Final Report will add the analysis of the impact of COVID-19 on this industry

Global Cancer Gene Therapy Market report 2020 analysis in-depth development status, market size, growth, production and services, current and future trends. This report provides market dynamics, drivers, competitive landscape, opportunities and latest strategies to help the emerging players to make crucial decisions. The Cancer Gene Therapy research report covers niche markets, potential risks and comprehensive competitive strategy analysis in different fields.

The Cancer Gene Therapy market contains top manufactures with business overview, product sales, price and gross margin for the forecast period. This report analyzes in detail for the potential risks and opportunities which can be focused on.

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Top Key Manufactures of Cancer Gene Therapy Market:

The global impacts of the coronavirus disease 2019 (COVID-19) are already starting to be felt, and will significantly affect the Cancer Gene Therapy in 2020. This report helps users in comprehending the key product segments and their future developments. And also provide the perspectives for the impact of COVID-19 from the long and short term. The Cancer Gene Therapy market declared the influence of the crisis on the industry chain, especially for marketing channels. Timely update the industry economic revitalization plan of the country-wise government.

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The Cancer Gene Therapy market analysis and forecast by types, by applications, by regions, SWOT analysis which is included the industry growth rate, market constraints and challenges, characteristics and business expansion plans for the upcoming years.

on the basis of types, the Cancer Gene Therapy market from 2015 to 2025 is primarily split into:

on the basis of applications, the Cancer Gene Therapy market from 2015 to 2025 covers:

The report assesses the key opportunities in the market and the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2015-2025).

Geographical Segmentation:

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Years considered for this report:

Key questions answered in this report:

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Detailed TOC of Cancer Gene Therapy Market Report Growth, Challenges and Forecast to 2020-2025:

1 COVID-19 Impact on Cancer Gene Therapy Market Overview

1.1 Product Definition and Market Characteristics

1.2 Global Cancer Gene Therapy Market Size

1.3 Cancer Gene Therapy market Segmentation

1.4 Global Macroeconomic Analysis

1.5 SWOT Analysis

2. COVID-19 Impact on Cancer Gene Therapy Market Dynamics

2.1 Cancer Gene Therapy Market Drivers

2.2 Cancer Gene Therapy Market Constraints and Challenges

2.3 Emerging Market Trends

2.4 Impact of COVID-19

2.4.1 Short-term Impact

2.4.2 Long-term Impact

3 Associated Industry Assessment

3.1 Supply Chain Analysis

3.2 Industry Active Participants

3.2.1 Suppliers of Raw Materials

3.2.2 Key Distributors/Retailers

3.3 Alternative Analysis

Continued

For Detailed TOC https://www.absolutereports.com/TOC/16296409#TOC

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Email: [emailprotected]

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View original post here:
Global Cancer Gene Therapy Market Analysis by Size: 2025, Impact of Covid-19 on Industry Chain, Market Growth, Drivers | Business Overview with Top...

Recommendation and review posted by Bethany Smith

The global cancer gene therapy market is estimated to surpass $4,188.5 million by 2027, exhibiting a CAGR of 23.0% from 2020 to 2027.

The report aims to offer a clear picture of the current scenario and future growth of the global Cancer Gene Therapy market. The report provides scrupulous analysis of global market by thoroughly reviewing several factors of the market such as vital segments, regional market condition, market dynamics, investment suitability, and key players operating in the market. Besides, the report delivers sharp insights into present and forthcoming trends & developments in the global market.

The report articulates the key opportunities and factors propelling the global Cancer Gene Therapy market growth. Also, threats and limitations that have the possibility to hamper the market growth are outlined in the report. Further, Porters five forces analysis that explains the bargaining power of suppliers and consumers, competitive landscape, and development of substitutes in the market is also sketched in the report.

For More Detail Insights, Download Sample Copy of the Report at: https://www.researchdive.com/download-sample/477

The report reveals various statistics such as predicted market size and forecast by analyzing the major factors and by assessing each segment of the global Cancer Gene Therapy market. Regional market analysis of these segments is also provided in the report. The report segments the global market into four main regions including Asia-Pacific, Europe, North America, and LAMEA. Moreover, these regions are sub-divided to offer an exhaustive landscape of the Cancer Gene Therapy market across key countries in respective regions. Furthermore, the report divulges some of the latest advances, trends, and upcoming opportunities in every region.

Furthermore, the report profiles top players active in the global Cancer Gene Therapy market. A comprehensive summary of 10 foremost players operating in the global market is delivered in the report to comprehend their position and footmark in the industry. The report highlights various data points such as short summary of the company, companys financial status and proceeds, chief company executives, key business strategies executed by company, initiatives undertaken & advanced developments by the company to thrust their position and grasp a significant position in the market.

RESEARCH METHODOLOGY

The research report is formed by collating different statistics and information concerning the Cancer Gene Therapy market. Long hours of deliberations and interviews have been performed with a group of investors and stakeholders, including upstream and downstream members. Primary research is the main part of the research efforts; however, it is reasonably supported by all-encompassing secondary research. Numerous product type literatures, company annual reports, market publications, and other such relevant documents of the leading market players have been studied, for better & broader understanding of market penetration. Furthermore, medical journals, trustworthy industry newsletters, government websites, and trade associations publications have also been evaluated for extracting vital industry insights.

Connect with Our Analyst to Contextualize Our Insights for Your Business:https://www.researchdive.com/connect-to-analyst/477

KEY MARKET BENEFITS

KEY MARKET SEGMENTS

The global Cancer Gene Therapy market is segmented on the basis of the following:

Global Cancer Gene Therapy Market By Product Type:

Global Cancer Gene Therapy Market By Applications:

Global Cancer Gene Therapy Market By Regions:

Top Leading key players stated in Global Cancer Gene Therapy Market report are:

Sirion Biotech, Vigene Biosciences, Bluebird bio, Ziopharm, Cellectis, Cobra, Finvector, Uniqure, Sarepta Therapeutics.

The report also summarizes other important aspects including financial performance, product portfolio, SWOT analysis, and recent strategic moves and developments of the leading players.

Contact Us:

Mr. Abhishek PaliwalResearch Dive30 Wall St. 8th Floor, New YorkNY 10005 (P)+ 91 (788) 802-9103 (India)+1 (917) 444-1262 (US) TollFree : +1 -888-961-4454Email:[emailprotected]LinkedIn:https://www.linkedin.com/company/research-diveTwitter:https://twitter.com/ResearchDiveFacebook:https://www.facebook.com/Research-DiveBlog:https://www.researchdive.com/blogFollow us on:https://covid-19-market-insights.blogspot.com

More:
Growth Outlook: Cancer Gene Therapy Market Is Projected to Grow at a Substantial Rate by 2027 Report by ResearchDive - The Think Curiouser

Recommendation and review posted by Bethany Smith

CAMBRIDGE, Mass., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Voyager Therapeutics, Inc. (NASDAQ: VYGR) today reported its third quarter 2020 financial results, program progress and corporate updates.

During the third quarter, we took important steps to advance our lead programs for Parkinsons disease and Huntingtons disease with the presentation of positive long-term clinical results and the filing of an IND, respectively. Together with our partner, Neurocrine, we are currently focused on resuming enrollment in the RESTORE-1 clinical trial for Parkinsons disease pending the requested review and assessment of patient imaging data by the DSMB. For our Huntingtons disease program, the FDA has provided clarity regarding the additional information it is requesting pursuant to our IND filing. We plan to work with the FDA to respond to these requests to allow for an IND clearance and the start of VY-HTT01s clinical evaluation, said Andre Turenne, President and CEO of Voyager. We look forward to continuing our progress on these two important programs, along with our broadening AAV gene therapy portfolio to treat severe neurological diseases.

Recent Program and Corporate Highlights

VY-AADC (NBIb-1817) for Parkinsons Disease

VY-HTT01 for Huntingtons Disease

Novel AAV Capsid Discovery Program

Recent Corporate Updates

Third Quarter 2020 Financial Results

Financial Guidance

About Voyager TherapeuticsVoyager Therapeutics is a clinical-stage gene therapy company focused on developing life-changing treatments for severe neurological diseases. Voyager is committed to advancing the field of AAV gene therapy through innovation and investment in vector engineering and optimization, manufacturing, and dosing and delivery techniques. Voyagers wholly owned and partnered pipeline focuses on severe neurological diseases for which effective new therapies are needed, including Parkinsons disease, Huntingtons disease, Friedreichs ataxia, and other severe neurological diseases. For more information on Voyager Therapeutics, please visit the companys website at http://www.voyagertherapeutics.com or follow @VoyagerTx on Twitter and LinkedIn.

Voyager Therapeutics is a registered trademark, and TRACER is a trademark, of Voyager Therapeutics, Inc.

Forward-Looking Statements This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as may, might, will, would, should, expect, plan, anticipate, believe, estimate, undoubtedly, project, intend, future, potential, or continue, and other similar expressions are intended to identify forward-looking statements. For example, all statements Voyager makes regarding Voyagers ability to deliver patient imaging data to the DSMB for the RESTORE-1 Phase 2 clinical trial, the review of such data by the DSMB prior to year-end, and pending the DSMBs evaluation of such data the resumption of enrollment in the RESTORE-1 Phase 2 clinical trial; the submission by Neurocrine Biosciences of an expedited safety report relating to the RESTORE-1 clinical trial in a timely manner; Voyagers efforts to work with the FDA to resolve additional information requests relating to the IND application for VY-HTT01, the clearance of the VY-HTT01 IND application by the FDA and the initiation of a Phase 1b clinical trial of VY-HTT01; Voyagers continuing efforts in the discovery and engineering of novel AAV capsids, including progressing non-human primate studies of selected novel capsids; the contributions that will be made to Voyager by key senior level officers and a new member to the Voyager Board of Directors; the timing, progress, activities, goals and reporting of results of Voyagers preclinical programs and clinical trials and its research and development programs; the potential clinical utility of its product candidates; Voyagers ability to add new programs to its pipeline; the regulatory pathway of, and the timing or likelihood of its regulatory filings and approvals for, any of its product candidates; Voyagers anticipated financial results, including Voyagers available cash, cash equivalents and marketable debt securities; Voyagers ability to fund its operating expenses with its current cash, cash equivalents and marketable debt securities through a stated time period; and the ability of Voyager to maintain a high level of business critical activity and maintain a level of scientific leadership during the COVID-19 health crisis are forward looking statements.

All forward-looking statements are based on estimates and assumptions by Voyagers management that, although Voyager believes such forward-looking statements to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Voyager expected. Such risks and uncertainties include, among others, the ability to provide imaging data to the DSMB for the RESTORE-1 Phase 2 clinical trial, and the ability for the DSMB to complete its evaluation and to resolve questions that may exist regarding such patient data; the ability for Voyager to meet the information requests of, and to resolve questions raised by, the FDA relating to the IND application for VY-HTT01; the ability of Voyager to progress its research and engineering program for novel capsids and to conduct non-human primate studies; the initiation and conduct of preclinical studies and clinical trials; the availability of data from preclinical studies and clinical trials, and the ability to effectively present such data; Voyagers scientific approach and general development progress; the ability to attract and retain talented contractors and employees; the ability to create and protect intellectual property; the sufficiency of cash resources; the possibility or the timing of the exercise of development, commercialization, license and other options under collaborations; the commercial potential of Voyagers product candidates; the severity and length of the COVID-19 health crisis, the imposition of governmental controls and guidance addressing the COVID health crisis; and the financial and human resources available to Voyager to manage the COVID-19 health crisis. These statements are also subject to a number of material risks and uncertainties that are described in Voyagers Annual Report on Form 10-K filed with the Securities and Exchange Commission, as updated by its subsequent filings with the Securities and Exchange Commission. All information in the press release is as of the date of this press release, and any forward-looking statement speaks only as of the date on which it was made. Voyager undertakes no obligation to publicly update or revise this information or any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

Investors:Paul CoxVP, Investor Relations857-201-3463pcox@vygr.com

Media:Sheryl Seapy W2Opure949-903-4750sseapy@purecommunications.com

Selected Financial Information($-amounts in thousands, except per share data)(Unaudited)

Read the original post:
Voyager Therapeutics Announces Third Quarter 2020 Financial Results and Corporate Updates - GlobeNewswire

Recommendation and review posted by Bethany Smith

The gene therapy market has undergone a series of transformation from past few years. Initially gene therapy of monogenetic diseases was popular; however now the gene therapy market is gaining popularity for treatment of cancer. Cancer gene therapy refers to a process of treatment of cancer by inserting therapeutic DNA into patient. Cancer gene therapy is gaining popularity as a result of its success rate in preclinical and clinical trial stages. The most common technique for cancer gene therapy involves replacing a mutated gene that is causing cancer with a healthy copy of gene. Other technique involves inactivation of a gene that is not working properly. A new technique that is being introduced to cancer gene therapy market involves insertion of new genes into the body that would help to fight against tumor cells.

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North America followed by Europe dominates the global market for cancer gene therapy market due to large number of aging population and technological advancement in the region. Asia is expected to witness high growth in cancer gene therapy market, due to increasing government initiatives, rising economy and improvement in healthcare infrastructure in the region. Some of the key driving forces for cancer gene therapy market in emerging countries are increasing R&D investment, large pool of patients and rising government funding.

For Information On The Research Methodology request here @https://www.persistencemarketresearch.com/methodology/2988

Several unmet medical needs for treatment of cancer have encouraged R&D of cancer gene therapy. Various factors, such as increasing prevalence of cancer, rising government initiatives, increasing funding from various government and non-government organizations, are driving the global cancer gene therapy market. In addition, ethical acceptance of gene therapy for treatment of diseases and growing popularity of DNA vaccines is driving the global cancer gene therapy market. However, less awareness and high cost involved in treatment are restraining the growth of global market for cancer gene therapy.

