Archive for October, 2020

This article was originally published here

J Chem Inf Model. 2020 Oct 27. doi: 10.1021/acs.jcim.0c00929. Online ahead of print.

ABSTRACT

CRISPR-Cas12a is a genome-editing system, recently also harnessed for nucleic acid detection, which is promising for the diagnosis of the SARS-CoV-2 coronavirus through the DETECTR technology. Here, a collective ensemble of multimicrosecond molecular dynamics characterizes the key dynamic determinants allowing nucleic acid processing in CRISPR-Cas12a. We show that DNA binding induces a switch in the conformational dynamics of Cas12a, which results in the activation of the peripheral REC2 and Nuc domains to enable cleavage of nucleic acids. The simulations reveal that large-amplitude motions of the Nuc domain could favor the conformational activation of the system toward DNA cleavages. In this process, the REC lobe plays a critical role. Accordingly, the joint dynamics of REC and Nuc shows the tendency to prime the conformational transition of the DNA target strand toward the catalytic site. Most notably, the highly coupled dynamics of the REC2 region and Nuc domain suggests that REC2 could act as a regulator of the Nuc function, similar to what was observed previously for the HNH domain in the CRISPR-associated nuclease Cas9. These mutual domain dynamics could be critical for the nonspecific binding of DNA and thereby for the underlying mechanistic functioning of the DETECTR technology. Considering that REC is a key determinant in the systems specificity, our findings provide a rational basis for future biophysical studies aimed at characterizing its function in CRISPR-Cas12a. Overall, our outcomes advance our mechanistic understanding of CRISPR-Cas12a and provide grounds for novel engineering efforts to improve genome editing and viral detection.

PMID:33107304 | DOI:10.1021/acs.jcim.0c00929

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Molecular Dynamics Reveals a DNA-Induced Dynamic Switch Triggering Activation of CRISPR-Cas12a - DocWire News

Theres a new industry that is rising, that is promising to be as disruptive as AI and blockchain, that industry is genomics. With the benefit of CRISPR, affordable human genome sequencing, and advances in data science, a handful of companies are positioning themselves to take advantage of this new advent of healthcare. We will explore what is genomics, what companies are positioning themselves for this future, and why it matters.

Genomics is the study of a persons genes (the genome), the field reviews the interactions of those genes with each other and with the persons environment. The genome is an organisms complete set of DNA which programs the individual with different physical traits. Virtually every single cell in the body contains a complete copy of the approximately 3 billion DNA base pairs, or letters, that make up the human genome. With the power of data science it is now possible to study how genes interact, and in some cases edit genes in order to modify a single DNA letter, or base, in a gene.

There are multiple exponential technologies that have merged to enable the easy and cost-effective sequencing of the complete human genome. Sequencing the first human genome cost 2.7 Billion and took 13 years. Due to Moores Law and other exponential technologies the cost has now been reduced to $1000, and is projected to be further reduced to $100.

This means we are entering an era where anyone can have their complete human genome sequenced, in search of errors, or predispositions to certain illnesses or health issues.

Multiple companies are clamoring for a marketplace where initially consumers will demand to have their genome sequenced, and eventually, medical professionals will demand it. This is driving the force behind many of the genomic companies in the marketplace, the second driving force is the transformative power of CRISPR technology.

To familiarize oneself with CRISPR, one must first understand that there are multiple use cases for the terminology. In biology, CRISPR refers to DNA sequences naturally found in the genomes of bacteria and other microorganisms. CRISPRs are the sequences of a crucial component of the immune system that protect bacteria from viruses. The CRISPR immune system defends itself from viral attack by destroying the genome of the invading virus. This is where CRISPR technology then enters the scene.

For popular usage and in how we will explain it, CRISPR is shorthand for CRISPR-Cas9. CRISPR in combination with a protein called Cas9 (or CRISPR-associated) is an enzyme that acts like a pair of molecular scissors, capable of cutting strands of DNA. While the idea of gene editing has been around since the 1950s, CRISPR has enabled a cost-effective level of gene editing with a precision that has never before been available.

There are currently dozens of companies that are taking advantage of genomics, we will review five of the leading companies that are publicly traded.

What sets CRSPR Therapeutics apart is the all-star team of founders, this includes Dr. Emmanuelle Charpentier whose seminal research unveiled the key mechanisms of the CRISPR-Cas9 technology, laying the foundation for the use of CRISPR-Cas9 as a versatile and precise gene-editing tool. Numerous awards have recognized her work, including the Breakthrough Prize in Life Science.

CRISPR Therapeutics is developing an efficient and versatile CRISPR/Cas9 gene-editing platform into therapies to treat hemoglobinopathies, cancer, diabetes, and other diseases.

The first therapy that they are advancing is targeting the blood diseases -thalassemia and sickle cell disease, this has now entered clinical testing, as has the first allogeneic CAR-T program targeting B-cell malignancies. While sickle cell is a disease with an arguable small market, once the technology is mature they can advance to targeting other disease vectors.

Invitae Corporation is primed to take advantage of the rapidly decreasing cost of sequencing a human genome. This is a genetic information company that specializes in providing information for genetic diagnostics, preimplantation, and carrier screening for inherited disorders, miscarriage analysis, and hereditary cancer. Basically, any big data that can be provided from sequencing the human genome, Invitae Corporation offers.

Recently, Invitae Corporation partnered with ArcherDX to bring comprehensive cancer genetics and precision oncology to patients worldwide.

For anyone searching to take advantage of a company that is sequencing human genomes, they are a market leader.

Pacific Biosciences of California, Inc. is a biotechnology company founded in 2004 that develops and manufactures systems for gene sequencing and some novel real-time biological observation. Theyve developed a single molecule, real-time (SMRT) Sequencing technology that delivers high consensus accuracy with unprecedented read lengths. This a new way to study the synthesis and regulation of DNA, RNA, and proteins by harnessing advances in biochemistry, optics, nanofabrication, and more.

Some of the current applications they are working on include detecting epigenetic changes during sequencing to open the door to easier exploration of DNA modification to connect genotype with phenotype. This will enable understanding the effects of epigenetics on a broad range of biological processes, including gene expression, host-pathogen interactions, environmental response, DNA damage, and DNA repair. Furthermore, it will uncover the role of epigenetics in the inheritance of traits from one generation to the next.

Twist Biosciences Corp manufactures synthetic DNA for clients in the biotechnology industry. Theyve designed a DNA synthesis platform to address the limitations of throughput, scalability, and cost inherent in legacy DNA synthesis methods. This allows them to achieve precision manufacturing of DNA at scale.

The high-throughput silicon platform enables Twist Biosciences to miniaturize the chemistry necessary for DNA synthesis. This miniaturization allows the company to reduce the reaction volumes by a factor of 1,000,000 while increasing throughput by a factor of 1,000, enabling the synthesis of 9,600 genes on a single silicon chip at full scale.

This is essentially an easy way for other companies to order DNA as needed.

Illumina, Inc develops, manufactures, and markets integrated systems for the analysis of genetic variation and biological function. The company provides a line of products and services that serve the sequencing, genotyping and gene expression, and proteomics markets.

The technology is currently being used to assist with COVID-19, they enable companies working around the clock to track transmission, conduct surveillance, develop therapies and vaccines for any type of viral infection.

Some of their current offerings include access to fast, high-quality, sample-to-data next-generation sequencing (NGS) services such as RNA and whole-genome sequencing services.

While we have listed some of the primary companies that are taking advantage of low-cost human genome sequencing, and gene editing, there are many other companies that are promising. The healthcare industry is ripe for disruption; investors that strategically become shareholders in some of these market leaders will be best positioned for the advent of a new industry. Investors should ensure that they become familiar with genomics, with a special emphasis on CRISPR.

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Investing in Genomics and CRISPR - Everything You Need to Know - Securities.io

CRISPR, the gene-editing device that could someday make deadly diseases a thing of the past, has been the subject of endless fascination and controversy. Now take that and put it on steroids.

Those CRISPR breakthroughs youve heard about (including that scandalous one) were all made possible by the CRISPR-Cas9 system. Cas9 can remove small pieces of harmful DNA with unreal precision, but now an upgrade to the CRISPR-Cas3 systemhas created what could be a miracle or a monster. Cas3 targets DNA, chases it and chomps down an entire strand like Pac-Man eats Power Pellets. Because Cas3 can remove much longer stretches of DNA in pathogenic bacteria quickly and accurately, it could be how we finally figure out to genetically warp pathogens so they no longer make us sick.

Cas3 is a really potent bacterial immune system that targets phagesit can chew up the whole phage genome, UCSF microbiologist and professor Joseph Bondy-Denomy, who recently led a study published in Nature Methods, told SYFY WIRE. Our focus was deleting large non-mobile regions. So we simply started targeting different regions and isolating survivors. We were surprised to see the bacteria survived this and could repair the big cut.

CRISPR actually spawned in bacteria as a defense against their nemeses, viruses known as bacteriophages. Think of bacteriophages as those candy-colored ghosts who want nothing better than to take down Pac-Man. They especially act like Pinky, that pink phantom who is always trying to ambush him in chase mode. Cas3 and Cas9 are both enzymes in the bacterial immune system. When phages threaten bacteria, the bacteria fight back by messing with their genes. They steal some viral DNA and incorporate it into their own, which makes RNA that binds to its DNA mirror image in the phage. CRISPR enzymes will then obliterate the enemy.

Now imagine that a CRISPR enzyme can be manipulated to edit out genetic information in other things besides bacteriophages, including the bacteria that originally evolved this immune system. Having Pac-Man chew up the DNA that makes pathogenic bacteria cause illness could render it harmless.

Cas9 can snap up a small piece of DNA. Cas3 is part of a different bacterial immune system, and behaves more like the pixelated yellow guy with an endless appetite. Think of Pac-Man eating one Power Pellet at a time versus an entire row of them. It chomps on one strand of the DNA double helix and leaves the other strand exposed. When there is an entire strand of harmful DNA that needs to be deleted, what would take Cas9 a hundred bites to erase will take Cas3 just one. This genetic Pac-Man can chow down on as many as 100 bacterial genes. But how exactly does it chew?

Cas3 has a helicase domain which hydrolyzes ATP and pushes it along DNA while it cuts, Bondy-Denomy said.

Meaning, Cas3 is the type of enzyme thatbreaks down ATPadenosine triphosphate, the main source of energy in all life-formsthrough the process of hydrolysis. It reacts with water to break bonds that release high amounts of energy which fuel processes inside cells and makes it possible for those cells to transfer energy from one area to another so an organism can survive. Experimenting with this Pac-Man in a lab and modifying it will enable scientists to study parts of bacterial DNA that have defied understanding. Bacteria often have long strands DNA that originally came from outside sources, and this is where Cas3 comes in. Some of these DNA stretches have no use. Others could be dangerous.

The research team modified the CRISPR-Cas3 system of the pathogenic Pseudomonas aeruginosa and other species of bacteria, some of which were also pathogens. They were able to prove that it was possible for bacteria to function after DNA erasure.

In the future, it could potentially disarm over a thousand types of pathogenic bacteria that swarm in the gut. Not much is known about most of them except food poisoning culprit E.coli and a few others. There are certain genes in these types of bacteria that make you want to hold a paper bag over your face, but imagine if those could be deleted and you never had to worry about food poisoning again. Bondy-Denomy can see even further beyond that.

One of the most promising future uses for Cas3 is deleting large regions of bacterial genomes to screen for new phenotypes, new molecules that get produced, and vaccine production, he said.

Could this potentially be used on the COVID-19 virus? CRISPR systems did originally evolve to fight off viruses, so you never know.

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Pac-Man meets genetics in new DNA editing that plays like the game - SYFY WIRE

The Global CRISPR Technology Market report by Orbis Research provides a complete view of the Global CRISPR Technology Market. The report also comprises market desirability analysis, regional segments, distribution channel, and the route of administration are benchmarked based on market size, market growth, and general attractiveness. The Global CRISPR Technology Market research report offers detailed information which covers market growth, production, consumption, export, revenue, supply, import, market overview, market segmentation and market growth factors analysis. This report contains several drivers and restraints for the Global CRISPR Technology Market with the growth of the market during the forecast period. Likewise, the report includes a comprehensive analysis of segments based on type, application, and geographical regions. The Global CRISPR Technology Market also provides major manufacturers, industry chain analysis, competitive insights, and market share analysis.

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The Major Players Covered in Global CRISPR Technology Market are:The key players covered in this studyThermo Fisher ScientificMerck KGaAGenScriptIntegrated DNA Technologies (IDT)Horizon Discovery GroupAgilent TechnologiesCellectaGeneCopoeiaNew England BiolabsOrigene TechnologiesSynthego CorporationToolgen

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Market segment by Regions/Countries, this report coversUnited StatesEuropeChinaJapanSoutheast AsiaIndiaCentral & South America

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The Global CRISPR Technology Market has been created through high level primary search (observations and surveys of experienced analysts), secondary research (trade journals, industry body database, and reputable paid bases). The study also includes a complete quantitative and qualitative estimations by evaluating data gathered from major market participants and industry analysts from the global market. This report by Global Info Research delivers a complete analysis of dominant trends in the global market, certain government regulations, and macro & micro economic pointers. The report helps the user to understand the landscape of industrial growth with several characteristics of the global market.

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CRISPR Technology Market SWOT Analysis, Latest Trends, By Top Key Players- Thermo Fisher Scientific Merck KGaA GenScript Integrated DNA Technologies...

On Oct. 7, an amazing advancement for women occurred for the first time in history: Emmanuelle Charpentier and Jennifer A. Doudna, a duo of female scientists, received the Nobel Prize in Chemistry without a male contributor listed on the award. They were awarded this prize due to their research in genome editing with the tool called CRISPR. Whether you remember reading about CRISPR in AP Biology in high school or are actively involved with CRISPR as a chemistry or bioengineering student, what remains clear is that these two women paved the way for the next generation of female scientists, and for how genetic diseases will be cured.

The Point talked with a female professor and two female students via email about this advancement. Each had much to share about their experiences as women in this field. Heidi Woelbern, a biology professor at PLNU, uses CRISPR in her research. Olivia Owen and Kaitlyn Morgan are both biochemistry majors.

The Point: What is genome editing and how has Charpentier and Doudnas work changed the course of science in relation to DNA experiments?

Heidi Woelbern: CRISPR technology is revolutionary. The ability to edit genes within the genome is foundational to understanding what exactly they do. When I was in graduate school in the early 2000s, a graduate student might spend two years developing a mouse model in which a single gene was knocked out. For instance, if you were interested in diabetes, you might knock out one of the many genes thought to play a role in diabetes. You would then study the mouse to see if diabetes was ameliorated or then still persisted. With CRISPR technology, a knockout mouse model can be developed in about one month. The gene-editing capabilities are more precise, vastly cheaper and produce results in a fraction of the time.

Olivia Owen: The work of these two women with CRISPR is revolutionary. Its going to be the foundation for so many other scientific and medical breakthroughs, and its already being used in numerous ways to treat cancer and genetic diseases.

Kaitlyn Morgan: I am currently in genetics [class] right now and am learning about CRISPR. It really excited me after learning that these two women were the pioneers of developing the CRISPR model to influence new technological advances in treating disease by altering the genome.

TP: What was your initial reaction when you found out that Charpentier and Doudna had won this prize?

HW: I was thrilled to see this. I love that it was a team of women, working collaboratively, in different countries (Emmanuelle Charpentier was working in Europe, predominantly in Germany and Jennifer Doudna in the U.S.). They shared ideas, their new findings, and even their researchers. It appears (from the outside) to be very collaborative and productive. I love that they both are biochemists. There is so much to learn when one pairs the chemistry and behavior of molecules in isolation and then applies that knowledge into increasingly complex biological models

OO: My initial reaction to finding out that a duo of women won the Nobel prize was excitement. There are so few women in the biochemical engineering field that its so cool to have successful women in the field to look up to.

KM: My initial reaction when finding out that these two women won the Nobel prize in chemistry really motivated me. It reminded me that I am capable and smart enough to pursue a degree in science.

TP: What is your experience in either learning or interacting with CRISPR/genome-editing software?

HW: In collaboration with Dr. Dorrell (biology) and Dr. Jansma (chemistry) we have been working on mutating a gene thought to play a role in cervical cancer. Dr. Jansma has analyzed the E7 oncoprotein from the human papillomavirus. She has been able to determine altered chemical characteristics of E7 based upon some minor changes in the gene (and thus the protein). Using site directed mutagenesis, we are generating these same variants from Dr. Jansmas studies and introducing them into a biologically relevant system to determine if the chemistry can explain the biology. This project thus far has not utilized CRISPR technology. However, we certainly could utilize this technology in the future; especially if we wanted to move into an animal model system.

TP: Are there any female chemists or scientists who are role models for you?

OO: Growing up, I always loved Marie Curie because she was a brilliant chemist even when there were no other women in her field. With these recent advancements in CRISPR, its going to be exciting that young girls are going to have more female role models to look up to.

KM: Honestly, the two women [Jennifer Doudna and Emmanuelle Charpentier] are my role models. The scientific advancement of genome editing that these two women discovered I believe is going to impact the science world by ultimately changing the way doctors treat patients. Overall, these two women have reminded me to keep on working hard and staying focused on my path to pursuing my degree because anything is possible.

Jennifer A. Dounda said in an article from Omniscience, One of the problems in the biotech world is the lack of women in leadership roles, and Id like to see that change by walking the walk.

You can learn more about these women and this years Nobel Prize award ceremony through the official Nobel Prize YouTube channel.

