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Category Archives: Transhuman News

Systemic Therapies Linked With Herpes Zoster Risk in Patients With Psoriasis – AJMC.com Managed Markets Network

Posted: June 23, 2021 at 6:45 am

Corresponding author George Kuo, PhD, of the Linkou Chang Gung Memorial Hospital, in Taiwan, and colleagues, explained that it has previously been shown that patients with psoriasis face a higher risk of HZ infection.

However, the association between HZ risk and different systemic therapies, especially biologic agents, remains controversial, they wrote.

Biologic agents can be highly effective at treating psoriasis, but they also result in suppression of cell-mediated immunity, raising the risk that they increase risk of bacterial and viral infections.

Kuo and colleagues sought to understand the risk on a therapy-by-therapy basis. To do so, they identified 92,374 patients in the Taiwan National Health Insurance Research Database who were newly diagnosed with psoriasis between 2001 and 2013. The investigators tracked these patients for a median of 6.8 years, noting the use of anti-psoriasis therapies and looking for diagnoses of HZ infection.

In all, 4834 patients (5.2%) were diagnosed with HZ. The authors found that older age, female sex, hypertension, dyslipidemia, psoriatic arthritis, and a relatively high Charleston comorbidity index score were all associated with increased risk of HZ infection. Concurrent exposure to steroids and statins was also linked with an increased risk. However, the 3 therapies identified as increasing HZ risk each more than quadrupled the risk of infection: etanercept (HR, 4.78; 95% CI, 1.5115.17); adalimumab (HR, 5.52; 95% CI, 1.7217.71); and methotrexate plus azathioprine (HR, 4.17; 95% CI, 1.789.82).

Kuo and colleagues said this is the first report to link etanercept and adalimumab to HZ infection. In addition to finding that methotrexate plus azathioprine significantly increased the risk, they also found that methotrexate combined with any biologic agent increased risk, though not to a statistically significant level.

Another biologic, ustekinumab (Stelara) was also studied, and none of those patients became infected with HZ. However, Kuo and colleagues said that could be due to the fact that it was not approved in Taiwan until 2011, and therefore there was a limited amount of follow-up time for those patients in the study.

Conversely, 2 psoriasis treatmentsphototherapy and acitretin (Soriatane)were associated with a lower risk of psoriasis. Phototherapy had a HR of 0.76 (95% CI, 0.600.96) and acitretin had a HR of 0.39 (95% CI, 0.240.64). Kuo and colleagues said the lower risk associated with acitretin may be due to the lower level of immunosuppression associated with acitretin monotherapy. In the case of phototherapy, which uses UV light, they suggested that the benefit is linked with the increased level of vitamin D associated with UV exposure. Earlier reporting has suggested that vitamin D therapy can lower the risk of HZ.

The authors noted limitations including the unavailability of several other biologics at the time of the study, and a lack of data related to psoriasis severity, which limited their ability to adjust their findings based on severity or laboratory results. However, they noted that in previous studies, the use of systemic therapies or a psoriatic arthritis diagnosis have been used as proxies for labeling cases moderate to severe, suggesting that the patients in this study could be assumed to be in the same category.

Reference

Ting SW, Ting SY, Lin YS, Lin MS, Kuo G. Risk of herpes zoster in psoriasis patients receiving systemic therapies: a nationwide population-based cohort study. Sci Rep. Published online June 3, 2021. doi:10.1038/s41598-021-91356-3

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Psoriasis Market Analysis, Size, Regional Outlook, Competitive Strategies and Forecasts to 2027 The Manomet Current – The Manomet Current

Posted: at 6:45 am

The research report presents a comprehensive assessment of the Psoriasis Market and contains thoughtful insights, facts, historical data, and statistically supported and industry-validated market data. Psoriasis with 100+ market data Tables, Pie Chat, Graphs & Figures spread through Pages and easy to understand detailed analysis. Psoriasis market future, competitive analysis by Psoriasis Market Players, Deployment Models, Opportunities, Future Roadmap, Value Chain, Major Player Profiles.

Psoriasis market report records and concentrates the main rivals likewise furnishes the bits of knowledge with vital industry Analysis of the key elements impacting the market. Psoriasis Market Report contains revenue numbers, product details, and sales of the major firms. Additionally, it provides a breakdown of the revenue for the global Psoriasis market. The report contains basic, secondary and advanced information pertaining to the Psoriasis Market global status and Psoriasis market size, share, growth, trends analysis, segment and forecast.

Global psoriasis market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market is growing at a healthy CAGR in the above-mentioned research forecast period.

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Psoriasis Market competition by top manufacturers/players, with sales volume, Price (USD/Unit), Revenue (Million USD) and market share for each manufacturer/player; the top players including:

Novartis AG, Pfizer Inc., Merck & Co., Inc, Takeda Pharmaceutical Company Limited, Abbvie Inc., Bayer AG, Boehringer Ingelheim International GmbH, Sun Pharmaceuticals Industries Ltd., Johnson & Johnson Services, Inc, AstraZeneca and others. .

