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VectorY and Wageningen University Sign Strategic Collaboration for the Development of Novel Baculovirus-based AAV Production Technologies – Business…

AMSTERDAM--(BUSINESS WIRE)--VectorY Therapeutics, a biotech company focusing on the development of innovative gene therapy approaches for the treatment of muscular and neurodegenerative disorders through vectorized antibodies, today announces a collaboration with Wageningen University to develop novel baculovirus-based technologies for the production of safe and affordable AAV gene therapies.

One of the most important challenges for the gene therapy industry is to develop robust and scalable manufacturing processes that yield safe therapies. VectorY, together with its partner Wageningen University, is making an important strategic investment in these therapies of the future, by developing a production platform capable of successfully manufacturing safe products at a significant lower COGS. The collaboration represents an important step to enable the medical and economical feasibility of gene therapy for diseases that affect larger patient populations.

Under the terms of the collaboration, the Bioprocess Engineering and Virology Groups at Wageningen University and VectorY Therapeutics will work together on two projects. One will utilize the molecular toolbox to generate innovative stable baculovirus genome seeds for AAV production at large scale. The second will focus on the design and evaluation of an intensified and scalable baculovirus production process in bioreactors using state of the art bioprocess technologies.

We are very pleased to be collaborating with VectorY to develop proprietary, next generation AAV expression systems and industry-leading bioprocessing capabilities, said Monique van Oers, Professor of Virology, Wageningen University.

We are honored to partner with Wageningen University, a significant pioneer in the Baculovirology and Bioprocessing field. This partnership will further strengthen VectorYs proprietary AAV production technologies for the development of Next Generation Gene Therapies, added Alexander Vos, CEO VectorY Therapeutics.

ENDS

Notes to Editors

About VectorY

VectorY combines the therapeutic potential of antibodies and gene therapy to develop long-lasting therapeutic solutions for muscular and neurodegenerative diseases with high unmet medical need. Founded in October 2020, and based in the Amsterdam Science Park, VectorY is a fully integrated gene therapy company focused on the development of innovative therapeutics based on a novel AAV gene therapy platform andantibody- based targeted degradation technologies, and proprietary manufacturing technology. VectorY develops proprietary & partnered programs and product candidates are based on new technologies that will enable the next generation of highly scalable manufacturing processes within VectorYs own manufacturing facilities. VectorYs manufacturing capabilities will include a state-of-the-art multi-product GMP facility in the Netherlands, with the capability to deliver suspension based AAV viral vector manufacturing of up to 2000L for both clinical and commercial supply.

For more information, see http://www.vectorytx.com

Wageningen University & Research

The mission of Wageningen University and Research is To explore the potential of nature to improve the quality of life. Under the banner Wageningen University & Research, Wageningen University and the specialised research institutes of the Wageningen Research Foundation have joined forces in contributing to finding solutions to important questions in the domain of healthy food and living environment. With its roughly 30 branches, 6.800 employees and 12.900 students, Wageningen University & Research is one of the leading organisations in its domain. An integrated approach to problems and the cooperation between various disciplines are at the heart of Wageningens unique approach. As such, the Laboratory of Virology and The Bioprocess Engineering group work closely together in a number of biotechnological projects aimed at the further development of the baculovirus expression system for vaccine production and gene therapy applications. By combining our research efforts we can optimally profit from knowledge gained in fundamental virology and new technological developments in bioprocess engineering.

For more information, see https://www.wur.nl/en.htm

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VectorY and Wageningen University Sign Strategic Collaboration for the Development of Novel Baculovirus-based AAV Production Technologies - Business...

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EdiGene Enters Strategic R&D Collaboration with Haihe Laboratory of Cell Ecosystem to Develop Hematopoietic Stem Cell Regenerative Therapies and…

BEIJING & CAMBRIDGE, Mass.--(BUSINESS WIRE)--EdiGene, Inc., a global biotechnology company focused on translating gene-editing technologies into transformative therapies for patients with serious genetic diseases and cancer, announced a research and development collaboration with Haihe Laboratory of Cell Ecosystem to develop hematopoietic stem cell regenerative therapies and platform technology by combining resources and expertise from both sides.

The Haihe Laboratory of Cell Ecosystem, run by the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, is focused on conducting fundamental research, innovation, and translation in the cell ecosystem.

Under the agreement, both parties will jointly develop hematopoietic stem cell regenerative therapies, including the development of innovative genetically-modified hematopoietic stem cell therapies and the exploration of novel biomarkers to optimize quality control for stem cell production.

With top-notch resources and industry-university-research cooperation, well facilitate the development of cell-based medicine and therapies, said Professor Tao Cheng, Deputy Director of Haihe Laboratory of Cell Ecosystem and President of the Institute of Hematology and Blood Diseases Hospital at the Chinese Academy of Medical Sciences and Peking Union Medical College, a leading hematology researcher who has made a series of discoveries relating to the regulatory and regenerative mechanisms of hematopoietic stem cells. Hematopoietic stem cells (HSCs) have the potential for long-term self-renewal and can differentiate into various types of mature blood cells. These stem cells can be harnessed to provide treatment for a broad range of diseases such as hematological tumors, autoimmune diseases, and hereditary blood disorders. We believe that this collaboration with EdiGene will accelerate the innovation and translation in the field of HSCs, thus enabling healthier patients with new therapies."

Professor Cheng was awarded the second prize of the National Natural Science Award 2020 as the first author of work on basic and translational research that advanced the development of adult hematopoietic stem cells for therapeutic applications.

EdiGene is scaling up clinical translation and development of the first gene-editing hematopoietic stem cell therapy in China following the 2021 approval by the China National Medical Products Administration its IND for its investigational therapy ET-01. Our team has extensive experience in the development and translation of cutting-edge technologies including hematopoietic stem cell and gene editing, said Dong Wei, Ph.D., CEO of EdiGene. "This collaboration with Haihe Laboratory of Cell Ecosystem will further our exploration in the field of hematopoietic stem cells. The partnership with this leading academic institute and our translational know-how enable us to move forward in bringing more innovative treatment options to patients in China and around the world.

In 2021, EdiGene initiated a Phase I multicenter clinical trial of ET-01, its gene-editing hematopoietic stem cell therapy for transfusion-dependent -thalassemia. EdiGene has enrolled the first patient at the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College. Currently, the clinical trial is being conducted in Tianjin and Guangdong-Hong Kong-Macao Greater Bay Area (Greater Bay Area). EdiGene also presented its latest research on new surface markers and migration of hematopoietic stem cells at the 63rd Annual Meeting of the American Society of Hematology (ASH) in 2021.

About Haihe Laboratory of Cell Ecosystem

The Haihe Laboratory of Cell Ecosystem ("the Laboratory"), run by the Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, is one of the five registered Haihe Laboratories approved by Tianjin Municipal People's Government. With the goal of promoting population health with cell ecosystem, the Laboratory adheres to developing technological frontier, enhancing peoples health, and promoting research, innovation, and development of cell ecosystem in five key areas: cellular ecosystem, cellular ecology and immunity, cellular ecological imbalance and major diseases, cellular ecological reconstruction and frontier technology of cellular ecological research.

About Institute of Hematology and Blood Diseases Hospital (IH), Chinese Academy of Medical Sciences & Peking Union Medical College (CAMS/PUMC)

Founded in 1957, IH is a tertiary specialty hospital under the National Health Commission of China and is the supporting unit of the National Clinical Research Center of Hematologic Diseases and the State Key Laboratory of Experimental Hematology. It is also the main founding unit of Tianjin Base, the core base of the Chinese medical science and technology innovation system with the goal of becoming "the innovation hub of hematology in China." IH mainly engages in basic research, applied research, clinical diagnosis and treatment of hematological diseases, standard-setting, new technology research, new drug evaluation, and translation in hematology and related fields. IH is leading in the diagnosis and treatment of hematological diseases in China and a global scale and has made original achievements. Since 2010, IH has been awarded first place in the Hospital Specialty Reputation Ranking (Hematology) for 12 consecutive years. It has won first place in the Hematology Specialty Ranking for ten consecutive years since 2010 and ranked the first in hematology by the Scientific and Technological Evaluation Metrics (STEM) for Chinese hospitals for eight consecutive years since 2014.

About EdiGene, Inc

EdiGene is a global, clinical-stage biotechnology company focused on translating gene editing technologies into transformative therapies for patients with serious genetic diseases and cancer. The company has established its proprietary ex vivo genome-editing platforms for hematopoietic stem cells and T cells, in vivo therapeutic platform based on RNA base editing, and high-throughput genome-editing screening to discover novel targeted therapies. Founded in 2015, EdiGene is headquartered in Beijing, with offices in Guangzhou and Shanghai, China and Cambridge, Massachusetts, USA. More information can be found at http://www.EdiGene.com.

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EdiGene Enters Strategic R&D Collaboration with Haihe Laboratory of Cell Ecosystem to Develop Hematopoietic Stem Cell Regenerative Therapies and...

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Global Protein Expression Market Research Report 2021 Featuring Major Players – Agilent Technologies, Bio-Rad Laboratories, Thermo Fisher Scientific,…

DUBLIN--(BUSINESS WIRE)--The "Protein Expression Global Market Report 2021: COVID-19 Growth and Change to 2030" report has been added to ResearchAndMarkets.com's offering.

The global protein expression market is expected to grow from $2.01 billion in 2020 to $2.13 billion in 2021 at a compound annual growth rate (CAGR) of 6%. The market is expected to reach $3.03 billion in 2025 at a CAGR of 9.2%.

Major players in the protein expression market are Agilent Technologies, Bio-Rad Laboratories, Thermo Fisher Scientific Inc., New England Biolabs and Promega Corporation.

The protein expression market consists of sales of protein expression vectors, competent cells, reagents, equipment and related services. Protein expression is a process in which proteins are synthesized, modified, regulated and controlled in living organisms according to the host cell. Protein expression included yeast expression, insect expression, and bacterial expression, algal expression and mammalian cell expression.

The protein expression market covered in this report is segmented by protein expression into yeast expression, mammalian expression, algae expression, insect expression, bacterial expression, cell-free expression. It is also segmented by end use into pharmaceutical and biotechnological companies, academic research, contract research organizations; by product into reagents, competent cells, expression vectors, services, instruments and by application into therapeutic, industrial, research.

Government regulations related to protein therapeutics and production of biologics may hinder the protein expression market growth. Government regulations on biologics to undergo rigorous preclinical and clinical trials prior to regulatory approval, and time consuming process for approval of biologics with regards to health and the safety of any individual are restraining the market growth.

Marketing and distribution of biologics including insulin, hormones, therapeutic antibodies, and vaccines depends upon the successful completion of clinical trials, which is a long, expensive, and uncertain process. According to FDA, for an approval of new biologic, Under the regulations (21 CFR 314.81(b)(2)(vii) and 601.70, a clinical trial approval usually takes 10- 12 months where firms are required to submit a report annually on the status of clinical safety, clinical efficiency, clinical pharmacology, and nonclinical toxicology study.

Companies in the industry are increasingly adopting Microfluidics technology to enhance protein expression tests in order to reduce the time, cost, labor, and increase the accuracy and performance. The microfluidics technology effectively analyzes biological samples than the traditional (macroscale) instruments.

Microfluidics technology is used to measure the expression of proteins on cells and optimizes the output to generate results regarding protein expression. Therapeutics-on-a-chip (TOC) uses microfluidic platform and is able to synthesize proteins in a point of care setting to reduce cost associated with storage and transportation of therapeutic proteins.

For instance, companies such as MissionBio, NanoCellect Biomedical, RainDance Technologies and Sphere fluidics have implemented this technology in protein expression test.

Increase in demand for biologics to counter various genetic disorders and chronic diseases is one the major factors driving the research and sales of protein expression market. Biologics is a medicine produced from living organisms or contains components of living organisms such as protein, tissue, genes, allergens, cells, blood components, blood, and vaccines.

The increasing use of biologics (therapeutic protein and others) to cure chronic diseases such as cancer, cardiovascular conditions and genetic disorders, is increasing the demand for protein expression devices and equipment. According to the World Health Organization, chronic disease prevalence is expected to rise by 57% globally, by the year 2020.

Hence the rising demand for biologics is driving the protein expression market. For instance, according to an article published by Chemistry World, analysts expect the biologics market to hold a market share of more than a quarter of the entire pharmaceutical market by 2020. The global biologics market is expected to grow at 9.9% during 2018-2024.

The Protein Expression market in the U.S. is governed by Food and Drug Administration (FDA) that lays down a series of guidelines for the manufacturers and retailers of this industry. Within FDA, Center for Drug Evaluation and research (CDER) regulates biological products under FDA 101 which includes gene therapy products and vaccines. These regulations ensure quality, safety and efficacy of biological therapeutics products, and speed up innovations that make these products safer, and effective.

The US's FDA announced a fast-track initiative to review its drugs and biologics policy to speed the availability of therapies to patients with serious conditions, orphan drugs for rare disease, while preserving the safety and efficacy standards. FDA also removed a rule (Section 610.21 of the FDA code) which specified minimal potency limits for certain antibodies and antigens.

The European Medicines Agency has also introduced policies which include a provision to waive the scientific advice fee, which encourage more academic groups and small companies to propose candidates for biologics.

Key Topics Covered:

1. Executive Summary

2. Protein Expression Market Characteristics

3. Protein Expression Market Trends and Strategies

4. Impact Of COVID-19 On Protein Expression

5. Protein Expression Market Size and Growth

5.1. Global Protein Expression Historic Market, 2015-2020, $ Billion

5.1.1. Drivers Of the Market

5.1.2. Restraints On the Market

5.2. Global Protein Expression Forecast Market, 2020-2025F, 2030F, $ Billion

5.2.1. Drivers Of the Market

5.2.2. Restraints On the Market

6. Protein Expression Market Segmentation

6.1. Global Protein Expression Market, Segmentation by Protein Expression, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.2. Global Protein Expression Market, Segmentation by End Use, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.3. Global Protein Expression Market, Segmentation by Product, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

6.4. Global Protein Expression Market, Segmentation by Application, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7. Protein Expression Market Regional and Country Analysis

7.1. Global Protein Expression Market, Split by Region, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

7.2. Global Protein Expression Market, Split by Country, Historic and Forecast, 2015-2020, 2020-2025F, 2030F, $ Billion

Companies Mentioned

For more information about this report visit https://www.researchandmarkets.com/r/iix75m

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Global Protein Expression Market Research Report 2021 Featuring Major Players - Agilent Technologies, Bio-Rad Laboratories, Thermo Fisher Scientific,...

