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Archive for December, 2020

How to Break a Sugar Addiction | INTEGRIS – Integris

Those cookies you smell at the holidays, the ice cream that makes your eyes light up in the summertime and the candy jar full of tempting chocolates all have one thing in common they're loaded with sugar.

There's something about sugar that speaks to your brain, evoking feelings of happiness with each bite of food or each sip of your favorite sugary drink you consume. It's part nostalgia and part chemical reaction. The more you eat, the more you crave, which can lead you down a road of long-term health problems.

We're here to discuss what makes sugar so habit-inducing, how you can kick your cravings and which foods you can substitute to please your sweet tooth.

What's wrong with sugar, you ask? Everything. Outside of making things taste better, sugar has no nutritional value and is full of empty calories. These calories can create weight problems and, in turn, heighten your risk of heart disease and stroke.

That's only the physical downside. The psychological component is real, too. Sugar releases dopamine and can increase serotonin production, a hormone that can boost your mood.

In reality, sugar isn't any different than comfort food or a satisfying fast food meal loaded with simple carbohydrates. These carbohydrates are high on the glycemic index, meaning it takes less time to turn them into glucose. During this quicker digestion process, you may feel good in the short term, but hunger will quickly set in since sugary foods lack nutrients and leave you unsatisfied.

It can turn into a vicious cycle. At first, the sugar you eat tastes good, bringing on a "high" when your brain initiates the dopamine release. Then, the sugar causes your insulin levels to increase, leading to a drop in blood sugar levels. As your blood sugar falls, your appetite and hunger levels increase. Your body then craves sugar again to fix any hunger deficiencies or feelings of unease, even if the fix is only temporary.

According to the American Heart Association, eight out of 10 adults are trying to lower their sugar intake. On average, adults consume around 77 grams of sugar a day. That equals about 60 pounds of sugar over the course of a year. Imagine lugging around a dozen five-pound sacks of sugar. That's what you're putting in your body!

If you're determined to kick your sugar habit, it's OK to stop cold turkey. The Mayo Clinic recommends taking a two-week break from sugar to reset your body. This doesn't have to be an outright cleanse, but try to limit yourself to foods with little to no added sugars or sweeteners shoot for less than 5 grams of added sugars per serving.

Start by cutting out sugary drinks. They are the biggest culprit, accounting for almost half of the added sugars Americans consume. A 12-ounce can of soda can contain as much as 10 teaspoons of sugar. Think of it this way: The American Heart Association recommends men eat only nine teaspoons of added sugar each day, while women and children should consume six teaspoons. Just like that, you can exceed your daily sugar allotment in five or six gulps of your favorite soda.

The spoonfuls and spoonfuls of sugar in soda explain why there are so many calories in a drink the size of your hand. There are four calories in a gram, so a soda containing 40 grams of sugar has 160 calories. It's easy to see how calories add up when that 12-ounce soda turns into a 44-ounce drink at your favorite fast food restaurant.

You should also stay away from any baked goods, desserts and candy. Cereals, even the so-called "healthier" options, still have added sugars that can creep up on you. Then there are unassuming foods, such as pizza or pasta sauces, that you wouldn't normally associate with having added sugars. A half-cup of a store-bought marinara sauce contains anywhere from 2 to 4 grams of added sugar, which amounts to a teaspoon.

As a general rule, look for words that end in "ose" sucrose, fructose, glucose, maltose, lactose or dextrose. This is an easy indicator to spot added sugars. Don't let ingredients that sound better for you fool you, either. Honey, agave, maple syrup, brown rice syrup and juice concentrate are still added sugars.

Now that you've reduced your sugar intake, what comes next? For starters, introduce more whole foods whole grains, fruits, vegetables and lean meats to your diet. Many fruits and vegetables still contain natural sugars, but the starch and fiber in these foods slows the digestion process and leaves you feeling more full. You can learn more by reading our blog post on healthy carbs.

Eating fruit for an after-dinner snack can satisfy your cravings for sugar without leaving you feeling like you've cheated. Certain fruits, such as grapes and bananas, have high sugar contents. Berries are generally a low-sugar choice, so sneak some blueberries, raspberries or blackberries into your yogurt or oatmeal.

Ditching sugary drinks isn't easy, but try swapping them for water or sparkling water. Better yet, try flavored sparkling water. The carbonation will mimic the fizz from soda without the added sugar or calories. For more on sparkling water, check out our blog post on carbonated drinks.

When making food selections at the grocery store, be wary of hidden sugars that are often added to low-fat products. Things with fat tend to have flavor, so removing fat from products can leave them bland. Food manufacturers add sugars back into products to make them more enjoyable. Any benefit you think you're getting from a product with less fat may be just as bad for you if it's loaded with additives or sugars.

It's important to remember correcting bad sugar habits doesn't mean an outright boycott of sweet foods. Instead, take control by adding small amounts of sugar. For example, drizzle a small amount of honey on your yogurt to treat yourself. It's better than the alternative, which is pre-packaged flavored yogurts loaded with added sugar.

If you place an order at your local coffee shop, it's no longer a question of if you want cream or sugar added. Artificial sweetenersare just as popular of an option nowadays to help curb sugar habits.

These synthetic sugar substitutes received a bad reputation years ago for their link to cancer, but subsequent studies haven't found a clear connection to causing cancer in humans, according to the National Cancer Institute.

With those concerns out of the way for now, the FDA has approved five artificial sweeteners for use: aspartame (Equal), acesulfame-K (Sweet One), neotame, saccharin (Sweet'N Low) and sucralose (Splenda).

But just because the FDA approves their use doesn't mean you should swap sugar for artificial sweeteners and keep the same diet. Artificial sweeteners can temporarily help by weaning you off added sugars, but long-term use could play a role in how you view foods.

Think of artificial sweeteners as a concentrated version without the calories a little goes a long way. According to Harvard Health, the sweetness from artificial additives can make you more likely to develop a sweet tooth and crave sweets even more. Plus, the psychological component can alter the way you think. For example, if you tell yourself you're saving calories by drinking a diet soda instead of a regular soda, you may be more inclined to eat cake for dessert. In this case, you cancel out any benefits of drinking a diet soda with something full of added sugars.

Before you make any dietary changes or consider cutting sugar from your daily routine, connect with an INTEGRIS Health primary care physicianto learn more about how to implement changes.

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Outlook on the Biopreservation Global Market to 2026 – Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others – GlobeNewswire

Dublin, Dec. 21, 2020 (GLOBE NEWSWIRE) -- The "Biopreservation Market by Type, Application, End-user, and Geography - Global Forecast to 2026" report has been added to ResearchAndMarkets.com's offering.

Biopreservation is a process that assists in the conservation of biospecimens such as DNA, saliva, and plasma. This process of biopreservation generally increases the durability, shelf life, and purity of the biosamples. The types of equipment in this process include freezers, liquid nitrogen, consumables, and also media & laboratory information management systems.

This process is also used to preserve food and extend its shelf life, specifically by using lactic acid bacteria. Growth in healthcare spending is assumed for better access to quality healthcare and advanced technology products such as biopreservation facilities, thereby widening the growth expectations. Moreover, the bio-banks, hospitals, and gene banks, which are major end-users for this market, are stimulating the key providers to establish technologically advanced biopreservation products to improve patient outcomes. The Biopreservation Market is projected to grow at a rate of 9.2% CAGR by 2026.

The biopreservation market has been analyzed by utilizing the optimum combination of secondary sources and in-house methodology, along with an irreplaceable blend of primary insights. The real-time assessment of the market is an integral part of our market sizing and forecasting methodology. Our industry experts and panel of primary participants have helped in compiling relevant aspects with realistic parametric estimations for a comprehensive study. The participation share of different categories of primary participants is given below:

In the market for biopreservation, the application of biopreservation consists of therapeutic applications, research applications, clinical trials, and other applications. The biopreservation is primarily applied in therapeutics due to the advancements in regenerative medicine & customized medicine, an increase in the shift of cord blood banking, and the rising incidence of chronic diseases.

The end-users of the biopreservation market include biobanks, gene banks, hospitals, and other end users. The biobanks segment is expected to have a major share in the market. The major share of this segment is attributed to the increasing preference for the preservation of stem cells and the rising numbers of sperm and egg banks.

Further, according to the regional market of biopreservation, the North American region is recorded for the colossal share in the market. This is due to the continuous drug developments and the arrival of advanced therapies in the domain of biomedical research. Additionally, the increasing requirement of expensive and improved treatment for patients' chronic diseases is the key factor.

The rising incidence of chronic diseases, including cardiac, renal diseases, diabetes, and obesity, is the crucial factor that will propel the biopreservation market growth in the prevailing period. Government initiatives to encourage stem cell therapies to treat the disease, which will again propel market growth. Conversely, the strict regulations for producing biopreservation products and the evolution of room temperature storage procedures may limit the biopreservation market growth.

Merck KGaA, Avantor, Inc., Bio-Techne Corporation, BioLife Solutions, Inc., Thermo Fisher Scientific Inc, ThermoGenesis Holdings, Inc., Worthington Industries, Inc., Chart Industries, Inc, So-Low Environmental Equipment Co., Inc., Princeton BioCision, LLC, Shanghai Genext Medical Technology Co. Ltd, Exact Sciences Corporation, Helmer Scientific, Inc., CryoTech, Inc., Arctiko, Nippon Genetics Europe, PHC Holdings Corporation, STEMCELL Technologies, Inc., AMS Biotechnology, and OPS Diagnostics. These are the few companies list of the biopreservation market.

Since the rapid increase in the number of research and developments gives the way of potentials for market growth, the biopreservation of biological samples has become a crucial segment. This helps the researchers to access the data of the number of people by the preserved biological samples.

This research presents a thorough analysis of market share, the present trends, and forthcoming evaluations to explain the approaching investment pockets.

This research provides market insights from 2020 to 2026, which is predicted to allow the shareholders to capitalize on the forthcoming opportunities.

This report further offers comprehensive insights into the region, which helps to understand the geographical market and assist in strategic business planning and ascertain future opportunities.

