

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On the basis of source, the global dermal regeneration matrix device market is segmented into cow collagen, silicone and shark cartilage. On the basis of end user, the global dermal regeneration matrix device market is segmented into hospitals and dermatology centers. The hospital segment is expected to contribute significantly to the total market in terms of market share. According to World Health Organization, over 265,000 deaths are caused due to burns each year. The majority of the burn cases occur in low and middle-income countries. Injuries such as traffic collisions, falls, burns, drowning, poisoning and others are expected to kills around five million people worldwide. Thus, the demand for dermal regeneration growth matrix is expected to be high in the low and middle-income countries over the forecast period.

On the basis of region, the global dermal regeneration matrix device market is segmented into five key regions: North America, Latin America, Europe, Asia Pacific and Middle East & Africa.

Some of the major players in the global dermal regeneration matrix device market include

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How to choose the right eye cream to target your skin concerns – Lifestyle Asia

By daniellenierenberg

Not all eye creams are made the same. Heres how to choose the best one for everything youre looking to fix.

Picture this: Youve been staying up late from all the Netflix bingeing and it shows with the heavy eye bags youre carrying under your peepers. You slap on some eye cream thats gotten rave reviews online, only to find that it doesnt help reduce those bags at all. What gives?

The key here is to read the fine print: Specifically, the ingredients list. No, were not asking you to check out which ingredients you might be sensitive to. In fact, the key ingredients in your eye cream actually play a big factor in determining which eye care woes youd like to solve.

Allow us to elucidate.

Fine lines and crows feet around the eye area are, unfortunately, where the first signs of ageing appear. Chalk it up to the skin around the eye area being the thinnest. It also doesnt help that youre probably tugging and pulling at your eyes more than you should putting on contact lenses, drawing your eyeliner, and even the act of removing your eye makeup contributes to this.

If you want to alleviate or diminish fine lines around the eye area, youll want to pick an eye cream that has retinol or peptides, as well as hyaluronic acid in it.

Retinol, as you may already know, is a super ingredient perfect for anti-ageing. The Vitamin A derivative helps increase collagen production and cell turnover rate, though have a bad rap of sensitising skin and making it susceptible to irritation (especially if youve just started using it). Peptides are arguably less invasive, and also do the job of helping your skin create collagen, though some researchers say its effects are much milder. As for hyaluronic acid, it helps plump skin with hydration, which will help fill out those wrinkles.

There are many reasons why you have dark eye circles. It could be hereditary or an underlying health condition both of which you should probably consult a doctor about. But if your dark eye circles stem from a bad lifestyle and lack of sleep, we might be able to help you out. The best eye cream you need to look out for should contain Vitamin C, niacinamide, liquorice, kojic acid, or retinol.

Vitamin C is an antioxidant, and having it in your skincare will help protect skin cells from free radicals caused by UV exposure. In eye creams, Vitamin C will hinder melanin production while lightening pigmentation and brown spots. Your dark eye circles will eventually be evened out with a more radiant outlook. Niacinamide is typically great for blemishes as it controls sebum production in the skin. It also works to reduce hyper-pigmentation and bolsters your skins ceramide production, meaning it helps even out and protect the skins barrier function. In eye creams, this hero ingredient will help improve uneven skin tone.

For those who want a plant-derivative option, liquorice or liquorice root is a popular all-natural option to lighten skin that has gone through sun damage. Thanks to the Glabridin compound in liquorice, any eye cream with this ingredient will also have UV-blocking enzymes to protect against future damages. Similarly, kojic acid also helps to lighten sun-damaged skin, as well as age spots and scars.

Are puffy eyes the bane of your existence? Do people always give you a concerned look and ask if youve been crying? Weve got the solution for you. The best eye cream you can get to remedy this problem is one that contains caffeine.

Caffeine, as you already know, is a diuretic, which increases the excretion of water from bodies. Most eye creams that have caffeine in it claims to help awaken your eyes, but what it actually does is to relieve water retention from your eyes, a common cause of puffiness. It also helps with certain types of dark eye circles by reducing the build-up of blood which causes the dark discolouration under your eyes. For that all-important de-puffing function, youll want to look for ingredients that target skin elasticity and water retention.

(Header image credit: Hadi Safari/Unsplash)

This article was first published on Lifestyle Asia Kuala Lumpur.

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CRISPR cows could boost sustainable meat production, but regulations, wary consumers stand in the way – Genetic Literacy Project

By daniellenierenberg

When Ralph Fisher,a Texas cattle rancher, set eyes on one of the worlds first cloned calves in August 1999, he didnt care what the scientists said: He knew it was his old Brahman bull, Chance, born again. About a year earlier, veterinarians at Texas A&M extracted DNA from one of Chances moles and used the sample to create a genetic double. Chance didnt live to meet his second self, but when the calf was born, Fisher christened him Second Chance, convinced he was the same animal.

Scientists cautioned Fisher that clones are more like twins than carbon copies: The two may act or even look different from one another. But as far as Fisher was concerned, Second Chance was Chance. Not only did they look identical from a certain distance, they behaved the same way as well. They ate with the same odd mannerisms; laid in the same spot in the yard. But in 2003, Second Chance attacked Fisher and tried to gore him with his horns. About 18 months later, the bull tossed Fisher into the air like an inconvenience and rammed him into the fence. Despite 80 stitches and a torn scrotum, Fisher resisted the idea that Second Chance was unlike his tame namesake,telling the radio program This American Life that I forgive him, you know?

In the two decades since Second Chance marked a genetic engineering milestone, cattle have secured a place on the front lines of biotechnology research. Today, scientists around the world are using cutting-edge technologies, fromsubcutaneous biosensorstospecialized food supplements, in an effort to improve safety and efficiency within the$385 billion global cattle meat industry. Beyond boosting profits, their efforts are driven by an imminent climate crisis, in which cattle play a significant role, and growing concern for livestock welfare among consumers.

Gene editing stands out as the most revolutionary of these technologies. Although gene-edited cattle have yet to be granted approval for human consumption, researchers say tools like Crispr-Cas9 could let them improve on conventional breeding practices and create cows that are healthier, meatier, and less detrimental to the environment. Cows are also beinggiven genesfrom the human immune system to create antibodies in the fight against Covid-19. (The genes of non-bovine livestock such as pigs and goats, meanwhile, have been hacked togrow transplantable human organsandproduce cancer drugs in their milk.)

But some experts worry biotech cattle may never make it out of the barn. For one thing, theres the optics issue: Gene editing tends to grab headlines for its role in controversial research and biotech blunders. Crispr-Cas9 is often celebrated for its potential to alter the blueprint of life, but that enormous promise can become a liability in the hands of rogue and unscrupulous researchers, tempting regulatory agencies to toughen restrictions on the technologys use. And its unclear how eager the public will be to buy beef from gene-edited animals. So the question isnt just if the technology will work in developing supercharged cattle, but whether consumers and regulators will support it.

Cattle are catalysts for climate change. Livestockaccount for an estimated 14.5 percent of greenhouse gas emissions from human activities, of which cattle are responsible for about two thirds, according to the United Nations Food and Agriculture Organization (FAO). One simple way to address the issue is to eat less meat. But meat consumption is expected to increasealong with global population and average income. A 2012reportby the FAO projected that meat production will increase by 76 percent by 2050, as beef consumption increases by 1.2 percent annually. And the United States isprojected to set a recordfor beef production in 2021, according to the Department of Agriculture.

For Alison Van Eenennaam, an animal geneticist at the University of California, Davis, part of the answer is creating more efficient cattle that rely on fewer resources. According to Van Eenennaam, the number of dairy cows in the United Statesdecreasedfrom around 25 million in the 1940s to around 9 million in 2007, while milk production has increased by nearly 60 percent. Van Eenennaam credits this boost in productivity to conventional selective breeding.

You dont need to be a rocket scientist or even a mathematician to figure out that the environmental footprint or the greenhouse gases associated with a glass of milk today is about one-third of that associated with a glass of milk in the 1940s, she says. Anything you can do to accelerate the rate of conventional breeding is going to reduce the environmental footprint of a glass of milk or a pound of meat.

Modern gene-editing tools may fuel that acceleration. By making precise cuts to DNA, geneticists insert or remove naturally occurring genes associated with specific traits. Some experts insist that gene editing has the potential to spark a new food revolution.

Jon Oatley, a reproductive biologist at Washington State University, wants to use Crispr-Cas9 to fine tune the genetic code of rugged, disease-resistant, and heat-tolerant bulls that have been bred to thrive on the open range. By disabling a gene called NANOS2, he says he aims to eliminate the capacity for a bull to make his own sperm, turning the recipient into a surrogate for sperm-producing stem cells from more productive prized stock. These surrogate sires, equipped with sperm from prize bulls, would then be released into range herds that are often genetically isolated and difficult to access, and the premium genes would then be transmitted to their offspring.

Furthermore, surrogate sires would enable ranchers to introduce desired traits without having to wrangle their herd into one place for artificial insemination, says Oatley. He envisions the gene-edited bulls serving herds in tropical regions like Brazil, the worldslargestbeef exporter and home to around 200 million of the approximately 1.5 billion head of cattle on Earth.

Brazils herds are dominated by Nelore, a hardy breed that lacks the carcass and meat quality of breeds like Angus but can withstand high heat and humidity. Put an Angus bull on a tropical pasture and hes probably going to last maybe a month before he succumbs to the environment, says Oatley, while a Nelore bull carrying Angus sperm would have no problem with the climate.

The goal, according to Oatley, is to introduce genes from beefier bulls into these less efficient herds, increasing their productivity and decreasing their overall impact on the environment. We have shrinking resources, he says, and need new, innovative strategies for making those limited resources last.

Oatley has demonstrated his technique in mice but faces challenges with livestock. For starters, disabling NANOS2 does not definitively prevent the surrogate bull from producing some of its own sperm. And while Oatley has shown he can transplant sperm-producing cells into surrogate livestock, researchers have not yet published evidence showing that the surrogatesproduceenough quality sperm to support natural fertilization. How many cells will you need to make this bull actually fertile? asks Ina Dobrinski, a reproductive biologist at the University of Calgary who helped pioneer germ cell transplantation in large animals.

But Oatleys greatest challenge may be one shared with others in the bioengineered cattle industry: overcoming regulatory restrictions and societal suspicion. Surrogate sires would be classified as gene-edited animals by the Food and Drug Administration, meaning theyd face a rigorous approval process before their offspring could be sold for human consumption. But Oatley maintains that if his method is successful, the sperm itself would not be gene-edited, nor would the resulting offspring. The only gene-edited specimens would be the surrogate sires, which act like vessels in which the elite sperm travel.

