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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia – BioSpace

BOSTON--(BUSINESS WIRE)-- Follica, Inc. (Follica), a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions, today announced positive feedback from a meeting with the U.S. Food and Drug Administration (FDA) as the company prepares to advance its lead program into Phase 3 development following a successful safety and efficacy optimization study for the treatment of hair loss in male androgenetic alopecia announced in December 2019.

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Follicas approach, which is designed to stimulate the growth of new follicles and new hair, is being developed as a potential new option for the millions of people seeking treatments to grow new hair. (Graphic: Business Wire)

Follica plans to launch its Phase 3 program this year. Overall, approximately 280 patients will be enrolled, with efficacy assessed against two co-primary endpoints: visible (non-vellus) hair count and patient-reported outcomes on a pre-established scale. The randomized, controlled, double-blinded studies will be conducted in multiple centers across the U.S. A maximal use study to further understand the pharmacokinetics of the treatment will be conducted in parallel. The trial design is consistent with feedback from the FDA during the End of Phase 2 meeting.

In the U.S. alone, 47 million men are affected by progressive hair loss caused by androgenetic alopecia, a condition that is largely unresolved today, leaving many dissatisfied with the current available treatments and looking for a new alternative. Our recent safety and optimization study points to a new level of effect, enabled by our proprietary approach, which stimulates the growth of new follicles and new hair, said Jason Bhardwaj, chief executive officer of Follica. Were grateful to the FDA for their guidance as we prepare for our pivotal program, and we look forward to advancing the development of our treatment regimen, which has demonstrated strong potential to address the current need for those who seek treatment for androgenetic alopecia.

Follicas approach is based on generating an embryonic window in adult scalp cells via a series of short office-based treatments with its proprietary Hair Follicle Neogenesis (HFN) device. The scalp treatments, which last just a few minutes, stimulate stem cells and enable the growth of new hair follicles. A topical drug is then applied to enhance efficacy by growing and thickening new hair follicles and hair on the scalp.

Follica reported topline results from its safety and optimization study in December 2019. That trial was designed to select the optimal treatment regimen using Follicas proprietary HFN device in combination with a topical drug and successfully met its primary endpoint. The selected treatment regimen demonstrated a statistically significant 44% improvement of visible (non-vellus) hair count after three months of treatment compared to baseline (p < 0.001, n = 19). Across all three treatment arms, the overall improvement of visible (non-vellus) hair count after three months of treatment was 29% compared to baseline (p < 0.001, n = 48), reflecting a clinical benefit across the entire trial population and a substantially improved outcome with the optimal treatment regimen. Additionally, a prespecified analysis comparing the 44% change in visible (non-vellus) hair count to a 12% historical benchmark set by approved pharmaceutical products established statistical significance (p = 0.005).

In addition to the safety and optimization study, Follica has validated its approach in prior clinical studies using prototype HFN devices with different treatment parameters and therapeutic compounds. Follicas translational work builds on research by George Cotsarelis, M.D., who isolated and characterized the expression pattern of stem cells from a critical region of the follicle. An expert in epithelial stem cell biology, Dr. Cotsarelis is chair of the department of dermatology at the University of Pennsylvania and a co-founder of Follica.

About Androgenetic Alopecia Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 90 million people who are eligible for treatment in the United States alone. Only two drugs, both of which have demonstrated a 12% increase of non-vellus hair count over baseline for their primary endpoints, are currently approved for the treatment of androgenetic alopecia1. The most effective current approach for the treatment of hair loss is hair transplant surgery, comprising a range of invasive, expensive procedures for a subset of patients who have enough donor hair to be eligible. As a result, there remains a significant need for safe, effective, non-surgical treatments to grow new hair.

About Follica Follica is a biotechnology company developing a regenerative platform designed to treat androgenetic alopecia, epithelial aging and other related conditions. Founded by PureTech (LSE:PRTC), a co-inventor of the current platform, and a group of world-renowned experts in hair follicle biology and regenerative medicine, Follicas experimental treatment platform has been shown to stimulate the development of new hair follicles and hair in three previously conducted clinical studies. The companys proprietary treatment is designed to induce an embryonic window via a device with optimized parameters to initiate hair follicle neogenesis, the formation of new hair follicles from epithelial (skin) stem cells. This process is enhanced through the application of a topical compound. Follica completed a safety and efficacy optimization study in 2019, and its Phase 3 program in male androgenetic alopecia is expected to begin in 2020. Follicas technology is based on work originating from the University of Pennsylvania that has been further developed by Follicas internal program. Follicas extensive IP portfolio includes IP exclusively licensed from the University of Pennsylvania as well as Follica-owned IP.

1 Olsen EA et al, J Am Acad Dermatol. 2002 Sep;47(3):377-85Olsen EA et al, J Am Acad Dermatol. 2007 Nov;57(5):767-74. Epub 2007 Aug 29Price VH et al, J Am Acad Dermatol. 2002 Apr;46(4):517-23Kaufman et al, J Am Acad Dermatol. 1998 Oct; 39(4):578-589

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Follica Announces Positive Feedback From End of Phase 2 Meeting With FDA for Its Lead Program to Treat Male Androgenetic Alopecia - BioSpace

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Hope Realized – CU Anschutz Today

Not anymore.

Thanks to significant philanthropic support from The Sprout Foundation, a Denver-area foundation funded by Suzanne and Bob Fanch, and gifts from others including Wag and Annalee Schorr, the Ehlers-Danlos Syndrome Center of Excellence was launched in 2019. The goal of the center is to eventually develop a cure for EDS at the Gates Center for Regenerative Medicine, while better addressing the clinical needs of patients today through specialty care at Childrens Hospital Colorado. The clinical components of this new center address the critical need for patient-centered, coordinated EDS care where physicians come together to agree on the treatment plan, rather than leaving the patient and their family to determine the course of action.

Calla Winchell, left, with her grandfather, Dr. Wag Schorr, and her mother, Dr. Kate Schorr.

Simultaneously, the Gates Center for Regenerative Medicine scientists are conducting leading-edge research with the ultimate goal of finding a cure. Today, this research is aimed at discovering the genetic underpinnings of hypermobile EDS and leveraging this information to develop future therapies for patients like Calla.

The Fanches said, Sprout Foundation has funded research and the outstanding staff at the Gates Center for Regenerative Medicine to accelerate the cure for this life-changing disorder and also for clinical care to patients through the EDS Center of Excellence.

Joining in this effort are Callas own grandparents, Wag Schorr, an accomplished nephrologist and 1963 CU School of Medicine alumnus, and his wife, Annalee.

An essential component of the EDS Center of Excellence is a translational research program, which leverages existing campus resources and partnerships, including the Gates Center for Regenerative Medicine and the Colorado Center for Personalized Medicine.

The research program at the Gates Center is led by Dennis Roop, PhD, director of the Gates Center, in partnership with Ganna Bilousova, PhD, and Igor Kogut, PhD. The program brings EDS patients genetic information from clinical visits to the Gates Center where researchers are working on future treatments for the condition. In this virtuous cycle, patients inform future therapies in the lab that, in turn, could ultimately change lives back in the clinic.

Calla is one of those patients. She is motivated by the possibility of improving EDS research.

In preclinical models, scientists are collecting stem cells from Calla and other patients that indicate a possible mutation. These studies, using multiple patients, allow for a more accurate portrait of the errors in DNA. Early findings at the Gates Center suggest that a possible mutation for the hypermobile form of EDS may have been identified. The hope is that this research will lead to a potential treatment in the coming years.

Scientists are growing skin cells in the lab using Callas stem cells, with the EDS gene mutations removed. If successful, the modified stem cells will hook onto sites of inflammation and grow new cells restoring function to damaged tissues and organs. It sounds like science fiction, but it could be a reality at the CU Anschutz Medical Campus in the years to come.

The research advances taking place at the Gates Center will ultimately mean incredible hope and healing for people like Calla, and others with rare genetic disorders, who are eager to regain their health and their independence.

Im thrilled, she said. Im excited to receive coordinated care and treatments that will help me get back to my life. What if I could go to the grocery store and not have to use a wheelchair anymore?

By bringing research together with clinical care, the EDS Center of Excellence is helping turn such possibilities into realities.

Callas care plan is coordinated by a team of experts at the EDS multidisciplinary clinic at Childrens Hospital Colorado, led by the Medical Director of the Special Care Clinic Ellen Roy Elias, MD, in close collaboration with Kourtney Santucci, MD.

The clinic places the patient at the center of care, and brings forward all of the right health professionals required to determine a comprehensive care plan. In this model, the patient is seen by a team of specialists in a single day, with the goal of having a treatment plan at the end of the visit.

Callas grandfather, Dr. Schorr, says no more will Calla and others like her have to create a center of excellence for themselves as they traverse a complex and fragmented healthcare system to ensure their needs are met.

The pioneering work taking place at the EDS Center of Excellence began with Dr. Schorrs vision. In 2016, as a member of the Gates Center for Regenerative Medicine Advisory Board, Dr. Schorr approached director Dennis Roop and began laying the groundwork for research efforts in EDS, which he and Annalee funded later that year. Dr. Schorrs vision and commitment made it possible to develop the EDS Center of Excellence as a place to realize scientific advances in EDS research.

CU is poised for another breakthrough in medicine, said Dr. Schorr. I believe that EDS patients will soon have access to effective treatments, and possibly even a cure. If we are precise with our research and resources, we can resume our place at the forefront of the medical world. Thats our responsibility.

Another must, said Dr. Schorr, is to empower visionaries in their fields to pave the path toward new discoveries and major medical advances.

Leading this charge is CU School of Medicine Dean and Vice Chancellor for Health Affairs John Reilly, Jr., MD. Dean Reilly said, One of the great advantages of having our pediatric hospital partner, Childrens Hospital Colorado, and a research entity like the Gates Center on campus is the opportunity to collaborate. By bringing some of the best minds together to lead the next generation in EDS research, we get remarkable innovation, and leading-edge treatments and care. What our philanthropic partners have built here is inspiring, and together we are determined to bring hope to patients and their families. It has been exciting to see two families with a long friendship come together with a shared goal to create a center that will have a positive effect on so many patients and families.

With each new discovery at the EDS Center of Excellence, lives will improve through better care and better health. Each new discovery brings new opportunity for people with EDS to live lives they never knew they could have.

Guest Contributor: Courtney Keener, CU Anschutz Office of Advancement.

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Hope Realized - CU Anschutz Today

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Dermal Regeneration Matrix Device Market to Exhibit Increased Demand in the Coming Years – Lake Shore Gazette

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

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

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

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

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

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

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

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

Some of the major players in the global dermal regeneration matrix device market include Integra LifeSciences Corporation, Platelet BioGenesis, Avita Medical, Stratatech, Organogenesis Inc., Smith & Nephew, Inc., ACell Inc., Symatese and others.

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Dermal Regeneration Matrix Device Market to Exhibit Increased Demand in the Coming Years - Lake Shore Gazette

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Future Growth of Cosmetic Skin Care Market by New Business Developments, Top Companies and Forecast to 2026 – Bulletin Line

Cosmetic Skin CareMarketBusiness Insights and Updates:

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

Cosmetic skin care is a variety of products which are used to improve the skins appearance and alleviate skin conditions. It consists different products such as anti- aging cosmetic products, sensitive skin care products, anti- scar solution products, warts removal products, infant skin care products and other. They contain various ingredients which are beneficial for the skin such as phytochemicals, vitamins, essential oils, and other. Their main function is to make the skin healthy and repair the skin damages.Get PDF Samplecopy(including TOC, Tables, and Figures) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-cosmetic-skin-care-market

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Future Growth of Cosmetic Skin Care Market by New Business Developments, Top Companies and Forecast to 2026 - Bulletin Line

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Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell…

Ample Market Research has recently published a report Human Embryonic Stem Cells Market . The key objective of this report is to highlight various trends and dynamics, new and innovative technology and mergers and acquisitions that are expected to make a positive impact on the overall industry. This report studies the Human Embryonic Stem Cells market size (value and volume) by players, regions, product types and end industries, history data 2014-2018 and forecast data 2019-2025; This report provides a detailed analysis of the prospects for the global Human Embryonic Stem Cells industry up to 2024, including an assessment of the impact of COVID-19.

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Human Embryonic Stem Cells Market Latest Research Report 2018- 2025 covers a complete market structure across the world with a detailed industry analysis of major key factors. This report provides strategic recommendations consulted by the industrial experts including market forecasts, profit, supply, raw materials, manufacturing expenses, the proportion of manufacturing cost structure, latest market trends, demands and much more.

Global Human Embryonic Stem Cells Market is valued approximately USD XX billion in 2019 and is anticipated to grow with a healthy growth rate of more than XX% over the forecast period 2020-2026. Due to COVID-19 pandemic, the market is facing challenges because of government protocols to stay at home across the world. Human Embryonic Stem Cells (hESCs) are derived from blastocyst and are capable of differentiating into number of cell types that make up the human body as well as it replicates indefinitely and produce non-regenerative tissues such as neural and myocardial cells. They are used in treating a number of blood and genetic disorders related to the immune system, cancers, and disorders as well as used in investigational studies of early human development, genetic diseases and toxicology testing. The technological advancement involving stem cells therapy, rising demand for regenerative medicines, R&D in toxicology testing, technological advancements for the production of embryonic stem cells through alternative methods and increasing prevalence of genetic disorders are the few factors responsible for growth of the market over the forecast period. Furthermore, the introduction of innovative products and other strategic advancements by market players will create lucrative opportunities for the market. For instance, as per companys news release in January 2019, Stemcell Technologies Inc. launched mTeSRl Plus, an enhanced version of mTeSR1. mTeSR Plus is the stabilized feeder-free maintenance medium for human embryonic stem (ES) and induced pluripotent stem (iPS) cells. However, ethical concern related to stem cell research is the major factor restraining the growth of global Vegetable Chips market during the forecast period.

The regional analysis of global Human Embryonic Stem Cells market is considered for the key regions such as Asia Pacific, North America, Europe, Latin America and Rest of the World. Asia Pacific is the leading/significant region across the world due to the presence of several prominent entities incorporated in the U.S. Whereas, Asia-Pacific is also anticipated to exhibit highest growth rate / CAGR over the forecast period 2020-2026.

This report discusses the key drivers influencing Human Embryonic Stem Cells market growth, demand, the challenges and the risks faced by key players and the market as a whole. It also analyzes key emerging trends and their impact on current and future development.

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Key players analyzed in the Human Embryonic Stem Cells Insight Report: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell Technologies Inc., Biotime, Inc. / Cell Cure Neurosciences LTD, Thermo Fisher Scientific, Inc., CellGenix GmbH, ESI BIO, PromoCell GmbH, Lonza Group AG, Kite Pharma, Cynata Therapeutics Ltd.