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Not just bones, calcium is vital for heart too: Study – Hindustan Times

The human heart, the size of a fist, located just behind and slightly left of the breastbone, tirelessly beats an average of 100,000 times a day. However, conditions that stop the heart from pumping blood efficiently can cause serious problems and ultimately require a heart transplantation.

In a study published in the journal 'Science Translational Medicine', researchers from Osaka University showed that a previously unknown mutation can lead to a condition called dilated cardiomyopathy, which is one of the main causes of heart failure.

Heart failure refers to an incurable condition where the heart is no longer able to meet the body's demands in terms of blood supply. It is one of the most common causes of death and it affects almost 40 million people worldwide, representing a huge public health problem. One of the main factors leading to heart failure is a disease called dilated cardiomyopathy (or DCM). DCM is characterized by dilation of the heart's chambers and a pumping disfunction. Previous research has shown that DCM is often inherited and has a genetic basis. However, for up to 80 per cent of the familial DCM cases, the genetic mutation causing the disease has still not been known.

ALSO READ: Can Omicron cause heart damage? Here's what experts say

The research team identified a gene called BAG5 as a novel causative gene for DCM. First, they studied patients from different families, highlighting a correlation between loss of function mutations in the BAG5 gene and DCM. The researchers found that this mutation has a complete penetrance, meaning that 100 per cent of the individuals presenting it will develop the disease. They then found in a mouse model of dilated cardiomyopathy that mice without BAG5 exhibited the same symptoms of human DCM, such as dilatation of the heart's chambers and irregular heart rhythm. This indicated that mutations that erase the function of BAG5 can cause cardiomyopathy.

"Here we showed that loss of BAG5 perturbs calcium handling in mouse cardiomyocytes," said Dr. Hideyuki Hakui, lead author of the study. BAG5 is important for calcium handling in the heart muscle cells, and calcium is essential for a regular rhythm and overall health of the cardiac muscle, explaining why a loss of BAG5 leads to cardiomyopathy.

"After demonstrating that BAG5 mutations led to loss of functional BAG5 protein," continued Dr. Yoshihiro Asano, senior author of the study, "we also showed that administration of an AAV9-BAG5 vector in a murine model could restore cardiac function. This finding suggests that gene therapy with adeno-associated viruses (AAV) should be further investigated as a possible treatment alternative to heart transplantation for patients who are BAG5 deficient." AAV gene therapy refers to an innovative form of therapy aimed at fixing mutated genes in diseases that have a genetic cause like DCM. Therefore, these findings have paved the way for a potential precision medicine treatment based on gene therapy.

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Not just bones, calcium is vital for heart too: Study - Hindustan Times

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Gene Therapy Cell Culture Media Market Size | Global Industry Trends, Segmentation, Business Opportunities And Forecast To 2029 The Oxford Spokesman…

New Jersey, United States,-The research study presented in this report offers a complete and intelligent analysis of the competition, segmentation, dynamics, and geographical advancement of the Gene Therapy Cell Culture Media Market. It takes into account the CAGR, value, volume, revenue, production, consumption, sales, manufacturing cost, prices, and other key factors related to the Gene Therapy Cell Culture Media market. The authors of the report have segmented the Gene Therapy Cell Culture Media market as per product, application, and region. Segments of the Gene Therapy Cell Culture Media market are analyzed on the basis of market share, production, consumption, revenue, CAGR, market size, and more factors. The analysts have profiled leading players of the Gene Therapy Cell Culture Media market, keeping in view their recent developments, market share, sales, revenue, areas covered, product portfolios, and other aspects.

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The report includes company profiling of almost all important players of the Gene Therapy Cell Culture Media market. The company profiling section offers valuable analysis on strengths and weaknesses, business developments, recent advancements, mergers and acquisitions, expansion plans, global footprint, market presence, and product portfolios of leading market players. This information can be used by players and other market participants to maximize their profitability and streamline their business strategies. Our competitive analysis also includes key information to help new entrants to identify market entry barriers and measure the level of competitiveness in the Gene Therapy Cell Culture Media market.

Key Players Mentioned in the Gene Therapy Cell Culture Media Market Research Report:

Fujifilm Holdings Corporation, HiMedia Laboratories Pvt., Ltd, Lonza Group Ltd, Sartorius AG, Thermo Fisher Scientific Inc., Merck KGaA, Danaher Corporation, Takara Holdings Inc., Novartis International AG, Bio-Techne Corporation.

Gene Therapy Cell Culture MediaMarket Segmentation:

Gene Therapy Cell Culture Media Market, By Media Type

Serum-containing Media Serum-free Media Stem Cell Media Specialty Media Chemically Defined Media

Gene Therapy Cell Culture Media Market, By End User

Biotechnology & Pharmaceutical Industry Academic Institute Research Laboratory

The Gene Therapy Cell Culture Media market is segmented as per the type of product, application, and geography. All of the segments of the Gene Therapy Cell Culture Media market are carefully analyzed based on their market share, CAGR, value and volume growth, and other important factors. The report also provides accurate estimations about the CAGR, revenue, production, sales, and other calculations for the Gene Therapy Cell Culture Media market. Each regional market is extensively studied in the report to explain why some regions are progressing at a high rate while others at a low rate. We have also provided Porters Five Forces and PESTLE analysis for a deeper study on the Gene Therapy Cell Culture Media market

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Gene Therapy Cell Culture Media Market Report Scope

Geographic Segment Covered in the Report:

TheGene Therapy Cell Culture Mediareport provides information about the market area, which is further subdivided into sub-regions and countries/regions. In addition to the market share in each country and sub-region, this chapter of this report also contains information on profit opportunities. This chapter of the report mentions the market share and growth rate of each region, country and sub-region during the estimated period.

North America (USA and Canada) Europe (UK, Germany, France and the rest of Europe) Asia Pacific (China, Japan, India, and the rest of the Asia Pacific region) Latin America (Brazil, Mexico, and the rest of Latin America) Middle East and Africa (GCC and rest of the Middle East and Africa)

Key questions answered in the report:

1. Which are the five top players of the Gene Therapy Cell Culture Media market?

2. How will the Gene Therapy Cell Culture Media market change in the next five years?

3. Which product and application will take a lions share of the Gene Therapy Cell Culture Media market?

4. What are the drivers and restraints of the Gene Therapy Cell Culture Media market?

5. Which regional market will show the highest growth?

6. What will be the CAGR and size of the Gene Therapy Cell Culture Media market throughout the forecast period?

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VMI provides a holistic overview and global competitive landscape with respect to Region, Country, and Segment, and Key players of your market. Present your Market Report & findings with an inbuilt presentation feature saving over 70% of your time and resources for Investor, Sales & Marketing, R&D, and Product Development pitches. VMI enables data delivery In Excel and Interactive PDF formats with over 15+ Key Market Indicators for your market.

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Verified Market Research is a leading Global Research and Consulting firm that has been providing advanced analytical research solutions, custom consulting and in-depth data analysis for 10+ years to individuals and companies alike that are looking for accurate, reliable and up to date research data and technical consulting. We offer insights into strategic and growth analyses, Data necessary to achieve corporate goals and help make critical revenue decisions.

Our research studies help our clients make superior data-driven decisions, understand market forecast, capitalize on future opportunities and optimize efficiency by working as their partner to deliver accurate and valuable information. The industries we cover span over a large spectrum including Technology, Chemicals, Manufacturing, Energy, Food and Beverages, Automotive, Robotics, Packaging, Construction, Mining & Gas. Etc.

We, at Verified Market Research, assist in understanding holistic market indicating factors and most current and future market trends. Our analysts, with their high expertise in data gathering and governance, utilize industry techniques to collate and examine data at all stages. They are trained to combine modern data collection techniques, superior research methodology, subject expertise and years of collective experience to produce informative and accurate research.

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Gene Therapy Cell Culture Media Market Size | Global Industry Trends, Segmentation, Business Opportunities And Forecast To 2029 The Oxford Spokesman...

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Beware of unproven stem cell therapies – The Jackson Sun

RANDY HUTCHINSON| Better Business Bureau

The FDA says that stem cell products may offer the potential to treat many medical conditions and diseases for which few alternative treatments exist, but almost all of them have yet to be proven to be effective or safe. That hasnt stopped unscrupulous medical professionals and other promoters from touting them as miracle cures.

Stem cells are sometimes called the bodys master cells because they develop into blood, brain, bones and the bodys other organs. Stem cells that come from bone marrow or blood are routinely used to treat cancer and other disorders of the blood and immune system. But other uses, including treating COVID-19, have not been properly studied under an FDA Investigational New Drug Application, which includes providing sufficient data from human clinical testing to help evaluate a products potential risks.

The FDA cites these potential safety concerns for unproven treatments:

There are safety risks even with your own stem cells and contamination can occur if cells are manipulated after removal.

The FTC and Georgia Attorney General sued the co-founders of the Stem Cell Institute of America for allegedly targeting seniors with bogus claims that its therapy could treat arthritis, joint pain and other orthopedic ailments. The agencies said the company also claimed its stem cell therapy is comparable or superior to surgery, steroid injections and painkillers. A related company trained chiropractors and other healthcare practitioners in making similar claims. They also hosted free educational seminars for consumers at which they promoted injections that cost approximately $5,000 per joint, with many patients receiving multiple injections.

This wasnt the FTCs first enforcement action against deceptive stem cell therapy claims. In 2018, a California physician and his companies settled with the FTC over claims their amniotic stem cell therapy could treat Parkinsons disease, autism, macular degeneration, cerebral palsy, multiple sclerosis, heart attacks and a host of other serious ailments. The defendants earned at least $3.3 million offering injections that cost up to $15,000.

The only stem cell products approved by the FDA for use in the United States consist of blood-forming stem cells derived from umbilical cord blood. Theyre approved for limited use in patients with disorders that affect the production of blood.

In bringing the most recent action, the Acting Director of the FTCs Bureau of Consumer Protection said, At best, the use of unproven products or therapies can cost consumers thousands of dollars without affording them any results. At worst, it can be harmful to their health.

If youre considering a stem cell treatment, the FDA says to make sure its FDA-approved or being studied under an Investigational New Drug Application. The FTC and BBB offer these additional tips:

Randy Hutchinson is the president of the Better Business Bureau of the Mid-South. Reach the BBB at 800-222-8754.

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Beware of unproven stem cell therapies - The Jackson Sun

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Stem Cell Therapy Market Size, Business Opportunities and Forecast to 2029 The Oxford Spokesman – The Oxford Spokesman

New Jersey, United States,-ThisStem Cell TherapyMarketreport provides a clear picture of key players growth as well as the qualitative aspects of business in each area. ThisStem Cell TherapyMarket Report provides a current report on revenue generation, recent trends, financial status, and costing, as well as business profiles and financial status. The competitive landscape and potential growth factors are presented in thisStem Cell TherapyMarket Report.This way market report buyers can get a clear picture of the significant growth and the resulting market strategy. Granular market data would help monitor potential profitability and make critical growth decisions.

Significant industry central participants are included in thisStem Cell Therapymarket report. Diverse market factors like sort, size, applications, and end-clients have been incorporated to examine organizations altogether in thisStem Cell Therapymarket report. Significant mainstays of the organizations, companies and industries that influence the high points and low points of organizations are moreover recollected for thisStem Cell Therapymarket report.The research, interviews with key market players, and questionnaire have been compiled based on the continuous changes in the market, challenges and restraints faced by organizations, and global autonomies to expand the field in the coming years.

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This unique Stem Cell Therapy market report also discusses COVID-19 impact and influence on the worldwide market. How might one work around it or come up with fresh techniques so that COVID-19 doesnt stifle market growth are also discussed this report. This fascinating Stem Cell Therapy market report has proven to be of great benefit to current market participants by providing them with a broad understanding of market dynamics. This Stem Cell Therapy market report is a reliable technique of the general industry scenario that indicates basic leadership if they will gain or lose money in this market.

Key Players Mentioned in the Stem Cell Therapy Market Research Report:

Osiris Therapeutics Medipost Co. Ltd., Anterogen Co. Ltd., Pharmicell Co. Ltd., HolostemTerapieAvanzateSrl, JCR Pharmaceuticals Co. Ltd., Nuvasive RTI Surgical Allosource

Stem Cell TherapyMarket Segmentation:

Stem Cell Therapy Market, By Cell Source

Adipose Tissue-Derived Mesenchymal Stem CellsBone Marrow-Derived Mesenchymal Stem CellsCord Blood/Embryonic Stem CellsOther Cell Sources

Stem Cell Therapy Market, By Therapeutic Application

Musculoskeletal DisordersWounds and InjuriesCardiovascular DiseasesSurgeriesGastrointestinal DiseasesOther Applications

Stem Cell Therapy Market, By Type

Allogeneic Stem Cell Therapy Market, By ApplicationAutologous Stem Cell Therapy Market, By Application

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Stem Cell Therapy Market Report Scope

Determining the pulse of the market becomes easy through this in-detail Stem Cell Therapy market analysis. Key players can find all competitive data and market size of major regions like North America, Europe, Latin America, Asia-Pacific and Middle East. As part of the competitive analysis, certain strategies are profiled which are pursued by key players such as mergers, collaborations, acquisitions and new product launches. These strategies will greatly help industry players to strengthen their market position and grow their business.

Key questions answered in the report:

1. Which are the five top players of the Stem Cell Therapy market?

2. How will the Stem Cell Therapy market change in the next five years?

3. Which product and application will take a lions share of the Stem Cell Therapy market?

4. What are the drivers and restraints of the Stem Cell Therapy market?

5. Which regional market will show the highest growth?

6. What will be the CAGR and size of the Stem Cell Therapy market throughout the forecast period?

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VMI provides a holistic overview and global competitive landscape with respect to Region, Country, and Segment, and Key players of your market. Present your Market Report & findings with an inbuilt presentation feature saving over 70% of your time and resources for Investor, Sales & Marketing, R&D, and Product Development pitches. VMI enables data delivery In Excel and Interactive PDF formats with over 15+ Key Market Indicators for your market.

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About Us: Verified Market Research

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Stem Cell Therapy Market Size, Business Opportunities and Forecast to 2029 The Oxford Spokesman - The Oxford Spokesman

Recommendation and review posted by Bethany Smith

Penn Highlands Healthcare surgeon pioneers innovative ACL surgery offering faster recovery – The Courier-Express

DuBOIS Cayleigh Walkers hopes for a successful basketball season were almost benched when she tore her ACL playing summer league basketball at the YMCA in July 2021. However, the Clearfield High School sophomore resumed training just three weeks following her August surgery, fast tracking her return to the court with the Lady Bison varsity basketball team.

I was going up the court and felt it pop, Cayleigh recalled. I was in so much pain. I had to sit out the rest of the game while some of the parents tried to stretch it out. I was eager to have it examined because we were leaving for the beach two days later. Fortunately I was able to get an appointment to have it examined the next morning.