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Innovation of some innovative therapy with better success rate is expected to offer good opportunity for cancer gene therapy. In addition, despite of high cost involved in R&D, pharmaceutical companies are showing increased interest in this field. This is expected to offer good potential for cancer gene therapy market. Currently, most of the cancer gene therapy products are in clinical trial phases. The market is expected to rise after clearance or success of these products from clinical trials. Some of the major companies operating in the global cancer gene therapy market are Cell Genesys, Advantagene, GenVec, BioCancell, Celgene and Epeius Biotechnologies. Other leading players in cancer gene therapy market include Introgen Therapeutics, ZIOPHARM Oncology, MultiVir and Shenzhen SiBiono GeneTech

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To support companies in overcoming complex business challenges, we follow a multi-disciplinary approach. At PMR, we unite various data streams from multi-dimensional sources. By deploying real-time data collection, big data, and customer experience analytics, we deliver business intelligence for organizations of all sizes.

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See the article here:
The Cancer Gene Therapy market to personify growth in the next decade - Eurowire

Recommendation and review posted by Bethany Smith

NEW YORK Would you buy something you cant see?

Thats the question posed by two New York brothers whove lost much of their vision to a rare degenerative eye disorder and have dedicated their lives and livelihoods to raising money for a cure.

Bradford Manning, 35, and his 30-year-old brother, Bryan, are the founders of the clothing brand Two Blind Brothers. Theyve hit on a strategy thats helped raise more than $700,000 for the cause: selling mystery boxes full of an assortment of their ultra-soft shirts, cozy socks, knit beanies and sunglasses.

The two turn over all profits from the boxes and their other sales to groups like the Foundation Fighting Blindness, funding research on retinal eye ailments like the one theyve suffered from since they were 5, Stargardt disease. Its an inherited form of macular degeneration that causes central vision loss over time.

We just wanted to try and help and raise awareness, and just do something good, said Bryan.

Since 2016, when they left their previous careers Brad worked for an investment firm and Bryan sold software theyve picked up celebrity supporters like Ice-T and entrepreneur Richard Branson. Ellen DeGeneres helped with one of her famous Shutterfly checks for $30,000.

And the sale of their mystery boxes, costing from $30 to $200, is now a social media phenomenon.

Customers have included relatives of the blind, among them parents with vision impaired children; some have posted unboxing videos on TikTok, Facebook and Instagram, with a few opening boxes blindfolded.

The brothers hit on the idea in 2015, when a gene therapy discovered by an underfunded researcher for an unrelated juvenile eye disease was about to hit the market.

It was mind boggling to us, Bryan said. Our whole lives they were like, Oh, a cure is down the line, a cure is down the line. This one isnt for us, but it is happening, and the Foundation Fighting Blindness kicked this off with just a tiny charitable gift to this brilliant researcher.

Soon after, they were separated while shopping at Bloomingdales. When they reconnected, they found that they had purchased the same soft shirt.

It was the feel of it. It felt so soft and comfortable that we both keyed upon it, and then we had this idea, well what if we could take this sense of touch to a different place, make super comfortable clothing and turn over the profits to researchers at work on eye diseases, Bryan said.

With advice from friends in the fashion industry, two blind brothers became Two Blind Brothers.

The casual line of super soft Henleys, hoodies, polos and T-shirts for men and women, along with offerings for kids, are made of sustainable bamboo mixed with cotton and spandex. Theyve incorporated Braille indicating the color of each garment into some of the designs they sell online at Twoblindbrothers.com.

The goods were originally manufactured in Texas, mostly by visually impaired people. But as theyve grown, most of the operation moved to Los Angeles.

Brad was diagnosed at 7 after their mother, a nurse, found a doctor who determined that Stargardt disease was the cause of his declining vision.

The doctor told her to take him home, get him a magnifier and maybe teach him Braille, and good luck, Bryan recalled. But they would not give up on their sons. Today, their condition has slowed, leaving both with peripheral vision.

The brothers include their story in every mystery box, with some special thanks.

When someone shops blind, they prove something remarkable, they write. They prove that genuine trust is real.

Read the original here:
How two blind brothers became Two Blind Brothers for a cause - The Columbian

Recommendation and review posted by Bethany Smith

Would you buy something you cant see?Thats the question posed by two New York brothers whove lost much of their vision to a rare degenerative eye disorder and have dedicated their lives and livelihoods to raising money for a cure.Bradford Manning, 35, and his 30-year-old brother, Bryan, are the founders of the clothing brand Two Blind Brothers. Theyve hit on a strategy thats helped raise more than $700,000 for the cause: selling mystery boxes full of an assortment of their ultra-soft shirts, cozy socks, knit beanies and sunglasses.The two turn over all profits from the boxes and their other sales to groups like the Foundation Fighting Blindness, funding research on retinal eye ailments like the one theyve suffered from since they were 5, Stargardt disease. Its an inherited form of macular degeneration that causes central vision loss over time.We just wanted to try and help and raise awareness and just do something good, said Bryan.Since 2016, when they left their previous careers Brad worked for an investment firm and Bryan sold software theyve picked up celebrity supporters like Ice-T and entrepreneur Richard Branson. Ellen DeGeneres helped with one of her famous Shutterfly checks for $30,000. And the sale of their mystery boxes, costing between $30 to $200, is now a social media phenomenon.Customers have included relatives of the blind, among them parents with vision impaired children; some have posted unboxing videos on TikTok, Facebook and Instagram, with a few opening boxes blindfolded. The brothers hit on the idea in 2015, when a gene therapy discovered by an underfunded researcher for an unrelated juvenile eye disease was about to hit the market. It was mind boggling to us, Bryan said. Our whole lives they were like, 'Oh, a cure is down the line, a cure is down the line.' This one isnt for us, but it is happening, and the Foundation Fighting Blindness kicked this off with just a tiny charitable gift to this brilliant researcher.Soon after, they were separated while shopping at Bloomingdales. When they reconnected, they found that they had purchased the same soft shirt.It was the feel of it. It felt so soft and comfortable that we both keyed upon it, and then we had this idea, well what if we could take this sense of touch to a different place, make super comfortable clothing and turn over the profits to researchers at work on eye diseases, Bryan said.With advice from friends in the fashion industry, two blind brothers became Two Blind Brothers.The casual line of super soft Henleys, hoodies, polos and T-shirts for men and women, along with offerings for kids, are made of sustainable bamboo mixed with cotton and spandex. Theyve incorporated Braille indicating the color of each garment into some of the designs they sell online at Twoblindbrothers.com.The goods were originally manufactured in Texas, mostly by visually impaired people. But as theyve grown, most of the operation moved to Los Angeles. Brad was diagnosed at 7 after their mother, a nurse, found a doctor who determined that Stargardt disease was the cause of his declining vision. The doctor told her to take him home, get him a magnifier and maybe teach him Braille, and good luck, Bryan recalled. But they would not give up on their sons. Today, their condition has slowed, leaving both with peripheral vision. The brothers include their story in every mystery box, with some special thanks.When someone shops blind, they prove something remarkable, they write. They prove that genuine trust is real.

Would you buy something you cant see?

Thats the question posed by two New York brothers whove lost much of their vision to a rare degenerative eye disorder and have dedicated their lives and livelihoods to raising money for a cure.

Bradford Manning, 35, and his 30-year-old brother, Bryan, are the founders of the clothing brand Two Blind Brothers. Theyve hit on a strategy thats helped raise more than $700,000 for the cause: selling mystery boxes full of an assortment of their ultra-soft shirts, cozy socks, knit beanies and sunglasses.

The two turn over all profits from the boxes and their other sales to groups like the Foundation Fighting Blindness, funding research on retinal eye ailments like the one theyve suffered from since they were 5, Stargardt disease. Its an inherited form of macular degeneration that causes central vision loss over time.

We just wanted to try and help and raise awareness and just do something good, said Bryan.

Since 2016, when they left their previous careers Brad worked for an investment firm and Bryan sold software theyve picked up celebrity supporters like Ice-T and entrepreneur Richard Branson. Ellen DeGeneres helped with one of her famous Shutterfly checks for $30,000.

And the sale of their mystery boxes, costing between $30 to $200, is now a social media phenomenon.

Customers have included relatives of the blind, among them parents with vision impaired children; some have posted unboxing videos on TikTok, Facebook and Instagram, with a few opening boxes blindfolded.

The brothers hit on the idea in 2015, when a gene therapy discovered by an underfunded researcher for an unrelated juvenile eye disease was about to hit the market.

It was mind boggling to us, Bryan said. Our whole lives they were like, 'Oh, a cure is down the line, a cure is down the line.' This one isnt for us, but it is happening, and the Foundation Fighting Blindness kicked this off with just a tiny charitable gift to this brilliant researcher.

Soon after, they were separated while shopping at Bloomingdales. When they reconnected, they found that they had purchased the same soft shirt.

It was the feel of it. It felt so soft and comfortable that we both keyed upon it, and then we had this idea, well what if we could take this sense of touch to a different place, make super comfortable clothing and turn over the profits to researchers at work on eye diseases, Bryan said.

With advice from friends in the fashion industry, two blind brothers became Two Blind Brothers.

The casual line of super soft Henleys, hoodies, polos and T-shirts for men and women, along with offerings for kids, are made of sustainable bamboo mixed with cotton and spandex. Theyve incorporated Braille indicating the color of each garment into some of the designs they sell online at Twoblindbrothers.com.

The goods were originally manufactured in Texas, mostly by visually impaired people. But as theyve grown, most of the operation moved to Los Angeles.

Brad was diagnosed at 7 after their mother, a nurse, found a doctor who determined that Stargardt disease was the cause of his declining vision.

The doctor told her to take him home, get him a magnifier and maybe teach him Braille, and good luck, Bryan recalled. But they would not give up on their sons. Today, their condition has slowed, leaving both with peripheral vision.

The brothers include their story in every mystery box, with some special thanks.

When someone shops blind, they prove something remarkable, they write. They prove that genuine trust is real.

The rest is here:
How two blind brothers created a one-of-a-kind shopping experience to raise money for a cure - WXII The Triad

Recommendation and review posted by Bethany Smith

As my colleagues and I first described in 2014, we can use CRISPR genome editing to duplicate the most powerful form of gene drive, a ubiquitous natural phenomenon that happens when a genetic change is inherited more frequently than usual. Encode the CRISPR machinery next to a useful edit weve made in the genome, and genome editing will reoccur in every generation, replacing the original with the edited version without limit. In principle, releasing such organisms would gradually alter entire wild populations and associated ecosystems.

Thankfully, driven changes spread slowly and can be readily overwritten, which means that, unlike pandemic viruses, gene drive would be hard to misuse. If developed wisely, safe and controllable ecological editing could help eradicate animal-borne diseases such as malaria, humanely control rodents and insect pests without using poisons, and solve increasingly urgent conservation problems by harnessing tools already present in nature.

Unfortunately, many of these applications are being developed in secret not because my colleagues prefer it that way, but because current scientific incentives still favor secretive research.

That was deeply troublesome even before the pandemic. Today, it sets a precedent that scientists can pursue self-spreading technologies with no required safeguards and negligible public oversight.

Moreover, developing interventions to change our environment is fundamentally different from medical research. If your doctor recommends that you take a new drug, you can always decline. But if we develop interventions to change our environment, and a community decides to use them, everyone there will be affected. We know that actively inviting and responding to concerns and criticism from the public can identify and correct flaws early enough to make a difference so why not here?

A 2016 report by the US National Academies concurred, noting, The best course of action is to ensure that the people who could be affected by a proposed project or policy have an opportunity to have a voice in decisions about it. Experts acting alone will not be able to identify or weigh the true costs and benefits of gene drives.

Its now 2020, and most research still takes place out of public view. Society rewards the first to publish, causing most scientists to keep their experimental plans to themselves lest someone else throw more money and hands at a promising idea and take all the credit. The system endures, even though closeted research is both less efficient and more dangerous: Small teams of similarly trained specialists working in isolation cant reliably predict the consequences of their work, nor invite others to help them improve their designs.

Despite years of lobbying by many of us in the field, funders of gene-drive research have struggled to agree on which safeguards should be required to prevent accidental releases of gene-drive systems into the wild, let alone require transparency and community guidance. Publishers of high-profile journals have similarly declined to act. Crucially, both have cited the absence of a central organizing body to establish standards.

Unlike COVID-19, this is a problem that the World Health Organization can easily solve in this case, by creating a registry for ecological editing research just like they did for CRISPR gene therapy. Doing so would improve our science, our ethics, and the odds that these technologies will one day save millions of lives, not to mention set a better precedent for future research into self-spreading agents.

The question is what should be required to register a project. Based on our work with the communities of Nantucket and Marthas Vineyard on immunizing the local white-footed mice to prevent transmission of Lyme disease which by community preference doesnt involve gene drive or any DNA not found in wild mice weve identified a few key criteria:

Scientists should disclose the nature of the proposed alteration and why its worth considering. People deserve to know enough about the project to suggest changes and share concerns.

Researchers should assess the risk of accidental spread and detail any safeguards that would prevent it from happening if organisms should escape or be deliberately released from a laboratory or field trial site.

Any projects aiming to edit an organism responsible for a real-world problem should require sponsorship by a community interested in pioneering the application who will help to guide the research.