Key Topics Covered:

1. Executive Summary

2. Industry Outlook2.1. Industry Overview2.2. Industry Trends

3. Market Snapshot3.1. Market Definition3.2. Market Outlook3.2.1. PEST Analysis3.2.2. Porter Five Forces3.3. Related Markets

4. Market characteristics4.1. Market Evolution4.2. Market Trends and Impact4.3. Advantages/Disadvantages of Market4.4. Regulatory Impact4.5. Market Offerings4.6. Market Segmentation4.7. Market Dynamics4.7.1. Drivers4.7.2. Restraints4.7.3. Opportunities4.8. DRO - Impact Analysis

5. Type: Market Size & Analysis5.1. Overview5.2. Biopreservation Media5.2.1. Nutrient Media5.2.2. Sera5.2.3. Growth Factors & Supplements5.3. Biospecimen Equipment5.3.1. Temperature Control Systems5.4. Freezers5.5. Cryogenic Storage Systems5.6. Thawing Equipment5.7. Refrigerators5.7.1. Accessories5.7.2. Alarms & Monitoring systems5.7.3. Incubators5.7.4. Centrifuges5.7.5. Other Equipment

6. Application: Market Size & Analysis6.1. Overview6.2. Therapeutic Applications6.3. Research Applications6.4. Clinical Trials6.5. Other Applications

7. End User: Market Size & Analysis7.1. Overview7.2. Biobanks7.3. Gene Banks7.4. Hospitals7.5. Other End Users

8. Geography: Market Size & Analysis8.1. Overview8.2. North America8.3. Europe8.4. Asia Pacific8.5. Rest of the World

9. Competitive Landscape9.1. Competitor Comparison Analysis9.2. Market Developments9.2.1. Mergers and Acquisitions, Legal, Awards, Partnerships9.2.2. Product Launches and execution

10. Vendor Profiles10.1. Merck KGaA10.1.1. Overview10.1.2. Financials10.1.3. Products & Services10.1.4. Recent Developments10.1.5. Business Strategy10.2. Avantor, Inc10.2.1. Overview10.2.2. Financials10.2.3. Products & Services10.2.4. Recent Developments10.2.5. Business Strategy10.3. Bio-Techne Corporation10.3.1. Overview10.3.2. Financials10.3.3. Products & Services10.3.4. Recent Developments10.3.5. Business Strategy10.4. BioLife Solutions, Inc10.4.1. Overview10.4.2. Financials10.4.3. Products & Services10.4.4. Recent Developments10.4.5. Business Strategy10.5. Thermo Fisher Scientific Inc10.5.1. Overview10.5.2. Financials10.5.3. Products & Services10.5.4. Recent Developments10.5.5. Business Strategy10.6. ThermoGenesis Holdings, Inc10.6.1. Overview10.6.2. Financials10.6.3. Products & Services10.6.4. Recent Developments10.6.5. Business Strategy10.7. Worthington Industries, Inc10.7.1. Overview10.7.2. Financials10.7.3. Products & Services10.7.4. Recent Developments10.7.5. Business Strategy10.8. Chart Industries, Inc10.8.1. Overview10.8.2. Financials10.8.3. Products & Services10.8.4. Recent Developments10.8.5. Business Strategy10.9. So-Low Environmental Equipment Co.,Inc10.9.1. Overview10.9.2. Financials10.9.3. Products & Services10.9.4. Recent Developments10.9.5. Business Strategy10.10. Princeton BioCision, LLC10.10.1. Overview10.10.2. Financials10.10.3. Products & Services10.10.4. Recent Developments10.10.5. Business Strategy

11. Companies to Watch11.1. Shanghai Genext Medical Technology Co. Ltd11.1.1. Overview11.1.2. Products & Services11.1.3. Business Strategy11.2. Exact Sciences Corporation11.2.1. Overview11.2.2. Products & Services11.2.3. Business Strategy11.3. Helmer Scientific, Inc11.3.1. Overview11.3.2. Products & Services11.3.3. Business Strategy11.4. CryoTech, Inc11.4.1. Overview11.4.2. Products & Services11.4.3. Business Strategy11.5. Arctiko11.5.1. Overview11.5.2. Products & Services11.5.3. Business Strategy11.6. Nippon Genetics Europe11.6.1. Overview11.6.2. Products & Services11.6.3. Business Strategy11.7. PHC Holdings Corporation11.7.1. Overview11.7.2. Products & Services11.7.3. Business Strategy11.8. STEMCELL Technologies, Inc11.8.1. Overview11.8.2. Products & Services11.8.3. Business Strategy11.9. AMS Biotechnology11.9.1. Overview11.9.2. Products & Services11.9.3. Business Strategy11.10. OPS Diagnostics11.10.1. Overview11.10.2. Products & Services11.10.3. Business Strategy

12. Analyst Opinion

13. Annexure13.1. Report Scope13.2. Market Definitions13.3. Research Methodology13.3.1. Data Collation and In-house Estimation13.3.2. Market Triangulation13.3.3. Forecasting13.4. Report Assumptions13.5. Declarations13.6. Stakeholders13.7. Abbreviations

For more information about this report visit https://www.researchandmarkets.com/r/pl06wm

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

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Outlook on the Biopreservation Global Market to 2026 - Profiling Avantor, BioLife Solutions and ThermoGenesis Among Others - GlobeNewswire

These Families Raised Millions To Fund Treatment For Their Kids’ Genetic Disorders. It Hasn’t Happened. – KCUR

Over the last several years, parents from across the country have appeared on television and news outlets to raise money to develop treatments for their children with rare genetic disorders.

Many of these families, including one from Kansas City, Missouri, have pinned their hopes on one Texas researcher, Dr. Steven Gray of the University of Texas Southwestern Medical Center in Dallas, who claims to be on the verge of treating a number of rare conditions. They've raised millions of dollars to fund his research, although breakthroughs haven't happened to the extent many had hoped.

While gene therapy holds great promise, the growing trend of family-funded research concerns some medical ethicists, who say that suggestions to parents that treatments may be imminent can raise thorny ethical issues.

These are parents. They are desperate. says Mayo Clinic bioethicist Megan Allyse. They are willing to try almost anything. They are in a pretty vulnerable position for somebody to come along and say, Give me your money, and I can make this better.

Further complicating the picture is the recent entry into the field of a private company, Taysha Gene Therapies, which says it will accelerate Grays research. That has divided his supporters and raised concerns about families who might be left behind.

Kim Fry, of Kansas City, Missouri, has a video on her phone of her son, Charlie, that was made in 2018 when he was 5 months old. It shows her bright-eyed boy gently shaking in his father's lap, as if shivering from cold.

Those little tremors sent the family on a year-long odyssey that led to a frightening diagnosis. A genetic test showed Charlie had an incredibly rare mutation in a single gene, SLC6A1. The mutation typically causes intellectual disabilities and epilepsy starting around the age of three-and-a-half that can severely affect patients for the rest of their lives.

Doctors told Kim and Nate there was no treatment available to help their son.

At that moment, you just feel crushed and kind of begin grieving for the life you think your childs going to have, Kim said.

Rare genetic disorders have generally received little attention from biotech companies because the markets for treatments are so small.

But shortly after the diagnosis, Kim met Amber Freed, a mother from Denver who seemed to have found a solution. After her son, Maxwell, was diagnosed with the same mutation a year earlier, Freed met Gray, a molecular biologist who had focused on gene therapy while doing a post-doctoral fellowship at UNC Chapel Hill.

Gray was developing treatments or even possible cures for conditions caused by single-gene mutations, and he had agreed to work on SLC6A1. But it would be up to Freed to provide Gray with the millions of dollars he would need to do this work.

With the possibility of a treatment suddenly on the table, Kim and Nate immediately joined Amber in raising money through the organization she started, SLC6A1 Connect, and their own campaign, A Cure For Charlie. Their goal was to create a treatment and bring it to clinical trial before Charlie turned three-and-half, hoping to block the severe effects of the mutation and giving him a chance to live a regular life.

Once the funding is there, then all the science is going to move into place, so really the only hurdle that were facing right now between us and the cure is the funding, Nate said in fall of 2019.

Family fundraisers

Family fundraisers are a departure from how medical research is usually funded, typically through the National Institutes of Health, large foundations and advocacy groups.

Nevertheless, families like the Frys have appeared on news outlets and in publications throughout the country in recent years, from Good Morning America and ABC News to People magazine and countless local news shows, to raise money for research.

The children have been diagnosed with many different genetic disorders, but their stories are similar. They all have rare gene mutations that will lead to serious mental or physical declines or early death, and their parents are pinning their hopes on Gray to develop treatments.

They call themselves the Steve Gray Parents.

Gray himself has appeared in articles and videos, including one produced by UT Southwestern about Willow Canaan, a girl from Mississippi who has multiple sulfatase deficiency.

A lot of the families that we interact with, they are coming to us with really sick kids. I think knowing their story, knowing that one child, gives us a face, gives us a mission that if we can move fast enough theres hope that we could treat and we make things different for that specific child, Gray said in one video.

Gray became a go-to researcher for rare disease families after his treatment of Hannah Sames, a girl from New York with a degenerative genetic disorder called giant axonal neuropathy.

In a 2016 clinical trial, Sames was injected with a manufactured virus that contained a working copy of the gene that was mutated. Through this adeno-associated virus delivery method, the normal gene would take over from the mutated one and stop the degeneration from happening.

The treatment slowed the progress of Hannahs disease, according to Gray, but it wasnt a cure. In a 2019 interview on Connecticut Public Radio, Hannahs mother, Lori, said the family was seeking additional treatment.

But Gray thinks the same method could be used to treat and possibly cure all kinds of genetic disorders, including the SLC6A1 mutation

Were due for another leap in technology, Gray told KCUR in 2019. Were going to have a better virus technology, better ways to deliver genes, and I can see that just making a further leap for the whole field.

Gray, who says he has been involved in developing treatments for two dozen diseases, has accepted money from families to pay for the high costs of manufacturing viruses, doing toxicology studies and running clinical trials. Many of these family groups had raised more than a $1 million each from their friends, relatives and neighbors.