Written By: Elaine Alfaro

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Women in Science: Thoughts on the 2020 Nobel Prize in Chemistry - Loma Beat

A new business intelligence report released by HTF MI with title Global COVID-19 CRISPR Technology Market Insights by Application, Product Type, Competitive Landscape & Regional Forecast 2025 is designed covering micro level of analysis by manufacturers and key business segments. TheGlobal COVID-19 CRISPR Technology Market survey analysisoffers energetic visions to conclude and study market size, market hopes, and competitive surroundings. The research is derived through primary and secondary statistics sources and it comprises both qualitative and quantitative detailing. Some of the key players profiled in the study are Thermo Fisher Scientific (United States), Merck KGaA (Germany), Genscript Biotech (United States), Integrated DNA Technologies, Inc. (United States), Horizon Discovery Group (United Kingdom), Agilent Technologies (United States), Cellecta, Inc. (United States), GeneCopoeia, Inc. (United States), New England Biolabs (United States) and Origene Technologies, Inc. (United States).

Whats keeping Thermo Fisher Scientific (United States), Merck KGaA (Germany), Genscript Biotech (United States), Integrated DNA Technologies, Inc. (United States), Horizon Discovery Group (United Kingdom), Agilent Technologies (United States), Cellecta, Inc. (United States), GeneCopoeia, Inc. (United States), New England Biolabs (United States) and Origene Technologies, Inc. (United States) Ahead in the Market? Benchmark yourself with the strategic moves and findings recently released by HTF MIGet Free Sample Report + All Related Graphs & Charts @:https://www.htfmarketreport.com/sample-report/2833424-global-covid-19-crispr-technology-market

Market Overview of Global COVID-19 CRISPR TechnologyIf you are involved in the Global COVID-19 CRISPR Technology industry or aim to be, then this study will provide you inclusive point of view. Its vital you keep your market knowledge up to date segmented by Applications [Application I, Application II], Product Types [Enzymes, Kits, gRNA, Libraries and Design Tools] and major players. If you have a different set of players/manufacturers according to geography or needs regional or country segmented reports we can provide customization according to your requirement.

This study mainly helps understand which market segments or Region or Country they should focus in coming years to channelize their efforts and investments to maximize growth and profitability. The report presents the market competitive landscape and a consistent in depth analysis of the major vendor/key players in the market along with impact of economic slowdown due to COVID.

Furthermore, the years considered for the study are as follows:Historical year 2014-2019Base year 2019Forecast period** 2020 to 2026 [** unless otherwise stated]

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

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The titled segments and sub-section of the market are illuminated below:The Study Explore the Product Types of COVID-19 CRISPR Technology Market: Enzymes, Kits, gRNA, Libraries and Design Tools

Key Applications/end-users of Global COVID-19 CRISPR Technology Market: Application I, Application II

Top Players in the Market are: Thermo Fisher Scientific (United States), Merck KGaA (Germany), Genscript Biotech (United States), Integrated DNA Technologies, Inc. (United States), Horizon Discovery Group (United Kingdom), Agilent Technologies (United States), Cellecta, Inc. (United States), GeneCopoeia, Inc. (United States), New England Biolabs (United States) and Origene Technologies, Inc. (United States).

Region Included are: ** Confirmation on availability of data would be informed prior purchase

Important Features that are under offering & key highlights of the report: Detailed overview of COVID-19 CRISPR Technology market Changing market dynamics of the industry In-depth market segmentation by Type, Application etc Historical, current and projected market size in terms of volume and value Recent industry trends and developments Competitive landscape of COVID-19 CRISPR Technology market Strategies of key players and product offerings Potential and niche segments/regions exhibiting promising growth A neutral perspective towards COVID-19 CRISPR Technology market performance Market players information to sustain and enhance their footprint

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Major Highlights of TOC:Chapter One: Global COVID-19 CRISPR Technology Market Industry Overview1.1 COVID-19 CRISPR Technology Industry1.1.1 Overview1.1.2 Products of Major Companies1.2 COVID-19 CRISPR Technology Market Segment1.2.1 Industry Chain1.2.2 Consumer Distribution1.3 Price & Cost Overview

Chapter Two: Global COVID-19 CRISPR Technology Market Demand2.1 Segment Overview2.1.1 APPLICATION 12.1.2 APPLICATION 22.1.3 Other2.2 Global COVID-19 CRISPR Technology Market Size by Demand2.3 Global COVID-19 CRISPR Technology Market Forecast by Demand

Chapter Three: Global COVID-19 CRISPR Technology Market by Type3.1 By Type3.1.1 TYPE 13.1.2 TYPE 23.2 COVID-19 CRISPR Technology Market Size by Type3.3 COVID-19 CRISPR Technology Market Forecast by Type

Chapter Four: Major Region of COVID-19 CRISPR Technology Market4.1 Global COVID-19 CRISPR Technology Sales4.2 Global COVID-19 CRISPR Technology Revenue & market share

Chapter Five: Major Companies List

Chapter Six: Conclusion

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Key questions answered What impact does COVID-19 have made on Global COVID-19 CRISPR Technology Market Growth & Sizing? Who are the Leading key players and what are their Key Business plans in the Global COVID-19 CRISPR Technology market? What are the key concerns of the five forces analysis of the Global COVID-19 CRISPR Technology market? What are different prospects and threats faced by the dealers in the Global COVID-19 CRISPR Technology market? What are the strengths and weaknesses of the key vendors?

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CRISPR Technology Market Will Generate New Growth Opportunities in the upcoming year - Aerospace Journal

CRISPR and Cas Genes Market provides an in-depth insight into Sales and Trends Forecast: 2020-2025:

Global CRISPR and Cas Genes 2020 Report consists of important factors such as the latest trends, performance drivers, key players, revenue, growth rate and volume sales, and consumer insights. The most recent report by regal intelligence on global CRISPR and Cas Genes market analyses the impact of COVID 19 on the industry. The reports comprehend the global industry outlook in the light of the current market situation, trends, prominent players in the industry, and how these factors are expected to boost the CRISPR and Cas Genes market during the forecast period. The research study by regal intelligence analyses factors that are dynamic and will affect the CRISPR and Cas Genes market in the near future.

Global CRISPR and Cas Genes market competition by TOP MANUFACTURERS, with production, price, revenue (value) and each manufacturer including

CRISPR Therapeutics, AstraZeneca, Addgene, Caribou Biosciences, Inc., Cellectis, Editas Medicine, Inc., Egenesis, F. Hoffmann-La Roche Ltd., Horizon Discovery Group Plc, Genscrip, Danaher Corporation, Intellia Therapeutics, Inc., Lonza, Merck KGaA, New En

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Global CRISPR and Cas Genes Market forecast to 2025 providing information such as company profiles, product picture, and specification, capacity, production, price, cost, revenue, and contact information. Upstream raw materials and equipment and downstream demand analysis are also carried out. The Global CRISPR and Cas Genes market trends and marketing channels are analyzed. Finally, the feasibility of new investment projects is assessed and overall research conclusions offered.

Years Considered to Estimate the CRISPR and Cas Genes Market Size:

History Year: 2015-2019

Base Year: 2019

Estimated Year: 2020

Forecast Year: 2020-2025

Region Coverage (Regional Production, Demand & Forecast by Countries, etc.):

CRISPR and Cas Genes Market regional analysis covers the following regions North America, Europe, Asia-Pacific, South America, Middle East & Africa.

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Product Type Coverage CRISPR and Cas Genes Market Size & Forecast, Major Company of Product Type, etc.):

General Type

On the basis of the end users/applications, this report focuses on the status and outlook for major applications/end users, consumption (sales), market share and growth rate for each application, including

Biomedical

Some of the key questions answered in this report:

Any Questions? Feel Free To Enquire Here. We will Put You On The Right Path: https://www.eonmarketresearch.com/enquiry/72556

Major Point of TOC:

Part I CRISPR and Cas Genes Industry Overview

Chapter One:CRISPR and Cas Genes Industry Overview

Chapter Two:CRISPR and Cas Genes Up and Down Stream Industry Analysis

Part II Asia CRISPR and Cas Genes Industry (The Report Company Including the Below Listed But Not All)

Chapter Three:Asia CRISPR and Cas Genes Market Analysis

Chapter Four:2015-2020 Asia CRISPR and Cas Genes Productions Supply Sales Demand Market Status and Forecast

Chapter Five:Asia CRISPR and Cas Genes Key Manufacturers Analysis

Chapter Six:Asia CRISPR and Cas Genes Industry Development Trend

Part III North American CRISPR and Cas Genes Industry (The Report Company Including the Below Listed But Not All)

Chapter Seven:North American CRISPR and Cas Genes Market Analysis

Chapter Eight:2015-2020 North American CRISPR and Cas Genes Productions Supply Sales Demand Market Status and Forecast

Chapter Nine:North American CRISPR and Cas Genes Key Manufacturers Analysis

Chapter Ten:North American CRISPR and Cas Genes Industry Development Trend

Part IV Europe CRISPR and Cas Genes Industry Analysis (The Report Company Including the Below Listed But Not All)

Chapter Eleven:Europe CRISPR and Cas Genes Market Analysis

Chapter Twelve:2015-2020 Europe CRISPR and Cas Genes Productions Supply Sales Demand Market Status and Forecast

Chapter Thirteen:Europe CRISPR and Cas Genes Key Manufacturers Analysis

Chapter Fourteen:Europe CRISPR and Cas Genes Industry Development Trend

Part V CRISPR and Cas Genes Marketing Channels and Investment Feasibility

Chapter Fifthteen:CRISPR and Cas Genes Marketing Channels Development Proposals Analysis

Chapter Sixteen:Development Environmental Analysis

Chapter Seventeen:CRISPR and Cas Genes New Project Investment Feasibility Analysis

Part VI Global CRISPR and Cas Genes Industry Conclusions

Chapter Eighteen:2015-2020 Global CRISPR and Cas Genes Productions Supply Sales Demand Market Status and Forecast

Chapter Nineteen:Global CRISPR and Cas Genes Industry Development Trend

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CRISPR and Cas Genes Market Insight | Strategic Industry Evolutionary Analysis Focus on Leading Key Players and Revenue Growth Analysis by Forecast To...

CRISPR Technology Marketanalysis is provided for the Global market including development trends by regions, competitive analysis of CRISPR Technologymarket. CRISPR TechnologyIndustryreport focuses on the major drivers and restraints for the key players.

According to the CRISPR Technology Market report, the global market is expected to witness a relatively higher growth rate during the forecast period. The report provides key statistics on the market status of Global and Chinese CRISPR Technology Market manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry

Major Key Contents Covered in CRISPR TechnologyMarket:

Ask for Sample PDF for in-depth information on CRISPR TechnologyMarket Report@https://inforgrowth.com/sample-request/6475179/crispr-technology-market

Then, the report explores the international major players in detail. In this part, the report presents the company profile, product specifications, capacity, production value, and 2015-2019 market shares for each company.

After the basic information, the report sheds light on the production. Production plants, their capacities, global production, and revenue are studied. Also, the CRISPR TechnologyMarket Sales growth in various regions and R&D status are also covered.

Through the statistical analysis, the report depicts the global and Chinese total market of CRISPR Technologymarket including capacity, production, production value, cost/profit, supply/demand, and Chinese import/export. The total market is further divided by company, by country, and by application/type for the competitive landscape analysis.

CRISPR TechnologyMarket Report Segmentation:

Product Type:

Application:

Key Players:

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Metabolic Renewal is a weight loss program designed specifically for women.

The program aims to boost your metabolism by modifying your diet and exercise routine based on your specific hormone type. Yet, the science behind these claims is suspect.

Despite several downsides, it has become popular among those looking to enhance their energy levels, curb cravings, and promote overall health.

This article examines the pros and cons of Metabolic Renewal to determine whether you should give it a try.

BOTTOM LINE: While Metabolic Renewal may promote short-term weight loss, many aspects of the plan arent backed by evidence. Additionally, its difficult to sustain long term and may lead to weight regain once you resume a normal diet.

Metabolic Renewal was designed by Dr. Jade Teta, an integrative physician who specializes in natural health and fitness. The program is intended to optimize womens metabolism using Dr. Tetas 4 M framework Mindset, Movement, Meals, and Metabolics.

The idea that seven distinct hormone types exist is central to the program, as well as that determining your specific hormone type may enhance your metabolism.

Metabolic Renewal offers a 12-week meal plan with recipes tailored to your hormone type.

It also includes access to a collection of 15-minute workouts, along with guidebooks on balancing hormone levels and eliminating belly fat.

Metabolic Renewal is a weight loss program that claims to optimize womens metabolism based on hormone type.

The first step of Metabolic Renewal is to determine your hormone type using their online quiz, which collects information about your age, menstrual cycle, medical history, and health goals.

A guide called The Hormone-Balancing Roadmap provides detailed information on how to follow the plan depending on your hormone type.

Meal plans are based on what Dr. Teta calls the 3-2-1 Diet, which provides three meals per day, two of which contain only protein and vegetables and one of which offers a small portion of starch.

The program includes a detailed meal plan with recipes, but youre permitted to create your own meals based on the 3-2-1 Diets principles, adding snacks as needed.

Metabolic Renewal also includes a 12-week workout plan thats divided into 4 phases. Throughout the program, youre required to exercise for 15 minutes 3 times per week using the plans Intelligent Workouts, which claim to combine resistance and cardio training.

On your days off, youre encouraged to walk for a set amount of time thats determined by your hormone type. Doing so is said to help maintain any changes to your metabolism.

Furthermore, Metabolic Renewal offers a private online community for its customers.

Metabolic Renewal provides a custom meal plan and exercise regimen based on your supposed hormone type.

Metabolic Renewal doesnt eliminate any foods outright but encourages a low carb, high protein diet. Fruits, grains, fats, and oils can all be enjoyed in moderation.

While no foods are banned, you should limit processed foods and items high in carbs and sugar.

Metabolic Renewal doesnt eliminate any foods outright but encourages you to restrict your intake of processed and high carb foods. Instead, youre meant to emphasize vegetables and high quality proteins.

Although Metabolic Renewal hasnt been studied specifically, it may offer several health benefits.

Several aspects of the program may aid short-term weight loss.

For starters, Metabolic Renewal encourages a diet rich in unprocessed whole foods, including meat, fish, poultry, and vegetables.

These foods are not only often lower in calories than processed foods but also rich in important nutrients like vitamins, minerals, and antioxidants.

Additionally, some research links a lower intake of processed foods to a decreased risk of obesity (1).

Metabolic Renewal is also low in carbs, with most meals consisting of vegetables and a source of protein. Some studies show that low carb diets promote short-term weight loss and fat loss (2, 3).

Whats more, increasing your protein intake may keep you feeling full for longer, which likewise supports weight loss (4).

Metabolic Renewal doesnt require you to count calories, measure your food, or track macronutrients. It also offers several ways to customize your meal plan, making it a good fit for those who prefer more flexibility.

In fact, you can easily swap in other recipes from the meal plan or create your own meals using the basic principles of the diet.

Plus, it offers options for paleo, keto, vegan, and vegetarian diets.

Although no studies have examined Metabolic Renewal, its very flexible and may promote weight loss at least in the short term.

Although Metabolic Renewal may offer some benefits, theres no evidence to support many aspects of the plan.

The idea that there are seven specific female hormone types isnt backed by science.

In fact, most of the benefits of this program are likely due to its diet and lifestyle changes not optimizing female metabolism.

The programs quick, 15-minute workouts that take place 3 times per week are said to maximize efficiency without stressing your metabolism.

While this idea may appeal to some people, it may be unsuitable for those who are more physically active or prefer certain workouts, such as cardio or weightlifting.

Metabolic Renewal retails for $67, which includes either online access or the printed program and set of DVDs.

This price tag is higher than many other programs, so its an important consideration for those on a tight budget.

Keep in mind that Metabolic Renewal is a short-term program designed to be followed for 12 weeks.

Although many short-term diets lead to rapid weight loss, youre likely to regain weight after you resume a normal diet. Thats partly because brief dietary changes dont often translate to long-term lifestyle habits (5).

Several core elements of Metabolic Renewal are scientifically suspect, including the concept of specific hormone types. Furthermore, the diet is expensive and may lead to weight regain.

Metabolic Renewal provides a 12-week meal plan, although you can still create your own meals using the basic principles of the diet.

Here is a sample 3-day meal plan for Metabolic Renewal.

The sample menu above details some of the meals that you can enjoy on Metabolic Renewal, including breakfast smoothies and dishes packed with veggies and protein.

Metabolic Renewal is a program intended to optimize womens metabolism by making changes to their diet and exercise routine.

Although the diet is very flexible and may lead to short-term weight loss, many aspects are rooted in unfounded health claims. Furthermore, its short-term nature makes weight regain likely once you resume a normal diet.

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Metabolic Renewal Review: Pros, Cons, and Effectiveness - Healthline

By Stephanie Bowens| StarNews Correspondent

Polycystic Ovary Syndrome is one of the most common, yet treatable, causes of infertility in women. PCOS affects 1 in 10 women of childbearing age, according to the Office On Womens Health, and women who have the condition experience hormonal imbalance and metabolism problems that may affect their appearance and overall health.

Dr. Nicholas Bodenheimer, DO, an obstetrician-gynecologist withNovant Health OB/GYN Bolivia, said hes treated many women who have PCOS. He said the condition is typically characterized by hyperandrogenism, or elevated levels of androgens, such as testosterone, irregular or no menstrual periods and polycystic ovaries revealed on an ultrasound. Bodenheimer said despite the name, you dont have to have polycystic ovaries or small cysts on yourovaries to be diagnosed with PCOS. He recommends women discuss their concerns with a gynecologist.

1. Imbalances of hormones, including insulin and testosterone, play key role in PCOS symptoms.

The exact cause of PCOS is unknown. However, PCOS is associated with insulin resistance, obesity and high levels of androgens.