Even so, says Dobrinski, Thats a very detailed difference and Im not sure how that will work with regulatory and consumer acceptance.

In fact, American attitudes towards gene editing have been generally positive when the modification is in the interest of animal welfare. Many dairy farmers prefer hornless cows horns can inflict damage when wielded by 1,500-pound animals so they often burn them off in apainful processusing corrosive chemicals and scalding irons. Ina study published last yearin the journal PLOS One, researchers found that most Americans are willing to consume food products from cows genetically modified to be hornless.

Still, experts say several high-profile gene-editing failures in livestock andhumansin recent years may lead consumers to consider new biotechnologies to be dangerous and unwieldy.

In 2014, a Minnesota startup called Recombinetics, a company with which Van Eenennaams lab has collaborated, created a pair of cross-bred Holstein bulls using the gene-editing tool TALENs, a precursor to Crispr-Cas9, making cuts to the bovine DNA and altering the genes to prevent the bulls from growing horns. Holstein cattle, which almost always carry horned genes, are highly productive dairy cows, so using conventional breeding to introduce hornless genes from less productive breeds can compromise the Holsteins productivity. Gene editing offered a chance to introduce only the genes Recombinetics wanted. Their hope was to use this experiment to prove that milk from the bulls female progeny was nutritionally equivalent to milk from non-edited stock. Such results could inform future efforts to make Holsteins hornless but no less productive.

The experiment seemed to work. In 2015, Buri and Spotigy were born. Over the next few years, the breakthrough received widespread media coverage, and when Buris hornless descendant graced thecover of Wired magazine in April 2019, it did so as the ostensible face of the livestock industrys future.

But early last year, a bioinformatician at the FDA ran a test on Buris genome and discovered an unexpected sliver of genetic code that didnt belong. Traces of bacterial DNA called a plasmid, which Recombinetics used to edit the bulls genome, had stayed behind in the editing process, carrying genes linked to antibiotic resistance in bacteria. After the agency publishedits findings, the media reaction was swift and fierce: FDA finds a surprise in gene-edited cattle: antibiotic-resistant, non-bovine DNA,readone headline. Part cow, part bacterium?readanother.

Recombinetics has since insisted that the leftover plasmid DNA was likely harmless and stressed that this sort of genetic slipup is not uncommon.

Is there any risk with the plasmid? I would say theres none, says Tad Sonstegard, president and CEO of Acceligen, a Recombinetics subsidiary. We eat plasmids all the time, and were filled with microorganisms in our body that have plasmids. In hindsight, Sonstegard says his teams only mistake was not properly screening for the plasmid to begin with.

While the presence of antibiotic-resistant plasmid genes in beef probably does not pose a direct threat to consumers, according to Jennifer Kuzma, a professor of science and technology policy and co-director of the Genetic Engineering and Society Center at North Carolina State University, it does raise the possible risk of introducing antibiotic-resistant genes into the microflora of peoples digestive systems. Although unlikely, organisms in the gut could integrate those genes into their own DNA and, as a result, proliferate antibiotic resistance, making it more difficult to fight off bacterial diseases.

The lesson that I think is learned there is that science is never 100 percent certain, and that when youre doing a risk assessment, having some humility in your technology product is important, because you never know what youre going to discover further down the road, she says. In the case of Recombinetics. I dont think there was any ill intent on the part of the researchers, but sometimes being very optimistic about your technology and enthusiastic about it causes you to have blinders on when it comes to risk assessment.

The FDA eventually clarified its results, insisting that the study was meant only to publicize the presence of the plasmid, not to suggest the bacterial DNA was necessarily dangerous. Nonetheless, the damage was done. As a result of the blunder,a plan was quashedforRecombinetics to raise an experimental herd in Brazil.

Backlash to the FDA study exposed a fundamental disagreement between the agency and livestock biotechnologists. Scientists like Van Eenennaam, who in 2017 received a $500,000 grant from the Department of Agriculture to study Buris progeny, disagree with the FDAs strict regulatory approach to gene-edited animals. Typical GMOs aretransgenic, meaning they have genes from multiple different species, but modern gene-editing techniques allow scientists to stay roughly within the confines of conventional breeding, adding and removing traits that naturally occur within the species.

That said, gene editing is not yet free from errors and sometimes intended changes result in unintended alterations, notes Heather Lombardi, division director of animal bioengineering and cellular therapies at the FDAs Center for Veterinary Medicine. For that reason, the FDA remains cautious.

Theres a lot out there that I think is still unknown in terms of unintended consequences associated with using genome-editing technology, says Lombardi. Were just trying to get an understanding of what the potential impact is, if any, on safety.

Bhanu Telugu, an animal scientist at the University of Maryland and president and chief science officer at the agriculture technology startup RenOVAte Biosciences, worries that biotech companies willmigrate their experimentsto countries with looser regulatory environments. Perhaps more pressingly, he says strict regulation requiring long and expensive approval processes may incentivize these companies to work only on traits that are most profitable, rather than those that may have the greatest benefit for livestock and society, such as animal well-being and the environment.

What company would be willing to spend $20 million on potentially alleviating heat stress at this point? he asks.

On a windywinter afternoon, Raluca Mateescu leaned against a fence post at the University of Floridas Beef Teaching Unit while a Brahman heifer sniffed inquisitively at the air and reached out its tongue in search of unseen food. Since 2017, Mateescu, an animal geneticist at the university, has been part of a team studying heat and humidity tolerance in breeds like Brahman and Brangus (a mix between Brahman and Angus cattle). Her aim is to identify the genetic markers that contribute to a breeds climate resilience, markers that might lead to more precise breeding and gene-editing practices.

In the South, Mateescu says, heat and humidity are a major problem. That poses a stress to the animals because theyre selected for intense production to produce milk or grow fast and produce a lot of muscle and fat.

Like Nelore cattle in South America, Brahman are well-suited for tropical and subtropical climates, but their high tolerance for heat and humidity comes at the cost of lower meat quality than other breeds. Mateescu and her team have examined skin biopsies and found that relatively large sweat glands allow Brahman to better regulate their internal body temperature. With funding from the USDAs National Institute of Food and Agriculture, the researchers now plan to identify specific genetic markers that correlate with tolerance to tropical conditions.

If were selecting for animals that produce more without having a way to cool off, were going to run into trouble, she says.

There are other avenues in biotechnology beyond gene editing that may help reduce the cattle industrys footprint. Although still early in their development,lab-cultured meatsmay someday undermine todays beef producers by offering consumers an affordable alternative to the conventionally grown product, without the animal welfare and environmental concerns that arise from eating beef harvested from a carcass.

Other biotech techniques hope to improve the beef industry without displacing it. In Switzerland, scientists at a startup called Mootral areexperimenting with a garlic-based food supplementdesigned to alter the bovine digestive makeup to reduce the amount of methane they emit. Studies have shown the product to reduce methane emissions by about 20 percent in meat cattle, according to The New York Times.

In order to adhere to the Paris climate agreement, Mootrals owner, Thomas Hafner, believes demand will grow as governments require methane reductions from their livestock producers. We are working from the assumption that down the line every cow will be regulated to be on a methane reducer, he told The New York Times.

Meanwhile, a farm science research institute in New Zealand, AgResearch, hopes to target methane production at its source by eliminating methanogens, the microbes thought to be responsible for producing the greenhouse gas in ruminants. The AgResearch team isattempting to developa vaccine to alter the cattle guts microbial composition, according to the BBC.

Genomic testing may also allow cattle producers to see what genes calves carry before theyre born, according to Mateescu, enabling producers to make smarter breeding decisions and select for the most desirable traits, whether it be heat tolerance, disease resistance, or carcass weight.

Despite all these efforts, questions remain as to whether biotech can ever dramatically reduce the industrys emissions or afford humane treatment to captive animals in resource-intensive operations. To many of the industrys critics, including environmental and animal rights activists, the very nature of the practice of rearing livestock for human consumption erodes the noble goal of sustainable food production. Rather than revamp the industry, these critics suggest alternatives such as meat-free diets to fulfill our need for protein. Indeed,data suggestsmany young consumers are already incorporating plant-based meats into their meals.

Ultimately, though, climate change may be the most pressing issue facing the cattle industry, according to Telugu of the University of Maryland, which received a grant from the Bill and Melinda Gates Foundation to improve productivity and adaptability in African cattle. We cannot breed our way out of this, he says.

Dyllan Furness is a Florida-based science and technology journalist. His work has appeared in Quartz, OneZero, and PBS, among other outlets. Follow him on Twitter @dyllonline

This article was originally published at Undark and has been republished here with permission. Follow Undark on Twitter @undarkmag

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CRISPR cows could boost sustainable meat production, but regulations, wary consumers stand in the way - Genetic Literacy Project

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First lab-made ‘mini-hearts’ mimic the real thing – Futurity: Research News

By daniellenierenberg

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You are free to share this article under the Attribution 4.0 International license.

Researchers have created, for the first time, a miniature human heart model in the laboratory.

The mini-hearts are complete with all primary heart cell types and a functioning structure of chambers and vascular tissue.

The organoids are small models of the fetal heart with representative functional and structural features. They are, however, not as perfect as a human heart yet. That is something we are working toward.

These mini-hearts constitute incredibly powerful models in which to study all kinds of cardiac disorders with a degree of precision unseen before, says Aitor Aguirre, assistant professor of biomedical engineering at Michigan State Universitys Institute for Quantitative Health Science and Engineering and senior author of the study on the work on the bioRxiv preprint server. In the United States, heart disease is the leading cause of death.

The researchers created the human heart organoids, or hHOs for short,by way of a novel stem cell framework that mimics the embryonic and fetal developmental environments.

Organoidsmeaning resembling an organare self-assembling 3D cell constructs that recapitulate organ properties and structure to a significant extent, says first author Yonatan Israeli, a graduate student in Aguirres lab.

The innovation deploys a bioengineering process that uses induced pluripotent stem cellsadult cells from a patient to trigger embryonic-like heart development in a dishgenerating a functional mini-heart after a few weeks. The stem cells are obtained from consenting adults and therefore free of ethical concerns.

This process allows the stem cells to develop, basically as they would in an embryo, into the various cell types and structures present in the heart, Aguirre says. We give the cells the instructions and they know what they have to do when all the appropriate conditions are met.

Because the organoids followed the natural cardiac embryonic development process, the researchers studied, in real time, the natural growth of an actual fetal human heart.

This technology allows for the creation of numerous hHOs simultaneously with relative ease, contrasting with existing tissue engineering approaches that are expensive, labor intensive and not readily scalable.

One of the primary issues facing the study of fetal heart development and congenital heart defects is access to a developing heart. Researchers have been confined to the use of mammalian models, donated fetal remains, and in vitro cell research to approximate function and development.