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Galapagos announces departure of CSO Piet Wigerinck later this year – StreetInsider.com

Posted: at 6:45 am

News and research before you hear about it on CNBC and others. Claim your 1-week free trial to StreetInsider Premium here.

Mechelen, Belgium; 22 June 2021, 22.01 CET; regulated information Galapagos NV (Euronext & NASDAQ: GLPG) announces the departure of Dr. Piet Wigerinck later this year.

Dr. Piet Wigerinck joined Galapagos as Senior Vice President Development in 2008 and became Chief Scientific Officer in 2012, overseeing the discovery of novel drug targets through to clinical Proof-of-Concept studies. He led his teams through the very first clinical research done in healthy volunteers at Galapagos and was responsible for the Phase 2 FITZROY and DARWIN programs for filgotinib, which later became Galapagos first commercial product Jyseleca. Under his leadership, Galapagos achieved a significant portfolio of over 100 patent families.

Effective immediately, all early-stage development activities will be added to late-stage clinical development under the responsibility of Chief Medical Officer Dr. Walid Abi-Saab. Piet will remain with the company the coming five months to steer progression of early research while a new leader is sought.

We are grateful to Piet for his strong scientific leadership over the years. Piets vision to identify novel druggable targets has resulted in a large, data-rich pipeline of promising molecules in multiple disease areas which ultimately was partnered with Gilead in a landmark deal. The results with TYK2 inhibitor GLPG3667 and the patient studies with Toledo molecule GLPG3970 expected this summer form part of his considerable legacy, said Onno van de Stolpe, CEO of Galapagos.

Galapagos retains all guidance for full year 2021 newsflow, including the report of topline results this summer from a Phase 1b trial with TYK2 inhibitor GLPG3667 in psoriasis, and three patient studies with lead Toledo candidate SIK2/3 inhibitor GLPG3970 in psoriasis, ulcerative colitis, and rheumatoid arthritis.

About Galapagos

Galapagos NV discovers and develops small molecule medicines with novel modes of action, several of which show promising patient results and are currently in development in multiple diseases. Our pipeline comprises discovery through Phase 3 programs in inflammation, fibrosis and other indications. Our ambition is to become a leading global biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. More information at http://www.glpg.com.

This press release contains inside information within the meaning of Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation).

Except for filgotinibs approval for the treatment of rheumatoid arthritis by the European Commission and Japanese Ministry of Health, Labour and Welfare, our drug candidates are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.

Jyseleca is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies.

Contact

Investors:Elizabeth GoodwinVP Investor Relations +1 781 460 1784

Sofie Van GijselSenior Director Investor Relations+32 485 19 14 15ir@glpg.com

Media:Carmen VroonenGlobal Head of Communications & Public Affairs+32 473 824 874

Evelyn FoxDirector Executive Communications+31 6 53 59 19 99communications@glpg.com

Forward-looking statements

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, that are subject to risks, uncertainties and other factors that could cause actual results to dier materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trial and product development activities, competitive developments, and regulatory approval requirements, including the risk that data from the ongoing and planned clinical research programs in rheumatoid arthritis, Crohns disease, ulcerative colitis, idiopathic pulmonary fibrosis, osteoarthritis, and other inflammatory indications may not support registration or further development due to safety, efficacy or other reasons, the timing or likelihood of regulatory authorities approval of marketing authorization for filgotinib for RA, UC or any other indication, such regulatory authorities requiring additional studies, changes in our management board and key personnel, our ability to effectively transfer knowledge during this period of transition, the search and recruitment of a suitable successor to lead our research organization, Galapagos strategic R&D ambitions, including progress on our fibrosis portfolio, and potential changes of such ambitions, Galapagos reliance on collaborations with third parties, including the collaboration with Gilead for filgotinib, the uncertainty regarding estimates of the commercial potential of filgotinib, the timing of and the risks related to implementing the amendment of our arrangement with Gilead for the commercialization and development of Jyseleca (filgotinib), the uncertainties relating to the impact of the COVID-19 pandemic and our strategy, business plans and focus, as well as those risks and uncertainties identified in our Annual Report on Form 20-F for the year ended 31 December 2020 and our subsequent filings with the SEC. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The forward-looking statements contained herein are based on managements current expectations and beliefs and speak only as of the date hereof, and Galapagos makes no commitment to update or publicly release any revisions to forward-looking statements in order to reflect new information or subsequent events, circumstances or changes in expectations.

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How This Gut-Health Advocate Gets Her Skin So Good – The Cut

Posted: at 6:44 am

Why Is Your Skin So Good

Do you ever see someone on Instagram and think,Why is your skin so good?We do, so we started asking.

Photo: Courtesy of Carla Oates

Long before people were talking about the microbiome and searching for the perfect bowel movement in the name of beauty, Carla Oates was aware of the link between the gut and skin. I had eczema as a child and a teenager, and at about 13, my mom eliminated certain foods from my diet and introduced other foods, she says. So from a very young age, I saw the connection between what we put into our body and our skin. But it especially hit home when her own daughter experienced eczema at the age of 10 and she stumbled across research that looked at the connection between certain types of bacteria and eczema allergies.