Androgens, often called male hormones, are hormones, such as testosterone, that are important for normal male sexual development, but women also make small amounts of androgens. Androgens control development of male traits, and women with PCOS have more androgens than normal.

Normally, in healthy women testosterone is largely bound by a protein called sex hormone binding globulin, leaving just a very small amount of freely circulating bioactive free testosterone. However, insulin resistance can disrupt this, and Bodenheimer said many women with PCOS have insulin resistance. Insulin resistance can cause a low level of sex hormone bind globulins, Bodenheimer said. So, if you have a low level of that you have an increase of testosterone in the body which can lead to hyperandrogenism.

Insulin resistance refers to when the bodys cells do not respond normally to insulin, a vital hormone that regulates blood sugar (glucose) in the body.

2. Irregular menstrual cycles are common symptoms of PCOS.

Higher than normal androgen levels in women can prevent the ovaries from releasing an egg (ovulation) during each menstrual cycle.

Bodenheimer said PCOS symptoms that often bring patients in to see him include excessive facial hair growth, absence of a menstrual period, irregular menstrual bleeding, or unsuccessfully trying to get pregnant for over a year. We see a lot of different types of clinical manifestations from PCOS, but probably the most common we see are menstrual disorders, Bodenheimer said. That can range from irregular menstrual periods to heavy menstrual periods to someone who is not having any menstrual periods. If we see women who are anovulatory, meaning they arent having regular menstrual cycles, that can lead to infertility.

Bodenheimer said usually in a 28-day cycle around cycle day 14 a woman ovulates so an egg is released. If someone is not ovulating, the egg is not released, he said. Thats how that leads to infertility.

Bodenheimer said there are various treatment options for infertility caused by PCOS.

3. PCOS often causes abnormal hair growth.

Bodenheimer said, for women with PCOS, increased levels of testosterone in the body can lead to excessive hair growth on their arms and face as well as acne. According to OWH, the excessive hair growth is called hirsutism and affects up to 70 percent of women with PCOS, causing them to have too much hair on the face, chin, or parts of the body where men usually have hair, and acne can appear on the face, chest, and upper back.

According to the OWH, other symptoms of PCOS include thinning hair, hair loss on the scalp or male-pattern baldness, weight gain or difficulty losing weight and darkening of skin, particularly along neck creases, in the groin, and underneath breasts.

4. Research has linked PCOS to other health problems, such as hypertension and sleep apnea.

According to OWH, studies have found links between PCOS and diabetes, high blood pressure and unhealthy cholesterol, sleep apnea, depression and anxiety and endometrial cancer. OWH indicates more than half of women with PCOS will have diabetes or prediabetes before age 40, and women with PCOS are at higher risk for high blood pressure compared with women of the same age without PCOS.

Problems with ovulation, obesity, insulin resistance, and diabetes, which are all common issues in women with PCOS, increase the risk of developing endometrial cancer, according to OWH.

Additionally, Bodenheimer said, For women with PCOS who do get pregnant we see increased risk of gestational diabetes as well as hypertensive disorders such as preeclampsia.

5. PCOS treatment focuses on managing symptoms.

Bodenheimer said treatment for PCOS focuses on treating and managing patients symptoms. When developing a treatment plan, the physician typically considers the patients symptoms, their plans for having children, and the patients risk of long-term health problems such as diabetes and heart disease.

If patients desire future fertility and are planning to become pregnant, then we see if they are ovulating or not, and we can usually do that by checking lab work, he said. If we are treating someone with PCOS who is not ovulating, we can treat them with medicine to help them ovulate, he said.

But Bodenheimer said one of the risks of using fertility drugs include pregnancy with multiples, such as twins.

If they are not desiring fertility in the immediate future, then we try things like birth control pills to help regulate those menstrual periods, Bodenheimer said.

He said he also sometimes discusses lifestyle modifications, including diet and weight loss. Some studies show losing five to 10 percent of their current body weight may induce spontaneous ovulation again, he said.

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5 things to know about Polycystic Ovary Syndrome - StarNewsOnline.com

We are always living in a state of survival. This might be any type of chronic illness, virus or maybe a lifestyle related disease. Whatever it is, fasting can help with many health issues and in addition can help with strengthening your immune system. I think if you try it you will be surprised by the benefits that you see, even if you are practicing time-restricted feeding (TRF) eating within the same time window each day, for example have a 12 hour period in which you eat, and the other 12 hours of the day in which you eat nothing. This will lead to more conscious eating habits as well.

Studies have shows how especially after a 72 hour water only fast the immune system strengthens and even the metabolism slightly increases. I dont suggest that length of fast for everyone, however you still can practice fasting for improving your health.

I love the fasting lifestyle for so many reasons, including:

Improving immunity

Efficiently cleaning up dead cells

Improving digestion

Reducing the risk of many types of cancer

Slowing down the aging process

Its an easy way to lose fat

It helps regulate your hormones

Its convenient

You can save time from cooking and shopping

Its easy to do, no matter which diet you choose to follow

And its all under your control

Heres a few suggestions if you would like to try it:

If you want to try longer than 18 to 20 hours then make sure that you listen to your body. If you experience any dizziness, diarrhea, headaches or stomach pain then its time to stop, break your fast, and try again next time.

If you are taking medication then you must let your physician know before you practice fasting.

Identify your goals why would you like to practice fasting? For example, are you doing it to heal your diabetes, or just to lose a few pounds, or maybe for some more serious health problems? You need to know what type of fasting schedule is the best for you.

Women can be much more sensitive to fasting, although it is great for balancing hormones. So its very important, especially for women, to break the fast with a low carbohydrate, high protein, and moderate fat meal. This can help not to raise insulin (the fat storage and blood sugar regulating hormone) so quickly.

During the fast you generally dont need any supplements. However, it depends on the length of your fast. If you are fasting for longer than 20 hours you may need to supplement with salt, potassium chloride, and magnesium. When you are doing fasting the body uses glycogen (sugar) for energy which, depending on your bodys state, can take 20 to 36 hours. Each gram of glycogen in the cell holds about 3 grams of water, so when you deplete your glycogen storage you also lose electrolytes too. Thats why you may feel low energy, brain fog and a little dizzy too.

Probably you now understand that I am really a fan of water only fasting. This can be done daily, for example a daily 14 hour fast and then 10 hours in which to eat your meals. Or it can be done as prolonged fasting. You just need to be sure that you know why youre doing it and what you want to achieve so you can make your own fasting schedule.

Fasting is free so just try it out, and if you dont like it then change your schedule. Just pay attention your body, it will tell you whats best.

Resources:

Intermittent fasting: Surprising update

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4808902/

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6478699/

Fasting for 72 hours can reset your entire immune system (The Source)

Fasting triggers stem cell regeneration of damaged, old immune system

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4102383/

Ayda Ersoy, nutritionist (Dip.C.N., Dip.S.N.), master trainer (CPT ACE, NCSF, CanfitPro), registered yoga teacher, founder, Health Angel Nutrition, Fitness and Wellness, founder, SMS (Stability, Mobility Strength) Intuitive Training System.

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Fasting is one of the easiest ways to strengthen immunity - The Garden Island

Hormones are natural substances made by our glands in our body and the network of glands that make hormones is termed as endocrine systems. These hormones are carried through bloodstream and act as a messenger between one part to another part of our body. Hormone therapy is one of the major modalities of medical treatment for cancers which involves manipulation of the endocrine systems through exogenous administration of steroid hormones or drugs inhibiting or interrupting activities of specific hormones.

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Surgical removal of certain endocrine organs for instance oophorectomy can also be employed as a part of hormone therapy. In hormone therapy physician generally start with hormone receptor test that let caregivers to measure amount of cancer proteins or hormone receptors within a cancer tissue. By estimating the amount of hormones such as estrogen or progesterone the test either can be positive or negative. A positive test indicates growth of cancer cells with the help of hormones.

In such cases physician divert the hormone therapy by blocking the interaction of hormones with the hormone receptor. Alternatively, in case of negative hormone receptor test which signifies null effect of hormones in growth and development of cancer cells other effective treatments can be rendered to cure cancer.

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A hormone therapy can be rendered either before or after a primary treatment. In case it is rendered before the primary treatment it is medically termed as neoadjuvant treatment which kills. Neoadjuvant treatments help to kill cancer cells and contribute to the effectiveness of the primary therapy. If hormone therapy is given after the primary cancer treatment, it is called adjuvant treatment. Adjuvant therapy is given to improve the chance of a cure.

Now a day hormone therapy is widely used in treating breast and prostate cancer. In breast cancer the female hormone estrogen are primarily responsible for stimulating the growth and development of breast cancer cell in majority of cases. Recently in 2014, aromatase inhibitors such as Arimidex and Femara have been approved for treating breast cancers through hormone therapy. Apart from these FDA approved Zoladex Lupron can also be used in curing breast cancers through hormone therapy. In case of prostate cancer a variety of medications can be used as hormone therapy.

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Male hormones, such as testosterone, stimulate prostate cancer to grow. Hormone therapy is given to help stop hormone production and to block the activity of the male hormones. Some of the antiandrogens used as inhibitors of prostate cancer cell growth encompass flutamide, enzalutamide, bicalutamide, and nilutamide among others. some of the other cancers to which hormone therapy is gaining acceptance now a day include womb cancer, kidney cancer, ovarian cancer among others.

Major drivers to global cancer hormone therapy include rising incidences of cancer across globe. Statistically according to WHO cancer accounts for 8.2 million deaths in 2012 and it is estimated that annual cancer cases is expected to rise from 14 million in 2012 to 22 million by 2022. Rising awareness among physician and patients towards alternative cancer therapy processes such as target therapy, immunotherapy or hormone therapy is likely to uplift the market in forthcoming years.

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Side-effects associated with hormone therapy are major restraints to growth and acceptance of therapy. Some of the common side-effects associated with hormone therapy for cancer include nausea, vaginal spotting, irregular menstrual periods, skin rashes, loss of appetite, vaginal dryness, impotence and male breast enlargement among others.

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This post was contributed by a community member. The views expressed here are the author's own.

On Sunday, November 1st, at 2 am, clocks will be turned one hour back for Daylight Savings Time, so when the clock reads 10 am on Sunday morning, your brain and body will insist that it is really 11 am.

"Gaining' an hour in the fall is much easier for our bodies than 'losing' an hour in the spring," says Dr. Praveen Rudraraju, medical director of the Center for Sleep Medicine at Northern Westchester Hospital. "For many, sleep has become more elusive in these uncertain times.

"Sleep specialists are seeing an unprecedented numbers of patients suffering from insomnia and other sleep disturbances due to the pandemic, which presents a unique set of multiple stressors," he adds. "There's no quick fix for the anxiety that's keeping people awake as they worry about their jobs, income, the health and safety of loved ones, social isolation and an uncertain future. There is actually a hormonal basis for this kind of insomnia. Anxiety triggers the production of stimulating chemicals in the body that keep people awake.

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To get the most out of sleep, Dr. Rudraraju says that both the quality and quantity are important. Most adults need seven to eight hours of sleep in order to feel refreshed and alert. Sleeping less than five hours a night can raise the risk of cardiovascular disease by 40 percent, while chronic insomnia quadruples the risk of stroke. Numerous studies have linked poor-quality sleep to weight gain. Ghrelin, a hormone linked to hunger, increases when people sleep poorly.

Dr. Rudraraju advises people to practice good sleep hygiene:

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If you often wake up groggy, have trouble falling asleep or staying asleep, feel sleepy all day long or snore, you may need a sleep study to assess the possibility of a sleep disorder. An at-home sleep study can find out if you do have a sleep issue, but an in-hospital sleep study can diagnose whether it is caused by an underlying medical condition.

One of the most common disorders is sleep apnea, typically characterized by loud snoring and feelings of constant tiredness. The condition interrupts a person's breathing hundreds of

times a night, depriving the brain and heart of oxygen. Untreated sleep apnea increases the risk of high blood pressure, heart attack, stroke, obesity, diabetes and mental illness. It also puts people at increased risk of heart failure, arrhythmias or irregular heartbeats, and increases the risk of driving accidents.

For more information or to make an appointment for a sleep center study, visit nwh.northwell.edu/sleep-center or call 914-666-1114.

About Northern Westchester Hospital

Northern Westchester Hospital (NWH), a member of Northwell Health, provides quality, patient-centered care that is close to home through a unique combination of medical expertise, leading-edge technology, and a commitment to humanity. Over 650 highly-skilled physicians, state-of-the-art technology and professional staff of caregivers are all in place to ensure that you and your family receive treatment in a caring, respectful and nurturing environment. NWH has established extensive internal quality measurements that surpass the standards defined by the Centers for Medicare & Medicaid Services (CMS) and the Hospital Quality Alliance (HQA) National Hospital Quality Measures. Our high-quality standards help to ensure that the treatment you receive at NWH is among the best in the nation. For more information, please visit http://www.nwhc.net and connect with us on Facebook.

About Northwell Health

Northwell Health is New York State's largest health care provider and private employer, with 23 hospitals, nearly 800 outpatient facilities and more than 14,200 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 72,000 employees 17,000-plus nurses and 4,500 employed doctors, including members of Northwell Health Physician Partners are working to change health care for the better. We're making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We're training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, Twitter, Instagram and LinkedIn.

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Black licorice may look and taste like an innocent treat, but this candy has a dark side. On Sept. 23, 2020, it was reported that black licorice was the culprit in the death of a 54-year-old man in Massachusetts.

How could this be? Overdosing on licorice sounds more like a twisted tale than a plausible fact.

I have a longstanding interest in how chemicals in our food and the environment affect our body and mind. When something seemingly harmless like licorice is implicated in a death, we are reminded of the famous proclamation by Swiss physician Paracelsus, the Father of Toxicology: "All things are poison, and nothing is without poison; the dosage alone makes it so a thing is not a poison."

I am a professor in the department of pharmacology and toxicology and author of the book Pleased to Meet Me: Genes, Germs, and the Curious Forces That Make Us Who We Are.

The unfortunate man who recently succumbed to excessive black licorice consumption is not alone. There are a smattering of similar case reports in medical journals, in which patients experience hypertension crisis, muscle breakdown or even death.

Adverse reactions are most frequently seen in people over the age of 40 who are eating far more black licorice than the average person. In addition, they are usually consuming the product for prolonged periods of time.

In the most recent case, the Massachusetts man had been eating a bag and a half of black licorice every day for three weeks.

Licorice is a flowering plant native to parts of Europe and Asia. Its scientific name, Glycyrrhiza, is derived from the Greek words "glykos" (sweet) and "rhiza" (root). The aromatic and sweet extract from its root has long been used as an herbal remedy for a wide variety of health maladies, from heartburn and stomach issues to sore throats and cough.

However, there is insufficient evidence to support that licorice is effective in treating any medical condition.

Glycyrrhizin (also called glycyrrhizic acid) is the chemical in black licorice that gives the candy its signature flavor, but it also leads to its toxic effects.

Glycyrrhizin mimics the hormone aldosterone, which is made by the adrenal glands when the body needs to retain sodium and excrete potassium. Sodium and potassium work together as a kind of cellular battery that drives communication between nerves and the contraction of muscles. Too much glycyrrhizin upsets the balance of these electrolytes, which can raise blood pressure and disturb the heart's rhythm.

Other symptoms of excessive licorice intake include swelling, muscle pain, numbness and headache. Examination of the man who died from consuming too much licorice revealed that he had dangerously low levels of potassium, consistent with glycyrrhizin toxicity.

It should be noted that a number of licorice-based foods do not contain real licorice, but use a flavoring substitute called anise oil, which does not pose the dangers discussed here. In addition, despite its name, red licorice rarely contains licorice extract. Instead, red licorice is infused with chemicals that impart its cherry or strawberry flavor.

Products that contain real licorice are usually labeled as such, and list licorice extract or glycyrrhizic acid among the ingredients. Be advised that some products, such as black jelly beans or Good & Plenty, are mixtures of different candies that contain both anise oil and licorice extract.

Licorice is produced from the Glycyrrhiza glabra plant. (Franz Eugen Khler/Khler's Medizinal-Pflanzen/Wikimedia)

Glycyrrhizin has the distinct licorice flavor and is 50 times sweeter than sugar and has been used in other types of candy, soft drinks, tea, Belgian beers, throat lozenges and tobacco.

This can make it challenging to keep track of how much glycyrrhizin has been consumed, and a combination of these products could trigger adverse effects.

Some people take dietary or health supplements that already contain licorice, which increases the risk of toxic effects from eating black licorice candy. Certain medications such as hydrochlorothiazide are diuretics that cause increased urination, which can lower potassium levels in the body.

Glycyrrhizin also lowers potassium levels, further disrupting the balance of electrolytes, which can produce muscle cramps and irregular heart rhythms.

People with certain preexisting conditions are more susceptible to black licorice overdose.

For example, patients who already have low potassium levels (hypokalemia), high blood pressure or heart arrhythmia are likely to have greater sensitivity to the effects of excessive licorice. Those with liver or kidney deficiencies will also retain glycyrrhizin in their bloodstream for longer times, increasing their risk of experiencing its adverse effects.

If you're a fan of black licorice, there is no need to ban it from your pantry. Eaten in small quantities from time to time, licorice poses no significant threat to otherwise healthy adults and children. But it is advisable to monitor your intake.

With Halloween approaching, be sure to remind your kids that candy is a 'sometimes food', especially the black licorice. The FDA has issued warnings about the rare but serious effects of too much black licorice, advising that people avoid eating more than two ounces of black licorice a day for two weeks or longer.

The agency states that if you have been eating a lot of black licorice and experience an irregular heart rhythm or muscle weakness, stop eating it immediately and contact your health care provider.