Now we can have the best of both worlds, a precise human model to study these diseasesa tiny human heartwithout using fetal material or violating ethical principles. This constitutes a great step forward, Aguirre says.

Whats next? For Aguirre, the process is twofold. First, the heart organoid represents an unprecedented look into the nuts and bolts of how a fetal heart develops.

In the lab, we are currently using heart organoids to model congenital heart diseasethe most common birth defect in humans affecting nearly 1% of the newborn population, Aguirre says. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.

And second, while the hHO is complex, it is far from perfect. For the team, improving the final organoid is another key avenue of future research.

The organoids are small models of the fetal heart with representative functional and structural features, Israeli says. They are, however, not as perfect as a human heart yet. That is something we are working toward.

The researchers are excited about the wide-ranging applicability of these miniature hearts. They enable an unprecedented ability to study many other cardiovascular-related diseasesincluding chemotherapy-induced cardiotoxicity and the effect of diabetes, during pregnancy, on the developing fetal heart.

Additional researchers from Michigan State and Washington University in St. Louis contributed to the work.

The American Heart Association and the National Institutes of Health funded the study.

Source: Michigan State University

Original Study DOI: 10.1101/2020.06.25.171611

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Liver Disease Stem Cell Therapy | NSI Stem Cell

By daniellenierenberg

Stem Cell Therapy for Liver Cirrhosis

Chronic Liver Disease is a major concern for the entire country as it ranks as the fifth largest killer in the world. When the liver sustains serious damage, it loses the ability to repair itself and begins to function less and less effectively until it reaches the point that it no longer works, which is a life-threatening condition. An effective liver failure therapy was pursued for decades before the discovery of stem cells offered the possibility of effective liver stem cell therapy. Until the advent of Advanced Liver Stem Cell Therapy, the only therapy option for liver disease was a full organ transplant. Our bone marrow-derived stem cell therapies for liver conditions are an innovative therapy practiced in the United States that is safe and effective.*

We want to see patients with liver disease have a better quality of life and even be able to reverse the damage done. Liver stem cell therapy is one of our latest and most exciting therapies, joining those available at our clinic like stem cell therapy for Neurological or Spinal Cord Conditions.

The liver is a multi-functional organ that plays a role in digestion, blood sugar control, blood clotting factors for healing, making amino acids, increasing red blood cell growth, fat and cholesterol transport, and the removal of waste, especially toxic exposures and the metabolization of medications into their active ingredients. Much research has been done on this vital organ, and we now understand how Liver Stem Cell Therapy can positively impact liver health and function.

A number of things can contribute to Liver Disease. Here are some of the most commonly seen diagnoses in our offices:

Cirrhosis is the medical term that is used to describe liver disease that permanently scars the liver, which results in reduced function, pain, waste build up, and ultimately death of the liver. Its potentially lethal consequences make effective cirrhosis of he liver therapy a matter of the utmost importance.

When this condition is present, normal liver cells are replaced by scar tissue that cannot maintain healthy liver function. Acute liver failure may be life-threatening. Stem Cell Therapy for Liver Cirrhosis is a form of liver cirrhosis therapy that addresses damage as well as helps to generate fresh, healthy tissue.

Not too long ago, a diagnosis of liver failure was a death sentence, as the condition was deemed irreversible. However, new advances in stem cell regeneration have made Liver Stem Cell Therapy, including Stem Cell Therapy for Liver Cirrhosis, a reality.

More than three-quarters of the liver is made up of hepatocyte liver cells, which are special in that their average lifespan is only 150 days. What this means is that the liver is constantly renewing and growing new cells to replace weak and dying cells. It is the only organ in the body that can easily replace damaged cells. But when too many cells are damaged or die off too soon, the liver cannot keep up and it begins to fail into Liver Disease. Helping the organ to grow new cells is one of the functions of NSIs Liver Stem Cell Therapy.

The liver is a regenerative organ. But it is limited in this ability and can only maintain the regenerative pace when there are enough energy, healthy cells, blood, oxygen, and proper nutrients available. Liver Disease can quickly get out of control and can progress to Cirrhosis and Liver Failure very rapidly. Liver Stem Cell Therapy is designed to help reverse this damage and speed the process of cell regeneration.

Although the liver can heal itself, there is a point of no return, and there are not enough signs to indicate there is a problem until it is too late. Prior to Liver Stem Cell Therapy, once the line was crossed between Chronic Liver Disease and the final stage of liver failure, there were few options. Transplantation was the only effective therapy option for liver failure.

But it, too, is not without its share of risks and drawbacks. Rejection of the donor organ, infections, and surgery complications are at the top of the list. It is estimated that for every donor organ, there are 30 patients on a waiting list, and many people die from end-stage Liver Disease waiting for a donor organ.

This is why there has been such a fervent interest in liver failure therapy using stem cells here at NSI Stem Cell Centers.

Going back to as far as the year 2000, researchers have been conducting studies that showed that hepatocyte cells could grow on non-liver cell sources. This means there do not have to be associated liver cells to stimulate the liver cells to continue multiplying. This phenomenon is called transdifferentiation and is integral to Liver Stem Cell Therapy. Our bone marrow-derived stem cell therapies for liver conditions are an innovative therapy practiced in the United States that is safe and effective.*

Today, stem cells that are taken from the patients own fatty deposits are the only stem cells that have successfully been used in addressing liver disease. The major advantage that comes from such stem cells is that they do indeed come from the patient, so rejection is not an issue and there is a much higher success rate and a much-improved growth of new liver cells seen for the patient.

The stem cells are harvested and then transplanted into the damaged liver, where they transdifferentiate into hepatocyte cells. The stem cells also become cells that help with blood and oxygen delivery and waste removal, so the liver can regenerate faster.

To learn more about how Liver Stem Cell Therapy can help you fight your liver disease, contact us today at NSI Stem Cell and set up an appointment at one of our Florida locations. Our phone number is (877) 278-3623, or use our Contact Page. Be sure to ask for our FREE brochure that explains all of our Stem Cell Therapies. We look forward to hearing from you.

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Cosmetic Skin Care Market Increasing Demand, Industry Share with Industry Study Pandemic Impact Product Overview and Scope, Opportunities, Market…

By daniellenierenberg

Cosmetic Skin Care market research report is generated with a nice blend of industry insight, talent solutions, practical solutions and use of technology to advance user experience. The key research methodology used in this Cosmetic Skin Care market document by DBMR research team is data triangulation which involves data mining, analysis of the impact of data variables on the market, and primary (industry expert) validation. Nowadays, businesses get highly benefited with the different segments covered in the Cosmetic Skin Care market research report which provides better market insights to them with which they can drive the business into right direction.

An influential Cosmetic Skin Care market report analyses key factors of the market that gives precise and accurate data and information which is useful for the business. The scope of this Cosmetic Skin Care market report extends from market scenarios to comparative pricing between major players, cost and profit of the specified Cosmetic Skin Care market regions. The data collected to structure this Cosmetic Skin Care market document is based on the data collection modules with large sample sizes. The market data is analysed and forecasted using well established Cosmetic Skin Care market statistical and coherent models. No stone is left unturned while preparing this Cosmetic Skin Care market research report.

some of the Global Cosmetic Skin Care Market key players Involved in the study are LOral, Unilever, New Avon Company, Este Lauder Companies, Espa, Kao Corporation, Johnson & Johnson Services, Inc., Procter & Gamble, Beiersdorf, THE BODY SHOP INTERNATIONAL LIMITED, Shiseido Co.,Ltd., Coty Inc., Bo International, A One Cosmetics Products, Lancme, Clinique Laboratories, llc., Galderma Laboratories, L.P., AVON Beauty Products India Pvt Ltd, Nutriglow Cosmetics Pvt. Ltd, Shree Cosmetics.

Global cosmetic skin care market is set to witness a substantial CAGR of 5.5% in the forecast period of 2019- 2026.

Complete study compiled with over 100+ pages, list of tables & figures, profiling 10+ companies. Ask for Sample @ https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market&SR

Keep yourself up-to-date with latest Cosmetic Skin Care market trends and changing dynamics due to COVID Impact and Economic Slowdown globally. Maintain a competitive edge by sizing up with available business opportunity in Cosmetic Skin Care Market various segments and emerging territory.

**Moreover, it will also include the opportunities available in micro markets for stakeholders to invest, detailed analysis of competitive landscape and product services of key players**

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Inimitable Expertise:Analysts will provide deep insights about the reports Global major countries (United States, Canada, Germany, France, UK, Italy, Russia, Spain, China, Japan, Korea, India, Australia, New Zealand, Southeast Asia, Middle East, Africa, Mexico, Brazil, C. America, Chile, Peru, Colombia) market size (sales, revenue and growth rate) of Cosmetic Skin Care industry

Global Cosmetic Skin Care Market: Regional Analysis

Asia Pacific: China, Japan, India, and Rest of Asia Pacific

Europe: Germany, the UK, France, and Rest of Europe

North America: The US, Mexico, and Canada

Latin America: Brazil and Rest of Latin America

Middle East & Africa: GCC Countries and Rest of Middle East & Africa

By Product: Anti-Aging Cosmetic Products, Skin Whitening Cosmetic Products, Sensitive Skin Care Products, Anti-Acne Products, Dry Skin Care Products, Warts Removal Products, Infant Skin Care Products, Anti-Scars Solution Products, Mole Removal Products, Multi Utility Products

By Application: Flakiness Reduction, Stem Cells Protection against UV, Rehydrate the skins surface, Minimize wrinkles, Increase the viscosity of Aqueous, Others

By Gender: Men, Women

Check Complete Report Details of Cosmetic Skin Care Market @ https://www.databridgemarketresearch.com/toc/?dbmr=global-cosmetic-skin-care-market&SR

Major factors covered in the report:

**Global Cosmetic Skin Care Market summary

**Economic Impact on the Industry

** Cosmetic Skin Care Market Competition in terms of Manufacturers

**Production, Revenue (Value) by geographical segmentation

**Production, Revenue (Value), Price Trend by Type

** Cosmetic Skin Care Market Analysis by Application

**Cost Investigation

**Industrial Chain, Raw material sourcing strategy and Downstream Buyers

**Marketing Strategy comprehension, Distributors and Traders

**Study on Market Research Factors

**Global Cosmetic Skin Care Market Forecast

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**Supporting acquisition strategies

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Executive Summary

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Best Anti Aging Advances to ComeHow We’ll Soon Be Looking Younger – The Kit

By daniellenierenberg

On April 15, 2002, the FDA approved a temporary treatment for wrinkles that would revolutionize aging. All of a sudden, you could waltz into a derms office and get your frown lines ironed out faster than it would take to iron an actual shirt. It was called botulinum toxin,Botox for short.

