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Stem cells are believed to play a key role in hair loss – FLWL News

By daniellenierenberg

Using a brush or comb, in the shower, passing your hand through your hair In a 2015 IFOP survey, three out of four French people (76%) without baldness declared that they lost their hair. In addition, after 65 years, three in ten men suffer from androgenetic alopecia (or baldness). In general, therefore, we often see a loss of density with age, both in men and in women. However, science has long looked into the phenomenon of age-related hair loss, both to understand its origin and to treat it. Focusing on stem cells seems to offer the best hope for a cure, based on numerous studies.

The hair transplant procedure is indeed a sometimes expensive and invasive procedure. As for drugs, finasteride used for androgenetic alopecia in men can induce side effects such as loss of libido and erectile dysfunction while minoxidil can cause hypertrichosis. Today, researchers therefore seem to be looking more at alternative solutions, and in particular by focusing on stem cells.

Stem cells, directly linked to hair lossFor decades, researchers have always focused on keratinocytes, cells that make up the epidermis and integuments (body hair, hair, etc.). However, as part of a study conducted by the University of Calgary (Canada), the team of researchers focused on a small cell group present in hair follicles and in skin stem cells. : fibroblasts. And according to them, these fibroblasts are the main cause of age-related hair loss.

By studying the sparse coat of elderly mice, they noticed that fibroblast stem cells had lost their regenerative function or were malfunctioning. There werent enough of them to regenerate fibroblasts. As a result, the fibroblasts and hair follicles began to miniaturize and were no longer able to produce hair, explains Biernaskie, head of the research team.

Remember that fibroblasts are important because they send messages to keratinocytes to force them to divide, and in so doing, orchestrate the growth cycles of hair follicles allowing the production of new hairs. When the fibroblasts become scarce, the signal then becomes too weak to reach the keratinocytes and maintain the process of capillary growth. For Jeff Biernaskie: if we want to one day succeed in preventing hair loss or re-grow those that are already falling, we must work to preserve the function of these stem cells which are found in the hair follicles.

Against hair loss, but not only!This finding may help guide future research on hair loss more precisely. Scientists at the University of Calgary are particularly hoping to find a way to prevent this degeneration by blocking certain genetic mutations that occur directly in stem cells in fibroblasts.

They also believe that this will have wider implications. Indeed, Wisoo Shin, lead author of the study, points out that similar fibroblasts are found in most of our organs, maintaining their integrity and promoting tissue regeneration. Finding a way to promote self-renewal to produce new functional fibroblasts into old age therefore also offers the hope of being able to treat certain injuries and help the skin to regenerate.

Lamia spent a couple of years interning at an organization that offered medical consultation before joining the editorial team at FLWL News. An enthusiastic fitness freak in the room, she offers the best amounts of insights and craft-based writing style to keep us up to date about the medicine industry, health and science.

Email:lamia@flwl.orgPhone: +1 512-845-8162

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Brain organoids reveal neuronal flaws in syndrome tied to autism – Spectrum

By daniellenierenberg

Electric organoid: Neurons derived from people with 22q11.2 syndrome are hyperexcitable and show calcium-signaling deficits.

Courtesy of Pasca lab

Neurons derived from people with 22q11.2 deletion syndrome, a genetic condition linked to autism, show deficits in electrical activity and calcium signaling, according to a new study1. A single gene appears to be largely responsible for these defects, the study shows.

Up to 20 percent of people who lack part or all of the chromosomal region 22q11.2 have autism. Individuals with the deletion may also have schizophrenia, seizures, heart defects, immune dysfunction or learning problems.

The new findings uncover factors that may contribute to the development of psychiatric conditions associated with 22q11.2 deletion syndrome. They could also help researchers identify new therapeutic targets, says lead author Sergiu Pasca, associate professor of psychiatry and behavioral sciences at Stanford University in California.

The syndrome is relatively common, occurring in up to 1 in 4,000 newborns, Pasca says. But researchers do not fully understand how genes in the 22q11.2 region contribute to autism or other conditions, he adds.

To solve this molecular puzzle, Pasca and his team reprogrammed skin cells from 15 people with the deletion and 15 controls into induced pluripotent stem cells. Using a technique they developed in 2015, they coaxed these cells to turn into neurons, which self-organize in a dish into spherical clusters called organoids. The organoids show some key features of the developing cerebral cortex, a brain region implicated in autism.

The neurons derived from people with 22q11.2 syndrome spontaneously fire four times as frequently as neurons derived from controls, the researchers found. And the electrical activity of the 22q cells does not set off the usual spike in calcium levels, which is crucial for neurons to exchange messages.

In some other syndromes tied to schizophrenia and autism, calcium-channel genes are mutated. But the number of channels and the speed at which they work in 22q neurons is the same as in control neurons. Instead, the 22q cells show an unusually low voltage difference across the cell membrane when they arent firing, causing the signaling defects and hyperexcitability, the researchers found.

The researchers suspected that a gene called DGCR8 might be responsible for the neuronal deficits in the organoids because it lies within 22q11.2 and is linked to abnormal electrical activity in the neurons of mice2. DGCR8 is essential for the synthesis of short RNA fragments, called microRNAs, that regulate gene expression.

Lowering DGCR8s expression levels in control neurons reproduced the abnormalities seen in 22q neurons. In contrast, boosting the genes activity in 22q neurons or treating them with antipsychotic drugs prevented them from being overly excitable and reversed their calcium-signaling defects. The study was published 28 September in Nature Medicine.

Previous studies have analyzed lab-grown neurons derived from people with schizophrenia or autism-related disorders such as Rett and fragile X syndromes. But most used only a few human-derived cell lines, says Guo-li Ming, professor of neuroscience at the University of Pennsylvania in Philadelphia. The new study, Ming says, has a total of 30 human lines thats a huge effort.

By studying brain organoids derived from so many people, the researchers were able to identify the gene that might be involved in the psychiatric conditions associated with 22q11.2 syndrome, says Sally Temple, scientific director of the Neural Stem Cell Institute in Rensselaer, New York. Whenever we have a light shining ahead, saying, This is what you should really be looking at, it means that were making progress, she says.

The study participants with 22q11.2 syndrome vary in their psychiatric diagnoses, and yet all the brain organoids derived from their cells show the same neuronal abnormalities. Thats somewhat surprising, because we know there are a lot of differences in the genetic background of different people, Ming says.

The deletion might conspire with other factors to ultimately determine which psychiatric conditions a person has, Pasca says. It could be that the deletion causes cellular defects, and once there is a stressor such as social stress, disease develops. Its also unclear whether these cellular defects are related to the high prevalence of seizures in people with 22q11.2 syndrome, he says.

The hallmarks of most neuropsychiatric conditions can change over time, says Giuseppe Testa, director of the stem cell epigenetics unit at the European Institute of Oncology in Milan, Italy. Studies that look at a larger number of people with 22q11.2 deletion syndrome or other neurodevelopmental conditions could help to elucidate the relationship between the neuronal defects observed in the lab and the psychiatric manifestations of the conditions, Testa says. The new study, however, is a great resource for understanding how the 22q11.2 deletion contributes to schizophrenia and autism, he says.

Pascas team is trying to pinpoint molecules that could open new therapeutic avenues for 22q11.2 deletion syndrome. The antipsychotics they tested restore the unusual voltage differences in the 22q neurons, but they dont address the core mechanisms responsible for psychiatric conditions linked to the syndrome, Pasca says.

Whats more, antipsychotics have many side effects, and not all individuals respond to them, he says. We need better therapies we need to identify what the key molecular players are and target those.

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

By daniellenierenberg

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

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

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

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

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

SOURCE AIVITA Biomedical, Inc.

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U of T’s Medicine by Design invests $1 million to advance new ideas in regenerative medicine – News@UofT

By daniellenierenberg

Patients with cystic fibrosis experience recurrent lung infections that eventually destroy their airways, shortening their average life expectancy to 50 years in Canada. Current drug treatments, which target a malfunctioning pathway in cells that causes the infections, are costly and have varying effectiveness.

Now, with funding from Medicine by Design, a researcher at the Hospital for Sick Children (SickKids) is combining stem cells, gene editing and computational modelling to try to hijack an alternative cell pathway in the hopes of restoring lung function in these patients.

If successful, our study will be the first to provide proof-of-concept that this alternative approach to treating cystic fibrosis is effective, saysAmy Wong, a scientist working in developmental and stem cell biology at SickKids who is also an assistant professor in the department of laboratory medicine and pathobiology in the University of Torontos Temerty Faculty of Medicine.

Wongs project is one of seven across U of T and its affiliated hospitals that have been awarded 2020New Ideas AwardsandSeed Fundawards from Medicine by Design. Through a $1 million investment, Medicine by Design is supporting research aimed at advancing new concepts expected to be important to regenerative medicine in the coming years. The funded projects will have potential impacts in diseases and conditions such as vision loss, amyotrophic lateral sclerosis (ALS), intestinal disease in premature babies and more.

Supporting novel strategies and approaches is crucial to moving regenerative medicine into the future, saysMichael Sefton, executive director of Medicine by Designand a University Professor at U of Ts Institute of Biomedical Engineeringand thedepartment of chemical engineering & applied chemistry in the Faculty of Applied Science & Engineering.

Our 2020 New Ideas project portfolio integrates mathematical modelling, physics and computational biology with stem cell biology and biomedical engineering, and strengthens engagement with clinicians who are key to translating our research into patient impact. We are particularly delighted this year to support so many outstanding early-career researchers, who will ensure Toronto remains a global leader in regenerative medicine for years to come.

Wong is one of three investigators to receive a 2020 New Ideas Award, which is valued at $100,000 per year for up to two years. Four additional projects were selected for Seed Fund Awards of $100,000 each for one year to further develop their potential.

Medicine by Design selected the funded projects from among 36 short-listed proposals, which were evaluated and ranked through an external peer review process. Applications were submitted by clinicians and researchers at U of T and its affiliated hospitals from a wide range of disciplines including biochemistry, biomedical engineering, developmental and stem cell biology, immunology, neuroscience and surgery.

Medicine by Design builds on decades of made-in-Canada excellence in regenerative medicine dating back to the discovery of stem cells in the early 1960s by Toronto researchers James Till and Ernest McCulloch. Regenerative medicine uses stem cells to replace diseased tissues and organs, creating therapies in which cells are the biological product. It can also mean triggering stem cells that are already present in the human body to repair damaged tissues or to modulate immune responses. Increasingly, regenerative medicine researchers are using a stem cell lens to identify critical interactions or defects that prepare the ground for disease, paving the way for new approaches to preventing disease before it starts. Medicine by Design is made possible thanks in part to a $114-million grant from theCanada First Research Excellence Fund.

Current cystic fibrosis drug treatments target a genetic mutation that causes epithelial cells, which line the airway and act as a barrier against viruses, to function improperly. The mutation affects the function of an important ion channel in cells, called CFTR, which helps to maintain the right balance of fluid in the airways. Poor function causes mucosal obstructions in the airways and prevents clearance of foreign pathogens, which leads to chronic infections and ultimately destroys airway tissue.

In her project, Wong will explore an alternative ion channel in the epithelial cells to determine if it can be hijacked and used to compensate for the lack of function caused by the mutant CFTR. The research will be conducted using a combination of stem cell-derived lung models, gene editing and computational modelling.

Wongs project builds on decades of cystic fibrosis research at SickKids, where the cystic fibrosis gene was first identified 30 years ago.

To date, more than 2,000 mutations in the cystic fibrosis gene have been identified, says Wong. SickKids scientists and U of T researchers have become the epicentre of incredible cystic fibrosis research to understand how this disease works at the genetic and molecular level.