Cayleigh and her parents chose Penn Highlands Orthopedics and Sports Medicine for her care. At Penn Highlands, she was examined by Tyler Beers, PA-C, who tested her range of motion and felt around the injured area. He gave her a brace to wear and ordered an MRI which was scheduled the following week when the Walkers returned from their vacation.

The MRI revealed the torn ACL. The next day, Cayleigh met with Dr. Matthew A. Varacallo, medical director of Orthopedic Robotic Surgery at Penn Highlands Healthcare. The orthopedic surgeon specializes in sports medicine, total joint reconstruction, accelerated rehabilitation protocols and functional return to sports after surgeries and procedures.

Named to the Top 65 Total Knee Replacement Surgeons to Know by Beckers ACS Review, Dr. Varacallo pioneered the innovative Fertilized ACL technique along with Dr. Chad Lavender, an orthopedic surgeon at Marshall University in West Virginia. Currently, they are the only two surgeons in the US using the technique when performing ACL reconstruction surgery.

Typically, when an ACL tear occurs, one third of the athletes re-tear the same side or injure the other knee; but, the theory behind the Fertilized ACL technique is to improve and expedite bone tunnel healing rates, followed by graft revascularization and ligamentization (the process by which the tendon becomes a ligament) to improve graft function and incorporation into the knee joint, explained Dr. Varacallo.

The Fertilized ACL procedure begins when bone marrow is removed from the tibia the long bone on the inside of the lower leg which is rich in growth hormone and stem cells. A specialized perfusionist takes 60 milliliters of the bone marrow and spins it down to bone marrow aspiration concentrate (BMAC) which is used to initiate healing. The BMAC is mixed with bone graft. Small tunnels are then made in the femur and tibia to place the graft during the procedure. The bone graft mixture and stem cells/growth factors are then injected into the tunnels to help stimulate them to heal faster. Once the tunnels heal, the tendon can in theory possibly transform into a ligament faster.

This is truly a cutting edge procedure, explained Dr. Varacallo. In traditional ACL surgeries, the pressurized tunnels can be risk factors for re-injury because they can take up to six or seven months to heal. However, with the Fertilized ACL procedure, the tunnels heal faster because the graft starts to incorporate into the body faster. In fact, four weeks post surgery, you cannot even see the bone tunnels, the surgeon added.

Dr. Varacallo considers Cayleigh the poster child for successful ACL reconstruction because she is achieving milestones sooner than expected, and Samantha (Sam) Morgan, MS ATC PES, a certified athletic trainer with Penn Highlands Healthcare as well as with the Clearfield Area School District agrees.

Three days following surgery, Cayleigh began rehab, and at three and one half weeks post op she was running, and six to seven weeks following surgery she was punting a soccer ball. In contrast, with traditional ACL surgery, we would not see that type of progress until three or four months post op, Ms. Morgan detailed.

According to Dr. Varacallo, Cayleigh is several months ahead of where she should be in terms of her progress based on the functional testing ACL Report Card, The Report Card, which is used to measure how well a patient is meeting 15 different functional test milestones at two, four, six and eight months post op, was developed at the University of Kentucky where Dr. Varacallo completed his fellowship in Orthopedic Surgery and Sports Medicine.

The ACL Report Card is a great benchmark tool because it not only shows the medical team the patients progress, it gives the athlete something to shoot for in their rehab, said Dr. Varacallo.

I had four months of rehab five days a week, Cayleigh said, The first few weeks were challenging because I was in some pain, but Sam pushed me and helped me get through it.

At two months after surgery, Cayleigh was testing stronger on the surgery side than on the other non-injured side. One of the factors that contributed to her faster recovery was that prior to surgery she and the other patients who have Fertilized ACL reconstruction surgery have prehab.

We cannot operate on a stiff and weak knee, so prior to surgery, we have the patient undergo motion and strengthening exercises to improve outcomes following surgery, Dr. Varacallo explained. The stronger the knee heading into surgery, the faster the recovery.

In addition to enhancing flexibility, prehab teaches patients the exercises they will be doing during post-surgery rehab so that they are already familiar with what their physical therapy will entail.

Cayleigh had aggressive prehab, said Morgan. In addition to promoting flexibility of the knee, it is an educational tool that helps the patient understand the how and why of the injury and healing. Three days following surgery, Cayleigh started rehab, and because she had the prehab, she already knew how to perform her exercises.

The prehab, surgery and rehab are all interdependent on each other. In fact, Dr. Varacallo uses an analogy to tie the process together. I think of the reconstruction and healing process as a house the prehab is the foundation, surgery is the main living level and rehab is the attic.

According to Cayleighs mother, Tammy Walker, her daughters fast recovery is a combination of three factors, Dr. Varacallos innovative Fertilized ACL technique, the aggressive rehabilitation and equally important the determination by Cayleigh and Morgan to get her back to where she could play again.

We are very impressed with Dr. Varacallo, said Walker. He was very thorough and went through everything with us and even called to check on her progress following the surgery.

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Penn Highlands Healthcare surgeon pioneers innovative ACL surgery offering faster recovery - The Courier-Express

Recommendation and review posted by Bethany Smith

Ashley Cain supports parents of girl, 5, battling same cancer which killed his baby – The Mirror

Exclusive:

Football ace Ashley Cain and his girlfriend Safiyya Vorajee have been supporting parents of children battling cancer. The couple's baby girl Azaylia died last April

Image: Instagram)

Footballer Ashley Cain has been offering hope and solace to parents of a little girl battling the cancer that claimed the life of his own precious daughter.

Reality star Ashley and girlfriend Safiyya Vorajee have been supporting dozens of sick childrens families since the death of their baby girl.

Beloved Azaylia died last April after a courageous fight against the blood cancer acute myeloid leukaemia.

The ex-Coventry City winger and his partner have now struck up a special friendship with the family of five-year-old Esha Nadeswaran, who has spent eight months fighting the same disease at Londons Great Ormond Street Hospital.

Her dad Rishya, 45, of Gants Hill, North East London, said: Esha is our absolute hero and she is incredible. With our journey, it is like a marathon with no finish. We dont know when it is going to end and so we cant even pace ourselves.

There have been days where Ive gone to bed, crawled up and cried alone. But no matter how bad a day you are having and how much you hurt inside, Ashley reminded me you must stay positive and happy for your child.

He told me not to think too far ahead and do whatever I needed to do to support Esha. Its horrible to be told your child has cancer.

Listening to Ashley, and how vulnerable he felt, really struck a chord. Our chat has kept me going.

Former Ex On The Beach star Ashley, 31, and Safiyya, 34, were devastated to lose Azaylia when she was just eight months old.

She had been given stem cell treatment, which involves replacing damaged cells with healthy ones from a blood-match donor.

Ashley said Azaylia had the heart of a lion and he was given precious extra months with her after 100,000 people registered to be a donor.

The couple got involved in Eshas battle after Rishya and wife Kavitha, 41, appealed to members of the South Asian community to volunteer to be stem cell donors.

Esha has been in hospital since last May. She has had gruelling chemo and, in October, an emergency stem cell transplant. With her parents at her bedside, constant care includes regular platelet and red blood cell transfusions.

Rishya recalls the day they received the diagnosis. He says: She had been having tummy issues. Doctors ran tests and we were told wed receive the results in a fortnight. Two hours after returning home, they rang and we knew something was badly wrong. We rushed back and were told she had an acute form of leukaemia. It has been utterly heartbreaking.

Eshas Sri Lankan heritage meant it was hard to find a donor match and the family launched a social media campaign. Safiyya then reached out.

Rishya says: I arranged a Zoom chat with Safiyya and Ashley and I spoke father to father about what it feels like to be told your child has cancer. It was very emotional.

Ashley and Safiyya also recorded a video message on Eshas birthday.

Rishya, who works in banking, says: Esha really liked it. She is such a caring little girl and the way she has bounced back to defy doctors is something of a miracle.

She is always the one who goes from room to room cheering up the other children.

Rishya and his family now have 10,000 Instagram followers. But what they havent shared is their sacrifices to give her the best possible chance of survival.

Forming a Covid bubble, Rishya and his wife have had to live apart from elder daughter Ria, 10, who is with her grandparents.

They see her once a week at arms length and were apart at Christmas and on both girls birthdays. Its been really tough, says Rishya. My wife and I take it in turns to stay with Esha. The Young Lives vs Cancer charity has kindly been able to offer accommodation for the other to stay nearby.

We have been locked in this bubble for months now and its exhausting.

Ashley and Safiyya have helped dozens of parents. They set up a foundation raising money for treatment that may not be available on the NHS.

Image:

He says: No matter how painful it is, our mission is to really help and battle for these kids fighting cancer.

We speak to parents privately and try to guide them through the experience. We know first hand the stress and trauma parents have to go through.

Eshas dad and I talked about appreciating every single moment, making sure your child thinks theres nothing wrong. You need to stay positive and be the best you can be.

The pain of losing Azaylia is with us every minute. We go to her resting place every day and I want to hold this pain forever to use it effectively to help other children have a better chance.

Safiyya adds: So many children are suffering and we want to help.

The couple are planning a fundraising cycling event in June in conjunction with the Tour of Cambridgeshire.

Ashley says: Wed like everyone to wear orange and create a sea of orange so that Azalyia can look down from heaven and see what an amazing effect she has had on this world.

To join the cycle event, go to cycleforazaylia.com. Get updates on Esha at instagram.com/for_esha

Esha has the illness that cost Azaylia her life acute myeloid leukaemia, cancer of the white blood cells.

It starts in the bone marrow and spreads to the bloodstream and is very rare in young children.

The risk increases with age and it is most common in people aged over 75.

Acute leukaemia means it progresses quickly and chemotherapy is the main treatment, killing off as many unhealthy cells as possible and reducing the risk of the patient suffering a relapse.

Stem cell therapy involves removing a persons unhealthy cells and replacing them with healthy ones from a donor.

The new cells travel in the blood of the patient to the bone marrow, where they attach and grow.

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Ashley Cain supports parents of girl, 5, battling same cancer which killed his baby - The Mirror

Recommendation and review posted by Bethany Smith

Complete response following treatment of plasma cell leukemia with venetoclax and dexamethasone: A case report – DocWire News

This article was originally published here

J Oncol Pharm Pract. 2022 Jan 27:10781552221074269. doi: 10.1177/10781552221074269. Online ahead of print.

ABSTRACT

INTRODUCTION: Plasma cell leukemia (PCL) is a rare but aggressive variant of multiple myeloma (MM) with a poor prognosis. Due to the limited number of prospective clinical trials studying PCL, treatment options are often extrapolated from data available for the treatment of MM. Venetoclax has recently demonstrated antimyeloma activity in patients with relapsed/refractory MM carrying the t(11;14) translocation. However, few cases have reported the analogous efficacy of venetoclax in PCL.

CASE REPORT: A 64-year-old Caucasian male developed relapsed PCL despite treatment with hyperCD (hyperfractionated cyclophosphamide and dexamethasone) and Dara-KRd (daratumumab, carfilzomib, lenalidomide, dexamethasone). Due to the refractory nature of his disease and the presence of a t(11:14) translocation, the patient was subsequently initiated on venetoclax 400 mg daily and dexamethasone 4 mg once weekly.

MANAGEMENT AND OUTCOME: The patient achieved a complete response by International Myeloma Working Group criteria three months after initiating venetoclax-dexamethasone, including a repeat bone marrow biopsy that showed no abnormal plasma cells. He successfully underwent consolidation with melphalan-based autologous stem cell transplantation. He remains disease-free 9 months after venetoclax initiation.

DISCUSSION: Combination all-oral therapy with venetoclax and dexamethasone can induce deep hematologic responses in patients with relapsed/refractory PCL carrying the t(11;14) translocation.

PMID:35084252 | DOI:10.1177/10781552221074269

Original post:
Complete response following treatment of plasma cell leukemia with venetoclax and dexamethasone: A case report - DocWire News

Recommendation and review posted by Bethany Smith

Doctor Innovates Cell Therapy in India; Seeks to Make Vision Restoration 80% Cheaper – The Better India

For Dr Jogin Desai, CEO and co-founder of Eyestem, a leading Indian cell therapy company, a meeting in 2015 with ophthalmologist Dr Rajani Battu for a medical appointment changed everything. Following the appointment, she introduced him to patients diagnosed with degenerative diseases of the eye and the terrible suffering they have to endure.

It was an eye-opener for Desai, a native of Ahmedabad and an expert in the field of drug development. Desai, at the time, was CEO of Cenduit, an industry leader in the IRT (interactive response technology) market and the eClinical field.

From school students who cannot see their blackboards to families with children suffering from blindness because of genetic disorders and senior citizens who have lost all agency due to their inability to read, the conversation opened my eyes to a world that I didnt know existed. In the same week, I met Prof S. Ramaswamy at Instem (Institute for Stem Cell and Regenerative Medicine), again for something completely unrelated, and we discussed the possibilities of how the next two-three decades will evolve with the maturation of cell and gene therapy products worldwide, recalls Desai, in a conversation with The Better India.

Following the meeting, it dawned on Desai at the time that the world is on the cusp of a fundamental change in the healthcare landscape that will evolve over the next few decades.

Today, Dr Rajani Battu is the chief medical officer at Eyestem.

Diseases that were previously incurable will start becoming curable. As I dove deeper, I understood that most of these therapies developed in the West will cost upwards of $450,000 (about Rs 3.5 Crore) per injection. This, I believe, presented a once-in-a-lifetime opportunity for a platform that can help disrupt this paradigm and create an incredible impact on the lives of patients. I made the decision to establish Eyestem within two days of these meetings in late 2015, adds Desai.

Eyestems vision is to create a scalable cell therapy platform to treat incurable diseases and democratise access to these newer technologies.

Incorporated in late 2015, Eyestem started operations in early 2017.

As cell and gene therapies become available across the world, they will only be available to the top 0.01 % of the worlds population. Our purpose is simple: We aim to democratise access by creating a therapy that is available to a large part of the bottom 99.99% of the population in the world. To our knowledge, we are the only company in the world with such a mission. While it is hard to predict the price of the therapy at this stage we anticipate the therapy to cost 80-90% cheaper than such comparable therapies in the West. The only purpose to start Eyestem has been ensuring that the therapy reaches the people that need it the most, claims Desai.

Through its flagship product Eyecyte-RPE, the company replaces lost retinal pigment epithelium cells. It is designed to restore sight for patients in the early stages of Age-Related Macular Degeneration (AMD) and arrest losses for those in the later stages.