Eighteen years later, a few units of Botox every three months has become the norm for millions around the world (more than seven million yearly in the U.S. alone). Now, if someone had told your grandparents, or even your parents, 20 years ago that people would be getting their foreheads frozen to look younger, they likely would have scoffed at the idea. So just imagine what other wild fixes could be coming to a medi-spa near you.

Its exciting to think about how the next 10 years will look, says Dr. Rohan Bissoondath, medical director of Calgarys Preventous Cosmetic Medicine clinic. With lifespan increasing, people are routinely going to be living into their hundreds, so we want to look great as well. From magic pills to creams that mimic injections, we take a look at the incredible innovations on the horizon.

The best products worth your time, money and energy get beauty news and more delivered to your inbox with our daily newsletter.

The way science is progressing, facelifts are set to become obsolete, says Dr. Lisa Kellett of Torontos DLK on Avenue. I think that the gold standard will eventually be finding ways to regenerate and kick-start our own collagen instead of doing a facelift. Kellett is already trying out cutting-edge technology to accomplish this, such as a laser that delivers growth factors right in the dermis to regenerate tissue. Its pretty snazzy stuff, but she anticipates even greater advances in coming years. I think well be able to use stem cells in conjunction with technology to regenerate collagenI think thats what well be doing one day.

Botox in a cream? This has been in the pipeline for a while, says Bissoondath. The challenge is getting the molecules to penetrate the skin so that they can act on the muscle. Maybe on crows feet because its a thinner area, thinner muscles; that may be an area where we see some utility for it, but its still out there. Topical Botox had some success in trials, but scientists still have kinks to work out. In the meantime, a Botox cream might be beneficial even if it doesnt reach muscles, says Bissoondath. I see the potential for having it in a cream and applying it to the whole face, not necessarily affecting facial expressions, but giving an improved glow and better skin quality.

If you want to smooth, you get Botox. If you want to brighten, you get IPL. If you want to tighten, you get Thermage. But what if there was a treatment that did it all? I think thats the future of aging, says Kellett, who is just about to launch such a treatment at her clinic. Marketed as the next generation of laser and light-based platform technology, Ethera is a multiple modality device that can tackle everything from dark spots and skin laxity to textural issues and wrinkles. It means that when patients come in, theyre not just doing one thing, says the doc. Instead, in the same appointment, shes able to address a variety of concerns with a single machine.

Okay, this is very cool. Something I think is possible is a pill to replace exercise, says Bissoondath, who adds that this could be developed in the not so distant future. With the advances were making in understanding the functions of our body down to the cellular level and intracellular level, and understanding how our mitochondria actually ages, were looking at ways now where we can manipulate that from a pill perspective. The pill wouldnt deliver all the benefits of physical activity, such as the positive impact on our mood, but it would replicate its effects on our body. It wont take the place of walking around outside and soaking up natureit cant do the mental part of it. But as far as the physiologic, biochemical part of it, were really understanding that better and making big strides. Its exciting.

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US FDA-approved ointment found to treat, kill viral infections including Covid-19 – ETHealthworld.com

By daniellenierenberg

Washington: A US pharma company has successfully tested a Food and Drug Administration-approved over the counter ointment as the first line of defence against the deadly coronavirus that has so far killed over eight lakh people globally.

Scientists associated with the project said the FDA-registered non-prescription over the counter (OTC) ointment has been proven to prevent, treat and kill viral infections including coronavirus.

As per the lab report states, no infectious virus was detected after 30 seconds of T3X treatment, the pharma company said in a statement.

This is a big deal. It is the type of protection a lot of people have been hoping for and could be a first line of defence against the COVID virus. It is a powerful and effective layer of prevention, Huber said.

He was speaking after the company released the results of an independent laboratory evaluation of a topical medical formulation that mitigates coronavirus from entering the body through the nasal passages, thereby significantly reducing the likelihood of people becoming infected with the virus.

A recent study by the Massachusetts Institute of Technology (MIT) concluded that people contract COVID-19 and other viruses primarily through the nose. However, virus may still enter a body through the mouth and the eyes.

T3X is an FDA registered, over-the-counter formulation, which means that no prescription is needed. It is easy to use and can be self-administered without the assistance of medical personnel or technicians, the company said.

The research concludes that APT T3X effectively neutralises viral infectivity within seconds. The anti-viral efficacy supports the topical intranasal use of APT T3X to decrease the viral load of exposure.

Under the conditions tested, APT T3X displays a 99.9% virucidal activity against human coronavirus NL63, the company said.

The testing was performed over two months, in May and June. All definitive anti-viral assays were performed in triplicate, it said.

The product was initially developed eight years ago for resistant-bacterial infections, but its formulation additionally provides powerful anti-fungal and anti-viral therapies. It has no documented side effects. However, patients diagnosed with Lyme disease should be aware of a potential Herx reaction shortly after use, the company said.

A total of 22,864,873 people have contracted coronavirus globally so far, according to the Johns Hopkins University's COVID resource centre.

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Cartilage Is Grown in the Arthritic Joints of Mice – The New York Times

By daniellenierenberg

The researchers wanted to turn those awakened stem cells into cartilage. The recipe that worked was to treat the stem cells with bone morphogenetic protein, which is used to help fuse bones.

The scientists also used a drug called Avastin, which prevents the stem cells from getting a blood supply. Unlike bone and bone marrow, cartilage has no blood supply, and the drug helped stimulate the stem cells to turn into cartilage.

The investigators provided the drugs directly to the ends of bones, putting them in a gel.

The cartilage that grew in the mice not only looked like normal but lasted for four months, a quarter of the animals lifetimes. Dr. Chan and Dr. Longaker envision a time when doctors will be able to resurface arthritic joints or, even better, to treat people who are just beginning to develop arthritis, perhaps staving off the sort of damage that even joint replacements cannot fix.

If the strategy works in humans, then early treatment may be the best approach, Dr. Marx said.

Arthritis deforms joints and changes bones, he said. By the time people have hips or knees replaced, irreversible damage may be done. Legs may be bowed, bones damaged.

You cannot totally turn back the clock, Dr. Marx said. At that point, he said, adding cartilage will not fix it.

He worries, though, that orthopedists may not wait for rigorous studies the method of awakening the dormant cells is relatively simple, and the drugs required are already on the market.

Faced with a patient with aching knees, orthopedists may be tempted to say, Lets try this. You dont have much to lose, Dr. Marx noted.

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Steadman Philippon Research Institute receives prestigious matching grant from the National Institutes of Health – Vail Daily News

By daniellenierenberg

Steadman Philippon Research Institute has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health. Steadman Philippon Research Institutes Chief Scientific Officer Johnny Huard, Ph.D. will serve as the principal investigator.

Marc J. Philippon, M.D., who serves as managing partner of The Steadman Clinic and co-chair of SPRI and Scott Tashman, Ph.D., director of biomedical engineering at SPRI, will serve as co-principal investigators. The clinical trials are expected to begin enrolling in the fall of 2020.

The award, administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, ranks as one of the most significant in SPRIs history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act a law passed in December 2016 to accelerate medical discovery and innovation to support the NIH-established Regenerative Medicine Innovation Project.

The Regenerative Medicine Innovation Project aims to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for protecting patient safety during the conduct of research.

This is a really great honor for SPRI, said Huard in a news release. Past recipients of these RMIP awards have been Albert Einstein College of Medicine, Boston Childrens Hospital, Columbia University Health Sciences, Childrens Hospital of Philadelphia, Harvard University, University of Colorado Denver and Yale University.So, we are in very good company.

Huard first came to Vail in 2015 and has served as the director of the Center for Regenerative Sports Medicine in addition to his role as the institutes chief scientific officer.

The grant anticipates over $2.8 million from the NIH and requires a 1:1 match from SPRI over the next five years, pending availability of federal funds. The clinical trials and resulting publications and reports will take place over the next five years. A generous SPRI benefactor committed to fund the first year of the match, and Dr. Huard is hopeful that with the NIH matching the funds, more philanthropists will be inspired to become involved in this groundbreaking project.

Our donors have been so generous in supporting all that we do here at SPRI, Huard said. And I am very grateful and confident that we will raise the funds necessary to complete these trials over the next five years.

The trial is entitled, The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:

The idea behind the trial is to delay osteoarthritis in the knee, Huard said. Our goal is to delay the need for that first knee replacement in a patient for as long as we can. Over time SPRI intends to expand this area of research to other joints including hip and shoulder.

This clinical trial is designed to determine whether senolytic and/or antifibrotic agents will improve the beneficial effect of bone marrow stem cells for the treatment of symptomatic knee osteoarthritis. The trial will include four groups, totaling 100 patients, to investigate the teams hypothesis that the use of these agents will improve patient outcomes.

One of the great things that I love about this particular clinical trial is that we are actively involving our orthopedic surgeons and our biomotion lab staff as well, Huard said. This will truly be a team effort over the next five years.

Those world-class surgeons are led by Dr. Philippon, considered one of the worlds foremost orthopedic surgeons. The biomotion lab is under the direction of Dr. Tashman. The contributions of these two leaders and the talented roster of surgeons, clinicians and technicians in their departments will be critical to the success of the upcoming clinical trials. SPRIs Center for Outcomes-Based Orthopaedic Research and its director, Grant Dornan, are also participating in this project by contributing the statistical outcomes.

Dr. Philippon is not only a world-class surgeon but he is also an innovator, Huard said. He always wants to improve and is still willing to try new things to enhance patient outcomes. Dr. Tashman is the same way. Like everyone here at SPRI and The Steadman Clinic, they are embracing the cutting-edge technology available to them and finding new and better ways to treat patients and, most importantly, reduce patients recovery time and get them back to their active lives as quickly and safely as possible.

Huard notes that the rare combination of a globally recognized research institute like SPRI and a world-class orthopedic surgery clinic like The Steadman Clinic in the same building is one of the key factors in the awarding of this RMIP grant.

Weve got something here in Vail that many other research institutes dont have, Huard said. We have one of the worlds finest orthopedic clinics right next door, working hand-in-hand with us every day.

Dr. Huard and Dr. Tashman along with Suzanne Liv Page, J.D., our director of grants and contracts have worked diligently to prepare and gain acceptance of this grant proposal from the NIH, Philippon said. Our surgeons here at The Steadman Clinic eagerly await the opportunity to participate in the trial. Johnny, Scott and their staff have put SPRI into position to undertake major trials and studies like this one and we are all very honored that the NIH has given SPRI this incredible opportunity.