Though these families have been effective at raising money, bioethicist Allyse worries that without the peer review process that traditional funders use, they may not be in the best position to decide what research is likely to get results.

The potential problem with going around that process is that its possible to sort of go down avenues that are less supported by the literature, that are less in line with the scientific consensus, Allyse said.

But those doubts have done little to discourage dedicated parents like Amber Freed.

In early December 2019, Freed hosted the second annual SLC6A1 research symposium in a hotel conference room in downtown Baltimore. Freed quit her job in finance after her sons diagnosis to dedicate herself to advancing a treatment, and she began organizing annual SLC6A1 research symposiums in 2018 to drum up interest in the work.

Shes also held charity golf tournaments, set up fundraising campaigns with companies like Amazon and Pizza Hut, and helped arrange the creation of genetically altered mice in China for research.

During the last two years, Freed has cultivated relationships with genetic researchers from all over the world, and as the sleepy scientists who traveled to Baltimore to take part in the symposium wandered into the conference room early on a Friday morning, she greeted them like family, with big hugs and smiles.

Alex Smith

Despite Freeds seemingly endless enthusiasm, she made clear in her welcoming speech to the scientists that, unlike them, her involvement in SLC6A1 research didnt happen by choice.

But to be honestI dont want to be here, read a slide projected behind her at the end of her remarks.

Some improvements but no 'home run'

Toward the end of the day, Gray took the podium to deliver an update on research from his lab. For many in the audience, this was the days main event.

His teams early research using the treatment showed some improvements in motor and behavioral skills in young, genetically altered mice that were treated before symptoms had appeared. But there was no change in mice that already had symptoms.

I think treating at an early age, were seeing some signs of improvements and some nice signals that our vector is doing something positive, but, you know, its not a home run, Gray explained.

Though it wasnt the result Freed dreamed of, she was encouraged that the research appeared to be on the right path.

Gray insisted he had tried to be careful about managing expectations for families funding his work, but between symposium talks, he also said he had recently shifted course on working with them.

Im really having to say no a lot now, Gray told KCUR. Im kind of moving into a point where we were trying not to say no, and we were trying to work on everything that the science made sense. But there is a point where you just have to say, You know Ive got to focus on what Im doing, and theres a limit.

While Grays work did lead to a treatment for Hannah Sames, similar breakthroughs havent come in time for other families.

Laura King Edwards of Charlotte, North Carolina, started working with her family to raise money for Grays work after her baby sister, Taylor, was diagnosed with a form of a rare disorder called infantile Batten disease in 2006.

The family didnt have a lot of hope the research would lead to a treatment in time to help Taylor, and she died two years ago at age 20.

Edwards says that looking back, she sometimes regrets all the time she spent running a fundraising organization.

Id spend hours up at night dealing with tech issues on our website, for example, or responding to emails from people all over the world, knowing that thats time that maybe I couldve spent with my little sister while she was still here, Edwards says.

Nevertheless, even after Taylor was gone, her family continued to support Grays work through their organization, Taylor's Tale.

A new player

Not long after the conference in Baltimore, however, the race for a SLC6A1 treatment slowed to a crawl.

When the COVID-19 pandemic hit, scientific studies and medical trials across the country were stopped and research funds were directed to coronavirus research.

The therapists who work with Amber and Kims sons were unable to meet with them in person, and the boys started to backslide on some of their developmental progress.

Then, after the initial waves of the coronavirus subsided, hopes for Grays research came roaring back to life when a new company, Taysha Gene Therapies, announced it would partner with UT Southwestern, offering a boost to the research and development beyond what families could provide.

They could get it to a certain place, said Taysha founder R.A. Session II, But when it needs to get to kind of the meaningful level in order to get it into late-stage clinical trials, this is where they just dont necessarily have the capability. And so I think this is where you would see programs then transitioning into a companys hands in order to kind of pursue them and move them forward.

In April, Taysha announced a partnership with UT Southwestern that would fund Grays research and work to move it more quickly into clinical trials and possible treatment. Gray was named chief scientific officer.

The company said the family fundraising would no longer be needed.

For some parents, like Doug and Kasey Woleben of Dallas, that was great news. Theyve raised around $1 million for research to treat Leigh syndrome, which affects their 8-year-old son, Will.

We were excited, thrilled to know that were now off the hook for millions and millions and millions of dollars. And that Taysha and UT Southwestern are trying to push this program and move it forward as quickly as possible. So for us, it was a miracle, Kasey said.

But Taysha's involvement and its timeline have brought disappointment for other families. The company's first clinical trials, to treat a mutation that causes Tay Sachs disease, were planned to start in Canada at the end of 2020 but only received approval from the Canadian government this week.

The company says it plans to seek permission to test treatments for three other conditions, including the SLC6A1 mutation, by the end of 2021, but it has not announced any dates for beginning trials.

For Amber Freed and Kim Fry, Tayshas timeline is problematic. Both of their sons were expected to exhibit epilepsy symptoms before the end of next year and so they would see little benefit from treatment initiated after that.

Im very disappointed, Freed said in September. If you had asked me this time last year, I would have fully expected to be in a clinical trial right now.

Different priorities

Session insists that Tayshas timeline and priorities on are based on what the research shows is safe and effective.

Weve allowed the science to kind of move forward at the pace the science moves, Session says. Then we move it forward into the clinic based on that science.

But to Freed, the goal of fast-tracking to trial, even one that would have only resulted in a slight improvement for her son, appears much less likely now that Taysha is involved.

Once you hand over the reins to a biotech, you lose decision-making power as a nonprofit organization, and you abide by their timeline and not necessarily your own, Freed said. In my case, we are racing to get this therapy into children like Maxwell and Charlie as quickly as possible, so we need it done tomorrow.

For other Gray supporters, however, the future is even less clear. Tayshas development pipeline does not include treatments for some of the conditions that Gray had previously been working with families to develop, including Charcot-Marie Tooth, Krabbe disease and multiple sulfatase deficiency.

UT Southwestern researchers will continue to research those conditions, according to a university spokesman, and Taysha says it plans to expand its pipeline in the future.

Terry Pirovolakis, who had enlisted Grays help to develop a treatment for spastic paraplegia 50, which affects his son, Michael, will not be involved with Tayshas work. Hell only continue to work with UT Southwestern directly.

From my perspective, it was, thats great. Tayshas gonna come in and maybe save the world, but I dont want to be part of it 'cause theyve got a lot of stuff they gotta work out, and Im not going to wait around for them to figure it out, Pirovolakis said.

Pirovolakis, who lives in Toronto, has raised more than $1.5 million since May 2019 through his online campaign, Cure Michael, which was the most successful GoFundMe campaign in Canada last year.

Expectations vs. reality

He says that while he has been comfortable working with Gray, he believes that drug companies, which depend on the involvement of families for rare disease research, can mislead parents about what might be possible for their children.

The industry, as a whole, I think, maybe sets expectations that are higher than reality," Pirovolakis said. "We see these presentations at the conferences of these kids doing amazing things, like a 4-year-old that has no brain function pretty much, going to school two years later. Its remarkable.

"But that was five or 10 years of research. So I think that expectations from the industry are maybe what cloud us as parents in the hope that something amazing is gonna happen for our kids.

CureCMT4J, a foundation created to advance research on Charcot-Marie Tooth by parent advocate Jocelyn Duff, an early supporter of Gray, also is no longer involved with the researchers work. Duff said the organization had moved in a different direction, but she declined the provide details. The group had raised $1.3 million as of fall 2020.

Some ethicists have also raised questions about the costs of rare disease treatment, and they point to a drug previously developed by members of the Taysha team as a prime example of their concern.

Several members of the Taysha team, including Session, directors Sean Nolan and Phillip Donenberg, and others, earned their reputation for success as part of a AveXis, a company that developed the breakthrough treatment for spinal muscular atrophy, Zolgensma.

Zolgensma was introduced by drug giant Novartis last year with a price tag of more than $2.1 million, making it the most expensive drug in the country.

On the one hand, you could say thats a winning team, said Megan Allyse. On the other hand, you could say is that the team you want to be on if what youre trying to do is generate not just effective treatments, but accessible treatments?

Session says that Taysha currently has no plans regarding the pricing or accessibility of any treatments the company might develop.

We should be so blessed to be able to have a discussion on pricing because then were talking about an approved therapy, Session says. But were not there yet. So what I would say is the company is focused on getting these drugs into patients effectively and safely as efficiently as possible.

Taysha announced in November that it raised more than $275 million in private financing and an initial public offering.

For Kim Fry and Amber Freed, however, the focus is still very much on what can be done for their sons.

The women are continuing to raise money, but they have shifted to other researchers and technologies. And they have adjusted their expectations.

Frys son, Charlie, started having more significant seizures earlier in the year and is now taking medication to reduce them.

She still thinks a treatment within the next year or two could help her son and others like him, although not in the way she had once imagined.

It may not be a 100% home run where they live 100% the life we hoped. But theyll still have a better life than they are living today, Fry said. I lose sleep every night over the thought that it might be too late, but Im still hopeful that there will be benefit for them.

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These Families Raised Millions To Fund Treatment For Their Kids' Genetic Disorders. It Hasn't Happened. - KCUR

Taysha Gene Therapies Announces Queen’s University’s Receipt of Clinical Trial Application Approval from Health Canada for Phase 1/2 Clinical Trial of…

TSHA-101 will be the first bicistronic vector to enter a first-in-human clinical study, which is a significant milestone for Taysha and for the field of gene therapy, said Suyash Prasad, MBBS, M.SC., MRCP, MRCPCH, FFPM, Chief Medical Officer and Head of Research and Development of Taysha. GM2 is a devastating lysosomal storage disease with no approved treatments and todays CTA approval marks a formative moment for children suffering from this rapidly progressive and fatal disease.