Most important, scientists should be required to register their plans before any technology development begins. Its easier to make changes in response to advice from peers and interested communities before becoming too invested and, in a field where a single mistake could affect millions, its best to invite external advice early on.

An ecological editing registry endorsed by funders, major journals, and scientific societies would enable the high-profile discipline of gene-drive research to serve as a field trial for open and community-responsive technology development, with beneficial effects that could spread far beyond genome editing.

Thats not to say that all research should be open; we certainly dont want to disclose how to make a pandemic, should we be so unlucky as to live in a universe in which its possible. Rather, we should establish transparent, publicly accessible standards to help determine whether, when, and how research that could impact everyone should proceed. Speaking as a scientist who bears a share of moral responsibility for the most prominent self-spreading technology, the best time to do this was several years ago but this year will do nicely.

Kevin Esvelt is an assistant professor at the MIT Media Lab, where he directs the Sculpting Evolution group. An evolutionary engineer, he is an inventor of CRISPR-based gene drive and a founder of the community-guided Mice Against Ticks project to prevent Lyme disease.

Read this article:
The ethical way to alter organisms - The Boston Globe

Recommendation and review posted by Bethany Smith

Introduction

Last week, the Teladoc (TDOC) and Livongo (LVGO) merger was completed. That means that Livongo doesn't trade anymore. If you still had your Livongo shares, you got (or will get if your broker is a bit slower) 0.5920 per share of Livongo in Teladoc shares plus cash of $11.33, paid with a special dividend of $7.09 on October 29th, and the rest when your shares were changed to Teladoc shares.

(Source)

As a former shareholder of Livongo, you may not be completely familiar with how Teladoc is positioned now. If there is a buy-out or a merger, that always generates mixed feelings, or at least it should. If it doesn't, it means that you had a bad stock in your portfolio.

With Potential Multibaggers, my marketplace service here on Seeking Alpha, I try to find multibaggers early on. I picked Livongo as a Potential Multibagger on December 26, 2019. The stock then traded at $24.86 and had a market cap of just $2.5B. The stock returned 462.2%, so it's more than a fivebagger in less than a year. But still, quite a few shareholders, from both companies, didn't feel great about the merger.

I think Teladoc could still be a multibagger at this point for patient investors. I think most investors underestimate that this combined company could represent the future of our healthcare system. In this article, written from a bird's eye perspective, I will try to explain why.

I think a lot of people know that the American healthcare system (and that of most Western countries) is unsustainable. It's too expensive but nobody seems to find a way out to cut costs.

The problem is that our healthcare is one of the last sectors that has not been disrupted by tech yet. The system originates from a time when bigger was better because it was more affordable to have standard procedures. Long ago, there was a family doctor and he knew you and you knew him and you had a personal relationship with that man (female doctors almost didn't exist back then).

After the Second World War, two evolutions emerged that made this system unsustainable: people reached a higher and higher age and the Baby Boomers were born. That put pressure on both ends of the healthcare system and the solutions were more scale and introducing standard procedures, so the productivity of healthcare workers became higher. Specialized care also contributed to more efficiency. And it worked.

But there was a side effect. People don't feel connected to the people that should care for them. They often feel treated like numbers, like patients at best, but mostly not like individual people. I'm not throwing a stone here at doctors, nurses and other healthcare workers. They often share that feeling. They don't have the time to deeply care about people. Their time is limited, they have to reach the quota. A doctor is not paid for listening to you. He's paid per patient that he handles. In other words, the less he or she listens, the more the doctor is incentivized. And that wears out a lot of healthcare workers.

Normally, such a market would correct itself. If you are not properly served in Lowe's (LOW), you go to Home Depot (HD) or the other way around. If one is really not giving enough attention to its clients, the company will go bankrupt eventually. That's where the efficiency of the market plays its role.

But in healthcare, the patients are not the customers. They are the goods, as it were. Customers are the paying party. And who pays for healthcare costs? Exactly, the insurance companies. Their only objective is as little costs as possible and that's why they pay per visit, for example.

But this creates the strange effect that a doctor that treats you very well is only paid once, while a bad doctor, who follows the wrong procedure and has to repair the damage or gives the wrong diagnosis, is rewarded each time he or she treats you and so earns more money than the good doctor.

To fix the healthcare system, a little reparation here and there won't help. We saw in the last decades that tech has entered almost every industry and has disrupted industries completely. Think of how Amazon (AMZN) made Sears obsolete. The same thing should (and probably will) happen in healthcare.

Disruption comes from the Latin verb 'disrumpere', which means to break apart and that is what healthcare needs: breaking things apart to build them up again. The bottom line of every healthcare reform should be to use tech and turn the system upside down. Health should be rewarded and paid for, not sickness.

All insurance is meant for emergency cases, except for healthcare insurance. Doctors are incentivized to do as many consults and tests as possible because someone makes money on that: the doctor himself or the hospital, mostly both. A hospital, for example, makes 10 or 20 times more money if you go to the emergency room than if you use an online platform to talk to a telehealth doctor.

As a patient, if you see a doctor, most of that little time you spend with him or her is dedicated to tests, collecting data. But suppose the doctor already would have all the data when you come in and he or she has already been able to look into your case, your history, and tens of up-to-date data points before you came in, that doctor could have time for that which we all crave when we visit a doctor: talking about what you exactly have and what it means, what we can do to get better, a discussion about what the underlying cause could be, talking about the psychological effects that your condition brings with it, what the best plan of action would be for you, etc. In other words, the doctor could become some kind of health coach, a professional that, with the help of precise data, could prescribe a trajectory to better health, hold you accountable, help you when sticking to the plan is tough etc. A doctor could partly become a real healthcare worker, not just a sickcare worker.

That would mean that you wouldn't have to visit a doctor as often. If you have a chronic condition, you could be monitored 24/7 by sensors, assisted by AI, as Livongo does for diabetes. You are not only monitored but you also get health nudges. That means that you would know exactly what is the right path for you. And that path is much more individualized than most people can imagine.

Hemant Taneja, a venture capitalist of General Catalyst who founded Livongo with Glen Tullman, calls this new space in healthcare 'health assurance'.

(Hemant Taneja, right, together with Livongo founder Glen Tullman, source)

Taneja is convinced that health assurance industry will see several $100B+ companies. I suspect that he was the great driving force behind the Livongo/Teladoc merger, together with Glen Tullman. They realized that Livongo can become so much more combined with Teladoc than on its own.

This is how health assurance is defined:

Health assurance is an emerging category of consumer-centric, data-driven healthcare services that are designed to bend the cost curve of care and help us stay well. Built on the principles of open technology standards, these services employ empathetic user design and responsible AI. This is the future of your health experience.

If you want to know more about this, you could read Taneja's interesting book Unhealthcare.

(Source)

Now that you know the basics of the concept of health assurance, I think you can see the potential for Teladoc and Livongo in this market. There is no company that is as well-positioned as the combination of Teladoc and Livongo. Livongo brings measuring, data collection and especially AI to the table, Teladoc has a worldwide network of telehealth.

Investors who just see what there is now could get scared away from Teladoc. They look at the number of telehealth visits that could slow down after the peak of the coronavirus and they are afraid that Teladoc will just have been a COVID-19-induced fad. But if you look at the future, you see that this company could be in the sweet spot when healthcare will be disrupted over the next decade.

Insurance companies will help them with this. As we have already seen, they just want to pay as little as possible. Livongo saved insurance companies $88 per patient per month. The reason: the monitoring of diabetes patients, the fact that they have a diabetes coach that is always available and the health nudges reduce the medical costs dramatically. $88 per patient per month means more than $1,000 per year per patient. I think you see the potential.

Besides that, the patients also feel freer than before. Their diabetes doesn't control their lives as much. They need less medication and if they need it, the data will indicate it before the attack.

This is just for diabetes. That's already a big market. But Livongo doesn't just focus on diabetes but also on hypertension and obesity. Those are two huge markets as well. The hypertension market is estimated to be $23B in 2026 and the obesity treatment market is estimated to be around $20B in 2026. But suppose you add the weight loss market to this, which is worth about $70B in the US alone, and you can see the potential.

The obesity-related healthcare costs are estimated at around $147B annually, so this might mean big savings for healthcare spending.

There will certainly be other companies in this space than just Livongo and Teladoc, companies that will also focus on other domains, but so far, I don't see any competitor that is as advanced as Livongo/Teladoc is.

When I pick a Potential Multibagger, I turn a company inside out and that means that I know Livongo, its founders Glen Tullman and Hemant Taneja and what the company exactly does really well.

I didn't know Teladoc as well before the merger was announced. I had it on my watchlist, but I had not done a really deep dive. When I did, I found a lot that I liked. This statement by Teladoc's CEO Jason Gorevic on the closing of the merger is worth reading word for word if you want to understand the combination of the companies:

Both Teladoc Health and Livongo were founded with the same mission: to create a new kind of healthcare experience, one that empowers people everywhere to live their healthiest life. Today's news (the merger, FGTV) dramatically accelerates our ability to make this a reality for the tens of millions of consumers and healthcare professionals we serve around the world. Together, our team will achieve the full promise of whole-person virtual care, leveraging our combined applied analytics, expert guidance and connected technology to deliver, enable and empower better health outcomes."

There are a few critical phrases here. Let's look at them one by one.

"a new kind of healthcare experience" This is the disruption that I mentioned. Not just fine-tuning the current system, but a completely fresh start.

"one that empowers people everywhere to live their healthiest life".

This is the health assurance that I was talking about. Helping people to live their healthiest life is the reverse of what the current healthcare system thrives on. Empowerment means that people will be able to decide for themselves and take their health into their own hands. The 'everywhere' in this phrase refers to the global footprint Teladoc has.

"whole-person virtual care"

This refers to everything from health assurance to data, treatment plans, health nudges, and specialized diagnosis and surgery. Teladoc/Livongo will be the only one-stop-shop for taking your healthcare into your own hands. Healthcare is one of the few paternalistic sectors left. Paternalistic here means: "We know everything, you don't. Your only function is to give us the money and shut up."

Again, that's not throwing a stone to healthcare workers. I have a really, really deep respect for the people working in healthcare and this pandemic has highlighted even more how crucial they are. Several of my friends work in the sector.

They actually often feel the same frustration as patients. They don't have enough time to really listen, which would help them to diagnose more accurately, they have to do too much administration, they lose precious time gathering simple data and there are no efficient follow-up programs. Most healthcare workers would love to have the time to establish a human connection with each of their patients and listen to every detail that could count. But there is just no time. That's why a lot of people seek help from all kinds of coaches.

This is Teladoc's representation of whole-person care:

(Source)

Let's look into this in a bit more detail.

As you see from the graph, and I think this is really important, the category Wellness and Prevention is included in that care too. It is explained as 'Complete regular screenings and improve nutrition, exercise and well-being'. That means planning your health.

No company flies blindly and every company has a clearly-defined goal for the future often with step-by-step roadmaps. But for health, the advice is often: "Eat well and exercise." That's like saying to a company: "Execute well and make money." In other words, although it's true, it's too general.

A personal note here to illustrate what I mean. For years, I was very tired and I had trouble staying awake after meals or after drinking coffee. The advice I got from my doctors? Eat healthily, do regular exercise.

I found out 5 years ago that I have a milk allergy but I had to find out all about what it meant for my life (dairy-free cooking, avoiding almost all cookies, but also potato chips etc.) on my own. It would have been great to have a specialist that could have coached me there.

The example of my own life is just to illustrate the truth about healthcare that we all intuitively know but that is not acknowledged enough under this system: we are all individuals, with our differences, our unique needs. In stock terms, we are as different as a steel producer stock and a SaaS stock. I'm a man of 6 feet and 5 inches and almost always, I get the same dose of medicine as a woman of barely 5 feet high.

We are on the brink of other breakthroughs in healthcare: stem cell therapy, gene therapy, cheap genome sequencing, CRISPR, and many more. All these trends point in one direction: individualized healthcare. Medicine will not be a mass-produced, mass-prescribed drug anymore. We will evolve to personalized medicine.

Initially, people will be split into different groups based on certain data points (age, weight, condition...) and later it will be really about you, the individual. Your genome, your microbiome, your allergies, your reactions to certain drugs, everything will be known and taken into account for your prescription. Lots of medicines contain milk, for example, as a filling agent. Each time again, I have to say this to a doctor and sometimes there are even no medicines on the market without milk. These will be produced in the individualized healthcare that will come, if only for me. Medicines will be prepared on who you are, not on who the masses are.

But it will be much more than just medicines. Which supplements should you take? What is the perfect exercise regimen for your type of body? How could you build up your condition for that marathon or triathlon you always dreamed of without the risk of an injury because of your specific body composition? What are the best shoes for your feet so they can be 3D-printed? What is the best diet for the specific microbes that you have in your gut? What are the diseases you are genetically susceptible to and what can you change in your lifestyle to prevent them?

Don't get me wrong, I'm not a pie-in-the sky thinker. This will not be for the first years, of course not. And at first, it could be unevenly distributed, as a lot has been throughout healthcare's history. The first individualized programs could come with a hefty price ticket. But probably that will democratize, as a lot of procedures have in healthcare. Or maybe it will democratize from the start but with different degrees of quality, a bit like smartwatches.

The medical know-how of Teladoc, its wide network of doctors and health specialists, combined with Livongo's AI, data gathering and processing capabilities, make that this company is, like no other that I know, prepared for the future of healthcare.

I haven't seen any other AI healthcare platform that even comes close to that of Livongo at this point. With its AI+AI approach (aggregate, interpret + apply, iterate) it has already learned a lot, both from the whole pool of patients as from individual patients. With more patients because of the merger, there will be more data and more data means more insights and new products over time.