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Cord Stem Cell Banking Market with High CAGR in Coming Years | Global Players Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS…

By daniellenierenberg

The research, analysis and estimations about the market have been performed with the steadfast knowledge in this Cord Stem Cell Banking Market report. This market report helps to obtain information about all the above factors by giving actionable market insights and comprehensive market analysis. Analysis and discussion of important industry trends, market size, sales volume, and market share are also estimated in this market report. To achieve maximum return on investment (ROI), its very fundamental to figure out market parameters such as brand awareness, market landscape, possible future issues, industry trends & customer behaviour where this Cord Stem Cell Banking Market report comes into picture.

Request for sample copy or PDF Herehttps://www.databridgemarketresearch.com/request-a-sample?dbmr=global-cord-stem-cell-banking-market

Global Cord Stem Cell Banking Market report gives clear idea to Healthcare industry in regard with what is already available in the market, what market anticipates, the competitive environment, and what to be get done to surpass the competitor. This market report serves a great purpose of better decision making and achieving competitive advantage. The report supports in evaluating brand awareness, market landscape, possible future issues, industry trends and customer behaviour with which refined business strategies can be fixed. Cord Stem Cell Banking Market report has been comprised of a significant data along with future forecast and detailed analysis on a global and regional level.

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

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

Browse Detailed TOC, Tables, Figures, Charts and Companies @https://www.databridgemarketresearch.com/toc?dbmr=global-cord-stem-cell-banking-market

Market Definition: Global Cord Stem Cell Banking Market

Cord stem cells banking is nothing but the storing of the cord blood cell contained in the umbilical cord and placenta of a newborn child. This cord blood contains the stem cells which can be used in future to treat disease such as leukemia, thalassemia, autoimmune diseases, and inherited metabolic disorders, and few others.

Segmentation: Global Cord Stem Cell Banking Market

Cord Stem Cell banking Market : By Storage Type

Cord Stem Cell banking Market : By Product Type

Cord Stem Cell banking Market : By Service Type

Cord Stem Cell banking Market : By Indication

Cord Stem Cell banking Market : By Source

Cord Stem Cell banking Market : By Geography

Key Developments in the Cord Stem Cell banking Market:

Cord Stem Cell banking Market : Drivers

Cord Stem Cell banking Market : Restraint

Scope of the Cord Stem Cell banking Market Report :

The report shields the development activities in the Cord Stem Cell banking Market which includes the status of marketing channels available, and an analysis of the regional export and import. It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments. This will benefit the reports users, that evaluates their position in Cord Stem Cell banking market as well as create effective strategies in the near future.

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Cord Stem Cell Banking Market with High CAGR in Coming Years | Global Players Lifecell, StemCyte India Therapeutics Pvt. Ltd, Viacord, SMART CELLS...

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A bright future for genomics and gene therapy in the UK – Health Service Journal

By daniellenierenberg

This is paid-for content from our commercial partners.Find out more

So-called scientific breakthroughs are often in the headlines, but in reality, ground-breaking medical innovations adhere to a slow process characterised by cautious clinical experimentation and gradual but continuous improvement before reaching patients. After years of effort, gene therapy looks set to become a routine medical approach to address serious unmet medical need.

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There are two types of gene therapy approved for commercial use today. The first, in vivo, uses a modified virus, administered directly into the body to correct the target cells original genetic defect. The second, ex vivo, takes the patients own cells away from their body for genetic modification with a virus and then puts them back into the patient. Ex vivo gene therapy is dominated by two cell types; CD34+ haematopoietic stem cells (bone marrow stem cells) that can be modified to correct certain genetic disorders, and cytotoxic T-cells that can be altered and trained to kill cancerous cells.

The cell and gene therapy industry in the UK is supported by the formation and growth of many companies with promising assets in clinical development. This thriving biotech community is also supported by a robust and prosperous contingent of specialist manufacturing companies. These companies were key to the recent national covid-19 vaccine manufacturing response because the process for making genetically modified adenovirus such as the SARs-COV-02 vaccine, (as developed at the Oxford University Jenner Institute), is very similar to the process for making viruses for gene therapy.

UK leadership in gene therapy is no accident. As specified in our National Industrial Strategy, the UKs many research councils, in particular the Medicines Research Council, are active in funding the development and translation of treatments. In the UK right now, there are approximately 127 clinical trials testing new cell and gene therapy medicines, which represents 12 per cent of the global total. The government is readying the NHS to support these trials and transition these treatments into more common use through funding of the Advanced Therapy Treatment Centres (ATTC), a multiyear multi-million-pound project coordinated by the Cell and Gene Therapy Catapult and comprising centres of excellence throughout the UK.

In the UK right now, there are approximately 127 clinical trials testing new cell and gene therapy medicines, which represents 12 per cent of the global total. The government is readying the NHS to support these trials

The ATTCs aim to develop and harmonise adoption of the one and done treatment paradigm by developing the appropriate frameworks and systems to support clinical adoption of these novel therapies. The ATTCs and the NHS are also working in partnership to develop novel medicines assessment and reimbursement paradigms which fairly recognise the ultra-long-term medical benefits that can accrue from a one-time gene therapy treatment. Increased adoption of gene therapy, which is proving to be an approach that can reduce the long-term healthcare burden of chronic disease management, has the potential to significantly lighten the NHS resources required for support of several chronic conditions.

As a future example of the UK commitment to gene therapies, we are also leading the practical application of genetic sequencing (genomics). Formation of the National Genomic Test Directory and support for the 100,000 genomes project by Genomics England are critical steps to improve the diagnosis of patients and identification of a new wave of one-off treatments that could be capable of delivering long-term clinical benefit.

Cell and gene therapies are a revolution in medicine and have even been described as the future of the healthcare system. When you consider that 80 per cent of rare diseases have a genetic component, these treatments could transform the prospects of thousands of people living with these conditions, creating a more economically sustainable and brighter future for them and their families.

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Research Roundup: Lasting Immunity to COVID-19 and More – BioSpace

By daniellenierenberg

Every week there are numerous scientific studies published. Heres a look at some of the more interesting ones.

Multiple Studies Suggest Lasting Immunity to COVID-19 After Infection

Although probably not enough time has passed to know definitively, several studies are now suggesting that even mild cases of COVID-19 stimulate lasting immune responses, not only in disease-fighting antibodies, but in B- and T-cells.

Things are really working as theyre supposed to, Deepta Bhattacharya, an immunologist at the University of Arizona, and an author of one of the studies, told The New York Times.

Its difficult, probably impossible, to predict how long those immune responses will last, but many of the researchers believe the results are promising for long-term protection.

This is exactly what you would hope for, Marion Pepper, an immunologist at the University of Washington and an author of a study currently being reviewed by the journal Nature. All the pieces are there to have a totally protective immune response.

Pepper notes that the protective effects cant be completely evaluated until there is proof that people exposed to the virus a second time can fight it off. But the data suggests the immune system is indeed able to fight resistance a second time. Some of this qualification comes from unconfirmed reports of people being reinfected by the virus.

Antibody responses are typically relatively short-lived, disappearing from the blood weeks or months after being produced. Generally, the majority of the B-cells that produce antibodies die off, too. But the body keeps some longer-lived B-cells that are able to manufacture virus-fighting antibodies should the immune system be triggered by re-exposure to the virus. Some stay in the bloodstream while others wait in the bone marrow where they manufacture small numbers of antibodies that can sometimes be observed years, even decades later. Several studies, some by Bhattacharya and Pepper, have identified antibodies at low levels in the blood months after people recovered from COVID-19.

The antibodies decline, but they settle in what looks like a stable nadir, Bhattacharya said. These have been observed about three months after symptoms show up. The response looks perfectly durable.

Additional studies, including one published in the journal Cell, have isolated T-cells from recovered patients that can attack SARS-CoV-2. In laboratory studies, the T-cells produced signals to fight the virus and cloned themselves in large numbers to fight the potential infection.

This is very promising, said Smita Iyer, an immunologist at the University of California, Davis, who was not involved in the new studies, but has researched immune responses to the novel coronavirus in rhesus macaques. This calls for some optimism about herd immunity, and potentially a vaccine.

It's still has not been definitely determined if milder cases of COVID-19 will lead to long-term or even medium-term immunity. There have been some studies that suggest it does not and some newer studies suggesting it does. Iyer notes that the recent paper indicates, You can still get durable immunity without suffering the consequences of infection.

This idea is reinforced by Eun-Hyung Lee, an immunologist at Emory University who was not involved in these studies. He told The New York Times, Yes, you do develop immunity to this virus, and good immunity to this virus. Thats the message we want to get out there.

Why Seasonal Flu Vaccines Only Last a Year

As most everyone knows, flu vaccines only last about a year. Some of this is related to viral mutations. But in fact, the actual immunity itself caused by the vaccine does not appear to last longer than a year, even though the flu vaccine increases the number of antibody-producing cells specific for the flu in the bone marrow. Researchers out of Emory Vaccine Center found that for most newly-generated plasma cell lineages, between 70 and 99% of the cells were gone after one year, but that the levels of antibody-secreting cells in blood correlated with long-term response in the bone marrow.

Gut Bacteria Can Help Immuno-Oncology Therapies

Researchers with the University of Calgary identified gut bacteria that help our immune system fight cancerous tumors. This also helped provide more information about why immunotherapy works in some cases, but not others. By combining immunotherapy with specific microbial therapy, they believe they can help the immune system and immunotherapy be more effective in treating three types of cancer: melanoma, bladder and colorectal cancers. They found that specific bacteria were essential for immunotherapy to work in colorectal cancer tumors in germ-free mice. The bacteria produced a small molecule called inosine that interacts directly with T-cells and together with immunotherapy.

An Online Calculator to Predict Stroke Risk

Scientists at the University of Virginia Health System developed an online tool that measures the severity of a patients metabolic syndrome, a mix of conditions that includes high blood pressure, abnormal cholesterol levels and excess body fat. With it, they can then predict the patients risk for ischemic stroke. The study discovered that stroke risk increased consistently with metabolic syndrome severity even in patients that did not have diabetes. The tool is available for free at https://metscalc.org/.

A Link Between Autism and Cholesterol

Researchers at Harvard Medical School, Massachusetts Institute of Technology (MIT) and Northwestern University identified a subtype of autism that is the result of a cluster of genes that regulate cholesterol metabolism and brain development. They believe this information can help design precision-targeted therapies for this specific type of autism and improve screening efforts for earlier diagnosis of autism. They analyzed the DNA from brain samples that they then confirmed with the medical records of autistic individuals. They found that children with autism and their parents had significant alterations in lipid blood. However, there is much more to be understood, emphasizing the complexity of autism, which is affected by a variety of genetic and environmental factors.