Wong says that, while the idea of targeting an alternative pathway is not necessarily ground-breaking on its own, its the array of tools now available that makes the idea a potential game changer.

We have access to an incredible resource of primary cells and stem cells from more than 100 individuals with cystic fibrosis harbouring various mutations. Wong says.Our lab has developed human lung models from stem cells that can be used to model lung disease such as cystic fibrosis. And with new advanced tools in single-cell genomics and gene-editing, coupled with key collaborations for computational modelling, we are poised to find new therapeutic targets for cystic fibrosis.

Leo Chou, an assistant professor at the Institute of Biomedical Engineering, andHyun Kate Lee, an assistant professor in the department of biochemistry in the Temerty Faculty of Medicineboth Medicine by Design New Investigators are also leading 2020 New Ideas projects.

Chou, along with co-investigatorsJulie Lefebvre, a scientist at SickKids and U of T assistant professor of molecular genetics, andValerie Wallace, a senior scientist at the Krembil Research Institute, University Health Network and a U of T professor of laboratory medicine and pathobiology and ophthalmology, will focus on cell transplantation in the retina, a process that has demonstrated encouraging pre-clinical results such as partial vision restoration in several animal disease models.

Recent research had demonstrated that this restoration is a result of the transfer of proteins complex molecules required for the structure, function and regulation of the bodys tissues between host tissue and donor cells. But the scope of that transfer process is not well understood. Chous project will develop an imaging approach to detect the transfer of mRNA molecules between host and donor cells. The outcomes from this project will inform the future design of cell transplantation therapies and lead to novel methods to deliver therapeutics. This project could improve therapies for retinal diseases and visual impairments, and inform strategies for other degenerative disorders.

Lee and co-investigatorPenney Gilbert,an associate professor at the Institute of Biomedical Engineering, will look at a common but not well-understood structure called the neuromuscular junction (NMJ), which mediates communication between neurons and muscles throughout the body. Defects in NMJ integrity and function underlie fatal diseases such as ALS. NMJ diseases, which affect more than 500,000 people globally, lack effective treatments. This project will use stem cells derived from reprogrammed skin cells of healthy people to develop NMJs in culture. Through high-resolution imaging, the healthy human NMJs will be studied both on their own and along with NMJs built from ALS patient cells. Through this work, the research team aims to identify genes to target to improve the health of NMJs, which could eventually help prevent or delay NMJ degeneration and even promote regeneration.

Michael Garton, an assistant professor at the Institute of Biomedical Engineering, has received a Seed Fund award to tackle the challenge of translating the genetic tools of synthetic biology an area of research that aims to create or redesign biological components using engineering methods into effective medical therapies against a number of diseases.

But they are difficult to translate into human therapies, Garton says, because the bodys T-cells immune cells that detect and destroy cells containing foreign material will identify these tools as foreign and destroy them.

Instead of switching off the T-cells, Gartons goal is to use computational modelling and high-throughput screening to selectively turn off the bodys foreign antigen display system so the immune system will still respond to foreign invaders when necessary, but allow cells containing synthetic tools to survive. If successful, this approach could enable a new generation of synthetic biology-enhanced cell therapies for a range of diseases.

Medicine by Design funding will help to facilitate the integration of synthetic biology and regenerative medicine and aid the development of cell-based therapies that perform better than nature, says Garton.

Other Seed Fund projects will encompass research in repairing the heart after paediatric cardiac surgery, treating an intestinal emergency in premature babies and creating a database for cell lineage paths.

John Parkinson, a senior scientist at SickKids and a U of T professor of biochemistry and molecular genetics, along with co-investigatorsJason Maynes, Wasser Chair in Anesthesia and Pain Medicine at SickKids and a U of Tassociate professor of anesthesiology and biochemistry, andWilliam Navarre, an associate professor in the department of molecular genetics, will investigate manipulating the microbiome, or community of microorganisms in the gut, to improve cardiac repair in post-operative treatment of a congenital heart disorder. Through a process that will identify prebiotics in breast milk that help enhance the production of molecules that research has shown can aid cardiac repair, the team will organize both observational (how disease alters the microbiome) and interventional (how the microbiome alters the disease) multi-site trials, which will provide the opportunity to immediately translate findings into changes in patient care regimens and improve outcomes.

CliniciansAgostino Pierro, a surgeon at the Division of General and Thoracic Surgery at SickKids and a U of T professor of surgery and physiology, and Philip Sherman, a senior scientist and gastroenterologist at the Division of Gastroenterology, Hepatology and Nutrition at SickKids and U of T professor of dentistry, pediatrics and laboratory medicine and pathobiology, have proposed a novel way of enhancing gut repair for a common intestinal emergency in premature babies, called necrotizing enterocolitis (NEC). A leading cause of death for these infants, NEC causes complications such as blindness, intellectual disability, repeat hospitalizations and gut damage even in those that survive. This project will look at whether intestinal organoids organ-like structures grown in the laboratory from stem cells that mimic some of the functions of native intestines can potentially stimulate repair of the gut and recovery from NEC. The project will define how to best transplant organoids, identify how the organoids protect the intestine from injury and assess if organoid transplantation is a valid new treatment for NEC.

Lincoln Stein, who is head of adaptive oncology at the Ontario Institute for Cancer Research and a professor in the department of molecular genetics at U of T, has received seed funding to build a database called Cytomics Reactome, which will be freely available to Canadian and international researchers. The database will build on recent technologies that open the door to the possibility of deciphering cell lineage paths the series of steps that lead a young, undifferentiated cell into a specialized one at single-cell resolution. To accelerate the path from basic research to clinical application, the database will systematically organize pre-existing knowledge of cell lineage paths into a comprehensive, interactive and easily accessible map that can serve as a framework for interpretation and integration of the latest experimental findings.

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Discover The Augustinus Bader Wonder Cream Loved By The A List – Grazia

By daniellenierenberg

Two years ago I received an Augustinus Bader cream in a goody bag. I hadnt heard of it at the time, so paid little attention, although it looked nice enough a sleek, big blue bottle with rose gold accents. Shortly after, having just run out of my current moisturiser, I dug it out to give it a go. A few days later, forensically inspecting my skin in the mirror as I am wont to do in my more idle moments, I thought this stuff is actually really great. This was swiftly followed by another thought oh dear when I discovered it costs a whopping 205 a pop (for 50ml, you can get 15ml for 65). But it was too late, I was hooked. And that is how I became a woman who drops 205 on a moisturiser.

I am probably the least glamorous and definitely least well-known member of the Augustinus Bader fan club, which has swiftly reached legendary status in the beauty world and beyond. Kim Kardashian West, Naomi Campbell, Kate Bosworth, Priyanka Chopra and Diane Kruger all love the cult brand. Victoria Beckham invited Professor Bader to sit front row at her AW20 show; she also tapped his talents to collaborate with her on her debut skincare line (from seeing VB up close I can testify that this is a woman who knows good skincare, and the Cell Rejuvenating Power Serum is indeed excellent).

Professor Augustinus Bader and Victoria Beckham Getty

The latest addition to the Bader fan club is Emma Corrin. Prepping the new Diana for The Crowns Zoom press junket this week, her makeup artist Florrie White revealed she used The Cream and The Face Oil on the young actress. I use The Cream on everyone; me and my clients, White tells me. It instantly plumps and smooths the skin with three perfect pumps and creates a calm and luxurious base for every make-up look. Everyone always comments on how lovely it feels on their skin.

Today Augustinus Bader is a cult phenomenon but the founder is a man who seems to be more at home in a laboratory than on a red carpet. A leader in stem cell biology, and head of stem cell research at the University of Leipzig, Professor Bader has spent over 30 years focusing on how reawakening these cells can aid the healing process in particular embarking on a mission to help burns victims. In 2008, Bader formulated a groundbreaking wound gel that could help heal third-degree burns without the aid of surgery or skin grafts.

It was this breakthrough that led to the founding of the skincare line. After all, if it could have this effect on serious injuries, imagine what the technology could do for those of us lucky enough to have run-of-the-mill skin niggles? The brand launched with two hero products: The Cream and The Rich Cream which, according to the brand literature, contain patented TFC8 (Trigger Factor Complex) technology, which supports the skins natural processes, leaving all skin types mature, dry, oily, or sensitive looking restored, renewed and regenerated.

I was useless at science at school and all this technical talk is pure gobbledygook to me. What I can tell you is what its done for me. My skin is super sensitive, I have eczema, and have found that Augustinus Bader creams genuinely help to soothe it when it is aggravated. I have found that since using it, my complexion appears clearer, more even and the Holy Grail of beauty dewy (despite drinking gallons of water a day, I have never achieved that before). My mum, who observes me with the scrutiny that only mothers do, confirms that my skin looks great (I am privvy only to this information because she thought it was a result of finally listening to her by stopping smoking and making the hours before midnight count). Is it expensive? Well, yes, theres no way around that. However, in much the same way that I think that an impeccably cut designer jacket earns its value back in cost per wear, I have found that since using The Cream and The Rich Cream my skincare regime has simplified.

Sure, theres an element of hype involved. I still find it thrilling to be In The Know about something. But, for me and my skin, Augustinus Bader lives up to it. Believe me, I wish it wasnt true (I am not snobby with beauty products, and would happily wax lyrical about a 5 wonder find if Id discovered one), but thats the 205 price I have to pay and Id say its worth it.

READ MORE: 'I Just Love The Way A Polished Lipstick Completes A Look': Victoria Beckham's New Posh Lipsticks Explained In Her Own Words

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SGEN: The 3 Top Biotech Stocks That Hedge Fund Managers LOVE – StockNews.com

By daniellenierenberg

The biotech industry has been soaring this year, with the SPDR S&P Biotech ETF (XBI) up 26.6% year to date so far. The race for a COVID vaccine has primarily driven this performance, but what if there was another segment of the biotech industry that top hedge fund managers are all going after right now? While many managers are known to take risks, its certainly worth looking into if there is a consensus between them.

The AlphaClone Alternative Alpha ETF (ALFA) tracks an index of equity securities that hedge funds have significant exposure to. The ETFs top three holdings are all biotech firms working on cancer drugs. While many investors have their attention on biotech and pharmaceutical companies working on a COVID vaccine, big money has been focused on the next big thing in biotech, the future oncology drug boom.

Cancer is the second leading cause of death in the U.S. behind heart disease. Almost everyone knows someone that has been affected by one of the many vicious types of cancer. There are now numerous companies focused on ways to treat and cure the various forms. While COVID is at the forefront, cancer is a long-term play. There is even an ETF that covers the cancer industry, the Loncar Cancer Immunotherapy ETF (CNCR), which is up over 39% over the last six months.

As the oncology drug market is expected to reach $394 billion by 2027, here are the three top cancer stocks based on a consensus of hedge fund managers: Seattle Genetics (SGEN), Fate Therapeutics (FATE), and Blueprint Medicines (BPMC).

Seattle Genetics (SGEN)

SGEN is a biotech firm focused on developing antibody-drug conjugates. Its lead lymphoma drug, Adcetris, has been performing quite well since it launched, and it is the primary growth driver for the company. The drugs label was also expanded, providing more revenue for the company. SGEN has been collaborating with Takeda (OTCMKTS:TKPHF), a Japanese pharmaceutical company, for the global development and commercialization of Adcetris.

In addition to Adcetris, the company has a promising pipeline of drug candidates for its antibody-drug conjugate (ADC) technology. In December, the FDA granted accelerated approval to Padcev to treat patients with metastatic bladder cancer, who were previously treated with a checkpoint inhibitor and platinum-based chemotherapy. This drug was created in collaboration with Astellas Pharma (OTCMKTS:ALPMF), another pharmaceutical company.