The study was conducted using an objective combination of primary and secondary information including inputs from key participants in the industry. The report contains a comprehensive market and vendor landscape in addition to a SWOT analysis of the key vendors.

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Strategic Points Covered in Table of Contents

Study Coverage: It includes key manufacturers covered, key market segments, the scope of products offered in the global Conductive Nylon market, years considered, and study objectives. Additionally, it touches the segmentation study provided in the report on the basis of the type of product and application.

Executive Summary: It gives a summary of key studies, viz. production, market growth rate, competitive landscape, market drivers, trends, and issues, and macroscopic indicators.

Production by Region: Here, the report provides information related to import and export, revenue, production, and key players of all regional markets studied.

Profile of Manufacturers: Each player profiled in this section is studied on the basis of SWOT analysis, their products, production, value, capacity, and other vital factors.

Market Size by Manufacturer

Consumption by Region

Market Size by Type,by Application

Production Forecast and Consumption Forecast

Industry Chain, Upstream, and Downstream Customers Analysis

Key Findings, Opportunities and Challenges, Threats, and Affecting Factors

Appendix

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In the end, this report additionally presents product specification, producing method, and product cost structure. Production is separated by regions, technology, and applications. The Human Embryonic Stem Cells Market report includes investment come analysis and development trend analysis. The key rising opportunities of the fastest growing international Human Embryonic Stem Cells industry segments are coated throughout this report. This report provides information about the import, export, consumption and consumption value. The report then provides one of the most crucial aspects of the Human Embryonic Stem Cells Market the forecast for the next five to six years based on the previous as well as current data.

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Excellent growth of Human Embryonic Stem Cells Market- Comprehensive study by key players: Astellas Pharma Inc/ Ocata Therapeutics, Stemcell...

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Catherine Deveney: There’s so much more to achieving good mental health than just taking medication – Press and Journal

Women, say recent studies, are more likely than men to become depressed during lockdown. Apparently, they worry more, drink more and eat more junk food.

Who says that equals depression? Just because we are slumped in a corner with a glass of vino and three left-over Easter eggs doesnt mean we arent enjoying ourselves.

The findings are quite ironic. About 70% of those taken into intensive care with coronavirus are male. How come women are more depressed when men are more likely to die?

Women cry, men die. I would have put that the other way round men die, women cry but it might have suggested some kind of cause and effect which, according to one psychologist I spoke to, is not necessarily the case.

Hes gone, a female patient told him triumphantly, speaking of her husband. Dead? he asked, taken aback. No, he left me and I feel fabulous.

Mental Health Awareness week ended a fortnight ago. Why deliberately wait until its over to write about depression? Because right now, mental health is an ongoing issue and useful as campaigns are, awareness-raising doesnt end after seven days. It is the start, not the end, of the journey. A puppy is not just for Christmas, we dont only love our mothers one day a year and good mental health is not a seven day, creation-of-the-universe process.

Nor is it, as we sometimes mistakenly think, a recipe for feeling good all the time; a panacea of happiness that leaves us in a Julie Andrews bubble of raindrops on roses and whiskers on kittens. Many of us are challenged right now but good mental health is not the ability to be permanently happy. Its the ability to deal with unhappiness and challenges and even the depression that being alive and human occasionally brings in a resilient, balanced way.

Does it trivialise psychological difficulties, or encourage addiction, to joke about marital difficulties, or over-indulgence in wine and chocolate? Or does it put psychological difficulty into perspective an expected, but temporary, part of life that we learn to manage rather than obliterate?

The late American comedian Joan Rivers once spoke to me in an interview about her reputation for outrageousness. She joked about everything, she said, because it sucked the power out of difficulty and gave it to her. It put tragedy in its box.

It was a striking feature of interviewing comedians that in person they were rarely like their funny, high-energy stage personas. Mostly, they were deeply serious and introspective. Their introspection sharpened the observation that informed their performances. So what are you going to do if you dont laugh at life. Cry?

In a recent documentary, Tony Blairs old media manager Alastair Campbell, who has suffered from depression for most of his life, interviewed a geneticist. For the purposes of the programme, Campbell had looked into various research programmes, from the use of magic mushrooms to interrupt negative thought processes to experimental head vibration treatments. But it was the simple metaphor the geneticist used that struck him.

Think of a jar, she suggested. In that jar were all the different components affecting our mental health genetics, personal experiences, environmental factors. We cant make the jar smaller, but we can raise the height of it with things that make us feel good spending time with family and friends, pursuing hobbies and a healthy approach to diet, exercise and sleep.

When Campbell listed the things that created space in his jar he realised everything he had written down concerned people, lifestyle and creativity, rather than scientific solutions such as medication.

One of the themes emphasised for good mental health is kindness. There is no doubt that helping someone else, focusing on their needs, forces us out of the vortex of our own particular difficulties into someone elses frame of reference. It makes us, as well as them, feel good.

What the jam jar model reminds us, though, is that we need to be kind to ourselves as well as others.

Perhaps that includes at least attempting to think outside the box, to resist being limited by conformity or constrained by convention, because thats when lifes possibilities open up.

I smiled recently while reading the story of a young, unknown Czech painter who was baffled when her paintings were stolen from a museum. After all, she wasnt Picasso. And they were 6ft by 4ft so you could hardly walk out with them tucked under your arm.

When she met the thief at court, he was a heavily tattooed ex-con. Instead of shunning him, she asked to get to know him for two reasons.

Firstly, she wanted to paint him. Secondly, she wanted to know why he had stolen them. They were beautiful, he said eventually.

Perhaps theft is taking self-kindness too far. But the artists kind response, her curiosity about life, her ability to do the unexpected, struck me as something that would extend her mental health jar quite considerably.

An extension that I suspect limits her need for a glass of vino and three left-over Easter eggs.

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Catherine Deveney: There's so much more to achieving good mental health than just taking medication - Press and Journal

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COVID-19 Impact on Male Breast Cancer Treatment Market Research Report: Probable Key Development To Be Observed Market States And Outlook Across By…

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Key companies operating in the global COVID-19 Impact on Male Breast Cancer Treatment market include , Pfizer, Roche, GlaxoSmithKline, Sanofi, Novartis, Bayer, Bristol-Myers Squibb, Eli Lilly, AstraZeneca, Teva Pharmaceutical, Sun Pharmaceutical, BioNumerik Pharmaceuticals, Seattle Genetics, Accord Healthcare Male Breast Cancer Treatment

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Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global COVID-19 Impact on Male Breast Cancer Treatment market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global COVID-19 Impact on Male Breast Cancer Treatment Market Segment By Type:

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Global COVID-19 Impact on Male Breast Cancer Treatment Market Segment By Application:

, Hospitals, Clinics, Other

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global COVID-19 Impact on Male Breast Cancer Treatment market.

Key companies operating in the global COVID-19 Impact on Male Breast Cancer Treatment market include , Pfizer, Roche, GlaxoSmithKline, Sanofi, Novartis, Bayer, Bristol-Myers Squibb, Eli Lilly, AstraZeneca, Teva Pharmaceutical, Sun Pharmaceutical, BioNumerik Pharmaceuticals, Seattle Genetics, Accord Healthcare Male Breast Cancer Treatment

Key questions answered in the report:

For Discount, Customization in the Report: https://www.qyresearch.com/customize-request/form/1800824/covid-19-impact-on-global-male-breast-cancer-treatment-market

TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Male Breast Cancer Treatment Revenue1.4 Market Analysis by Type 1.4.1 Global Male Breast Cancer Treatment Market Size Growth Rate by Type: 2020 VS 2026 1.4.2 Medication 1.4.3 Chemotherapy 1.4.4 Others1.5 Market by Application 1.5.1 Global Male Breast Cancer Treatment Market Share by Application: 2020 VS 2026 1.5.2 Hospitals 1.5.3 Clinics 1.5.4 Others1.6 Coronavirus Disease 2019 (Covid-19): Male Breast Cancer Treatment Industry Impact 1.6.1 How the Covid-19 is Affecting the Male Breast Cancer Treatment Industry 1.6.1.1 Male Breast Cancer Treatment Business Impact Assessment Covid-19 1.6.1.2 Supply Chain Challenges 1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products 1.6.2 Market Trends and Male Breast Cancer Treatment Potential Opportunities in the COVID-19 Landscape 1.6.3 Measures / Proposal against Covid-19 1.6.3.1 Government Measures to Combat Covid-19 Impact 1.6.3.2 Proposal for Male Breast Cancer Treatment Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Global Growth Trends by Regions2.1 Male Breast Cancer Treatment Market Perspective (2015-2026)2.2 Male Breast Cancer Treatment Growth Trends by Regions 2.2.1 Male Breast Cancer Treatment Market Size by Regions: 2015 VS 2020 VS 2026 2.2.2 Male Breast Cancer Treatment Historic Market Share by Regions (2015-2020) 2.2.3 Male Breast Cancer Treatment Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy 2.3.1 Market Top Trends 2.3.2 Market Drivers 2.3.3 Market Challenges 2.3.4 Porters Five Forces Analysis 2.3.5 Male Breast Cancer Treatment Market Growth Strategy 2.3.6 Primary Interviews with Key Male Breast Cancer Treatment Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Male Breast Cancer Treatment Players by Market Size 3.1.1 Global Top Male Breast Cancer Treatment Players by Revenue (2015-2020) 3.1.2 Global Male Breast Cancer Treatment Revenue Market Share by Players (2015-2020) 3.1.3 Global Male Breast Cancer Treatment Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Male Breast Cancer Treatment Market Concentration Ratio 3.2.1 Global Male Breast Cancer Treatment Market Concentration Ratio (CR5 and HHI) 3.2.2 Global Top 10 and Top 5 Companies by Male Breast Cancer Treatment Revenue in 20193.3 Male Breast Cancer Treatment Key Players Head office and Area Served3.4 Key Players Male Breast Cancer Treatment Product Solution and Service3.5 Date of Enter into Male Breast Cancer Treatment Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Male Breast Cancer Treatment Historic Market Size by Type (2015-2020)4.2 Global Male Breast Cancer Treatment Forecasted Market Size by Type (2021-2026) 5 Male Breast Cancer Treatment Breakdown Data by Application (2015-2026)5.1 Global Male Breast Cancer Treatment Market Size by Application (2015-2020)5.2 Global Male Breast Cancer Treatment Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Male Breast Cancer Treatment Market Size (2015-2020)6.2 Male Breast Cancer Treatment Key Players in North America (2019-2020)6.3 North America Male Breast Cancer Treatment Market Size by Type (2015-2020)6.4 North America Male Breast Cancer Treatment Market Size by Application (2015-2020) 7 Europe7.1 Europe Male Breast Cancer Treatment Market Size (2015-2020)7.2 Male Breast Cancer Treatment Key Players in Europe (2019-2020)7.3 Europe Male Breast Cancer Treatment Market Size by Type (2015-2020)7.4 Europe Male Breast Cancer Treatment Market Size by Application (2015-2020) 8 China8.1 China Male Breast Cancer Treatment Market Size (2015-2020)8.2 Male Breast Cancer Treatment Key Players in China (2019-2020)8.3 China Male Breast Cancer Treatment Market Size by Type (2015-2020)8.4 China Male Breast Cancer Treatment Market Size by Application (2015-2020) 9 Japan9.1 Japan Male Breast Cancer Treatment Market Size (2015-2020)9.2 Male Breast Cancer Treatment Key Players in Japan (2019-2020)9.3 Japan Male Breast Cancer Treatment Market Size by Type (2015-2020)9.4 Japan Male Breast Cancer Treatment Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Male Breast Cancer Treatment Market Size (2015-2020)10.2 Male Breast Cancer Treatment Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Male Breast Cancer Treatment Market Size by Type (2015-2020)10.4 Southeast Asia Male Breast Cancer Treatment Market Size by Application (2015-2020) 11 India11.1 India Male Breast Cancer Treatment Market Size (2015-2020)11.2 Male Breast Cancer Treatment Key Players in India (2019-2020)11.3 India Male Breast Cancer Treatment Market Size by Type (2015-2020)11.4 India Male Breast Cancer Treatment Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Male Breast Cancer Treatment Market Size (2015-2020)12.2 Male Breast Cancer Treatment Key Players in Central & South America (2019-2020)12.3 Central & South America Male Breast Cancer Treatment Market Size by Type (2015-2020)12.4 Central & South America Male Breast Cancer Treatment Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Pfizer 13.1.1 Pfizer Company Details 13.1.2 Pfizer Business Overview and Its Total Revenue 13.1.3 Pfizer Male Breast Cancer Treatment Introduction 13.1.4 Pfizer Revenue in Male Breast Cancer Treatment Business (2015-2020)) 13.1.5 Pfizer Recent Development13.2 Roche 13.2.1 Roche Company Details 13.2.2 Roche Business Overview and Its Total Revenue 13.2.3 Roche Male Breast Cancer Treatment Introduction 13.2.4 Roche Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.2.5 Roche Recent Development13.3 GlaxoSmithKline 13.3.1 GlaxoSmithKline Company Details 13.3.2 GlaxoSmithKline Business Overview and Its Total Revenue 13.3.3 GlaxoSmithKline Male Breast Cancer Treatment Introduction 13.3.4 GlaxoSmithKline Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.3.5 GlaxoSmithKline Recent Development13.4 Sanofi 13.4.1 Sanofi Company Details 13.4.2 Sanofi Business Overview and Its Total Revenue 13.4.3 Sanofi Male Breast Cancer Treatment Introduction 13.4.4 Sanofi Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.4.5 Sanofi Recent Development13.5 Novartis 13.5.1 Novartis Company Details 13.5.2 Novartis Business Overview and Its Total Revenue 13.5.3 Novartis Male Breast Cancer Treatment Introduction 13.5.4 Novartis Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.5.5 Novartis Recent Development13.6 Bayer 13.6.1 Bayer Company Details 13.6.2 Bayer Business Overview and Its Total Revenue 13.6.3 Bayer Male Breast Cancer Treatment Introduction 13.6.4 Bayer Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.6.5 Bayer Recent Development13.7 Bristol-Myers Squibb 13.7.1 Bristol-Myers Squibb Company Details 13.7.2 Bristol-Myers Squibb Business Overview and Its Total Revenue 13.7.3 Bristol-Myers Squibb Male Breast Cancer Treatment Introduction 13.7.4 Bristol-Myers Squibb Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.7.5 Bristol-Myers Squibb Recent Development13.8 Eli Lilly 13.8.1 Eli Lilly Company Details 13.8.2 Eli Lilly Business Overview and Its Total Revenue 13.8.3 Eli Lilly Male Breast Cancer Treatment Introduction 13.8.4 Eli Lilly Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.8.5 Eli Lilly Recent Development13.9 AstraZeneca 13.9.1 AstraZeneca Company Details 13.9.2 AstraZeneca Business Overview and Its Total Revenue 13.9.3 AstraZeneca Male Breast Cancer Treatment Introduction 13.9.4 AstraZeneca Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.9.5 AstraZeneca Recent Development13.10 Teva Pharmaceutical 13.10.1 Teva Pharmaceutical Company Details 13.10.2 Teva Pharmaceutical Business Overview and Its Total Revenue 13.10.3 Teva Pharmaceutical Male Breast Cancer Treatment Introduction 13.10.4 Teva Pharmaceutical Revenue in Male Breast Cancer Treatment Business (2015-2020) 13.10.5 Teva Pharmaceutical Recent Development13.11 Sun Pharmaceutical 10.11.1 Sun Pharmaceutical Company Details 10.11.2 Sun Pharmaceutical Business Overview and Its Total Revenue 10.11.3 Sun Pharmaceutical Male Breast Cancer Treatment Introduction 10.11.4 Sun Pharmaceutical Revenue in Male Breast Cancer Treatment Business (2015-2020) 10.11.5 Sun Pharmaceutical Recent Development13.12 BioNumerik Pharmaceuticals 10.12.1 BioNumerik Pharmaceuticals Company Details 10.12.2 BioNumerik Pharmaceuticals Business Overview and Its Total Revenue 10.12.3 BioNumerik Pharmaceuticals Male Breast Cancer Treatment Introduction 10.12.4 BioNumerik Pharmaceuticals Revenue in Male Breast Cancer Treatment Business (2015-2020) 10.12.5 BioNumerik Pharmaceuticals Recent Development13.13 Seattle Genetics 10.13.1 Seattle Genetics Company Details 10.13.2 Seattle Genetics Business Overview and Its Total Revenue 10.13.3 Seattle Genetics Male Breast Cancer Treatment Introduction 10.13.4 Seattle Genetics Revenue in Male Breast Cancer Treatment Business (2015-2020) 10.13.5 Seattle Genetics Recent Development13.14 Accord Healthcare 10.14.1 Accord Healthcare Company Details 10.14.2 Accord Healthcare Business Overview and Its Total Revenue 10.14.3 Accord Healthcare Male Breast Cancer Treatment Introduction 10.14.4 Accord Healthcare Revenue in Male Breast Cancer Treatment Business (2015-2020) 10.14.5 Accord Healthcare Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology 15.1.1 Methodology/Research Approach 15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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COVID-19 Impact on Male Breast Cancer Treatment Market Research Report: Probable Key Development To Be Observed Market States And Outlook Across By...