The trial will be a single arm, open-label Phase 1/2 trial evaluating the use of TSHA-101 for the treatment of infants with GM2. The study will be sponsored by Queens University and led by Jagdeep S. Walia, MBBS, FRCPC, FCCMG, Clinical Geneticist and Associate Professor Head, Division of Medical Genetics (Department of Pediatrics) at Queens, and Director of Research (Department of Pediatrics), at the Kingston Health Sciences Centre.

Preclinical evidence to date supports our belief that TSHA-101, when given intrathecally as a bicistronic transgene packaged into a single AAV9 vector, has the potential to address the lysosomal enzyme deficiency, to change the disease trajectory and to improve patient survival, said Dr. Jagdeep S. Walia. We are pleased to have the support of Health Canada as we continue to advance TSHA-101.

Todays CTA approval is a culmination of our teams and Dr. Walias tireless efforts and a momentous occasion for children affected by GM2 along with their parents and caregivers, said RA Session II, Founder, President and CEO of Taysha. We are grateful to our partners at Queens University for their work to advance this gene therapy into the clinic.

About GM2 Gangliosidosis

GM2 gangliosidosis is a rare and fatal monogenic lysosomal storage disorder and a family of neurodegenerative genetic diseases that includes Tay-Sachs and Sandhoff diseases. The disease is caused by defects in the HEXA or HEXB genes that encode the two subunits of the -hexosaminidase A enzyme. These genetic defects result in progressive dysfunction of the central nervous system. There are no approved therapies for the treatment of the disease, and current treatment is limited to supportive care.

About TSHA-101

TSHA-101 is an investigational gene therapy administered intrathecally for the treatment of infantile GM2 gangliosidosis. The gene therapy is designed to deliver two genes HEXA and HEXB driven by a single promoter within the same AAV9 construct, also known as a bicistronic vector. This approach allows the simultaneous expression of a 1:1 ratio of the two subunits of protein required to generate a functional enzyme. It is the first and only bicistronic vector currently in clinical development and has been granted Orphan Drug and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA).

About Taysha Gene Therapies

Taysha Gene Therapies (Nasdaq: TSHA) is on a mission to eradicate monogenic CNS disease. With a singular focus on developing curative medicines, we aim to rapidly translate our treatments from bench to bedside. We have combined our teams proven experience in gene therapy drug development and commercialization with the world-class UT Southwestern Gene Therapy Program to build an extensive, AAV gene therapy pipeline focused on both rare and large-market indications. Together, we leverage our fully integrated platforman engine for potential new cureswith a goal of dramatically improving patients lives. More information is available at http://www.tayshagtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as anticipates, believes, expects, intends, projects, and future or similar expressions are intended to identify forward-looking statements. Forward-looking statements include statements concerning or implying the potential of our product candidates, including TSHA-101, to positively impact quality of life and alter the course of disease in the patients we seek to treat, our research, development and regulatory plans for our product candidates, the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed. Forward-looking statements are based on managements current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our Securities and Exchange Commission (SEC) filings, including in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, which is available on the SECs website at http://www.sec.gov. Additional information will be made available in other filings that we make from time to time with the SEC. Such risks may be amplified by the impacts of the COVID-19 pandemic. These forward-looking statements speak only as of the date hereof, and we disclaim any obligation to update these statements except as may be required by law.

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Taysha Gene Therapies Announces Queen's University's Receipt of Clinical Trial Application Approval from Health Canada for Phase 1/2 Clinical Trial of...

After years of potential, cell and gene therapy is ready for the pharmaceutical mainstream – PMLiVE

The argument for continued investment

C> is a high potential and maturing sector, and is an already crowded environment, playing host to numerous start-ups and now, through M&A, recognised big pharma firms. Much like the rush to find a COVID-19 vaccine that dominates headlines worldwide, not every company involved will be able to succeed.

But finnCaps finnLife watch list of 50 leading AIM-listed biotech companies demonstrates that there is room for numerous companies to contribute to, and profit from, C>. Examining three entirely different approaches to CAR-T therapy, it is possible to see just how much space there is for this exciting sector, therefore displaying the case for continued investment.

Innovative CAR-T therapy demonstrates the depth of C> potential

CAR-T therapy in its existing form is a relatively new and specialised approach at treating cancer. It takes T cells from a patients bloodstream and genetically modifies them in a laboratory. These T cells are then injected back into the bloodstream with the aim of targeting and killing cancer cells.

While it has been shown to be an effective treatment, there are risks and side effects. One is the two-step autologous process (the slow time it takes for cell expansion sometimes as long as two weeks) while another is cytokine release syndrome (CRS), which occurs when cytokine molecules are inadvertently released, but too quickly to target just the tumours and instead target healthy cells.

The next generation of CAR-T treatments shows that there is space for a multitude of start-ups to be active in the C> space as they all help find varied solutions to these problems without negating the effectiveness of CAR-T.

One example is Horizon Delivery, a company that is developing its CYAD-02 project, which will help transport T cells more effectively to the tumour via the use of SMARTvector products.

The product underwent its first phase 1 trial test in January 2020 with a patient who was suffering from acute myeloid leukaemia. Horizon Delivery is also an industry leader in CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) screenings, meaning they can identify key genes or genetic sequences that draw out specific functions of a cell type from thousands of potential variants.

In a cancer context, this means they can route out and exclusively eliminate problematic cells that may have shown signs theyd resist a future cancer treatment.

Another example is Maxcyte, a global cell- based therapies and life sciences company that is developing its CARMA process, where a patients peripheral blood mononuclear cells (PBMCs) are removed and modified. The modified cells can then be used to target an array of different cancers.

Currently the company is conducting a phase 1 trial for advanced ovarian cancer in a dose escalation trial that will treat four separate cohorts the fourth of which was administered in March 2020.

Another example which shows the versatility of new CAR-T innovation is provided by Oxford Biomedica, a gene and cell therapy company specialising in the development of gene-based medicines.

Rather than a contained project or platform, its contribution to CAR-T is through a contract manufacturing development organisation. Collaborating with pharma companies, Oxford Biomedica uses its infrastructure to produce other companies licensed products, including Novartis Kymriah treatment (alongside other undisclosed CAR-T-related products).

With fast-moving innovation finally allowing multiple C> treatments to gain regulatory approval, along with a huge pipeline of upcoming therapies and an influx of funding and M&A activity, investing in C> no longer entails taking a bet on potential the future is finally here.

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After years of potential, cell and gene therapy is ready for the pharmaceutical mainstream - PMLiVE

Regenerative Medicine in Pharma 2020 – Opportunities, Challenges, and Unmet Needs – GlobeNewswire

Dublin, Dec. 23, 2020 (GLOBE NEWSWIRE) -- The "Regenerative Medicine in Pharma - Thematic Research" report has been added to ResearchAndMarkets.com's offering.

Regenerative medicine is a multidisciplinary field that seeks to develop the science and tools that can help repair, augment, replace, or regenerate damaged or diseased human cells, tissues, genes, organs, or metabolic processes, to restore normal function. It may involve the transplantation of stem cells, progenitor cells, or tissue, stimulation of the body's own repair mechanisms, or the use of cells as delivery vehicles for therapeutic agents such as genes and cytokines.

It is widely anticipated that Gene therapy is the most valuable regenerative medicine sector however, this market is also expected to be slowed down by high cost of therapies, which may limit its accessibility.Existing programs will facilitate the approval and development of regenerative medicines, however, a reimbursement system especially for curative therapies is warranted.

The Regenerative Medicine in Pharma report combines primary research from a cross-specialty panel of experts with in-house analyst expertise to provide an assessment of the development landscape.

This report assesses -

Scope

Key Topics Covered:

For more information about this report visit https://www.researchandmarkets.com/r/7trz9r

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Regenerative Medicine in Pharma 2020 - Opportunities, Challenges, and Unmet Needs - GlobeNewswire

Gene Therapy for Rare Disease Market Prospects Pinpoint Higher Traction from Developed Nations during 2020-2026 | Coherent Market Insights | Kite…

Global Gene Therapy for Rare Disease Market Report, Sales and Consumption Status and Prospects Professional Research, the report classifies the Global Gene Therapy for Rare Disease Market in a precise manner to offer detailed insights about the aspects responsible for augmenting as well as restraining market growth.

Gene Therapy for Rare Disease Market report provides a thoroughly researched abstract of the key players with considerable shareholdings at a global level regarding demand, sales, and income by providing better products and services. Research Report outlines a forecast for the Gene Therapy for Rare Disease market between 2020 and 2027. In terms of value, the Gene Therapy for Rare Disease industry is expected to register a steady CAGR during the forecast period.

In recent past, most of the gene therapies received orphan drug designations. Orphan drugs are generally defined as those medicines with one or more indications approved under the Orphan Drug Act of 1983. The Orphan Drug Act supports the development of innovative treatments for rare disease patients. The creation of the orphan drug designation with the passage of the Orphan Drug Act in 1983 has facilitated the development and approval of drugs for rare diseases and 2017 and 2018, were marked by the highest number of orphan drug and indication approvals to date. Production of gene therapies is associated with use of high-end technologies, high research and development costs, and skilled scientists and researchers, which reflects in high prices of these therapies.

Note: *The Download PDF brochure only consists of Table of Content, Research Framework, and Research Methodology

Get PDF Brochure Of This Research Report @ https://www.coherentmarketinsights.com/insight/request-pdf/2321

The key players profiled in this report include: Kite Pharma, Inc. (Gilead Sciences, Inc.), Novartis International AG, Juno Therapeutics Inc. (Celgene Corporation), Bluebird Bio, Inc., Spark Therapeutics, Inc., uniQure N.V, Orchard Therapeutics Plc., PTC Therapeutics, Inc., and BioMarin Pharmaceutical Inc.

Regions included:

o North America (United States, Canada, and Mexico)

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

o Global (China, Japan, Korea, India, and Southeast Asia)

o South America (Brazil, Argentina, Colombia)

o The Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria, and South Africa)

Key Benefits:

o This study gives a detailed analysis of drivers and factors limiting the market expansion of Gene Therapy for Rare Disease

o The micro-level analysis is conducted based on its product types, end-user applications, and geographic

o Porters five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players

o By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Gene Therapy for Rare Disease market

Table of Contents

Report Overview: It includes the Gene Therapy for Rare Disease market study scope, players covered, key market segments, market analysis by application, market analysis by type, and other chapters that give an overview of the research study.