Some scientists have further cautioned against the routine use of licorice in the form of a dietary supplement or tea for its alleged health benefits.

A review article from 2012 warned that "the daily consumption of licorice is never justified because its benefits are minor compared to the adverse outcomes of chronic consumption."

Bill Sullivan, Professor of Pharmacology & Toxicology; author of Pleased to Meet Me: Genes, Germs, and the Curious Forces That Make Us Who We Are, Indiana University.

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

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Can You Really Overdose on Black Licorice? Here's The Science on The Hidden Dangers - ScienceAlert

CARLSBAD, Calif., Oct. 28, 2020 /PRNewswire/ --Qualigen Therapeutics, Inc. (Nasdaq: QLGN) today announced receipt of written feedback to its Type B Pre-IND (Pre-Investigational New Drug application) meeting request from the U.S. Food and Drug Administration (FDA) that is in general agreement with the Company's planned clinical development of AS1411, a nucleolin-targeting DNA aptamer drug candidate, for the treatment of COVID-19.

The FDA's response solidifies Qualigen's intention to reprioritize its clinical development program and to first advance AS1411 into clinical trials (for treatment of COVID-19) in the first half of calendar 2021, to be followed next by seeking to advance ALAN into clinical trials against acute myeloid leukemia. ALAN is AS1411 attached to a gold nanoparticle.

"We are delighted with the FDA's thoughtful and thorough response to our Pre-IND meeting request which provides a pathway for us to move forward with filing the IND application and initiation of a clinical trial in the first half of calendar 2021," stated Michael Poirier, President, Chief Executive Officer and Chairman of Qualigen. "We are in agreement with the FDA's additional recommendations and believe their responses provided the clarity needed to move forward to get AS1411 into clinical trials for the treatment of hospitalized patients with COVID-19.In addition, we look forward to further investigating the potential use of AS1411 as a broader spectrum antiviral therapeutic."

In its Pre-IND meeting request, the Company requested regulatory guidance on its planned randomized, multicenter study to evaluate the safety and efficacy of AS1411 in hospitalized patients with COVID-19. The FDA's recommendation is to commence with a Phase 2a proof-of-concept study to evaluate safety and initial efficacy in determining the appropriate dose with outcomes assessed at Day 28. The Company and the FDA agree that a Phase 1 clinical trial is not needed here, because in a previous clinical trial against cancer AS1411 has already been shown to meet Phase 1 safety requirements.

"There continues to be a need for novel treatments for COVID-19," stated Paula Bates, PhD, Professor of Medicine at the University of Louisville, who co-invented the technology. "We know that nucleolin plays an important role in the infectivity of viruses and were able to demonstrate in our AS1411 preclinical studies, the aptamer was effective against the SARS-CoV-2 virus at doses indicated to be safe in humans by previous research. As a result, we believe AS1411 has the potential to be a promising therapeutic for COVID-19, as well as for other viral infections."

Extensive preclinical research conducted at the University of Louisville has demonstrated that AS1411 has potent anti-viral activity against SARS-CoV-2 infection, the novel coronavirus responsible for COVID-19. Qualigen has held an exclusive license to AS1411 since 2018, and in June 2020 Qualigen entered into an exclusive license agreement for the University of Louisville's pending U.S. patent for the use of AS1411 for inhibiting or treating COVID-19.

About Qualigen Therapeutics, Inc.Qualigen Therapeutics, Inc. is a biotechnology company focused on developing novel therapeutics for the treatment of cancer and infectious diseases, as well as maintaining and expanding its core FDA-approved FastPack System, which has been used successfully in diagnostics for almost 20 years. The Company's cancer therapeutics pipeline includes ALAN (AS1411-GNP), RAS-F and STARS. ALAN (AS1411-GNP) is a DNA coated gold nanoparticle cancer drug candidate that has the potential to target various types of cancer with minimal side effects. The foundational aptamer of ALAN, AS1411, is also being studied for use in treating or even preventing viral-based infectious diseases, including COVID-19. RAS-F is a family of RAS oncogene protein-protein interaction inhibitor small molecules for preventing mutated RAS genes' proteins from binding to their effector proteins; preventing this binding could stop tumor growth, especially in pancreatic, colorectal and lung cancers. STARS is a DNA/RNA-based treatment device candidate for removal from circulating blood of precisely targeted tumor-produced and viral compounds. Because Qualigen's therapeutic candidates are still in the development stage, Qualigen's only products that are currently commercially available are FastPack System diagnostic instruments and test kits, used in physician offices, clinics and small hospitals around the world. The FastPack System menu includes rapid point-of-care diagnostic tests for cancer, men's health, hormone function, vitamin D status and antibodies against SARS-CoV-2. Qualigen's facility in Carlsbad, California is FDA and ISO Certified and its FastPack product line is sold worldwide by its commercial partner Sekisui Diagnostics, LLC. For more information on Qualigen Therapeutics, Inc., please visit https://www.qualigeninc.com/.

Forward-Looking StatementsThis news release contains forward-looking statements by the Company that involve risks and uncertainties and reflect the Company's judgment as of the date of this release. These statements include those related to the timing of the filing and (if any) acceptance of an IND application for AS1411 as a therapy against COVID-19 and the timing of the related clinical trials (if any), and the possible effectiveness of AS1411 against COVID-19 or other viral infections. Actual events or results may differ from the Company's expectations. For example, there can be no assurance that clinical trials will be approved to begin by or will proceed as contemplated by any projected timeline; that the Company will successfully develop any drugs or therapeutic devices; that preclinical or clinical development of the Company's drugs or therapeutic devices will be successful; that future clinical trial data will be favorable or that such trials will confirm any improvements over other products or lack negative impacts; that any drugs or therapeutic devices will receive required regulatory approvals or that they will be commercially successful; that patents will issue on the Company's owned and in-licensed patent applications; that such patents, if any, and the Company's current owned and in-licensed patents would prevent competition; that the Company will be able to procure or earn sufficient working capital to complete the development, testing and launch of the Company's prospective therapeutic products; that the Company will be able to maintain or expand market demand and/or market share for the Company's diagnostic products generally, particularly in view of COVID-19-related deferral of patients' physician-office visits and FastPack reimbursement pricing challenges; that adoption and placement of FastPack PRO System instruments (which are the only FastPackinstruments on which the Company's SARS-CoV-2 IgGtest kits can be run) will be widespread; that the Company will be able to manufacture the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits successfully; that any commercialization of the FastPack PRO System instruments and SARS-CoV-2 IgGtest kits will be profitable; or that the FDA will ultimately approve an Emergency Use Authorization for the Company's SARS-CoV-2 IgG test. The Company's stock price could be harmed if any of the events or trends contemplated by the forward-looking statements fails to occur or is delayed or if any actual future event otherwise differs from expectations. Additional information concerning these and other risk factors affecting the Company's business (including events beyond the Company's control, such as epidemics and resulting changes) can be found in the Company's prior filings with the Securities and Exchange Commission, available atwww.sec.gov. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this news release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

SOURCE Qualigen, Inc.

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Qualigen Therapeutics Receives Positive Pre-IND Response from FDA for the Clinical Development of AS1411 as a Treatment for COVID-19 - PRNewswire

Its not often that breast cancer is overshadowed by another health crisis, but such is life in pandemic times. But what should never take a backseat where breast cancer is concerned is the importance of screening and prevention.

Screening for breast cancer is really important because, while it is quite common and can be deadly, when caught early it is much more treatable and less deadly, said Christy Bridges, a physicians assistant with the Orange County Health Department in Hillsborough. The idea for doing a screening is your looking at someone who doesnt have any symptoms and looking for a concern or a problem. Because you would only screen if you could do something about it. Breast cancer is a cancer we can do something about by screening.

The most-commonly used tool for breast cancer screening is the mammogram. It is recommend women of average risk for breast cancer start discussing screening with their care provider at age 40. Between ages 40 and 50 theres not a strong base of evidence showing any real benefit in undergoing a mammogram. After reaching age 50 the evidence is more clear that breast cancer screening with mammogram is effective. The recommendation of screening every two years with a mammogram starts at age 50.

Health care providers will order a mammogram for a patient. Many health care facilities, like UNC Healthcare, do mammogram screenings at multiple locations. The patient goes in for the mammogram and is given the results through a letter, or if there is a determination that additional follow up is needed, then that can be done either at the time of the screening or at a follow up appointment.

Its often believed that family history is a big factor in the likelihood of being diagnosed with breast cancer. But this is not necessarily so, said Bridges.

Most women who are diagnosed with breast cancer do not have a family history. For women who have a family history of breast cancer, we want to discuss that and its good for us to know that so we can determine if they would benefit from a specific, like targeted testing to determine if they have a genetic marker that makes them more of a risk. But the vast number of women who are diagnosed with breast cancer dont have a genetic history. While it is a risk factor, its not the only one.

As far as types of cancer, breast cancer is the most common of new cancer cases in North Carolina, according to 2017 statistics from the Centers for Disease Control, making it more common than lung and colon cancers. It is less deadly than lung cancer, but it still is the second-leading cause of cancer deaths in the state.

While there may not be much difference in the number of breast cancer cases, minorities often face a higher mortality rate.

What we unfortunately see sometimes is that breast cancer is diagnosed at a later stage in African American or Latino women, Bridges said. If youre diagnosed at a later stage, or a more advanced stage of breast cancer, that decreases your likelihood of surviving it. Women-of-color should take any breast cancer concerns seriously and take any opportunity for screening.

Surgery and surgery with radiation is the most common treatment for breast cancer, if it is caught early enough and before it has spread beyond the breast. If the cancer is a more spread, then chemotherapy can be used. Other treatments include hormonal therapy and targeted therapy. Although there are many layers of treatment for breast cancer, the message health professionals want to make clear is the earlier cancer is diagnosed, the easier the treatment tends to be.

For some risk factors, like age and family history, little can be done to decrease the the chance of a cancer diagnosis. But there are steps that can be taken to cut down on other risk factors.

Things you do have control over that are risk factors for breast cancer that someone can alter or change include not being physically active, Bridges said. Increasing your physical activity is protective from breast cancer. Being overweight is a risk factor. Keeping your weight to a healthy level is protective. Alcohol can be a risk factor. Hormonal therapy, like post-menopausal hormone replacement therapy that can be useful in certain instances, can also have some risks. Thats worth a discussion with your care provider.

One of the biggest risk factors is for women who are not connected with a health care provider, or are underinsured. One program that the Orange County Health Department participates in is the Breast and Cervical Cancer Control Program, or the BCCCP, which is a federal and state program with funding to help screen women for breast and cervical cancer who are underinsured or uninsured. The Orange County Health Department participates in the program to help women who may not have a health care provider or be connected to care.

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Screening the key to breast cancer prevention, treatment - newsoforange.com

The American Cancer Society recommends that all women over the age of 40 years should undergo regular breast screening and practice breast self-examination.

Over the years, breast cancer has become the nemesis of Indian women, overtaking cervical cancer to establish its dominance as the most common cancer in Indian women. The sheer number of cases is so huge that even with both sexes combined, breast cancer ranks as the number one among all cancers in terms of numbers. So, what causes it? Factors are numerous such as: 1) Prolonged exposure to oestrogen during reproductive phase of life which can be due to early menarche, late menopause, delayed child birth or lack of children etc; 2) Obesity; 3) Increased breast density; 4) Genetic mutations; 5) Familial mutations; and 6) Exposure to ionizing radiation.

Breast lumps, like most cancers, are silent killers. They sneak up stealthily on unsuspecting patients with painless, hard masses which are noticed accidentally only after they become big enough to be palpable. Diagnosis is further delayed by societal taboos and denial mentality of patients. Studies have shown that a number of factors such as educational status, religion, marital status and socio-economic status contribute to a delay in diagnosis of breast cancer in Indian women. Lack of education and low socio-economic status, contribute to avoidance of breast cancer screening and even if a mass is identified, these women are reluctant to seek medical help as they prioritize needs of family over theirs and fear the economic burden of medical treatment and loss of income as they would have to discontinue their jobs. Divorced and widowed women, especially in the older age group, often find themselves living alone without a support system. This results in a delay in seeking remedial therapy for any breast mass, even if they identify it at an early stage.

Another variable causing delay in diagnosis of breast cancer is the rampant use of alternative medicine. Many patients report to a doctor after having tried alternative therapies for resolution of mass. If the mass is malignant, the therapies dont work, causing tumor progression and often present as a metastatic disease. Indian women most commonly present as Stage IIb and above, unlike their western counterparts who undergo rigorous screening which helps in detecting small non-palpable tumours. In advanced disease, there maybe skin ulcers, nipple erosion, nipple inversion, bloody nipple discharge, bone pain, breathing difficulty, etc. It is high time that we educate our women, starting with our family members, about the value for routine screening of breast cancer and to ensure that they seek medical help at the earliest, if a mass is detected. Catching it early gives us the best shot at curing the disease completely.

The American Cancer Society recommends that all women over the age of 40 years should undergo regular breast screening and practice breast self-examination which is a series of simple steps that women can perform on themselves on a monthly basis to identify suspicious lumps. If a lump is identified, it is not a cause for panic. It is advisable to contact a family doctor or an oncologist, as most breast lumps, especially in younger age groups, are benign or harmless. The oncologist will examine the patient and advise a mammogram and needle evaluation of the breast lump, either as a Fine Needle Aspiration Cytology (FNAC) or Trucut biopsy, which yields more tissue. If malignancy is confirmed in the specimen, then further staging workup is done in the form of Ultrasound Abdomen, Chest X-ray, PET CT scan, etc. based on physicians judgment.

Treatment for breast cancer consists of the following modalities: Surgery, Radiation, Chemotherapy and Hormonal therapy, used in combination based on stage, tumour type, age and general condition of patient. Each of these treatment modalities can be further tailored for each patient. For patients who wish to preserve the breast, it is possible to so in early breast cancer by breast conservation techniques; similarly, chemotherapy drugs and regimens vary based on tumour types and its hormonal receptor markers. Radiation therapy has evolved over the years to become extremely precise, allowing patients to be treated with limited adverse events.

Once treatment is complete, patients have to be close follow up for a number of years. Some patients who have hormone receptor markers positive in their tumour tissue are advised to take hormonal therapy for 5-10 years.

In conclusion, breast cancer is not the death sentence it once was. Advanced treatment options have ensured that patients presenting at any stage can enjoy a long and healthy life. In the words of Cayla Mills, You never know how strong you are until being strong is the only choice you have. Help is at hand.

(Dr M Banu Priyaa is the Clinical Lead and Consultant Radiation Oncologist at Kauvery Cancer Institute, Chennai)

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How social stigma and delayed diagnosis affect Indian women with breast cancer - The News Minute

First of all it is important to make clear that andropause isn't the male version of menopause, says consultant urologist Dr Datesh Daneshwal.

"While all women go through menopause, all men do not experience andropause. It's not supposed to happen to every man and it only affects a very small percentage of men," he says.

Andropause is a condition where men experience a decrease in their testosterone levels that is not normal. While all men do start losing testosterone after the age of 30, the decrease isn't very significant (about 1% a year) and should not affect their well-being. Very different from menopause which signifies a sudden decrease in a womans hormone levels that causes ovulation to cease.

But sometimes, when a man's biochemical dip is more drastic, it can cause a broad range of symptoms that affect their overall health and temperament.

These symptoms include a decline in muscle mass and strength, a buildup of body fat, a loss of bone density, flagging energy, emotional instability, deranged sugar and cholesterol levels, lowered fertility and fading virility.

"A drop in testosterone coupled with these symptoms is what is classified as andropause. When it interferes with your well-being and health," explains Dr Datesh. "Many people have a misconception that testosterone is purely for sexual function which it is not. It is the elixir that keeps the brain sharp, affects one's mood, muscle bulk and weight management and also collesterol and sugar levels. Low testosterone can cause insomnia and depression and, of course, sexual dysfunction too. Men need a certain level of testosterone to function well in all aspects of their life and if it dips too low, their health is at risk," says Dr Datesh

Getting help

David was 38 when he started noticing the symptoms.

"I was experiencing a gradual but progressive decline of erectile function, decreased libido, frequent and more prolonged periods of low moods, decreased energy levels and frustration, sadness and despair that my interest in the opposite gender was not what it once was," says David who is now 61.

Although he initially started taking Viagra to help with his sexual dysfunction, David decided to consult a doctor when the symptoms persisted.

"For many years, l absorbed myself in my work and largely shrugged off and just accepted my symptoms without question. ince retiring a few years ago, l have had the time to become more aware of the physical and psychological fallout these symptoms have been having on me. The biggest psychological symptom was the diminishing confidence that l keenly felt in pursuing new relationships with women (l am, and always have been, a single guy) not least because l was conscious of the increasing difficulty of consummating such relationships.

"On a physical level, l felt myself becoming more anxious and subject to low moods as well as experiencing decreasing energy levels. I felt that l owed it to myself to get my symptoms properly evaluated by qualified professionals in this area," he said.

David was diagnosed with hypogonadism, a condition where the body doesn't produce enough testosterone which can occur from birth or later in life, often from injury or infection. He is currently on testosterone replacement treatment as well as medicine for erectile dysfunction which he says has helped him tremendously.

"Physically, l feel more energised, l have a stronger libido and my erectile functioning difficulties have been greatly improved, with further improvements anticipated after further testosterone injections. Psychologically, my confidence in interacting with women has been greatly boosted l think this is the most dramatic change l have notice.

"My advise to other men who are going through this is to not ignore the symptoms but to take action! Go and get specialist advice initially from your doctor and better still from a Urologist who has special expertise in this area. Please do not be embarrassed about talking through your symptoms with a doctor or urologist, particularly around erectile dysfunction. Remember that these medical people have seen and heard it all before many, many times. ln most cases your symptoms are likely to be physiological rather than psychological and can be resolved with treatment," says David.