In April, the FDA approved Tukysa for the treatment of metastatic HER2-positive breast cancer. Investors should also be happy with the news Merck (MRK) plans to buy a 2.9% stake in SGEN. The companies are co-developing and selling SGENs breast cancer therapy, ladiratuzumab vedotin.

The company is rated a Strong Buy in our POWR Ratings system, with a grade of A in Trade Grade, Buy & Hold Grade, and Peer Grade. Those are three out of the four components that make up the POWR Ratings. The stock is also ranked #2 out of 377 Biotech stocks.

Fate Therapeutics (FATE)

FATE is a clinical-stage biopharmaceutical company engaged in the development of programmed cellular immunotherapies for cancer and immune disorders. The company has been building up its pipeline of immuno-oncology product candidates. These treatments are designed to elicit an immune response in patients with cancer.

The companys progress with FT596 is encouraging. FT596 is cell cancer immunotherapy derived from its iPSC line. The induced pluripotent stem cell (iPSC) platform provides a competitive advantage for the company as iPSC cells are stem cells that can become almost any cell type. They are grown from the same cell instead of a patients donated cells. This means that one engineered cell line can be manufactured for many patients, creating what is known as off the shelf immunotherapy.

If the development of this type of therapy is successful, this would reduce the cost of manufacturing and provide a potential cash cow for the company. FATE has entered into collaborations with other companies for fund and research expertise. It is currently working with Ono Pharmaceutical (OTCMKTS:OPHLY) for two off-the-shelf iPSC-derived CAR T-cell product candidates, and Janssen Biotech develop iPSC-derived CAR NK and CAR T-cell product candidates.

FATE is rated a Strong Buy in our POWR Ratings system. It holds a grade of A in Trade Grade, Buy & Hold Grade, and Peer Grade. It is also ranked #24 out of 377 stocks in the Biotech industry. The stock is up a whopping 145.3% after finishing the day up 6.7%.

Blueprint Medicines (BPMC)

BPMC is a biopharmaceutical company focused on improving patients lives with diseases driven by abnormal kinase activation. The company has developed a small molecule drug pipeline in cancer. The firms lead product, Ayvakit, was approved by the FDA in January to treat metastatic gastrointestinal stromal tumor. The drug generated $5.7 million in the second quarter, so its off to a good start.

The company is also looking to expand its label as it is being studied for advanced and smoldering forms of systemic mastocytosis, a condition where certain immune cells, called mast cells, build up under the skin and, or in the bones, intestines, and other organs. If approved for other labels, that should help drive further growth.

Last month, the FDA approved the companys second drug, Gavreto, for the treatment of RET fusion-positive NSCLC or non-small lung cancer. BPMC worked on the drug with Roche (OTCMKTS:RHHBY). Lung cancer is responsible for more cancer deaths than any other in men and women. If Gavreto can become a standard treatment, it could become a goldmine for the company. The drug can also treat medullary thyroid cancers.

BPMC is rated a Strong Buy in our POWR Ratings system. It has grades of A in Trade Grade, Buy & Hold Grade, and Peer Grade. It is also the #9 ranked stock in the Biotech industry. The stock is up over 27% for the past three months and 8.5% over the past week.

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SGEN shares were unchanged in after-hours trading Friday. Year-to-date, SGEN has gained 75.72%, versus a 9.31% rise in the benchmark S&P 500 index during the same period.

David Cohne has 20 years of experience as an investment analyst and writer. Prior to StockNews, David spent eleven years as a Consultant providing outsourced investment research and content to financial services companies, hedge funds, and online publications. David enjoys researching and writing about stocks and the markets. He takes a fundamental quantitative approach in evaluating stocks for readers. More...

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Gray Hair: What You Need to Know about Causes and Possible Prevention – Coveteur

By daniellenierenberg

Find out what the pros had to say.

You never forget your first. Grey hair, that is. Maybe you pluck it? Heck, its just oneout of sight, out of mind, right? Yeah, we know, you pluck one and five more grow back in its place, and then those five turn into tenyou get the idea. Nothing that a good dye job cant fix. That is, until a pandemic forces you into quarantine with no access to your colorist, and it becomes brutally apparent just how grey your hair actually is these days. This standoff between my stealthy foe and I got me thinking: We know we cant reverse grey hair, but can we slow its progression or delay its initial onset? I called on the pros to find out, but first, some basic hair biology.

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A protein called melanin is responsible for the color of our hair, and the cells in the hair follicles that make melanin are called melanocytes. Melanocytes are made by stem cells in the root of the hair, says Dr. Morgan Rabach, board-certified dermatologist, assistant professor at Mount Sinai School of Medicine, and co-founder of LM Medical NYC, and over time the stem cells die out and stop making melanocytes, leaving us with no cells to color the hair.

The age at which we start to go grey varies and depends on many factors. Dr. Caroline Robinson, MD, FAAD, and dermatologist and founder of Tone Dermatology, believes there is likely a genetic tendency at play in most cases of greying hair, but, like many genetic tendencies, there are environmental factors that influence how these changes show up in each of us. Dr. Rabach concurs, adding that grey hair is a combination of genetics and lifestyle.

Premature greying is generally considered less than 20 years old and it is thought to be an inherited predisposition. However, premature greying can also be attributed to certain illnesses and deficiencies. Dr. Robinson notes the importance of annual physicals and doctor visits when it comes to premature greying, as it could be an early sign of metabolic abnormalities in a select population.

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Search results for grey hair yield a slew of information centered around the notion that going grey is a result of an accumulation of hydrogen peroxide in the follicle, and that it could be eradicated by a topical pseudocatalase cream. This claim seems to have originated from a segment of research on vitiligo, which then appeared to have been manipulated for headlines. Dr. Robinson weighed in with her thoughts on the claim, saying, There are no double-blinded, controlled clinical studies to support the use of topical pseudocatalase-based creams for loss of pigmentation in hair.

Similarly, some products have appeared on the market claiming to re-pigment the hair, but the consensus among experts is that the claims are unfounded. I havent seen any convincing evidence for products that claim to reverse or prevent greying of the hair, says Holden.

We know all too well the havoc that stress wreaks on our overall health, but the type of stress were referring to here is oxidative stressthe imbalance of free radicals and antioxidants in the body, which leads to cell and tissue damage. In oxidative stress, free radicals damage our cells and tissues when our body doesnt have enough antioxidants to combat them, and in our hair, this oxidative stress can damage the cells that produce melanin, says Kate Holden, consultant trichologist.

The pros agree that oxidative stress plays a key role in the loss of hair pigmentation. From recent research we know that oxidative stress, the same type of stress that our skin faces in response to UV rays and pollution, can be an important factor in the loss of hair pigmentation, says Dr. Robinson. While oxidative stress occurs naturally in our bodies, environmental factors can increase its effects, such as alcohol, smoking, sugar and processed foods, cortisol levels, etc.

In addition, a recent study conducted by a group of Harvard researchers looked at the impact of stress (like, say, the kind you feel during a worldwide pandemic) on pigment-producing cells and found that the hyper-activation of the sympathetic nerves caused the depletion of melanocyte stem cells. Trichologist Leata A. Williams explains, When we are under stress, our bodies signal the fight-or-flight response, and it is the nerves that send the response to our hair follicles, causing the hair to grey.

Just think of how many world leaders have gone grey while in officethats the sympathetic nervous system depleting their hair follicles of melanocytes. And although most of us will never feel the stress of running a country, were still susceptible to the same greying effect from our everyday lives.

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Unfortunately for us, the pros agree that there is no real evidence to suggest that we can turn back the clock and re-pigment or slow the greying of hair in any tangible way. What we can do, however, is engage in healthy lifestyle behaviors that promote our overall health, and increase our intake of antioxidants. Increasing antioxidant intake through foods in our diet (leafy veggies, fruit) has not directly been shown to impact greying hair, but it can help to decrease overall oxidative stress levels in the body, says Dr. Robinson, which is something she discusses with her patients.

Dr. Rabach agrees and adds that she believes that a stress-free and healthy lifestyle makes your whole body healthier, and this would be reflected in the youthfulness of your hair. While we may not be able to reverse or halt grey hairs from popping up, what is encouraging is Dr. Rabachs belief that through good hair health, nutritious diet, and stress management, we might be able to delay their initial appearance. Increasing your antioxidant intake, whether it be from your diet, a multivitamin, or even a product formulated for hair health, will be beneficial in reducing oxidative stress and may help delay the initial onset of grey hair, says Dr. Rabach, who also encourages the use of hair products with antioxidants.

According to Dr. Robinson, there are some reports that Platelet Rich Plasma (PRP) therapy an in-office procedure that involves scalp injection of a processed form of ones own bloodcan promote hair re-pigmentation or slow greying because of its ability to deliver growth factors to the the hair follicle. While it sounds promising, more data needs to be gathered to determine its efficacy as a hair treatment.

Bottom line: Dont waste your money on products that claim to turn back the clock on grey hair, and focus instead on increasing your antioxidant intake and mitigating the effects of oxidative stress. Here are a couple products to get you started.

$17

Dr. Rabach promotes the use of antioxidant-rich hair products to help protect against the effects of oxidative stress. Look for one that is formulated with powerful superfruits like goji, acai, and pomegranate, and includes biotin for the added hair-nurturing benefits.

Buy

$65

This ingestible powder is chock-full of antioxidant-rich superfoods, adaptogens, and a probiotic blend to help your body resist stress, support detoxification, and support immunity. Add a teaspoon to water or a cold beverage of your choice, and reap the benefits of this all-natural, whole-food blend and help fend off the effects of oxidative stress.

Buy

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Citius Pharmaceuticals Signs an Exclusive Worldwide Licensing Agreement with Novellus Therapeutics for Unique iMSC-Therapy for Acute Inflammatory…

By daniellenierenberg

CRANFORD, N.J., Oct. 7, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, announced that it has signed an exclusive agreement with Novellus Therapeutics Limited ("Novellus") to license iPSC-derived mesenchymal stem cells (iMSCs), and has created a new subsidiary, NoveCite, that will be focused on developing cellular therapies.

NoveCite has a worldwide exclusive license from Novellus, an engineered cellular medicines company, to develop and commercialize NoveCite mesenchymal stem cells ("NC-iMSCs") to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with COVID-19. Several cell therapy companies using donor-derived MSC therapies in treating ARDS have demonstrated that MSCs reduce inflammation, enhance clearance of pathogens and stimulate tissue repair in the lungs. Almost all these positive results are from early clinical trials or under the emergency authorization program.

NC-iMSCs are the next generation mesenchymal stem cell therapy. They are believed to be differentiated and superior to donor-derived MSCs. Human donor-derived MSCs are sourced from human bone marrow, adipose tissue, placenta, umbilical tissue, etc. and have significant challenges (e.g., variable donor and tissue sources, limited supply, low potency, inefficient and expensive manufacturing). iMSCs overcome these challenges because they:

Globally, there are 3 million cases of ARDS every year out of which approximately 200,000 cases are in the United States. The COVID-19 pandemic has added significantly to the number of ARDS cases. Once the COVID patients advance to ARDS, they are put on mechanical ventilators. Death rate among patients on ventilators can be as high as 50% depending on associated co-morbidities. There are no approved treatments for ARDS, and the current standard of care only attempts to provide symptomatic relief.

"NoveCite iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of the high potency seen in Novellus' pre-clinical studies, and because iMSCs are iPSC-derived, and therefore overcome the manufacturing challenges associated with donor derived cells," said Myron Holubiak, Chief Executive Officer of Citius.

"We are excited to be part of this effort because of the promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by COVID-19," said Dr. Matthew Angel, Chief Science Officer of Novellus. "Our iMSC technology has multimodal immunomodulatory mechanisms of action that make it potentially promising therapy to treat acute respiratory diseases."