There is no cure for Dry Age-Related Macular Degeneration in the world. It is the largest cause of blindness for people over 50. It is estimated that over 170 million people (40 million of which are in India) suffer from this disease. Eyestem is looking to take Eyecyte-RPE for Dry AMD through clinical trials and is one of six companies worldwide pursuing this treatment, he says.

Underpinning this type of treatment are Induced-Pluripotent Stem Cell (iPSC)-based products. An iPSC is a cell that can be developed into any cell of the body. At present, there are no iPSC-based products approved anywhere in the world.

Over the next ten years, Desai explains that several such products will start becoming available in the market and diseases such as inherited blindness/pulmonary fibrosis/diabetes which were hitherto considered incurable will start becoming curable.

Subsequently, an explosion in iPSC based therapeutics combined with gene engineering will be the next wave of pharma innovation. A lot of diseases occur when the cells of our body die early or are malfunctioning. At its most basic detail, one can create tissue of any kind (be it brain, heart, lung, eye, liver, kidney) through iPSC and replace the lost/damaged cells of the body. For example, in Dry AMD, the RPE layer degenerates and our treatment would be to inject that layer (from a healthy donor) back into the body part to treat the disease, he explains.

Curing Incurable Blindness and Other Diseases

So, how does Eyestems flagship product, Eyecte-RPE, work as a mode of treatment?

The Retinal Pigment Epithelium (RPE) is one of ten layers of the retina and acts as a foundation on which the rest of the retina sits. In Dry AMD, the RPE layer disintegrates and the retinal layers disintegrate just as a building collapses when the foundation collapses.

We have grown the RPE layer in our lab and this is Eyecyte-RPE, our flagship product. This product has been injected into special models of blind rats. We have proven that the rats where our product is injected can retain their sight while the ones that are controlled rats go blind. This animal experiment has been done at Oregon Health and Science University which is a global centre of excellence for macular degeneration research. The DCGI (Drugs Controller General of India) has approved manufacturing only for clinical trials and we have not yet applied for commercial manufacturing, he explains.

In addition to this, Eyestem is also among one of five companies globally advancing the treatment of Retinitis Pigmentosa (RP) to the market called Eyecyte-PRP. Eyecyte-PRP replaces the photoreceptor cells that are lost as a consequence of this disease. RP is a group of rare, genetic disorders that involve loss of the light-sensing photoreceptor cells in the retina. It affects children and causes total blindness by the time they reach their 20s and 30s. It is estimated to affect 4 million children worldwide, of which 1.5 million are in India. Human trials for Eyecyte-PRP to treat retinitis pigmentosa is expected to begin in the second half of FY 2023.

Similarly, Eyestem is also looking to treat Idiopathic Pulmonary Fibrosis (IPF), a serious chronic disease that affects the tissue surrounding the alveoli (tiny air sacs in your lungs), with a pluripotent stem cell-based approach.

Our first human trials for our Aircyte-AEC treatment to treat idiopathic pulmonary fibrosis will begin in the second half of FY2024. Aircyte-AEC is a suspension of lung alveolar epithelial cells that are lost due to this disease. It is worth noting that pulmonary fibrosis occurs as an end-stage event in several other diseases like COVID-19, Tuberculosis and Chronic Obstructive Pulmonary Disease, notes Desai.

Meanwhile, for the sake of clarification, we asked Desai whether cell therapy necessarily means stem cell therapy? Yes, it means the same from a laymans perspective. The only difference is that there are clinics that advertise stem cell therapy for patients in India as well as the US. It is important to remember that none of these stem cell therapy products are approved by the DCGI in India or the FDA in the United States, he notes.

State of Cell Therapy in India, Funding and Moving Ahead

There are only a handful of companies in India that are pursuing cell therapy. According to Desai, the developed world, especially countries like Israel, Japan and the United States, are at least two decades ahead of India in that regard.

As more incurable diseases become curable (think diabetes or cancer) it is absolutely imperative for India to develop a base of such product development research or else we will find ourselves in a situation similar to the HIV epidemic (and cell therapy is not easy to reverse engineer unlike HIV medicines). Our patients will be at the mercy of predatory pricing of global pharma unless globally innovative products are manufactured and made available locally. Our nine-member team at Eyestem, a majority of whom are cell biology scientists specializing in this field, is looking to significantly address this issue in advance, says Desai.

Meanwhile, Desai claims that his venture has been very selective in raising funds so far since its purpose is not to raise rounds of money with higher valuations but to benefit end patients. They are laser-focused on creating affordable cell therapy and hence have set themselves a benchmark of not spending more than $4 million from idea to first in human trials. Most pharmaceutical companies, he claims, spend 10 times this amount to reach this stage.

Any drug development venture needs smart money. We were fortunate to have interest from a group of investors who have multi-decade experience in global drug development. Two institutional investors (Endiya Partners and Kotak Private Equity) joined in a subsequent pre-series A round. We are currently raising our series A and we are halfway there. About 30% has been committed by current shareholders and we have a soft commitment from a global venture fund for the other 20%. We anticipate closing this round in the next 8-12 weeks. Investors invest in ventures like ours due to the promise of immense market potential for these therapies. As soon as one obtains human data, startups like ourselves reach an inflexion point and become extremely valuable, claims Desai.

Please Note: The Better India does not verify for the future efficacy of any therapy or medical treatment mentioned in the article. Kindly consult your doctor for an informed medical opinion.

(Edited by Vinayak Hegde)

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Doctor Innovates Cell Therapy in India; Seeks to Make Vision Restoration 80% Cheaper - The Better India

Recommendation and review posted by Bethany Smith

Hemochromatosis gene: Definition, signs, and is it hereditary? – Medical News Today

The hemochromatosis gene, known as HFE, helps regulate the bodys absorption of iron. Some people can inherit a mutation to this gene that causes their bodies to absorb too much iron. Most cases occur due to C282Y and H63D mutations. When this happens, a person can develop hemochromatosis.

A person may develop symptoms related to too much iron in the body, such as joint pain, fatigue, and a loss of libido. Over time, they may also develop serious complications, such as liver damage.

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) states that rare forms of hemochromatosis, called non-HFE hemochromatosis, occur due to mutations in the HAMP and HJV genes. Healthcare professionals may also refer to the HJV gene as the HFE2 gene.

If these mutations occur, a person will develop complications and symptoms at a younger age. They may also develop complications by the time they are teenagers.

This article reviews what the hemochromatosis gene is, symptoms associated with hemochromatosis, and more on how a person inherits the gene.

Hereditary hemochromatosis is a genetic disease that alters how the body regulates iron absorption. The condition causes a persons iron levels to increase to dangerous levels.

According to the National Human Genome Research Institute, in the case of hereditary hemochromatosis, a person is likely to develop the condition if they inherit two copies of the mutated hemochromatosis gene, or HFE gene. However, it is important to note that not everyone who inherits two copies will experience symptoms.

A person who inherits one copy of the mutated gene will either not develop signs and symptoms or experience mild symptoms.

When functioning normally, this gene helps regulate and prevent the excessive absorption of iron. When too much iron circulates in the body, it can cause damage to tissues and organs.

Some affected areas include:

Hereditary hemochromatosis affects approximately 1 million people in the United States.

When too much iron consistently enters the body, a person may start to experience symptoms related to the condition.

The NIDDK states that common symptoms of too much iron include:

People may also experience a darkening of their skin color, which initially appears on sun-exposed areas such as their face. This is often known as bronzing.

Not everyone will develop symptoms. Additionally, symptoms usually occur after a person reaches 40 years old, and females may develop symptoms 10 years later compared to males.

Without treatment, a person may develop complications that could cause additional symptoms. Some potential complications include:

Both parents can carry the hereditary hemochromatosis gene.

According to the National Human Genome Research Institute, a child that inherits two copies of the mutated gene has a high risk of developing hemochromatosis. However, having two copies does not guarantee a child will develop the condition.

When a person inherits only one copy of the gene, they may not develop any symptoms of the condition at all, or they may only develop slight symptoms. In these cases, they may become silent carriers of the condition.

In other words, if they have a child with another silent carrier, their child has a chance of inheriting two mutated genes and a higher chance of developing hemochromatosis.

Parents pass the hemochromatosis gene to their children. A child inherits two copies of the gene, one from each parent.

The affected genes may be recessive or dominant, which affects how many copies of the genes a person needs to develop the condition.

According to the Genetic and Rare Diseases Information Center (GARD), a child of two recessive gene carriers has a:

On the other hand, a child with a dominant gene change has a:

Several potential mutations can occur within the genes that can cause hereditary hemochromatosis to develop.

The location of the mutation determines the type of hereditary hemochromatosis a person may develop. Healthcare professionals classify the type of hereditary hemochromatosis based on the age of onset, which genes are affected, and how it is inherited.

A person can inherit an autosomal recessive condition if they inherit one copy of a mutated gene from each parent.

Individuals can develop an autosomal dominant condition if they inherit a single copy of the mutated gene from one parent. A person has a 50% chance of inheriting the mutated gene and developing the condition.

GARD states that the mutations can occur on the following genes:

Type 5 hereditary hemochromatosis occurs due to changes with the FTH1 gene. Only one family in Japan has reported the condition.

According to a 2015 article, healthcare professionals perform gene testing for hereditary hemochromatosis if they suspect a person has an iron overload alongside high levels of ferritin, which is a blood protein that stores iron, and transferrin, which is a protein in that transports iron the blood. High levels can indicate that a person has hemochromatosis.

Gene testing can confirm a hereditary hemochromatosis diagnosis.

A person with hemochromatosis will need regular testing as part of their treatment. Testing can help check iron levels and look for complications related to too much iron.

A doctor may recommend some common tests, such as a complete blood count to check for iron and protein levels, a liver biopsy to check for liver damage, and an MRI.

A person with hemochromatosis has a good chance of living a normal, healthy lifespan provided they seek treatment for their condition.

Without diagnosis and treatment, a person has a higher chance of developing serious health complications, such as liver damage or heart disease, that can affect a persons overall outlook and life expectancy.

The most common treatment for reducing iron in the blood is via phlebotomy, or drawing blood. In addition, a doctor may recommend dietary changes, iron chelation therapy, and treating any complications of the disease.

At first, a person will likely need regular blood draws. Once their blood iron levels reach a normal level, the number of blood draws will vary based on how well their ferritin and transferrin saturation levels stay within the normal range.

Regular treatment can help prevent complications and reduce their impact on a persons life if they have already begun. As a result, a person should seek treatment even if complications have already started.

A person who has a sibling living with hereditary hemochromatosis should speak with a doctor about undergoing genetic testing due to an increased risk of also having the mutated genes.

Additionally, a person with a parent who either has the condition or is a known carrier should speak with a doctor about genetic testing.

Finally, a person who knows they may have the mutated genes should speak with a doctor if they develop any symptoms that could indicate a problem with iron absorption.

Hereditary hemochromatosis can occur when a person inherits one or more copies of a mutated HFE gene. Hemochromatosis results in the body absorbing too much iron, which can lead to complications, such as cirrhosis.

A person should seek treatment for the condition as soon as possible to help prevent complications. Treatment typically involves blood draws to help reduce iron levels.

A person should also contact a doctor if they experience symptoms of iron absorption issues and have a known family member who either is living with the condition or may be a carrier.

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Hemochromatosis gene: Definition, signs, and is it hereditary? - Medical News Today

Recommendation and review posted by Bethany Smith

The pandemic of radicalization has begun, and we can’t ignore it – GuelphToday

This week on Market Squared we look at the trucker convoys and protests that befuddle us, and why mocking them, or ignoring them, is not an option

I submit the following to GuelphToday for this weeks column knowing that Im about to nuke my email from orbit. It had a good run.

So lets talk about whats going on in Ottawa right this moment (at noon on Saturday), and what happened here in Guelph last weekend.

Though theres a difference in scale, the intention and desire of the ones organizing these two gatherings are more or less the same, but while the so-called 'Freedom Convoy' has gotten a lot of attention, whats happened in Guelph with these anti-mandate groups has gotten practically none.

Last weekend, a couple of hundred people who dont consider themselves anti-mask or anti-vaccine walked though Old Quebec Street making noise while maskless to say theyre fed up with the pandemic and pandemic restrictions. Im glad were finally doing this, one woman said. Another man asked the stunned people looking on in Old Quebec Street to take off their masks and show off their smiles.

If I were to have stopped and asked those people what they just saw, they would probably be hard pressed to explain it to me. A lot of those people were too young to remember the 'freak outs'of the 1960s, and the one security guard I saw arrived on the scene several minutes late. It was over and done in less than eight minutes.

Consider what happened last Saturday as an experiment. It was an experiment for those participating to see how far they can push things, and it was an experiment for our city leadership: Can they ignore whats almost literally happening under their nose?

I know 90 per cent of the eligible population is fully vaccinated, but this is not just a matter of being vaccinated because Ive been told by a few of the people participating in these rallies that theyve gotten two jabs. Its also worth noting that over 80 per cent of Canadian truckers are fully vaccinated, but look at the attention wrought by the other 20.

To understand the inherent danger, you have to understand how people are indoctrinated. To use the word feels disturbing, but there is a continuum of information, or misinformation, that people go down and it starts with the simplest of ideas, an idea that youve already thought about in the course of the last 22 months: Arent you sick of this?

I talked to one man a few weeks ago who told me that he wont get vaccinated because he doesnt trust the government and he doesnt trust big pharma. Hey, fair enough. My sense is that a majority of Canadians, if asked, will enunciate some level of mistrust in most institutions, from the Government of Canada to the Loyal Order of Water Buffaloes. But this is how it begins.

The seeds of doubt, perhaps long sowed in the person, are then fertilized with a rapidly changing information landscape. With COVID-19 weve seen the scientific process happen in real time, and the best advice of March 2020 (disinfecting your groceries anyone?) has now been proven by researchers as pointless and ineffective in stopping the spread.

So now you dont know what to believe. Its possible you might have once trusted your family doctor, if you have a family doctor, but he or she is saying all the things you hear from the three levels of government and the World Health Organization. If you cant trust them, how can you trust your doctor? Are they in on it (whatever it is)?

Youre told to wear a mask, but some people you know on Facebook say that they dont work. Youre told to get a vaccine, but then youre told some vaccines have side effects, and those same online friends are now telling you that the other vaccines are bad, or that theyre gene therapy to change your DNA(theyre not).

And now you see the real plot and intentions. COVID-19, whether its real or fake, is a means to an end. That end could be Agenda 2021, or Agenda 2030, or the Great Reset, or some other international conspiracy to grind people under foot or de-populate the planet. All of this sounds crazy, but its also the best case scenario.