Strength training exercises and a healthy lifestyle can stimulate the body's own production of testosterone. Photo: Pixabay

The stigma is real

Although there is a lot of literature available or andropause, men rarely seek medical help even when the symptoms can be affecting their life significantly, notes Dr Datesh.

"There is a stigma associated with this, unfortunately. And that's because we immediately associate testosterone with sexual function. That's why we need to raise awareness about how men need healthy levels of testosterone to lead a healthy life all around. If you are over 40 and are not feeling yourself notice that you put on weight, lose muscle bulk, emotional instability, find you are no longer attracted to your partner anymore, come and get tested. All it takes is a simple blood test and if it is because of low levels of testosterone, there is a solution now. You can get treated and change your life not just for yourself but for your family too," says the urologist from Prince Court Medical Centre.

Hormone replacement therapies for men come in the forms of pills, injections and gels although the most effective and popular option in Malaysia are thelong-term injections that are adinistered every three months.

"Hormone replacement is a science though and cannot be administered simply without ruling out a few things. First and most importantly, we have to make sure that the patient has no signs of prostate cancer because testosterone is fuel for prostate cancer cells. Second, while testosterone administered externally may help with a man's virility, it may affect his fertility. These things have to be discussed with the patient before he starts on treatment," says Dr Datesh.

How long a patient has to be on them really depends on the individual, he says.

I have had patients who, after a couple of doses, were feeling better and able to resume an active lifestyle which can stimulate the body's ability to produce it's own testosterone," he explains.

Men experiencing the symptoms of andropause are advised to make healthier lifestyle choices. Aerobic exercise to release endorphins that improve mood, strength training to increase blood flow and strengthen the hear as well a healthy diet and a decrease in alcohol and tobacco intake.

Muscle-building exercises, he says, can encourage the body's own production of testosterone.

"But a person experiencing andropause will not have the energy to do weight training - they'd need a boost of hormones get they them feeling energised enough to start exercising and building their body up," he says.

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Andropause: Not the same as menopause but needs to be addressed - The Star Online

Oct. 27, 2020 05:02 UTC

ALAMEDA, Calif.--(BUSINESS WIRE)-- Exelixis, Inc. (NASDAQ: EXEL) today announced that Takeda Pharmaceutical Company Limited (Takeda), its partner responsible for the clinical development and commercialization of CABOMETYX (cabozantinib) in Japan, and Ono Pharmaceutical Co., Ltd. (Ono), have submitted a supplemental application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for Manufacturing and Marketing approval of CABOMETYX in combination with OPDIVO (nivolumab) for the treatment of patients with unresectable, advanced or metastatic renal cell carcinoma (RCC).

Takeda and Onos application is based on the results of CheckMate -9ER, a phase 3 pivotal trial evaluating CABOMETYX in combination with OPDIVO in previously untreated patients with advanced or metastatic RCC compared with sunitinib. In CheckMate -9ER, CABOMETYX in combination with OPDIVO demonstrated superior overall survival, doubled median progression-free survival and objective response rate, and demonstrated a favorable safety profile versus sunitinib. These results were presented as a Proffered Paper during a Presidential Symposium at the European Society for Medical Oncology Virtual Congress 2020.

Following our recent announcement that the U.S. FDA accepted and granted Priority Review to our supplemental new drug application for CABOMETYX in combination with OPDIVO for the treatment of advanced renal cell carcinoma, were excited that our partner Takeda along with Ono have also advanced this combination regimen toward potential regulatory approval in Japan, said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. The results of the CheckMate -9ER trial suggest CABOMETYX in combination with OPDIVO may become an important new treatment option for patients with advanced kidney cancer in need of new therapies.

Per the terms of Exelixis and Takedas collaboration and license agreement, Exelixis is eligible to receive a $10 million milestone payment from Takeda as a result of this latest submission for RCC. Following the milestone associated with this regulatory filing, Exelixis will be eligible to receive a first-sale milestone payment of $20 million from Takeda related to the combination of CABOMETYX and OPDIVO for the treatment of RCC. Exelixis continues to be eligible to receive additional development, regulatory and first-sale milestones for potential future cabozantinib indications, and is also eligible for sales revenue milestones and royalties on net sales of cabozantinib in Japan. Takeda fully funds cabozantinib development activities that are exclusively for the benefit of Japan and has the opportunity to share the costs associated with global cabozantinib clinical trials, providing the company opts into those trials.

Takeda received approval in March 2020 from the Japanese MHLW to manufacture and market CABOMETYX as a treatment for patients with curatively unresectable or metastatic RCC.

About CheckMate -9ER

CheckMate -9ER is an open-label, randomized, multi-national phase 3 trial evaluating patients with previously untreated advanced or metastatic RCC. A total of 651 patients (23% favorable risk, 58% intermediate risk, 20% poor risk; 25% PD-L11%) were randomized to receive OPDIVO plus CABOMETYX (n=323) vs. sunitinib (n=328). The primary endpoint is progression-free survival. Secondary endpoints include overall survival and objective response rate. The primary efficacy analysis is comparing the doublet combination vs. sunitinib in all randomized patients. The trial is sponsored by Bristol Myers Squibb and Ono Pharmaceutical Co. and co-funded by Exelixis, Ipsen and Takeda Pharmaceutical Company Limited.

About RCC

The American Cancer Societys 2020 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the U.S.1 Clear cell RCC is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; for patients with advanced or late-stage metastatic RCC, however, the five-year survival rate is only 12%.2 Approximately 32,000 patients in the U.S. and 71,000 worldwide will require systemic treatment for advanced kidney cancer in 2020.3

About 70% of RCC cases are known as clear cell carcinomas, based on histology.4 The majority of clear cell RCC tumors have below-normal levels of a protein called von Hippel-Lindau, which leads to higher levels of MET, AXL and VEGF.5,6 These proteins promote tumor angiogenesis (blood vessel growth), growth, invasiveness and metastasis.7,8,9,10 MET and AXL may provide escape pathways that drive resistance to VEGF receptor inhibitors.6,7

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC and for the treatment of patients with HCC who have been previously treated with sorafenib. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX in combination with OPDIVO is not indicated for advanced RCC.

CABOMETYX Important Safety Information

Warnings and Precautions

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of perforations and fistulas, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic event requiring medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension occurred in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Proteinuria: Proteinuria occurred in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

The most commonly reported (25%) adverse reactions are: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, and vomiting.

Drug Interactions

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. Johns wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. CABOMETYX is not recommended for use in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information https://cabometyx.com/downloads/CABOMETYXUSPI.pdf.

OPDIVO INDICATIONS

OPDIVO (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

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

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

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

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO (nivolumab) is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with progression after platinum-based chemotherapy and at least one other line of therapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

OPDIVO (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

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

OPDIVO (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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

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

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

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

OPDIVO (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO IMPORTANT SAFETY INFORMATION

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not be inclusive of all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur at any time after starting or discontinuing YERVOY. Early identification and management are essential to ensure safe use of YERVOY. Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue YERVOY depending on severity. In general, if YERVOY requires interruption or discontinuation, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less followed by corticosteroid taper for at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reaction is not controlled with corticosteroid therapy. Institute hormone replacement therapy for endocrinopathies as warranted.

Immune-Mediated Pneumonitis

OPDIVO can cause immune-mediated pneumonitis. Fatal cases have been reported. Monitor patients for signs with radiographic imaging and for symptoms of pneumonitis. Administer corticosteroids for Grade 2 or more severe pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In patients receiving OPDIVO monotherapy, fatal cases of immune-mediated pneumonitis have occurred. Immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 6% (25/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 4.4% (24/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 1.7% (2/119) of patients. In NSCLC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%) immune-mediated pneumonitis. Four patients (0.7%) died due to pneumonitis. The incidence and severity of immune-mediated pneumonitis in patients with NSCLC treated with OPDIVO 360 mg every 3 weeks in combination with YERVOY 1 mg/kg every 6 weeks and 2 cycles of platinum-doublet chemotherapy were comparable to treatment with OPDIVO in combination with YERVOY only. The incidence and severity of immune-mediated pneumonitis in patients with malignant pleural mesothelioma treated with OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks were similar to those occurring in NSCLC.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO: Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO can cause immune-mediated colitis. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. Withhold OPDIVO monotherapy for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon re-initiation of OPDIVO. When administered with YERVOY, withhold OPDIVO and YERVOY for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 26% (107/407) of patients including three fatal cases. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated colitis occurred in 10% (5/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 10% (52/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated colitis occurred in 7% (8/119) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated diarrhea/colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%).

Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. Addition of an alternative immunosuppressive agent to the corticosteroid therapy, or replacement of the corticosteroid therapy, should be considered in corticosteroid-refractory immune-mediated colitis if other causes are excluded.

Immune-Mediated Hepatitis

OPDIVO can cause immune-mediated hepatitis. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. For patients without HCC, withhold OPDIVO for Grade 2 and permanently discontinue OPDIVO for Grade 3 or 4. For patients with HCC, withhold OPDIVO and administer corticosteroids if AST/ALT is within normal limits at baseline and increases to >3 and up to 5 times the upper limit of normal (ULN), if AST/ALT is >1 and up to 3 times ULN at baseline and increases to >5 and up to 10 times the ULN, and if AST/ALT is >3 and up to 5 times ULN at baseline and increases to >8 and up to 10 times the ULN. Permanently discontinue OPDIVO and administer corticosteroids if AST or ALT increases to >10 times the ULN or total bilirubin increases >3 times the ULN. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 13% (51/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 20% (10/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 7% (38/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hepatitis occurred in 8% (10/119) of patients.

In Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients receiving OPDIVO.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%).

Immune-Mediated Endocrinopathies

OPDIVO can cause immune-mediated hypophysitis, immune-mediated adrenal insufficiency, autoimmune thyroid disorders, and Type 1 diabetes mellitus. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency, thyroid function prior to and periodically during treatment, and hyperglycemia. Withhold for Grades 2, 3, or 4 endocrinopathies if not clinically stable. Administer hormone replacement as clinically indicated and corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone-replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism. Withhold OPDIVO for Grade 3 and permanently discontinue for Grade 4 hyperglycemia.

In patients receiving OPDIVO monotherapy, hypophysitis occurred in 0.6% (12/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 9% (36/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypophysitis occurred in 4% (2/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypophysitis occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated hypophysitis occurred in 3.4% (4/119) of patients. In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 5% (21/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, adrenal insufficiency occurred in 18% (9/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 7% (41/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, adrenal insufficiency occurred in 5.9% (7/119) of patients. In patients receiving OPDIVO monotherapy, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 9% (171/1994) of patients. Hyperthyroidism occurred in 2.7% (54/1994) of patients receiving OPDIVO monotherapy. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (89/407) of patients. Hyperthyroidism occurred in 8% (34/407) of patients receiving this dose of OPDIVO with YERVOY. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (11/49) of patients. Hyperthyroidism occurred in 10% (5/49) of patients receiving this dose of OPDIVO with YERVOY. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 22% (119/547) of patients. Hyperthyroidism occurred in 12% (66/547) of patients receiving this dose of OPDIVO with YERVOY. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, hypothyroidism or thyroiditis resulting in hypothyroidism occurred in 15% (18/119) of patients. Hyperthyroidism occurred in 12% (14/119) of patients. In patients receiving OPDIVO monotherapy, diabetes occurred in 0.9% (17/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, diabetes occurred in 1.5% (6/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, diabetes occurred in 2.7% (15/547) of patients.

In a separate Phase 3 trial of YERVOY 3 mg/kg, severe to life-threatening endocrinopathies occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. Six of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

OPDIVO can cause immune-mediated nephritis. Monitor patients for elevated serum creatinine prior to and periodically during treatment. Administer corticosteroids for Grades 2-4 increased serum creatinine. Withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 increased serum creatinine. In patients receiving OPDIVO monotherapy, immune-mediated nephritis and renal dysfunction occurred in 1.2% (23/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 2.2% (9/407) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 4.6% (25/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated nephritis and renal dysfunction occurred in 1.7% (2/119) of patients.

Immune-Mediated Skin and Dermatologic Adverse Reactions

OPDIVO can cause immune-mediated rash, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), some cases with fatal outcome. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4 rash. For symptoms or signs of SJS or TEN, withhold OPDIVO and refer the patient for specialized care for assessment and treatment; if confirmed, permanently discontinue. In patients receiving OPDIVO monotherapy, immune-mediated rash occurred in 9% (171/1994) of patients. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 22.6% (92/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, immune-mediated rash occurred in 35% (17/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 16% (90/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, immune-mediated rash occurred in 14% (17/119) of patients.

YERVOY can cause immune-mediated rash or dermatitis, including bullous and exfoliative dermatitis, Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-bullous exfoliative rashes. Withhold YERVOY until specialist assessment for Grade 2 and permanently discontinue for Grade 3 or 4 exfoliative or bullous dermatologic conditions.

In a separate Phase 3 trial of YERVOY 3 mg/kg, immune-mediated rash occurred in 15% (76/511) of patients, including Grade 3-5 (2.5%).

Immune-Mediated Encephalitis

OPDIVO can cause immune-mediated encephalitis. Fatal cases have been reported. Evaluation of patients with neurologic symptoms may include, but not be limited to, consultation with a neurologist, brain MRI, and lumbar puncture. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. In patients receiving OPDIVO monotherapy, encephalitis occurred in 0.2% (3/1994) of patients. Fatal limbic encephalitis occurred in one patient after 7.2 months of exposure despite discontinuation of OPDIVO and administration of corticosteroids. Encephalitis occurred in one melanoma patient receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg (0.2%) after 1.7 months of exposure. Encephalitis occurred in one RCC patient receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg (0.2%) after approximately 4 months of exposure. Encephalitis occurred in one MSI-H/dMMR mCRC patient (0.8%) receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg after 15 days of exposure.

Other Immune-Mediated Adverse Reactions

Based on the severity of the adverse reaction, permanently discontinue or withhold OPDIVO, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. Dose modifications for YERVOY for adverse reactions that require management different from these general guidelines are summarized as follows. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 neurological toxicities. Withhold for Grade 2 and permanently discontinue YERVOY for Grade 3 or 4 myocarditis. Permanently discontinue YERVOY for Grade 2, 3, or 4 ophthalmologic adverse reactions that do not improve to Grade 1 within 2 weeks while receiving topical therapy OR that require systemic therapy. Across clinical trials of OPDIVO monotherapy or in combination with YERVOY , the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1.0% of patients receiving OPDIVO: myocarditis, rhabdomyolysis, myositis, uveitis, iritis, pancreatitis, facial and abducens nerve paresis, demyelination, polymyalgia rheumatica, autoimmune neuropathy, Guillain-Barr syndrome, hypopituitarism, systemic inflammatory response syndrome, gastritis, duodenitis, sarcoidosis, histiocytic necrotizing lymphadenitis (Kikuchi lymphadenitis), motor dysfunction, vasculitis, aplastic anemia, pericarditis, myasthenic syndrome, hemophagocytic lymphohistiocytosis (HLH), and autoimmune hemolytic anemia. In addition to the immune-mediated adverse reactions listed above, across clinical trials of YERVOY monotherapy or in combination with OPDIVO, the following clinically significant immune-mediated adverse reactions, some with fatal outcome, occurred in <1% of patients unless otherwise specified: autoimmune neuropathy (2%), meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome/myasthenia gravis, nerve paresis, angiopathy, temporal arteritis, pancreatitis (1.3%), arthritis, polymyositis, conjunctivitis, cytopenias (2.5%), eosinophilia (2.1%), erythema multiforme, hypersensitivity vasculitis, neurosensory hypoacusis, psoriasis, blepharitis, episcleritis, orbital myositis, scleritis, and solid organ transplant rejection. Some cases of ocular IMARs have been associated with retinal detachment.

If uveitis occurs in combination with other immune-mediated adverse reactions, consider a Vogt-Koyanagi-Harada-like syndrome, which has been observed in patients receiving OPDIVO and YERVOY and may require treatment with systemic steroids to reduce the risk of permanent vision loss.

Infusion-Related Reactions

OPDIVO can cause severe infusion-related reactions, which have been reported in <1.0% of patients in clinical trials. Discontinue OPDIVO in patients with Grade 3 or 4 infusion-related reactions. Interrupt or slow the rate of infusion in patients with Grade 1 or 2. Severe infusion-related reactions can also occur with YERVOY. Discontinue YERVOY in patients with severe or life-threatening infusion reactions and interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions. In patients receiving OPDIVO monotherapy as a 60-minute infusion, infusion-related reactions occurred in 6.4% (127/1994) of patients. In a separate trial in which patients received OPDIVO monotherapy as a 60-minute infusion or a 30-minute infusion, infusion-related reactions occurred in 2.2% (8/368) and 2.7% (10/369) of patients, respectively. Additionally, 0.5% (2/368) and 1.4% (5/369) of patients, respectively, experienced adverse reactions within 48 hours of infusion that led to dose delay, permanent discontinuation or withholding of OPDIVO. In melanoma patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, infusion-related reactions occurred in 2.5% (10/407) of patients. In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg, infusion-related reactions occurred in 8% (4/49) of patients. In RCC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 5.1% (28/547) of patients. In MSI-H/dMMR mCRC patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg, infusion-related reactions occurred in 4.2% (5/119) of patients. In MPM patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, infusion-related reactions occurred in 12% (37/300) of patients.

In separate Phase 3 trials of YERVOY 3 mg/kg and 10 mg/kg, infusion-related reactions occurred in 2.9% (28/982).