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Acupuncture For Fertility And TCM Improve Chances Of Conception And Pregnancy And Mitigates Side Effects Of IVF Treatment – Press Release – Digital…

Acuwellness Center offers acupuncture for infertility. Research suggests that acupuncture, along with traditional Chinese medicine, can serve as an effective treatment for infertility and other reproductive disorders.

According to announcements released by Acuwellness Center, and Sharareh (Sherry) Daghighi DAOM, LAc, FABORM, the wellness center offers acupuncture for fertility. Research-backed evidence suggests that fertility acupuncture can be a useful treatment procedure to complement IVF and ART treatments. Combined with other TCM protocols, acupuncture can enhance physiological processes essential for fertility. Acupuncture as a treatment modality for infertility can assist in preparation for IVF, IUI, and other ART protocols. Fertility acupuncture helps control unwanted side effects associated with IVF and ART treatments. It improves implantation and pregnancy rates. The wellness clinic will coordinate with a subject's reproductive endocrinologist to prepare a custom infertility treatment plan to optimize her chances at conception.

Sources reveal that alternative treatment procedures that use acupuncture and herbs can improve the symptoms of many health conditions, including polycystic ovarian syndrome (PCOS), which is not an uncommon condition among women in the United States. PCOS can result in diabetes, hirsutism, infertility, and obesity. Acuwellness Center is also an established Encino dermatology clinic where eczema, psoriasis, acne, rosacea, fungal infections, etc. are treated using herbal formulations, dietary supplements, and acupuncture. The wellness clinic prescribes herbs for acne, and it has delivered excellent results in treating this condition. TCM eschews the use of topical ointments that may contain harsh chemicals. Acuwellness Center treats acne by recommending dietary and lifestyle changes, acupuncture, and herbal medicines. It prescribes Chinese herbs for eczema.

Sharareh (Sherry) Daghighi DAOM, LAc, FABORM, of Acuwellness Center said, At Acuwellness Center, we offer services such as acupuncture, herbal medicine, and nutritional consultation in a friendly, relaxing environment. Our areas of expertise are woman's health, fertility, internal medicine, and TCM dermatology. Our mission is to provide a tranquil, healing environment where your mind, body, and spirit can relax and recover from the stress of everyday living.

On acupuncture and herbs for premature ovarian failure, Daghighi said, Premature Ovarian Failure (POF) is defined as a cessation of ovarian function in women younger than 40 years of age. It is characterized by the occurrence of irregular and light menstruation (oligomenorrhea), primary or secondary amenorrhea (no menstruation) with elevated levels of gonadotrophins like follicle-stimulating hormone (FSH), and low estrogen levels. Women with POF will also have menopausal symptoms such as hot flashes, night sweats, vaginal dryness, irritability, difficulty concentrating, and decreased sexual desire.

She continued to say, Studies have shown that Acupuncture and herbal medicine can treat premature ovarian failure. Acupuncture can induce ovulation and regulate the menstrual cycle, other studies have shown some herbal formulas such as Zuo Gui Wan or a modification of this formula can induce ovulation, lower FSH levels, and regulate menstrual cycle for certain POF patients. At Acuwellness Center, we offer Acupuncture and herbal medicine services for infertility, including premature ovarian failure, we can help achieve your fertility goals or just reduce menopausal symptoms.

For more information, go to https://www.acuandherbs.com/infertility-acupuncture.html

Media ContactCompany Name: Acuwellness CenterContact Person: Sharareh (Sherry) DaghighiEmail: Send EmailPhone: (818) 642-3512Address:16260 Ventura Blvd, Ste LL16 City: EncinoState: CA 91436Country: United StatesWebsite: https://www.acuandherbs.com/infertility-acupuncture.html

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Fertility startups see burst in demand as minds turn to baby-making – Sifted

The coronavirus lockdown has led to rising interest in video games, sex toys, sourdough bread and alsobabies.

Or at least thats what may explain a spike in demand for some of Europes fertility startups over the past few months, according to founders interviewed by Sifted.

Startups such as ExSeed, which does at-home male fertility test, and Legacy, a sperm testing and freezing startup, have both recorded a jump in orders.

Switzerlands Legacy says its seen days where orders spiked to more than 10x usual volume and has had to launch additional capacity to handle the order volume for test samples.

Part of this is the natural growth of the company, but Id estimate at least 50% of the growth is attributable due to Covid-19 concerns, says chief executive Khaled Kteily.

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Kteily says there are worries that catching Covid-19 might affect male fertility. The increase in orders may have also been spurred by the temporary closure ofphysical clinics during lockdown, instead prompting couples to get treatment ready from home.

Meanwhile, Copenhagen-based ExSeed told Sifted the number of at-home male fertility tests priced at 150 have trebled during the lockdown. App-downloads, programme-subscriptions, and web traffic have also more than doubled since February across Denmark and the UK.

This boost is being matched by investor interest as well; ExSeed told Sifted it is now in the final stages of closing a round led by Hambro Perks, building on a previous raise of 1m.

Demand has also been way up for Paris-born Apricity, a digital-first fertility platform which offers at-home blood tests and consultations for women, followed by in-person treatment across a series of partner physical clinics.

Chief executive Caroline Noublanche thinks that the surge in interest is in part because people have had more time for themselves and to address important personal topics such as fertility

UK-based consultant Adrian Lower, who does not work with any of these startups but is a practising gynaecologist, agrees the lockdown has also given us the time to consider every aspect of our health, including our future fertility, adding he is not surprised that the pandemic has spurred a rise in demand for at-home services.

Covid-19 has highlighted just how precious our health is.

In recent years, the fertility industry has raised millions in venture capital funds, particularly in Northern Europe.

This is part of a broader rise in interest in digital doctor app startups such a Doctolib and Babylon Health which are reshaping our relationship with healthcare systems.

But it is also linked to the emergence of femtech as a significant investment category (set to be worth $50bn by 2025, according to Frost & Sullivan) dominated by big startups like Clue, Ava and Natural Cycles.

Now, coronavirus and the recent spike in demand for fertility tech has helped bring investment buzz back to this segment which stretches across supplements, ovulation trackers and testing kits for both men and women.

I have a lot of contact with potential investors during lockdown. Healthtech appears to them as one of the key areas of investment post-Covid and femtech is one of the subdomains VCs say they want to focus on, says Apricity chief executive Caroline Noublanche.

Spains WOOM a fertility tracker and community app for women also secured a $2m round just last month, pulling in two new investors.

Nonetheless, while people may have become more interested in their fertility in lockdown, it prompted some couples to delay parenthood for at least a short time.

Natural Cycles, a hormone-checking tool for women, told Sifted that the rate of users switching the app-mode from prevent to planning a pregnancy decreased by 3% week-over-week between March and April; perhaps triggered by fresh financial fears, relationship pressures, or illness. The company also said that it had seen a boost in orders for women wanting a natural birth control delivered right to the door.

Meanwhile, Maven a virtual womens clinic has recorded twice as many bookings for online mental health appointments across its fertility clients between March and May, suggesting the pandemic is putting an emotional strain on would-be parents.

WOOM also says it suffered a 25% traffic drop after the announcement of Covid-19 pandemic. Nonetheless, the startup says its traffic is now 19 points higher than pre-pandemic.

This boost seen by fertility startups will help shake off fears that the sector was at risk of seeing investment interest wane, as attention shifted to other areas of womens health like menopause, sex, endometriosis, and breastfeeding.

[Investors are] looking for the next big thing in femtech, Anya Roy, cofounder of Syrona Women told Sifted earlier this year, adding male investors were slowly seeing the investment benefits of womens health.

Two studies also recently cast doubt on the role of fertility apps and wearables role in assisting womens chances of conceiving, given their lack of scientific backing.

Nonetheless, investors say theres room for growth in the still-nascent fertility startup sector, with smartphones providing new tools to streamline the diagnosis and conception process. One in seven couples also still experience difficulties conceiving.

Its more crowded in the fertility and the contraceptive space, but theres no clear winner there yet, says Louise Samet, partner at venture capital firm Blossom Capital.

We havent seen a Spotify or a really large company come out in that space yet I think that theres still huge potential.

Traditional IVF clinics are also beginning to digitise to keep up with the boom of healthtech apps.

Salve is a startup that helps IVF with patient-doctor management via a white-labelled app, providing secure messaging and enhanced data sharing. Its chief executive Charlie Kenny tells Sifted they have signed over 30 new clinics worldwide since the coronavirus outbreak began, and has seen that rapid growth continue.

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Myriad Genetics Announces Publication of a Prospective Clinical Study of the EndoPredict Test in Women with Early-Stage Breast Cancer | 2020-06-04 |…

SALT LAKE CITY, June 04, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN, Myriad” or the Company”), a global leader in molecular diagnostics and precision medicine, today announced the publication of a prospective study demonstrating that the EndoPredict® test predicts which patients with ER+, HER2- early-stage breast cancer will benefit from neoadjuvant therapy. The article titled, The EndoPredict score predicts response to neoadjuvant chemotherapy and neoendocrine therapy in hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer patients from the ABCSG-34 trial,” appeared online in the European Journal of Cancer.

This study demonstrated that the EndoPredict (EP) test predicted response to neoadjuvant chemotherapy or neoadjuvant endocrine therapy in women with ER+, HER2 negative early-stage breast cancer,” said Peter Dubsky, M.D., lead author, speaking on behalf of the Austrian Breast and Colorectal Cancer Study Group (ABCSG). Based on these findings and prior studies, we are confident the EndoPredict test can add valuable information to aid in personalized treatment selection in neoadjuvant therapy and provides an important basis for future design of neoadjuvant clinical trials.”

The primary objective of this prospective study was to test the predictive value of the EndoPredict test regarding tumor response after neoadjuvant chemotherapy (NaCT) or neoadjuvant endocrine therapy (NET) within the ABCSG-34 trial. The analysis included data from 217 women with HR+ breast cancer. Of these, 134 patients were assigned to receive NaCT (eight cycles of anthracycline/taxane) according to aggressive clinico-pathologic tumor features. The remaining 83 patients were clinically identified as having luminal A-like types of breast cancer and were assigned to receive NET (six months of letrozole). The primary endpoint was residual cancer burden RCB0/I (i.e., good tumor response) vs. RCB II/III (i.e., poor tumor response) at time of surgery.

In the neoadjuvant chemotherapy group, 125 patients had high EP scores and nine had a low EP score. The results show that 26.4 percent of those with a high score showed a good tumor response (RCB0/I) to neoadjuvant chemotherapy, while all patients with a low score showed only a poor tumor response (Table 1). In the luminal A” group receiving neoendocrine therapy, 39 patients had a high EP score and 44 had a low EP score. The results show that 27.3 percent of those with a low EndoPredict score and 7.7 percent with a high score achieved excellent tumor response (RCB0/I) to neoendocrine therapy (Table 1).

EndoPredict Low Score

EndoPredict High Score

0.0

%

26.4

%

p=0.0001

In this prospective study, we demonstrated that the EndoPredict test is a useful tool pre-operatively,” said Ralf Kronenwett, M.D., director of International Medical Affairs at Myriad. In two distinct ER-positive, HER2-negative cohorts selected by clinicians to receive neoadjuvant chemotherapy or neoadjuvant endocrine therapy, EndoPredict identified patients with poor neoadjuvant treatment response. Clinicians can use information to determine who might forgo these therapies prior to surgery.”

About EndoPredict EndoPredict is a second-generation, 12-gene molecular prognostic test for patients diagnosed with breast cancer. The test provides vital information that helps clinicians devise personalized treatment plans for their patients. EndoPredict has been validated in more than 4,000 patients with node-negative and node-positive cancer and has been used clinically in more than 20,000 patients. In contrast to first-generation multigene prognostic tests, EndoPredict detects the likelihood of late metastases (i.e., metastasis formation after more than five years) and, therefore, can guide treatment decisions regarding the need for chemotherapy, as well as extended anti-hormonal therapy. Accordingly, therapy decisions backed by EndoPredict confer a high level of diagnostic safety. For more information, please visit: http://www.endopredict.com.