Researchers Grow First Functioning Mini Human Heart Model

Investigators with Michigan State University grew the first miniature human heart model in the laboratory that is complete with all primary heart cell types and a functioning structure of chambers and vascular tissue. They utilized induced pluripotent stem cells which were obtained from consenting adults and created a functional mini heart in a few weeks. The primary value was in giving them an unprecedented view into how a fetal heart develops.

In the lab, we are currently using heart organoids to model congenital heart diseasethe most common birth defect in humans affecting nearly 1% of the newborn population, said Aitor Aguirre, senior author and assistant professor of biomedical engineering at MSUs Institute for Quantitative Health Science and Engineering. With our heart organoids, we can study the origin of congenital heart disease and find ways to stop it.

Another area of focus is that improving on the final organoid will help with future research. Current heart organoids are not identical yet to human hearts and so are flawed in their use as research models.

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Research Roundup: Lasting Immunity to COVID-19 and More - BioSpace

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Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 – Scientect

By daniellenierenberg

The research study on Global Cell Therapy Manufacturing market 2019 presents an extensive analysis of current Cell Therapy Manufacturing market size, drivers, trends, opportunities, challenges, as well as key Cell Therapy Manufacturing market segments. Further, it explains various definitions and classification of the Cell Therapy Manufacturing industry, applications, and chain structure.In continuation of this data, the Cell Therapy Manufacturing report covers various marketing strategies followed by key players and distributors. Also explains Cell Therapy Manufacturing marketing channels, potential buyers and development history. The intent of global Cell Therapy Manufacturing research report is to depict the information to the user regarding Cell Therapy Manufacturing market forecast and dynamics for the upcoming years.The Cell Therapy Manufacturing study lists the essential elements which influence the growth of Cell Therapy Manufacturing industry. Long-term evaluation of the worldwide Cell Therapy Manufacturing market share from diverse countries and regions is roofed within the Cell Therapy Manufacturing report. Additionally, includes Cell Therapy Manufacturing type wise and application wise consumption figures.

The Final Report will cover the impact analysis of COVID-19 on this industry.

Download Sample of This Strategic Report:https://www.kennethresearch.com/sample-request-10225722

After the basic information, the global Cell Therapy Manufacturing Market study sheds light on the Cell Therapy Manufacturing technological evolution, tie-ups, acquisition, innovative Cell Therapy Manufacturing business approach, new launches and Cell Therapy Manufacturing revenue. In addition, the Cell Therapy Manufacturing industry growth in distinct regions and Cell Therapy Manufacturing R&D status are enclosed within the report.The Cell Therapy Manufacturing study also incorporates new investment feasibility analysis of Cell Therapy Manufacturing. Together with strategically analyzing the key micro markets, the report also focuses on industry-specific drivers, restraints, opportunities, and challenges in the Cell Therapy Manufacturing market.

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Global Cell Therapy Manufacturing Market Segmentation 2019:The study also classifies the entire Cell Therapy Manufacturing market on basis of leading manufacturers, different types, various applications and diverse geographical regions.Overall Cell Therapy Manufacturing market is characterized by the existence of well-known global and regional Cell Therapy Manufacturing vendors. These established Cell Therapy Manufacturing players have huge essential resources and funds for Cell Therapy Manufacturing research as well as developmental activities. Also, the Cell Therapy Manufacturing manufacturers focusing on the development of new Cell Therapy Manufacturing technologies and feedstock. In fact, this will enhance the competitive scenario of the Cell Therapy Manufacturing industry.

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

Based on Therapy Type, the Cell Therapy Manufacturing market is categorized into: Allogeneic Cell Therapy Autologous Cell Therapy

Based on Technology, the Cell Therapy Manufacturing market is categorized into: Somatic Cell Technology Cell Immortalization Technology Viral Vector Technology Genome Editing Technology Cell Plasticity Technology 3D Technology

Based on Source, the Cell Therapy Manufacturing market is categorized into: IPSCs Bone Marrow Umbilical Cord Adipose Tissue Neural Stem Cells

Based on Application, the Cell Therapy Manufacturing market is categorized into: Musculoskeletal Cardiovascular Gastrointestinal Neurological Oncology Dermatology Other

Global Cell Therapy Manufacturing Market Regional Analysis:The companies in the world that deals with Cell Therapy Manufacturing mainly concentrate following regions.North America, Europe, Asia Pacific, Latin America, and Middle East & AfricaGlobal Cell Therapy Manufacturing Industry Report Covers following Topics:01: Cell Therapy Manufacturing Market Overview02: Global Cell Therapy Manufacturing Sales, Revenue (value) and Market Share by Players03: Cell Therapy Manufacturing Market Sales, Revenue (Value) by Regions, Type and Application (2014-2018)04: Region wise Top Players Cell Therapy Manufacturing Sales, Revenue and Price05: worldwide Cell Therapy Manufacturing Industry Players Profiles/Analysis06: Cell Therapy Manufacturing Cost Analysis07: Industrial Chain, Cell Therapy Manufacturing Sourcing Strategy and Downstream Buyers08: Cell Therapy Manufacturing Marketing Strategy Analysis, Distributors/Traders09: Cell Therapy Manufacturing Industry Effect Factors Analysis10: Global Cell Therapy Manufacturing Market Forecast (2019-2026)11: Cell Therapy Manufacturing Research Findings and Conclusion12: Appendix

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Worldwide Cell Therapy Manufacturing Market Different Analysis:Competitors Review of Cell Therapy Manufacturing Market: Report presents the competitive landscape scenario seen among top Cell Therapy Manufacturing players, their company profile, revenue, sales, business tactics and forecast Cell Therapy Manufacturing industry situations.Production Review of Cell Therapy Manufacturing Market: It illustrates the production volume, capacity with respect to major Cell Therapy Manufacturing regions, application, type, and the price.

Sales Margin and Revenue Accumulation Review of Cell Therapy Manufacturing Market: Eventually explains sales margin and revenue accumulation based on key regions, price, revenue, and Cell Therapy Manufacturing target consumer.

Supply and Demand Review of Cell Therapy Manufacturing Market: Coupled with sales margin, the report depicts the supply and demand seen in major regions, among key players and for every Cell Therapy Manufacturing product type. Also interprets the Cell Therapy Manufacturing import/export scenario.

Other key reviews of Cell Therapy Manufacturing Market: Apart from the above information, correspondingly covers the company website, number of employees, contact details of major Cell Therapy Manufacturing players, potential consumers and suppliers. Also, the strengths, opportunities, Cell Therapy Manufacturing market driving forces and market restraints are studied in this report.

Highlights of Global Cell Therapy Manufacturing Market Report:* This report provides in detail analysis of the Cell Therapy Manufacturing and provides market size (US$ Million) and Cumulative Annual Growth Rate (CAGR (%)) for the forecast period: 2019 2029.* It also elucidates potential revenue opportunity across different segments and explains attractive investment proposition matrix for world Cell Therapy Manufacturing market.* This study also provides key insights about Cell Therapy Manufacturing market drivers, restraints, opportunities, new product launches, approvals, regional outlook, and competitive strategies adopted by the leading Cell Therapy Manufacturing players.* It profiles leading players in the worldwide Cell Therapy Manufacturing market based on the following parameters company overview, financial performance, product portfolio, geographical presence, distribution strategies, key developments and strategies and future plans.* Insights from Cell Therapy Manufacturing report would allow marketers and management authorities of companies to make an informed decision with respect to their future product launches, market expansion, and Cell Therapy Manufacturing marketing tactics.* The world Cell Therapy Manufacturing industry report caters to various stakeholders in Cell Therapy Manufacturing market. That includes investors, device manufacturers, distributors and suppliers for Cell Therapy Manufacturing equipment. Especially incorporates government organizations, Cell Therapy Manufacturing research and consulting firms, new entrants, and financial analysts.*Various strategy matrices used in analyzing the Cell Therapy Manufacturing market would provide stakeholders vital inputs to make strategic decisions accordingly.Global Cell Therapy Manufacturing Market Report Provides Comprehensive Analysis of Following: Cell Therapy Manufacturing Market segments and sub-segments Industry size & Cell Therapy Manufacturing shares Cell Therapy Manufacturing Market trends and dynamics Market Drivers and Cell Therapy Manufacturing Opportunities Supply and demand of world Cell Therapy Manufacturing industry Technological inventions in Cell Therapy Manufacturing trade Cell Therapy Manufacturing Marketing Channel Development Trend Global Cell Therapy Manufacturing Industry Positioning Pricing and Brand Strategy Distributors/Traders List enclosed in Positioning Cell Therapy Manufacturing Market.

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Moreover, the report organizes to provide essential information on current and future Cell Therapy Manufacturing market movements, organizational needs and Cell Therapy Manufacturing industrial innovations. Additionally, the complete Cell Therapy Manufacturing report helps the new aspirants to inspect the forthcoming opportunities in the Cell Therapy Manufacturing industry. Investors will get a clear idea of the dominant Cell Therapy Manufacturing players and their future forecasts.

About Kenneth Research:

Kenneth Research provides market research reports to different individuals, industries, associations and organizations with an aim of helping them to take prominent decisions. Our research library comprises of 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 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 significant analysis on various markets with pure business intelligence and consulting services on different industries across the globe. In addition to that, our internal research team always keep a track on 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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Cell Therapy Manufacturing Market 2020 Report Including COVID-19 Impact Analysis and Forecast till 2029 - Scientect

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Cell Therapy Processing Market is Booming Worldwide to Show Significant Growth by 2026 Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co.,…

By daniellenierenberg

Cell therapy is the administration of living cells to replace a missing cell type or to offer a continuous source of a necessary factor to achieve a truly meaningful therapeutic outcome. There are different forms of cell therapy, ranging from transplantation of cells derived from an individual patient or from another donor. The manufacturing process of cell therapy requires the use of different products such as cell lines and instruments. These cell therapies are used for the treatment of various diseases such as cardiovascular disease and neurological disorders.

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Key Players:

Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co., Inc. (FloDesign Sonics),NantWorks, LLC,Neurogeneration, Inc.,Novartis AG,Plasticell Ltd.,Regeneus Ltd,StemGenex, Inc.

Increase in the incidence of cardiovascular diseases, rise in the demand for chimeric antigen receptor (CAR) T cell therapy, increase in the R&D for the advancement in the research associated with cell therapy, increase in the potential of cell therapies in the treatment of diseases associated with lungs using stem cell therapies, and rise in understanding of the role of stem cells in inducing development of functional lung cells from both embryonic stem cells (ESCs) & induced pluripotent stem (iPS) cells are the key factors that fuel the growth of the cell therapy processing market.