Complications of Allogeneic Hematopoietic Stem Cell Transplantation

Fatal and other serious complications can occur in patients who receive allogeneic hematopoietic stem cell transplantation (HSCT) before or after being treated with a PD-1 receptor blocking antibody or YERVOY. Transplant-related complications include hyperacute graft-versus-host-disease (GVHD), acute GVHD, chronic GVHD, hepatic veno-occlusive disease (VOD) after reduced intensity conditioning, and steroid-requiring febrile syndrome (without an identified infectious cause). These complications may occur despite intervening therapy between PD-1 or CTLA-4 receptor blockade and allogeneic HSCT.

Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risks of treatment with a PD-1 receptor blocking antibody or YERVOY prior to or after an allogeneic HSCT.

Embryo-Fetal Toxicity

Based on mechanism of action, OPDIVO and YERVOY can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO or YERVOY and for at least 5 months after the last dose.

Increased Mortality in Patients with Multiple Myeloma when OPDIVO is Added to a Thalidomide Analogue and Dexamethasone

In clinical trials in patients with multiple myeloma, the addition of OPDIVO to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials.

Lactation

It is not known whether OPDIVO or YERVOY is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO or YERVOY, advise women not to breastfeed during treatment and for at least 5 months after the last dose.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO (n=268). Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 066, serious adverse reactions occurred in 36% of patients receiving OPDIVO (n=206). Grade 3 and 4 adverse reactions occurred in 41% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse reactions reported in 2% of patients receiving OPDIVO were gamma-glutamyltransferase increase (3.9%) and diarrhea (3.4%). In Checkmate 067, serious adverse reactions (74% and 44%), adverse reactions leading to permanent discontinuation (47% and 18%) or to dosing delays (58% and 36%), and Grade 3 or 4 adverse reactions (72% and 51%) all occurred more frequently in the OPDIVO plus YERVOY arm (n=313) relative to the OPDIVO arm (n=313). The most frequent (10%) serious adverse reactions in the OPDIVO plus YERVOY arm and the OPDIVO arm, respectively, were diarrhea (13% and 2.2%), colitis (10% and 1.9%), and pyrexia (10% and 1.0%). In Checkmate 227, serious adverse reactions occurred in 58% of patients (n=576). The most frequent (2%) serious adverse reactions were pneumonia, diarrhea/colitis, pneumonitis, hepatitis, pulmonary embolism, adrenal insufficiency, and hypophysitis. Fatal adverse reactions occurred in 1.7% of patients; these included events of pneumonitis (4 patients), myocarditis, acute kidney injury, shock, hyperglycemia, multi-system organ failure, and renal failure. In Checkmate 9LA, serious adverse reactions occurred in 57% of patients (n=358). The most frequent (>2%) serious adverse reactions were pneumonia, diarrhea, febrile neutropenia, anemia, acute kidney injury, musculoskeletal pain, dyspnea, pneumonitis, and respiratory failure. Fatal adverse reactions occurred in 7 (2%) patients, and included hepatic toxicity, acute renal failure, sepsis, pneumonitis, diarrhea with hypokalemia, and massive hemoptysis in the setting of thrombocytopenia. In Checkmate 017 and 057, serious adverse reactions occurred in 46% of patients receiving OPDIVO (n=418). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, pulmonary embolism, dyspnea, pyrexia, pleural effusion, pneumonitis, and respiratory failure. In Checkmate 032, serious adverse reactions occurred in 45% of patients receiving OPDIVO (n=245). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, pneumonitis, pleural effusion, and dehydration. In Checkmate 743, serious adverse reactions occurred in 54% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were pneumonia, pyrexia, diarrhea, pneumonitis, pleural effusion, dyspnea, acute kidney injury, infusion-related reaction, musculoskeletal pain, and pulmonary embolism. Fatal adverse reactions occurred in 4 (1.3%) patients and included pneumonitis, acute heart failure, sepsis, and encephalitis. In Checkmate 025, serious adverse reactions occurred in 47% of patients receiving OPDIVO (n=406). The most frequent serious adverse reactions reported in 2% of patients were acute kidney injury, pleural effusion, pneumonia, diarrhea, and hypercalcemia. In Checkmate 214, serious adverse reactions occurred in 59% of patients receiving OPDIVO plus YERVOY. The most frequent serious adverse reactions reported in 2% of patients were diarrhea, pyrexia, pneumonia, pneumonitis, hypophysitis, acute kidney injury, dyspnea, adrenal insufficiency, and colitis. In Checkmate 205 and 039, adverse reactions leading to discontinuation occurred in 7% and dose delays due to adverse reactions occurred in 34% of patients (n=266). Serious adverse reactions occurred in 26% of patients. The most frequent serious adverse reactions reported in 1% of patients were pneumonia, infusion-related reaction, pyrexia, colitis or diarrhea, pleural effusion, pneumonitis, and rash. Eleven patients died from causes other than disease progression: 3 from adverse reactions within 30 days of the last OPDIVO dose, 2 from infection 8 to 9 months after completing OPDIVO, and 6 from complications of allogeneic HSCT. In Checkmate 141, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=236). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were pneumonia, dyspnea, respiratory failure, respiratory tract infection, and sepsis. In Checkmate 275, serious adverse reactions occurred in 54% of patients receiving OPDIVO (n=270). The most frequent serious adverse reactions reported in 2% of patients receiving OPDIVO were urinary tract infection, sepsis, diarrhea, small intestine obstruction, and general physical health deterioration. In Checkmate 142 in MSI-H/dMMR mCRC patients receiving OPDIVO with YERVOY, serious adverse reactions occurred in 47% of patients. The most frequent serious adverse reactions reported in 2% of patients were colitis/diarrhea, hepatic events, abdominal pain, acute kidney injury, pyrexia, and dehydration. In Checkmate 040, serious adverse reactions occurred in 49% of patients receiving OPDIVO (n=154). The most frequent serious adverse reactions reported in 2% of patients were pyrexia, ascites, back pain, general physical health deterioration, abdominal pain, pneumonia, and anemia. In Checkmate 040, serious adverse reactions occurred in 59% of patients receiving OPDIVO with YERVOY (n=49). Serious adverse reactions reported in 4% of patients were pyrexia, diarrhea, anemia, increased AST, adrenal insufficiency, ascites, esophageal varices hemorrhage, hyponatremia, increased blood bilirubin, and pneumonitis. In Checkmate 238, Grade 3 or 4 adverse reactions occurred in 25% of OPDIVO-treated patients (n=452). The most frequent Grade 3 and 4 adverse reactions reported in 2% of OPDIVO-treated patients were diarrhea and increased lipase and amylase. Serious adverse reactions occurred in 18% of OPDIVO-treated patients. In Attraction-3, serious adverse reactions occurred in 38% of patients receiving OPDIVO (n=209). Serious adverse reactions reported in 2% of patients who received OPDIVO were pneumonia, esophageal fistula, interstitial lung disease and pyrexia. The following fatal adverse reactions occurred in patients who received OPDIVO: interstitial lung disease or pneumonitis (1.4%), pneumonia (1.0%), septic shock (0.5%), esophageal fistula (0.5%), gastrointestinal hemorrhage (0.5%), pulmonary embolism (0.5%), and sudden death (0.5%).

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Hormone Replacement Drugs Market Insights, Forecast to 2026

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Description

By Product Type

Hormone replacement drugs refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.Market Analysis and Insights: Global Hormone Replacement Drugs MarketThe global Hormone Replacement Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX%% during 2021-2026.Global Hormone Replacement Drugs Scope and SegmentThe global Hormone Replacement Drugs market is segmented by company, region (country), by Type, and

By Application

Hormone replacement drugs refers to the treatment of the patients with hormone deficiency due to conditions such as dwarfism or women nearing menopause, which requires replacement of hormones in the body whose levels have become low.Market Analysis and Insights: Global Hormone Replacement Drugs MarketThe global Hormone Replacement Drugs market size is projected to reach US$ XX million by 2026, from US$ XX million in 2020, at a CAGR of XX%% during 2021-2026.Global Hormone Replacement Drugs Scope and SegmentThe global Hormone Replacement Drugs market is segmented by company, region (country), by Type, and by Application. Players, stakeholders, and other participants in the global Hormone Replacement Drugs market will be able to gain the upper hand as they use the report as a powerful resource. The segmental analysis focuses on revenue and forecast by region (country), by Type, and by Application for the period 2015-2026.The major regions covered in the report are North America, Europe, China, Rest of Asia Pacific, Central & South America, Middle East & Africa, etc. It includes revenue analysis of each region for the year 2015 to 2026.By the type, the market is primarily split into, Estrogen Hormone, Growth Hormone, Thyroid Hormone, Testosterone HormoneBy the application, this report covers the following segments, Menopause, Hypothyroidism, Growth Hormone Deficiency, Male Hypogonadism, Other DiseasesCompetitive Landscape:The Hormone Replacement Drugs key manufacturers in this market include:, Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

Some of the Top Key player Operating in The Report Are

Eli Lilly, Pfizer, AbbVie, Novo Nordisk, Merck KGaA, Mylan, Bayer, Teva, Novartis, Abbott, Roche, Endo International, Ipsen, ANI Pharmaceuticals, TherapeuticsMD

By Region

North America

oU.S.

oCanada

Europe

oGermany

oU.K.

oFrance

oItaly

oSpain

oRest of Europe

Asia Pacific

oChina

oIndia

oJapan

oRest of Asia Pacific

Middle East & Africa

oGCC

oSouth Africa

oRest of Middle East & Africa

Latin America

oBrazil

oMexico

oRest of Latin America

Competitive Landscape

It is important for every market participant to be familiar with the competitive scenario in the global Hormone Replacement Drugs industry. In order to fulfill the requirements, the industry analysts have evaluated the strategic activities of the competitors to help the key players strengthen their foothold in the market and increase their competitiveness.

Key questions answered in the report:

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Table of Contents

1 Market Overview of Hormone Replacement Drugs1.1 Hormone Replacement Drugs Market Overview1.1.1 Hormone Replacement Drugs Product Scope1.1.2 Market Status and Outlook1.2 Global Hormone Replacement Drugs Market Size Overview by Region 2015 VS 2020 VS 20261.3 Global Hormone Replacement Drugs Market Size by Region (2015-2026)1.4 Global Hormone Replacement Drugs Historic Market Size by Region (2015-2020)1.5 Global Hormone Replacement Drugs Market Size Forecast by Region (2021-2026)1.6 Key Regions, Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.1 North America Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.2 Europe Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.3 China Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.4 Rest of Asia Pacific Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.5 Latin America Hormone Replacement Drugs Market Size YoY Growth (2015-2026)1.6.6 Middle East & Africa Hormone Replacement Drugs Market Size YoY Growth (2015-2026)

2 Hormone Replacement Drugs Market Overview by Type2.1 Global Hormone Replacement Drugs Market Size by Type: 2015 VS 2020 VS 20262.2 Global Hormone Replacement Drugs Historic Market Size by Type (2015-2020)2.3 Global Hormone Replacement Drugs Forecasted Market Size by Type (2021-2026)2.4 Estrogen Hormone2.5 Growth Hormone2.6 Thyroid Hormone2.7 Testosterone Hormone

3 Hormone Replacement Drugs Market Overview by Application3.1 Global Hormone Replacement Drugs Market Size by Application: 2015 VS 2020 VS 20263.2 Global Hormone Replacement Drugs Historic Market Size by Application (2015-2020)3.3 Global Hormone Replacement Drugs Forecasted Market Size by Application (2021-2026)3.4 Menopause3.5 Hypothyroidism3.6 Growth Hormone Deficiency3.7 Male Hypogonadism3.8 Other Diseases

4 Global Hormone Replacement Drugs Competition Analysis by Players4.1 Global Hormone Replacement Drugs Market Size (Million US$) by Players (2015-2020)4.2 Global Top Manufacturers by Company Type (Tier 1, Tier 2 and Tier 3) (based on the Revenue in Hormone Replacement Drugs as of 2019)4.3 Date of Key Manufacturers Enter into Hormone Replacement Drugs Market4.4 Global Top Players Hormone Replacement Drugs Headquarters and Area Served4.5 Key Players Hormone Replacement Drugs Product Solution and Service4.6 Competitive Status4.6.1 Hormone Replacement Drugs Market Concentration Rate4.6.2 Mergers & Acquisitions, Expansion Plans

5 Company (Top Players) Profiles and Key Data5.1 Eli Lilly5.1.1 Eli Lilly Profile5.1.2 Eli Lilly Main Business and Companys Total Revenue5.1.3 Eli Lilly Products, Services and Solutions5.1.4 Eli Lilly Revenue (US$ Million) (2015-2020)5.1.5 Eli Lilly Recent Development and Reaction to Covid-195.2 Pfizer5.2.1 Pfizer Profile5.2.2 Pfizer Main Business and Companys Total Revenue5.2.3 Pfizer Products, Services and Solutions5.2.4 Pfizer Revenue (US$ Million) (2015-2020)5.2.5 Pfizer Recent Development and Reaction to Covid-195.3 AbbVie5.5.1 AbbVie Profile5.3.2 AbbVie Main Business and Companys Total Revenue5.3.3 AbbVie Products, Services and Solutions5.3.4 AbbVie Revenue (US$ Million) (2015-2020)5.3.5 Novo Nordisk Recent Development and Reaction to Covid-195.4 Novo Nordisk5.4.1 Novo Nordisk Profile5.4.2 Novo Nordisk Main Business and Companys Total Revenue5.4.3 Novo Nordisk Products, Services and Solutions5.4.4 Novo Nordisk Revenue (US$ Million) (2015-2020)5.4.5 Novo Nordisk Recent Development and Reaction to Covid-195.5 Merck KGaA5.5.1 Merck KGaA Profile5.5.2 Merck KGaA Main Business and Companys Total Revenue5.5.3 Merck KGaA Products, Services and Solutions5.5.4 Merck KGaA Revenue (US$ Million) (2015-2020)5.5.5 Merck KGaA Recent Development and Reaction to Covid-195.6 Mylan5.6.1 Mylan Profile5.6.2 Mylan Main Business and Companys Total Revenue5.6.3 Mylan Products, Services and Solutions5.6.4 Mylan Revenue (US$ Million) (2015-2020)5.6.5 Mylan Recent Development and Reaction to Covid-195.7 Bayer5.7.1 Bayer Profile5.7.2 Bayer Main Business and Companys Total Revenue5.7.3 Bayer Products, Services and Solutions5.7.4 Bayer Revenue (US$ Million) (2015-2020)5.7.5 Bayer Recent Development and Reaction to Covid-195.8 Teva5.8.1 Teva Profile5.8.2 Teva Main Business and Companys Total Revenue5.8.3 Teva Products, Services and Solutions5.8.4 Teva Revenue (US$ Million) (2015-2020)5.8.5 Teva Recent Development and Reaction to Covid-195.9 Novartis5.9.1 Novartis Profile5.9.2 Novartis Main Business and Companys Total Revenue5.9.3 Novartis Products, Services and Solutions5.9.4 Novartis Revenue (US$ Million) (2015-2020)5.9.5 Novartis Recent Development and Reaction to Covid-195.10 Abbott5.10.1 Abbott Profile5.10.2 Abbott Main Business and Companys Total Revenue5.10.3 Abbott Products, Services and Solutions5.10.4 Abbott Revenue (US$ Million) (2015-2020)5.10.5 Abbott Recent Development and Reaction to Covid-195.11 Roche5.11.1 Roche Profile5.11.2 Roche Main Business and Companys Total Revenue5.11.3 Roche Products, Services and Solutions5.11.4 Roche Revenue (US$ Million) (2015-2020)5.11.5 Roche Recent Development and Reaction to Covid-195.12 Endo International5.12.1 Endo International Profile5.12.2 Endo International Main Business and Companys Total Revenue5.12.3 Endo International Products, Services and Solutions5.12.4 Endo International Revenue (US$ Million) (2015-2020)5.12.5 Endo International Recent Development and Reaction to Covid-195.13 Ipsen5.13.1 Ipsen Profile5.13.2 Ipsen Main Business and Companys Total Revenue5.13.3 Ipsen Products, Services and Solutions5.13.4 Ipsen Revenue (US$ Million) (2015-2020)5.13.5 Ipsen Recent Development and Reaction to Covid-195.14 ANI Pharmaceuticals5.14.1 ANI Pharmaceuticals Profile5.14.2 ANI Pharmaceuticals Main Business and Companys Total Revenue5.14.3 ANI Pharmaceuticals Products, Services and Solutions5.14.4 ANI Pharmaceuticals Revenue (US$ Million) (2015-2020)5.14.5 ANI Pharmaceuticals Recent Development and Reaction to Covid-195.15 TherapeuticsMD5.15.1 TherapeuticsMD Profile5.15.2 TherapeuticsMD Main Business and Companys Total Revenue5.15.3 TherapeuticsMD Products, Services and Solutions5.15.4 TherapeuticsMD Revenue (US$ Million) (2015-2020)5.15.5 TherapeuticsMD Recent Development and Reaction to Covid-19

6 North America Hormone Replacement Drugs by Players and by Application6.1 North America Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)6.2 North America Hormone Replacement Drugs Market Size by Application (2015-2020)

7 Europe Hormone Replacement Drugs by Players and by Application7.1 Europe Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)7.2 Europe Hormone Replacement Drugs Market Size by Application (2015-2020)

8 China Hormone Replacement Drugs by Players and by Application8.1 China Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)8.2 China Hormone Replacement Drugs Market Size by Application (2015-2020)

9 Rest of Asia Pacific Hormone Replacement Drugs by Players and by Application9.1 Rest of Asia Pacific Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)9.2 Rest of Asia Pacific Hormone Replacement Drugs Market Size by Application (2015-2020)

10 Latin America Hormone Replacement Drugs by Players and by Application10.1 Latin America Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)10.2 Latin America Hormone Replacement Drugs Market Size by Application (2015-2020)

11 Middle East & Africa Hormone Replacement Drugs by Players and by Application11.1 Middle East & Africa Hormone Replacement Drugs Market Size and Market Share by Players (2015-2020)11.2 Middle East & Africa Hormone Replacement Drugs Market Size by Application (2015-2020)

12 Hormone Replacement Drugs Market Dynamics12.1 Covid-19 Impact: Industry Trends12.2 Covid-19 Impact: Market Drivers12.3 Covid-19 Impact: Market Challenges12.4 Porters Five Forces Analysis

13 Research Finding /Conclusion

14 Methodology and Data Source14.1 Methodology/Research Approach14.1.1 Research Programs/Design14.1.2 Market Size Estimation14.1.3 Market Breakdown and Data Triangulation14.2 Data Source14.2.1 Secondary Sources14.2.2 Primary Sources14.3 Disclaimer14.4 Author List

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The future of the United Kingdoms nuclear deterrent depends, in part, on decisions being made right now in the U.S. Congress. At stake are Britains plans to build a replacement for its current nuclear warhead. According to the U.K. defense secretary and senior U.S. officials, the United Kingdoms program is reliant on the United States pursuing its own new warhead program of record, the W93. But the Donald Trump administrations Fiscal Year 2021 request for funds for the W93 was first nixed by House appropriators and then excluded from the stopgap continuing resolution. It is neither clear whether the W93 program will eventually make it into the budget proper, nor whether it would be taken up immediately by a potential incoming Joe Biden administration.