About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the EndoPredict test adding valuable information to aid in personalized treatment selection in neoadjuvant therapy and providing an important basis for future design of neoadjuvant clinical trials; and the Company's strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

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Myriad Genetics Announces Publication of a Prospective Clinical Study of the EndoPredict Test in Women with Early-Stage Breast Cancer | 2020-06-04 |...

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Myeloproliferative Disorders Drugs Market Industry Trends and Developments Through 2026 – Cole of Duty

Myeloproliferative disorders are disease of blood and bone marrow which have unknown cause and there are wide range of symptoms. The treatment of myeloproliferative disorders generally depends on the type and presence of symptoms. Myeloproliferative disorders is generally considered as clonal disorder which begins with one or more change in the DNA of a single stem cells in the bone marrow. The changes to the hematopoietic stem cell cause the cell to reproduce repeatedly, creating more abnormal stem cells and these abnormal cells become one or more types of blood cells. Myeloproliferative disorders gets worst with time as the number of extra blood cells build up in the bone marrow and bloodstream.

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Emergence of new treatment for the myeloproliferative disorders and availability of novel drug drive the market for myeloproliferative disorders drugs market in the near future. Rising incidence of myeloproliferative disorders and presence of strong product pipeline spur the myeloproliferative disorders drugs market. Growing geriatric population, change in lifestyle and growing awareness among general population is expected to drive the market of myeloproliferative disorders in the forecast period.

Advancement in the treatment for oncology further expand the treatment option for myeloproliferative disorders. Various clinical trial undergoing for the treatment of myeloproliferative disorders which further drive the growth of the myeloproliferative disorders drugs market. However, high cost of drug and treatment along with the lack of awareness among the population in developing and under developed nations hinder the growth of myeloproliferative disorders drugs market.

The global myeloproliferative disorders drugs market is segmented on basis of Type, Drug Type, Distribution Channel, End User and Geography.

Improvement in the symptoms and reduction of in splenomegaly among patients receiving available therapy is expected to boost the market of myeloproliferative disorders. Development in new therapeutic drug and target therapy further drive the market growth of myeloproliferative disorders. Increased research and development and increased funding by the government towards the development of novel therapy spur the market growth. With the discovery of specific gene mutations in myeloproliferative disorders the market is expected to grow in the forecast period owing to increased adoption of new drugs and increased awareness along with the favorable reimbursement scenarios for the treatment of myeloproliferative disorders.

How the Coronavirus Threat has Taken Global Business into Uncharted Waters

The North America market holds the largest revenue share for myeloproliferative disorders drugs, due to presence of major pharmaceutical players undergoing various clinical innovation, government initiative and increase research and development funding for the Myeloproliferative disorders. Europe is expected to contribute for the second largest revenue share after North America in the global myeloproliferative disorders drugs market, owing to merging treatment option and development of oncology drug discovery and rising prevalence of myeloproliferative disorders.

Asia Pacific is expected to show rapid growth, due to increasing number of vascular surgeons and low cost of peripheral interventions. China is expected to register fast growth, due to significant increase in the number of innovative firm and research organization and increasing importance of pharmaceutical research & development activities and investments in research for developing new drugs. Latin America and Middle East & Africa are projected to exhibit sluggish growth in myeloproliferative disorders Drugs market, due to proper healthcare systems and adoption of new drug and therapy.

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Examples of some of the key manufacturer present in the global myeloproliferative disorders drugs market are,

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Myeloproliferative Disorders Drugs Market Industry Trends and Developments Through 2026 - Cole of Duty

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Stem Cell Banking Market to Witness Huge Growth in Coming Years 2020-2027 – Jewish Life News

Stem cell banking or preservation is a combined process of extraction, processing and storage of stem cells, so that they may be used for treatment of various medical conditions in the future, when required. Stem cells have the amazing power to get transformed into any tissue or organ in the body. In recent days, stem cells are used to treat variety of life-threatening diseases such as blood and bone marrow diseases, blood cancers, and immune disorders among others.

The market of stem cell banking is anticipated to grow with a significant rate in the coming years, owing to factors such as, development of novel technologies for stem cell preservation and processing, and storage; growing awareness on the potential of stem cells for various therapeutic conditions. Moreover, increasing investments in stem cell research is also expected to propel the growth of the stem cell banking market across the globe. On other hand rising burden of major diseases and emerging economies are expected to offer significant growth opportunities for the players operating in stem cell banking market.

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Key Points of the Report:

In addition, the report focuses on leading industry players with information such as company profiles, components and services offered, financial information of last 3 years, key development in past five years.

1. Cordlife2. ViaCord (A Subsidiary of PerkinElmer)3. Cryo-Save AG4. StemCyte India Therapeutics Pvt. Ltd.5. Cryo-Cell International, Inc.6. SMART CELLS PLUS.7. Vita 348. LifeCell9. Global Cord Blood Corporation10. CBR Systems, Inc.

The Insight Partners has segmented the global Stem Cell Banking Market:

The source segment includes, placental stem cells (PSCS), dental pulp-derived stem cells (DPSCS), bone marrow-derived stem cells (BMSCS), adipose tissue-derived stem cells (ADSCS), human embryo-derived stem cells (HESCS), and other stem cell sources. Based on service type the market is segmented into, sample processing, sample analysis, sample preservation and storage, sample collection and transportation. Based on application, the market is segmented as, clinical applications, research applications, and personalized banking applications.

The report covers key developments in the Stem Cell Banking market as organic and inorganic growth strategies. Various companies are focusing on organic growth strategies such as product launches, product approvals and others such as patents and events. Inorganic growth strategies witnessed in the market were acquisitions, and partnership & collaborations. These activities have paved way for expansion of business and customer base of market players.

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global Stem Cell Banking market based on various segments. It also provides market size and forecast estimates from year 2017 to 2027 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. The Stem Cell Banking market by each region is later sub-segmented by respective countries and segments. The report covers analysis and forecast of 18 countries globally along with current trend and opportunities prevailing in the region.

The report analyzes factors affecting Stem Cell Banking market from both demand and supply side and further evaluates market dynamics affecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trends. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the Stem Cell Banking market in these regions.

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Stem Cell Banking Market to Witness Huge Growth in Coming Years 2020-2027 - Jewish Life News

Recommendation and review posted by Bethany Smith

Market Analysis and Technological Opportunities of Cell Therapy Manufacturing Market till 2030 – Cole of Duty

Prophecy Market Insights Cell Therapy Manufacturing market research report provides a comprehensive, 360-degree analysis of the targeted market which helps stakeholders to identify the opportunities as well as challenges. The research report study offers keen competitive landscape analysis including key development trends, accurate quantitative and in-depth commentary insights, market dynamics, and key regional development status forecast 2020-2029. It incorporates market evolution study, involving the current scenario, growth rate, and capacity inflation prospects, based on Porters Five Forces and DROT analyses.

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An executive summary provides the markets definition, application, overview, classifications, product specifications, manufacturing processes; raw materials, and cost structures.

Market Dynamics offers drivers, restraints, challenges, trends, and opportunities of the Cell Therapy Manufacturing market

Segment Level Analysis in terms of types, product, geography, demography, etc. along with market size forecast

Regional and Country- level Analysis different geographical areas are studied deeply and an economical scenario has been offered to support new entrants, leading market players, and investors to regulate emerging economies. The top producers and consumers focus on production, product capacity, value, consumption, growth opportunity, and market share in these key regions, covering

The comprehensive list of Key Market Players along with their market overview, product protocol, key highlights, key financial issues, SWOT analysis, and business strategies. The report dedicatedly offers helpful solutions for players to increase their clients on a global scale and expand their favour significantly over the forecast period. The report also serves strategic decision-making solutions for the clients.

Competitive landscape Analysis provides mergers and acquisitions, collaborations along with new product launches, heat map analysis, and market presence and specificity analysis.

Segmentation Overview:

Cell Therapy ManufacturingMarket Key Companies:

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

The Cell Therapy Manufacturing research study comprises 100+ market data Tables, Graphs & Figures, Pie Chat to understand detailed analysis of the market. The predictions estimated in the market report have been resulted in using proven research techniques, methodologies, and assumptions. This Cell Therapy Manufacturing market report states the market overview, historical data along with size, growth, share, demand, and revenue of the global industry.

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The study analyses the manufacturing and processing requirements, project funding, project cost, project economics, profit margins, predicted returns on investment, etc. This report is a must-read for investors, entrepreneurs, consultants, researchers, business strategists, and all those who have any kind of stake or are planning to foray into the Cell Therapy Manufacturing industry in any manner.

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Prophecy Market Insights is specialized market research, analytics, marketing/business strategy, and solutions that offers strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high-value opportunities in the target business area. We also help our clients to address business challenges and provide the best possible solutions to overcome them and transform their business.

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Neal D. Shore, MD, FACS Discusses Impact, Treatment Implications of the Phase III HERO Trial – Cancer Network

Results presented at the 2020 ASCO Virtual Scientific Program demonstrated that once daily oral relugolix (Relumina), a gonadotrophin-releasing hormone (GnRH) antagonist, induced sustained castration in 96.7% of patients with advanced prostate cancer, meeting the trials primary endpoint. These findings met the superiority threshold for relugolix when compared with leuprolide (Lupron).

In an interview with CancerNetwork, Neal D. Shore, MD, FACS of the Carolina Urologic Research Center discussed the significance of these findings and the benefits of relugolix as a GnRH antagonist.

Transcription:

So, if I could summarize how this new once daily oral GnRH antagonist medication could change the landscape of treatment for our patients with advanced prostate cancer, I would say that historically and contemporaneously, we only have a parenteral administration of testosterone (T) suppression medications, whether they're given intramuscularly or subcutaneously, or by an implant. This trial, the HERO trial, now has established that once daily oral relugolix, a GnRH antagonist so you don't get surge of testosterone you avoid clinical flare, will offer patients and physicians another significant tool to consider for achieving testosterone suppression not only because it is highly effective in achieving testosterone suppression, but if patients choose to stop medication, their testosterone recovery is much faster so they get back to the benefits of having normal testosterone. And even more significantly, the mechanism of action of an antagonist over an agonist will afford patients and physicians some comfort in knowing that there's a marked decrease in the risk of having a cardiovascular event. Interestingly, during this time of concern, as it relates to the COVID pandemic, patients can take medication at home and don't necessarily need to come into the clinic and put themselves at risk for receiving a parental injection as well as the healthcare team. So, I think these are all very significant developments.

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Coming Together to Solve COVID-19 Mysteries | University of Pennsylvania Almanac – UPENN Almanac

Coming Together to Solve COVID-19 Mysteries

As the COVID-19 pandemic began to be felt, scientists at Penn started work todevelop a vaccineandassess possible treatments. But the scope of COVID-19 studies at the University goes much broader. Scientists whose typical work finds them investigating autoimmune disease, influenza, HIV/AIDS, Ebola, cancer, hemophilia and more, are now applying their deep understanding of biology to confront a novel threat.

What Does SARS COVID-19 Do To Our Lungs? Another respiratory infection, influenza, has been a focus of research led by Andrew Vaughan, Penn Vet assistant professor of biomedical sciences. But Dr. Vaughan didnt hesitate to begin studies of the novel coronavirus once its eventual impact became apparent. Now, graduate students and research specialists in his labworking no more than two together at a time to maximize social distancingare conducting new experiments focused more specifically on the biology of SARS-CoV-2, alongside parallel efforts by Edward Morrissey from PSOM. Knowing that the ACE2 receptor on lung cells is the gateway for the virus into the human body, theyre genetically manipulating alveolar type-two lung cells, which are particularly essential for continuing oxygen exchange deep in the lungs, to alter or block ACE2 gene expression to try to prevent viral entry.

Why are Men Worse Off Than Women? In a separate project, Dr. Vaughan is partnering with Montserrat Anguera, Penn Vet associate professor of biomedical sciences, to explore a curious feature of COVID-19 disease: the fact that more men than women become severely ill and die. A number of hypotheses have been put forward to explain the disparity, but the two labs are investigating one particular possibility.

Dr. Anguera had posted something on Twitter saying that the ACE2 gene happens to be on the X chromosome, meaning that women have two copies of it, said Dr. Vaughan. I immediately texted her and said, I think theres something to that.

Hormone expression levels are another factor that may influence sex differences in disease. Together, Drs. Anguera and Vaughans groups are both studying ACE2 expression and exposing alveolar type-two cells to various hormones to see how expression of viral receptors, ACE2 and others, changes. Ultimately wed like to see if this changes susceptibility to infection, working withSusan Weissand others, said Dr. Vaughan.

Do Genetics Influence Susceptibility? Individual differences in how people respond to infection may be influenced by their unique genomic sequences. PIK Professor Sarah Tishkoff of PSOM and SAS is probing the rich sources of genomic data her group already had in hand to look for patterns that could explain differences in disease susceptibility. Using genomic data from 2,500 Africans collected for another project, Dr. Tishkoffs team is looking for patterns of genetic diversity. Early findings suggest that natural selection may have acted upon on a version of the ACE2 gene, making it more common in some African populations with high exposure to animal viruses.

She is also collaborating withAnurag Vermaand Giorgio Sirugo of Penn Medicine to analyze genetic variation in samples from thePenn Medicine Biobank, looking in particular at people of African descent.

How is the Immune System Reacting? The immune system is what eliminates the virus, saidE. John Wherry, chair of Systems Pharmacology and Translational Therapeutics at PSOM. The immune system is what we need to activate with a good vaccine. But also, especially in many respiratory infections, the immune system is what also causes damage. A healthy outcome means your immune system is striking a balance between killing off the virus and not doing so much damage that it kills you.

Dr. Wherry and Michael Betts, professor of microbiology, have embarked on a study to discern both the magnitude of patients immune responses as well as their flavor, that is, what components in the immune system are being activated by the coronavirus. They are doing so by working with clinicians at HUP and, soon, atPenn Presbyterian Medical Center, to collect blood samples from patients with severe and more mild infections, as well as patients who have recovered from illness, to profile their immune reactions. Variety across patients strongly suggests that the treatments that work for one patient may not for another, Drs. Wherry and Betts note. They are speaking daily with their colleagues on the front lines of COVID-19 care, relaying what theyre finding out in the lab.

The PSOMs Ronald Collman, professor of medicine, andFrederic Bushman, William Maul Measey Professor in Microbiology, have been devoting attention to how the community of bacteria, viruses, fungi and parasites that dwell in the respiratory tract affect health and disease risk. They are now addressing that question in the context of COVID-19. According to Dr. Collman, The microbiome can help set the tone for the immune response to infections, influencing whether a patient ends up with mild or severe disease. And second, the microbiome is where infectious agents that can cause infection can arise from. So if a patient dies of an eventual pneumonia, the pathogen that caused that pneumonia may have been part of that individuals respiratory tract microbiome.