Executive Summary: This section of the report gives information about Gene Therapy for Rare Disease market trends and shares, market size analysis by region and analysis of Global market size. Under market size analysis by region, analysis of market share and growth rate by region is provided.

Profiles of International Players: Here, key players of the Gene Therapy for Rare Disease market are studied on the basis of gross margin, price, revenue, corporate sales, and production. This section gives a business overview of the players and shares their important company details.

Regional Study: All of the regions and countries analyzed in the Gene Therapy for Rare Disease market report is studied on the basis of market size by application, the market size by product, key players, and market forecast.

The research study can answer the following Key questions:

What will be the progress rate of the Gene Therapy for Rare Disease Market for the conjecture period, 2020-2027?What are the prominent factors driving the Gene Therapy for Rare Disease Market across different regions?Who are the major vendors dominating the Gene Therapy for Rare Disease industry and what are their winning strategies?What will be the market scope for the estimated period?What are the major trends shaping the expansion of the industry in the coming years?What are the challenges faced by the Gene Therapy for Rare Disease Market?

Major Highlights of TOC:

Chapter One: Global Gene Therapy for Rare Disease Market Industry Overview

1.1Gene Therapy for Rare Disease Industry

1.1.1 Overview

1.1.2 Products of Major Companies

1.2Gene Therapy for Rare Disease Market Segment

1.2.1 Industry Chain

1.2.2 Consumer Distribution

1.3 Price & Cost Overview

Chapter Two: Global Gene Therapy for Rare Disease Market Demand

2.1 Segment Overview

2.1.1 APPLICATION 1

2.1.2 APPLICATION 2

2.1.3 Other

2.2 Global Gene Therapy for Rare Disease Market Size by Demand

2.3 Global Gene Therapy for Rare Disease Market Forecast by Demand

Chapter Three: Global Gene Therapy for Rare Disease Market by Type

3.1 By Type

3.1.1 TYPE 1

3.1.2 TYPE 2

3.2Gene Therapy for Rare Disease Market Size by Type

3.3Gene Therapy for Rare Disease Market Forecast by Type

Chapter Four: Major Region of Gene Therapy for Rare Disease Market

4.1 Global Gene Therapy for Rare Disease Sales

4.2 Global Gene Therapy for Rare Disease Revenue & market share

Chapter Five: Major Companies List

Chapter Six: Conclusion

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Gene Therapy for Rare Disease Market Prospects Pinpoint Higher Traction from Developed Nations during 2020-2026 | Coherent Market Insights | Kite...

Gene Therapy Market Regions, Type and Application, Futuristic Study – Factory Gate

Global Gene Therapy Market Research Report provides an complete recent proceeding in the market. The analysis supplies important data with figurative tables, graphs, charts, and statistics, an in-depth analysis of the market. The analysis highlights this markets fundamental dynamics for the forecast period (2020-2026), involving the trends, opportunities, restraints, and a lot more. The Gene Therapy analysis introduces a thorough evaluation to forecast the current market size, share, value, volume, gross sales, drivers, restraints, opinions by industry experts, and invaluable insights by the industrys prospective rise.

Every section of this report particularly consists of the research key elements of the market. The Gene Therapy industry dynamics segment permeates deep by the drivers, restraints, trends, and opportunities from this market. The quantitative and qualitative analysis, we help you with detailed and in-depth research on the Gene Therapy market. We also have centered on SWOT, PESTEL, along with different analysis of the industry.

Checkout FREE Report Sample of Gene Therapy Market Report for Better Recognizing: https://www.futuristicreports.com/request-sample/106731

(Kite Pharma Inc., Spark Therapeutics Inc., Novartis, GlaxoSmithKline PLC, Applied Genetic Technologies Corporation, NewLink Genetics Corp, Transgene SA, Oxford BioMedica, Genethon, Bluebird biInc.)

Youre able to thoroughly measure the competitions weaknesses and strengths together with our competitive analysis. The report, we have used total production and dispatch analysis in point of origin. Additionally, youre advised about the latest Gene Therapy industry advancements that will help you stay ahead of the competition. Our analysts are always on the feet to always track and analyze developments or changes in the Gene Therapy market. The analysis is full of statistical demonstrations and market statistics associated with sales, volume, CAGR, and share and regional and global predictions.

Gasoline Electric Solar

Rare Diseases Neurological Disorders Oncological Disorders Cardiovascular Diseases Infectious disease Other

The report supplies how big the Gene Therapy market will be in 2026 considering the studys base year 2019 and 2020. The market dynamics predominant in North America, Europe, Asia Pacific, Middle East, and Africa, and Latin America were taken into consideration and estimating the rise of the worldwide sector.

Key Questions Answered in this Report:

Futuristic Reports

Name: Alex CubbinsTel: +1-408-520-9037Email: [emailprotected]

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Gene Therapy Market Regions, Type and Application, Futuristic Study - Factory Gate

News briefing: Merck buys into A2’s T cell therapy platform; Small Soligenix reports PhIII fail in head and neck cancer – Endpoints News

Merck is dipping its toes into a cell therapy partnership with A2 Biotherapeutics, with an offer to co-fund clinical development and allogeneic manufacturing activities through Phase I.

In particular, the pharma giant has its eyes on an undisclosed candidate utilizing A2s Tmod platform, which combines activation and blocking mechanisms in order to kill tumor cells while sparing healthy ones.

The deal features an upfront, an equity investment and reimbursement of certain expenses. Merck is also promising opt-in and milestone payments plus royalties, while keeping the door open for collaboration on a separate program.

A2 Biotherapeutics, which closed $71.5 million in Series B funding in October, has two other programs that are further along in the lead optimization phase.

The new pact brings Mercks immunotherapy and other expertise for the Tmod candidate especially in the later stages of development, manufacturing and commercialization and enables A2 to build allogeneic product development and manufacturing capabilities, said Scott Foraker, A2s president and CEO. Amber Tong

Small rare diseases biotech Soligenix $SNGX did not have a good Tuesday.

The Princeton, NJ-based company posted a Phase III fail in head and neck cancer, saying its SGX942 program did not produce a statistically significant outcome. Soligenix had been looking to treat severely inflamed mucous membranes resulting from other cancer therapies, but came up short.

Tuesdays news crushed the companys stock price, as shares were sliced by more than half at a 54% drop as the market opened. The price rebounded slightly by the end of the day, but still resulted in a 49% loss.

Soligenix did not report a p-value from the primary endpoint, which was the median duration of severe oral mucositis. They did note the data showed a 56% reduction compared to placebo, as the median in the control arm came in at 18 days and 8 days in the treatment arm.

The company tried to shine a light on a positive secondary endpoint 50% reduction in the duration of SOM in the per-protocol population. Soligenixs p-value came in here at 0.049, just clearing the statistically significant hurdle. The biotech said this endpoint may point to some evidence of biological activity.

The study enrolled 268 patients randomized 1:1 to receive either SGX942 or placebo. Soligenix said it will turn its attention toward another program, SGX301, in the treatment of cutaneous T cell lymphoma. Max Gelman

Tapping a new source for new gene therapy programs, BridgeBio has set up a three-year alliance with the University of California, San Francisco to identify early translational research that it can accelerate into the clinic.

BridgeBio, which is based in the Bay Area, said the deal follows a six-month pilot and is designed to formalize collaborative relationships with academic scientists.

The collaborations may initially take the form of sponsored research agreements with certain labs, it added, which may then lead to creation of new affiliate companies under the BridgeBio portfolio.

That pipeline currently lists three programs, utilizing AAV vectors to deliver corrective genes for congenital adrenal hyperplasia, Canavan disease and nonsyndromic hearing loss, respectively.

They are ready for more. Earlier this year, BridgeBio inked an agreement with Catalent to secure dedicated gene therapy development and manufacturing capacity to support its needs down the line. Amber Tong

Gritstone Oncology $GRTS has some new cash to play with.

The Emeryville, CA-based biotech announced Wednesday morning it had raised $110 million in private placement funding. Wednesdays deal valued company shares at $3.34 apiece, or Tuesdays closing price, and Gritstone said the funding would be primarily directed toward its GRANITE and SLATE pipeline candidates, two cancer immunotherapies.

News of the funding was met with cheers by investors, as Gritstones stock was up more than 13% in early Wednesday trading.

GRANITE, a personalized neoantigen-based immunotherapy, is being evaluated in combination studies in the Phase II portion of a Phase I/II study for microsatellite stable colorectal cancer. SLATE is also neoantigen-based and uses the same delivery system as GRANITE, but contains a fixed set of antigens rather than personalized. Its also being looked at in combination studies at the Phase II portion of a Phase I/II trial for NSCLC.

The financing was led by existing and new investors, including Redmile Group, Avidity Partners and EcoR1 Capital. The deal is expected to close by Dec. 28. Max Gelman

After closing its Series A round, Epsilon Molecular Engineering opened it back up, bagging 570 million ($5.5 million) total from investors, two bank loans and leasing.

The Saitama University spinout will use the funds for its work with heavy chain single domain antibodies, including collaborative research with Kitasato University and Kao Corporation on potential Covid-19 treatments.

EME aims to discover medium sized molecular bio-drugs with new modalities using its proprietary VHH technology, president Naoto Nemoto said in a statement. We will leverage this financing to accelerate collaborative research with pharmaceutical manufacturers and internal research using its own pipeline.

The round was led by Mitsubishi UFJ Capital, with help from Gunma Medical Engineering Vitalization Investments, Gunma Bank and Kao Corporation. EME also went forward with a subordinated loan from Shoko Chukin Bank, a loan from Saitama Resona Bank, and a lease from Syutoken Leasing. Nicole DeFeudis

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News briefing: Merck buys into A2's T cell therapy platform; Small Soligenix reports PhIII fail in head and neck cancer - Endpoints News

Biopharma Money on the Move: December 16-22 – BioSpace

Last call for raising funds beforeChristmas, andthese companies didnt hesitate to scoop up their bags of cash.