And Livongo will double down on its AI and data analysis. Revealera.com is a website that looks at jobs, job openings and it tries to find relevant information from these data.

It showed that of all publicly-traded companies, Livongo had the highest percentage of job openings that require data science and machine learning. 16% of Livongo's jobs openings ask for experience in those fields.

This clearly shows to me that Teladoc/Livongo is skating where the puck will be, not just where it is.

If you look at the combination of the two companies that merged, you can see that they are very complementary. These are Teladoc's key growth strategies and in blue, Livongo could help to accelerate Teladoc's strategy:

(Source)

The companies estimate that there will be $500M in synergies.

(Source)

Now, I know that it's all too common in an acquisition or a merger to overestimate these synergies by a wide margin. But in this case, I think the synergy opportunities are actually very conservative. The companies even acknowledge that in their merger presentation:

There will be a lot of cross-selling, as there is only a 25% overlap in the customers of the companies. Even before the merger officially was closed, Livongo was cross-sold in two deals already by Teladoc.

The first deal was Fresenius Medical Care, a company specialized in working with patients that suffer from CKD (chronic kidney disease). Partnerships and distribution are quintessential in healthcare and in its field, Fresenius is a big player. It provides dialysis for 347,000 kidney patients. The press release of Fresenius explains:

This marks the first time Livongo will use its robust virtual care solutions to specifically support those with CKD and is a significant step forward in Fresenius Medical Care's efforts to provide a more coordinated care experience. With earlier intervention, Fresenius Health Partners also seeks to increase optimal dialysis starts, as well as offer earlier evaluation of transplantation and home dialysis options.

This shows that the possibilities for Livongo to branch out are numerous.

The second deal was with Florida Blue, part of GuideWell Mutual Holding. Together with its merging partner Teladoc, Livongo will offer Florida Blue members with diabetes virtual care, including connected devices, advanced data science, and telehealth.

Being the only one-stop-shop for digital healthcare will provide Teladoc/Livongo with a competitive advantage that others simply don't have at the moment. The companies shared an example about Claire, an imaginary future client. You can see the different stages and situations in which she can be helped by Teladoc after the merger with Livongo:

As you can see, there is not a single moment in the whole process that Claire has to leave the platform. In this way, Teladoc and Livongo show that they are very complimentary. And the data component of Livongo, combined with preventive healthcare, gives Teladoc a lot of flexibility to introduce even more products, each one more and more targeted and eventually personalized.

There are risks to every investment, of course, although I generally believe that too many investors overemphasize risk. What is risk? Risk is not the same as volatility, no matter what some want you to believe. Volatility is risky if you are a short-term investor. If you need the money in 2 years, volatility is a risk. But if you need the money in, let's say, 20 years, why would it matter if a certain stock is up or down 50% this year or the next?

If you read the great book 100 baggers by Chris Mayer, you'll see that ALL (!) of the 100 baggers (stocks that turn your $10K into $1M) saw drops of 50% and more at least once. Most several times, and often they dropped substantially more than 50%.

Risk is the chance that you will lose your money permanently, not volatility. That also means that you should look at risks in their context. All companies make mistakes and if you sell because of a mistake, you'll never find multibaggers. Do I need to remind you of the Amazon Fire phone, the Netflix Quikster failure, the Windows phone, Google Plus and so many more mistakes? Don't let one failed product mislead you. The company as a whole is much more important.

Having said that, what will I keep my eyes on for Teladoc?

First, I want to see that Livongo really has an impact on Teladoc because health assurance is more a part of what Livongo does right now. There is a risk that Teladoc doesn't leverage Livongo's capacities enough.

The second element that I will watch is how the two companies work together when it comes to company culture. Teladoc has a good tracking record when it comes to acquisitions and giving them a place where they feel good inside of the company but this merger with Livongo is on a whole different level. I see some good signs because Teladoc CEO Jason Gorevic and Livongo's founder and executive chairman have already come out together several times and the two seem to share the same vision.

The third and final element of risk that I want to touch on is competition. At this moment, I don't see any competitor that is even close to Teladoc after the merger with Livongo but that can always change fast, of course. On the other hand, this market is so big that there will be several winners. And the size of the market, that's the next topic of this article.

The market cap of the combined company is around $30B at this moment. For Potential Multibagger stocks, I want to see the possibility that the stock could be a tenbagger in the next 10 years. For Teladoc, I think this is still possible, despite its already substantial market cap. The company has everything it needs to start a new era in healthcare as I showed, and it's in a gigantic market. This is the title of recent research:

Global Digital Health Market was Valued at USD 111.4 billion in 2019 and is Expected to Reach USD 510.4 billion by 2025, Observing a CAGR of 29.0% during 2020-2025

Teladoc operates in a TAM (total addressable market) of $510B in 2025 and at this moment it is the only 360 digital health company. That's a great position to be in. For those who wouldn't know: TAM is the yearly total addressable market. The fact that Teladoc projects a CAGR (compound annual growth rate) of 30% to 40% seems conservative to me. If you would add the synergies, it will be at least to the higher end of that margin, in my opinion.

If Teladoc could just bring in 3% of that TAM of 2025, that would already mean $15.3B. If you slap a P/S ratio of 20 on that, you already have a company with a market cap of more than $300B. A P/S of 20 might seem aggressive but for a company growing at more than 30% per year and gross margins which will probably be in the mid-70s, I think it's very reasonable. You can tinker with the numbers but the conclusion to me is always that if Teladoc executes well, it has the potential to become a giant.

I'm not saying that the company will already have 3% of the global digital health market by 2025, mind you. I think revenue of 1% of the TAM, about $5.1B, is possible at that moment, though, and much more growth will be in the pipeline.

There are always a lot of ifs but when I look at Teladoc, I can see the potential to become really big, ten times or more bigger than today.

With a lot of healthcare disruption knocking at the door, such as cheap genome sequencing, CRISPR, personalized medicines and much more, data will become more and more important for healthcare. Livongo's AI will add that to Teladoc.

The combination of Teladoc and Livongo definitely has the first-mover advantage in a very important and big emerging market because it can provide a 360 degrees one-stop-shop for personalized digital healthcare.

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In the meantime, keep growing!

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Excerpt from:
Teladoc Is A Strong Buy: A Radical Healthcare Change Will Come - Seeking Alpha

Recommendation and review posted by Bethany Smith

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Recommendation and review posted by Bethany Smith

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Nov 10, 2020--

Merck (NYSE: MRK):

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement inProgression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib

Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA met the trials primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. LENVIMA plus everolimus also met the trials primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor). The safety profiles of both KEYTRUDA plus LENVIMA and LENVIMA plus everolimus were consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.

The results for KEYTRUDA plus LENVIMA versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of KEYTRUDA-based combinations for the first-line treatment of advanced renal cell carcinoma, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.

The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy, said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers.

Merck and Eisai are continuing to study the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

About KEYNOTE-581/CLEAR (Study 307)

KEYNOTE-581/CLEAR (Study 307) is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861 ) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The primary endpoint is PFS by independent review per RECIST v1.1 criteria. Key secondary endpoints include OS, ORR and safety. The study enrolled approximately 1,050 patients who were randomized to one of three treatment arms to receive:

About Renal Cell Carcinoma (RCC)

Worldwide, it is estimated there were more than 403,000 new cases of kidney cancer diagnosed and more than 175,000 deaths from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA 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 tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall...

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Global Progenitor Cell Product Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2026 - Zenit News

Recommendation and review posted by Bethany Smith

KENILWORTH, N.J.--(BUSINESS WIRE)--Nov 9, 2020--

Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients With Metastatic Non-Small Cell Lung Cancer To Stop for Futility and Patients to Discontinue Ipilimumab

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that it will be stopping KEYNOTE-598, a Phase 3 trial investigating KEYTRUDA, Mercks anti-PD-1 therapy, in combination with ipilimumab (Yervoy ), compared with KEYTRUDA monotherapy, for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] 50%) with no EGFR or ALK genomic tumor aberrations. Merck is discontinuing the study following the recommendation of an independent Data Monitoring Committee (DMC), which determined the benefit/risk profile of the combination did not support continuing the trial. At an interim analysis, the combination of KEYTRUDA and ipilimumab showed no incremental benefit in overall survival (OS) or progression-free survival (PFS), the studys dual primary endpoints, compared with KEYTRUDA alone and crossed futility boundaries. No new safety signals for KEYTRUDA monotherapy were observed, however the combination of KEYTRUDA and ipilimumab was associated with a higher incidence of grade 3-5 adverse events (AEs), serious AEs, and AEs leading to discontinuation or death, compared with KEYTRUDA monotherapy. Merck will inform study investigators of the recommendation from the DMC and the DMC is advising that patients in the study discontinue treatment with ipilimumab/placebo. Data from this study will be submitted for presentation at an upcoming scientific congress and communicated to regulatory agencies.

We conducted KEYNOTE-598 in order to explicitly explore whether combining our anti-PD-1 therapy, KEYTRUDA, with ipilimumab provided additional benefits beyond treatment with KEYTRUDA alone in the metastatic non-small cell lung cancer setting, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. It is very clear that in this study, the addition of ipilimumab did not add clinical benefit but did add toxicity. KEYTRUDA monotherapy remains a standard of care for the treatment of certain patients with metastatic non-small cell lung cancer whose tumors express PD-L1.

While the combination of an anti-PD-1 therapy plus ipilimumab has been approved in certain indications, studies supporting these approvals have, for the most part, not compared the combination directly with anti-PD-1 monotherapy. Bristol Myers Squibb has reported topline results of CheckMate-915, a Phase 3 study in adjuvant melanoma that directly compared treatment with ipilimumab in combination with an anti-PD-1 therapy versus the anti-PD-1 therapy alone. In two separate news releases issued over the last year, the company announced the study did not meet its co-primary endpoints in the all-comer population or in patients whose tumors expressed PD-L1 <1%. These data have not yet been presented.

Merck has an extensive clinical development program in lung cancer and is advancing multiple registration-enabling studies with KEYTRUDA in combination with other treatments and as monotherapy. The lung program is evaluating KEYTRUDA across all stages of disease and lines of therapy in over 200 trials with more than 10,000 patients.

About KEYNOTE-598

KEYNOTE-598 (ClinicalTrials.gov, NCT03302234 ) is a randomized, double-blind, Phase 3 trial investigating KEYTRUDA in combination with ipilimumab compared to KEYTRUDA monotherapy for the first-line treatment of patients with metastatic NSCLC whose tumors express PDL1 (TPS 50%) with no EGFR or ALK genomic tumor aberrations. The dual primary endpoints are OS and PFS. Secondary endpoints include objective response rate, duration of response and safety. The study enrolled 568 patients who were randomized (1:1) to receive:

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die of lung cancer than die of colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. Small cell lung cancer (SCLC) accounts for about 10% to 15% of all lung cancers. Before 2014, the five-year survival rate for patients diagnosed in the U.S. with NSCLC and SCLC was estimated to be 5% and 6%, respectively.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. 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.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA 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 tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients. Pneumonitis occurred in 8% (31/389) of patients with cHL receiving KEYTRUDA as a single agent, including Grades 3-4 in 2.3% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. The incidence of new or worsening hypothyroidism was higher in 389 patients with cHL (17%) receiving KEYTRUDA as a single agent, including Grade 1 (6.2%) and Grade 2 (10.8%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and post-marketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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/PD-L1 blocking antibody. 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/PD-L1 blockade and allogeneic HSCT. Follow patients closely for evidence of transplant-related complications and intervene promptly. Consider the benefit versus risk of treatment with a PD-1/PD-L1 blocking antibody prior to or after an allogeneic HSCT.

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients with advanced NSCLC; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

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Merck Announces KEYNOTE-598 Trial Evaluating KEYTRUDA (pembrolizumab) in Combination With Ipilimumab Versus KEYTRUDA Monotherapy in Certain Patients...

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Pune, Maharashtra,India, November 9 2020 (Wiredrelease) Origius Systems Private Limited :The increasing occurrence of chronic ailments and obesity all over the world is driving the global biopreservation market growth. The North America region is expected to lead the market growth in the projected period.

A latest report by Research Dive on the global biopreservation market reveals that the market is projected to hit $13,576.3 million by 2027, rising at a CAGR of 13.8% from 2020 to 2027. The report states the current outlook and future growth of the market. The research report is a perfect source of guidance for companies and individuals interested in investing in the market.

The report covers the following aspects:

A brief introduction of the market with its definition, advantages, and application areas. Inclusive insights on the market situation, dynamics, statistics, growth rate, revenues, market shares, and future predictions. Major market segments, drivers, limitations, and investment suitability. Current scenario of the global and regional market from the perspective of companies, countries, and end industries. Insights on foremost market players, current market trends & developments, SWOT Analysis, Porter Five Analysis, and winning business strategies.

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Factors Impacting the Market Growth:

According to the report, growing occurrence of chronic ailments like diabetes, cardiac, degenerative conditions affecting the joints, nerves, bones, and others as well as obesity all over the world are thrusting the demand for biopreservation techniques, which is fueling the growth of the market. Additionally, the increasing investments in R&D and development of advanced biopreservation products is expected to unlock rewarding opportunities for the market growth. However, greater costs involved in biopreservation processes, reliability concerns, and invention of low-priced processes are likely to detain the biopreservation market growth.

Segment Analysis:

The report segments the biopreservation market into type, biospecimen, application, end use, and region.

Based on biospecimen, the report divides the market into: Stem Cells Human Tissue Organs

Among these, the human tissue segment is expected to witness highest growth in the biopreservation market all through the projected period; mainly due to rising cases of chronic ailments, degenerative disorders, and obesity.