About Citius Pharmaceuticals, Inc.

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

About Novellus, Therapeutics, Limited

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

About NoveCite iMSC (NC-iMSC)

NoveCite's mesenchymal stem cell therapy product is derived from a human induced pluripotent stem cell (iPSC) line generated using a proprietary mRNA-based (non-viral) reprogramming process. The NC-iMSCs produced from this clonal technique are differentiated from human donor-derived MSCs (bone marrow, placenta, umbilical cord, adipose tissue, or dental pulp) by providing genetic homogeneity. In in-vitro studies, NC-iMSCs exhibit superior potency and high cell viability. NC-iMSCs secrete immunomodulatory proteins that may reduce or prevent pulmonary symptoms associated with acute respiratory distress syndrome (ARDS) in patients with COVID-19. NC-iMSC is an allogeneic (unrelated donor) mesenchymal stem-cell product manufactured by expanding material from a master cell bank.

First generation (human donor-derived) MSCs are isolated from donated tissue followed by "culture expansion". Since only a relatively small number of cells are isolated from each donation, first generation MSCs are increased by growing the cells in culture. Unfortunately, these type of MSCs start to lose potency, and ultimately become senescent. Each donation produces a limited number of MSCs, so a continuous supply of new donors is needed to produce commercial scale. The number and quality of MSCs that can be isolated from different donors can vary substantially.

About Acute Respiratory Distress Syndrome (ARDS)

ARDS is an inflammatory process leading to build-up of fluid in the lungs and respiratory failure. It can occur due to infection, trauma and inhalation of noxious substances. ARDS accounts for approximately 10% of all ICU admissions and almost 25% of patients requiring mechanical ventilation. Survivors of ARDS are often left with severe long-term illness and disability. ARDS is a frequent complication of patients with COVID-19. ARDS is sometimes initially diagnosed as pneumonia or pulmonary edema (fluid in the lungs from heart disease). Symptoms of ARDS include shortness of breath, rapid breathing and heart rate, chest pain (particularly while inhaling), and bluish skin coloration. Among those who survive ARDS, a decreased quality of life is relatively common.

Safe Harbor

This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: the risks associated with developing the NoveCite technology as a treatment for ARDS; risks associated with developing any of our product candidates, including any licensed from Novellus, Inc., including that preclinical results may not be predictive of clinical results and our ability to file an IND for such candidates; our need for substantial additional funds; the estimated markets for our product candidates, including those for ARDS, and the acceptance thereof by any market; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; the early stage of products under development, including the NoveCite technology; our ability to obtain, perform under and maintain licensing, financing and strategic agreements and relationships; our ability to attract, integrate, and retain key personnel; risks related to our growth strategy; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.

Contact:Andrew ScottVice President, Corporate Development(O) 908-967-6677 x105(M) 646-522-8410ascott@citiuspharma.com

View original content:http://www.prnewswire.com/news-releases/citius-pharmaceuticals-signs-an-exclusive-worldwide-licensing-agreement-with-novellus-therapeutics-for-unique-imsc-therapy-for-acute-inflammatory-respiratory-conditions-including-covid-19-related-acute-respiratory-distress-syndrom-301147409.html

SOURCE Citius Pharmaceuticals, Inc.

Company Codes: NASDAQ-SMALL:CTXR

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Can You Prevent Gray Hair? The Answer Isn’t Black & White, Experts Say – mindbodygreen.com

By daniellenierenberg

Essentially, graying hair is just natural, whether you have a full head of silver or patches of gray throughout. Loss of pigmentation in hair is something out of our control, agrees celebrity colorist and Redken brand ambassadorMatt Rez. Its largely due to genetics and aging in general, and unfortunately there arent any existing treatments to reverse those grays to their natural vigor.

Specifically, your pigment-producing cells (called melanocytes) start to deteriorate, leading to sprouted grays. The melanocytes are pigment producing cells located near the bulb of the hair and their stem cells, explains hair transplant surgeon James S. Calder, M.D., medical director of Ziering Medical. When your hair ages, those melanocytes dont function as well or start to migrate away from the hair bulb, which causes a sprinkling of grays. And according to Calder, no supplement, nor diet, can successfully prevent the process forever.

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Who are the winners of the in-cosmetics Global Awards 2020? – Premium beauty

By daniellenierenberg

Despite the challenges brought about by Covid-19, leading cosmetic manufacturers, including Mibelle Biochemistry, Cargill Beauty, Givaudan Active Beauty and Lucas Meyer, put forward their most creative innovations for consideration by the in-cosmetics Global Awards jury.

Judged across three categories - Best Active Ingredient, Best Functional Ingredient and Best Green Ingredient - by some of the industrys foremost experts, the awards recognise the cosmetic ingredient manufacturers who are helping to push the boundaries of innovation, while responding to evolving consumer demands.

The winners were announced yesterday during a virtual ceremony from a list of finalists dominated by skin care ingredients.

Scooping both the Gold and Silver awards in the Best Active Ingredient category, Vytrus Biotech was recognised for its Kannabia Sense and Deobiome Noni ingredients.

Kannabia Sense took the top accolade. This probiotic treatment stimulates the skin microbiota to produce an in-situ postbiotic cocktail that promotes the synthesis of cutaneous oxytocin. Recommended for use in sensitive skin treatments, anti-ageing cosmetic products and delicate facial treatments, it is made from plant stem cells of Cannabis sativa.

Deobiome Noni is a prebiotic deodorant treatment that reduces the generation of body odour while allowing the skin to breathe and respecting the skin microbiota.

Closing the category, Mibelle Biochemistry and Clariant Active were announced as this years joint Bronze Award winners.

Alpine Rose Active, Mibelle Biochemistrys novel senolytics concept, was chosen for its ability to eliminate senescent skin cells and protect skin proteins from oxidative stress.

Clariant Active was applauded for Prenylium. Thanks to Clariants Plant Milking technology, Prenylium is extracted from the root of the mulberry tree (Morus Alba) without causing any damage. This innovative and sustainable approach to sourcing helps to stimulate root growth and results in a concentration of prenylated flavonoids 2000% higher than what is typically found in mulberry root extracts.

German cosmetic manufacturer Symrise took the top award in the Best Functional Ingredient category for its Symrise SymEffect Sun. Based entirely on renewable raw materials from responsible sources, the new ingredient combines the advantages of conventional sunscreen products with the increasing sustainability requirements of consumers.

Also demonstrating a sustainable approach to sun protection, Dow Chemical was awarded the Silver award for its SunSpheres BIO SPF Booster, a bio-based and readily biodegradable SPF boost that enables greater SPF efficiency in suncare and daily skincare products.

The category also honoured two bronze award winners: Clariant and Gattefoss. The former was awarded for Velsan Flex which, thanks to its high water solubility and Renewable Carbon Index (RCI) of 93%, offers preservation boosting powers together with broad formulation flexibility. Gattefosss Emulium Dolcea MB a natural origin O/W emulsifier - has the ability to create a wider range of textures, from fluid serum to thick butter in a wide range of applications, such as skincare, suncare, make up and haircare.

As sustainability continues to drive cosmetic manufacturers to assess the ingredients used in their formulations, this years Green Ingredient Award - in partnership with Ecovia Intelligence - recognises the ingredients championing sustainability in the personal care and beauty market.

Henry Lamotte Oils Paradise Nut Oil/Magdalena River Nut Oil scooped the Gold Award for its ability to support the regeneration of the skins lipid film, while improving the water retention capability of the skin, reducing trans-epidermal water loss.

Unveiled as the Silver Award winner, Cargill Beautys FiberDesign Sensation was praised for its approach to sustainability and upcycling. Derived from 100% natural origins, the texturiser and emulsion stabiliser, designed specifically for skincare, is based on citrus peel fibres from the pectin production side stream.

Joining the line-up of award winners, Minasolve SAS scooped the Bronze Award for its A-Leen Aroma-3, a nature-derived perfuming agent that also offers a broad-spectrum antimicrobial effect. It is a 100% natural version of phenylpropanol, it is produced from cassia essential oil.

Cosmetic Ingredients - October 2020

For more information on the latest cosmetic ingredients launches, also read our special issue:

How far will clean beauty go?

Interest in upcycled ingredients expected to rise in the cosmetics industry

Driven by new consumer preferences, demand for cupuau butter is on the rise

in-cosmetics Awards 2020

Ingredient news: Akott, BASF, Berkem, Clariant, Codif, Covestro, DSM, Firmenich, Givaudaun, Grolman, Imerys, Inter Actifs, Lubrizol, Mibelle, Sederma, Seppic, Silab, Symrise

Read online for free or download the pdf version here.

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The luxury skincare splurge that will help repair your skin cells – Dazed

By daniellenierenberg

Alex Peters is Dazed Beautys news writer. She picked up the phrase Its all happening from Almost Famous as a teen and it now exclusively makes up her vocabulary. Although in theory she likes the idea of a queer mullet, she is currently rocking the latest lockdown trend: Kajillionaire hair. Here, she shares her choice for Product of the Week a weekly round-up of the Dazed Beauty team and wider communitys must-have buys.

Brand: Augustinus Bader

Product: The Cream

Price: 205

As head of stem cell research at the University of Leipzig, Professor Augustinus Bader spent 30 years working with burns victims, developing a groundbreaking gel in 2008 that could heal third-degree burns without the need for skin grafts. Its this revolutionary stem cell technology the patented Trigger Factor Complex (TFC8) which lies at the heart of his skincare label and its hero product The Cream.

Powered by this technology, with consistent use (the Cream asks that you remain devoted to it for 27 days, using nothing else), the products activate and orchestrate the body's innate regenerative processes which basically means that when you use them your skin cells repair themselves. This helps with reducing the signs of ageing and environmental damage, reducing scarring and redness, and improving tone and texture.

Thats all very scientific, but the most important question is does it actually work? And for me it does. My skin is on the oily side as well as being sensitive and acne-prone so I use the Cream, rather than the Rich Cream which is better suited to dry skin types. The cream itself has a light texture that absorbs quickly and doesnt feel sticky. Two pumps is enough to cover your face and it goes on very smoothly. It has quite a distinctive scent, so if you are nose-sensitive be prepared. Its hard to describe clinical rather than artificial. It comes in a weighty blue and copper tube that feels fancy when youre using it.

I am not always great at using it consistently, particularly since we test out so many products as part of our job, but I have found that when I do, my skin looks noticeably better. My tone is more even and less red, the texture is better, scars look more faded, and I would tentatively say that it seems like I get fewer spots.

I would like to say, however, that the product is definitely on the higher end of the spectrum price-wise, and if you cannot afford it, please do not worry. There are a lot of great options out there that are more affordable and also very effective. If this is something that you can afford, I would highly recommend.

If I were communicating to an alien only using hand gestures, I would describe it with... Just a solid thumbs up. Or through elaborately miming the process of cell renewal.

It sounds like... A reassuring older German professor telling you efferyzing vill be alright and in the background the sound of a fire crackling.

If it was a meme it would be... Sorry to this man. Totally unrelated but its my favourite meme.

The fictional character who would use it is... Bette Porter from The L Word.