As I explored that link further, I decided to put my family on a gut-healing protocol. That includes taking some of the digestive irritants and foods that cause a lot of problems for people, like dairy, gluten, corn, and soy, completely out of our diet. We became kind of staunch on it and started introducing more probiotic-rich, lacto-fermented foods. I would make coconut kefir and put it in my daughters smoothies. I was making her buckwheat porridge in the morning. I tried to incorporate sauerkraut where I could with the kids, which was a little bit challenging because I didnt always love the taste of it, Oates remembers. And I saw such a huge difference in not only my daughters skin but her focus she had some issues with focusing at school. Oatess own skin healed, too.

Then came the deluge of questions asking what she was doing differently. All I was doing was eating fermented foods, she says. But she received enough inquiries that in 2009, she founded the Beauty Chef, where she creates bio-fermented, probiotic whole-food powders, elixirs, and supplements meant to support gut health, and yes, glowing skin. In the years since, Oates has shared some of her favorite gut-supporting recipes in her books, The Beauty Chef Gut Guide: With 90+ Delicious Recipes and Weekly Meal Plans and The Beauty Chef: Delicious Food for Radiant Skin, Gut Health, and Wellbeing.

Oates recognizes that eating clean and incorporating supplements into your diet can be a luxury, but at its core, she says, its all about going back to the basics. Dont take supplements if you cant afford to get them. Just go back to trying to really embrace a healthy diet. Your microbiome loves fiber, leafy greens, nuts, legumes a Mediterranean diet, basically. Take processed foods out. Incorporate bone broths that are rich in connective tissue. Grow a little garden in your yard, put some spices and herbs in it, and make big batches of stews it can be that simple.

The same goes for your skin-care routine. I have customers saying, Im using this, this, this, this, this, that supplement, and that supplement, and Im not seeing any differences. What can I do? What else can I take? she says. But the people that have the best results, they pare it back. After all, she points out, the skin has its own microbiome. So youve got an ecosystem on your skin, and if youre suffocating it, and confusing your skin with too many ingredients, that causes so many imbalances. Let your skin breathe.

Below, Oates walks us through her go-tos, including the toner that smells like apple-cider vinegar but really works, the face oil that made her skin brighter, and the mineral sunscreen she has been using for years.

GLOW is a bio-fermented whole-foods powder fermentation makes all of the nutrients in the ingredients more bioavailable to the skin. This is not just your daily essential skin powder. Its your daily wellness powder. Its amazing for your gut, but we also get incredible feedback from people saying it improves their skin even hormonal acne. Its great for more lustrous hair, stronger nails, more energy, and a better and happier tummy. Weve had people who notice a difference within a week. We also have people who might have some hormonal acne, and it can take up to a couple of months weve got some incredible before-and-afters.

Weve got lots of different types of bacteria in GLOW thats the base of all of our products and then to make them even more potent and efficacious, we add medicinal herbs. In the powder, we have broad-spectrum B vitamins from sprouted quinoa, biotin, and niacinamide, which is important for skin structural integrity. We have provitamin A from fermented microalgae that is grown in Western Australia, and we know that provitamin A is really important for skin cellular renewal. Its super-rich in polyphenols and antioxidants that are really important for supporting gut health.

I love it with water, and its great in a smoothie it makes every smoothie tastes delicious. Berries and plums have a rosy note, so you do get some of that, but its primarily berry-flavored. Weve got maqui berries in there, and they have higher levels of antioxidants than blueberries, and weve also got grape skins in there. Weve got Kakadu plums, which are Australian plums that have been used for thousands of years in Aboriginal culture for their medicinal benefits.

Ill follow it with our COLLAGEN Inner Beauty Boost, a bio-fermented, probiotic elixir. It doesnt actually contain real collagen but supports your bodys ability to make it and slow down the degradation of existing collagen. Inflammation and oxidative stress are some of the main drivers of the breakdown of collagen, so weve got a host of anti-inflammatory ingredients in it, and its super-rich in antioxidants, too.

I love concocting things. I wrote a book in 2002 called Feeding Your Skin. Its basically a recipe book for skin care Ive made cleansers, moisturizers, and fresh food masks for years. Now oil cleansers are very in vogue.

I use lots of different oils depending on what Ive got in my cupboard, but often, I make a combination of jojoba, apricot, and almond oils I generally dont put more active oils like rosehip in there because youre taking it off anyway. And if I run out of oils, I even just use the olive oil thats in my kitchen.