The United Kingdoms new warhead will be housed in the U.S. Navys proposed new Mk7 aeroshell, and is intended to be developed in parallel with the W93 warhead, sharing key design parameters and using some common non-nuclear components. In April, U.K. Defence Secretary Ben Wallace wrote to members of Congress on relevant committees, claiming that their support to the W93 program in this budget cycle is critical to the success of our replacement warhead program and to the long-term viability of the U.K.s nuclear deterrent. Senior Trump administration officials have also repeatedly told Congress that a failure to fund the W93 will prevent the United States from supporting the British program. The future of a nuclear deterrent that the United Kingdomcallsits ultimate insurance policy as a nation and a contribution to the ultimate guarantee of collective Euro-Atlantic security is being called into question.

Most media discussion of Wallaces letter focused on the propriety of the defense secretary lobbying Congress. But Wallaces letter was remarkable on grounds of substance, not just process. At face value, his letter made very serious claims, suggesting that the fate of the United Kingdom as a nuclear power is in the hands not of members of Parliament, but of congressional appropriators. These claims deserve close interrogation not least by Parliament, which has so far failed in its duty of scrutiny. British legislators should be asking why, exactly, a new warhead is needed; what the backup plan in case U.S. assistance is disrupted; what military and technical requirements are being set for the new warhead; whether the United Kingdoms fraying infrastructure can deliver what is asked of it; and how much this endeavor will cost. Buried in these questions are significant risks and long-term strategic choices for the United Kingdom, the future of its nuclear deterrent, and Anglo-American defense ties.

Dependent Deterrent

The United Kingdoms nuclear force is strongly dependent, in material and programmatic terms, on the United States. The Royal Navy deploys four nuclear-armed submarines equipped with the U.S.-built and maintained Trident II D-5 submarine-launched ballistic missile, drawing from a common missile pool at Kings Bay, Georgia. The essence of this cooperative relationship on delivery systems has been in place since the conclusion of the Polaris Sales Agreement in 1963, signed after Prime Minister Harold Macmillan persuaded President John F. Kennedy to sell the United Kingdom the Polaris submarine-launched ballistic missile. Bilateral cooperation on warhead-relevant matters, including the transfer to the United Kingdom of special nuclear material and non-nuclear weapon components, is authorized under the 1958 U.K.-U.S. Mutual Defense Agreement, which freed London from Washingtons postwar prohibition on nuclear cooperation under the 1946 McMahon Act.

The United Kingdom is currently working on a successor submarine, the Dreadnought class, which will replace the currently deployed Vanguard class in the 2030s, and which will share a common missile compartment with Americas own successor class, the Columbia. In 2006, Prime Minister Tony Blair secured from President George W. Bush an agreement that the United Kingdom would participate in a missile life extension program so that the Dreadnought class could continue to carry the Trident II D-5. In addition, London would be invited to participate in any program to replace or further life extend the D-5. A program is now underway to develop a successor missile once the D-5 leaves service in 2042, currently designated the D-5 Life Extension 2.

The basic parameters of the British warhead are thus set by the need for it to be certified for use with an American missile system and housed in an American aeroshell. The United Kingdoms current nuclear warhead, the Holbrook, is sometimes referred to as an Anglicized version of the U.S. W76. It is certainly a similar design, and is referred to as such by U.S. national laboratories, although the degree of similarity is not publicly known. Several non-nuclear components of the warhead are known to be procured from the United States, including the arming, fusing, and firing system; neutron initiator; and the gas transfer system. The United Kingdom has made some updates to the Holbrook while the United States has conducted a life extension of the W76, now designated the W76-1, including at least the incorporation of the Mk4a arming, fusing, and firing system. However, it has not been publicly disclosed whether the United Kingdom has conducted an equally extensive life extension program of its own.

There is little reason to believe that the United Kingdom wishes to depart significantly from this model when it comes to building the next warhead. The structural incentives to hew closely to U.S. plans are strong. Procurement of non-nuclear components from the United States is seen as an obvious cost-saving measure, and reliance on U.S. facilities and information-sharing gives Britain a hedge against technological risks in design and certification. An explicit goal of the United Kingdoms program to modernize its nuclear infrastructure has in recent years been to increase engagement with the United States to align capabilities and requirements for any future warhead decision.

Unless the United Kingdom wants to diverge significantly from the United States, then its new warhead program needs a parallel U.S. program against which to align. Enter the W93. The announcement of a new program of record was good news for the U.K. nuclear establishment, which had been in a holding pattern during several years of U.S. deliberations and interservice wrangling. But the United Kingdom fields only one warhead in its nuclear arsenal, and so has considerably less margin for error than the United States, which already has two warhead types delivered by submarine-launched ballistic missiles (the W76-1 and W88, plus a lower-yield W76-2 variant), as well as the redundancy of two alternative delivery vehicles (land-based intercontinental ballistic missiles and strategic bombers), each with their own warhead types. The United Kingdom also appears to be working toward a rather pressing deadline. According to official U.K. statements, a replacement warhead could be needed as early as the late 2030s, and it has previously been estimated to take 17 years from a procurement decision to the eventual production of the warhead.

This sense of urgency leaves Britain in an uncomfortable position, because many in Congress do not appear convinced that the United States truly needs the W93 program to start right away. Funding for the W93 program was not anticipated to be required for two more years, and the timing of the administrations request has provoked pushback from Democratic legislators. One possible theory is that Trump administration officials want the W93 on the books before a potential Biden administration enters office. Another more concrete explanation is that U.S. defense officials might not trust the National Nuclear Security Administration the semi-autonomous agency within the Department of Energy which manufactures the United States nuclear warheads to deliver the W93 on schedule, and would like a more generous margin of error. The National Nuclear Security Administration request is only for the first of seven phases of warhead development, and calls for the relatively modest sum of $53 million, alongside a Pentagon request for $32 million for the Navy Mk7 program. The latter request, unlike that of the National Nuclear Security Administration, was originally approved by House appropriators.

Even if a potential incoming Biden administration agreed with the requirement for a new warhead for its submarine-launched ballistic missiles, it might still choose to delay the program. This could be a symbolic gesture toward reducing emphasis on nuclear weapons, or a practical recognition both that National Nuclear Security Administration already has four life extension or modification programs to execute and a new sea-launched cruise missile warhead to produce, and that the U.S. nuclear modernization program is shaping up to be spectacularly expensive at a time of COVID-19 induced budget pressure. Even without a conscious decision to delay the program, it might still be pushed back if a Biden administration wished to consider the W93 in the context of a Nuclear Posture Review, which would take time to complete.

Unanswered Questions

The United Kingdom, in other words, is in quite a bind. The defense secretary has stated, in writing, that the viability of the British deterrent depends on a program which the U.S. Congress might be about to stymie. It could be the case that, if work on the Mk7 aeroshell can start even in the absence of National Nuclear Security Administration funding for the W93, the United Kingdom could begin work on its own program. But the longer that Britain proceeds without a parallel U.S. warhead program in place, the greater the risks it would be incurring. Vanishingly little is publicly known about the decision-making process which has led to this point, which makes the precise degree of risk facing the United Kingdom very difficult to judge.

Congress has now had four public hearings at which the W93 was discussed, including several references to the programs importance to the United Kingdom, and the administration has given briefings on the rationale behind the program. Yet in the United Kingdom, where the stakes are allegedly much higher, the sum total of the governments public output on the warhead is a vaguely written statement to Parliament, and confirmation that the warhead will use the Mk7 aeroshell. This leaves open several key questions.

Why Has the United Kingdom Decided to Build a New Warhead, Rather Than Seeking to Further Refurbish or to Remanufacture Holbrook?

The fact that the United Kingdom has decided to build a new warhead at all, rather than seeking to further prolong the life of the Holbrook, is something that needs justifying. Has the United Kingdom made an independent judgment that a replacement warhead is essential, or is this decision simply the combination of a U.S. decision to proceed with W93 and the United Kingdoms preference for alignment? Ever since the 2006 White Paper in which the decision to renew the ballistic missile submarine force was taken, the U.K. government has repeatedly told Parliament that at some point a decision on whether to build a new warhead would be need to be made. That decision has now been made, and Parliament and the public do not know why.

It is not clear that the United States sees a critical need to replace the W76-1, which has recently been life-extended, providing for additional decades of use. Some discussions of the W93s role suggest that it could exist in parallel with both the W76-1 and the W88 as one of Americas three submarine-launched ballistic missile warheads. Were the United States to decide that the W76-1 could be further life-extended, or remanufactured from scratch, the U.K. government has not yet provided any public reasoning why the same could not be done for the Holbrook. Such reasons can certainly be imagined: there might be materials used in the original U.K. design that have now aged, and cannot for technical, legal, or safety reasons be remanufactured other than at disproportionate cost. There is also a case to be made that further life-extending old warheads introduces a degree of risk of technical failure that is unacceptably high for a country that depends on a single design, and that changes in the security environment, such as developments in missile defenses, could set future military requirements that the current warhead cannot meet. These arguments, however, have not yet been publicly made by the U.K. government.

What Are the Critical U.S. Activities on Which the U.K. Replacement Warhead Will Depend in the Next Few Years, and What Is the United Kingdoms Backup Plan if These Activities Are Not Funded?

The U.K. government has emphasized the need for its warhead to be compatible with Americas Trident system. What this probably means in practice is that the United Kingdom needs to know key parameters of the Mk7 aeroshell which will define the size, shape, mass distribution, and other aspects of the British warhead which will fit inside it. Beyond that, in order for the United Kingdom to be able to cooperate closely with the United States on key scientific and engineering aspects of the warheads design, manufacturing, and certification, the United Kingdom will need to know U.S. intentions for various design choices. Until the United States starts work on the W93 program, the United Kingdom will either have to delay its own choices or make assumptions about likely U.S. decisions in order to begin necessary work. Either path could involve increased costs and technical risk.

Beyond a small delay, more serious disruption to the W93 program raises very challenging questions: would the United Kingdom pursue indigenous production of components that would otherwise have been procured from the United States, and if so, at what risk and cost? If the United Kingdom still wishes to remain aligned with the United States, are there alternatives to a replacement warhead based on the W93/Mk7? More broadly, Parliament might ask whether such close alignment to the United States is truly worth the accompanying loss of sovereignty. It is often assumed that the United Kingdom has simply no other option, and a more independent program would certainly involve taking a greater share of technical risk and would very likely incur greater financial costs. Nevertheless, close alignment with the United States has downsides as well as upsides, including greater vulnerability to disruption or delayed supply of materials, components, and expertise, and less discretion in setting military and other requirements for the warhead. This is a strategically important choice which has not yet been fully debated in public.

What Are the Likely Requirements for the W93, and How Do These Relate to the U.K. Program?

Assuming that the W93 program does go ahead, the first phases of its development will involve, among other things, the drafting of military characteristics and a stockpile-to-target sequence. Taken together, these will define the performance requirements and physical characteristics of the weapon, as well as the environments and threats it will be exposed to that must be taken into account in its design. This will require deciding, for example, what explosive yield the warhead will have, what defenses it must defeat including nuclear, hit-to-kill, and (potentially) directed energy weapons and what kind of hardening and countermeasures will be necessary. Choices will also be made regarding surety requirements, such as whether to use insensitive high explosives, which could mean a relative increase in mass and volume.

Requirements set in the United States during this process are likely to determine or strongly influence several characteristics of the British warhead. Embedded in those requirements are important implications for U.K. policy and strategy, and although London is likely to have a voice in U.S. discussions over such questions, it will not have a deciding vote. Briefings by U.S. officials suggest, for example, that the W93 is intended to be of higher yield than the W76-1. If the United Kingdom were to follow this path, the overall explosive yield of its operational stockpile could increase for the first time since it began deploying Trident in 1994. The emphasis placed by U.S. officials on the W93s flexibility implies variable yield, which would be somewhat consistent with the existing lower-yield warhead variant the U.K. reportedly deploys at present, but would leave the United Kingdom vulnerable to accusations that it was reinforcing a global trend toward the development of supposedly more usable nuclear options. Any potential improvement to the warheads ability to strike hard targets might also draw criticism from those opposed to enhancements in nuclear weapon capabilities, as was the case when the U.K. began introducing the Mk4a arming, fusing and firing system. Lastly, U.K. defense planners might be thinking about future deterrence requirements for countries other than Russia, the traditional driver of U.K. warhead needs. This might have an impact on the requirements for a new warhead, such as on the question of the new warheads weight, which helps determine the maximum range that missiles can reach. This is a potentially relevant factor when considering the risk that future developments in anti-submarine warfare might complicate U.K. operations.

Can the United Kingdom Successfully Execute a Warhead Replacement Program?

The state of the United Kingdoms nuclear weapons infrastructure suggests that the country will face significant challenges in producing its next warhead, even if cooperation with the United States runs entirely smoothly. By now, at least three key U.K. facilities should have been up and running: Pegasus (to handle enriched uranium components), Mensa (to assemble and disassemble warheads), and Hydrus (to conduct hydrodynamic tests). None is fully operational. Pegasus has been suspended after initial designs were judged too expensive and unwieldy, Mensa is now being built at least six years late and at more than twice the original cost, and Hydrus has been replaced by a joint U.K.-French hydrodynamic facility in France not scheduled to be fully operational for the United Kingdom at least until 2022.

More fundamentally, this will be the first warhead the United Kingdom has designed for some thirty years, and the first ever without explosive nuclear testing. It will also be designed just as the last generation of Atomic Weapons Establishment employees with firsthand experience designing new warheads are retiring. With civil nuclear projects also planned for the coming decades, the Atomic Weapons Establishment will be facing considerable workforce recruitment, training, and retention challenges.

How Much Will the United Kingdoms New Warhead Cost?

In the context of the COVID-19 crisis, the forecast hit to the U.K. economy caused by Brexit, and an ongoing strategic review, there is likely to be financial pressure on the warhead program even if it is shielded from immediate cuts. Yet the government is staying remarkably coy about the projected costs of the new warhead. The 2006 White Paper estimated the cost to be 2 to 3 billion pounds ($2.6 to $3.9 billion). This estimate was confirmed in government documents as late as 2013. Since then, however, no official estimate has been provided, although the 2013 Trident Alternatives Review, a government-published document though not a statement of policy estimated the cost of a new submarine-launched ballistic missile warhead to be 4 billion pounds in 2012 prices.

The Nuclear Warhead Capability Sustainment Program, under which much of the supporting infrastructure for building a new warhead was supposed to be built, has an overall budget of 21 billion pounds spread out from 2005 to 2025, and is subject to the scrutiny requirements applied to major projects. The government has said that the program to build the new warhead will also be subject to those requirements, but is not giving a specific cost estimate, citing national security concerns. Likewise, it has not said which parts of the Nuclear Warhead Capability Sustainment Program will be subsumed under the new warhead program. It is certainly tricky to separate the costs of the new warhead from the overall costs of having nuclear infrastructure capable of maintaining the existing warhead. And yet not only has the U.K. government done so in the past making it difficult to imagine national security grounds for withholding the information now the U.S. government has also provided estimates of how much the W93 might cost: $14.4 billion, according to the Nuclear Security Administrations last published assessment.

Take Back Control

The United Kingdoms replacement nuclear warhead program is a long-term, complex, and expensive endeavor. It deserves proper scrutiny. And while many of the technical details of the U.K. warhead must remain classified, the broad parameters of the decision the government has made and the risks the program faces are fair game for public debate. The British public learned of the decision to replace the Holbrook warhead not because the government decided to announce it, but because U.S. officials told Congress and reporters in February. In several respects, the transparency of the U.S. government, and the persistence of Congress in extracting answers, is throwing the opacity of the United Kingdoms nuclear warhead program into stark relief. It is time for Parliament to take back control.

Matthew Harries (@harries_matthew) is a senior research fellow at the Royal United Services Institute for Defence and Security Studies (RUSI). He previously worked on the staff of the U.K. House of Commons Foreign Affairs Committee. Prior to that, he was managing editor of Survival and a senior fellow at the International Institute for Strategic Studies (IISS). This article is drawn from a research project supported by the John D. and Catherine T. MacArthur Foundation.