Alex Peters's Product of the Week

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US Food and Drug Administration Approves Opdivo (nivolumab) + Yervoy (ipilimumab) as the First and Only Immunotherapy Treatment for Previously…

By daniellenierenberg

DetailsCategory: AntibodiesPublished on Saturday, 03 October 2020 15:56Hits: 667

Opdivo + Yervoy is the first new systemic therapy in over 15 years to be approved by the FDA in this setting1,2

Approval is based on CheckMate -743 in which Opdivo + Yervoy demonstrated superior overall survival vs. standard of care chemotherapy1

Approval marks third indication for Opdivo + Yervoy-based treatments in thoracic cancers and seventh indication overall

PRINCETON, NJ, UA I October 2, 2020 IBristol Myers Squibb (NYSE: BMY) today announced that Opdivo (nivolumab) 360 mg every three weeks plus Yervoy (ipilimumab) 1 mg/kg every six weeks (injections for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).1 This approval is based on a pre-specified interim analysis from the Phase 3 CheckMate -743 trial in which Opdivo + Yervoy (n=303) demonstrated superior overall survival (OS) versus the platinum-based standard of care chemotherapy (n=302) (Hazard Ratio [HR]: 0.74 [95% Confidence Interval [CI]: 0.61 to 0.89]; P=0.002), with a median OS (mOS) of 18.1 months (95% CI: 16.8 to 21.5) versus 14.1 months (95% CI: 12.5 to 16.2), respectively.1 These results were observed after 22.1 months of minimum follow-up.3 At two years, 41% of patients treated with Opdivo + Yervoy were alive and 27% with chemotherapy.1,3

Malignant pleural mesothelioma is a rare cancer with limited treatment options. When it is diagnosed in advanced stages, the five-year survival rate is approximately 10 percent, said study investigator Anne S. Tsao, M.D., professor and Section Chief Thoracic Medical Oncology and Director of the Mesothelioma Program at The University of Texas M.D. Anderson Cancer Center.2,4 The survival results from the CheckMate -743 trial show that the combination of nivolumab and ipilimumab could become a new front-line standard of care option. This is exciting news, instilling hope for patients with this devastating disease and for the healthcare providers who care for them.1,3

Opdivo and Yervoy are associated with Warnings and Precautions including immune-mediated: pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, skin adverse reactions, encephalitis, other adverse reactions; infusion reactions; complications of stem-cell transplant that uses donor stem cells (allogeneic); embryo-fetal toxicity; and increased mortality in patients with multiple myeloma when Opdivo is added to a thalidomide analogue and dexamethasone, which is not recommended outside of controlled clinical trials.1Yervoy is associated with the following Warnings and Precautions: severe and fatal immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic hematopoietic stem cell transplant after Yervoy, embryo-fetal toxicity and risks associated when administered in combination with Opdivo.5 Please see the Important Safety Information section below.

This is the third indication for an Opdivo + Yervoy-based combination in the first-line treatment of a form of thoracic cancer.1Opdivo + Yervoy is approved by the FDA as a first-line treatment for patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L11% as determined by an FDA-approved test, and without EGFR or ALK genomic tumor aberrations.1 It is also approved in combination with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent NSCLC with no EGFR or ALK genomic tumor aberrations regardless of PD-L1 expression.1

Thoracic cancers can be complex and difficult to treat, and we are focused on developing immunotherapy options that may have the potential to extend patients lives, said Adam Lenkowsky, general manager and head, U.S., Oncology, Immunology, Cardiovascular, Bristol Myers Squibb.2,6 Just a few months ago, Opdivo + Yervoy-based combinations received two first-line indications for certain patients with non-small cell lung cancer. Now, Opdivo + Yervoy is approved for use in another type of thoracic cancer, previously untreated unresectable MPM. With todays announcement, Opdivo + Yervoy becomes the first new systemic therapy approved in more than 15 years in this setting, and may offer these patients a chance for a longer life. 1

Opdivo + Yervoy is a unique combination of two immune checkpoint inhibitors that features a potentially synergistic mechanism of action, targeting two different checkpoints (PD-1 and CTLA-4) to help destroy tumor cells: Yervoy helps activate and proliferate T cells, while Opdivo helps existing T cells discover the tumor.1,7 Some of the T cells stimulated by Yervoy can become memory T cells, which may allow for a long-term immune response.7,8,9,10,11,12 Targeting of normal cells can also occur and result in immune-mediated adverse reactions, which can be severe and potentially fatal.1 Please see the Important Safety Information section below.

This approval was granted less than six weeks following the submission of a new supplemental Biologics License Application (sBLA), which was reviewed under the FDAs Real-Time Oncology Review (RTOR) pilot program. The RTOR program aims to ensure that safe and effective treatments are available to patients as early as possible.13 The review was also conducted under the FDAs Project Orbis initiative, enabling concurrent review by the health authorities in Australia, Brazil, Canada and Switzerland.

About CheckMate -743

CheckMate -743 is an open-label, multi-center, randomized Phase 3 trial evaluating Opdivo plus Yervoy compared to chemotherapy (pemetrexed and cisplatin or carboplatin) in patients with histologically confirmed unresectable malignant pleural mesothelioma and no prior systemic therapy or palliative radiotherapy within 14 days of initiation of therapy (n=605).1 Patients with interstitial lung disease, active autoimmune disease, medical conditions requiring systemic immunosuppression, or active brain metastasis were excluded from the trial.1In the trial, 303 patients were randomized to receive Opdivo 3 mg/kg every two weeks and Yervoy 1 mg/kg every six weeks; 302 patients were randomized to receive cisplatin 75 mg/m2 or carboplatin AUC 5 plus pemetrexed 500 mg/m2 in 3-week cycles for six cycles.1 Treatment in both arms continued until disease progression or unacceptable toxicity or, in the Opdivo + Yervoy arm, up to 24 months.1 The primary endpoint of the trial was OS in all randomized patients.1 Additional efficacy outcome measures included progression-free survival (PFS), objective response rate (ORR) and duration of response (DOR), as assessed by BICR utilizing modified RECIST criteria.1

Select Safety Profile from CheckMate -743 Study

Treatment was permanently discontinued for adverse reactions in 23% of patients treated with Opdivo + Yervoy, and 52% had at least one dose withheld for an adverse reaction.1 An additional 4.7% of patients permanently discontinued Yervoy alone due to adverse reactions. Serious adverse reactions occurred in 54% of patients receiving Opdivo + Yervoy.1 The most frequent (2%) serious adverse reactions in patients receiving Opdivo + Yervoy were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism.1 Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis.1 The most common (20%) adverse reactions were fatigue (43%), musculoskeletal pain (38%), rash (34%), diarrhea (32%), dyspnea (27%), nausea (24%), decreased appetite (24%), cough (23%) and pruritus (21%).1 The median number of doses was 12 for Opdivo and 4 for Yervoy.3

About Malignant Pleural Mesothelioma

Mesothelioma is a rare but aggressive form of cancer that often forms in the lining of the lungs.2,14 There are approximately 3,000 cases diagnosed in the United States each year.14 Malignant pleural mesothelioma is the most common type of the disease.2 It is most frequently caused by exposure to asbestosand diagnosis is often delayed, with the majority of patients presenting with advanced disease.2,15 Prognosis is generally poor: in patients with advanced malignant pleural mesothelioma, median survival is approximately one year and the five-year survival rate is approximately 10%.2

INDICATIONS

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with intermediate or poor risk, previously untreated advanced renal cell carcinoma (RCC).

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab), in combination with YERVOY (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational CAR T cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early- to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Bristol Myers Squibbs Patient Access Support

Bristol Myers Squibb remains committed to providing assistance so that cancer patients who need our medicines can access them and expedite time to therapy.

BMS Access Support, the Bristol Myers Squibb patient access and reimbursement program, is designed to help appropriate patients initiate and maintain access to BMS medicines during their treatment journey. BMS Access Support offers benefit investigation, prior authorization assistance, as well as co-pay assistance for eligible, commercially insured patients. More information about our access and reimbursement support can be obtained by calling BMS Access Supportat 1-800-861-0048 or by visiting http://www.bmsaccesssupport.com.

About the Bristol Myers Squibb and Ono Pharmaceutical Collaboration

In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for patients with cancer in Japan, South Korea and Taiwan.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

References

SOURCE: Bristol-Myers Squibb

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FDA Grants Fast Track Status to Aegle Therapeutics’ AGLE-102 for the Treatment of Dystrophic Epidermolysis Bullosa – PRNewswire

By daniellenierenberg

BOSTON and MIAMI, Oct. 1, 2020 /PRNewswire/ -- Aegle Therapeutics Corporation today announced theU.S. Food and Drug Administration(FDA) has granted Fast Track designation to AGLE-102 for the treatment of patients with dystrophic epidermolysis bullosa ("DEB"), a rare genetic pediatric skin blistering disorder. AGLE-102 is an extracellular vesicle ("EV") therapy that delivers proteins, genetic material and regenerative healing factors to diseased and damaged tissue. AGLE-102 will be evaluated in DEB patients in a phase 1/2a trial initiating in 2021.

The Fast Track program is intended to facilitate the development and review of drug candidates that treat serious conditions and fill an unmet medical need. A drug candidate with Fast Track designation is eligible for greater access to the FDA for the purpose of expediting the drug product candidate's development, review and potential approval.

"We are pleased to have received Fast Track designation for AGLE-102. Aegle's EV therapy is unique in that it delivers collagen 7 protein, COL7A1 mRNA and regenerative healing factors to potentially address the complex nature of DEB," said Evangelos Badiavas, MD, PhD, Chief Scientific Officer atAegle Therapeutics. "This designation will expedite the development and regulatory review of AGLE-102 and highlights the importance of providing novel treatments to this patient population."

AboutAegle Therapeutics Corporation

Aegle Therapeutics (www.aegletherapeutics.com) is a privately held biotechnology company developing extracellular vesicles, including exosomes, secreted by mesenchymal stem cells as therapy for the treatment of dystrophic epidermolysis bullosa and other severe dermatological conditions. Aegle anticipates entering the clinic with AGLE-102 in early 2021.

ContactAegle Therapeutics CorporationShelley A. HartmanChief Executive Officer[emailprotected]

SOURCE Aegle Therapeutics Corporation

http://www.aegletherapeutics.com

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Global Skin Care Cosmetic Market 2020 Global Industry Analysis by Trends, Growth, Company Overview and Forecast by 2027 Latest Research Report by…

By daniellenierenberg

Reportspedia added a new research report to its exhaustive repository. The research report presents an unbiased approach to understanding the market trends and dynamics of the Skin Care Cosmetic Market. Analysts have studied the past data pertaining to the market and compare it to the up-to-date market trends to paint an objective picture of the trajectory of the market. The Skin Care Cosmetic report includes SWOT analysis and Porters five forces analysis to give the readers a comprehensive estimation of the various factors likely to drive and restrain the overall market.

Key Player Mentioned:

The Body Shop International PLCKao CorporationUnilever PLCAvon Products IncJohnson & JohnsonProcter & GambleBeiersdorf AGLOreal S.A.The Estee Lauder Companies Inc

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Regional Segment Analysis:North America (U.S.; Canada; Mexico), Europe (Germany; U.K.; France; Italy; Russia; Spain etc.), Asia-Pacific (China; India; Japan; Southeast Asia etc.), South America (Brazil; Argentina etc.), Middle East & Africa (Saudi Arabia; South Africa etc.)

Global Skin Care Cosmetic Industry Market provides a 360-degree outlook of the market for advanced technologies, key drivers, regulatory and future trends for brief to medium-term and long-term predict period. This Skin Care Cosmetic Market report study market size, industry conditions, and forecasts, competitive landscape, and growth opportunities.

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Global Skin Care Cosmetic Market Size & Share, By Product Types,

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Stem Cells Protection Against UVFlakiness ReductionRehydrate the Skin SurfaceMinimize wrinklesIncrease the viscosity of Aqueous

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Global Skin Care Cosmetic Market competitive landscape supplies details by vendors, including company overview, total business revenue (financials), market potential, international existence, Keyword sales, and earnings generated, market share, cost, production sites and centers, SWOT analysis, product launch. During the period of 2020-2027, this analysis provides the sales, market share for each player enclosed in this report.