Based on application, the report classifies the market into: Therapeutic Research Clinical Trials

Among these, the therapeutic segment is projected to show noteworthy growth during the forecast period. This is mainly owing to the developments in treatment techniques, personalized drugs, regenerative drugs, increasing trend for cord blood banking, and increasing occurrence of chronic ailments worldwide.

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Regional Analysis:

The report states the scenario of the global biopreservation market across several regions including: Europe LAMEA North America Asia Pacific

Among these, the North America region is projected to grab the highest market share of the biopreservation market in the forecast period. This is attributed to the growing awareness about personalized drugs, rising R&D in regenerative medicines, increasing prevalence of obesity, and chronic ailments.

Market Players and Business Strategies:

The report cites some of the leading players in the global biopreservation market which includes: Avantor, Inc. Bio-Techne Exact Sciences Corporation Merck KGaA ThermoGenesis Corp. BioLifeSolutions Inc. BioCision Chart Industries Thermo Fisher Scientific Inc. Worthington Industries, Inc.

The report highlights some of the wining business strategies of the players such as mergers and acquisitions, ground-breaking advances, geographical expansions, new product inventions, and many more.Quick Download Top Companies Development Strategies Summary Report

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Research Dive is a market research firm based in Pune, India. Maintaining the integrity and authenticity of the services, the firm provides the services that are solely based on its exclusive data model, compelled by the 360-degree research methodology, which guarantees comprehensive and accurate analysis. With unprecedented access to several paid data resources, team of expert researchers, and strict work ethic, the firm offers insights that are extremely precise and reliable. Scrutinizing relevant news releases, government publications, decades of trade data, and technical & white papers, Research dive deliver the required services to its clients well within the required timeframe. Its expertise is focused on examining niche markets, targeting its major driving factors, and spotting threatening hindrances. Complementarily, it also has a seamless collaboration with the major industry aficionado that further offers its research an edge.

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This content has been published by Origius Systems Private Limited company. The WiredRelease News Department was not involved in the creation of this content. For press release service enquiry, please reach us at contact@wiredrelease.com.

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Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Alopecia market.

Trusted Business Insights presents an updated and Latest Study on Alopecia Market 2020-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Alopecia market during the forecast period (2020-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

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Report Overview: Alopecia Market

The global alopecia market size was valued at USD 1.5 billion in 2020 and is expected to expand at a CAGR of 8.4% over the forecast period 2021-2027. Rising prevalence of androgenetic alopecia and alopecia areata diseases is the key factor driving market growth.

Lifestyle alterations, such as immoderate intake of tobacco and alcohol, and escalating stress indices are considered as strong triggers for the disease. Though the exact disease cause remains unknown, the genetic factors have been linked to several cases. Moreover, the rise in disposable incomes as well as building emphasis on aesthetics are poised to drive the market demand and product penetration for alopecia.

Aging and hormonal anomalies have been listed as potent causative agents for alopecia. Furthermore, gender plays a key role in disease susceptibility. According to the American Hair Loss Association, it was stated that over 95% of loss of hair in men is caused due to androgenetic alopecia. In addition, a steady increase in consumer awareness toward alopecia therapeutic options are likely to positively impact the market in the future.

Moreover, the rising prevalence of chronic diseases, such as acute stress disorder, Polycystic Ovary Disease (PCOD), hyperthyroidism, hypothyroidism, cancer, lupus, and hypopituitarism across the globe, is expected to augment the revenue growth over the forecast period.

Continuous development of new therapeutic strategies is anticipated to boost growth through the projection period. Emergence of rapid-action JAK inhibitors and hair growth stimulation through PRP treatment and pluripotent stem cells are propelling the market growth. The upcoming launch of some breakthrough products indicates a favorable future for the global market.

Disease Type Insights: Alopecia Market

Based on disease types, the market is categorized into androgenetic, areata, cicatricial, totalis, universalis, traction, and others. Between the types, alopecia areata lead the segment in 2019, capturing almost 30% of total market share. The segment growth is supported by a high disease prevalence worldwide and increasing consumer awareness. The disorder is most prevalent in people suffering from autoimmune diseases, namely Downs syndrome, diabetes, and hyperthyroidism. Alopecia areata can progress into alopecia universalis and totalis.

Androgenetic alopecia is estimated to exhibit the fastest growth, driven majorly by the anticipated launch of multiple promising pipeline candidates and an escalating incidence rate. Androgens spawn the condition in people with a genetic disposition to alopecia. Various treatment strategies such as licensed oral, topical, and surgical therapies are accessible for androgenetic alopecia.

End-use Insights: Alopecia Market

Dermatology clinics generated the maximum revenue among all the end-use segments in 2019 and are forecasted to exhibit a lucrative growth rate over the next few years. Increasing number of transplantation and restoration surgeries, coupled with the widespread application of prescription medicines, is expected to contribute significantly to the market position of dermatology clinics.

Homecare settings are powered by broadening penetration of laser treatment and a rise in regulatory sanctions of home-use products. Furthermore, advanced technology, increasing emphasis on convenience, patient compliance, and market presence of contemporary products such as helmets, laser combs, and laser caps are projected to fuel the homecare segment growth.

Key FDA-sanctioned home-use products include Theradome hair grow helmet by Theradome, Inc., iRestore laser hair growth system by Freedom Laser Therapy, Inc., and Hair Max Advanced Laser Comb & HairMax Laser Band 82 by Lexington International.Sales Channel Insights

Based on sales channel, the market is bifurcated into prescription and OTC products. In 2019, prescription products lead the segment and are expected to expand at a significant CAGR over the forecast period. Finasteride and corticosteroids are a few majorly prescribed products for alopecia.Increasing demand for cost-effective treatment, easy accessibility of therapies, and addressing adverse effects associated with approved medications are fueling the requirement for OTC medicines. In addition, an upsurge in the quantity of FDA-licensed OTC products for alopecia is another growth-booster.Gender InsightsAlopecia is less prominent in women than in men. According to the U.S. National Library of Medicine and the American Hair Loss Association, nearly 50% of men experience some grade of hair fall by 50 years of age. Androgen is a leading cause of androgenetic alopecia in men. Moreover, expanding geriatric population base and increasing intake of tobacco are some of the additional factors poised to augment the alopecia market growth.

Female hair-loss occurs irrespective of age; however, almost 40% of women tend to suffer from hair loss by 50 years of age. Female alopecia is driven by an alarming rise in PCOS incidence rates, escalating number of cosmetic practices, and harmful lifestyle patterns. An increase in health consciousness among women is expected to increase the market growth.

Regional Insights: Alopecia Market

Key regional markets include North America, Asia Pacific, Europe, Latin America, and Middle East and Africa (MEA). North America contributed more than 34.0% market share in 2019. Enlarging disease prevalence, technological advancements, novel product development, and increasing disposable income are few contributors to North Americas market share.Asia Pacific region is positioned to exhibit the fastest growth over the next few years. Large population base and rising consumer awareness toward available treatment options are the key factors driving regional growth. Economic betterment and increased per capita healthcare spending, in developing countries such as India, China, and Singapore are expected to create strong commercial opportunities.Alopecia Market Share InsightsSome of the major companies operating in the market include

Rising R&D activities to improve treatment options, accelerated regulatory approvals, and strategic business initiatives undertaken by the key players sum up the major competitive approaches paving the road for expansion. For instance, Johnson & Johnson Services, Inc. launched a public health initiative at the global level to provide comprehensive health solutions in Africa, in April 2016.This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2015 to 2027. Trusted Business Insights has segmented the global alopecia market report on the basis of disease type, end use, sales channel, gender, and region:

Disease Type Outlook (Revenue, USD Million, 2015 2027)

End-use Outlook (Revenue, USD Million, 2015 2027)

Sales Channel Outlook (Revenue, USD Million, 2015 2027)

Gender Outlook (Revenue, USD Million, 2015 2027)

Looking for more? Check out our repository for all available reports on Alopecia in related sectors.

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Global Male Hypogonadism Market: Snapshot

Hypogonadism in males refers to a condition in the male body where the testes show a significantly reduced level of functioning than normal. The overall result of male hypogonadism is a reduction in the rate of biosynthesis of male sex hormones. This state is more commonly known as interrupted stage 1 puberty. Hypoandrogenism, or the low androgen or testosterone level in a male can vary in severity from person to person. It is often the cause of partial or complete infertility. There are multiple forms of male hypogonadism and even more ways to classify them. Most endocrinologists commonly classify male hypogonadism on the basis of the level of defectiveness of the male reproductive system.

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In many cases, doctors also measure the level of gonadotropins to classify a patient between primary and secondary male hypogonadism. Primary male hypogonadism refers to the cause of the condition being due to defective gonads. There are different types of primary male hypogonadism, including Turner syndrome and Klinefelter syndrome. Secondary male hypogonadism is caused by defects in pituitary or hypothalamic glands. They include Kallmann syndrome and hypopituitarism.

Global Male Hypogonadism Market: Overview

Male Hypogonadism refers to a clinical condition, wherein the testes fail to produce enough testosterone leading to delayed puberty or incomplete development. The condition is related to impaired development of muscle mass, development of breast tissues, impaired body hair growth, and lack of deepening of the voice.

The male Hypogonadism market can be segmented by therapy, type, drug delivery, and geography.

The report presents an in-depth analysis of the global male hypogonadism market with current trends and future estimates to explain the imminent investment pockets. The quantitative analysis of the market for the forecast period from 2017 to 2025 will enable stakeholders to capitalize on the prevailing growth opportunities.

Global Male Hypogonadism Market: Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

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Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

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Male Hypogonadism Market Projected to be Resilient During 2025 - The Market Feed

Recommendation and review posted by Bethany Smith

PHILADELPHIA, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Passage Bio, Inc. (NASDAQ: PASG), a genetic medicines company focused on developing transformative therapies for rare, monogenic central nervous system disorders, and Invitae (NYSE: NVTA), a leading medical genetics company, announce a collaboration to facilitate genetic testing and support early identification of GM1 gangliosidosis (GM1) through Invitaes Detect Lysosomal Storage Disorders (Detect LSDs). The two companies also are partnering to provide educational clinical trial information to clinicians and patients.

Early identification and intervention are crucial steps in providing effective treatment to patients with GM1, particularly in the infantile form where onset occurs within the first six months of a patients life, said Bruce Goldsmith, Ph.D, president and chief executive officer of Passage Bio. By combining Invitaes no-charge testing and counseling with information on clinical trials, clinicians will be able to intervene sooner and more efficiently, shortening the timeline to reliable diagnosis. As we plan to initiate our Phase 1/2 trial for PBGM01 soon, this partnership will be an important part of our support for patients and will also serve as a key resource to patients with GM1 and their families.

The Detect LSDs program offers genetic testing and genetic counseling at no charge to patients to encourage earlier diagnosis of lysosomal storage disorders like GM1 and, as a result, earlier access to clinical trials. In addition, Invitae provides clinical trial information and education to clinicians and patients who may benefit. Currently, the Detect LSDs program is available to patients within the United States and Canada.

Increasing access to genetic testing supports earlier diagnosis, enables clinical trials to develop new treatments and helps clinicians provide precision therapies sooner for better overall outcomes, said Robert Nussbaum, M.D., chief medical officer of Invitae. Were pleased Passage Bio has joined us in this effort.

Additional details, as well as terms and conditions of the Detect LSDs program, can be found at https://www.invitae.com/en/detectLSDs/.

About GM1

GM1 gangliosidosis (GM1) is a rare and often life-threatening monogenic recessive lysosomal storage disease caused by mutations in the GLB1 gene, which encodes lysosomal acid beta-galactosidase (-gal). Reduced -gal activity results in the accumulation of toxic levels of GM1 ganglioside in neurons throughout the brain, causing rapidly progressing neurodegeneration. GM1 manifests as a continuum of disease and is most severe in the Infantile form, which is characterized by onset in the first 6 months of life with hypotonia (reduced muscle tone), progressive CNS dysfunction, and rapid developmental regression. Life expectancy for infants with GM1 is two to four years, and infantile GM1 represents approximately 62.5% of the incidence of 0.5 to 1 in 100,000 live births. Currently, there are no approved disease-modifying therapies available.

About Passage Bio

At Passage Bio (Nasdaq: PASG), we are on a mission to provide life-transforming gene therapies for patients with rare, monogenic CNS diseases that replace their suffering with boundless possibility, all while building lasting relationships with the communities we serve. Based in Philadelphia, PA, our company has established a strategic collaboration and licensing agreement with the renowned University of Pennsylvanias Gene Therapy Program to conduct our discovery and IND-enabling preclinical work. This provides our team with unparalleled access to a broad portfolio of gene therapy candidates and future gene therapy innovations that we then pair with our deep clinical, regulatory, manufacturing and commercial expertise to rapidly advance our robust pipeline of optimized gene therapies into clinical testing. As we work with speed and tenacity, we are always mindful of patients who may be able to benefit from our therapies. More information is available at http://www.passagebio.com.