The type of oil you should use on your skin really depends on your skin type. So, for example, if I had really oily skin, I would not use olive oil to cleanse. But my skin is kind of combination and gets dry in areas, so olive oil will be completely fine for me. I will say that Im such a big believer in people that have really oily skin doing oil cleansing. Lighter oils like jojoba are really effective because when you strip your skin of oil, it sends a message to the brain to produce more oil, which then sends your oil glands into overdrive because theyre like, Oh my God, I need to go into production. So cleansing with oil tricks your brain into thinking youve produced enough oil you just need to make sure that, if youve got really oily skin thats congested and prone to breakouts, you remove it with a warm muslin cloth.

This is a really cool product. I think because were known as an ingestible brand, people forget about it. Occasionally, I will write an email to our team going, Guys, do not forget about the Probiotic Skin Refiner. Its a game-changer!

Basically, its a bio-fermented whole-food extract its the liquid that comes from the fermentation of our powders. Its got a low pH of 3.5, so its naturally exfoliating, and thats because of the lactic-acid fermentation. And you know, lactic acid is also an alpha hydroxy acid (AHA), so it helps to not only increase cellular turnover but also synthesize collagen and increase natural moisturizing patches in the skin.

After I wash my face, I pat it all over with a muslin pad soaked in it. The only thing I would say is that because the Probiotic Skin Refiner is an AHA, make sure that youre putting an SPF on after, especially if youre going outside.

The reason that I never brought it out when we first started the Beauty Chef is hilarious. I had this incredible, nutrient-dense extract that was coming off the fermented foods. I was bottling some of it, and then we were disposing of the rest of it, which was such a waste. But I was using it on my skin, and my friends and family wanted to know what my routine was. I said, Look, Im using this stuff, but it smells really bad. They got really annoyed with me because once they started using it, they were like, I dont understand why you dont put this out in your product range. I said, Because it smells like apple-cider vinegar cause its fermented. Its got a really strong scent. They were like, We dont care: It works. Its amazing. Give us more. One reviewer actually said, My husband goes, Oh my God, what is that smell? I was lying in bed next to him. But genuinely, if you put a cream on top of it, the smell dissipates within seconds, and because its so effective, people just dont seem to care.

I do moisturize a bit more as Im aging. Im predisposed to eczema. Since I began paying attention to my gut, I havent had a really bad eczema breakout for like 20-something years, which is amazing, but I do genetically have dry skin. My son and I were talking about it the other night. Like, my mom had really scaly legs, and now both of my kids are prone to eczema as well because my husband has eczema, so they got a double whammy of being predisposed to really dry skin.

Emma Lewishams a New Zealander, and I have just been introduced to her. Shes focused on sustainability and generous with sharing information about her journey and how she is moving toward truly sustainable packaging. And not only that, but her products are highly efficacious. Theyre rich in natural botanicals. This is called the 72-Hour Crme, and Ive really noticed that my skin looks so much plumper. It really does give my skin that kind of dewy radiance that I love I dont mind that feeling when I put on some oil and then I put on a really beautiful moisturizer that makes my skin kind of shiny and dewy; I much prefer that to feeling like my skin is cracking. Its got a lovely smell; its very subtle, a little bit soapy. Its sort of old-fashioned but vegan and cruelty-free.

Photo: Courtesy of the Retailer

I love Marie Veroniques story her daughters a scientist, and they did the range together. Her products have lots of really amazing natural ingredients, but theyre also highly active. In this oil, specifically, I love the combination of high-performing actives with carotenoid antioxidants, which are amazing for protecting the skin from free-radical damage and helping to prevent collagen from degradation. Its also rich in essential fatty acids, which are crucial for maintaining and building a healthy skin barrier. Ill alternate it with Sunday Rileys C.E.O. Glow Vitamin C + Turmeric Face Oil (below).

I love vitamin C, and I love turmeric theyre both anti-inflammatory. I definitely noticed a difference in my skin tone and texture with this. Theyre brighter and smoother. Its a really beautiful oil.

I used to put coconut oil it was called Reef Oil on as a teenager and bake my skin. And I saw a facialist, I think was in my early 20s, and she said, Carla, youve got some sun damage. So I became much more conscious about sun protection, but I grew up in Australia in the 70s. And, oh my gosh, my mom was always out in the sun with her Reef Oil on as well. I will say that vitamin D is also really good for your skin, your immune health, and your bone health, and that a percentage of the worlds population is deficient in vitamin D, but lets find that balance between getting enough and protecting ourselves.

Ive been using mineral sunscreens for a long time I prefer ingredients like zinc oxide that physically protect you from the sun. But the problem with a lot of physical blockers is that they make your skin look white. Sometimes my husband at the beach will be like, Oh my God. Especially when youre going out to work, you dont want to look like youve got this white face. So what I love about this Coola sunscreen is that its really smooth and it dissipates. You dont notice it, and its such a great experience. Its also fragrance free.

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Side Effects of Hand Sanitizer, Risks, and How to Use It Safely – Healthline

Posted: at 6:44 am

Hand sanitizer has become more popular than ever, in large part due to its effectiveness during the COVID-19 pandemic. Portable hand sanitizer products kill germs on your hands and other surfaces on contact, helping to slow the spread of transmissible diseases like COVID-19.