Working with nurses at HUP to collect samples, Drs. Collman and Bushman are analyzing the microbiome of both the upper and lower portions of the respiratory tract of COVID-19 patients. Their labs are using these samples to identify the types and quantities of organisms that compose the microbiome to find patterns in how they correlate with disease.

What Drugs Might Make An Impact? Absent a vaccine, researchers are looking to existing drugssome already approved by the US FDA for other maladiesto help patients recover once infected. Throughout his career,Ronald Harty, Penn Vet professor of pathobiology and microbiology, has worked to develop antivirals for other infections, such as Ebola, Marburg and Lassa Fever.

Though many of the biological details of how SARS-CoV-2 interacts with the human body are distinct from the other diseases Dr. Harty has studied, his group noticed a similarity: A sequence hes targeted in other virusesa motif called PPxYis also present in the spike protein of SARS-CoV-2, which the coronavirus uses to enter cells.

This caught our eye, said Dr. Harty, and piqued our interest in the very intriguing possibility that this PPxY motif could play a role in the severity of this particular virus. He is testing antivirals he has helped identify that block the replication of Ebola, Marburg and other viruses to see if they make a dent on the activity of SARS-CoV-2. Those experiments will be done in collaboration with colleagues whose labs can work in BSL-III or -IV laboratories.

Also of interest is the speculation that the coronavirus might disrupt cell-cell junctions in the human body, making them more permeable for virus spread.

Another faculty member is assessing whether a drug developed for a very different conditionpulmonary arterial hypertension(PAH)could serve coronavirus patients. Henry Daniell, vice-chair and W.D. Miller Professor in Penn Dentals department of basic and translational sciences, shared news that a drug grown in a plant-based platform to boost levels of ACE2 and its protein product, angiotensin (1-7), was progressing to the clinic to treat PAH. Dr. Daniell is now working withKenneth Margulies, PSOM professor of medicine and physiology and research and fellowship director of the Heart Failure and Transplant Program, to explore whether this novel oral therapy can improve the clinical course of patients with symptomatic COVID-19 infection.

Reduced ACE2 expression has been linked to acute respiratory distress, severe lung injury, multi-organ failure and death, especially in older patients. The earlier preclinical studies in PAH animal models showed that orally delivered ACE2 made in plant cells accumulated ten times higher in the lungs than in the blood and safely treated PAH. Now, new clinical studies have been developed to explore whether oral supplementation of ACE2 and angiotensin-1-7 can help mitigate complications of COVID-19 disease. The fact that freeze-dried plant cells can be stored at room temperature for as long as a year and can be taken at home by COVID-19 patients make this novel approach an attractive potential option.

This trial has been given a high priority by the Penn Clinical Trial Working Group, said Dr. Daniell. Im pleased that this looks to be on the cusp of moving forward to help the growing number of COVID-19 patients.

As the coronavirus began to spread in the US, Joshua Plotkin, Walter H. and Leonore C. Annenberg Professor of the Natural Sciences, began to raise alarms about Philadelphias St. Patricks Day parade. His studies of the 1918 flu pandemic had explored disease incidence and spread, and it was hard to avoid noticingthe role of the Liberty Loan paradedown Broad Street in triggering a rampant spread of flu back then. Now, with work conducted with two graduate students and faculty member Simon Levin fromPrinceton University, Dr. Plotkin has mathematically sound advice for policymakers hoping to effectively stem the spread of a pandemic. In apreprint on arXiv.org, they share optimal, near-optimal, and robust strategies.

Their analysis makes the realistic assumption that policymakers can only enforce social distancing for a limited amount of time and aims to minimize the peak incidence of disease. The optimal strategy, they found, is to start by introducing moderate social distancing measures to keep the incidence rate the same for a period of time. This would mean that every person with COVID-19 would infect one additional person. Then the intervention should switch over to a full suppressionthe strongest possible quarantinefor the rest of the period. At the end of that period, all restrictions would be lifted.

This works because you dont want to fully suppress disease spread right off the bat, said Dr. Plotkin, because then at the end, after you remove restrictions, there will be a second peak that is just as large as the first. By employing a moderate suppression at the beginning, youre building up a population of people who are going to recover and become immune, without letting the epidemic get out of control.

Dr. Plotkin and colleagues are hoping to share the findings widely to help navigate a likely second wave of COVID-19.

Adapted from a story by Katie Baillie, Penn TodayVisithttps://tinyurl.com/pennandcovid for the full story.

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Coming Together to Solve COVID-19 Mysteries | University of Pennsylvania Almanac - UPENN Almanac

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The Best Over-The-Counter Products For Treating Hyperpigmentation – Harper’s Bazaar Singapore

Photo: Getty

If you struggle with dark spots and discolouration, youre not alone. In fact, according to Dr. Dennis Gross, board-certified dermatologist and founder ofDr. Dennis Gross Skincare, the number one skin concern for women is not ageing or wrinkles, its hyperpigmentation. But what exactly is it and how do you treat it?

Hyperpigmentation, the term used to describe areas of unevenpigmentation, is caused when melanin (what gives your hair and skin its colour) is overproduced in certain spots, causing the area to look darker than your natural skin tone. Theses brown patches are most commonly caused by excessive sun exposure, hormone imbalances (as a result of birth control or pregnancy), and inflammation or injury to the skin (a breakout, abug bite, or even an area you might have scratched or picked at too much). Hyperpigmentation usually appears on the face, neck, and dcolletage.

Related article:15 Essential Beauty Treatments To Try Now That Youve Got The Time

Hyperpigmentation is notoriously difficult to treat, but it is doable. If youre really serious about it, its best to visit a dermatologist for in-clinic treatments such as light therapy and peels. However, theres also a host of pigmentation fighting products that you can add to your everyday routine. The key is to look for formulations that feature ingredients such as liquorice extracts, vitamin C and E, niacinamide, beta hydroxy acids, like salicylic, and alpha hydroxyl acids, like glycolic and lactic. Of course, the easiest way to deal with pigmentation is to avoid it altogether by using a good sunscreen and leaving spots alone, especially when theyre not ready. SPF will also help keep current pigmentation from darkening.

Related article:7 Zinc Oxide Sunscreens That Blend Like A Dream

While its unlikely a single product will completely erase dark spots, these ones will certainly help lighten them.

Emma Lewisham Skin Reset Pigmentation Correcting Serum

Emma Lewisham grew up worshiping New Zealands harsh summer sun and by her late 20s she started noticing discolouration and brown spots. But it was during her pregnancy that Lewishams uneven complexion really knocked her confidence. As a result, she set about creating a product that dealt with hyperpigmentation while remaining free of toxins, fillers, synthetic chemicals, and artificial colours and fragrances. Instead, Skin Reset is formulated from 24 of the most high-performing natural ingredients from around the world.

Each bottle contains 190 skin-beautifying ingredients such as organic prickly pear, which is known for its high concentration of vitamin E, and kakadu plum, which has the highest concentration of vitamin C in the world, alongside a host of other minerals, antioxidants, aminos, and omega fatty acids (3, 6, 9, and the rare beauty omega 7).

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Allies Of Skin Mandelic Pigmentation Corrector Night Serum

This next-generation overnight serum from home-grown clean skincare brand, Allies of Skin, is supercharged with a hardworking blend of 11% Mandelic, Lactic + Salicylic acid, 8 brighteners and 7 antioxidants and peptides, helping to treat stubborn pigmentation, melasma, large pores, persistent breakouts, uneven texture and even blackheads. While most AHA (Alpha-Hydroxy Acids) serums focus only on the exfoliation aspect that can sometimes lead to tightness and irritation, this multitasking booster is formulated to not only gently dissolve dead skin cells but also replenish moisture and strengthen the skins delicate barrier, with its hydrating blend of hyaluronic acid, niacinamide and essential fatty acids from organic rosehip and tamanu oil.

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Dr. Dennis Gross Skincare Professional Grade IPL Dark Spot Concentrated Serum

Part of Dr. Dennis Gross Skincares Clinical Grade range, the brands Professional Grade IPL Dark Spot Concentrated Serum boasts an innovative formula straight from his practice formulated to help fade the look of stubborn dark spots and discolouration for an even and radiant complexion.Jam-packed with 10% L-ascorbic acid, lactic acid, kojic acid,andarbutin, this pro-level formula is clinically shown to reduce the appearance of sunspots, age spots, and dark patches in just a few weeks.

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IDS Skincare Fair Complex

IDSis askincareline made to deliver highly visible results that surpass those achieved by most prescription products, without the side effects they often cause. The brands Fair Complex comes with a proprietary formulation of peptides and active ingredients that everyone can benefit from, regardless of skin tone. Alongside lines and wrinkles, skin dullness and hyperpigmentation it also works to target the signs of ageing. The skin-brightening formula is hydroquinone-free, but coupled with state-of-the-art ingredients and IDS patented NEULASTIN technology, it effectively prevents melanin over-production and visibly counteracts age spots and hyperpigmentation without irritations or side effects.

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Derma Lab Lumiclar Pure Vitamin C15

Formulated with 15% dermatological grade Vitamin C(one of the highest in the market), Derma Labs Lumiclar Pure Vitamin C15 penetrates deep into the skins epidermis and rapidly evens out the complexion for a radiant glow. Together with ultra-stable forms of ascorbic acid, skin becomes brighter, firmer, and more lifted. Vitamin Cs powerful antioxidant properties also reinforce the skins defence against free radicals, while the Derma Mimic Complex locks in moisture and strengthens skin barrier for hydrated, healthier skin.

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Drunk Elephant T.L.C Framboos Glycolic Night Serum

Drunk Elephants T.L.C Framboos Glycolic Night Serum is a high-tech gel that resurfaces dull skin, lifting dead skin cells away by gently dissolving the glue that holds them to the surface. Formulated with a combination of glycolic, lactic, tartaric, citric and salicylic acids, and blended with raspberry extract, T.L.C. Framboos sinks in easily and delivers an effective level of chemical exfoliation without the harsh side effects like dryness or sensitisation. Fine lines, wrinkles, and discolouration, along with excess oiliness and the appearance of pores, will appear dramatically reduced. Meanwhile, horse chestnut, bearberry, and white tea help to calm and soothe while improving the appearance of broken capillaries.

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Huxley Brightly Ever After Essence

A South Korean skincare brand that has recently launched in Singapore, Huxleys products are formulated around Sahara-sourced prickly pear, which is rich in vitamin E and brimming with antioxidants to prevent moisture from escaping while promoting healthy skin cell production for a more resilient, youthful appearance. The brands Brightly Ever After Essence offers a light, milky-textured formula that targets uneven skin tone, dark spots and hyperpigmentation. Its also enriched with niacinamide, a form of Vitamin B with brightening properties that aids in reducing dullness for an even skin tone.

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Related article:The Best Luxury Body Lotions To Try Now

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Meet ACE2, the Enzyme at the Center of the Covid-19 Mystery – WIRED

During the first chaotic months of the Covid-19 pandemic, it was already clear that the novel coronavirus spreading around the world didnt affect everyone equally. The earliest clinical data out of China showed that some people consistently fared worse than others, notably men, the elderly, and smokers. It made some scientists wonder: What if the elevated risk of severe infection and death shared by these different people all boils down to differences in a single protein?

Here's all the WIRED coverage in one place, from how to keep your children entertained to how this outbreak is affecting the economy.

Jason Sheltzer, a molecular biologist at Cold Spring Harbor Laboratory, started talking about this possibility with his partner, Joan Smith, a software engineer at Google, during the early days of their New York lockdown. We thought maybe the simplest explanation could be if all these factors affected the expression of ACE2, says Sheltzer.

ACE2, which stands for angiotensin-converting enzyme 2, is a protein that sits on the surface of many types of cells in the human body, including in the heart, gut, lungs, and inside the nose. Its a key cog in a biochemical pathway that regulates blood pressure, wound healing, and inflammation. ACE2s amino acids form a grooved pocket, allowing it to snag and chop up a destructive protein called angiotensin II, which drives up blood pressure and damages tissues. But angiotensin II isnt the only thing that fits in ACE2s pocket. So does the tip of the mace-like spike proteins that project from SARS-CoV-2, the coronavirus that causes Covid-19. Like a key turning in a latch, the virus gains entry to the cell through ACE2, then hijacks the cells protein-making machinery to make copies of itself. An infection begins.

In the early days of the pandemic, the thinking went something like this: The more ACE2 a person has, the easier it should be for the coronavirus to invade and advance through their tissues, causing more severe forms of the disease. The more ways inside someones cells, the higher the persons risk. Thats the hypothesis Sheltzer and Smith were interested in investigating. They werent alone. As the virus spread beyond China, other high-risk groups surfaced: people with heart conditions, high blood pressure, diabetes, and obesity. Many people in these groups take medications that are known to boost ACE2 expression. So again, scientists wondered, could that protein be responsible?

But as researchers began to probe the relationship between ACE2 and this dangerous new disease, the data refused to line up in any neat, predictable patterns. What we know now is that there arent any simplistic, reductionist explanations that can unify all the clinical data thats been recovered so far, says Sheltzer. Instead, a more complicated picture has emerged. But its one that still has ACE2 at the center of the action.

Smoking Dials Up the ACE2

Sheltzer and Smith, confined to their home, couldnt run any experiments to tease out their initial hypothesis. Instead, they combed through existing data sets from both animal and human studies that measured the level of gene expression in various tissues. Over and over, they found that women and men produced similar amounts of ACE2 inside their lung cells. They also couldnt find any differences between young adults and older ones. Aging didnt change ACE2 one way or another. But the smokers were a different story.

When they looked at gene expression inside the lungs of smokers versus nonsmokers, they saw a huge spike in ACE2 coming from one particular kind of cell: secretory goblet cells. The job of these mucous-makers is to coat the inside of the respiratory tract, protecting it from any irritants you might breathe in (like say, tar, nicotine, or any of the other 250 harmful chemicals in cigarette smoke). The more people smoked, the more their goblet cells multiplied in an effort to trap these chemicals before they could damage surrounding tissue. Those expanding goblet cell army ranks fueled a surge in ACE2, as Sheltzer and his coauthors described in a study published in Developmental Cell in mid-May.

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Meet ACE2, the Enzyme at the Center of the Covid-19 Mystery - WIRED

Recommendation and review posted by Bethany Smith

Adenomyosis Treatment Market 2019 | Analyzing The Impact Followed By Restraints, Opportunities And Projected Developments | UpMarketResearch – Medic…

The Adenomyosis Treatment Market report includes overview, which interprets value chain structure, industrial environment, regional analysis, applications, market size, and forecast. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report. The report provides an overall analysis of the market based on types, applications, regions, and for the forecast period from 2020 to 2026. It also offers investment opportunities and probable threats in the market based on an intelligent analysis.