About Invitae

Invitae Corporation (NYSE: NVTA) is a leading medical genetics company whose mission is to bring comprehensive genetic information into mainstream medicine to improve healthcare for billions of people. Invitae's goal is to aggregate the world's genetic tests into a single service with higher quality, faster turnaround time, and lower prices. For more information, visit the company's website atinvitae.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995, including, but not limited to: our expectations about timing and execution of anticipated milestones, including our planned IND submissions, initiation of clinical trials and the availability of clinical data from such trials; our expectations about our collaborators and partners ability to execute key initiatives; our expectations about manufacturing plans and strategies; our expectations about cash runway; and the ability of our lead product candidates to treat the underlying causes of their respective target monogenic CNS disorders. These forward-looking statements may be accompanied by such words as aim, anticipate, believe, could, estimate, expect, forecast, goal, intend, may, might, plan, potential, possible, will, would, and other words and terms of similar meaning. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including: our ability to develop and obtain regulatory approval for our product candidates; the timing and results of preclinical studies and clinical trials; risks associated with clinical trials, including our ability to adequately manage clinical activities, unexpected concerns that may arise from additional data or analysis obtained during clinical trials, regulatory authorities may require additional information or further studies, or may fail to approve or may delay approval of our drug candidates; the occurrence of adverse safety events; the risk that positive results in a preclinical study or clinical trial may not be replicated in subsequent trials or success in early stage clinical trials may not be predictive of results in later stage clinical trials; failure to protect and enforce our intellectual property, and other proprietary rights; our dependence on collaborators and other third parties for the development and manufacture of product candidates and other aspects of our business, which are outside of our full control; risks associated with current and potential delays, work stoppages, or supply chain disruptions caused by the coronavirus pandemic; and the other risks and uncertainties that are described in the Risk Factors section in documents the company files from time to time with the Securities and Exchange Commission (SEC), and other reports as filed with the SEC. Passage Bio undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

For further information, please contact:

Investors:Sarah McCabe and Zofia MitaStern Investor Relations, Inc.sarah.mccabe@sternir.com and zofia.mita@sternir.com

Media:Media:Gwen FisherPassage Bio215-407-1548gfisher@passagebio.com

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Passage Bio and Invitae Announce Collaboration to Facilitate Genetic Testing to Support Early Diagnosis and Greater Awareness of Clinical Trials for...

Recommendation and review posted by Bethany Smith

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Rare Disease Genetic Testing market.

Trusted Business Insights presents an updated and Latest Study on Rare Disease Genetic Testing Market 2020-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Rare Disease Genetic Testing market during the forecast period (2020-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Rare Disease Genetic Testing Market 2020 and Forecast 2021-2027 Includes Business Impact Analysis of COVID-19

Report Overview: Rare Disease Genetic Testing Market

The global rare disease genetic testing market size was valued at USD 690.1 million in 2020 and is projected to register a Compound Annual Growth Rate (CAGR) of 8.8% from 2021 to 2027. Misdiagnosis can result in interventions that could later be considered inappropriate for the underlying disorder. Thus, the need for an accurate and timely diagnosis for rare conditions drives the demand for genetic testing. Currently, the lack of awareness pertaining to these conditions is one of the primary challenges for the market. Thus, several efforts are being undertaken to help raise awareness about various aspects of rare and ultra-rare diseases, such as the challenges pertaining to diagnosis and clinical implementation of available diagnostic approaches.

Companies like Shire Plc are engaged in supporting domestic diagnostic testing for rare disorders in certain countries and offer learning programs for healthcare experts on genetic testing. Every country has developed its registry for rare diseases that acts as a focal point of information on these conditions. Patient registries and databases play a integral role in clinical research in the field of rare diseases and help in improving healthcare planning and patient care.

A rise in the number of available registries is one of the major driving factors of the market as it enables pool data to achieve a sufficient sample size for epidemiological and/or clinical research. Furthermore, technological advancements in data collection and interpretation for clinical practice has driven the market. Companies are making efforts to ensure efficient data collection from various ethnicities, which is expected to aid in the diagnosis of thousands of patients with the same condition.

In addition, companies, such as Centogene, combine genetic testing with metabolomics and proteomics to make their data analysis process as accurate as possible. The multi-omics approach helps better understand the impact of a given mutation on the protein as well as at the metabolite level. The company has also introduced a system to simplify the sample collection process, thereby driving the adoption of genetic tests for rare disease diagnosis.

Disease Type Insights: Rare Disease Genetic Testing Market

Neurological disorders segment accounted for the largest share of 12.9% in 2019. A substantial number of commercially-approved genetic tests for neurologic conditions coupled with a high prevalence of neurological diseases has accelerated the revenue growth in this segment. Tests offered by companies are recommended by several medical institutes, such as the American Academy of Neurology, American College of Medical Genetics, and Child Neurology Society.

Furthermore, the advent of high-throughput techniques, such as exome sequencing and whole-genome sequencing, has offered lucrative opportunities for companies offering tests for diseases, such as X-ALD. Exome sequencing and whole-genome sequencing have helped in addressing complicated cases of X-ALD that present an atypical disease course.

Moreover, immunologic disorders, such as Multiple Sclerosis (MS), are among the most prevalent rare diseases. The genetic profile of MS is one of the key focus areas among researchers in this field. This is primarily to obtain relevant insights pertaining to the causes and underlying physiology of diseases, resulting in a significant share of this segment.

End-use Insights: Rare Disease Genetic Testing Market

Research laboratories & CROs captured the maximum share of 46.9% of the market in 2019. This is primarily because in a substantial number of cases, blood samples collected from patients are sent to a laboratory for testing. Laboratories offer testing based on various specialties, including molecular, chromosomal, and biochemical genetic tests. For instance, ARUP Laboratories offers testing in molecular genetics, cytogenetics, genomic microarray, and biochemical genetics.

Laboratories also offer genetic counseling services that further accelerate the uptake of services among patients. Moreover, molecular genetic testing-based laboratory testing is rapidly increasing worldwide. Genetic tests are conducted by multiple laboratories, including those that are accredited with CLIA for clinical cytogenetics, pathology, and chemistry, among other specialties. These companies are involved in expanding their test portfolio by undertaking various strategic initiatives.

For instance, in January 2020, Quest Diagnostics acquired Blueprint Genetics to enhance its expertise in genetic disorders and rare diseases. Furthermore, in June 2018, Centogene launched its diagnostic laboratory in Cambridge, Massachusetts. Such initiatives depict the growing interest of diagnostic centers in genetic testing of rare diseases, which is likely to boost segment growth.

Technology Insights: Rare Disease Genetic Testing Market

Next Generation Sequencing (NGS) accounted for the largest share of 36.6% in 2019 owing to the high usage of Whole Exome Sequencing (WES). WES is being considered a highly potential method in a case where the genetic cause of disease is unknown and is difficult to identify. WES is becoming the standard of care for patients with undiagnosed rare diseases. This is attributed to the fact that exons make up around 1.5% of an individuals genome and contain 85% of all known disease-causing mutations.

Moreover, with the declining costs of WES, the cost of genetic testing is also anticipated to reduce significantly, making the test more affordable and accessible. In addition, medical coverage for WES-based genetic tests has favored segment growth. A substantial number of private health insurance agencies cover all or part of the cost of genetic testing, post recommendation by a healthcare professional. As compared to WES, clinical Whole Genome Sequencing (WGS) has lesser demand.

However, with a continuous decrease in cost, adoption of WGS is expected to amplify. For instance, the Rady Childrens Institute for Genomic Medicine offers singleton-rapid WGS and a trio-rapid WGS at a reasonable cost. In February 2020, Dante Labs launched an initiative to offer WGS to patients with rare diseases for USD 299. The service included WGS 30X on Novaseq6000 technology, data interpretation, and personalized therapy on these diseases.

Specialty Insights: Rare Disease Genetic Testing Market

Accounting for more than 40% revenue share, molecular genetic tests led the market in 2019. Rapid technological advancements and expertise in handling & managing high throughput technologies within clinical settings have driven the revenue in this segment. Molecular genetic test methods enable investigating single genes or short lengths of DNA for the detection of mutations or variations leading to genetic disorders.

Apart from rare diseases, the method also covers testing of ultra-rare diseases, which will augment the segment growth in future. Biochemical genetic tests are expected to register the second-fastest CAGR during the forecast period owing to their efficiency to assess the activity and amount of proteins & related abnormalities for the identification of changes in the DNA that can cause a metabolic disorder.

Also, the companies are expanding their test portfolio to capitalize on the potential opportunities present in this segment. In September 2019, Blueprint Genetics collaborated with ARCHIMEDlife to launch high-quality biochemical tests for rare diseases. Such developments are anticipated to boost the revenue share of the segment in the coming years.

Regional Insights: Rare Disease Genetic Testing Market

North America accounted for the largest market share of over 47% in 2019. Factors, such as high incidence of rare disorders, a large number of rare disorders registries, and the presence of substantial numbers of R&D facilities for rare & ultra-rare diseases, and extensive investments in the diagnosis of rare disorders in the region drives the market growth. As per the National Institutes of Health (NIH), around 30 million Americans have been identified with one of 7,000+ known rare diseases. Moreover, the number of patients undergoing disease testing is expected to increase in the coming years, thereby supporting market growth.

Asia Pacific is expected to register the fastest CAGR from 2020 to 2027 due to rising awareness and target population in Asian countries. China is attempting to shift the attention of the healthcare system towards the diagnosis and treatment of rare disorders. The government in the country has included rare disease management as a public health priority in its 2030 roadmap titledHealthy China 2030. Furthermore, in June 2018, the country released its first list of rare disorders to enable the patients to find solutions effectively at their local hospitals.

Key Companies & Market Share Insights: Rare Disease Genetic Testing Market

The development of technologies, such as WES & WGS, has significantly transformed genetic testing space by offering convenient and cost-effective methods that can be conducted for a wide range of conditions across multiple clinical settings. As a result, major diagnostic companies are engaged in expanding their product portfolio that can be used to conduct tests for rare and ultra-rare conditions.

In addition, they have undertaken various initiatives, such as mergers & acquisitions, to expand their offerings and subsequently strengthen their presence in this market. For example, the acquisition of GeneDX by OPKO. The acquisition helped the latter company to expand its business in the market. Similarly, Quest strengthened its presence in the market with the acquisition of Blueprint Genetics. Another important acquisition in the market is Qiagens acquisition by Thermo Fisher.

The companies have signed an agreement in March 2020; however, it is targeted to be completed by the first quarter of 2021, as ThermoFisher Scientific is lining up finances for the USD 11.5 billion deal, with an offering worth $2.2 billion. This deal is expected to impact the life science tools and reagents market significantly. With regard to rare disorder genetic testing, Thermo Fisher Scientific is engaged in research and provides sequencing for the Osteogenesis imperfecta and Vascular Ehlers-Danlos syndrome. Some of the prominent players in the rare disease genetic testing market include:

Key companies Profiled: Rare Disease Genetic Testing Market Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub segments from 2016 to 2027. For the purpose of this study, Trusted Business Insights has segmented the global rare disease genetic testing market report on the basis of disease type, technology, specialty, end use, and region:

Disease Type Outlook (Revenue, USD Million, 2016 2027)

Technology Outlook (Revenue, USD Million, 2016 2027)

Specialty Outlook (Revenue, USD Million, 2016 2027)

End-use Outlook (Revenue, USD Million, 2016 2027)

Looking for more? Check out our repository for all available reports on Rare Disease Genetic Testing in related sectors.

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Rare Disease Genetic Testing Market Analysis, COVID-19 Impact,Outlook, Opportunities, Size, Share Forecast and Supply Demand 2021-2027|Trusted...

Recommendation and review posted by Bethany Smith

When discussing a diagnosis of epilepsy, advances in genetic testing are proving that it is indeed all about the details. Comprehensive genetic testing is making it possible to drill down into those details. When testing is based on whole genome sequencing (WGS) technology, it is possible to identify genetic changes, or variants, in the 370-plus seizure-associated genes found amongst the 20,000 or so genes within the human genome or, more importantly, the large number of variants located within or spanning those genes. A single-method approach for detecting multiple variant types from a single patient sample can more accurately lead to a diagnosis, resulting in more-tailored medical management and providing a better basis for improved long-term outcomes and family planning.

In the United States, epilepsy is the fourth most common neurological condition, surpassed only by migraine, stroke, and Alzheimers disease. Each year, 150,000 people on average will develop epilepsy (48 out of 100,000) and its prevalence is currently estimated at around 2.2 million people (or 7.1 out of every 1,000 people). Epilepsy is a spectrum condition characterized by unpredictable seizures that can cause or co-occur with other health problems. There is a wide range of seizure types and the ability to control them varies from person-to-person, even within families. The cause of epilepsy is often unknown, but it is most often related to brain injury or genetics. However, the word epilepsy itself has nothing to do with the cause, severity, or type(s) of an individuals seizures.

Genetic seizure disorders span multiple classes. They can include specific syndromes in which a seizure is the only symptom as well as occur as part of broader neurodevelopmental conditions that present with additional features, such as intellectual disability. Seizures may also be present as a symptom of metabolic conditions and/or other disorders. Seizure disorders share symptoms (phenotypes) with many other conditions, which often make it difficult to determine the inheritance pattern from the family history. Causal variants may be inherited from a parent or simply show up new (de novo) in a persons DNA. In some cases, variants in multiple genes may together contribute to the clinical symptoms. Many different types of variants have been shown to cause seizure disorders.

This is why definitively diagnosing the genetic cause of epilepsy can be challenging. Traditionally, this is accomplished through multiple, sequential tests. This step-wise method typically begins with what is known as a chromosomal microarray, which involves structural analysis of a persons chromosomes and checks to make sure there are no large imbalances (extra or missing pieces) that could cause epilepsy. If the microarray does not reveal a positive result, the next step is usually single-gene or multi-gene panel testing, depending on the specific nature of the individuals symptoms. If no causal variant is identified with those tests, the final step is exome testing, if the patients insurance allows for multiple genetic tests. This results in a long process of repeated rounds of testing, with each individual round limited by the types of variants that can be detected, leaving gaps in variant coverage and detection, and therefore leaving gaps in the ability to properly diagnose a patient. That is because, as a general rule, microarray, panel, and exome tests individually do not perform well at detecting a broad spectrum of changes (variants) in genetic material.