TG Therapeutics

TG has been on the Nasdaq for over sevenyears now, but 2020 has been theyear for the New Yorkbiopharmato soar.With shares trading atless than $11 apiece in January, the stock is now well over $50 since theannouncementof positive topline results from two global Phase III trials for relapsing forms of MS.With a high probability of FDA approval, TG cashed inwith an upsized common stock offering,raising$300 millionto further develop and commercializetheir therapies.

BioAtla

This San Diego company hopped on the bandwagon of biopharma IPOs last week, offering 10.5M million shares at $18 apiece, a 38% increase, scooping up$189 millionin proceeds.BioAtlais developing a novel class of specific and selective antibody-based therapeutics.The companys conditionally active biologics only activate when they detect proximity to a tumor, thereby reducingsystemictoxicity.Funds will propel the companys two lead programs through three Phase II trials.

Cullinan Oncology

Breaking down the silos of drug research, Cullinan applies open innovation and collaboration to developa portfolio of first-in-class and best-in-classcancer therapies. With an oversubscribed$131.2 millionSeries C, the Cambridge company can advanceitsseven-candidatepipelineinto the clinic.Each candidate isstructured as a separate company managed by Cullinan. Two are currently in Phase I with an inhibitor drug for NSCLC and amonoclonal antibody reinvigorating the MICA/NKG2D axis.

Neurogene

New York-basedNeurogeneis establishing itself as a leader in gene therapies for neurological diseases. Last weeks$115 millionSeries B round willhelp advance multiple of the companys candidates into the clinic. The first of which targetslate infantileBattens Disease,a rare nervous system disorder that worsens over time and is fatal, usually 8-10 years old.The funds will also be used to build outNeurogenesadeno-associated virus vector GMP manufacturing capabilities.

Neuron23

Having worked undercover for two years, Neuron23 uncloakedlast weekwith$113.5 millionin financing for its launch.$30 million of the funds came from Westlake Village BioPartners, who just announcedtwo funds totaling$500 millionwith the intent to invest in Series A startups in the most promising companies.Neuron23 has hit the ground running, aiming to take on Parkinsons diseaseagainst giant Biogen, who recentlyorchestratedin a $1 billion dealwith Denaliwith the same target in mind. The plan is to start trials with healthy volunteers next year.

Neomorph

Established earlier this year, San Diego-based Neomorph raked in$109 millionin a Series A. The companys focus is on targeted proteindegradation, which offers opportunities for treatment developments across the board, including oncology.The Neomorph team has deep expertise in pharmacological approaches to targeted protein degradation and we are excited to be developing new therapeutics for patients with diseases that are currently difficult to treat, said scientific founderScottArmstrongMD, Professor of Pediatrics at Harvard Medical School and the Dana-Farber Cancer Institute.

AtsenaTherapeutics

Gene therapy startupAtsenaclosed on an oversubscribed$55 millionSeries A.The funds will be used to advance itsgene therapy for one of the most common cause of blindness in children through clinical trials.Leber congenital amaurosis (LCA) causes blindness in 2 to 3 out of 100,000 newborns.The company isalso planning for growth,looking to move into a larger space next yearto scale up gene therapy manufacturing. Ramping up across the board, theres a goal to hire 20 more positions with the move.

ONL Therapeutics

With support from Johnson & Johnson and more, Michigan-based ONL closed a$46.9 millionSeries B Preferred Stock financing round.The company is developing therapies for protecting the patients with retinal disease from vision loss.This funding supports the completion of a Phase 1 study in retinal detachment with ONLs lead compound ONL1204. In addition, the funding will advance ONL1204 in two chronic indications, glaucoma and dry age-related macular degeneration.

Peptilogics

Peptilogicsis the most recent biotech receiving investments fromPaypalsco-founder Peter Thiel. This week, Thiel participated in a$35 millionfinancing round for the Pennsylvania-basedcompany.The funds will be used to advancePeptilogicsproprietarycomputational peptide drug design and discovery platform. The platform discovers connections in diverse biomedical data and maps peptide sequences.

Octave Bioscience

Looking totakeitsfully integratedcare management platform to the next level, Octave completed a$32 millionSeries B financing round. The funds will allow thecompany to complete development of management products and services, expand clinical data and begin commercialization to neurologists and patients. Octaves first target has been multiple sclerosis patients, but will expand to other chronic, debilitating neurodegenerative diseases. Theplatformtracksblood-basedbiomarkers, enhanced MRI insights and mobile patient monitoring tools to feed intocare pathwaymodels to generatebetter patient outcomes and lower costs.

Vivace Therapeutics

Small molecule player Vivace closed a$30 millionSeries C for further development of its first-in-class therapies targeting the Hippo pathway. Funds will be usedto take its lead candidate into first-in-human studies in early 2021, targeting tumors dependent on activated YAP.Pre-clinical research has shown promise for the candidate both as a monotherapy and in combination with other anti-cancer therapies.

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Biopharma Money on the Move: December 16-22 - BioSpace

Ziopharm Oncology Announces Clearance of Taiwan’s First IND of Non-viral CAR-T for the Treatment of Relapsed CD19+ Leukemias and Lymphomas -…

Advances Eden BioCells clinical program to validate Rapid Personalized Manufacturing (RPM)

Clinical trial to study autologous CD19-specific CAR-T using RPM technology designed to reduce cost and simplify production for infusion the day after gene transfer

BOSTON, Dec. 21, 2020 (GLOBE NEWSWIRE) -- Ziopharm Oncology, Inc. (Ziopharm or the Company) (Nasdaq: ZIOP), today announced that the Taiwan Food and Drug Administration has cleared an investigational new drug application (IND) from Eden BioCell, a joint venture between Ziopharm and cell therapy company TriArm Therapeutics, for its phase 1 clinical trial to evaluate patient-derived CD19-specific CAR-T, using Ziopharms Rapid Personalized Manufacturing (RPM) technology. This is an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas and the first clinical study of autologous non-viral CD19-specific CAR-T in Taiwan.

This trial will utilize Ziopharms non-viral Sleeping Beauty cell engineering technology to infuse autologous CAR-T the day after T cells have been genetically modified. Ziopharms RPM CD19-specific CAR-T therapy results from the stable, non-viral insertion of DNA into the genome of resting T cells to co-express the chimeric antigen receptor (CAR), membrane-bound IL-15 (mbIL15) and a safety switch. The trial is being conducted at National Taiwan University Hospital.

This study is a testament to the relationship Ziopharm has quickly established with Eden BioCell and TriArm and the progress using patients T cells under RPM to target malignancies, said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. The results will help us understand the benefit of engineering T cells with membrane bound IL-15 which could benefit not only CAR-T, but also the engineering of T cells to express T-cell receptors.

Jay Zhang, Co-Founder and Chief Executive Officer of TriArm, added, We are very excited to receive clearance of our IND in Taiwan. The learnings from this study will build upon the encouraging early data we are seeing with patients treated with RPM CAR-T targeting CD19 malignancies under compassionate use. We believe our approach has the potential to transform CAR-T therapy by dramatically decreasing the amount of time needed for manufacturing engineered T cells, thereby increasing efficacy and decreasing cost.

CAR-T therapy has proved an effective therapy for B-cell cancers, noted Dr. Shang-Ju Wu, Division of Hematology, Department of Internal Medicine, National Taiwan University Hospital and Principal Investigator for the study. Further optimization by shortening the manufacturing time would be of great importance to make this therapy more available to patients. We are honored to be involved in the clinical development of this non-viral CAR-T therapy produced using RPM. We hope the data derived from this current trial will advance CAR-T therapy to benefit our patients.

Up to 24 patients with relapsed CD19+ leukemias and lymphomas will be enrolled in this phase 1 trial, with the goal of infusing 16 subjects (Taiwan FDA #1096030182). The primary endpoint of the study is to evaluate the safety and tolerability of autologous CD19-specific T cells manufactured using the RPM process.

About Eden BioCell In December 2018, Ziopharm and TriArm Therapeutics announced the launch of Eden BioCell to lead clinical development and commercialization of Sleeping Beauty-generated CAR-T therapies in Greater China. Ziopharm licensed the rights to Sleeping Beauty-generated CAR-T therapies targeting the CD19 antigen using Ziopharms RPM technology in Greater China to Eden BioCell. TriArm has committed up to $35 million to this joint venture, and Eden BioCell is owned 50-50 by Ziopharm and TriArm.

About TriArm TherapeuticsTriArm Therapeutics is a cell therapy company formed by Panacea Venture with R&D operations in Germany, United States and Greater China region. The company is dedicated to the treatment of cancer and autoimmune diseases.

About Ziopharm Oncology, Inc.Ziopharm is developing non-viral and cytokine-driven cell and gene therapies that weaponize the bodys immune system to treat the millions of people globally diagnosed with cancer each year. With its multiplatform approach, Ziopharm is at the forefront of immuno-oncology. Ziopharms pipeline is built for commercially scalable, cost effective T-cell receptor T-cell therapies based on its non-viral Sleeping Beauty gene transfer platform, a precisely controlled IL-12 gene therapy, and rapidly manufactured Sleeping Beauty-enabled CD19-specific CAR-T program. The Company has clinical and strategic collaborations with the National Cancer Institute, The University of Texas MD Anderson Cancer Center and Regeneron Pharmaceuticals. For more information, please visit http://www.ziopharm.com.

Forward-Looking Statements DisclaimerThis press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts, and in some cases can be identified by terms such as "may," "will," "could," "expects," "plans," "anticipates," and "believes." These statements include, but are not limited to, statements regarding the potential benefits of the Companys CAR-T therapy and the Companys expectations regarding the number of patients expected in this phase 1 clinical trial. Although Ziopharms management team believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Ziopharm, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, changes in Eden BioCells operating plans that may impact its cash expenditures, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Ziopharms product candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies and for which indication; the strength and enforceability of Ziopharms intellectual property rights; competition from other pharmaceutical and biotechnology companies as well as risk factors discussed or identified in the public filings with the Securities and Exchange Commission made by Ziopharm, including those risks and uncertainties listed in Ziopharms Quarterly Report on Form 10-Q filed by Ziopharm with the Securities and Exchange Commission. We are providing this information as of the date of this press release, and Ziopharm does not undertake any obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.