Whats more disturbing are the white supremacists and far-right figures who understand well how indoctrination works and have attached themselves to the anti-mandate movements, like the trucker convoy, to find new blood. The frightening thing is that the ones being recruited dont know or dont care that their perversion is happening, theyre just happy to have friends who believe as they believe.

And thats why we need to take these things seriously, the trucker rallies and the freak outs through local malls. To stand back and watch without saying anything is a kind of dereliction. To stand there and laugh, or to call those people names, is even worse.

Were rapidly approaching the second anniversary of the first lockdown because of COVID, and our public health leaders have started to pivot to the idea that COVID is something we must start learning to live with. Meanwhile, the pandemic of radicalization is just beginning, and living with it, like ignoring it, is not an option.

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The pandemic of radicalization has begun, and we can't ignore it - GuelphToday

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What competition? Vertex touts Trikafta’s competitive edge on back of strong 2021 – FiercePharma

Vertex finished out 2021 strong, smashing analysts sales expectations for the full year. Chalk it up to the companys entrenched position in cystic fibrosis, where Vertex expects to maintain its lead for years to come, according to CEO Reshma Kewalramani, M.D.

Vertex snared $7.57 billion in product revenues for 2021, signaling a 22% increase year over year. For 2022, the company expects to pull in sales of $8.4 billion to $8.6 billion. For now, that growth is firmly tethered to Vertexs bread-and-butter CF franchises.

The companys 2022 guidance suggests penetration of additional CF patients will occur more rapidly than expected with age expansion and full-year impact of ex-U.S. reimbursements, RBC Capital Markets Brian Abrahams wrote in a note to clients Wednesday.

During its call Wednesday, Vertex repeated estimates that there are more than 25,000 patients who could benefit from CF newcomer Trikafta and arent yet on therapy. The company splits those patients into three groups: those whove yet to start on Trikafta in countries where the drug was recently reimbursed, patients in territories where the drug hasnt been reimbursed and younger patients, who Vertex aims to address with future Trikafta label expansions.

RELATED:JPM 2022: Vertex's Trikafta holds the line as company lays groundwork for gene editing launch

Meanwhile, the $8.4 billion to $8.6 billion range Vertex laid out seems notoriously conservative, Evercore ISIs Liisa Bayko wrote in a note to clients. [W]e expect VRTX to beat and raise throughout the year, she added.

Trikafta, for its part, carried the bulk of the sales weight last year, bringing in $1.69 billion for the last three months of 2021. The drug made about $1.09 billion during that same period in 2020. Trikafta reaped full-year 2022 sales of $5.69 billion, marking a blockbuster-worthy increase over the $3.86 billion it made in 2020.

Older CF med Kalydeco proved to be the companys next top sellerthough by a significantly smaller marginwith fourth quarter sales of $152 million. The drug made $684 million for the year. Orkambi made $147 million for the quarterslightly down from 2020s $215 millionand $772 for the year, while Symdeko pulled $80 million in the fourth quarter and $420 million for all of 2021.

Vertex is working to branch out from its CF base, and analysts seem to share the companys hopes for phase 1/2 Type 1 diabetes candidate, VX-880. That drug could potentially unlock a multibillion-dollar opportunity, which is comparable to CF and nearly all upside in our model, RBCs Abrahams said. CF forms the backbone of Vertexs pharma business, and investors have long pushed the company to diversify.

Vertex has also pinned its hopes on its gene editing program for sickle cell disease and beta thalassemia, CTX001, as its next commercial launch, Kewalramani said. The company sees tremendous potential for the treatment, and Vertex has already kicked off launch preparations ahead of planned global regulatory submissions toward the end of the year. The company is building out market access, patient support and its doctor-facing teams, as well as finalizing its manufacturing and supply chain network, the company said during its earnings call.

RELATED: Fierce Biotech's top 10 data readouts in 2022 | CRISPR Therapeutics and Vertex's CTX001amyotrophic lateral sclerosis

Still, when it comes to CF, Vertex is confident it can maintain its place at the head of the table, Kewalramani said.

More patients around the globe are treated with a Vertex CFTR modulator today than ever before, and the vast majority of that is with Trikafta, which boasts remarkable clinical trial data, the CEO said. If theres any medicine that will compete with Trikafta, it has to go head-to-head against Trikafta in clinical trials.

It has to have improved benefit, and you have to have the long-term data, she added.

The only company that has that right now is Vertex, and the most advanced competitor to Trikafta is the companys own triple combo of tezecaftor and the experimental VX-121 and VX-561, which is in phase 3 testing.

Kewalramani highlighted recent real-world Trikafta data, garnered from more than 16,000 U.S. patients, which showed the drug led to an 87% reduction in risks of lung transplant, 77% fewer pulmonary exacerbations and a 74% reduction in risk of death.

That said, the company is on the cusp of a critical external event that should settle the viability of VRTXs dominance in CF that is ABBVs triplet data, Evercores Bayko said. Consensus opinion is pointing toward lackluster data from AbbVie, but, It would be an unwelcomed surprise if the data were comparable to Trikafta, the analyst added.

AbbVie's combo, which isin phase 2 testing, comes from the company's purchase ofGalapagos' CF pipeline for$45 million in late 2018.

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What competition? Vertex touts Trikafta's competitive edge on back of strong 2021 - FiercePharma

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US Office of Science and Technology Senior Advisor to Deliver Keynote Address at the 2022 ISPE Facilities of the Future Conference – PR Web

Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President

NORTH BETHESDA, Md. (PRWEB) January 27, 2022

The International Society for Pharmaceutical Engineering (ISPE) announced Matthew Hepburn, MD, Senior Advisor to the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy (OSTP), Executive Office of the President, as a confirmed keynote for the 2022 ISPE Facilities of the Future Conference, taking place on 12 February in North Bethesda, Maryland and virtually.

The opening keynote session COVID's Impact on Pharma Facilities of the Future will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. Hepburn will discuss Lessons Learned from Operation Warp Speed for Rapid Vaccine Development at the opening plenary session and the executive forum dinner.

The mission of OSTP is to maximize the benefits of science and technology to advance health, prosperity, security, environmental quality, and justice for all Americans. At the OSTP, Hepburn works on preparing the country for future pandemics, with a spotlight on the acceleration of vaccines, therapies, and test development.

Previously, Hepburn was the Director of Vaccine Development at Countermeasures Acceleration Group, formerly known as Operation Warp Speed, which is an effort between the Defense Department and the Department of Health and Human Services. During the Obama administration, he was the Director of Medical Preparedness for the White House National Security Council. Additionally, he served as an infectious disease doctor for the U.S. Army for over two decades.

Representatives from Bristol-Myers Squibb, CRB, and Merck will round out a compelling line-up of expert speakers at the opening plenary session.

Featuring technical presentations from regulatory authorities and industry leaders already planning and building facilities of the future, the 2022 ISPE Facilities of the Future Conference will explore topics such as patient-specific cell and gene therapy facilities, new developments in the use of artificial intelligence, innovations in treatment and the transforming technologies that produce them, and moving forward from the COVID-19 era.

To ensure this experience is accessible to all, this conference will be in North Bethesda, Maryland, with virtual componentsdelivering thought-provoking learning and global networking opportunities whether attendees choose to join us in-person or virtually.

Explore the agenda and register at ISPE.org/FOF22.

About ISPEThe International Society for Pharmaceutical Engineering (ISPE) is a not-for-profit association serving its Members through leading scientific, technical, and regulatory advancement across the entire pharmaceutical lifecycle. The 18,000 Members of ISPE are building solutions in the development and manufacture of safe, effective pharmaceutical and biologic medicines, and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters and training center in North Bethesda, Maryland, USA, and its operations center in Tampa, Florida, USA. Visit ISPE.org for more information.

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US Office of Science and Technology Senior Advisor to Deliver Keynote Address at the 2022 ISPE Facilities of the Future Conference - PR Web

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The Trend of CRISPR-Based Technologies in COVID-19 Disease: Beyond Genome Editing – DocWire News

This article was originally published here

Mol Biotechnol. 2022 Jan 29. doi: 10.1007/s12033-021-00431-7. Online ahead of print.

ABSTRACT

Biotechnological approaches have always sought to utilize novel and efficient methods in the prevention, diagnosis, and treatment of diseases. This science has consistently tried to revolutionize medical science by employing state-of-the-art technologies in genomic and proteomic engineering. CRISPR-Cas system is one of the emerging techniques in the field of biotechnology. To date, the CRISPR-Cas system has been extensively applied in gene editing, targeting genomic sequences for diagnosis, treatment of diseases through genomic manipulation, and in creating animal models for preclinical researches. With the emergence of the COVID-19 pandemic in 2019, there is need for the development and modification of novel tools such as the CRISPR-Cas system for use in diagnostic emergencies. This system can compete with other existing biotechnological methods in accuracy, precision, and wide performance that could guarantee its future in these conditions. In this article, we review the various platforms of the CRISPR-Cas system meant for SARS-CoV-2 diagnosis, anti-viral therapeutic procedures, producing animal models for preclinical studies, and genome-wide screening studies toward drug and vaccine development.

PMID:35091986 | DOI:10.1007/s12033-021-00431-7

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The Trend of CRISPR-Based Technologies in COVID-19 Disease: Beyond Genome Editing - DocWire News

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This remarkable tech can actually improve the eyesight of the visually impaired – BGR

A gene-editing treatment known as CRISPR appears to have positive results for people suffering from a rare visual disorder.

According to new reports, researchers injected seven volunteers with CRISPR to treat a rare vision disorder. Unlike other treatments, scientists designed CRISPR to fight diseases at a genetic level. Following the experiment, some of the volunteers noted a marked improvement in their eyesight. The affected individuals were all born with vision disorders, however, thanks to CRISPR, theyre now able to see better.

This is the first time scientists injected CRISPR directly into the human body. Previously, scientists had removed affected cells from the body and then conducted tests using the gene-editing procedure in the safety of a lab. From there, the scientists infused the modified cells back into the patients. With this experiment, though, the seven volunteers were injected directly with the treatment.

Scientists at the Casey Eye Institute conducted the study. The institute itself is part of the Oregon Health & Science University. Dr. Mark Pennesi shared the results of the CRISPR trial at the International Symposium on Retinal Degeneration late last year.

Following the injections, one of the patients shared that she was now able to safely navigate the area where she works. Another patient said that he could now see colors for the first time after the treatment. Both volunteers had suffered from LCA, or Leber congenital amaurosis, a severe vision impairment.

CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. Scientists engineered the treatment in 2012. It was intended to act as a biological tool for altering DNA. In the past ten years, though, scientists have found a multitude of other users for the gene-editing procedure.

Thats where the most recent study comes into play. By injecting the CRISPR directly into the body, scientists were able to see how it would more greatly affect it as a whole. Additionally, being able to inject it directly would allow them to treat disorders and diseases in areas where it isnt safe to remove cells, like the brain.

Because it focuses on editing things at a genetic level, scientists hope that CRISPR will open new doors to fighting cancer and other diseases. Once improved and thoroughly studied, it could become one of the most powerful treatments the medical community has available.

Its a really amazing technology and very powerful, Pennesi told NPR back in September.

Now that were seeing some additional pushes for the treatment, we could see some other studies appearing in the coming months. Of course, it is worth noting that not all the volunteers experienced any improvements. As such, theres no real timetable for when CRISPR could become a more widespread treatment.

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This remarkable tech can actually improve the eyesight of the visually impaired - BGR

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market 2022 Business Outlook with Pandemic Scenario Analysis and…

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market report will be very beneficial to both of the sides in the market that is an established firm and a relatively new entrant. It helps the established firms to know about the moves which are being performed by their competitors whereas it helps the new entrants by educating them about the market situations and the industry trends. This market report includes market share appraisals for regional and global levels, detailed overview of parent market potential and niche segments/regions exhibiting promising growth, in-depth analysis of the global order management software market and current & future trends to elucidate imminent investment pockets.

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The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is expected to witness market growth at a rate of 26.88% in the forecast period of 2021 to 2028. Data Bridge Market Research report on clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market provides analysis and insights regarding the various factors are expected to be prevalent throughout the forecast period while providing their impacts on the markets growth. The rise in the demand in the food industry for better products with improved quality and nutrient enrichment is escalating the growth of clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market.

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The major players covered in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report are Applied StemCell, ACEA BIO, Synthego, Thermo Fisher Scientific, GenScript, Addgene, Merck KGaA, Intellia Therapeutics, Inc, Cellectis, Precision Biosciences, Caribou Biosciences, Inc., Transposagen Biopharmaceuticals, Inc, OriGene Technologies, Inc., Novartis AG, New England Biolabs, Rockland Immunochemicals Inc., ToolGen, Inc., TAKARA BIO INC., Agilent Technologies, Inc., Abcam plc, and CRISPR Therapeutics AG among other domestic and global players.

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The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, company strengths and weaknesses, product launch, clinical trials pipelines, product approvals, patents, product width and breadth, application dominance, technology lifeline curve. The above data points provided are only related to the companies focus related to clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market.

Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) gene is referred to as a genome editing technology that permits the genetic material to be added, altered and removed in an organisms DNA.

Major factors that are expected to boost the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the forecast period are the rise in the incidence ofgeneticdisorders and the utilization of genome editing. Furthermore, the private and government funding is further anticipated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market. Moreover, the rise in thetechnologydevelopment in the CRISPR gene editing is further estimated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market. On the other hand, the off target effects and delivery is further projected to impede thegrowthof the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the timeline period.

In addition, the growing of the gene and cell therapy area and the CRISPR gene editing scope in the agriculture sector will further provide potential opportunities for the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the coming years. However, the ethical issues and consequences regarding the human genome editing might further challenge the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the timeline period.

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market Country Level Analysis

The clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market is analysed and market size information is provided by country, therapeutic application, application, technology, services, products and end users as referenced above.

The countries covered in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market report are U.S., Canada and Mexico in North America, Peru, Brazil, Argentina and Rest of South America as part of South America, Germany, Italy, U.K., France, Spain, Netherlands, Belgium, Switzerland, Turkey, Russia, Hungary, Lithuania, Austria, Ireland, Norway, Poland, Rest of Europe in Europe, Japan, China, India, South Korea, Australia, Singapore, Malaysia, Thailand, Indonesia, Philippines, Vietnam, Rest of Asia-Pacific (APAC) in Asia-Pacific (APAC), South Africa, Saudi Arabia, U.A.E, Kuwait, Israel, Egypt, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA).

North America dominates the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market due to the considerable investments made by biotechnology and pharmaceutical companies. Furthermore, the rise in the healthcare infrastructure will further boost the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the region during the forecast period. Asia-Pacific is projected to observe significant amount of growth in the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market due to the increasing of the per capita income. Moreover, the early accessibility of authorized therapies is further anticipated to propel the growth of the clustered regularly interspaced short palindromic repeats (CRISPR) gene-editing market in the region in the coming years.