This report focuses on the Global Adenomyosis Treatment Market trends, future forecasts, growth opportunities, key end-user industries, and market players. The objectives of the study are to present the key developments of the market across the globe.

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Key List Market Participants in the Market:Bayer AGFerring B.VJohnson & JohnsonNovartisMerckPfizerSpeciality European Pharma

By Types:Anti-inflammatory drugsHormone medicationsOther

By Applications:HospitalClinicOthers

Scope of the Adenomyosis Treatment Market Report:

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By Regions:North America (The USA, Canada, and Mexico)Europe (Germany, France, the UK, and Rest of Europe)Asia Pacific (China, Japan, India, and Rest of Asia Pacific)Latin America (Brazil and Rest of Latin America.)Middle East &Africa (Saudi Arabia, the UAE, South Africa, and Rest of Middle East & Africa).

Report Answers Following Questions:

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Adenomyosis Treatment Market Historic Data (2015-2019):

Adenomyosis Treatment Market Forecast (2020-2026):

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Male Hypogonadism Therapy Market Development, Market Trends, Key Driven Factors, Segmentation And Forecast To 2020-2026 – Weekly Wall

The market research report is a brilliant, complete, and much-needed resource for companies, stakeholders, and investors interested in the global Covid-19 Impact on Male Hypogonadism Therapy market. It informs readers about key trends and opportunities in the global Covid-19 Impact on Male Hypogonadism Therapy market along with critical market dynamics expected to impact the global market growth. It offers a range of market analysis studies, including production and consumption, sales, industry value chain, competitive landscape, regional growth, and price. On the whole, it comes out as an intelligent resource that companies can use to gain a competitive advantage in the global Covid-19 Impact on Male Hypogonadism Therapy market.

Key companies operating in the global Covid-19 Impact on Male Hypogonadism Therapy market include , Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD Male Hypogonadism Therapy

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Segmental Analysis

Both developed and emerging regions are deeply studied by the authors of the report. The regional analysis section of the report offers a comprehensive analysis of the global Covid-19 Impact on Male Hypogonadism Therapy market on the basis of region. Each region is exhaustively researched about so that players can use the analysis to tap into unexplored markets and plan powerful strategies to gain a foothold in lucrative markets.

Global Covid-19 Impact on Male Hypogonadism Therapy Market Segment By Type:

, Parenteral, Transdermal, Oral, Other

Global Covid-19 Impact on Male Hypogonadism Therapy Market Segment By Application:

, Hospitals, Drugstores, Other

Competitive Landscape

Competitor analysis is one of the best sections of the report that compares the progress of leading players based on crucial parameters, including market share, new developments, global reach, local competition, price, and production. From the nature of competition to future changes in the vendor landscape, the report provides in-depth analysis of the competition in the global Covid-19 Impact on Male Hypogonadism Therapy market.

Key companies operating in the global Covid-19 Impact on Male Hypogonadism Therapy market include , Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD Male Hypogonadism Therapy

Key questions answered in the report:

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TOC

1 Report Overview1.1 Study Scope1.2 Key Market Segments1.3 Players Covered: Ranking by Male Hypogonadism Therapy Revenue1.4 Market Analysis by Type 1.4.1 Global Male Hypogonadism Therapy Market Size Growth Rate by Type: 2020 VS 2026 1.4.2 Parenteral 1.4.3 Transdermal 1.4.4 Oral 1.4.5 Others1.5 Market by Application 1.5.1 Global Male Hypogonadism Therapy Market Share by Application: 2020 VS 2026 1.5.2 Hospitals 1.5.3 Drugstores 1.5.4 Others1.6 Coronavirus Disease 2019 (Covid-19): Male Hypogonadism Therapy Industry Impact 1.6.1 How the Covid-19 is Affecting the Male Hypogonadism Therapy Industry 1.6.1.1 Male Hypogonadism Therapy Business Impact Assessment Covid-19 1.6.1.2 Supply Chain Challenges 1.6.1.3 COVID-19s Impact On Crude Oil and Refined Products 1.6.2 Market Trends and Male Hypogonadism Therapy Potential Opportunities in the COVID-19 Landscape 1.6.3 Measures / Proposal against Covid-19 1.6.3.1 Government Measures to Combat Covid-19 Impact 1.6.3.2 Proposal for Male Hypogonadism Therapy Players to Combat Covid-19 Impact1.7 Study Objectives1.8 Years Considered 2 Global Growth Trends by Regions2.1 Male Hypogonadism Therapy Market Perspective (2015-2026)2.2 Male Hypogonadism Therapy Growth Trends by Regions 2.2.1 Male Hypogonadism Therapy Market Size by Regions: 2015 VS 2020 VS 2026 2.2.2 Male Hypogonadism Therapy Historic Market Share by Regions (2015-2020) 2.2.3 Male Hypogonadism Therapy Forecasted Market Size by Regions (2021-2026)2.3 Industry Trends and Growth Strategy 2.3.1 Market Top Trends 2.3.2 Market Drivers 2.3.3 Market Challenges 2.3.4 Porters Five Forces Analysis 2.3.5 Male Hypogonadism Therapy Market Growth Strategy 2.3.6 Primary Interviews with Key Male Hypogonadism Therapy Players (Opinion Leaders) 3 Competition Landscape by Key Players3.1 Global Top Male Hypogonadism Therapy Players by Market Size 3.1.1 Global Top Male Hypogonadism Therapy Players by Revenue (2015-2020) 3.1.2 Global Male Hypogonadism Therapy Revenue Market Share by Players (2015-2020) 3.1.3 Global Male Hypogonadism Therapy Market Share by Company Type (Tier 1, Tier 2 and Tier 3)3.2 Global Male Hypogonadism Therapy Market Concentration Ratio 3.2.1 Global Male Hypogonadism Therapy Market Concentration Ratio (CR5 and HHI) 3.2.2 Global Top 10 and Top 5 Companies by Male Hypogonadism Therapy Revenue in 20193.3 Male Hypogonadism Therapy Key Players Head office and Area Served3.4 Key Players Male Hypogonadism Therapy Product Solution and Service3.5 Date of Enter into Male Hypogonadism Therapy Market3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)4.1 Global Male Hypogonadism Therapy Historic Market Size by Type (2015-2020)4.2 Global Male Hypogonadism Therapy Forecasted Market Size by Type (2021-2026) 5 Male Hypogonadism Therapy Breakdown Data by Application (2015-2026)5.1 Global Male Hypogonadism Therapy Market Size by Application (2015-2020)5.2 Global Male Hypogonadism Therapy Forecasted Market Size by Application (2021-2026) 6 North America6.1 North America Male Hypogonadism Therapy Market Size (2015-2020)6.2 Male Hypogonadism Therapy Key Players in North America (2019-2020)6.3 North America Male Hypogonadism Therapy Market Size by Type (2015-2020)6.4 North America Male Hypogonadism Therapy Market Size by Application (2015-2020) 7 Europe7.1 Europe Male Hypogonadism Therapy Market Size (2015-2020)7.2 Male Hypogonadism Therapy Key Players in Europe (2019-2020)7.3 Europe Male Hypogonadism Therapy Market Size by Type (2015-2020)7.4 Europe Male Hypogonadism Therapy Market Size by Application (2015-2020) 8 China8.1 China Male Hypogonadism Therapy Market Size (2015-2020)8.2 Male Hypogonadism Therapy Key Players in China (2019-2020)8.3 China Male Hypogonadism Therapy Market Size by Type (2015-2020)8.4 China Male Hypogonadism Therapy Market Size by Application (2015-2020) 9 Japan9.1 Japan Male Hypogonadism Therapy Market Size (2015-2020)9.2 Male Hypogonadism Therapy Key Players in Japan (2019-2020)9.3 Japan Male Hypogonadism Therapy Market Size by Type (2015-2020)9.4 Japan Male Hypogonadism Therapy Market Size by Application (2015-2020) 10 Southeast Asia10.1 Southeast Asia Male Hypogonadism Therapy Market Size (2015-2020)10.2 Male Hypogonadism Therapy Key Players in Southeast Asia (2019-2020)10.3 Southeast Asia Male Hypogonadism Therapy Market Size by Type (2015-2020)10.4 Southeast Asia Male Hypogonadism Therapy Market Size by Application (2015-2020) 11 India11.1 India Male Hypogonadism Therapy Market Size (2015-2020)11.2 Male Hypogonadism Therapy Key Players in India (2019-2020)11.3 India Male Hypogonadism Therapy Market Size by Type (2015-2020)11.4 India Male Hypogonadism Therapy Market Size by Application (2015-2020) 12 Central & South America12.1 Central & South America Male Hypogonadism Therapy Market Size (2015-2020)12.2 Male Hypogonadism Therapy Key Players in Central & South America (2019-2020)12.3 Central & South America Male Hypogonadism Therapy Market Size by Type (2015-2020)12.4 Central & South America Male Hypogonadism Therapy Market Size by Application (2015-2020) 13 Key Players Profiles13.1 Eli Lilly 13.1.1 Eli Lilly Company Details 13.1.2 Eli Lilly Business Overview and Its Total Revenue 13.1.3 Eli Lilly Male Hypogonadism Therapy Introduction 13.1.4 Eli Lilly Revenue in Male Hypogonadism Therapy Business (2015-2020)) 13.1.5 Eli Lilly Recent Development13.2 Pfizer 13.2.1 Pfizer Company Details 13.2.2 Pfizer Business Overview and Its Total Revenue 13.2.3 Pfizer Male Hypogonadism Therapy Introduction 13.2.4 Pfizer Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.2.5 Pfizer Recent Development13.3 AbbVie 13.3.1 AbbVie Company Details 13.3.2 AbbVie Business Overview and Its Total Revenue 13.3.3 AbbVie Male Hypogonadism Therapy Introduction 13.3.4 AbbVie Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.3.5 AbbVie Recent Development13.4 Novo Nordisk 13.4.1 Novo Nordisk Company Details 13.4.2 Novo Nordisk Business Overview and Its Total Revenue 13.4.3 Novo Nordisk Male Hypogonadism Therapy Introduction 13.4.4 Novo Nordisk Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.4.5 Novo Nordisk Recent Development13.5 Merck KGaA 13.5.1 Merck KGaA Company Details 13.5.2 Merck KGaA Business Overview and Its Total Revenue 13.5.3 Merck KGaA Male Hypogonadism Therapy Introduction 13.5.4 Merck KGaA Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.5.5 Merck KGaA Recent Development13.6 Mylan 13.6.1 Mylan Company Details 13.6.2 Mylan Business Overview and Its Total Revenue 13.6.3 Mylan Male Hypogonadism Therapy Introduction 13.6.4 Mylan Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.6.5 Mylan Recent Development13.7 Bayer 13.7.1 Bayer Company Details 13.7.2 Bayer Business Overview and Its Total Revenue 13.7.3 Bayer Male Hypogonadism Therapy Introduction 13.7.4 Bayer Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.7.5 Bayer Recent Development13.8 Teva 13.8.1 Teva Company Details 13.8.2 Teva Business Overview and Its Total Revenue 13.8.3 Teva Male Hypogonadism Therapy Introduction 13.8.4 Teva Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.8.5 Teva Recent Development13.9 Novartis 13.9.1 Novartis Company Details 13.9.2 Novartis Business Overview and Its Total Revenue 13.9.3 Novartis Male Hypogonadism Therapy Introduction 13.9.4 Novartis Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.9.5 Novartis Recent Development13.10 Abbott 13.10.1 Abbott Company Details 13.10.2 Abbott Business Overview and Its Total Revenue 13.10.3 Abbott Male Hypogonadism Therapy Introduction 13.10.4 Abbott Revenue in Male Hypogonadism Therapy Business (2015-2020) 13.10.5 Abbott Recent Development13.11 Roche 10.11.1 Roche Company Details 10.11.2 Roche Business Overview and Its Total Revenue 10.11.3 Roche Male Hypogonadism Therapy Introduction 10.11.4 Roche Revenue in Male Hypogonadism Therapy Business (2015-2020) 10.11.5 Roche Recent Development13.12 Endo International 10.12.1 Endo International Company Details 10.12.2 Endo International Business Overview and Its Total Revenue 10.12.3 Endo International Male Hypogonadism Therapy Introduction 10.12.4 Endo International Revenue in Male Hypogonadism Therapy Business (2015-2020) 10.12.5 Endo International Recent Development13.13 Ipsen 10.13.1 Ipsen Company Details 10.13.2 Ipsen Business Overview and Its Total Revenue 10.13.3 Ipsen Male Hypogonadism Therapy Introduction 10.13.4 Ipsen Revenue in Male Hypogonadism Therapy Business (2015-2020) 10.13.5 Ipsen Recent Development13.14 ANI Pharmaceuticals 10.14.1 ANI Pharmaceuticals Company Details 10.14.2 ANI Pharmaceuticals Business Overview and Its Total Revenue 10.14.3 ANI Pharmaceuticals Male Hypogonadism Therapy Introduction 10.14.4 ANI Pharmaceuticals Revenue in Male Hypogonadism Therapy Business (2015-2020) 10.14.5 ANI Pharmaceuticals Recent Development13.15 TherapeuticsMD 10.15.1 TherapeuticsMD Company Details 10.15.2 TherapeuticsMD Business Overview and Its Total Revenue 10.15.3 TherapeuticsMD Male Hypogonadism Therapy Introduction 10.15.4 TherapeuticsMD Revenue in Male Hypogonadism Therapy Business (2015-2020) 10.15.5 TherapeuticsMD Recent Development 14 Analysts Viewpoints/Conclusions 15 Appendix15.1 Research Methodology 15.1.1 Methodology/Research Approach 15.1.2 Data Source15.2 Disclaimer15.3 Author Details

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Male Hypogonadism Therapy Market Development, Market Trends, Key Driven Factors, Segmentation And Forecast To 2020-2026 - Weekly Wall

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Jacobs School appoints new chair of Obstetrics and Gynecology – UB Now: News and views for UB faculty and staff – University at Buffalo Reporter

Sarah L. Berga has been appointed as the new chair of the Department of Obstetrics and Gynecology in the Jacobs School of Medicine and Biomedical Sciences at UB. She will also serve as president of UBMD Obstetrics & Gynecology, and medical director of Obstetrics and Gynecology and Maternal Fetal Medicine Program Development for Kaleida Health.

Bergas appointments, which began June 1, were announced by Michael E. Cain, vice president for health sciences and dean of the Jacobs School.