Hand sanitizer has proven itself useful in killing germs, but using it can have side effects. Overuse of hand sanitizer can lead to dry, cracked skin as well as redness or discoloration, and flaking. It can also pose a risk if its ingested or gets into your eyes.

Lets cover everything you need to know about using hand sanitizer safely.

The side effects of your hand sanitizer will come down to the formulas youre using. Hand sanitizer typically contains a high amount of alcohol (between 60 and 95 percent) meant to kill germs on your hands. Even if the alcohol content is low, your hand sanitizer may also contain other antiseptic ingredients that have been known to cause side effects.

Alcohol is an effective antiseptic, meaning that its proven to kill bacteria and viruses on organic surfaces. But alcohol is also known to have a drying effect on your skin.

When youre applying hand sanitizer to your hands multiple times each day, the product is taking moisture out of your skin. This can result in skin thats dry, flaky, and sensitive to the touch. In addition to being uncomfortable, the American Academy of Dermatology Association says that having dry skin can actually increase your chances of picking up germs.

You may notice that after hand sanitizer dries on your hands, itchy and red or discolored eczema patches tend to appear. Thats because if you have eczema, the chemicals can actually make your symptoms worse. Whether you use a foam, liquid, or a gel-based hand sanitizer, you may see increased eczema symptoms after use.

Hand sanitizer sometimes contains an ingredient called triclosan. According to the FDA, Triclosan is intended to kill bacteria, and has been used in products from toothpaste to body wash. The FDA also says some studies have indicated that high exposure to triclosan may disrupt natural hormone cycles and even impact fertility. More research is needed to fully understand triclosans impact on people, but the ingredient has already been banned from several types of products.

The FDA says that triclosan is intended to kill bacteria, but overuse of this ingredient in consumer products may be contributing to the rise in antibiotic-resistant bacteria. A 2015 research review of how triclosan is contributing to antibiotic resistance concluded that more research is necessary to determine how this chemical is actually impacting human health.

There are risks for using hand sanitizer, especially if you use it in ways other than instructed on the package instructions. These risks can typically be avoided by sticking to external use of hand sanitizer and avoiding contact with your eyes.

The high amounts of alcohol and other ingredients make hand sanitizer unsafe for human consumption. Texas Medical Center says that anyone who swallows a significant quantity of hand sanitizer can get sick with symptoms that resemble alcohol poisoning.

Hand sanitizer is meant for external use only. If you or someone you know has ingested it, call the Poison Control Hotline at 800-222-1222.

Its easy enough to apply hand sanitizer and accidentally touch your eye shortly afterward. But the high levels of alcohol in hand sanitizer can actually cause chemical burns on the outer layer of your eye. Typically, damage caused by hand sanitizer to your eyes will completely heal, but you may experience the following symptoms while it heals:

Theres a reason that doctors recommend washing your hands with soap and water over using hand sanitizer. Its because its very simple to accidentally overdo it with hand sanitizer and cause dry skin and other side effects.

In fact, if you use hand sanitizer so much that your hands get dried out, it may be easier for your hands to pick up germs from other surfaces.

Additionally, your skin may start to crack or bleed. Skin thats dried out and cracked may also be more susceptible to bacteria.

Read ingredient labels before you buy hand sanitizer and limit how much you use it to the product labels recommendations. For best results:

When used properly, hand sanitizer does have benefits, including:

To use hand sanitizer correctly, you should only use it when your hands are free from visible dirt. Use only a dime-sized amount (or less) and rub your hands together until the hand sanitizer has completely absorbed. For best results (and healthy skin), apply a moisturizer as soon as possible after the hand sanitizer has dried. This will help prevent some of the less than desirable side effects.

When hand sanitizer is used correctly, side effects and risks are minimal. When you overuse the product, it can cause dry hands and cracked skin. Some ingredients in hand sanitizer, such as triclosan, may cause health complications if you are exposed to them in large amounts. Always read ingredient labels before you buy and only use hand sanitizer according to the guidance on the product label.

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Mysteries of Epigenetics: There’s More to Genes Than DNA – SciTechDaily

Posted: at 6:44 am

Biologists at the Universities of Bath and Vienna have discovered 71 new imprinted genes in the mouse genome, a finding that takes them a step closer to unraveling some of the mysteries of epigenetics an area of science that describes how genes are switched on (and off) in different cells at different stages in development and adulthood.

To understand the importance of imprinted genes to inheritance, we need to step back and ask how inheritance works in general. Most of the thirty trillion cells in a persons body contain genes that come from both their mother and father, with each parent contributing one version of each gene. The unique combination of genes goes part of the way to making an individual unique. Usually, each gene in a pair is equally active or inactive in a given cell. This is not the case for imprinted genes. These genes which make up less than one percent of the total of 20,000+ genes tend to be more active (sometimes much more active) in one parental version than the other.