Investor Relations Contacts:Adam D. Levy, PhD, MBAEVP, Investor Relations and Corporate CommunicationsT: 508.552.9255E: alevy@ziopharm.com

Media Relations Contact:LifeSci Communications:Patrick BurseyT: 646.876.4932E: pbursey@lifescicomms.com

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Ziopharm Oncology Announces Clearance of Taiwan's First IND of Non-viral CAR-T for the Treatment of Relapsed CD19+ Leukemias and Lymphomas -...

Ocugen Establishes Vaccine Scientific Advisory BoardLeading experts to evaluate the clinical and regulatory path to approval in the US market of…

MALVERN, Pa., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Ocugen, Inc., (NASDAQ: OCGN), a leading biopharmaceutical company focused on discovering, developing and commercializing a pipeline of innovative therapies, today announced the appointment of a vaccine scientific advisory board comprised of leading academic and industry experts in the vaccine field to evaluate the clinical and regulatory path to approval in the US market of Bharat Biotechs COVAXIN, a whole-virion inactivated COVID-19 vaccine candidateto be co-developed by Ocugen and Bharat Biotech for the US market.

Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen remarked, We are thrilled to welcome this group of esteemed thought leaders to the Ocugen team to assist in our co-development with Bharat Biotech of COVAXIN. This unique yet traditional vaccine candidate is different from other options currently available in the US market with potentially broader coverage against multiple protein antigens of the virus.

The vaccine scientific advisory board consists of:

About Ocugen, Inc.Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing transformative therapies to cure blindness diseases. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug one to many and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. For more information, please visit http://www.ocugen.com.

Cautionary Note on Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as predicts, believes, potential, proposed, continue, estimates, anticipates, expects, plans, intends, may, could, might, will, should or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (the SEC), including the risk factors described in the section entitled Risk Factors in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.

Ocugen Contact:Ocugen, Inc.Sanjay SubramanianChief Financial Officerir@ocugen.com

Media Contact:LaVoieHealthScienceLisa DeScenzaldescenza@lavoiehealthscience.com+1 978-395-5970

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Ocugen Establishes Vaccine Scientific Advisory BoardLeading experts to evaluate the clinical and regulatory path to approval in the US market of...

Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in…

SOUTH SAN FRANCISCO, Calif., Dec. 23, 2020 (GLOBE NEWSWIRE) -- Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T) therapies for cancer today announced that theU.S. Food & Drug Administration(FDA) has cleared an Investigational New Drug (IND) application to study ALLO-715, Allogenes investigational BCMA AlloCAR T therapy, in combination with nirogacestat, SpringWorks Therapeutics investigational gamma secretase inhibitor (GSI), in patients with relapsed or refractory multiple myeloma. This combination is part of the companys multi-pronged strategy to develop a treatment for multiple myeloma and will be deployed in the ongoing UNIVERSAL trial. Enrollment in this cohort is expected to begin in the first quarter of 2021.

We are delighted that the FDA has cleared our IND application for ALLO-715 in combination with nirogacestat, said Rafael Amado, M.D., Executive Vice President of Research & Development and Chief Medical Officer of Allogene. We look forward to investigating this combination as part of our comprehensive anti-BCMA strategy aimed at optimizing cell therapy for patients with relapsed/refractory multiple myeloma.

Gamma secretase is an enzyme that cleaves BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to prevent the cleavage and shedding of BCMA, leading to an increase in the cell surface density of BCMA and reduced levels of soluble BCMA.1 Increasing BCMA surface expression with gamma secretase inhibitor may enable deeper and more durable responses to ALLO-715 in patients with multiple myeloma.

Multiple myeloma is the second most common hematological malignancy in the United States, with 32,270 new cases and 12,830 deaths estimated in 2020.2

The Phase 1 combination trial is being advanced pursuant to a clinical trial collaboration agreement that Allogene and SpringWorks entered into in January 2020. Under the terms of the agreement, Allogene is sponsoring and conducting the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and is assuming all development costs associated with the study, other than expenses related to the manufacturing of nirogacestat and certain expenses related to intellectual property rights. Allogene and SpringWorks have formed a joint development committee to oversee the clinical study.

About ALLO-715ALLO-715, an AlloCAR T therapy targeting B-cell maturation antigen (BCMA), is a potential novel treatment for multiple myeloma and other BCMA-positive malignancies. Multiple myeloma originates in the bone marrow and it is characterized by abnormalities in plasma cells that reproduce uncontrollably in the bone marrow and other disease sites.3 Multiple myeloma is incurable for most patients, as relapses occur despite most treatments available.4 Initial results from the Phase 1 UNIVERSAL study of ALLO-715 in relapsed/refractory multiple myeloma were presented at an oral session of the American Society of Hematology (ASH) annual meeting in December 2020. This study also uses ALLO-647, Allogene's anti-CD52 monoclonal antibody (mAb), as a part of its differentiated lymphodepletion regimen.

ALLO-715 utilizes the TALEN gene-editing technology pioneered and owned by Cellectis. Allogene has an exclusive license to the Cellectis technology for allogeneic products directed at the BCMA target. Allogene holds the global development and commercial rights for this investigational candidate.

About NirogacestatNirogacestat is an investigational, oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors, which are rare and often recurrent, debilitating and disfiguring soft-tissue tumors. Gamma secretase cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to desmoid tumor growth.

In addition, gamma secretase has been shown to directly cleave membrane-bound BCMA, resulting in the release of the BCMA extracellular domain, or ECD, from the cell surface. By inhibiting gamma secretase, membrane-bound BCMA can be preserved, increasing target density while reducing levels of soluble BCMA ECD, which may serve as decoy binding molecules for BCMA-directed therapies. Nirogacestats ability to enhance the activity of BCMA-directed therapies has been observed in preclinical models of multiple myeloma.

Nirogacestat has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of desmoid tumors (June 2018) and from the European Commission for the treatment of soft tissue sarcoma (September 2019). The FDA also granted Fast Track and Breakthrough Therapy Designations for the treatment of adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis (November 2018 and August 2019).

AboutAllogene TherapeuticsAllogene Therapeutics, with headquarters inSouth San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) therapies for cancer. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of off-the-shelf CAR T cell therapy candidates with the goal of delivering readily available cell therapy on-demand, more reliably, and at greater scale to more patients. For more information, please visitwww.allogene.com, and follow @AllogeneTx on Twitter and LinkedIn.

Forward-Looking StatementsThis press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The press release may, in some cases, use terms such as "predicts," "believes," "potential," "proposed," "continue," "estimates," "anticipates," "expects," "plans," "intends," "may," "could," "might," "will," "should" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Forward-looking statements include statements regarding intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: the ability and timing to initiate a clinical trial of ALLO-715 in combination with nirogacestat; ability to manufacture ALLO-715; the ability of ALLO-715 in combination with nirogacestat to enable deeper or more durable responses; and the potential benefits of AlloCAR T therapy. Various factors may cause differences between Allogenes expectations and actual results as discussed in greater detail in Allogenes filings with the SEC, including without limitation in its Form 10-Q for the quarter ended September 30, 2020. Any forward-looking statements that are made in this press release speak only as of the date of this press release. Allogene assumes no obligation to update the forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

AlloCAR T is a trademark of Allogene Therapeutics, Inc.

Allogene Media/Investor Contact:Christine CassianoChief Communications Officer(714) 552-0326Christine.Cassiano@allogene.com

1 Eastman S, Shelton C, Gupta I, Krueger J, Blackwell C, Bojczuk. Synergistic activity of belantamab mafodotin (anti-BCMA immuno-conjugate) with PF-03084014 (gamma-secretase inhibitor) in Bcma-expressing cancer cell lines. Blood. 2019;134(supplement_1):4401. doi.org/10.1182/blood-2019-123705.2 https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html3 Multiple myeloma - Genetics Home Reference - NIH. Retrieved from https://ghr.nlm.nih.gov/condition/multiple-myeloma#4 Sonneveld P, Broijl A. Treatment of relapsed and refractory multiple myeloma. Haematologica. 2016;101(4):396-406

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Allogene Therapeutics Receives IND Clearance from the U.S. Food and Drug Administration for ALLO-715 in Combination with Nirogacestat in...

Hey, soldiers and spies think twice about that home genetic ancestry test – Roll Call

Companies such as 23andMe, AncestrybyDNA, Genebase andFull Genomes, for example, are among dozensthat provide consumer genetic testing to identify susceptibility to potential diseases as well as to establish genealogies. It's not clear which American companies, if any, have ties to Beijing or have sold data to China.

The request to study security risks posed by genetic testing companies signals a potentialnew area of concern that extends beyond the traditional espionage, cybersecurity and supply chain risks typically associated with Beijing's global reach.

Lawmakers appear to be concerned that U.S. officials working for intelligence agencies and the Pentagon, acting in their personal capacities, may be providing their genetic information to private testing companies that could end up in Chinese hands, giving Beijing highly sensitive information that it could combine with other information it already has on them to target officials for espionage or attack. The United States, for example, already has accused China of hacking the Office of Personnel Management sometime between 2013 and 2015 and taking away highly sensitive information on top U.S. officials.

The measure also would ask multiple intelligence agencies to step up vigilance on Chinese activities in the United States as well as inside the borders ofclose U.S. allies known as the Five Eyes, which include Australia, Canada, New Zealandand the United Kingdom.

Lawmakers want the CIA, the Office of the Director of National Intelligence and the Defense Intelligence Agency to submit a report on efforts by foreign adversaries to build and supply telecom and cybersecurity equipment forthe closest U.S. allies. The United States has put significant pressure on allies not to buy 5G equipment from China's Huawei, which Washington sees as a national security risk to U.S. communications networks.