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

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Clustered Regularly Interspaced Short Palindromic Repeats (CRISPR) Gene-Editing Market 2022 Business Outlook with Pandemic Scenario Analysis and...

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US will buy additional doses of Covid-19 preventive drug Evusheld. What about Korea? – Korea Biomedical Review

AstraZeneca said the U.S. government agreed to purchase additional 500,000 doses of its Covid-19 preventive medicine Evusheld (tixagevimab/cilgavimab).

AZ had said that it would initially supply 1 million doses of Evusheld. However, if most of the doses go to the U.S., other countries will have limited access to AZs preventive therapy.

AZ welcomed the U.S. governments plan to buy 500,000 doses of Evusheld on Wednesday.

Evusheld is a combination drug mixing long-acting antibodies, tixagevimab and cilgavimab, derived from B cells donated by convalescent patients after Covid-19 infection.

The antibody treatment was discovered by Vanderbilt University Medical Center and licensed to AZ, which optimized the drug with half-life extension.

The medicine aims to prevent Covid-19 infection in immunocompromised people.

According to AZ, the half-life extension more than triples the durability of its action compared to conventional antibodies. In addition, the company said that the consecutive two doses of tixagevimab 150mg and cilgavimab 150 mg could afford up to 12 months of protection from Covid-19.

On Dec. 8, Evusheld received FDA approval for the pre-exposure prophylaxis of Covid-19 in people who experienced serious adverse reactions of Covid-19 vaccines or those with immune compromise. Earlier, the U.S. government signed a deal with AZ to purchase 700,000 doses of Evusheld.

The U.S. has confirmed the purchase of 1.2 million doses of Evusheld so far, and the additional 500,000 doses will be shipped to the U.S. within the first half of this year.

As the U.S. secured most of the initial supply of Evusheld, other countries will face a limited chance to purchase the preventive therapy.

Our headquarters basic stance is that we will apply for marketing license in countries that confirmed the pre-purchase of Evusheld, an official at AstraZeneca Korea said. As the quantity of Evusheld is insufficient, we are distributing the remaining stock of Evusheld, excluding those going to the U.S., to several developed countries in Europe.

This means that if the Korean government does not discuss a pre-purchase of Evusheld, AZ will not seek marketing approval pre-emptively.

The Ministry of Food and Drug Safety is doing a preliminary review on Covid-19 vaccines and treatments. But this happens only when a company submits related data.

The regulator is not reviewing Evusheld now.

However, the Korea Disease Control and Prevention Agency (KDCA) plans to discuss Evusheld purchase with AZ soon. The drug is expected to become an option for Korean immunocompromised people to prevent Covid-19.

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US will buy additional doses of Covid-19 preventive drug Evusheld. What about Korea? - Korea Biomedical Review

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Interview With Rory Moore, CEO Of Arctic Canadian Diamond Co. – JCK

Rory Moore (pictured) has worked at Ekati, the first diamond mine in Canadas Northwest Territories, on and off for years. He was part of the original crew that first developed the mine in the 1990s. In 2018, he rejoined what was then called Dominion Diamond. He then became its interim president in January 2020, and in November, he was appointed the full-time CEO of what is now called the Arctic Canadian Diamond Co.

Here, he talks with JCK about his view on the diamond market, how Arctic looks at Canadian cutting and Canadian-origin stones, and why Ekati might confound expectations and stay around for a while.

Can you bring us up to date on whats happening with Ekati and its current ownership structure?

With the onset of COVID, the diamond market closed. We had a partnership with Rio Tinto in the Diavik mine, which is a neighboring mine. After COVID, we [initially] elected to put Ekati on care and maintenance, because we had $200 million worth of diamonds in inventory, but we couldnt sell them. We didnt want to burn through our cash reserves quickly. However, when Diavik did continue to operate, we were obliged to pay our 40% interest in the operating costs, and that would have very quickly have chewed up our cash reserves. So, we [filed] for CCAA [insolvency protection].

That triggered its sale process and the former owners, Washington, participated in that and ultimately withdrew their bid to buy the assets, and then the debt holders stepped in, represented by the three principal organizations: DDJ Capital, Brigade Capital, and Western Asset Management. The three of them stepped in and bought the assets and [provided us] with some additional cash to reopen the mine and get going again.

We restarted the mine in January last year, which is in the dead of the Arctic winter, so that was challenging. We had lots of startup problems, but ultimately now we have got the mine running at a steady state. Fortunately, we had some nice tailwinds from a strong rough diamond market last year, so prices were very robust and that really helped us with our restart. We met our revenue targets last year despite all the challenges.

You have said you want to extend the mine life. How do you plan to do that?

The best days of Ekati are behind us in terms of quality of ore bodies. During the early years, when BHP owned the mine, the ore bodies were very rich and very close to the central infrastructure at the mine, which is the process plant. So operating costs were very low, and revenue was very high. It was a highly profitable mine.

As time has gone on, those bodies have been mined out, and we are now mining lower-value ore bodies further away from the plant. Our main open pit, Sable, is 17 kilometers north of the process plant. Its a lower-revenue ore body and theres additional transportation and logistics involved in getting the ore from the open pit to the process plant. Then, to the south, weve got our Misery underground mine, which is a high-revenue ore body that has now gone underground, so its mining at a lower production rate. And thats 25 kilometers south of the processing plant, so again, weve got to transport the ore to the plant.

What we faced going forward is, as these ore bodies come to their natural end, Stable in particular, they were not valuable enough to support conventional underground mining. And, so, what weve done is over the past four yearsand this is what Ive been working onis looking at alternative, more creative ways to mine these ore bodies so we can still mine them profitably.

Weve come up with a system, its called underwater remote mining. Essentially, we flood the pit, and after the open pit mining is completed, and we continue to mine it underwater, using specialized underwater surface mining machines that weve developed in conjunction with a company out of Holland called Royal IHC. We are very confident that its going to work, and the beauty of this method is that you only mine ore and not waste. So, with conventional mining, you have to mine a lot of waste. In fact, at Sable, theres seven times more waste [being mined] than ore. If you remove all that waste mining, suddenly your costs are dramatically lower, and youve got a profitable mining operation again. Thats the way we are going into the future.

We have designed all the equipment, and we are going to construct the first of that equipment this year. Then, were going to do a big production trial in 2024. Were building equipment this year, and then over 2023 and 2024, were gonna test that equipment and then implement it in 2024 for future mining at Sable, and then extend that to other ore bodies. The future of Ekati is underwater remote mining, which has not been done in this sort of setting at all in the past. We are spearheading some new innovative mining techniques.

Assuming that all comes to fruition, how long will that extend the mine life?

Initially, the first phase will take us to 2029. The other thing that were doing at the moment is developing a new conventional open-pit mine at the same time. That will take us to 2028. We also have the opportunity to extend mine life through underwater remote mining at Point Lake. That ore body has 50 million tons of kimberlite in it. So, if the underwater remote mining works, well get an additional 10 years of mining out of Point Lake. Then, we have another ore body that was mined by BHP called Fox, and that has 40 million tons of kimberlite left in it. Weve done studies to potentially develop it with underground conventional mining, and it doesnt make the grade. So, we would look to mine that underwater as well, which would add another 10 years of mine life. So, essentially, we have decades of mine life extension, but we have to prove the system first.

You said youre confident that will work.

Yes. Im very confident. Components of the technology have been routinely used in other applications, in conventional dredging operations throughout the world. We are putting it all together in a system that hasnt been used in this application. None of it is rocket science. Its all proven technology.

The owners have been very supportive, and they have been very open to funding our development of [the underwater remote mining] method. Weve got a stable operation now, and our immediate focus is to pay down the debt that we have, and weve already started that process this year. We had a good revenue year, and weve already paid down the debt very substantially.

There have been concerns raised about underwater mining from an environmental point of view. How do you respond to that?

In fact, this method is significantly more environmentally friendly than open-pit mining. Thats because, firstly, you dont have any big waste dumps. So, all that footprint of the waste dumps interfering with caribou migration or changing the landscape, that goes away. You have a closed water system, so all the water thats in the mine [goes to] a pond next door to the open-pit mine, where well settle out the sedimentary material. It will be a closed system. So, no water thats been disturbed or polluted in any way will get out into the secondary environment. Its very much contained and has an incredibly small footprint.

The machine has been devised so that all the hydraulic fluids in the machine are biodegradable. Id be lying to you if I said were not going to burst hydraulic hoses once in a while. We will have hydraulic oil spills, but [they will be] biodegradable hydraulic oils by design that will not contaminate the water in any meaningful way. So, the environmental impact is much lower, and thats a positive for the project as well.

What has been the reaction from the local community to Ekati restarting?

Our northern partners are very relieved that we are back in production. We have a lot of training and career opportunities for people of the north. There was big relief that we did come through the CCAA process, that weve hired a whole lot of new people, and our training programs, apprenticeship programs, leadership programs are back in place. Weve got partnerships with the local indigenous groups and communities. Theyve supported us very well, as has the government of Northwest Territories. Its all pretty positive, after a tough period of 10 months not being in production

You no longer have 40% ownership in the Diavik mine, as Rio Tinto took it over. How does that affect you?

On a practical basis, it doesnt impact us much, because we were essentially a passive partner in that. Rio Tinto operated that mine and we just participated in quarterly management committee meetings. It doesnt impact our workforce in any way, as we had nobody working at Diavik.

What it does impact is the product mix that we take to the market. We used to have a big production out of Ekati, supplemented by a fairly significant production out of Diavik, which gave us higher carats and higher volumes to sell into the rough market and gave us more options for product mix for our clients. Weve lost a bit of flexibility in accommodating our clients exact needs when it comes to the product mixes.

But the productions are fairly similar between Ekati and Diavik. So, the impact of that hasnt been too significant. Its more that weve just got a lower volume of diamonds to sell.

Your company has been renamed Arctic, which is probably a more potent name from a marketing point of view, in that it symbolizes Canada. Do you expect to get more involved in marketing your product?

We recognize that we are diamond producers, and thats what weve got to focus on. We are an active member of the Natural Diamond Council, and so we actively participate in that and contribute to that initiative through our membership fees. We think that the Natural Diamond Council is doing a great job of promoting natural diamonds. We recognize that if you wanted to do a good job of marketing a luxury product like diamonds, youve got to have a big budget for that, and thats just not where we fit in. All of us producers together are much more powerful than individuals trying to do that separately.

A lot of producers are looking into origin certification? Will you do that?

A percentage of our diamonds are sold through the Canadamark program. They tend to be the higher-quality goods. We think its an important consideration, given that the new generations of customers are much more concerned about the origin of the products that they buy and that the products have been produced a sustainable way. I think Canadian-origin diamonds are highly prized by millennials because they know that Canada has high environmental guidelines and social economic guidelines and the way we run our mines in Canada is of the highest standard. Thats not to say that a diamond produced in Africa has not been ethically produced, because the big mines in Africa are run according to the highest international standards. There may be a perception that all these African [stones] are still blood diamonds, but the reality is that the absolute majority of diamonds coming out of Africa are produced in a very ethical way. But Canada does have brand appeal.

Theres been talk of new factories in Canada. Thats been tried before, and it didnt work. Do you think Canadian cutting has a future?

I think its always going to be a challenge to manufacture diamonds in Canada, particularly in the north. You are competing against India, and India has really done an incredible job of capturing that part of the supply chain of diamonds. You cant compete on costs, and they actually have become incredibly skilled at polishing diamonds.

Its admirable to see people try, because the more we can capture business opportunities in Canada, the better. But I think its a struggle.

Do you expect rough diamond prices to continue to remain strong?

At the moment, everybody in the business expects that rough diamond prices will remain strong in the short- to medium-term. Obviously, its very difficult to predict longer term. Supply has been impacted by COVID, so supply of rough diamonds is lower than it was forecast to be. Demand is incredibly strong, fueled mostly by the U.S. and China. Theres been very strong demand for our product, and the commentary over the holiday season was that sales were very strong on the retail side. In the short-term, I think the macro factors for our industry, and for rough diamond prices, are very good.

(Photos courtesy of Arctic Canadian Diamond Co.)

Read more:
Interview With Rory Moore, CEO Of Arctic Canadian Diamond Co. - JCK

Recommendation and review posted by Bethany Smith

Isoflavones Market Research Report by Product, by Source, by Component, by Application, by Region – Global Forecast to 2026 – Cumulative Impact of…

Isoflavones Market Research Report by Product (Capsule, Liquid, and Powder), by Source (Chickpea, Red Clover, and Soybeans), by Component, by Application, by Region (Americas, Asia-Pacific, and Europe, Middle East & Africa) - Global Forecast to 2026 - Cumulative Impact of COVID-19

New York, Jan. 13, 2022 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Isoflavones Market Research Report by Product, by Source, by Component, by Application, by Region - Global Forecast to 2026 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p06202161/?utm_source=GNW

The Global Isoflavones Market size was estimated at USD 1,333.21 million in 2020 and expected to reach USD 1,412.48 million in 2021, at a CAGR 6.05% to reach USD 1,896.77 million by 2026.

Market Statistics:The report provides market sizing and forecast across five major currencies - USD, EUR GBP, JPY, and AUD. It helps organization leaders make better decisions when currency exchange data is readily available. In this report, the years 2018 and 2019 are considered historical years, 2020 as the base year, 2021 as the estimated year, and years from 2022 to 2026 are considered the forecast period.

Market Segmentation & Coverage:This research report categorizes the Isoflavones to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Product, the market was studied across Capsule, Liquid, Powder, and Tablet.

Based on Source, the market was studied across Chickpea, Red Clover, and Soybeans.

Based on Component, the market was studied across Daidzein, Formononetin, and Genistein.

Based on Application, the market was studied across Cosmetics & Personal Care, Food & Beverages, and Nutraceutical.

Based on Region, the market was studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, and Thailand. The Europe, Middle East & Africa is further studied across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Cumulative Impact of COVID-19:COVID-19 is an incomparable global public health emergency that has affected almost every industry, and the long-term effects are projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlying COVID-19 issues and potential paths forward. The report delivers insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecasts, considering the COVID-19 impact on the market.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies to help the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. It describes the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth during a forecast period.

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Isoflavones Market based on Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Market Share Analysis:The Market Share Analysis offers the analysis of vendors considering their contribution to the overall market. It provides the idea of its revenue generation into the overall market compared to other vendors in the space. It provides insights into how vendors are performing in terms of revenue generation and customer base compared to others. Knowing market share offers an idea of the size and competitiveness of the vendors for the base year. It reveals the market characteristics in terms of accumulation, fragmentation, dominance, and amalgamation traits.