Comprehensive testing based on WGS technology has the ability to detect a wide range of variant types not covered by traditional microarray, panel-based, or exome tests, as well as the ability to reanalyze patient data in the future without resequencing. Combining WGSs consistent, comprehensive sequence coverage with proprietary algorithms allows for the detection of variants without any size limitations. The result is more-comprehensive testing of the entire spectrum of variants and genes associated with genetic epilepsy. All of this is accomplished with a single blood draw (or saliva sample) and a turnaround time of six to eight weeks.

The ability to quickly establish a genetic cause of epilepsy utilizing WGS can provide the information necessary to control an individuals seizures as soon as possible. The longer a patient experiences uncontrolled seizures, the more likely they will suffer irreparable damage to the brain. Depending on their frequency and length, uncontrolled seizures can interfere with daily activities and can negatively impact someones quality of life. The sooner that clinicians can identify an individuals cause of seizures and treat it appropriately, the better the prognosis for the long-term management of disease.

Above: Image of aa sample collection kit from Variantyx.

In some cases, a genetic diagnosis may help guide the selection ofanti-seizure medications, as there are some well-known links between certain medications and specific genetic epilepsy disorders. Some medicines work better while others may cause adverse side-effects, all of which can be determined by pinpointing of the variant causing the disease. Comprehensive genetic testing may also bring to light the risk of epilepsy to other family members, including the risk of passing the disorder on to a child. A genetic diagnosis can also assist individuals and families in finding and accessing the proper resources, from advocacy groups to connections with families sharing in similar struggles, and in opening up the door to participation in clinical studies for individuals with a related genetic diagnosis.

In summary, a single-method approach for the detection of a genetic cause of epilepsy is achievable by identifying multiple-variant types from a single patient sample through WGS technology. The result is a cost-effective, comprehensive analysis of an individuals DNA summarized in a single, unified clinical report. Obtaining a genetic diagnosis through WGS may end what is often referred to as the diagnostic odyssey or the search for an answer by an individual or family as well as provide information to guide treatment and maximize a patients quality of life.

Link:
The Value of a Molecular Diagnosis of Epilepsy - Medical Device and Diagnostics Industry

Recommendation and review posted by Bethany Smith

Market Overview of Pre-Pregnancy Genetic Testing Market

The Pre-Pregnancy Genetic Testing market report provides a detailed analysis of global market size, regional and country-level market size, segmentation market growth, market share, competitive Landscape, sales analysis, impact of domestic and global market players, value chain optimization, trade regulations, recent developments, opportunities analysis, strategic market growth analysis, product launches, area marketplace expanding, and technological innovations.

The global Pre-Pregnancy Genetic Testing market size is expected to gain market growth in the forecast period of 2020 to 2025, with a CAGR of xx%% in the forecast period of 2020 to 2025 and will expected to reach USD xx million by 2025, from USD xx million in 2019.

Get PDF Sample Copy of this Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) @ https://www.marketresearchhub.com/enquiry.php?type=S&repid=2803369&source=atm

Market segmentation

Pre-Pregnancy Genetic Testing market is split by Type and by Application. For the period 2015-2025, the growth among segments provide accurate calculations and forecasts for sales by Type and by Application in terms of volume and value. This analysis can help you expand your business by targeting qualified niche markets.

segment by Type, the product can be split intoChorionic Villi Sampling (CVS)AmniocentesisPlacental BiopsyCordocentesisFetal Biopsy

Market segment by Application, split intoHospitalsClinicsDiagnostic CentersOther

Based on regional and country-level analysis, the Pre-Pregnancy Genetic Testing market has been segmented as follows:North AmericaUnited StatesCanadaEuropeGermanyFranceU.K.ItalyRussiaNordicRest of EuropeAsia-PacificChinaJapanSouth KoreaSoutheast AsiaIndiaAustraliaRest of Asia-PacificLatin AmericaMexicoBrazilMiddle East & AfricaTurkeySaudi ArabiaUAERest of Middle East & Africa

Regional analysis is another highly comprehensive part of the research and analysis study of the global Pre-Pregnancy Genetic Testing market presented in the report. This section sheds light on the sales growth of different regional and country-level Pre-Pregnancy Genetic Testing markets. For the historical and forecast period 2015 to 2025, it provides detailed and accurate country-wise volume analysis and region-wise market size analysis of the global Pre-Pregnancy Genetic Testing market.

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The report offers in-depth assessment of the growth and other aspects of the Pre-Pregnancy Genetic Testing market in important countries (regions), including:

North America (United States, Canada and Mexico)

Europe (Germany, France, UK, Russia and Italy)

Asia-Pacific (China, Japan, Korea, India and Southeast Asia)

South America (Brazil, Argentina, etc.)

Middle East & Africa (Saudi Arabia, Egypt, Nigeria and South Africa)

Pre-Pregnancy Genetic Testing competitive landscape provides details by vendors, including company overview, company total revenue (financials), market potential, global presence, Pre-Pregnancy Genetic Testing sales and revenue generated, market share, price, production sites and facilities, SWOT analysis, product launch. For the period 2015-2020, this study provides the Pre-Pregnancy Genetic Testing sales, revenue and market share for each player covered in this report.

In the competitive analysis section of the report, leading as well as prominent players of the global Pre-Pregnancy Genetic Testing market are broadly studied on the basis of key factors. The report offers comprehensive analysis and accurate statistics on revenue by the player for the period 2015-2020. It also offers detailed analysis supported by reliable statistics on price and revenue (global level) by player for the period 2015-2020.The key players covered in this studySequenom Laboratories (US)Illumina (US)Natera (US)Ariosa Diagnostics (US)BGI Health (China)LifeCodexx (Germany)Counsyl (US)

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The content of the study subjects, includes a total of 15 chapters:

Chapter 1, to describe Pre-Pregnancy Genetic Testing product scope, market overview, market opportunities, market driving force and market risks.

Chapter 2, to profile the top manufacturers of Pre-Pregnancy Genetic Testing , with price, sales, revenue and global market share of Pre-Pregnancy Genetic Testing in 2018 and 2019.

Chapter 3, the Pre-Pregnancy Genetic Testing competitive situation, sales, revenue and global market share of top manufacturers are analyzed emphatically by landscape contrast.

Chapter 4, the Pre-Pregnancy Genetic Testing breakdown data are shown at the regional level, to show the sales, revenue and growth by regions, from 2015 to 2020.

Chapter 5, 6, 7, 8 and 9, to break the sales data at the country level, with sales, revenue and market share for key countries in the world, from 2015 to 2020.

Chapter 10 and 11, to segment the sales by type and application, with sales market share and growth rate by type, application, from 2015 to 2020.

Chapter 12, Pre-Pregnancy Genetic Testing market forecast, by regions, type and application, with sales and revenue, from 2020 to 2025.

Chapter 13, 14 and 15, to describe Pre-Pregnancy Genetic Testing sales channel, distributors, customers, research findings and conclusion, appendix and data source.

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Pre-Pregnancy Genetic Testing Market : Drivers, Restraints, Opportunities, and Threats (20202025) - The Think Curiouser

Recommendation and review posted by Bethany Smith

Anthropologist Rayna Rapp will discuss the growth of genetic testing in reproduction in a virtual lecture, Wed., Nov. 11, 5:30 p.m.

Banking on DNA: Gendering the Ever-Expanding Horizon of Prenatal Genetic Testing and Reproductive Technology, a Bentson Deans Lecture, will consider the rapidly escalating role of genetic testing in reproduction and will highlight the benefits and burdens of intensified testing in family-making and their gendered implications. The knowledge and pressure to use such tests, scientists observe, has resulted in growing social and cultural awareness of disability rights, robust commercial investments in genome-based technologies, and the turn to big data in health research.

Rapp, a professor in NYUs Department of Anthropology and affiliated with NYUs Center for Disability Studies, is the author of the prize-winningTesting Women, Testing the Fetus: The Social Impact of Amniocentesis in America and of more than 100 articles and reviews on the politics of gender, medical anthropology, feminist theory, science studies, and disability studies.

An RSVP is required by emailing cas.events@nyu.edu. Zoom coordinates will be sent to attendees the day of the event.

Funded by theBentsonFoundation,BentsonDean's Lectures are traditionally delivered by current full-time College of Arts and Science professors as well as adjuncts and visiting professors who are leaders in their respective fields.

Read more:
The Implications of the Growing Role of Genetic TestingLecture by Anthropologist Rayna Rapp, Nov. 11 - NYU News

Recommendation and review posted by Bethany Smith

A recent market research report added to repository of Adroit Market Research is an in-depth analysis of Preimplantation Genetic Testing Market. On the basis of historic growth analysis and current scenario of Preimplantation Genetic Testing market place, the report intends to offer actionable insights on global market growth projections. Authenticated data presented in report is based on findings of extensive primary and secondary research. Insights drawn from data serve as excellent tools that facilitate deeper understanding of multiple aspects of global Preimplantation Genetic Testing market.

This report examines all the key factors influencing growth of global Preimplantation Genetic Testing market, including demand-supply scenario, pricing structure, profit margins, production and value chain analysis. Regional assessment of global Preimplantation Genetic Testing market unlocks a plethora of untapped opportunities in regional and domestic market places. Detailed company profiling enables users to evaluate company shares analysis, emerging product lines, pricing strategies, innovation possibilities and much more.

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The Preimplantation Genetic Testing Market carries out financial changes that occur year by years in market, with information about upcoming opportunities and risk to keeps you ahead of competitors. The report also describes top company profiles that present in market with trends worldwide. This research guided you for extending business.

The following manufacturers are covered in this report:

Thermo Fisher Scientific, Inc., Agilent Technologies, Inc., PerkinElmer, Inc., CooperSurgical, Inc., Beijing Genomics Institute (BGI), Abbott Laboratories, Natera, Inc., Genea Limited, Rubicon Genomics, Inc. and Oxford Gene Technology

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The report assesses key players in the Preimplantation Genetic Testing Market, studying their services, strategies, landmarks, growth plans, and recent developments. By studying multiple organizations covering small, medium, and large players the report enables emerging players to train themselves with knowledge of competition scenarios. The most critical aspect in the competitive landscape individual growth strategy is studied extensively by dwelling into the foregoing growth trajectory of the organization. Moreover, the study paints a picture of the individual standpoints of the players in the years to come, considering the drivers and trends.

It includes the major key players operating in the global regions. Several strategies adopted by top-level industries have been mentioned in this research report. Profiling of top key players has been done to get a detailed analysis of several industries. It helps to understand the global competition across the domestic and global platforms.

Global Preimplantation Genetic Testing market is segmented based by type, application and region.

Market by Types

by Test Type (Aneuploidy, Structural Chromosomal Abnormalities, Single Gene Disorders, X-linked Disorders, HLA Typing, Gender Identification) and Technology (Next Generation Sequencing, Polymerase Chain Reaction, Fluorescent In-Situ Hybridization, Comparative Genomic Hybridization, Single Nucleotide Polymorphism)

Regional Overview:

A thorough evaluation and assessment study of growth prospects through the forecast spam, 2020-25 has also been significantly included in this report. Proceeding beyond regional scope, country specific analysis with prime identification of production and consumption channels, logistics, investor preferences besides vendor activities have been discussed at length in this report, committed to encourage vendor specific business decisions, eying steady and strong foothold in the competition spectrum.

Some Points from Table of Content

Chapter 1: Market Overview, Drivers, Restraints and Opportunities, Segmentation overviewChapter 2: Market Competition by ManufacturersChapter 3: Production by RegionsChapter 4: Consumption by RegionsChapter 5: Production, By Types, Revenue and Market share by TypesChapter 6: Consumption, By Applications, Market share (%) and Growth Rate by ApplicationsChapter 7: Complete profiling and analysis of ManufacturersChapter 8: Manufacturing cost analysis, Raw materials analysis, Region-wise manufacturing expensesChapter 9: Industrial Chain, Sourcing Strategy and Downstream BuyersChapter 10: Marketing Strategy Analysis, Distributors/TradersChapter 11: Market Effect Factors AnalysisChapter 12: Market ForecastChapter 13: Preimplantation Genetic Testing Research Findings and Conclusion, Appendix, methodology and data source.

Points Covered in the Report:

The points that are discussed within the report are the major market players that are involved in the market such as market players, raw material suppliers, equipment suppliers, end users, traders, distributors and etc. The complete profile of the companies is mentioned. And the capacity, production, price, revenue, cost, gross, gross margin, sales volume, sales revenue, consumption, growth rate, import, export, supply, future strategies, and the technological developments that they are making are also included within the report. This report analysed 12 years data history and forecast. The growth factors of the market are discussed in detail wherein the different end users of the market are explained in detail. Data and information by market player, by region, by type, by application and etc., and custom research can be added according to specific requirements. The report contains the SWOT analysis of the market. Finally, the report contains the conclusion part where the opinions of the industrial experts are included.

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Global Preimplantation Genetic Testing Market: In-depth Analysis of Market Share, Size, Segmentaion, Top Players across the Region and Globe, Current...

Recommendation and review posted by Bethany Smith

The Global Direct-to-Consumer Genetic Testing (DTC-GT) Market report by dataintelo provides a detailed analysis of the area marketplace expanding; competitive landscape; global, regional, and country-level market size; impact market players; market growth analysis; market share; opportunities analysis; product launches; recent developments; sales analysis; segmentation growth; technological innovations; and value chain optimization. This is a latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions. The rapidly changing market scenario and initial and future assessment of the impact is covered in the report.