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This Line By Augustinus Bader Will Level Up Your Skincare Ritual – About Her

By daniellenierenberg

Beauty lovers,listen up!AugustinusBader Skincare, afavouritewithcelebritieslikeKim Kardashian West, Courtney Cox, Demi MooreandNaomi Campbell, is now available in the region. Launched in 2018 byProfessorAugustinusBader,a world-leading expert in stem cell research,the skincare rangehas a selection of hero products that are deserving of coveted space in your over-crammed cabinet.

AugustinusBader Skincare was born out ofabreakthroughwhile Bader,who has spent 30 years unlocking the bodys innate processes to self-heal and uncovered how to reawaken cells that go dormant over time due to ageing or trauma,was working tohelp burn victims, particularly children with traumatic injuries. In 2008,thegloballyrecognisedleader in stem cell biologyformulated a groundbreaking wound gel that heals even third-degree burns without surgery or skin grafts.

Professor Augustinus Bader

By2018,AugustinusBader Skincarehadlaunchedas abyproduct ofthepioneeringresearch intended to find a way to heal wounds without scarring.The CreamandThe Rich Creamwere the first two outstanding productscreated to help continue to fund this important scientific work to help more people around the world.They werefollowed byThe Body Cream,which was launched in 2019. All three creams contain patented TFC8 (Trigger Factor Complex) technology, which supports the skins natural processes, leaving all skin types, frommature, dryandoilytosensitive,looking restored and regenerated. TFC8 is comprised of natural amino acids, high-grade vitamins andsynthesisedmolecules naturally found in skin. It guides key nutrients and powerful natural ingredients to the skin cells, creating an optimal environment for the bodys innate processes of repair and renewal.

AugustinusBader Skincareisavailable exclusively in store at Harvey Nichols Dubai and Bloomingdales Middle East, and online atOunass.comandBloomingdales.ae.

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Life as a sickle cell warrior: How advocates are changing the face of the disease – TheGrio

By daniellenierenberg

It saddens me that when I tell people I have sickle cell the most common reply is what is that? sickle cell advocate Shamonica Wiggins shares with theGrio.

Sickle cell disease (SCD) is a group of red blood cell disorders occurring when a child inherits the sickle cell gene from both parents possessing the sickle cell trait. Those with the disease are often referred to as warriors because from the moment they are born, each day is its own battle.

Living with sickle cell has been a never-ending roller coaster, explains 31-year-old sickle cell warrior Shanice Williams. Sometimes everything is looking up, but the road is still bumpy mild to moderate crises and health issues. Other times Im flying down really fast always in crises, in the hospital, etc and I just have to wait until everything is going smooth again.

A sickle cell crisis occurs when the hard, sticky, sickle-shaped red blood cells of a SCD patient block blood flow causing extreme pain, anemia, fever and fatigue.

According to 24-year-old Sabah Imani, founder of the Sabah Imani Sickle Cell Foundation, sickle cell pain is almost indescribable. The best way I can put it is like having thousands and thousands of little needles running through your veins, something similar to a body part falling asleep but times 50.

In addition to the immense pain, sickle cell crises can also lead to a variety of serious ailments such as tissue damage, infections, fatal organ failure and stroke. Sickle cell warrior Tristan Lee, 37, suffered a stroke when he was 9 years old leaving him paralyzed on the left side of his body.

I spent months in the hospital after that, he says. When I was finally released, I had to do years of physical and occupational therapy to relearn how to walk, talk, and use the bathroom. I also had to begin routine blood transfusions every 3 weeks until I was 19 years old to avoid any risk of blood clots, and more complications from sickle cell.

Advocate Wiggins also suffered from strokes her first at the age of 3 and another more recently at the age of 30.

Experiencing something so traumatic, not once but twice, could break a person but I refuse to break. I bend from time to time, but breaking is not an option, she tells theGrio. As painful as this illness is, Im actually grateful that I have it. I truly believe learning to not only live, but thrive with this illness has made me a better person. It has made me a grateful person. An understanding person. A determined person and a compassionate person.

In between pain and hospitalizations, Wiggins spends her time advocating for the 100,000 Americans living with SCD. Earlier this month, that advocacy afforded her the opportunity to present at the White Houses roundtable discussion on Improving the Lives of Americans with Sickle Cell Disease.

I see sickle cell as a silent killer because although it claims the lives of so many nationwide and around the world, theres very little talk about it, so Im grateful for this platform, adds Wiggins.

Advocates like Wiggins, Imani, Williams, Lee, and 29-year-old Teonna Woolford are determined to drive the conversation forward, not simply for awareness, but because its truly a matter of life and death.

I would be irresponsible as an advocate if I did not speak on the fact that systemic racism and medical bias has held us back for far too long, says Woolford. Families impacted by sickle cell deserve the same quality and compassionate care as families impacted by other conditions such as cancer and cystic fibrosis. Sickle cell disease is far more prevalent than cystic fibrosis, yet we have far less resources.

Although sickle cell is not technically a Black disease, it is an evolutionary condition found most prevalent among people from regions of the world where malaria is common, including sub-Saharan Africa, South and Central America, Saudi Arabia, India and the Mediterranean (Greece, Sicily and Turkey). Because of this, SCD occurs in approximately 1 out of every 365 African-American births and 1 in 13 African Americans carry the sickle cell trait.

Ive been hospitalized over a hundred times, and some doctors would think, Heres this young Black person. Theyre just drug-seeking, shares 29-year-old Epiphany Samuels. What they dont understand is that Im in so much pain, Im praying for death, not drugs.

And Samuels is not alone. The pain of SCD is often as much a mental one as it is physical. Sickle cell warrior Hugh Holcomb shares that it gets really hard sometimes the loneliness from being in the hospital. Sometimes its hard to find the will to fight.

Because of this, Imani urges anyone who may know someone with SCDto really take the time to get to know and understand them.

Were so used to getting prejudged that all we want is for someone to take the time and care about us, just like you would for someone living with cancer or AIDS. As sickle cell patients, we do not look sick most of the time and that can be very misleading, she explains. We can be in the middle of the worst pain ever yet still sit and hold a conversation with you. We push ourselves to do certain activities that arent healthy for us but we just want that sense of normalcy.

Unfortunately, during this COVID-19 pandemic, normalcy is now a foreign concept even for those without SCD. But for people with underlying health conditions, this pandemic carries an extra layer of concern.

Were used to carrying sanitizer and always watching those around us for symptoms of being sick considering even a cold can push us into a crisis, or worse, possibly wind us up in ICU, says Williams.

And for Samuels, who found herself in the middle of a crisis at the height of the pandemic, navigating my sickle cell during coronavirus has been hard. There was this one moment where I was like, Oh, Epiphany, your eyes are turning green and youre in a whole lot of pain. Youre in a crisis.

She continues, I knew it was better for me to try to handle my crisis at home than to go to the ER because I can likely live through my crisis but I dont know if I can live through COVID.

Currently, the only known cure for SCD is a bone marrow or stem cell transplant from a close relative like a brother or sister. However, these procedures are extremely risky, and can have serious side effects, including frequent infections and death.

Both Imani and Woolford have undergone bone marrow transplants. Imani is now two years post transplant, and has since developed a skin care line based on the natural moisturizers she created to treat her drastically changing skin during chemotherapy and radiation treatments.

Unfortunately for Woolford, things didnt go quite as well.

It was a grueling process physically and even more so mentally, and at the end of my four-month hospital stay, I found out that I rejected the transplant, she says. That was 10 years ago, and probably the hardest thing I had ever been through. I had to let go of the dream that I would live a life free of sickle cell.

But in the years since, Woolford like many other sickle cell warriors has managed to transform her pain into power. Today, I am thriving and the happiest I have ever been. In a full circle moment, I contributed to the first ever publication of guidelines for bone marrow transplants and sickle cell disease through the American Society of Hematology. This is an incredible time for sickle cell disease. We recently had three new FDA-approved therapies after 20 years of having only one.

Tristan Lee shares in her optimism.

I believe, in my lifetime, we will have a universal cure for sickle cell disease. As long as we can continue to spread awareness and get medical professionals and people of all walks of life to join us in that awareness, we will have our cure that we desperately need.

Follow the above-mentioned advocates journeys via social media for more information on SCD.

This article is written in loving memory of Robert L. Stevenson.

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Autologous Stem Cell and Non-Stem Cell Based Therapies Market Industry Development Trends & Competitive Analysis by Leading Industry Players – The…

By daniellenierenberg

The Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market is expected to exceed more than US$ 4.5 Billion by 2024 at a CAGR of 4% in the given forecast period.

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the GE Healthcare, A&D Medical, Dragerwerk, Hill-Rom, and Philips Healthcare. Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

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Autologous stem-cell transplantation (also called autogenetic, autogenic, or autogenic stem-cell transplantation or auto-SCT) is that the autologous transplantation of stem cellswhich is, the uniform cells or stem cells (cells from which different styles of cells develop) area unit taken from someone, accumulated, and given back to an equivalent person later. Although its most frequently dead by means that of hematogenic vegetative cells (antecedent of cells that forms blood) in hematogenic stem cell transplantation, in some cases internal organ cells square measure used profitably to mend the damages because of heart attacks.

The scope of the report includes a detailed study of global and regional markets for Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market with the reasons given for variations in the growth of the industry in certain regions.

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The major driving factors of Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market are as follows:

The restraining factors of Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market are as follows:

The Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market has been segmented as below:

The Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market is Segmented on the lines of Product Analysis, Application Analysis, End-User Analysis and Regional Analysis. By Product Analysis this market is segmented on the basis of BP monitoring devices, Pulmonary pressure monitoring devices and ICP monitoring devices. By Application Analysis this market is segmented on the basis of Treating neurodegenerative, Autoimmune, Cardiovascular disorders skin transplant, Oncology and Other.

By End-User Analysis this market is segmented on the basis of Hospitals Sector, ASCs Sector and Others Sectors. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

This report provides:

1) An overview of the global market for Global Autologous Stem Cell and Non-Stem Cell Based Therapies Market and related technologies.2) Analyses of global market trends, with data from 2015, estimates for 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2024.3) Identifications of new market opportunities and targeted promotional plans for using topical acne treatment Market.4) Discussion of research and development, and the demand for new products and new applications.5) Comprehensive company profiles of major players in the industry.