Competitive Scenario:The Competitive Scenario provides an outlook analysis of the various business growth strategies adopted by the vendors. The news covered in this section deliver valuable thoughts at the different stage while keeping up-to-date with the business and engage stakeholders in the economic debate. The competitive scenario represents press releases or news of the companies categorized into Merger & Acquisition, Agreement, Collaboration, & Partnership, New Product Launch & Enhancement, Investment & Funding, and Award, Recognition, & Expansion. All the news collected help vendor to understand the gaps in the marketplace and competitors strength and weakness thereby, providing insights to enhance product and service.

Company Usability Profiles:The report profoundly explores the recent significant developments by the leading vendors and innovation profiles in the Global Isoflavones Market, including Archer Daniels Midland Company, BASF SE, Bio-Gen Extracts Pvt. Ltd., Cargill, Incorporated, Fujicco Co., Ltd., Futureceuticals Inc., GNC Holdings Inc., International Flavors & Fragrances, Inc., InVite Health, Inc., Koninklijke DSM N.V., Lactonova Nutripharm Pvt Ltd, Life Extension Foundation, Nexira Inc., NOW Foods, Nutra Green Biotechnology Co. Ltd., NutraScience Labs, Shaanxi Hongda Phytochemistry Co., Ltd., Shanghai Freemen, SK Bioland, and Xena Bio Herbals Pvt Ltd..

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyze penetration across mature segments of the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, certification, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and breakthrough product developments

The report answers questions such as:1. What is the market size and forecast of the Global Isoflavones Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Isoflavones Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Isoflavones Market?4. What is the competitive strategic window for opportunities in the Global Isoflavones Market?5. What are the technology trends and regulatory frameworks in the Global Isoflavones Market?6. What is the market share of the leading vendors in the Global Isoflavones Market?7. What modes and strategic moves are considered suitable for entering the Global Isoflavones Market?Read the full report: https://www.reportlinker.com/p06202161/?utm_source=GNW

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Isoflavones Market Research Report by Product, by Source, by Component, by Application, by Region - Global Forecast to 2026 - Cumulative Impact of...

Recommendation and review posted by Bethany Smith

Menopausal Symptoms and Cognitive Problems Connected, Study Says – Everyday Health

Although hot flashes are the quintessential symptom, there are several other menopause-related symptoms, such as brain fog or memory trouble, that women may not realize are connected to their changing hormones.

A new study published January 12 in the journalMenopause found a link between menopausal symptoms, especially depression and sexual dysfunction, and cognitive performance in areas such as memory, attention, and language skills.

Often women dont recognize these symptoms as part of menopause, says Margaret Nachtigall, MD, a gynecologist at NYU Langone Health and a clinical assistant professor at the NYU School of Medicine, both in New York City. Because cognitive issues can develop slowly, they might not see it as related to a loss of estrogen, she says.

According to theOffice on Womens Health, part of the Department of Health and Human Services, up to two-thirds of women in perimenopause report cognitive problems.

In the women that I see in clinic, that can manifest as difficulty remembering, the inability to find the right word for what they are trying to say, putting dishes in the cabinet instead of the dishwasher, not remembering everything on their list that they wanted at the store, or being in a meeting and forgetting what they were going to say, says Dr. Nachtigall.

RELATED: Predicting How Long the Menopausal Transition Will Last, and When Youll Reach Menopause: 10 Questions and Answers

To examine whether the cognitive performance of women is related to the severity of menopausal symptoms, investigators looked at 404 women in a rural area in north India. The subjects were between ages 40 and 65 and were not using hormone therapy (HT).

The women were divided in four groups so that researchers could look at the frequency and severity of different symptoms according to the stage in the menopause transition.

Researchers used standardized tools to record the presence and intensity of 21 different menopause symptoms, including sexual dysfunction, vasomotor symptoms (hot flashes), depression, and anxiety.

A Hindi version of the Mini-Mental State Examination (MMSE) was used to gauge cognitive performance and evaluate the effect of the severity of menopause symptoms on overall cognitive performance and its five domains, including

Investigators found that the kind of menopausal symptoms the women experienced were different depending on their life stage.

Researchers found that the cognitive performance of the women was linked to the severity of certain menopause symptoms, especially depression and sexual dysfunction.

Sexual dysfunction can manifest in different ways during menopause and people are often reluctant to talk about it, says Nachtigall. Some women feel as though they have vaginal dryness, itchiness, or a feeling like sandpaper in the vagina, she says.

A decrease in arousal or in sexual response and pleasure are also symptoms of sexual dysfunction, according to theNorth American Menopause Society.

The authors found no association between the severity of vasomotor symptoms and cognitive performance, although other studies have suggested that such an association exists.

In menopause, the ovaries arent producing any estrogen, notes Nachtigall. We have estrogen receptors almost everywhere brain, eyes, teeth, bones and so its not surprising that when we have a lack of estrogen that all these different symptoms can occur. It makes sense that a person with more menopause symptoms and more severe symptoms would also have a lower cognitive function, but interesting that they were able to show that in this study, she says.

These findings reflect what Nachtigall sees in her own practice. Often, people who have more hot flashes, more depression, and more symptoms of menopause in general are also the same people who experience difficulties with cognitive functioning.

This study provides further support that women should seek care when you are going through menopause or perimenopause, says Nachtigall. When you see a provider, talk about the symptoms you are experiencing, even if you dont think they are related to menopause, she says.

This can lead to an important discussion around different treatment options, including whether or not hormone therapy (HT) may help with your symptoms, says Nachtigall. Its been shown in multiple studies that estrogen does improve symptoms of cognitive functioning. Its also been shown in many studies that estrogen will reverse hot flashes, will improve mood, will improve sexual functioning and vaginal dryness, and therefore may be a good option for many people, she says.

Research published in Menopause in December 2019 found that there could be a cognitive benefit later in life for some women who had more exposure to estrogen, both through a longer reproductive window and the use of longer-term HT.

The risks and benefits of hormone therapy should be discussed with your doctor, as it is not appropriate for everyone, including women who have unexplained bleeding, estrogen receptor positive cancer or severe liver disease or a serious clotting disorder, says Nachtigall.

The findings of this study point to the fact that not all symptoms related to the menopause transition are hot flashes; there are other symptoms, says Stephanie S. Faubion, MD, the director of the Center for Womens Health at the Mayo Clinic in Rochester, Minnesota, and the medical director of theNorth American Menopause Society (NAMS).

Included in that are these cognitive type changes that women commonly describe, as well as mood issues that need to be addressed, says Dr. Faubion. That doesnt mean that all these symptoms can be treated with hormone therapy there could be other issues or conditions contributing to these symptoms that need to be addressed and evaluated, she adds.

RELATED: What Experts Want Women of Color to Know About Menopause

Its important to note that we dont know if giving hormone therapy during menopause helps with memory, short or long term. But we do know if youre going to take hormone therapy for other menopause symptoms hot flashes, night sweats it does tend to help with mood, she says. The relationship between depression and memory issues is well-established, adds Faubion.

If not through hormone therapy, is there a way to treat brain fog or memory issues? Solutions to memory issues might be related to sleep issues or an underlying sleep disorder. It may also be improved by managing stress or treating any underlying mood disorders, such as anxiety or depression, says Faubion.

Nachtigall echoes that sleep is an important issue and often a problem for women during the menopause transition. Many people that I see complain of insomnia, and thats one of the early signs of lack of estrogen that patients in menopause will experience, she says.

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Menopausal Symptoms and Cognitive Problems Connected, Study Says - Everyday Health

Recommendation and review posted by Bethany Smith

Quick and Easy Ways to Get Rid of Redness from Pimples and Acne – Healthline

Even 10-step skin care routine devotees get pimples. If youre suffering from red, irritated acne blemishes, there are ways you can minimize redness through skin care efforts.

However, if youve arrived to this page with little time to spare, there are also some tips for concealing blemishes until you can get the redness to go away for good.

The keys to reducing redness from acne are to apply anti-inflammatory compounds while being gentle to your skin. Thats right gentle. This means dont try to use every scrub or irritating product to treat your acne. Instead, try using a keep it simple approach.

If you apply too many oil-removing products, your skin could react the opposite way: It could start to overproduce oil, which will worsen your acne. The goal is to keep your skin clean and apply targeted products to reduce redness while your blemishes heal.

Here are some tips for reducing redness:

Sometimes, youll need to call in the professionals for consistent, painful, and inflamed pimples. A dermatologist can evaluate your skin and prescribe professional-level treatments, such as topical applications, chemical peels, or laser therapy.

Acne can also closely resemble rosacea, a condition that causes significant skin redness. Because the treatments for rosacea can be different from traditional acne-fighting approaches, its a good idea to see a dermatologist if youre not sure.

You can also apply a mild cortisone cream to an inflamed pimple to decrease redness and swelling. This should be done sparingly and only as a spot treatment, as topical steroids themselves can actually cause acne, as well other potential side effects such as skin thinning.

Sometimes, even your best efforts at reducing redness dont show enough immediate results. When this is the case, you can use makeup to cover up the redness. Heres how to start:

Youll want to use products that are all oil-free and noncomedogenic when concealing your pimple. Otherwise, youll run the risk of making it worse.

Consistent skin care is beneficial for reducing redness, and so is adopting an acne prevention plan. Your acne prevention skin care routine should include the following:

If this plan doesnt help your acne subside, see a dermatologist.

Acne redness can indicate underlying irritation and inflammation in your skin. A lot of this can be hormone-related, as hormones can determine how much oil your skin produces. However, you can use a consistent skin care routine with topical agents intended to reduce blemishes.

Keeping redness fighters (plus a good concealer) on hand isnt a bad idea for when the occasional blemish pops up. But remember to call your dermatologist if your blemish wont go away after a few days of at-home care.

Link:
Quick and Easy Ways to Get Rid of Redness from Pimples and Acne - Healthline

Recommendation and review posted by Bethany Smith

Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis – BMC Women’s Health…

Results of the search

We retrieved 139 records from the search of the electronic database and no other records from other sources (Fig.1). A total of 94 records were screened after duplicates were removed. We reviewed full copies of 13 and assessed them for eligibility. We identified four articles as possibly meeting the review inclusion criteria, and nine of them were ineligible for inclusion. One article was a non-randomized controlled trial that evaluated the clinical response of elagolix-treated women who did not achieve the primary outcome [22]. Two reviews, one on predictors of response to elagolix with add-back therapy and the other on medical treatment of uterine leiomyoma, were relevant to our research query [4, 23]. There was no outcome of interest in the four papers as two papers [3, 11] on elagolix pharmacotherapy and pharmacodynamics and another two more papers [14, 24] on drug-drug interactions were written. Adenomyosis was the topic of two more publications [25, 26]. We attempted to contact the trial authors for the full article but received no response. Therefore, we included four trials.

Four randomized controlled trials with 1949 participants were included in the study [27,28,29,30]. All four trials reported the primary outcome. All trials were sponsored by AbbVie [27,28,29,30].

All four studies were carried out in 323 locations across the United States, Puerto Rico, and Canada. One trial recruited participants from clinic settings [27]. The other three trials did not mention the location from which participants were recruited [28,29,30]. Three studies included premenopausal women aged 18 to 51 at the screening time [28,29,30], while one study recruited participants aged 2049 [27]. They underwent ultrasonography-confirmed diagnosis of uterine fibroids and heavy menstrual bleeding, as characterized by more than 80ml of menstrual blood loss per menstrual cycle for at least two cycles. The trials excluded participants due to a complex ovarian cyst, cancer, pelvic inflammatory disorder, osteoporosis history, or metabolic bone disease. Participants who had a myomectomy or hysterectomy for symptomatic uterine fibroid were exempted from the study [27,28,29,30].

Participants in the trials were randomized to the intervention and comparison groups. Two identical, double-blind, randomized, placebo-controlled, six-month phase 3 trials (Elaris Uterine Fibroids 1 and Elaris Uterine Fibroid 2) have been reported in one trial [29]. Elaris Uterine Fibroid-1 and Elaris Uterine Fibroid-2 participants were later randomized or pooled into a new study [30] to look at the long-term twelve-month safety and efficacy of elagolix with or without estradiol/norethindrone acetate. The meta-analysis included four trials that evaluated the primary outcomes. Three trials compared elagolix with placebo [27,28,29], and four trials compared to elagolix with estradiol/norethindrone acetate [27,28,29,30]. Only one trial compared elagolix to placebo at different doses of 100mg bd, 200mg bd, 300mg bd, 400mg qd, and 600mg qd [27]. One study was compared to placebo at doses of 300mg bd and 600mg qd [28]. Another trial was compared elagolix to placebo at a dose of 300mg bd [29].

In a comparison of elagolix to elagolix with estradiol/norethindrone acetate, one trial compared it at a dose of 0.5mg estradiol/0.1mg norethindrone acetate [27], while two trials compared it at a dose of 1.0mg estradiol/0.5mg norethindrone acetate [29, 30]. In one trial, elagolix was compared to elagolix with estradiol/norethindrone acetate at two doses: 0.5mg estradiol/0.1mg norethindrone acetate and 1.0mg estradiol/0.5mg norethindrone acetate [28]. All medications are taken orally as tablets or capsules. The duration of treatment differed between trials compared to elagolix versus placebo, as only one trial was three months [27], and the other two trials were six months [28, 29]. In contrast, the length of treatment differed between trials when comparing elagolix to elagolix with estradiol/norethindrone acetate, with a three-month [27], a six-month [28, 29], and a twelve-month [30] period.

The validated alkaline hematin method was used to quantify and evaluate the primary outcome in all four trials [27,28,29,30]. Any spotting or bleeding episodes on a sanitary pad were reported at the time of screening or during treatment. Participants kept an electronic daily bleeding diary (eDiary) and assessed bleeding patterns using the validated Mansfield-Voda-Jorgenson Menstrual Bleeding Scale [31]. All studies were followed up to at least three-months duration. The primary outcome was measured during the last month of the treatment period.

All four trials reported all secondary outcomes except for one study [27], which did not record bone mineral density due to a limited study time and a small sample size per group. Reduction of uterine and fibroid volume was calculated using trans abdominal or transvaginal ultrasound. The mean percentage change from baseline to the end of the treatment month was recorded.