Until now, researchers were aware of around 130 well-documented imprinted genes in the mouse genome the new additions take this number to over 200. Professor Tony Perry, who led the research from the Department of Biology & Biochemistry at Bath, said: Imprinting affects an important family of genes, with different implications for health and disease, so the seventy-plus new ones add an important piece of the jigsaw.

Close examination of the newly identified genes has allowed Professor Perry and his colleagues to make a second important discovery: the switching on and off of imprinted genes is not always related to DNA methylation, where methyl groups are added to genomic DNA (a process that is known to repress gene activity, switching them off). DNA methylation was the first known type of imprint, and was discovered around thirty years ago. From the results of the new work, it seems that a greater contribution to imprinting is made by histones structures that are wrapped up with genomic DNA in chromosomes.

A normal 4-day-old mouse embryo (L) and an embryo of the same age that has been manipulated to contain maternal chromosomes only (parthenogenote). At this stage, the embryos (blastocysts) appear similar, but the parthenogenote will soon die, underscoring the importance of inheriting imprinted genes from both parents. Different cell types are stained green or red. Credit: Dr. Maki Asami, University of Bath

Although scientists have known for some time that histones act as dimmer switches for genes, fading them off (or back on), until now it was thought that DNA methylation provided the major switch for imprinted gene activity. The findings from the new study cast doubt on this assumption: many of the newly identified genes were found to be associated with changes to the histone 3 lysine 27 (H3K27me3), and only a minority with DNA methylation.

Scientists have yet to work out how one parental version of a given gene can be switched (or faded) on or off and maintained that way while the other is in the opposite state. It is known that much of the on/off switching occurs during the formation of gametes (sperm and egg), but the precise mechanisms remain unclear. This new study points to the intriguing possibility that some imprinted genes may not be marked in gametes, but become active later in development, or even in adulthood.

Although it only involves a small proportion of genes, imprinting is important in later life. If it goes wrong, and the imprinted gene copy from one parent is switched on when it should be off (or vice versa), disease or death occur. Faulty imprinted genes are associated with many diseases, including neurological and metabolic disorders, and cancer.

We may underestimate how important the relationship between imprinting and disease is, as well as the relationship of imprinting to the inheritance of parentally-acquired disease, such as obesity, said Professor Perry. Hopefully, this improved picture of imprinting will increase our understanding of disease.

Reference: Genomic imprinting in mouse blastocysts is predominantly associated with H3K27me3 by Laura Santini, Florian Halbritter, Fabian Titz-Teixeira, Toru Suzuki, Maki Asami, Xiaoyan Ma, Julia Ramesmayer, Andreas Lackner, Nick Warr, Florian Pauler, Simon Hippenmeyer, Ernest Laue, Matthias Farlik, Christoph Bock, Andreas Beyer, Anthony C. F. Perry and Martin Leeb, 21 June 2021, Nature Communications.DOI: 10.1038/s41467-021-23510-4

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Atopic Eczema Treatment Market 2020 : Research Reveals Enhanced Growth During The Forecast Period 2026 KSU | The Sentinel Newspaper – KSU | The…

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Sanofi S.A. Regeneron Pharmaceuticals Inc.

LEO Pharma A/S

Medimmune LLC. (AstraZeneca)

Impact Analysis of COVID-19 Pandemic on Businesses: Know Short Term and Long Term Impact

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Industry study presents the global Atopic Eczema Treatment market size, historical breakdown data (2014-2019), and forecast (2020-2026). Production, revenue, and market share by key vendors, key regions, and type; The consumption of Atopic Eczema Treatment market in terms of volume is also provided for major countries (or regions), and for each application and product at the global level.

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Key Answers in the Report

In this study, the years considered to estimate the market size of Atopic Eczema Treatment Market:

Geographically, this report is segmented into several key regions, with sales, revenue, market share, and growth rate of Atopic Eczema Treatment in these regions, from 2020 to 2026, covering

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Regional Overview

In this part of the Atopic Eczema Treatment Market report, we will be taking a look at the geographical areas and the role they play in contributing to the growth of this line of business. The areas of interest in this document are as follows the Middle East and Africa, South and North America, Europe, and the Asia Pacific. From the Atopic Eczema Treatment Market report, it becomes clear which region is the largest contributor.

Latest Industry News

From this Atopic Eczema Treatment Market report, the reader will also get to learn about the latest developments in the industry. The reason is that these products or services have the potential to disrupt this line of business. If there is information about company acquisitions or mergers, this information will also be available in this portion of the Atopic Eczema Treatment Market report.

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Atopic Eczema Treatment Market 2020 : Research Reveals Enhanced Growth During The Forecast Period 2026 KSU | The Sentinel Newspaper - KSU | The...

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FDA Action Alert: Incyte and Ascendis – BioSpace

Posted: at 6:44 am

Incyte had a particularly big week scheduled with the U.S. Food and Drug Administration (FDA), which included two PDUFA dates and an advisory committee meeting. In addition, Ascendis had a target action date. However, the agency had a chance of plans. Read on for more information.