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Table of Contents

1 INTRODUCTION

2 EXECUTIVE SUMMARY

3 AUTOLOGOUS STEM CELL & NON STEM SELL THERAPY -TECHNOLOGY LANDSCAPE ANALYSIS

4 AUTOLOGOUS STEM CELL & NON STEM SELL THERAPY TECHNOLOGY INVESTMENT POTENTIAL

4.1 INVESTMENT CLIMATE ASSESSMENT4.1.1 INVESTOR NETWORKS4.1.1.1 PUBLIC FUNDING BODIES4.1.1.2 FUNDING/GRANTS FROM NGO ORGANIZATIONS4.1.1.3 PRIVATE INVESTORS AND VENTURE CAPITAL FIRMS4.1.1.4 INSIGHTS ON CURRENT AND FUTURE TECH-INVESTMENT TRENDS4.1.1.5 INVESTOR INCLINATION AND PATTERNS4.2 INVESTMENT OPPURTUNITIES4.2.1 LICENSING AND ACQUISITION4.2.2 ANALYSIS OF POTENTIAL APPLICATION AREAS FOR TECHNOLOGY INVESTMENT

5 AUTOLOGOUS STEM CELL MARKET LANDSCAPE ANALYSIS

6 AUTOLOGOUS STEM CELL & NON STEM SELL THERAPY TECHNOLOGY ADOPTION POTENTIAL AND DEVELOPMENT BY GEOGRAPHY

7 COMPETITIVE LANDSCAPE

8 PATENT ANALYSIS

9 TECHNOLOGY ANALYSIS AND ROAD MAPPING

10 ANALYST INSIGHTS AND RECOMMENDATIONS

11 COMPANY PROFILES

11.1 ANTRIA (CRO) (U.S.)

11.2 BIOHEART (U.S.)

11.3 BRAINSTORM CELL THERAPEUTICS (U.S.)

11.4 CYTORI (U.S.)

11.5 DENDREON CORPORATION (U.S.)

11.6 FIBROCELL (U.S.)

11.7 GENESIS BIOPHARMA (U.S.)

11.8 GEORGIA HEALTH SCIENCES UNIVERSITY (U.S.)

11.9 NEOSTEM (U.S.)

11.10 OPEXA THERAPEUTICS (U.S.)

11.11 ORGENESIS (U.S.)

11.12 REGENEXX (U.S.)

11.13 REGENEUS (AUSTRALIA)

11.14 TENGION (U.S.)

11.15 TIGENIX (BELGIUM)

11.16 VIRXSYS (U.S.)

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Regenerative medicine and war: The next breakthrough in treating injured veterans? – Genetic Literacy Project

By daniellenierenberg

Many Americans, and indeed people all over the world, were outraged when reports surfaced this past summer that President Trump had once dismissed the dead soldiers from one of World War Is iconic battles, The Battle of Belleau Wood, as suckers and losers. Amputees should be excluded from parades because nobody wants to see them, the article also reports he had said.

The president denied these claims, but the outcry highlighted the high regard in which the American public, and most of the world, holds veterans; people are united by the pride and respect for those brave enough to risk life and limb for their country.

In the United States, the number of injured soldiers returning home alive has risen from 75% to 92% since the Vietnam War, but combat takes a toll on the survivors. Its estimated that one in every 10 veterans alive today was injured seriously while serving. And, for many, the nature of the injury makes treatment very difficult. Soldiers can find themselves returning home with severe burns, spinal cord injuries, paralysis, blindness, deafness, brain injuries and loss of limbs, as well as psychological trauma, some linked directly to physical injuries.

The most significant development in recent years for severely maimed veterans and other victims of physical injuries is the acceleration of whats known as regenerative medicine. Regenerative medicine was first defined in 1999 and it encompasses many disciplines of science. Its goal is to provide clinicians with the tools to effectively repair or replace a patients damaged tissues and organs in order to return normal function.

The technology really emerged into the public consciousness in the 2000s because of the Iraq war and, since then, great strides have been made in applying it to treating many different healthcare issues. So, what about the specifics? What are the most promising breakthroughs in recent years?

Some of the most challenging war-related injuries involve bones. Severe burns, spinal cord injuries, blast injuries, traumatic brain injuriesthese seemingly disparate traumas can each lead to a painful complication during the healing process called heterotopic ossification (HO).

A team at Michigan Medicines Department of Surgery is focusing its research on how the healing process often goes awry. The problem often emerges at limb amputation sites. Weeks after surgery or injury, abnormal bones often form within soft tissues like muscleplaces where theyre not supposed to be, causing the patient agonizing pain.

Theres no way to prevent it and once its formed, theres no way to reverse it, said Benjamin Levi, M.D, co-head of the research team at the Center for Basic and Translational Research at Michigan Medicines Department of Surgery.

There may be a solution thanks to a collaborative study between Levi and a research group led by Stephen Kunkel, Ph.D. at Michigans Department of Pathology. It had been theorized that HO could be linked to inflammation at the site of injury or surgery. The researchers built on this theory by studying the cells that are present at the early stages of HO.

Working with mice, they have been able to identify a specific protein that is responsible for sending the signals that trigger stem cells within the bone to start this process of uncontrolled tissue growth. By targeting this protein and stopping its action, it could be possible to stop the process in the first place. This would improve the quality of life for many injured veterans.

Treating HO is very much a case of prevention being better than cure. Progressing this discovery into a therapeutic setting could eventually provide doctors with a mechanism to stop HO before it has a chance to develop. It would be a game changer for many veterans who would otherwise be left with this agonizing condition.

Severe blast injuries and bullet traumas also leave many veterans needing implants or prosthetics to replace bone that has been lost to severe injury. If you break a leg, a doctor will put it in a cast and allow the natural healing process to occur. If its a severe break, you may need surgery. But when a soldiers bone is ripped apart by a gunshot or a blast, the damage to the network of cells within the bone is so severe that it often cannot heal on its own.

Regenerative medicine may provide a solution. After leaving the US Army more than 20 years ago, solider Luis Alvarez founded a firm at the Massachusetts Institute of Technology that developed a paint derived from key proteins that can trigger bone regeneration. The inspiration behind Alvarezs innovation?

During my time in Iraq, I witnessed service members who suffered traumatic injuries undergo amputations weeks or months after the initial wound, because there was no reliable method for regenerating the bone.

The technology developed by his company allows doctors to coat implants with specific proteins, allowing them to trigger regeneration, thus aiding recovery of the damaged tissue. They are making great progress and looking to have something ready for doctors to use in clinics by 2021. Its an inspiring story. The company is rolling out multiple therapies heading into clinical trials over the next two years.

The military is also starting to invest heavily in one of the most exciting avenues of regenerative medicine to help veterans replace lost tissue. Bioprinting uses human cells mixed with specially designed bioinks to 3D print tissue-like structures for the purpose of regenerating damaged body parts. Using bioprinting, scientists can build replacement grafts using a patients own stem cells, thus removing the issues associated with transplant rejection. The technology is still in its infancy but, thanks to recent military investment, scientists are now applying bioprinting to the generation of skin grafts to treat the severe burns that many veterans are afflicted with.

Treating severe burns is an incredibly difficult process and many rarely heal completely. Patients can be left with extreme scarring, tight and itchy skin and disfigurement. When the skin is severely burned the body focuses on preventing infection by closing the wound as quickly as possible. New skin is generated but the structure is vastly different to normal tissue.

A 5-year research project led by Prof Jeff Biernaskie at the University of Calgary Faculty of Veterinary Medicine has made a big step forward.

What weve shown is that you can alter the wound environment with drugs, or modify the genetics of these progenitor cells directly, and both are sufficient to change their behaviour during wound healing. And that can have really quite impressive effects on healing that includes regeneration of new hair follicles, glands and fat within the wounded skin.

This research could lead to new drugs that greatly improve the healing process.

It is clear from the number of veterans currently coping with a compromised quality of life that we need to do more to treat their injuries. It is estimated that the number of veterans currently living with these life changing injuries is in the millions and their healthcare needs come at an immense economic cost. Fortunately, there is now a much stronger horse in the race to a cure.

Regenerative medicine was estimated to draw nearly $15 billion in investments in 2017. That figure is predicted to rise to in excess of $79 billion by 2026. Those are serious resources, providing hope that our veterans will benefit in the decade ahead.

Sam Moxon has a PhD in regenerative medicine and is currently involved in dementia research. He is a freelance writer with an interest in the development of new technologies to diagnose and treat degenerative diseases. Follow him on Twitter@DrSamMoxon

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Regenerative medicine and war: The next breakthrough in treating injured veterans? - Genetic Literacy Project

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Exosome Therapeutic Market Latest Industry Size, Growth, Share, Emerging Demands, and Competitive Landscape || Major Gaints Jazz Pharmaceuticals,…

By daniellenierenberg

Exosome Therapeutic Market analysis report encompasses infinite knowledge and information on what the markets definition, classifications, applications, and engagements are and also explains the drivers & restraints of the market which is obtained from SWOT analysis. Gathered market data and information is denoted very neatly with the help of most appropriate graphs, charts or tables in the entire report. Utilization of well established tools and techniques in this Exosome Therapeutic Market document helps to turn complex market insights into simpler version. Competitive analysis studies of this market report provides with the ideas about the strategies of key players in the market.

A large scale Exosome Therapeutic Market report endows with the data and statistics on the current state of the industry which directs companies and investors interested in this market. By applying market intelligence for this market research report, industry expert measure strategic options, summarize successful action plans and support companies with critical bottom-line decisions. The most appropriate, unique, and creditable global market report has been brought to important customers and clients depending upon their specific business needs. Businesses can accomplish great benefits with the different & all-inclusive segments covered in the Exosome Therapeutic Market research report hence every bit of market is tackled carefully.

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Market Analysis and Insights:Global Exosome Therapeutic Market

Exosome therapeutic market is expected to gain market growth in the forecast period of 2019 to 2026. Data Bridge Market Research analyses that the market is growing with a CAGR of 21.9% in the forecast period of 2019 to 2026 and expected to reach USD 31,691.52 million by 2026 from USD 6,500.00 million in 2018. Increasing prevalence of lyme disease, chronic inflammation, autoimmune disease and other chronic degenerative diseases are the factors for the market growth.

The major players covered in theExosome Therapeutic Marketreport areevox THERAPEUTICS, EXOCOBIO, Exopharm, AEGLE Therapeutics, United Therapeutics Corporation, Codiak BioSciences, Jazz Pharmaceuticals, Inc., Boehringer Ingelheim International GmbH, ReNeuron Group plc, Capricor Therapeutics, Avalon Globocare Corp., CREATIVE MEDICAL TECHNOLOGY HOLDINGS INC., Stem Cells Group among other players domestic and global.Exosome therapeutic market share data is available for Global, North America, Europe, Asia-Pacific, and Latin America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Get Full TOC, Tables and Figures of Market Report @https://www.databridgemarketresearch.com/toc/?dbmr=global-exosome-therapeutic-market&rp

Exosomes are used to transfer RNA, DNA, and proteins to other cells in the body by making alteration in the function of the target cells. Increasing research activities in exosome therapeutic is augmenting the market growth as demand for exosome therapeutic has increased among healthcare professionals.

Increased number of exosome therapeutics as compared to the past few years will accelerate the market growth. Companies are receiving funding for exosome therapeutic research and clinical trials. For instance, In September 2018, EXOCOBIO has raised USD 27 million in its series B funding. The company has raised USD 46 million as series a funding in April 2017. The series B funding will help the company to set up GMP-compliant exosome industrial facilities to enhance production of exosomes to commercialize in cosmetics and pharmaceutical industry.

Increasing demand for anti-aging therapies will also drive the market. Unmet medical needs such as very few therapeutic are approved by the regulatory authority for the treatment in comparison to the demand in global exosome therapeutics market will hamper the market growth market. Availability of various exosome isolation and purification techniques is further creates new opportunities for exosome therapeutics as they will help company in isolation and purification of exosomes from dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, and urine and from others sources. Such policies support exosome therapeutic market growth in the forecast period to 2019-2026.

This exosome therapeutic market report provides details of market share, new developments, and product pipeline analysis, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, product approvals, strategic decisions, product launches, geographic expansions, and technological innovations in the market. To understand the analysis and the market scenario contact us for anAnalyst Brief, our team will help you create a revenue impact solution to achieve your desired goal.

Global Exosome Therapeutic Market Scope and Market Size

Global exosome therapeutic market is segmented of the basis of type, source, therapy, transporting capacity, application, route of administration and end user. The growth among segments helps you analyse niche pockets of growth and strategies to approach the market and determine your core application areas and the difference in your target markets.

Based on type, the market is segmented into natural exosomes and hybrid exosomes. Natural exosomes are dominating in the market because natural exosomes are used in various biological and pathological processes as well as natural exosomes has many advantages such as good biocompatibility and reduced clearance rate compare than hybrid exosomes.