Moreover, increase in a number of clinical studies relating to the development of cell therapy processing, rise in adoption of regenerative drug, introduction of novel technologies for cell therapy processing, increase in government investments for cell-based research, increase in number of GMP-certified production facilities, large number of oncology-oriented cell-based therapy clinical trials, and rise in the development of allogeneic cell therapy are other factors that augment the growth of the market. However, high-costs associated with the cell therapies, and bottlenecks experienced by manufacturers during commercialization of cell therapies are expected to hinder the growth of the market.

The cell therapy processing market is segmented into offering type, application, and region. By type, the market is categorized into products, services, and software. The application covered in the segment include cardiovascular devices, bone repair, neurological disorders, skeletal muscle repair, cancer, and others. On the basis of region, the market is analyzed across North America (U.S., Canada, and Mexico), Europe (Germany, France, UK, Italy, Spain, and rest of Europe), Asia-Pacific (Japan, China, India, and rest of Asia-Pacific), and LAMEA (Latin America, Middle East, and Africa).

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KEY MARKET SEGMENTS

By Offering Type Products Services Software

By Application Cardiovascular Devices Bone Repair Neurological Disorders Skeletal Muscle Repair Cancer Others

By Region

North Americao U.S.o Canadao Mexico Europeo Germanyo Franceo UK

Key question and answered in the report include:

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Cell Therapy Processing Market is Booming Worldwide to Show Significant Growth by 2026 Cell Therapies Pty Ltd,Invitrx Inc.,Lonza Ltd,Merck & Co.,...

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Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health – Yahoo Finance

By daniellenierenberg

Dr. Johnny Huard will be the Principal Investigator on five-year clinical trial that focuses on Bone Marrow Stem Cell treatments to delay onset of osteoarthritis in the knee

VAIL, Colorado, Aug. 20, 2020 (GLOBE NEWSWIRE) -- Steadman Philippon Research Institute (SPRI) has been granted the prestigious Regenerative Medicine Innovation Project Investigator-Initiated Clinical Trials award from the National Institutes of Health (NIH). SPRI Chief Scientific Officer Johnny Huard, Ph.D. will serve as the principal investigator. Marc J. Philippon, M.D., who serves as managing partner of The Steadman Clinic and co-chair of SPRI and Scott Tashman, Ph.D., director of biomedical engineering at SPRI, will serve as co-principal investigators. The clinical trials are expected to begin enrolling in the Fall of 2020.

The award, administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases, ranks as one of the most significant in SPRIs history, both in size and recognition. Given the potential of regenerative medicine to enhance human health and treat disease, the United States Congress included a provision in the 21st Century Cures Act a law passed in December 2016 to accelerate medical discovery and innovation to support the NIH-established Regenerative Medicine Innovation Project (RMIP). The RMIP aims to accelerate the field by supporting clinical research on adult stem cells while promoting the highest standards for protecting patient safety during the conduct of research.

This is a really great honor for SPRI, said Dr. Huard, who first came to Vail in 2015 and has served as the director of the Center for Regenerative Sports Medicine in addition to his role as the institutes chief scientific officer. Past recipients of these RMIP awards have been Albert Einstein College of Medicine, Boston Childrens Hospital, Columbia University Health Sciences, Childrens Hospital of Philadelphia, Harvard University, University of Colorado Denver and Yale University.So, we are in very good company.

The grant anticipates over $2.8 million from the NIH and requires a 1:1 match from SPRI over the next five years, pending availability of federal funds. The clinical trials and resulting publications and reports will take place over the next five years. A generous SPRI benefactor committed to fund the first year of the match, and Dr. Huard is hopeful that with the NIH matching the funds, more philanthropists will be inspired to become involved in this groundbreaking project.

Our donors have been so generous in supporting all that we do here at SPRI, said Dr. Huard, and I am very grateful and confident that we will raise the funds necessary to complete these trials over the next five years.

The trial is entitled,The Use of Senolytic and Anti-Fibrotic Agents to Improve the Beneficial Effect of Bone Marrow Stem Cells for Osteoarthritis. Huard explains in laypersons terms:

The idea behind the trial is to delay osteoarthritis in the knee, said Huard. Our goal is to delay the need for that first knee replacement in a patient for as long as we can. Over time SPRI intends to expand this area of research to other joints including hip and shoulder.

This clinical trial is designed to determine whether senolytic and/or antifibrotic agents will improve the beneficial effect of Bone Marrow Stem Cells for the treatment of symptomatic knee osteoarthritis. The trial will include four groups, totaling 100 patients, to investigate the teams hypothesis that the use of these agents will improve patient outcomes.

One of the great things that I love about this particular clinical trial is that we are actively involving our orthopaedic surgeons and our biomotion lab staff as well, said Dr. Huard. This will truly be a team effort over the next five years.

Those world-class surgeons are led by Dr. Philippon, considered one of the worlds foremost orthopaedic surgeons. The biomotion lab is under the direction of Dr. Tashman. The contributions of these two leaders and the talented roster of surgeons, clinicians and technicians in their departments will be critical to the success of the upcoming clinical trials. SPRIs Center for Outcomes-Based Orthopaedic Research and its director Grant Dornan are also participating in this project by contributing the statistical outcomes.

Story continues

Dr. Philippon is not only a world-class surgeon but he is also an innovator, added Dr. Huard. He always wants to improve and is still willing to try new things to enhance patient outcomes. Dr. Tashman is the same way. Like everyone here at SPRI and The Steadman Clinic, they are embracing the cutting-edge technology available to them and finding new and better ways to treat patients and, most importantly, reduce patients recovery time and get them back to their active lives as quickly and safely as possible.

Huard notes that the rare combination of a globally recognized research institute like SPRI and a world-class orthopaedic surgery clinic like The Steadman Clinic in the same building is one of the key factors in the awarding of this RMIP grant.

Weve got something here in Vail that many other research institutes dont have, said Huard. We have one of the worlds finest orthopaedic clinics right next door, working hand-in-hand with us every day.

Dr. Huard and Dr. Tashman along with Suzanne Liv Page, J.D., our director of grants and contracts have worked diligently to prepare and gain acceptance of this grant proposal from the NIH, said Dr. Philippon. Our surgeons here at The Steadman Clinic eagerly await the opportunity to participate in the trial. Johnny, Scott and their staff have put SPRI into position to undertake major trials and studies like this one and we are all very honored that the NIH has given SPRI this incredible opportunity.

For further information or other inquiries about The Steadman Clinic or Steadman Philippon Research Institute, contact Lynda Sampson, Vice President of External Affairs (lsampson@sprivail.org).

Link to current SPRI clinical trials - https://www.sprivail.org/about-us/clinical-trials

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Steadman Philippon Research Institute (SPRI) Receives Multi-Million-Dollar Matching Grant from the National Institutes of Health - Yahoo Finance

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U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus…

By daniellenierenberg

NEW YORK, Aug. 14, 2020 (GLOBE NEWSWIRE) -- Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in cellular medicines for inflammatory diseases, today announced that the Oncologic Drugs Advisory Committee (ODAC) of the United States Food and Drug Administration (FDA) voted overwhelmingly in favor that the available data support the efficacy of remestemcel-L (RYONCIL) in pediatric patients with steroid-refractory acute graft versus host disease (SR-aGVHD).

Mesoblast Chief Medical Officer Dr Fred Grossman said: Steroid-refractory acute graft versus host disease is an area of extreme need, especially in vulnerable children under 12 years old where there is no approved therapy. We are very encouraged by todays outcome and are committed to working closely with the FDA as they complete their review of our submission regarding approval of RYONCIL for this life-threatening complication of an allogeneic bone marrow transplant.

The ODAC is an independent panel of experts that evaluates efficacy and safety of data and makes appropriate recommendations to the FDA.Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made solely by the FDA, and the recommendations by the panel are non-binding. RYONCIL has been accepted for Priority Review by the FDA with an action date of September 30, 2020, under the Prescription Drug User Fee Act (PDUFA). If approved by the PDUFA date, Mesoblast plans to launch RYONCIL in the United States in 2020.

Pediatric transplant physician Dr Joanne Kurtzberg, the Jerome Harris Distinguished Professor of Pediatrics and Professor of Pathology, and Director, Pediatric Blood and Marrow Transplant Program at Duke University Medical Center, said: This devastating condition has an extremely poor prognosis and there are no FDA-approved options for children under the age of 12. The clinical studies I have directed have demonstrated the potential for this treatment to fill a significant unmet medical need.

Conference CallAn audio webcast can be accessed via https://webcast.boardroom.media/mesoblast-limited/20200813/NaN5f3237e85300840019de909d

The archived webcast is also available on the Investor page of the Companys website http://www.mesoblast.com

About Acute Graft Versus Host Disease Acute GVHD occurs in approximately 50% of patients who receive an allogeneic bone marrow transplant (BMT). Over 30,000 patients worldwide undergo an allogeneic BMT annually, primarily during treatment for blood cancers, and these numbers are increasing.1 In patients with the most severe form of acute GVHD (Grade C/D or III/IV) mortality is as high as 90% despite optimal institutional standard of care.2,3 There are currently no FDA-approved treatments in the United States for children under 12 with SR-aGVHD, a potentially life-threatening complication of an allogeneic bone marrow transplant for blood cancer.

About RYONCILTM Mesoblasts lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising culture-expanded mesenchymal stem cells derived from the bone marrow of an unrelated donor. It is administered to patients in a series of intravenous infusions. RYONCIL is believed to have immunomodulatory properties to counteract the inflammatory processes that are implicated in steroid-refractory acute graft versus host disease by down-regulating the production of pro-inflammatory cytokines, increasing production of anti-inflammatory cytokines, and enabling recruitment of naturally occurring anti-inflammatory cells to involved tissues.

1. Niederwieser D, Baldomero H, Szer J. Hematopoietic stem cell transplantation activity worldwide in 2012 and a SWOT analysis of the Worldwide Network for Blood and Marrow Transplantation Group including the global survey. Bone Marrow Transplant 2016; 51(6):778-85. 2. Westin, J., Saliba, RM., Lima, M. (2011) Steroid-refractory acute GVHD: predictors and outcomes. Advances in Hematology 2011;2011:601953. 3. Axt L, Naumann A, Toennies J (2019) Retrospective single center analysis of outcome, risk factors and therapy in steroid refractory graft-versus-host disease after allogeneic hematopoietic cell transplantation. Bone Marrow Transplantation 2019;54(11):1805-1814

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

Mesoblasts Biologics License Application to seek approval of its product candidate RYONCIL (remestemcel-L) for pediatric steroid-refractory acute graft versus host disease (acute GVHD) has been accepted for priority review by the United States Food and Drug Administration (FDA), and if approved, product launch in the United States is expected in 2020. Remestemcel-L is also being developed for other inflammatory diseases in children and adults including moderate to severe acute respiratory distress syndrome. Mesoblast is completing Phase 3 trials for its product candidates for advanced heart failure and chronic low back pain. Two products have been commercialized in Japan and Europe by Mesoblasts licensees, and the Company has established commercial partnerships in Europe and China for certain Phase 3 assets.