Incytes Ruxolitinib Cream for Atopic Dermatitis

Incytehas a target action date of June 21, 2021, for its New Drug Application (NDA) for ruxolitinib cream, a selective JAK1/JAK2 inhibitor designed for topical application for atopic dermatitis (AD), a type of eczema. The NDA included data from the Phase III TRuE-AD clinical trial program of more than 1,200 people ages 12 and older. The company submitted a priority review voucher (PRV) with the NDA. The use of the PRV shortens the review period by four weeks. On June 11, the company reported the FDA had extended the review period for the NDA by three months to September 21, 2021. The agency indicated it needed time to review additional analyses the company submitted in response to an information request.

At the companys first-quarter financial report on May 4, Herve Hoppenot, Incytes chief executive officer, said, We expect an exciting year ahead for Incyte with the potential for multiple approvals, including ruxolitinib cream in atopic dermatitis, and several regulatory filings, notably parsaclisib in NHL and ruxolitinib cream in vitiligo. We are also initiating pivotal trials across key development programs for both tafasitamab and LIMBER this year.

Incytes Ruxolitinib for Steroid-Refractory Chronic Graft-Versus-Host Disease

Incyte also has a target action date of June 22 for its supplemental NDA for ruxoliltinib (Jakafi) for treatment of steroid-refractory chronic graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older. This sNDA is built on data from the Phase III REACH3 trial comparing ruxolitinib with best available therapy (BAT) in this patient population. In that study, patients receiving ruxolitinib had a significantly greater overall response rate (ORR) compared to BAT at Week 24, which was the primary endpoint of the study. The ORR was 49.7% in the ruxolitinib group compared to 25.6% in the BAT cohort. On June 8, 2021, Incyte announced the FDA had also extended the review period for the sNDA for Jakafi for this indication until September 22, 2021. Again, it was in response to additional information submitted as part of an FDA information request.

Chronic GVHD is a life-threatening complication following stem cell transplant that burdens a vulnerable patient population, which today has limited treatment options, said Peter Langmuir, Group Vice President, Oncology Targeted Therapies, Incyte, in a February 2021 statement. The acceptance of this sNDA represents an important milestone for Incyte as we continue our work towards helping more people living with GVHD, particularly for those who do not respond to steroids. We look forward to working closely with the FDA to bring this innovative therapy to patients and to providing continued support to the GVHD community in the United States.

FDAs AdCom to Review Incytes BLA for Retifanlimab Injection for Anal Cancer

In what is clearly a busy week for Incyte, the FDAs Oncologic Drugs Advisory Committee is holding a meeting on June 24 to discuss the companys Biologics License Application (BLA) for retifanlimab injection for the treatment of adults with locally advanced or metastatic squamous carcinoma of the anal canal (SCAC) who have progressed on or who are intolerant of platinum-based chemotherapy.

The BLA was accepted for Priority Review on January 21, 2021, and has a target action date of July 25, 2021. The submission was based on data from the Phase II POD1UM-202 trial. It enrolled 94 patients, including several with well-controlled HIV infection. There was an ORR of 14% for retifanlimab monotherapy.

Patients with SCAC who have progressed after first-line chemotherapy treatment currently have no approved treatments available, and we are encouraged that the FDAs acceptance of this BLA for Priority Review brings us one step closer to addressing this historically neglected, yet important, tumor, said Lance Leopold, Group Vice President, Immuno-Oncology Clinical Development, Incyte, in a January 21 statement. Despite SCAC being a rare disease, its incidence is increasing, and its impact is profound. We look forward to working with the FDA to potentially fill an unmet need and advance progress in SCAC for patients.

Ascendiss TransCon hGH for Pediatric GHD

Ascendis Pharmahas a target action date of June 25 for its BLA of TransCon hGH (lonapegsomatropin) for the treatment of pediatric Growth Hormone Deficiency (GHD). The drug is designed to release somatropin with the same action and distribution as once-a-day somatropin products, but with a once-a-week injection. The BLA is based on a clinical development program including eight clinical trials in more than 400 patients with GHD. In pediatric GHD, the pituitary gland does not generate enough growth hormone. The children are short, but may also experience metabolic abnormalities, psychosocial challenges and poor quality of life. The standard of care for GHD is a daily subcutaneous injection of hGH. On June 11, the FDA pushed back the PDUFA date until September 25, 2021. Ascendis indicated, like with the previous Incyte announcements, that after an FDA information request, the agency decided it was a major amendment and extended the target action date in order to provide more time to review the data.

During the companys first-quarter financial report on May 27, Jan Mikkelson, Ascendis Pharmas president and chief executive officer stated, With potential U.S. FDA approval for TransCon hGH now less than a month away, we believe we are one step closer to fulfilling our Vision 3x3 to build a leading biopharma company. Guided by our values of patients, science and passion, we have built a pipeline of three differentiated endocrinology rare disease product candidates by applying our TransCon technology to clinically validated parent drugs and/or targets. Each candidate targeting substantial unmet medical needs in larger markets where we have the potential to become the market leader.