Image: U.S. Navy (Photo by John Kowalski)

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Will America Help Britain Build a New Nuclear Warhead? - War on the Rocks

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This Wellness Supplements Market analysis report offers all-inclusive study about production capacity, consumption, import and export for all the major regions across the world. Furthermore, the statistical and numerical data such as facts and figures are represented very neatly in this report by using charts, tables or graphs. This market document also involves strategic profiling of the major players in the market, comprehensive analysis of their basic competencies, and thereby keeping competitive landscape of the market in front of the client. The global Wellness Supplements Market report covers all the market shares and approaches of the major competitors or the key players in the market.

Market Analysis and Insights: Global Wellness Supplements Market

Wellness supplements market is expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to USD 386.29 billion by 2027 growing at a CAGR of 6.45% in the above-mentioned forecast period. The growing awareness towards healthy lifestyles among the people globally will help in driving the growth of the wellness supplements market.

The major players covered in thewellness supplements marketreport areLife Extension, OPTAVIA LLC, Beachbody LLC, Natures Sunshine Products, Inc, Organo Gold., Thrive Life, LLC, Phytoscience Trvo, Oriflame Cosmetics AG, Melaleuca Inc, Shaklee Corporation, Arbonne International, LLC., Forever Living.com, L.L.C, Juice Plus+, Herbalife International of America, Inc, and Isagenix Worldwide LLC, Nikken Inc., Wellness Resources, Inc., The Daily Wellness Company, Otsuka Holdings Co. Ltd, Glanbia plc, Nestle, Nuskin, USANA Health Sciences, Inc., among other domestic and global players.Market share data is available for Global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

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

Increasing ageing population, raising disposable income in developing countries and rising demands towards the healthy and cosmetic products will likely to accelerate the growth of the wellness supplements market in the forecast period of 2020-2027. On the other hand, gradual shift towards newer technologies and natural products and growth potential offered by emerging markets will further boost various opportunities that will lead to the growth of the wellness supplements market in the above mentioned forecast period.

Lack of traditional food categories, high cost of supplement food products, regulatory issues and increasing incidence of health issues will likely to hamper the growth of the wellness supplements market in the above mentioned forecast period.

This wellness supplements market report provides details of new recent developments, trade regulations, import export analysis, production analysis, value chain optimization, market share, impact of domestic and localised market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographical expansions, technological innovations in the market. To gain more info on wellness supplements market contact Data Bridge Market Research for anAnalyst Brief, our team will help you take an informed market decision to achieve market growth.

Global Wellness Supplements Market Scope and Market Size

Wellness supplements market is segmented on the basis of dietary supplements, functional food and beverage, nutricosmetics and free from food. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Wellness Supplements Market Country Level Analysis

Wellness supplements market is analysed and market size insights and trends are provided by country, dietary supplements, functional food and beverage, nutricosmetics and free from food as referenced above.

The countries covered in the wellness supplements market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America dominates the wellness supplements market due to growing cognizance and acceptance of wellness products and increasing focus towards healthy lifestyles while Asia-Pacific is expected to grow at the highest growth rate in the forecast period of 2020 to 2027 due to rising aging population and growing disposable income of the region.

The country section of the wellness supplements market 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 consumption volumes, production sites and volumes, import export analysis, price trend analysis, cost of raw materials, down-stream and upstream value chain analysis 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 domestic tariffs and trade routes are considered while providing forecast analysis of the country data.

Healthcare Infrastructure growth Installed base and New Technology Penetration

Wellness supplements market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipments, installed base of different kind of products for wellness supplements market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the wellness supplements market. The data is available for historic period 2010 to 2018.

Customization Available: Global Wellness Supplements Market

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

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Wellness Supplements Market : Incredible Possibilities, Growth With Industry Study, Detailed Analysis 2020-2027 | Leading Players Life Extension,...

Newswise SAN ANTONIO, TEXAS (October 19, 2020) Texas Biomedical Research Institute (Texas Biomed) Professor Luis Martinez-Sobrido, Ph.D., recently released study findings, alongside colleagues at the University of Alabama at Birmingham and Aridis Pharmaceuticals, Inc. indicating that a human monoclonal antibody (hmAb) 1212C2 showed promise for further clinical development for preventative use or as a therapy for SARS-CoV-2, the virus that causes COVID-19. Earlier this year, the consortium of scientists isolated specific B cells from patients infected with SARS-CoV-2 and developed a panel of hmAbs that not only bind to SARS-CoV-2 infected cells, but also neutralize the ability of the virus to infect cells. The hmAb 1212C2 was subsequently licensed to Aridis Pharmaceuticals.

Taking the study a step further, the scientists have shown, as outlined in the study on BioRxiv, that delivering hmAb 1212C2 directly to the lung through inhalation using Aridis proprietary formulation and plasma half-life extension, or by injection showed significant reduction in viral load in the lungs.

Antibodies are proteins produced by the bodys immune system to fight off infections. Monoclonal antibodies are commercially or experimentally produced antibodies derived from the original antibody producing cell. Scientists worldwide have shown that the Receptor Binding Domain (RBD) region of SARS-CoV-2s Spike protein is a key target for any drug that aims to stop the virus from attaching to cells through the human angiotensin converting enzyme 2 (ACE2) protein. If the virus cant attach to the cell, it cant infect and propagate. The hmAbs were discovered by the labs of Dr. James Kobie and Dr. Mark Walter at the University of Alabama at Birmingham in collaboration with Dr. Martinez-Sobrido.

In both lab and animal experiments, hmAb 1212C2 produced a preventative and therapeutic effect against SARS-CoV-2. In hamster models, delivering formulated and plasma half-life extended hmAb 1212C2 through a nebulizer at low dosage produced a significant reduction of the virus and lessened disease progression in the lungs.

These are critical findings as we look to develop vaccines and therapies that are not only effective, but also efficiently manufactured and easily administered to patients, Dr. Martinez-Sobrido explained.

Nearly 40 million people globally have contracted COVID-19 with more than one million deaths, and the worldwide pandemic is not slowing down. Neutralizing antibodies developed either by natural infection or through vaccination, or administered as a therapeutic are critical to the overall protection of the human population.

Administering targeted human antibodies that bind tightly to SARS-CoV-2 is a promising approach to advance therapies. We must have more effective therapies to reduce the death rate from this ongoing pandemic. I am excited about the opportunity to advance hmAb 1212C2 with Aridis Pharmaceuticals, said Dr. Larry S. Schlesinger, President/CEO of Texas Biomed.

The cohort of scientists licensed hmAb 1212C2 to Aridis for further development as both a possible prophylactic for preventing COVID-19 and as a treatment for COVID-19, while also looking at opportunities to use this hmAb in combination with other hmAbs, or with other antiviral therapies.

Staff in Dr. Luis Martinez-Sobridos lab who contributed to this research include Jun-Gyu Park, Fatai Oladunni, Chengjin Ye and Kevin Chiem.

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Texas Biomed is one of the worlds leading independent biomedical research institutions dedicated to eradicating infection and advancing health worldwide through innovative biomedical research. Texas Biomed partners with researchers and institutions around the world to develop vaccines and therapeutics against viral pathogens causing AIDS, hepatitis, hemorrhagic fever, tuberculosis and parasitic diseases responsible for malaria and schistosomiasis disease. The Institute has programs in host-pathogen interaction, disease intervention and prevention and population health to understand the links between infectious diseases and other diseases such as aging, cardiovascular disease, diabetes and obesity. For more information on Texas Biomed, go towww.TxBiomed.org.

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Texas Biomed with the University of Alabama at Birmingham and Aridis Pharmaceuticals develop a neutralizing human monoclonal antibody against...

PICKERING, Ontario, Oct. 23, 2020 (GLOBE NEWSWIRE) -- The Organization of Canadian Nuclear Industries (OCNI) is proud to congratulate Ontario Power Generation on the opening of its Centre for Canadian Nuclear Sustainability CCNS Innovation and Collaboration Space in Pickering Ontario.

OCNI is also pleased to announce that it as signed a Community Partner Agreement of the CCNS under which OCNI will work closely with the CCNS in mobilizing Ontarios strong nuclear supply chain to develop the unique tooling and remote handling systems required for nuclear decommissioning activities.

OCNI, working out of its head office in Pickering just down the road from CCNS Innovation Hub, will use its extensive international network in collaborating with the CCNS to development export opportunities for innovative nuclear decommissioning solutions generated by the CCNS and its partner organizations in the nuclear supply chain.

The Canadian Nuclear Decommissioning Capabilities Catalog being prepared for OCNI will enable the CCNS to identify unique decommissioning competencies across the Canadian supply chain for deployment on OPGs Pickering decommissioning project as well as on offshore decommissioning projects, said OCNI President and CEO, Dr. Ron Oberth.

The CCNS welcomes OCNI as a community and industry partner and looks forward to engaging with OCNI and its many member companies who have developed unique capabilities in reactor deconstruction and nuclear materials management through work on refurbishment and life extension projects on CANDU reactors at Darlington, Bruce, Argentina and South Korea, added Carla Carmichael, OPGs Vice President of Decommissioning Strategy and lead for the CCNS. With its long history and experience, the Canadian nuclear supply chain is well poised to lead and advance innovations in the next phase of the nuclear lifecycle.

Organization of Canadian Nuclear Industries (OCNI) is an association of more than 220 Canadian suppliers to the nuclear industry that employ more than 15,000 highly skilled and specialized engineers, technologists, and trades people. OCNI companies design reactors, manufacture major equipment and components, and provide engineering services and support to CANDU nuclear power plants in Canada as well as to CANDU and Light Water Reactor (LWR) plants in offshore markets.

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OCNI congratulates the Centre for Canadian Nuclear Sustainability (CCNS) on the opening of its Innovation and Collaboration Space in Pickering -...

EXTON, Pa.--(BUSINESS WIRE)--Bentley Systems, Incorporated, (Nasdaq: BSY), the infrastructure engineering software company, has announced the winners of the Year in Infrastructure 2020 Awards. The annual awards program honors the extraordinary work of Bentley users advancing design, construction, and operations of infrastructure throughout the world.

Sixteen independent jury panels selected the 57 finalists from over 400 nominations submitted by more than 330 organizations from more than 60 countries.

Bentley Systems acknowledged 19 Year in Infrastructure 2020 Awards winners and 14 Special Recognition awardees on October 21 during the Year in Infrastructure 2020 Conference, held virtually for the first time. To see the Year in Infrastructure 2020 Awards finalists present their projects, click here.

The Year in Infrastructure 2020 Special Recognition awardees are:

Advancing Project and Asset LongevityHDRMarc Basnight BridgeDare County, North Carolina, United States

Advancing Bridge Asset Performance ModelingUlsan National Institute of Science and Technology (UNIST)A Smartwatch on the BridgeUlsan, Ulju-gun, South Korea

Advancing Industrial Asset Performance ModelingThe Institute of Engineering and Ocean Technology/Oil and Natural Gas Corporation LimitedChallenges in Addressing Life Extension of Ageing Platforms in Western Offshore of IndiaMumbai, India

Comprehensiveness in Industrial Digital TwinsVolgogradnefteproekt, LLCEthane-Containing Gas Processing Complex Construction SupportUst-Luga, St. Petersburg, Russia

Comprehensiveness in Transportation Digital TwinsPT. WASKITA Karya (Persero) TbkRailway Facility for Manggarai to Jatinegara: Package A - Phase II ( Main Line II )South Jakarta, Jakarta, Indonesia

Comprehensiveness in Urban Digital TwinsJSTI Group Co., Ltd.Hengjiang Avenue Rapid Transformation ProjectNanjing, Jiangsu, China

Comprehensiveness in a Connected Data EnvironmentRoads & Transport Authority (RTA)Collaborative Information System Implementation - Whole Lifecycle Common Data EnvironmentDubai, United Arab Emirates

Advancing Virtualization through Digital TwinsNetwork RailOvercoming Challenges Under COVID-19 LockdownWales and Western Region, United Kingdom

Advancing Model-based Delivery through Digital TwinsNYS Department of TransportationModel Based Contracting - NYS RT 28 over the EsopusMount Tremper, New York, United States

Advancing Mixed-Reality WorkflowsLiaoning Water Conservancy and Hydropower Survey and Design Research Institute Co., Ltd.Chaoyang Underground Pumping Station Project of the LXB Water Supply Project Phase IIChaoyang, Liaoning, China

Advancing Sustainability Digital TwinsShanghai Institute of Mechanical and Electrical Engineering Co., Ltd.Shanghai Electric Environmental Protection Group Technology Renovation and Expansion Project for Nantong Thermoelectric Waste IncinerationNantong, Jiangsu, China

Advancing Sustainable ArchitectureSwatch Ltd., Shigeru Ban, Itten+Brechbhl AGSwatch HeadquartersBiel, Bern, Switzerland

Advancing Sustainable EnergyGuangdong Hydropower Planning & Design InstituteGuangdong Yangjiang Pumped Storage Power StationYangjiang, Guangdong, China

Advancing Sustainable WaterJacobsSan Jose HeadworksSan Jose, California, United States

The winners of the Year in Infrastructure 2020 Awards for going digital advancements in infrastructure are:

4D Digital ConstructionDPR Construction2019 LSM DS Tech UpgradeDurham, North Carolina, United States

BridgesChongqing Communications Planning, Survey & Design Institute Co., Ltd.,Guizhou Communications Construction Group Co., Ltd.,Guizhou Bridge Construction Group Co., Ltd.Digital Design and Construction of Taihong Yangtze River BridgeChongqing, China

Buildings and CampusesVoyants Solutions Private LimitedBangladesh Regional Waterway Transport Project 1 Shasanghat (New Dhaka) IWT TerminalDhaka-Shasanghat, Narayanganj, Chandpur, and Barisal; Bangladesh

Digital CitiesCity of HelsinkiDigital City of SynergyHelsinki, Finland

Geotechnical EngineeringGolder Associates Hong Kong Ltd.Tuen Mun-Chek Lap Kok Link Tunnel, Southern LandfallHong Kong

Land and Site DevelopmentAAEngineering GroupDzhamgyr Mine - Project Implementation in Extreme ConditionsTalas Region, Kyrgyzstan

ManufacturingMCC Capital Engineering & Research Incorporation Ltd.BIM Technology-Based Construction of Digital Plant for Iron & Steel Base in Lingang, Laoting of HBIS Group Co., Ltd.Tangshan, Hebei, China

Mining and Offshore EngineeringAAEngineering GroupDigital Twin of AKSU Plant: From Concept to StartupAksu, Akmola Region, Kazakhstan

Power GenerationShanghai Institute of Mechanical and Electrical Engineering Co., Ltd.Shanghai Electric Environmental Protection Group Technology Renovation and Expansion Project for Nantong Thermoelectric Waste IncinerationNantong, Jiangsu, China

Project DeliverySwecoSweco | Digitalisation with BIMUnited Kingdom

Rail and TransitPOWERCHINA Huadong Engineering Corporation LimitedInnovative Application of Digital Engineering Technology in Shaoxing Rail and Transit ConstructionShaoxing, Zhejiang, China

Reality ModelingKhatib & AlamiGeo-enabling Reality Model Tips and TricksMuscat, Oman

Road and Rail Asset PerformanceRoads and Transport Authority (RTA)Collaborative Information System Implementation - Whole Lifecycle Common Data EnvironmentDubai, United Arab Emirates

Roads and HighwaysSichuan Road & Bridge (Group) Co., Ltd.BIM Technology Application on Chengdu-Yibin ExpresswayChengdu, Sichuan, China

Structural EngineeringWSPWSP Overcomes Complex Challenges with Bentleys Technology to Deliver Principal TowerLondon, England, United Kingdom

Utilities and CommunicationsSterlite Power Transmission LimitedSterlite BIMTripura, India

Utilities and Industrial Asset PerformanceShells QGC businessEvolution of Engineering Data, Documents and Information ManagementBrisbane, Queensland, Australia

Water and Wastewater Treatment PlantsHatchAshbridges Bay Treatment Plant OutfallToronto, Ontario, Canada

Water, Wastewater, and Stormwater NetworksDTK Hydronet SolutionsDigital Water Network Engineering & Asset Management of Dibrugarh Water Supply ProjectDibrugarh, Assam, India

All awards finalists and winners

Detailed descriptions of all nominated projects are in the print and digital versions of Bentleys 2020 Infrastructure Yearbook, which will be published in early 2021. To review the past editions of this publication, access Bentleys Infrastructure Yearbooks.

Image: YII 2020 Awards Trophy and Yearbook

Caption: All Year in Infrastructure 2020 Award winners, finalists, and nominees will be featured in the 2020 Infrastructure Yearbook, which will be published in early 2021.

About Bentley Systems

Bentley Systems (Nasdaq: BSY) is the infrastructure engineering software company. We provide innovative software to advance the worlds infrastructure sustaining both the global economy and environment. Our industry-leading software solutions are used by professionals, and organizations of every size, for the design, construction, and operations of roads and bridges, rail and transit, water and wastewater, public works and utilities, buildings and campuses, and industrial facilities. Our offerings include MicroStation-based applications for modeling and simulation, ProjectWise for project delivery, AssetWise for asset and network performance, and the iTwin platform for infrastructure digital twins. Bentley Systems employs more than 4,000 colleagues and generates annual revenues of more than $700 million, in 172 countries. http://www.bentley.com

2020 Bentley Systems, Incorporated. Bentley, the Bentley logo, AssetWise, iTwin, MicroStation, and ProjectWise are either registered or unregistered trademarks or service marks of Bentley Systems, Incorporated or one of its direct or indirect wholly owned subsidiaries. All other brands and product names are trademarks of their respective owners.

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Bentley Systems Announces Winners of Year in Infrastructure 2020 Awards - Business Wire