The Uterine Fibroid Symptom and Quality of Life questionnaires cumulative score were used to measure symptom severity reduction and change in health-related quality of life in women with symptomatic uterine fibroids. It was a disease-specific, self-administered, validated questionnaire. There were 37 questions in all, split into two parts. The first part consisted of an 8-item symptom severity scale. The second part consisted of a 29-item health-related quality of life subscale with six domains (concern, behaviors, energy/mood, power, self-consciousness, and sexual function). All items are rated on a 5-point scale, with symptom intensity items ranging from not at all to a great deal, and health-related quality of life items ranging from none of the time to all of the time. The cumulative score for each of the two components was determined by adding the symptom intensity and health-related quality of life subscale scores and translating them to a 0-to-100-point scale. Higher overall health-related quality of life scores indicated better quality of life, while lower symptom severity scores indicate better quality of life.

The percentage of increase in hemoglobin concentration from baseline to the last month of treatment was reported in all trials. Loss of bone mineral density was assessed by dual-energy x-ray absorptiometry scans of the lumbar spine, total hip, and femoral neck. The mean percentage change in bone mineral density from baseline to the last month of treatment was recorded in three studies [28,29,30]. Any adverse events were recorded beginning with the first dose of the study drug and continuing for up to 30days after completing the last dose of the study drug. All four trials identified common adverse events such as hot flushes, headaches, nausea, and fatigue. In this review, only two trials documented adverse events such as abdominal pain, dizziness, and hypertension [27, 28]. Other non-significant adverse events identified in clinical trials will not be addressed in this review.

The assessment risk of bias is shown in Figs.2 and 3. Figure2 shows the proportion of studies assessed as low, high or unclear risk of bias for each risk of bias indicator. Figure3 shows the risk of bias indicators for individual studies. The details of these trials are found in the table of characteristics of included studies (Table 1).

Risk of bias graph: review authors judgements about each risk of bias item presented as percentages across all included studies

Risk of bias summary: review authors judgements about each risk of bias item for each included study

Only one trial, with 271 participants, was reported to have been recruited in a clinic setting, while the other three were not [27]. The method of randomization was not reported in all four trials [27,28,29,30]. Thus, we judged random sequence generation as having an unclear risk of bias. Allocation concealment was not mentioned and regarded as unclear in four trials [27,28,29,30].

Participants, care provider, investigator and outcome assessor were masked in all four trials. The details on blinding were not recorded in all four trials, but the outcomes were unlikely to be influenced as it was objectively collected and measured using standardized methods [27,28,29,30]. Therefore, they are judged as having a low risk of bias.

More than 80% of participants completed the studies in two trials [27, 30]. Meanwhile, 74.4% of participants in one trial completed the study [28]. Approximately 129 of the 571 participants failing to complete the analysis due to hypoestrogenism side effects (n=39), withdrawal (n=38), loss of follow up (n=25), noncompliance (n=11), lack of efficacy (n=3), surgery (n=4) and other (n=9) [28]. About 78% of 791 participants completed studies in Elaris Uterine Fibroid-1 and Elaris Uterine Fibroid-2 [29]. The study drug was discontinued by similar proportions of women in both treatment groups (16.5% for elagolix with estradiol/norethindrone acetateand 19.4% for elagolix alone), with the most common primary reason being lost to follow-up (5.0%and 5.1%,respectively) in one trial [29]. Missing data were evenly balanced across groups, and the reasons were similar. The most common reasons for missing outcome data included withdrawal, noncompliance, loss to follow up, hypoestrogenism side effects, pregnancy, and surgery, which led to discontinuation.

All four trials reported the outcomes as specified in their methods section[27,28,29,30]. The outcomes listed in the registered protocol were those reported. Although changes in bone mineral density were assessed as an exploratory parameter, one trial did not report due to the short duration of the study and the relatively small sample size per group [27]. We graded it as having a low risk of bias.

We discovered that women with asymptomatic anemia and a hemoglobin level of less than 12g/dl at screening or during the study period were advised to take iron supplements in two trials [27, 30]. This could have an influence on the hemoglobin level at the end of the treatment period. Thus, we judged it as having a high risk of bias. We detected no other potential source of bias in the other two trials [28, 29].

There would be two comparisons evaluated in this review, i.e., comparing elagolix versus placebo and comparing elagolix versus estradiol/norethindrone acetate.

Elagolix has increased the number of patients with a reduction of menstrual blood loss of less than 80ml (RR 4.81, 95% CI 2.45 to 9.45; I2 statistic=89%; P<0.001; four trials, 869 participants; moderate quality evidence) (Fig.4, Table 2) [27,28,29] or more than 50% from baseline (RR 4.87, 95% CI 2.55 to 9.31; I2 statistic=87%; P<0.001; four trials, 869 participants; moderate quality evidence) (Fig.5, Table 2) [27,28,29] compared to placebo. The sensitivity analysis did not change the cumulative effect estimate. Table 3 showed the subgroup analysis for reduction of menstrual blood loss of less than 80ml or more than 50% reduction from baseline stratified by frequency of drug administration, uterine and fibroid volume (Additional file 1).

Comparison between elagolix and placebo for the outcome reduction of menstrual blood loss of less than 80ml

Comparison between elagolix and placebo for the outcome reduction of menstrual blood loss of more than 50%

For the secondary outcomes, elagolix has increased the number of patients with improved hemoglobin level (RR 2.46, 95% CI 1.93 to 3.13; I2 statistic=0%; P<0.001; four trials, 554 participants; moderate quality evidence) [27,28,29], reduced the mean percentage change in uterine volume (MD 34.50, 95% CI 43.48 to 25.53; I2 statistic=63%; P<0.001; four trials, 783 participants; moderate quality evidence) [27,28,29], fibroid volume (MD 31.39, 95% CI 44.69 to 18.09; I2 statistic=65%; P<0.001; four trials, 750 participants; moderate quality evidence) [27,28,29], severity of symptoms (MD 31.54, 95% CI 41.85 to 21.22; I2 statistic=96%; P<0.001; four trials, 814 participants; low quality evidence) [27,28,29], and improved health-related quality of life (MD 30.64, 95% CI 20.14 to 41.15; I2 statistic=95%; P<0.001; four trials, 812 participants; low quality evidence) [27,28,29] (Additional file 1, Table 2) compared to placebo.

Elagolix has reduced bone mineral density in lumbar spine (MD 2.82, 95% CI 3.30 to 2.35; I2 statistic=0%; P<0.001; three trials, 574 participants; moderate quality evidence) [28, 29], total hip (MD 1.97, 95% CI 2.37 to 1.57; I2 statistic=46%; P<0.001; three trials, 574 participants; moderate quality evidence) [28, 29] and femoral neck (MD 1.92, 95% CI 2.61 to 1.23; I2 statistic=34%; P<0.001; three trials, 574 participants; moderate quality evidence) [28, 29] (Fig.6, Table 2) compared to placebo.

Comparison between elagolix and placebo for the outcome of bone mineral density (A: lumbar spine, B: total hip, C: femoral neck)

There was no significant of severe, serious or adverse event led to discontinuation of elagolix treatment. Elagolix has increased the number of patients with side effect of hot flush (RR 7.47, 95% CI 4.99 to 11.18; I2 statistic=8%; P<0.001; four trials, 890 participants; moderate quality evidence) [27,28,29] and headache (RR 1.88, 95% CI 1.25 to 2.83; I2 statistic=0%; P<0.001; four trials, 890 participants; low quality evidence) [27,28,29] (Fig.7, Table 4) compared to placebo.

Comparison between elagolix and placebo for the outcome of adverse events (A: hot flush, B: headache)

B) Comparison between elagolix and elagolix with estradiol/norethindrone acetate.

There was no difference in menstrual blood loss of less than 80ml (RR 1.08, 95% CI 1.00 to 1.16; I2 statistic=56%; P=0.070; five trials, 1365 participants; moderate quality evidence) (Fig.8, Table 5) [27,28,29,30] or more than 50% reduction from baseline between the elagolix (RR 1.08, 95% CI 1.01 to 1.15; I2 statistic=43%; P=0.020; five trials, 1365 participants; high quality evidence) (Fig.9, Table 5) [27,28,29,30] and elagolix with estradiol/norethindrone acetate. The sensitivity analysis did not change the cumulative effect estimate. Table 6 showed the subgroup analysis for reduction of menstrual blood loss of less than 80ml or more than 50% reduction from baseline stratified by dosage and uterine volume (Additional file 1).

Comparison between elagolix and elagolix with estradiol/norethindrone acetate for the outcome reduction of menstrual blood loss of less than 80ml

Comparison between elagolix and elagolix with estradiol/norethindrone acetate for the outcome reduction of more than 50% menstrual blood loss

Foe secondary outcomes, there was no difference improvement in hemoglobin level between elagolix (RR 0.99, 95% CI 0.80 to 1.22; I2 statistic=68%; P=0.930; five trials, 899 participants; low quality evidence) [27,28,29,30] and elagolix with estradiol/norethindrone acetate. However, elagolix has reduced mean percentage change in uterine volume (MD 17.47, 95% CI 27.54 to 7.40; I2 statistic=58%; P<0.001; five trials, 1250 participants; moderate quality evidence) [27,28,29,30], fibroid volume (MD 23.18, 95% CI 28.98 to 17.38; I2 statistic=0%; P<0.001; five trials, 1208 participants; high quality evidence) [27,28,29,30], symptoms severity (MD 9.05, 95% CI 9.68 to 8.43; I2 statistic=0%; P<0.001; five trials, 1288 participants; high quality evidence) [27,28,29,30], and increased health-related quality of life (MD 9.94, 95% CI 5.82 to 14.06; I2 statistic=76%; P<0.001; five trials, 1287 participants; low quality evidence) [27,28,29,30] (Additional file 1, Table 5) compared to elagolix with estradiol/norethindrone acetate.

Elagolix has reduced bone mineral density in the lumbar spine (MD 2.63, 95% CI 3.12 to 2.14; I2 statistic=49%; P<0.001; four trials, 1126 participants; moderate quality evidence [28,29,30], and total hip (MD 1.93, 95% CI 2.56 to 1.31; I2 statistic=75%; P<0.001; four trials, 1126 participants; very low quality evidence) [28,29,30] except femoral neck (MD 0.77, 95% CI 1.84 to 0.30; I2 statistic=78%; P=0.160; four trials, 1126 participants; very low quality evidence) [28,29,30] (Fig.10, Table 5) compared to elagolix with estradiol/norethindrone acetate.

Comparison between elagolix and elagolix with estradiol/norethindrone acetate for the outcome of bone mineral density (A: lumbar spine, B: total hip, C: femoral neck)

There was no difference of severe, serious or adverse event led to discontinuation between elagolix treatment and elagolix with estradiol/norethindrone acetate. Elagolix has increased the number of patients with side effect of hot flush (RR 2.67, 95% CI 2.30 to 3.10; I2 statistic=0%; P<0.001; five trials, 1403 participants; moderate quality evidence) [27,28,29,30], reduced the number of patients with risk of nausea (RR 0.63, 95% CI 0.43 to 0.91; I2 statistic=0%; P=0.010; five trials, 1403 participants; low quality evidence) [27,28,29,30] and fatigue (RR 0.43, 95% CI 0.23 to 0.80; I2 statistic=0%; P=0.008; five trials, 1403 participants; low quality evidence) [27,28,29,30] (Fig.11, Table 7) compared to elagolix with estradiol/norethindrone acetate.

Comparison between elagolix and elagolix with estradiol/norethidrone acetate for the outcome adverse event (A: hot flush, B: nausea, C: fatigue)

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Elagolix treatment in women with heavy menstrual bleeding associated with uterine fibroid: a systematic review and meta-analysis - BMC Women's Health...

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Best Ways to Reverse Deadly Weight Gain Eat This Not That – Eat This, Not That

Excess weight gain is never great news. But one form of weight gain is more dangerous than others. Putting on belly fatalso known as visceral fat or abdominal fatis a major hazard to your health. That's because this type of fat lies deep within the abdomen, near vital organs like the liver, pancreas, and intestines. It's metabolically active, meaning it actively releases toxic substances into those organs and bloodstream that raise the risk of cancer, heart disease, and diabetes. The good news: If you've packed on abdominal fat, you can take specific steps to burn it off. Here's what science says are some of the most effective ways to reverse that potentially deadly weight gain. Read on to find out moreand to ensure your health and the health of others, don't miss these Sure Signs You've Already Had COVID.

The easiest way to reduce visceral fat is to lose weight. According to W. Scott Butsch, MD, an obesity medicine specialist with the Cleveland Clinic, weight loss alone can effectively reduce visceral fat. And just sending the scale slightly in the right direction can have a major effect on deadly belly fat gain. By losing 10% of your body weight, you may lose up to 30% of your body fat, he says.

Visceral fat lives for sugar. "Fructose, or sugar, causes fat cells to mature faster, specifically in the visceral fat," says the Cleveland Clinic. Reduce the amount of sugar in your dietlike sugar-sweetened drinks, simple carbs, baked goods, processed foods, and fast foodsand you'll likely see your waistline shrink.

RELATED: I'm a Doctor and Here's How to Lose Visceral Fat

Researchers at Wake Forest University found that dieters who slept five hours or less every night put on 2.5 times more belly fat than people who got an adequate amount of sleep. Not sleeping enough can increase the production of cortisol, a stress hormone that tells the body to hold onto fat around the abdomen. Poor sleep alters the production of leptin and ghrelin, two hormones that regulate appetite, and that can increase feelings of hunger. And just plain being tired can cause you to overeat to try and boost your energy. How much sleep is ideal? Experts say seven to nine hours a night.

RELATED: The #1 Place to Not Walk Into Now, Say Virus Experts

According to a 2020 study published in the journal Nutrients, exercise reduces visceral fat even if you don't lose weight. That's because it lowers circulating insulin (which tells the body to hang on to fat) and tells the liver to burn nearby belly fat deposits. The best kind of exercise for belly-fat reduction is moderate-intensity activity combined with strength training, a 2021 review of studies found.

RELATED: Diabetes Warning Signs You Need to Know, Say Experts

Reducing stress can provide a one-two punch in the battle of the bulge. Chronic feelings of stress cause the brain to produce more cortisol, which makes belly fat hang around. Stressing out can also lead to comfort-eating fatty and sugary foods. The combination is a shortcut to belly fat, says a study published in The Annals of the New York Academy of Sciences.

RELATED: 7 Reasons to Use Marijuana, Say Doctors

Several studies have found that a high-protein diet can burn belly fat and help keep it off. One of the latest was published this summer in the journal Scientific Reports: Researchers found that a test group that took a protein supplement along with a mildly calorie-restricted diet lost more visceral fat than a group that took a placebo. Protein fills you up faster and for longer, and studies have found that it reduces levels of ghrelin, the hormone that tells the body it's hungry.And to get through this pandemic at your healthiest, don't miss these 35 Places You're Most Likely to Catch COVID.

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Best Ways to Reverse Deadly Weight Gain Eat This Not That - Eat This, Not That

Recommendation and review posted by Bethany Smith


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