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

Forward-Looking StatementsThis announcement includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about the initiation, timing, progress and results of Mesoblasts preclinical and clinical studies, and Mesoblasts research and development programs; Mesoblasts ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblasts ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals (including any decision that the FDA may make based upon the recommendation of the ODAC in relation to the efficacy of remestemcel-L), manufacturing activities and product marketing activities, if any; the commercialization of Mesoblasts product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblasts product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblasts ability to enter into and maintain established strategic collaborations; Mesoblasts ability to establish and maintain intellectual property on its product candidates and Mesoblasts ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; and the pricing and reimbursement of Mesoblasts product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblasts actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

Release authorized by the Chief Executive.

For further information, please contact:

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U.S. FDA Advisory Committee Votes Nine to One in Favor of Remestemcel-L (Ryoncil) for Efficacy in Children With Steroid-Refractory Acute Graft Versus...

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Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims – Dexur

By daniellenierenberg

Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims

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By: Sruthy Iype  Aug. 20, 2020

Dexurs analysis of Medicare claims data showed that on an average, Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma (MM) compared to Darzalex and Empliciti which have 9 claims per patient. The analysis was based on a sample of Medicare patients between Jan 2019 and Dec 2019, and looked at the J code usage of the drugs for the condition.The number of claims per patient data is a proxy for the number of injections / IV infusions / doses required by a patient. The study also tries to contrast the usage of these medications across three diagnosis categories- MM patients who have not achieved remission (C9000), MM patients in remission (C9001), and MM patients in relapse (C9002).

Multiple myeloma is a form of blood cancer that involves the neoplastic proliferation of plasma cells, a type of white blood cells formed within the bone marrow. While the earlier stages of the disease tend to be asymptomatic, patients may experience symptoms like bone pain, bleeding, frequent infections, and anemia with progression of the cancer. Although there is no cure for MM, a number of treatment options including chemotherapy, stem cell transplantation, radiation therapy, and targeted therapy, can help in managing the progression of the disease and relieving the symptoms.

The drugs considered under this study are targeted therapies approved for the treatment of adult patients with multiple myeloma, alone or in combination with other medication. Unlike chemotherapy, these drugs specifically target the cancer cells and the mechanisms that support their growth, promising better results and fewer adverse effects. Kyprolis (carfilzomib) and Velcade (bortezomib) are proteasome inhibitors that can trigger apoptosis in cancer cells by blocking the action of proteasome, an enzyme complex that is critical in the regulation of cell-cycle. Darzalex (daratumumab) and Empliciti (elotuzumab) are monoclonal antibodies that enable the immune system to identify and kill cancer cells by targeting specific proteins on the cell surface.

The average usage of drug per patient was seen to be highest among MM patients who had not achieved remission, and least among MM patients in remission. An exception to this trend was Kyprolis, which had similar usage among patients in remission and patients in relapse, with the former having a marginally higher number of claims per patient.

Amgens Kyprolis had an average of 15.9 claims per patient in a year. The proteasome inhibitor indicated for the treatment of patients with relapsed/refractory MM, is used as a monotherapy, or as a combination therapy along with dexamethasone, or lenalidomide and dexamethasone.

Velcade, manufactured by Millennium Pharmaceuticals/Takeda Oncology in the U.S, had an average of 13.8 claims per patient in a year. It was noted to have the largest share of claims among the drugs, across the three diagnosis categories for multiple myeloma. Approved for the treatment of newly diagnosed and relapsed/refractory myeloma, the drug is used alone or as a part of combination therapies.

Darzalex, a CD38-directed cytolytic antibody by Janssen Biotech, had an average of 9.9 claims per patient in a year for MM. It is indicated for the treatment of MM as a monotherapy or in combination with other drugs including lenalidomide, dexamethasone, and bortezomib.

Bristol-Myers Squibbs Empliciti had an average of 9.3 claims per patient. It is a SLAMF7-directed immunostimulatory antibody approved for the treatment of MM in combination with lenalidomide and dexamethasone, or pomalidomide and dexamethasone

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Kyprolis and Velcade have 14 to 16 claims per patient per year for Multiple Myeloma compared to Darzalex and Empliciti which have 9 claims - Dexur

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Genmab Announces Janssen Granted US FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or…

By daniellenierenberg

Company Announcement

Copenhagen, Denmark; August 20, 2020 Genmab A/S (Nasdaq: GMAB) announced today that the U.S. Food and Drug Administration (U.S. FDA) has approved the use of DARZALEX (daratumumab) in combination with carfilzomib and dexamethasone (DKd) for the treatment of adult patients with relapsed/refractory multiple myeloma who have received one to three previous lines of therapy. A supplemental Biologics License Application (sBLA) for this indication was submitted by Genmabs licensing partner, Janssen Biotech, Inc. (Janssen), in February 2020. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

We are extremely pleased that multiple myeloma patients in the U.S. will now have yet another treatment option as this is the eighth overall U.S. FDA approval for DARZALEX and the fifth in the relapsed/refractory setting. In addition, DARZALEX is now the first CD38 antibody approved for use in combination with carfilzomib, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

The combination has been approved in two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on positive results from the Phase 3 CANDOR and Phase 1b EQUULEUS studies. CANDOR was an Amgen-sponsored study, co-funded by Janssen Research & Development, LLC. EQUULEUS was sponsored by Janssen Research & Development, LLC.

About the CANDOR studyThe Phase 3 trial (NCT03158688) was a randomized, open-label study that included 466 patients with multiple myeloma who had relapsed after 1 to 3 prior therapies. Patients were randomized to receive either DKd or carfilzomib and dexamethasone (Kd) alone. In the daratumumab treatment arm, patients received 8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 mg/kg once weekly for the remaining doses of the first 2 cycles, then every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for the remaining cycles or until disease progression. In both treatment arms carfilzomib was dosed twice weekly (20 mg/m2 on cycle 1 days 1 and 2 and 56 mg/m2 beginning on cycle 1 day 8 and thereafter) and dexamethasone was given weekly (40 mg orally or via IV infusion). The primary endpoint of the study was progression free survival (PFS).

About the EQUULEUS (MMY1001) Study The Phase 1b EQUULEUS (NCT01998971) study was an open label, multi-cohort trial that evaluated the safety, tolerability, and dose regimen of daratumumab when administered in combination with various treatment regimens for the treatment of multiple myeloma. Among the regiments evaluated, the combination of DKd compared to Kd alone was studied in 85 patients with relapsed/refractory multiple myeloma who had received one to three prior lines of therapy using a once-weekly dosing regimen. DKd was evaluated at a starting dose of 20 mg/m2, which was increased to 70 mg/m2 on Cycle 1, Day 8 and onward.

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

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

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

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

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

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

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

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

Contact: Marisol Peron, Corporate Vice President, Communications & Investor Relations T: +1 609 524 0065; E: mmp@genmab.com

For Investor Relations: Andrew Carlsen, Senior Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com

This Company Announcement contains forward looking statements. The words believe, expect, anticipate, intend and plan and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmabs most recent financial reports, which are available on http://www.genmab.com and the risk factors included in Genmabs most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at http://www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in this Company Announcement nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab; the Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo; HuMax; DuoBody; DuoBody in combination with the DuoBody logo; HexaBody; HexaBody in combination with the HexaBody logo; DuoHexaBody; HexElect; and UniBody. Arzerra and Kesimpta are trademarks of Novartis AG or its affiliates. DARZALEX and DARZALEX FASPRO are trademarks of Janssen Pharmaceutica NV. TEPEZZA is a trademark of Horizon Therapeutics plc.

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

Company Announcement no. 38CVR no. 2102 3884LEI Code 529900MTJPDPE4MHJ122

Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark

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Genmab Announces Janssen Granted US FDA Approval for DARZALEX (daratumumab) in Combination with Carfilzomib and Dexamethasone in Relapsed or...

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After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.’s MHRA Accepts CytoDyn’s Request to Enroll…

By daniellenierenberg

Patient enrollment to commence immediately

VANCOUVER, Washington, Aug. 20, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the Clinical Trials Unit of the Medicines & Healthcare product Regulatory Agency (MHRA) of the U.K. government authorized the Company to enroll for its ongoing Phase 3 COVID-19 trial for severe-to-critical patients in the United Kingdom. The MHRAs decision follows several months of its review of CytoDyns manufacturing processes and leronlimabs safety profile.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the MHRAs confidence in leronlimab to initiate enrollment of patients in the U.K. for our current CD12 protocol. CytoDyn recently requested fast track approval from the MHRA for its completed Phase 2 COVID-19 trial for the mild-to-moderate population, with strong efficacy and safety data. We believe leronlimab has multiple opportunities for several clinical indications and we are very optimistic about our future based upon how far we have advanced this drug in about 5 years. In addition, we plan to file a BLA for HIV in the U.K. within the next 4 weeks.

About Coronavirus Disease 2019CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a randomized clinical trial for mild-to-moderate patients in the U.S. Enrollment continues in its Phase 3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the country.

SARS-CoV-2 was identified as the cause of an outbreak of respiratory illness first detected in Wuhan, China. The origin of SARS-CoV-2 causing the COVID-19 disease is uncertain, and the virus is highly contagious. COVID-19 is believed to typically transmit person-to-person through respiratory droplets. Coronaviruses are a large family of viruses, some causing illness in people and others that circulate among animals. For confirmed COVID-19 infections, symptoms have included fever, cough, and shortness of breath. The symptoms of COVID-19 may appear in as few as two days or as long as 14 days after exposure. Clinical manifestations in patients have ranged from non-existent to severe and fatal. At this time, there are minimal treatment options for COVID-19.

About Leronlimab (PRO 140)The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first as a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer.Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting aPhase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells.The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA has agreed to provide written responses to the Companys questions concerning its recent Biologics License Application by September 4, 2020, in lieu of a Type A teleconference meeting for this HIV combination therapy.

CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than five years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking StatementsThis press releasecontains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as believes, hopes, intends, estimates, expects, projects, plans, anticipates and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Companys forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CYTODYN CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102Mobile: 503.341.3514mmulholland@cytodyn.com

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After Several Months of Providing Requested Information About Manufacturing and Safety of Leronlimab, U.K.'s MHRA Accepts CytoDyn's Request to Enroll...

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