Exosome is an extracellular vesicle which is released from cells, particularly from stem cells. Exosome functions as vehicle for particular proteins and genetic information and other cells. Exosome plays a vital role in the rejuvenation and communication of all the cells in our body while not themselves being cells at all. Research has projected that communication between cells is significant in maintenance of healthy cellular terrain. Chronic disease, age, genetic disorders and environmental factors can affect stem cells communication with other cells and can lead to distribution in the healing process. The growth of the global exosome therapeutic market reflects global and country-wide increase in prevalence of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases, along with increasing demand for anti-aging therapies. Additionally major factors expected to contribute in growth of the global exosome therapeutic market in future are emerging therapeutic value of exosome, availability of various exosome isolation and purification techniques, technological advancements in exosome and rising healthcare infrastructure.

Rising demand of exosome therapeutic across the globe as exosome therapeutic is expected to be one of the most prominent therapies for autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases treatment, according to clinical researches exosomes help to processes regulation within the body during treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases. This factor has increased the research activities in exosome therapeutic development around the world for exosome therapeutic. Hence, this factor is leading the clinician and researches to shift towards exosome therapeutic. In the current scenario the exosome therapeutic are highly used in treatment of autoimmune disease, chronic inflammation, Lyme disease and chronic degenerative diseases and as anti-aging therapy as it Exosomes has proliferation of fibroblast cells which is significant in maintenance of skin elasticity and strength.

Based on source, the market is segmented into dendritic cells, mesenchymal stem cells, blood, milk, body fluids, saliva, urine and others. Mesenchymal stem cells are dominating in the market because mesenchymal stem cells (MSCs) are self-renewable, multipotent, easily manageable and customarily stretchy in vitro with exceptional genomic stability. Mesenchymal stem cells have a high capacity for genetic manipulation in vitro and also have good potential to produce. It is widely used in treatment of inflammatory and degenerative disease offspring cells encompassing the transgene after transplantation.

Based on therapy, the market is segmented into immunotherapy, gene therapy and chemotherapy. Chemotherapy is dominating in the market because chemotherapy is basically used in treatment of cancer which is major public health issues. The multidrug resistance (MDR) proteins and various tumors associated exosomes such as miRNA and IncRNA are include in in chemotherapy associated resistance.

Based on transporting capacity, the market is segmented into bio macromolecules and small molecules. Bio macromolecules are dominating in the market because bio macromolecules transmit particular biomolecular information and are basically investigated for their delicate properties such as biomarker source and delivery system.

Based on application, the market is segmented into oncology, neurology, metabolic disorders, cardiac disorders, blood disorders, inflammatory disorders, gynecology disorders, organ transplantation and others. Oncology segment is dominating in the market due to rising incidence of various cancers such as lung cancer, breast cancer, leukemia, skin cancer, lymphoma. As per the National Cancer Institute, in 2018 around 1,735,350 new cases of cancer was diagnosed in the U.S. As per the American Cancer Society Inc in 2019 approximately 268,600 new cases of breast cancer diagnosed in the U.S.

Based on route of administration, the market is segmented into oral and parenteral. Parenteral route is dominating in the market because it provides low drug concentration, free from first fast metabolism, low toxicity as compared to oral route as well as it is suitable in unconscious patients, complicated to swallow drug etc.

The exosome therapeutic market, by end user, is segmented into hospitals, diagnostic centers and research & academic institutes. Hospitals are dominating in the market because hospitals provide better treatment facilities and skilled staff as well as treatment available at affordable cost in government hospitals.

Exosome therapeutic Market Country Level Analysis

The global exosome therapeutic market is analysed and market size information is provided by country by type, source, therapy, transporting capacity, application, route of administration and end user as referenced above.

The countries covered in the exosome therapeutic market report are U.S. and Mexico in North America, Turkey in Europe, South Korea, Australia, Hong Kong in the Asia-Pacific, Argentina, Colombia, Peru, Chile, Ecuador, Venezuela, Panama, Dominican Republic, El Salvador, Paraguay, Costa Rica, Puerto Rico, Nicaragua, Uruguay as part of Latin America.

Country Level Analysis, By Type

North America dominates the exosome therapeutic market as the U.S. is leader in exosome therapeutic manufacturing as well as research activities required for exosome therapeutics. At present time Stem Cells Group holding shares around 60.00%. In addition global exosomes therapeutics manufacturers like EXOCOBIO, evox THERAPEUTICS and others are intensifying their efforts in China. The Europe region is expected to grow with the highest growth rate in the forecast period of 2019 to 2026 because of increasing research activities in exosome therapeutic by population.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as new sales, replacement sales, country demographics, regulatory acts and import-export tariffs are some of the major pointers used to forecast the market scenario for individual countries. Also, presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of sales channels are considered while providing forecast analysis of the country data.

Huge Investment by Automakers for Exosome Therapeutics and New Technology Penetration

Global exosome therapeutic market also provides you with detailed market analysis for every country growth in pharma industry with exosome therapeutic sales, impact of technological development in exosome therapeutic and changes in regulatory scenarios with their support for the exosome therapeutic market. The data is available for historic period 2010 to 2017.

Competitive Landscape and Exosome Therapeutic Market Share Analysis

Global exosome therapeutic market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, product trials pipelines, concept cars, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companys focus related to global exosome therapeutic market.

Many joint ventures and developments are also initiated by the companies worldwide which are also accelerating the global exosome therapeutic market.

For instance,

Partnership, joint ventures and other strategies enhances the company market share with increased coverage and presence. It also provides the benefit for organisation to improve their offering for exosome therapeutics through expanded model range.

Customization Available:Global Exosome Therapeutic Market

Data Bridge Market Researchis a leader in advanced formative research. We take pride in servicing our existing and new customers with data and analysis that match and suits their goal. The report can be customised to include price trend analysis of target brands understanding the market for additional countries (ask for the list of countries), clinical trial results data, literature review, refurbished market and product base analysis. Market analysis of target competitors can be analysed from technology-based analysis to market portfolio strategies. We can add as many competitors that you require data about in the format and data style you are looking for. Our team of analysts can also provide you data in crude raw excel files pivot tables (Factbook) or can assist you in creating presentations from the data sets available in the report.

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Exosome Therapeutic Market Latest Industry Size, Growth, Share, Emerging Demands, and Competitive Landscape || Major Gaints Jazz Pharmaceuticals,...

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funded study sheds light on abnormal neural function in rare genetic disorder – National Institutes of Health

By daniellenierenberg

News Release

Monday, September 28, 2020

Findings show deficits in the electrical activity of cortical cells; possible targets for treatment for 22q11.2 deletion syndrome.

A genetic study has identified neuronal abnormalities in the electrical activity of cortical cells derived from people with a rare genetic disorder called 22q11.2 deletion syndrome. The overexpression of a specific gene and exposure to several antipsychotic drugs helped restore normal cellular functioning. The study, funded by the National Institutes of Health (NIH) and published in Nature Medicine, sheds light on factors that may contribute to the development of mental illnesses in 22q11.2 deletion syndrome and may help identify possible targets for treatment development.

22q11.2 deletion syndrome is a genetic disorder caused by the deletion of a piece of genetic material at location q11.2 on chromosome 22. People with 22q11.2 deletion syndrome can experience heart abnormalities, poor immune functioning, abnormal palate development, skeletal differences, and developmental delays. In addition, this deletion confers a 20-30% risk for autism spectrum disorder (ASD) and an up to 30-fold increase in risk for psychosis. 22q11.2 deletion syndrome is the most common genetic copy number variant found in those with ASD, and up to a quarter of people with this genetic syndrome develop a schizophrenia spectrum disorder.

This is the largest study of its type in terms of the number of patients who donated cells, and it is significant for its focus on a key genetic risk factor for mental illnesses, said David Panchision, Ph.D., chief of the Developmental Neurobiology Program at the NIHs National Institute of Mental Health. Importantly, this study shows consistent, specific patient-control differences in neuronal function and a potential mechanistic target for developing new therapies for treating this disorder.

While some effects of this genetic syndrome, such as cardiovascular and immune concerns, can be successfully managed, the associated psychiatric effects have been more challenging to address. This is partly because the underlying cellular deficits in the central nervous system that contribute to mental illnesses in this syndrome are not well understood. While recent studies of 22q11.2 deletion syndrome in rodent models have provided some important insights into possible brain circuit-level abnormalities associated with the syndrome, more needs to be understood about the neuronal pathways in humans.

To investigate the neural pathways associated with mental illnesses in those with 22q11.2 deletion syndrome, Sergiu Pasca, M.D., associate professor of psychiatry and behavioral sciences at Stanford University, Stanford, California, along with a team of researchers from several other universities and institutes, created induced pluripotent stems cells cells derived from adult skin cells reprogramed into an immature stem-cell-like state from 15 people with 22q11.2 deletion and 15 people without the syndrome. The researchers used these cells to create, in a dish, three-dimensional brain organoids that recapitulate key features of the developing human cerebral cortex.

What is exciting is that these 3D cellular models of the brain self-organize and, if guided to resemble the cerebral cortex, for instance, contain functional glutamatergic neurons of deep and superficial layers and non-reactive astrocytes and can be maintained for years in culture. So, there is a lot of excitement about the potential of these patient-derived models to study neuropsychiatric disease, said Dr. Pasca.

The researchers analyzed gene expression in the organoids across 100 days of development. They found changes in the expression of genes linked to neuronal excitability in the organoids that were created using cells from individuals with 22q11.2 deletion syndrome. These changes prompted the researchers to take a closer look at the properties associated with electrical signaling and communication in these neurons. One way neurons communicate is electrically, through controlled changes in the positive or negative charge of the cell membrane. This electrical charge is created when ions, such as calcium, move into or out of the cell through small channels in the cells membrane. The researchers imaged thousands of cells and recorded the electrical activity of hundreds of neurons derived from individuals with 22q11.2 deletion syndrome and found abnormalities in the way calcium was moved into and out of the cells that were related to a defect in the resting electrical potential of the cell membrane.

A gene called DGCR8 is part of the genetic material deleted in 22q11.2 deletion syndrome, and it has been previously associated with neuronal abnormalities in rodent models of this syndrome. The researchers found that heterozygous loss of this gene was sufficient to induce the changes in excitability they had observed in 22q11.2-derived neurons and that overexpression of DGCR8 led to partial restoration of normal cellular functioning. In addition, treating 22q11.2 deletion syndrome neurons with one of three antipsychotic drugs (raclopride, sulpiride, or olanzapine) restored the observed deficits in resting membrane potential of the neurons within minutes.

We were surprised to see that loss in control neurons and restoration in patient neurons of the DGCR8 gene can induce and, respectively, restore the excitability, membrane potential, and calcium defects, said Pasca. Moving forward, this gene or the downstream microRNA(s) or the ion channel/transporter they regulate may represent novel therapeutic avenues in 22q11.2 deletion syndrome.

Grants:MH107800; MH100900; MH085953; MH060233; MH094714

About the National Institute of Mental Health (NIMH):The mission of theNIMHis to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery and cure. For more information, visit theNIMH website.

About the National Institutes of Health (NIH):NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

NIHTurning Discovery Into Health

Khan, T. A., Revah, O., Gordon, A., Yoon, S., Krawisz, A. K., Goold, C., Sun, Y., Kim, C., Tian, Y., Li, M., Schaepe, J. M., Ikeda, K., Amin, N. D., Sakai, N., Yazawa, M., Kushan, L., Nishino, S., Porteus, M. H., Rapoport, J. L. Paca, S. (2020). Neuronal defects in a human cellular model of 22q11.2 deletion syndrome. Nature Medicine. doi: 10.1038/s41591-020-1043-9

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funded study sheds light on abnormal neural function in rare genetic disorder - National Institutes of Health

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