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Market Segmentation

The Global Direct-to-Consumer Genetic Testing (DTC-GT) Market has been divided into product types, application, and regions. These segments provide accurate calculations and forecasts for sales in terms of volume and value. This analysis can help customers increase their business and take calculated decisions.

By Product Types,Over-the-Counter (OTC) ChannelOnline Channel

By Applications,Ancestry-based Genetic TestsHealth and Wellness-based Genetic TestsEntertainment-based Genetic Tests

By Regions and Countries,Asia Pacific: China, Japan, India, and Rest of Asia PacificEurope: Germany, the UK, France, and Rest of EuropeNorth America: The US, Mexico, and CanadaLatin America: Brazil and Rest of Latin AmericaMiddle East & Africa: GCC Countries and Rest of Middle East & Africa

The regional analysis segment is a highly comprehensive part of the report on the global Direct-to-Consumer Genetic Testing (DTC-GT) market. This section offers information on the sales growth in these regions on a country-level Direct-to-Consumer Genetic Testing (DTC-GT) market.

The historical and forecast information provided in the report span between 2018 and 2026. The report provides detailed volume analysis and region-wise market size analysis of the market.

Competitive Landscape of the Direct-to-Consumer Genetic Testing (DTC-GT) Market

The chapter on competitive landscape provides information about key company overview, global presence, sales and revenue generated, market share, prices, and strategies used.

Major players in the global Direct-to-Consumer Genetic Testing (DTC-GT) Market include 24GeneticsAncestry.com LLCDante LabsEasyDNAGenebaseAtlas BiomedFamily Tree DNAMyHeritageMapmygenome

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The Direct-to-Consumer Genetic Testing (DTC-GT) Market Report Addresses:

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Direct-to-Consumer Genetic Testing (DTC-GT) Market 2020 Global Share, Growth, Size, Opportunities, Trends, Regional Overview, Leading Company Analysis...

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Preimplantation Genetic Testing Market Overview:

Reports and Data has recently published a new research study titled Global Preimplantation Genetic Testing Market that offers accurate insights for the Preimplantation Genetic Testing market formulated with extensive research. The report explores the shifting focus observed in the market to offer the readers data and enable them to capitalize on market development. The report explores the essential industry data and generates a comprehensive document covering key geographies, technology developments, product types, applications, business verticals, sales network and distribution channels, and other key segments.

The report is further furnished with the latest market changes and trends owing to the global COVID-19 crisis. The report explores the impact of the crisis on the market and offers a comprehensive overview of the segments and sub-segments affected by the crisis. The study covers the present and future impact of the pandemic on the overall growth of the industry.

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Competitive Landscape:

The global Preimplantation Genetic Testing market is consolidated owing to the existence of domestic and international manufacturers and vendors in the market. The prominent players of the key geographies are undertaking several business initiatives to gain a robust footing in the industry. These strategies include mergers and acquisitions, product launches, joint ventures, collaborations, partnerships, agreements, and government deals. These strategies assist them in carrying out product developments and technological advancements.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Natera, Inc.; CooperSurgical, Inc.; F. Hoffmann-La Roche AG; Illumina, Inc.; IGENOMIX; and others

An extensive analysis of the market dynamics, including a study of drivers, constraints, opportunities, risks, limitations, and threats have been studied in the report. The report offers region-centric data and analysis of the micro and macro-economic factors affecting the growth of the overall Preimplantation Genetic Testing market. The report offers a comprehensive assessment of the growth prospects, market trends, revenue generation, product launches, and other strategic business initiatives to assist the readers in formulating smart investment and business strategies.

To read more about the report, visit @ https://www.reportsanddata.com/report-detail/preimplantation-genetic-testing-market

Test Type (Revenue, USD Million; 20162026)

Type (Revenue, USD Million; 20162026)

Application(Revenue, USD Million; 20162026)

End Use (Revenue, USD Million; 20162026)

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Key Coverage in the Preimplantation Genetic Testing Market Report:

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Preimplantation Genetic Testing Market Analysis, Size, Market Trends, Latest Technology and Cost Structures with Future Forecasts to 2027 - PRnews...

Recommendation and review posted by Bethany Smith

The global Predictive Genetic Testing market is forecasted to reach a market value of ~US$ XX Mn/Bn by the end of 2029 registering a CAGR growth of around XX% during the forecast period (2019-2029). The recent market report provides a detailed analysis of the current structure of the Predictive Genetic Testing market along with the estimated trajectory of the market over the course of the stipulated timeframe.

The report provides an in-depth assessment of the numerous factors that are anticipated to impact the market dynamics with utmost precision and accuracy. The SWOT and Porters Five Forces Analysis provides a clear picture about the current operations of the various market players operating in the global Predictive Genetic Testing market.

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Segmentation analysis

key players in the predictive genetic testing market. The significant competitive strength of the existing players in the evolving landscape of the global predictive genetic testing market is anticipated to offer new prospect in widening the application of the predictive genetic testing, substantially driving predictive genetic testing market growth. The key manufacturers of the predictive genetic testing are greatly concentrated on the technical edification of the end users to improve consumer outcomes. Furthermore, the adoptions of advanced predictive genetic testing services is expected to create lucrative growth opportunities for the service and third-party market competitors. Growing inclination toward trend in predict is prevention is estimated to offer growth opportunity for Predictive genetic testing market. Selection of treatment regimen with Predictive genetic testing is projected to aid capturing higher share in Predictive genetic testing market.

Geographically, global Predictive genetic testing market is segmented into seven key regions viz. North America, Latin America, Europe, South Asia, East Asia Oceania and Middle East & Africa. North America is prominent region in Predictive genetic testing Market. Advancement in genetic care facilities, higher adoption to lifestyle changes, increase awareness about genetic disease, increase in preventative care and favorable government policies have improved the regulatory scenario for predictive genetic testing devices in north America. Additionally in Asia pacific region considerably higher market growth rate is expected due to constantly rising population and higher incidence of genetic abnormality. Relatively affecting the Predictive genetic testing market.

Some of the major key players competing in the global Predictive genetic testing Market are Myriad Genetics, Inc., Abbott Laboratories, Illumina, Inc., Genesis GeneticsThermo Fisher Scientific, Inc., Bio-Rad Laboratories Inc., , Agilent Technologies, F. Hoffmann-La Roche Ltd., Counsyl, Inc., ARUP Laboratories. BGI among others.

The report covers exhaustive analysis on:

Regional analysis includes

Report Highlights:

The report ponders over the market scenario in various geographies and highlights the major opportunities, trends, and challenges faced by market players in each region. An in-depth country wise analysis of each major region provides readers a deep understanding of the regional aspects of the market including, the market share, pricing analysis, revenue growth, and more.

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The market report on the Predictive Genetic Testing market addresses some important questions such as:

Crucial data enclosed in the report:

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Increasing Government Investments and Favorable Policies to Aid the Growth of the Predictive Genetic Testing Market 2019 2029 - Eurowire

Recommendation and review posted by Bethany Smith

NEW YORK, Nov. 09, 2020 (GLOBE NEWSWIRE) -- Axovant Gene Therapies Ltd. (NASDAQ: AXGT), a clinical-stage company developing innovative gene therapies, today announced that the U.S. Food and Drug Administration (FDA) has lifted its clinical hold and cleared the Investigational New Drug (IND) Application to initiate a registrational study of AXO-AAV-GM2 gene therapy to treat patients with Tay-Sachs disease and Sandhoff disease. AXO-AAV-GM2 is the first investigational gene therapy to achieve IND clearance for Tay-Sachs and Sandhoff diseases. The Company received a letter from the FDA indicating that it has satisfactorily addressed all issues related to the clinical hold.

The IND clearance of AXO-AAV-GM2, the first potentially curative treatment for Tay-Sachs and Sandhoff diseases to enter the clinic, marks a seminal moment for the entire GM2 gangliosidosis community. Along with AXO-AAV-GM1 for GM1 gangliosidosis, todays announcement represents the second IND clearance for Axovants gene therapy pipeline in the last 12 months, said Gavin Corcoran, M.D., Chief R&D Officer of Axovant. AXO-AAV-GM1 and AXO-AAV-GM2 are the first gene therapies to enter active clinical development in their indications. Each program captures the essence of our mission to liberate patients from debilitating neurological diseases by rapidly advancing these gene therapy programs into clinical development. We look forward to working with our study investigators, academic partners, the patient community, and families to begin enrollment in the study promptly.

Sue Kahn, Executive Director of the National Tay-Sachs & Allied Diseases Association (NTSAD), added, This is a big step toward a potential therapy for the GM2 community. It has been a long journey since NTSAD started supporting this promising gene therapy research in 2006. We are thrilled that it is now entering the clinic, bringing tremendous hope to families and the entire NTSAD community.

Axovant aims to advance the program through strategic partnerships with leading research organizations. The Company recently announced a partnership with Viralgen, an AskBio subsidiary, to support AAV-based vector manufacturing of clinical trial material for the registrational study. Additionally, through an existing genetic testing collaboration with Invitae, ongoing partnership with GM2 gangliosidosis patient groups, and collaboration with leading academic researchers at the University of Massachusetts Medical School and Massachusetts General Hospital, Axovant expects to begin patient identification and site startup activities in preparation for dosing children in the planned clinical study.

AXO-AAV-GM2 is an investigational gene therapy for Tay-Sachs and Sandhoff diseases, which are rare, monogenic neurodegenerative lysosomal storage disorders caused by mutations in the genes that encode -Hexosaminidase A, HEXA and HEXB. Children affected by Tay-Sachs and Sandhoff diseases suffer from a progressively debilitating disease course and reduced life expectancy. AXO-AAV-GM2 delivers two vectors encoding the HEXA and HEXB genes directly to the central nervous system to produce a fully functional -Hexosaminidase A enzyme. In 2019, clinical evidence from two patients under an investigator-initiated study found that treatment with AXO-AAV-GM2 was generally well-tolerated and associated with improved bioactivity outcomes. In addition, the data demonstrated the attainment of normal neurodevelopmental milestones and improvement in myelination. AXO-AAV-GM2 has been granted Orphan Drug and Rare Pediatric Disease Designation by the FDA.

The study will enroll both infantile and juvenile subjects with GM2 gangliosidosis in the U.S. The two-part trial, sponsored by Axovant, will consist of (1) a dose ranging cohort evaluating the safe and efficacious dose of the gene therapy, followed by (2) an efficacy cohort, both of which form the basis of the registrational program. Terence R. Flotte, M.D., Professor of Pediatrics and Dean at the University of Massachusetts Medical School, will serve as principal investigator on the clinical trial.

About AXO-AAV-GM2

AXO-AAV-GM2 is an investigational gene therapy for GM2 gangliosidosis (also known as Tay-Sachs and Sandhoff diseases), a set of rare and fatal pediatric neurodegenerative genetic disorders caused by defects in theHEXA(leading to Tay-Sachs disease) orHEXB(leading to Sandhoff disease) genes that encode the two subunits of the -hexosaminidase A (HexA) enzyme. These genetic defects lead to progressive neurodegeneration and shortened life expectancy. AXO-AAV-GM2 aims to restore HexA function by introducing a functional copy of theHEXAandHEXBgenes via delivery of two co-administered AAVrh8 vectors.

About Axovant Gene Therapies

Axovant Gene Therapies is a clinical-stage gene therapy company focused on developing a pipeline of innovative product candidates for debilitating neurodegenerative diseases. Our current pipeline of gene therapy candidates target GM1 gangliosidosis, GM2 gangliosidosis (also known as Tay-Sachs disease and Sandhoff disease), and Parkinsons disease. Axovant is focused on accelerating product candidates into and through clinical trials with a team of experts in gene therapy development and through external partnerships with leading gene therapy organizations. For more information, visit http://www.axovant.com.

In 2018, Axovant licensed exclusive worldwide rights from the University of Massachusetts Medical School for the development and commercialization of gene therapy programs for GM1 gangliosidosis and GM2 gangliosidosis, including Tay-Sachs and Sandhoff diseases.

Forward-Looking Statements

This press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. The use of words such as "will," "expect," "believe," "estimate," and other similar expressions are intended to identify forward-looking statements. For example, all statements Axovant makes regarding costs associated with its operating activities are forward-looking. All forward-looking statements are based on estimates and assumptions by Axovants management that, although Axovant believes to be reasonable, are inherently uncertain. All forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those that Axovant expected. Such risks and uncertainties include, among others, the impact of the Covid-19 pandemic on our operations, the initiation and conduct of preclinical studies and clinical trials; the availability of data from clinical trials; the development of a suspension-based manufacturing process; the scaling up of manufacturing, the expectations for regulatory submissions and approvals; the continued development of our gene therapy product candidates and platforms; Axovants scientific approach and general development progress; and the availability or commercial potential of Axovants product candidates. These statements are also subject to a number of material risks and uncertainties that are described in Axovants most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 11, 2020, as updated by its subsequent filings with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was made. Axovant undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts:

Investors

Parag MeswaniAxovant Gene Therapies Ltd.(212) 547-2523investors@axovant.com

Media

Josephine Belluardo, Ph.D. LifeSci Communications(646) 751-4361jo@lifescicomms.commedia@axovant.com

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Axovant Gene Therapies Announces FDA Clearance of IND for AXO-AAV-GM2 Gene Therapy in Tay-Sachs and Sandhoff Diseases - GlobeNewswire

Recommendation and review posted by Bethany Smith