At the new deadline, Mikkelsen stated, We have responded to all outstanding questions from the FDA and believe the complete package we have submitted satisfies all of FDAs requests and will enable a complete review of the application of lonapegsomatropin for pediatric GHD. We are committed to making lonapegsomatropin the market-leading therapy for treating pediatric GHD and look forward to continuing interactions with the FDA during the remainder of the review process.

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A comprehensive DNA test may be free for you, and the information in your test could save your life – KSL.com

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Have you put off getting a DNA test because it is too expensive or too limited?

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As DNA science has evolved, it has become a valuable tool for targeted treatment and precision medicine. Joel C. Eissenberg's published article in Missouri Medicine recommends DNA testing for individuals. He says, "Direct-to-consumer marketing of personal DNA sequence information uncouples the generation of personal health-related data from the physician-patient relationship."

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A comprehensive DNA test may be free for you, and the information in your test could save your life - KSL.com

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LEO Pharma announces European Commission approval of Adtralza (tralokinumab) as the first and only treatment specifically targeting IL-13 for adults…

Posted: at 6:44 am

BALLERUP, Denmark--(BUSINESS WIRE)--LEO Pharma A/S, a global leader in medical dermatology, today announced that the European Commission (EC) has approved Adtralza (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The European approval makes Adtralza the first high affinity, fully human monoclonal antibody approved to specifically bind to and inhibit the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.1,4,5

Adtralza will be available in a 150 mg/mL prefilled syringe for subcutaneous injection with an initial dose of 600 mg followed by 300 mg every other week.1 Adtralza can be used with or without topical corticosteroids (TCS).1

This European Commission approval of Adtralza means that clinicians across Europe now have an important new treatment option for adult patients with moderate-to-severe atopic dermatitis, which is a chronic, unpredictable skin disease, said Stephan Weidinger, MD, Department of Dermatology and Allergy, University Hospital Schleswig-Holstein, Kiel, Germany and tralokinumab clinical trial investigator. By specifically targeting IL-13 with high affinity, Adtralza has demonstrated that it can reduce atopic dermatitis signs and symptoms and sustain improvements over time.

The approval is based primarily on efficacy and safety results from the ECZTRA 1, 2 and ECZTRA 3 pivotal Phase 3 trials, which included more than 1,900 adult patients with moderate-to-severe atopic dermatitis.1 Safety data was evaluated from a pool of five randomized, double-blind, placebo-controlled trials, including ECZTRA 1, 2 and ECZTRA 3, a dose-ranging trial, and a vaccine response trial.1

This European Commission approval of Adtralza is an important development for the millions of adults in Europe who are living with this often uncontrolled skin disease, said Catherine Mazzacco, President and CEO of LEO Pharma. We are proud to have the opportunity to offer a new long-term treatment option for moderate-to-severe atopic dermatitis and are working closely with key stakeholders to enable access to Adtralza for eligible patients.

The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein. Additional regulatory filings are underway with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom and other health authorities worldwide.

About Adtralza (tralokinumab)

Adtralza (tralokinumab) is a fully human, monoclonal antibody developed to specifically neutralize the IL-13 cytokine, which plays a key role in the immune process underlying atopic dermatitis signs and symptoms. Adtralza specifically binds to the IL-13 cytokine with high affinity, thereby preventing interaction with the IL-13 receptor 1 and 2 subunits (IL-13R1 and IL-13R2).4,5

About the pivotal ECZTRA 1, 2, and ECZTRA 3 Trials

ECZTRA 1 and ECZTRA 2 (ECZema TRAlokinumab trials Nos. 1 and 2) were randomized, double-blind, placebo-controlled, multinational 52-week trials, which included 802 and 794 adult patients, respectively, to evaluate the safety and efficacy of Adtralza (300 mg) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.2

ECZTRA 3 (ECZema TRAlokinumab trial No. 3) was a double-blind, randomized, placebo-controlled, multinational 32-week trial, which included 380 adult patients, to evaluate the safety and efficacy of Adtralza (300 mg) in combination with TCS in adults with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.3

About atopic dermatitis

Atopic dermatitis is a chronic, inflammatory, skin disease characterized by intense itch and eczematous lesions.6 Atopic dermatitis is the result of skin barrier dysfunction and immune dysregulation, leading to chronic inflammation.7 Type 2 cytokines, including IL-13, play a central role in the key aspects of atopic dermatitis pathophysiology.4

About LEO Pharma

LEO Pharma helps people achieve healthy skin. The company is a leader in medical dermatology with a robust R&D pipeline, a wide range of therapies and a pioneering spirit. Founded in 1908 and owned by the LEO Foundation, LEO Pharma has devoted decades of research and development to advance the science of dermatology, setting new standards of care for people with skin conditions. LEO Pharma is headquartered in Denmark with a global team of 6,000 people, serving 93 million patients in 130 countries. In 2020, the company generated net sales of DKK 10,133 million. For more information please visit http://www.LEO-Pharma.com.

References

June 2021 MAT-46806

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