Dr. Berga rapidly emerged as our top candidate possessing the administrative, scientific, clinical, leadership and visionary skills needed to move the department forward, expand the departments basic and clinical research programs to fulfill the Jacobs Schools strategic goals, enhance the excellence of the departments graduate medical education and mentored research training programs, and develop and align a comprehensive clinical program at Kaleida Health and our community, Cain said.

Berga will succeed Vanessa Barnabei, who had served as chair since 2012. Barnabei has accepted a new position at the Jacobs School as associate dean for faculty advancement and development. In this new role, she will work with department chairs and chiefs, senior leaders in the offices of Faculty Affairs, the Medical Education and Education Research Institute, Diversity and Inclusion, Graduate Medical Education, Research Integration and others both within the school and beyond to promote opportunities for faculty scholarly activity, academic promotion, retention and wellness.She will continue in her clinical capacity, seeing patients at UBMD Obstetrics & Gynecology.

Berga comes to UB from the University of Utah School of Medicines Department of Obstetrics and Gynecology, where she served as professor and director of the Division of Reproductive Endocrinology and Infertility for two years.

(Berga) is an accomplished clinician, physician-investigator and educator, Cain said.

In addition, she is a diplomat of the National Board of Medical Examiners, the American Board of Obstetrics and Gynecology and the American Board of Obstetrics and Gynecology Division of Reproductive Endocrinology and Infertility.

I am totally thrilled to be joining the Jacobs School of Medicine and Biomedical Sciences, Kaleida Health and UBMD Obstetrics & Gynecology, Berga said. I was excited to be asked to look at the position; it is an amazing opportunity to build on what has been achieved to date at UB in the Jacobs School and in obstetrics, gynecology and womens health in particular.The new Oishei hospital is magnificent and the partnership with UB presents an unparalleled synergistic opportunity to expand programs, to conduct translational and clinical research, and to educate the next generation of womens health physicians and providers of all types.

Caring for patients through UBMD Obstetrics & Gynecology and Kaleida Health, Berga specializes in reproductive hormones, infertility and stress-induced hypothalamic hypogonadism (amenorrhea). Her clinical interests include in vitro fertilization (IVF), which she will be introducing to the UBMD practice, as well as perimenopause, hormone therapies and polycystic ovary syndrome.

Her research interests include determining the neuroendocrine mechanisms mediating stress-induced reproductive compromise and the impact of sex hormones on brain health in human and monkey models using neuroimaging and delineation of hormonal and cognitive patterns. Her research endeavors have been consistently funded by the National Institutes of Health, research foundations and industry.

Ive always been interested in how mindset attitudes and behaviors influence hormones and reproductive hormones in particular, Berga said.Her current research collaborations include understanding how stress and hormones influence brain and heart health in women.

Berga has authored or co-authored over 150 peer-reviewed scientific articles and written over 85 book chapters. In 2020, she was awarded the DeCherney Society Lifetime Distinguished Service Award by the Society for Reproductive Investigation. She currently serves as an associate editor for Human Reproduction Update. She has served on many NIH grant review committees.

Berga received her bachelors degree from the University of Virginia and her medical degree from the University of Virginia School of Medicine. She completed a residency in obstetrics and gynecology at Harvard Medical School, followed by a fellowship in reproductive endocrinology at University of California, San Diego School of Medicine.

She served as assistant professor, associate professor and professor at the University of Pittsburgh School of Medicine. She has also served as the James Robert McCord Professor and Chair in the Department of Gynecology and Obstetrics, Division of Reproductive Endocrinology and Infertility at the Emory University School of Medicine.

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Jacobs School appoints new chair of Obstetrics and Gynecology - UB Now: News and views for UB faculty and staff - University at Buffalo Reporter

Recommendation and review posted by Bethany Smith

The subtle signs that point the way towards haemochromatosis – The Irish Times

The first symptom I had was a hot flush. To say peri-menopausal was not on my radar is an understatement says Cathy Brooks, development manager with the UCD Foundation.

I had no idea. Id just lost my mum in October and I remember by Christmas being with friends in Collins Barracks, having a coffee walking around and I just started getting these hot flushes and I was thinking what the hell is this? To be honest, I just attributed it to the grief and losing my mum and all of that.

It was only when I googled it and I saw the symptoms that I thought, could I be? Im too young.

She was 39 at the time.

Initial blood tests suggested Cathy was not peri-menopausal but with her symptoms continuing she decided to seek advice from a second GP. On hearing her symptoms, the doctor immediately suspected haemochromatosis and decided to carry out a blood test.

I like to think Ive a very positive outlook on life, Cathy says, explaining how she made the decision that she wasnt going to focus on this. I just got on with living life.

Every year I go for a check-up in the haematology clinic in St Vincents . They do your bloods before and they check your liver, your heart all the organs that can be damaged. Its like going in for an annual MOT really, she continues.

Only in the last six months Ive started to get really achey in my index finger and my middle finger. When I close my fist I can feel my fingers kind of crunching. Thats a symptom of haemochromatosis.

Because Cathys joints are getting really stiff, she has been referred to a rheumatologist.

Cathy describes herself as being very active.

I do a lot of sport. I do it for my mental health as well as my physical health, she adds, discussing her love of rowing and cycling. But this year, like most of the world, Ive just been sitting on the couch eating, she says. Im more stiff now because Im not active.

Cathy has phlebotomies every three months to treat her haemochromatosis but shes keen that her blood doesnt go to waste just because of her condition.

If Ive to give blood for the rest of my life, I dont want my blood to be dumped because theres too much iron in it. I want my blood used. So I go to this clinic where they can use my blood, she says adding that people with haemochromatosis travel from all over the country to the clinic in Stillorgan for this very reason.

The service has been extended and now, many people with haemochromatosis can become regular blood donors at all blood donation clinics nationwide, including local community clinics.

Potential donors must meet specific haemochromatosis management criteria, the Irish Blood Transfusion Service states, which includes having completed iron depletion therapy, and not suffering from any serious complications as a result of haemochromatosis.

They must also satisfy standard blood donation criteria to be able to attend clinics to give blood which can then be used to save patients lives throughout the country

Thankfully, Cathy hasnt experienced any difficulties giving blood in Covid-19 times.

I happened to give blood about two weeks ago. Ive heard loads of people are having trouble giving blood during coronavirus. I havent had any problem. Ive had nothing but a positive experience with all of this and all the professionals.

What is haemochromatosis?

Haemochromatosis is a genetic condition which, in many people who have the condition, gives rise to excess iron absorption and retention within the body, explains Prof Suzanne Norris, professor of hepatology and gastroenterology, Trinity College, Dublin.

Over time, and its a very slow, gradual process, iron accumulation builds up and the iron is absorbed and deposited in various organs. We have the highest rate of haemochromatosis of any European and worldwide country

What are the symptoms of haemochromatosis?

Chronic fatigue is the main symptom, Prof Norris explains. Achey joints would be another. The problem with haemochromatosis is that it doesnt really have a symptom that would make you say aha thats haemochromatosis. Its all subtle signs. Its a disease thats under the radar because it doesnt produce a symptom that would make a doctor think that has to be that condition. Its literally chronic fatigue and unfortunately most chronic conditions will give rise to chronic fatigue.

How is haemochromatosis diagnosed?

To make the diagnosis, you need to have inherited the gene for excessive iron accumulation from both parents. Only about 50 per cent of people who have the two genes actually ever develop iron overload, so theres obviously another trigger, which may be environmental, we dont quite know, Professor Norris says.

What are the potential complications of haemochromatosis?

Typically the organs that end up having too much iron absorbed within them are the liver, the pancreas which may give rise to diabetes, the joints which may give rise to arthritis, Prof Norris explains.

Bronze diabetes, or brown discolouration of the skin is actually quite rare. There are other symptoms which may occur around depression and low mood. Its not clear whether thats just in relation to general inflammation because of the iron burden, or because of not feeling well and low mood associated with chronic ill health in that regard.

What is the treatment for haemochromatosis?

The treatment is very simple. Its blood letting or having blood removed on initially maybe a weekly or monthly basis in the acute stage when the person is coming in with a new diagnosis, ProfNorris explains.

Once the excess iron has been removed its like giving blood to the blood bank, you donate blood once or twice a year, that might be sufficient for most people. Some people may do it four times a year and that keeps the condition totally under control.

When the iron level is back within the normal range and its maintained at that level by either once to four times a year, depending on the persons needs, it keeps it completely under control and there is no risk of developing serious potential complications from late diagnosis once its diagnosed early, Professor Norris emphasises.

Our message is always, at this time of year, for healthcare professionals to really think about chronic fatigue could it be iron overload, rather than anaemia giving rise to chronic fatigue.

For more information, visit the Irish Haemochromatosis Association at haemochromatosis-ir.com (to donate 4, text IRON to 50300).

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The subtle signs that point the way towards haemochromatosis - The Irish Times

Recommendation and review posted by Bethany Smith

From the research lab to your doctor’s office here’s what happens in phase 1, 2, 3 drug trials – The Conversation US

For COVID-19, like all illnesses, the drugs and vaccines to treat or prevent the disease must be backed by rigorous evidence. Clinical trials are the source of this evidence.

With vaccines and drugs for the coronavirus already entering human testing, it is important to know what the different phases of clinical trials are testing for. I am a neurologist with the Alzheimers Therapeutic Research Institute at the University of Southern California. Our team has been developing and overseeing all phases of clinical trials for decades. I am here to help you understand this complicated and important process.

The earliest indications about whether an intervention is effective and safe come from preclinical trials. This research is done in the laboratory using cells or animals.

Researchers can get some information about safety and efficacy of a treatment from preclinical trials, but the results do not say whether what they are testing is safe or works in people.

Once a treatment shows promise in preclinical trials, researchers begin the process of working through the phases that have been established by the U.S. Food and Drug Administration. These phases are designed to do two things: protect patients during the process and make sure that the drug or treatment works.

Phase 1 trials are focused on safety. Researchers monitor kidney, liver, hormone and cardiac functions to look for adverse affects in human volunteers. They also look for biological signs of efficacy related to what they are hoping to treat. For example, if a trial was testing a vaccine, researchers might monitor immune activity to see if it increases.

Phase 1 clinical trials typically take around two months and involve small numbers of participants, usually 20 to 100 healthy volunteers or people with the condition that the intervention may treat. Researchers give the participants a range of medication dosages to help determine the lowest possible effective but safe dose. Some, but not all, phase 1 studies are randomized and placebo controlled, meaning that some portion of the subjects are given the real treatment and some get a placebo that does nothing. Neither the subject nor clinician knows who is receiving which treatment.

Drugs that pass phase 1 trials can be considered likely safe, but whether they work or not still remains to be seen.

In phase 2 trials, researchers focus on seeing if the treatment works, finding the safest effective dose and determining what symptoms, tests or outcomes are the best measures of efficacy of the treatment. Determining the best measures of success is important for designing the final stage of testing.

All phase 2 trials are randomized and placebo controlled.

This stage of research can take months to years, and only about one-third of drugs in phase 2 trials make it to the next phase.

In phase 2 trials, researchers give the drug to hundreds of subjects and watch for safety through regular testing. To measure effectiveness, researchers look at clinical responses such as the length of illness, severity of the illness or survival rates. Direct measures of a disease such as the amount of virus in a persons cells are also monitored, as well as biomarkers signals in the body that researchers know are changed by the targeted disease.

At this point, the researchers will use all the information they have gained to design the phase 3 trial. They decide what measures to use, the doses to test and the type, or cohort, of people to test.

If there is evidence in either phase 1 or phase 2 that the drug or vaccine is unsafe or ineffective, the teams will stop the trial.

Phase 3 trials are where researchers look to see if people that get the treatment are statistically better off than those dont. The trials are randomized and placebo controlled, and use the measures of success chosen from the phase 2 trial. Phase 3 trials are also designed to find any rare side effects of a treatment.

In order to get statistically meaningful data, phase 3 trials are big, normally including a few hundred to 3,000 people.

This is the final step before a drug is approved for public use. After a phase 3 trial is finished, the FDA puts together a panel of independent scientists to review the data. The panel decides, based on evidence of success and prevalence of side effects, if the benefits of the drug outweigh the risks enough to approve it for widespread use.

According to the FDA, only 25%-30% of drugs in phase 3 trials get approved.

Phase 4 trials are used to test approved treatments for the same medical condition but in a different dose or time frame or group of people. For example, a phase 4 trial could be used to test if a drug thats already approved for adults is safe and effective for children.

When a drug thats been approved for one purpose is studied for a different medical condition for example, testing the malaria drug hydroxychloroquine as a potential treatment for COVID-19 this is not a phase 4 trial. This is a phase 2 or 3 trial because it is designed to answer those early questions about how well the treatment works for the new condition.

News headlines are full of trial results concerning COVID-19 interventions. Its easy to get excited when reading about a new drug or vaccine. But early successes do not guarantee a treatment will work.

COVID-19, like Alzheimers, is a complex disease, and clinical trials to test treatments are particularly challenging, with highly variable outcomes. The process for drug and treatment approval is long, but is designed to guarantee that what a physician gives you will do help, not hurt, you.

[You need to understand the coronavirus pandemic, and we can help. Read The Conversations newsletter.]

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From the research lab to your doctor's office here's what happens in phase 1, 2, 3 drug trials - The Conversation US

Recommendation and review posted by Bethany Smith

We Cant Rely on the Systems That Everybody Else Relies On: Trans Texans Struggle With Health Care Access During COVID-19 – Texas Monthly

Avery Belyeu was anxious as she drove up to the mobile coronavirus testing site and rolled down her window to talk to a doctor in full protective gear. She had a fever and cough but was hesitant to get tested. Belyeu, along with an estimated 77 percent of trans Texans, does not have formal identification to match the name and gender she prefers. Going to a new health-care provider, she knew, meant having to explain her identity and the risk of being discriminated against. But her fear of the virus compelled her to go through with the test; later, it came back negative.

Im very privileged in the fact that I do have health insurance, Belyeu, who lives in Tarrant County and is the regional director of Lambda Legal, a LGBTQ advocacy organization, said. However, I was extremely nervous because I was sent to a testing location thats not my typical physicians office where they know who I am and they know my identity.

Belyeus story is similar to that of many trans Texans during the COVID-19 crisis, which has exacerbated the inequities the community had to face before the pandemic. UCLAs Williams Institute estimates that there are 125,350 adults in Texas who identify as transgenderthe second largest population in the country behind California. When it comes to receiving aid, and health care in particular, the community is often overlooked and discriminated against, in ways that make it more vulnerable during times of crisis.

Now more than ever Texans are connecting over shared stories. Enjoy your unlimited access to our site. To have TexasMonthly magazine delivered to your home, becomeasubscriber today.

In Texas, before the pandemic, trans people had more than four times the statewide rate of unemploymentand double the rate of poverty, and were more likely to experience homelessness and health problems. Though theres no record of the percentage of trans Texans who dont have health insurance, according to the Williams Institute, 26 percent of LGBT Texans are uninsured, compared with 17.7 percent of all Texans.

But even if they are insured, many trans Texans, like Belyeu, might be resistant to seek out coronavirus-related care. I have heard from trans people who delayed going to receive testing either because they didnt have health insurance, they were concerned about whether or not they would have access to testing, and delayed doing that for some time, Belyeu said. And I think that thats really the norm.

Before the pandemic, 22 percent of trans Texans did not see a doctor when they needed to because of fear of being mistreated as a transgender person, according to the 2015 Transgender Survey. The survey also found that 20 percent of trans Texans were denied coverage by their insurance because of their gender identity, and 30 percent of those who saw a health-care provider reported having at least one negative experienceverbal harassment, assault, refusal of treatmentrelated to being transgender.

There are community clinics around the state that focus on providing trans-affirming health care, and most have been able to stay open by providing telemedicine services. However, a majority of them are located in large metros, and not all are providing tests for COVID-19. In rural parts of the state, access to those same facilities can be few and far between.

Dr. Kelly Bennett is one of the few doctors in Lubbock who provides trans health care. She says many of her patients refuse to see any other doctors because of their anxieties ranging from overt discrimination to being misgendered or having to educate health providers about trans people. Shes even had new patients reach out then drive to see her from as far as Midland and Odessa (about two hours away) during this time. Patients are concerned that something will be done incorrectly, Bennett said. And they just dont want to explain [their gender] to somebody theyve never met, especially through the phone or on an awkward Zoom visit.

The gaps and barriers between trans Texans and services providing health care, mental-health care, and direct aid have resulted in organizations like Lambda Legal, a national legal organization litigating and advocating for LGBTQ people, to call for Governor Greg Abbott to expand health insurance to all Texans during the global pandemic. (They have not received a response from Abbott and are planning to raise the issue again to the Texas Health and Human Services executive council.) In recent years legislation has been drafted to address the inequities trans Texans facecalling for a transgender health-care committee and task forcesbut has not passed.

In lieu of state support, nonprofits and grassroots organizations across Texas have been left to pick up the slack.

The Montrose Center in Houston, which serves the LGBT community at large, has long had a disaster relief program for this very reason. Back in 2005, when busloads of survivors arrived in Houston during Hurricane Katrina, many trans individuals were turned back from shelters and denied clothes of their choice based on their gender identity. Anytime theres an economic impact or a disaster that disrupts the economy, said Kennedy Loftin, chief development officer at the Montrose Center, that community, which in some cases is already living on the margins, is just going to be more impacted every time.

Prior crises informed how the Montrose Center would handle the effects of COVID-19. Theyve continued to operate since stay-at-home orders took effect, with most case managers working remotely. In general, theyve seen an uptick in the need for basic necessities like food and shelter, but for the trans community, theyve seen an increase in mental health issues and suicides in particular.

The Montrose Center has also created a nonprofit incubator program, providing free resources, connections, and support to smaller organizations that focus specifically on serving transgender Texans and communities of color.

One organization receiving aid from the center, Save Our Sisters United, a Houston-based group for trans people of color, has in turn been providing direct financial assistance to its community.

When the pandemic started, Atlantis Narcisse, the organizations founder, immediately thought of the members of her community who were sex workers, gig workers, and service industry workers. With a grant from the Simmons Foundation, an organization that assists underfunded marginalized groups in Texas, her organization has provided its first direct assistance fund for food, hotel rooms, and medication like HRTs (hormone replacement therapy). This has never been donesomething that was for us by us, Narcisse said.

The organization has helped trans Texans like Alyssa Gamble, who was laid off in March from her housekeeping job at the Hilton hotel in downtown Houston, weeks before the citys stay-at-home order went into effect. In one fell swoop, Gamble lost her job, health care, and income to pay rent. Save Our Sisters was able to give her $150enough to get groceries and feminine hygiene products she needed before her unemployment money came through. Shes currently still unemployed and is receiving public assistance to pay for her housing and necessities.

Other aid groups have begun organizing online. Danny Roe, the assistant director of student diversity initiatives at Texas A&M Galveston, leads a trans support group. Its biweekly hour-long chats on Zoom have been a bright spot for memberssome are in quarantine with family members who arent accepting of them. Roe told me that one member became depressed because the coronavirus forced her long-planned appointment for electrolysis for facial hair removal to be pushed back. Others havent been able to see their trans-affirming primary care physicians because of their lack of telemedicine services and restrictions on running bloodwork.

All of these combined organizations and efforts versus the kind of funding that you see traditionally be passed down from either state, local, or federal coffers, its really a drop in the bucket, Emmett Schelling, executive director the Transgender Education Network of Texas, said. This is our community trying to do everything we can to meet people with just a little bit of assistance for them to survive through this. And unfortunately, we have to do this because we cant rely on the systems that everybody else relies on.

More:
We Cant Rely on the Systems That Everybody Else Relies On: Trans Texans Struggle With Health Care Access During COVID-19 - Texas Monthly

Recommendation and review posted by Bethany Smith

Blood sugar levels: what’s normal, what’s not and how to measure them – CNET

Sugar can lead to high blood sugar and contributes to the development of diabetes.

We all want to keep track of our health in every way we can -- you may weigh yourself daily, measure your waist-to-hip ratio, keep track of your blood pressure or monitor your resting heart rate. But how close of an eye do you keep on your blood sugar?

People with diabetes are all too familiar with their blood sugar levels, but the rest of us might not even think about them. However, consistently high blood sugar levels can coexist with Type 2 diabetes and cause serious health conditions like kidney disease, nerve problems or stroke.

Our Health & Wellness newsletter puts the best products, updates and advice in your inbox.

I hope I haven't scared you away, but when it comes to our health it's important to know exactly what's going on inside of our bodies. Without further ado, let's get into what blood sugar means, how to measure it and everything else you need to know.

Read more:How to eat less sugar without feeling deprived

Blood sugar, or glucose, is your body's main energy source. We get glucose from the food we eat, and our blood carries it around to all the cells in the body to give them energy to function. Glucose mainly comes from the carbohydrates we eat, though our bodies can convert protein and fat into sugar too if needed.

Glucose from protein is typically stored in the liver and doesn't enter the bloodstream, so eating protein-rich foods won't raise your blood sugar too much. Fats slow down the digestion of carbohydrates, which causes a delayed rise in blood sugar. A high blood sugar can be an issue because it usually leads to sugar crashes, which are no fun -- symptoms include fatigue, headaches and the jitters. So, eat meals balanced with protein, fat and carbs to avoid this.

Read more:How sugar can temporarily sabotage your immune system

Blood sugar is closely related to insulin, a hormone secreted by the pancreas that helps your body use glucose. Insulin keeps your blood sugar from getting too high or too low -- if you eat more sugar than you need in the moment, the hormone helps store the glucose in your liver until it's needed for energy.

You probably also know about blood sugar in the context of diabetes. Type 1 diabetes is a condition in which people are unable to make insulin, so they need to inject the hormone in order to keep their blood sugar levels stable. People with Type 2 diabetes, which usually occurs later in life, either don't secrete insulin or are resistant to it.

Read more:Is all sugar the same? The difference between "good" and "bad" sugars

If you have diabetes, you probably already keep a watchful eye on your blood sugar through the use of a continuous glucose monitor (a CGM) or a blood sugar meter (which involves pricking your fingertip). Blood sugar measurement is also typically included in routine lab work for people without diabetes -- your physician will usually order a glycated hemoglobin (A1C) test, which measures your average blood sugar over the past two to three months.

Say your A1C test comes back with no sign of diabetes -- constantly measuring your blood sugar can still be helpful. For instance, some people experiment with using a CGM to see how their body responds to different types of food. However, it's good to note that this is a fairly cost-intensive way of figuring out your nutrition, and writing down a food diary that includes how you felt after each meal will also help you figure out what to eat.

Check out these blood sugar monitors if you're looking for recommendations on how to keep track of your levels at home.

Your blood sugar level changes depending on what you've eaten, whether you've exercised and other factors (more on that later) but we have some general guidelines to determine what levels are healthy.

For generally healthy individuals (without diabetes) who haven't eaten for eight hours or more, a normal blood sugar level is between 70-99 mg/dL. When you've eaten in the past two hours, it should be no higher than 140 mg/dL. To refresh your chemistry knowledge, that unit is milligrams per deciliter (one tenth of a liter) and it's measuring the amount of glucose present in your blood.

Only a medical professional can diagnose diabetes or another issue with your blood sugar, so if you're concerned about your blood sugar levels, check with a doctor.

Again, only a doctor can diagnose a problem with your blood sugar. But you may be wondering how to know if it's something you should get checked out. There can be two main issues with your blood sugar -- either it's consistently too high or too low. Even if you don't have diabetes, there are some signs that your blood sugar levels are not functioning normally.

Hypoglycemia is a condition in which your blood sugar is too low. Signs include an irregular heartbeat, fatigue, shakiness and tingling or numbness in your face. If you consistently feel this way when you get hungry or between meals, talk to your healthcare provider.

On the flipside, hyperglycemia happens when your blood sugar is too high, and can happen to nondiabetics. Symptoms include frequent urination, increased thirst and headache. If you think you're hyperglycemic and can't keep fluids or food down, call for emergency medical assistance.

You can guess that carbohydrate intake and insulin production are at least partly responsible for your blood sugar levels. But the list is much longer -- almost every lifestyle choice you make can affect your blood sugar. Here's just a partial list.

Other surprising factors can affect your blood sugar, like a sunburn or gum disease, so if you're dealing with a blood sugar issue and can't figure out what's causing your spikes and dips, talk to a health care professional.

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.

More:
Blood sugar levels: what's normal, what's not and how to measure them - CNET

Recommendation and review posted by Bethany Smith

How Vaccines Go From the Research Lab to Your Doctor’s Office – The National Interest

For COVID-19, like all illnesses, the drugs and vaccines to treat or prevent the disease must be backed by rigorous evidence. Clinical trials are the source of this evidence.

With vaccines and drugs for the coronavirus already entering human testing, it is important to know what the different phases of clinical trials are testing for. I am a neurologist with the Alzheimers Therapeutic Research Institute at the University of Southern California. Our team has been developing and overseeing all phases of clinical trials for decades. I am here to help you understand this complicated and important process.

Preclinical trials

The earliest indications about whether an intervention is effective and safe come from preclinical trials. This research is done in the laboratory using cells or animals.

Researchers can get some information about safety and efficacy of a treatment from preclinical trials, but the results do not say whether what they are testing is safe or works in people.

Once a treatment shows promise in preclinical trials, researchers begin the process of working through the phases that have been established by the U.S. Food and Drug Administration. These phases are designed to do two things: protect patients during the process and make sure that the drug or treatment works.

Phase 1 trials

Phase 1 trials are focused on safety. Researchers monitor kidney, liver, hormone and cardiac functions to look for adverse affects in human volunteers. They also look for biological signs of efficacy related to what they are hoping to treat. For example, if a trial was testing a vaccine, researchers might monitor immune activity to see if it increases.

Phase 1 clinical trials typically take around two months and involve small numbers of participants, usually 20 to 100 healthy volunteers or people with the condition that the intervention may treat. Researchers give the participants a range of medication dosages to help determine the lowest possible effective but safe dose. Some, but not all, phase 1 studies are randomized and placebo controlled, meaning that some portion of the subjects are given the real treatment and some get a placebo that does nothing. Neither the subject nor clinician knows who is receiving which treatment.

Drugs that pass phase 1 trials can be considered likely safe, but whether they work or not still remains to be seen.

Phase 2 trials

In phase 2 trials, researchers focus on seeing if the treatment works, finding the safest effective dose and determining what symptoms, tests or outcomes are the best measures of efficacy of the treatment. Determining the best measures of success is important for designing the final stage of testing.

All phase 2 trials are randomized and placebo controlled.

This stage of research can take months to years, and only about one-third of drugs in phase 2 trials make it to the next phase.

In phase 2 trials, researchers give the drug to hundreds of subjects and watch for safety through regular testing. To measure effectiveness, researchers look at clinical responses such as the length of illness, severity of the illness or survival rates. Direct measures of a disease such as the amount of virus in a persons cells are also monitored, as well as biomarkers signals in the body that researchers know are changed by the targeted disease.

At this point, the researchers will use all the information they have gained to design the phase 3 trial. They decide what measures to use, the doses to test and the type, or cohort, of people to test.

If there is evidence in either phase 1 or phase 2 that the drug or vaccine is unsafe or ineffective, the teams will stop the trial.

Phase 3 trials

Phase 3 trials are where researchers look to see if people that get the treatment are statistically better off than those dont. The trials are randomized and placebo controlled, and use the measures of success chosen from the phase 2 trial. Phase 3 trials are also designed to find any rare side effects of a treatment.

In order to get statistically meaningful data, phase 3 trials are big, normally including a few hundred to 3,000 people.

This is the final step before a drug is approved for public use. After a phase 3 trial is finished, the FDA puts together a panel of independent scientists to review the data. The panel decides, based on evidence of success and prevalence of side effects, if the benefits of the drug outweigh the risks enough to approve it for widespread use.

According to the FDA, only 25%-30% of drugs in phase 3 trials get approved.

Phase 4 trials

Phase 4 trials are used to test approved treatments for the same medical condition but in a different dose or time frame or group of people. For example, a phase 4 trial could be used to test if a drug thats already approved for adults is safe and effective for children.

When a drug thats been approved for one purpose is studied for a different medical condition for example, testing the malaria drug hydroxychloroquine as a potential treatment for COVID-19 this is not a phase 4 trial. This is a phase 2 or 3 trial because it is designed to answer those early questions about how well the treatment works for the new condition.

A critical eye for medical news

News headlines are full of trial results concerning COVID-19 interventions. Its easy to get excited when reading about a new drug or vaccine. But early successes do not guarantee a treatment will work.

COVID-19, like Alzheimers, is a complex disease, and clinical trials to test treatments are particularly challenging, with highly variable outcomes. The process for drug and treatment approval is long, but is designed to guarantee that what a physician gives you will do help, not hurt, you.

[You need to understand the coronavirus pandemic, and we can help. Read The Conversations newsletter.]

Mindy Aisen, Clinical Professor of Neurology, University of Southern California

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Image: Reuters

Excerpt from:
How Vaccines Go From the Research Lab to Your Doctor's Office - The National Interest

Recommendation and review posted by Bethany Smith


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