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Hey, soldiers and spies think twice about that home genetic ancestry test - Roll Call

Population Testing for Hereditary Breast and Ovarian Cancer Worthwhile? – Medscape

This transcript has been edited for clarity.

Today I'd like to ask: Is population testing for hereditary breast and ovarian cancer worthwhile?

In women with BRCA1 and BRCA2 mutations, lifetime risks for breast and ovarian cancer are high. Risk-reducing surgeries and other interventions can lower cancer risks in this population.

Investigators created a model to compare population testing in unselected women vs referring women with a high-risk family history for genetic counseling and possible testing. With this model, they found that population testing prevented more cancers than did family historybased testing.

Many carriers of hereditary breast and ovarian cancer genes are currently identified only after a diagnosis of malignancy, underscoring the potential benefits of population screening. However, it's not clear that this report has adequately assessed the downstream implications of population testing.

In my practice, if family history suggests that a patient is at elevated risk for breast or ovarian cancer, I refer her to a credentialed genetics counselor with special expertise in hereditary cancers. Once counseled, patients then decide whether or not to proceed with genetic testing, and the counselor works with the patient and her clinicians to determine appropriate responses to the results of genetic testing.

I was not able to identify that the investigators included pretest genetic counseling in their model of population screening. However, if genetic counseling is not performed, the task of interpreting test results falls on the patient and her clinicians.

Women may not be prepared to respond appropriately to the results of genetic testing without expert counseling. Clinicians may likewise feel inadequately prepared to help patients understand and act on test results. Some patients might undergo inappropriate risk-reducing surgeries and other interventions, while others who would benefit from such interventions might fail to pursue them.

The demand for genetics counselors currently has outstripped supply. I acknowledge that population screening for genes associated with breast and ovarian cancer could identify more mutation carriers. However, until we can ensure that women will have access to experts who can help them interpret results of genetic testing, I'll continue with my approach of referring patients with high-risk family histories to a genetic counselor.

Thank you for the honor of your time. I am Andrew Kaunitz.

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Population Testing for Hereditary Breast and Ovarian Cancer Worthwhile? - Medscape

$2 million settlement reached in lawsuit against ob-gyn office in Norwich – theday.com

A $2 million settlement has been reached in a medical malpractice lawsuit filed by a Salem couple after their second daughter was born with cystic fibrosis. The mother said she accepted genetic testing at her obstetrician-gynecologists office, but the testing was never performed.

The mother, Elizabeth Trotter, who was pregnant with her first child in 2016 and a patient at OB-GYN Services in Norwich, said in a phone interview this week that she had wanted to be tested for everything because she did not know her medical history. She said she accepted genetic testing and thought the testing was performed.

She said she was told at 12 weeks that her blood work came back normal, so she assumed that meant everything was fine. She gave birth in January 2017 to a healthy baby girl, Paige.

When she was pregnant with her second daughter, Madelyn, now 2, she said she experienced a lot of complications, including preeclampsia and high blood pressure, and her daughter was born prematurely and spent over a month in the neonatal intensive care unit. Elizabeth, now 42,and her husband, Erik, now 47,found out during the newborn screen thatMadelyn was positive for cystic fibrosis.

The Trotters returned to OB GYN Services to ask how their daughter could have been born with this disease when the Cystic Fibrosis test performed on Beth in 2016 had been negative, according to The Reardon Law Firm, which represented the Trotters. The doctor consulted the records and determined that the test had never been ordered by the practice and had never been performed, despite being requested by Beth and acknowledged by the physician she spoke with.

Trotter said she got pregnant for the second time, without knowing that she was a carrier for cystic fibrosis and without being able to prepare.

Unfortunately, it took away our ability to make an educated choice for ourselves, and I truly feel that women should have the choice to figure out what is best for them and their family, Trotter said.

Herdoctor, David Kalla, declined to comment. A lawyer representing OB-GYN Services was out of the office until Monday and did not immediately respond to a request for comment.

Trotter said the settlement will help with expensive medical bills for her daughter's care. Cystic fibrosis "is a complex, chronic disease that primarily affects the lungs and digestive system," according to the Cystic Fibrosis Foundation.

The money that we did get from the settlement could be life-changing for her, she said. It could help her a lot with her care.

Trotter said she hopes the lawsuit brings more awareness to genetic testing and changes the standards of care for women. She added that sheis interested in potentially pursuing legislation that will empower womenand help themget genetic testing before they are pregnant.

Attorney Kelly Reardon, who settled the case for the maximum amount of insurance coverage available, said she believes what happened is that the practice had a relatively new electronic medical record software system and it was difficult to gain access to laboratory results through the software.

We think the fact that the test was never ordered was overlooked due to the software issue, she added.

She commended the Trotters for their courage and Dr. Kalla and the medical providers for taking the steps necessary to make sure the practice is more careful going forward about these types of errors. She said Dr. Kalla met with the family over Zoom to go over the changes.

I feel like it was an important case because it really allowed a family who went through a horrible situation to not only get financial compensation, which is important of course, but to also get some answers and have a conversation with the physician involved about the steps that his practice is taking to make sure that this type of scenario doesnt happen again, Reardon said.

k.drelich@theday.com

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$2 million settlement reached in lawsuit against ob-gyn office in Norwich - theday.com

Genetic Testing Market is Rapid Growing with COVID-19 Impact Analysis, Top Key Companies Abbott Laboratories, Bio-Rad Laboratories Inc., Competitive…

Genetic Testing Marketis expected to register aCAGR of +11.50%and is projected to reachUSD 24,834.19 Million by 2028.The Global Genetic Testing Market is expected to register substantial growth in the near future due to rise in incidence of genetic disorders & cancer and growth in awareness and acceptance of personalized medicines. Genetic testing is also known as DNA testing. Genetic testing is the study of gene present in cells and tissues. This study is further applied in the field of biology and medicine to better understand genetic disorders such as cancer, sickle cell anemia, cystic fibrosis, Down syndrome, and others. The scope of the report discusses the use of gene tests for the development of personalized medicine, targeted cancer treatment, and other genetic diseases. In addition, advancements in genetic testing techniques and increasing application of genetic testing in oncology are expected to boost the market growth during the forecast period.Genetic tests involve a set of lab tests for the study of the genetic makeup of patients and identify any gene mutations and alterations in the healthy structure of DNA leading to the development of genetic disorders. The Geographical Segmentation includes study of global regions such as North America, Latin America, Asia-Pacific, Africa, and Europe. The report is designed to incorporate both qualitative and quantitative aspects of the industry within each of the regions and countries involved in the study.

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Profiling Key Players:

Highlighted key points of this market research report:

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Genetic Testing Key Market Segments:

By Product Type:

Predictive Testing

Carrier Testing

Prenatal & Newborn Testing

Diagnostic Testing

Pharmacogenomic Testing

Others

By Technology Type:

Cytogenetic Testing/ Chromosome Analysis

Biochemical Testing

Molecular Testing

DNA Sequencing

Others

By Application Type:

Chromosome Analysis

Genetic Disease Diagnosis

Cardiovascular Disease Diagnosis

Others

Different top-level key players are also enlisted in order to obtain in-depth knowledge and informative data of companies. Some of the key players are also profiled in this research report, which includesGenetic TestingMarket. Different industry analysis tools such as SWOT and Porters five-technique are further used while analyzing the globalGenetic TestingMarket.

For More Inquiry Detailed TOC Of Research Report:https://www.marketresearchinc.com/enquiry-before-buying.php?id=16612

The report also draws attention to recent advancements in technologies and certain methodologies which further help to boost the outcome of the businesses. Furthermore, it also offers a comprehensive data of cost structure such as the cost of manpower, tools, technologies, and cost of raw material. The report is an expansive source of analytical information of different business verticals such as type, size, applications, and end-users. Furthermore, the report also caters the detailed information about the crucial aspects such as driving factors & challenges which will define the future growth of the market.

Table of Content:

Chapter 1: Genetic Testing Market Overview

Chapter 2: Global Economic Impact on Industry

Chapter 3: Genetic Testing Market Competition by Manufacturers

Chapter 4: Global Production, Revenue (Value) by Region

Chapter 5: Global Supply (Production), Consumption, Export, Import by Regions

Chapter 6: Global Production, Revenue (Value), Price Trend by Type

Chapter 7: Global Market Analysis by Application

Chapter 8: Manufacturing Cost Analysis

Chapter 9: Industrial Chain, Sourcing Strategy and Downstream Buyers

Chapter 10: Marketing Strategy Analysis, Distributors/Traders

Chapter 11: Genetic Testing Market Effect Factors Analysis

Chapter 12: Global Genetic Testing Market Forecast to 2028

Finally,all aspects of the Genetic Testing Market are quantitatively as well qualitatively assessed to study the Global as well as regional market comparatively. This market study presents critical information and factual data about the market providing an overall statistical study of this market on the basis of market drivers, limitations and its future prospects.

About Us:Market Research Inc is farsighted in its view and covers massive ground in global research. Local or global, we keep a close check on both markets. Trends and concurrent assessments sometimes overlap and influence the other. When we say market intelligence, we mean a deep and well-informed insight into your products, market, marketing, competitors, and customers. Market research companies are leading the way in nurturing global thought leadership. We help your product/service become the best they can with our informed approach.

Contact Us:AuthorKevinUS Address:51 Yerba Buena Lane, Ground Suite,Inner Sunset San Francisco, CA 94103, USACall Us: +1 (628) 225 1818Email:sales@marketresearchinc.com

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Toddler who received heart transplant due to get baby brother – Newsday

For Christmas this year, toddler Ruby Cotter is getting a toy kitchen, a ball pit and a baby brother.

Ruby will become a big sister not having met many other children in her 18 months of life, according to her dad, Brian Cotter, 36. Shes been isolated to protect her weakened immune system that is compromised by medication she will need to take indefinitely to stop her body from rejecting the donated heart she got in transplant surgery last Christmastime.

Shes played with older cousins a few times, and one friend shes seen once or twice a month, Brian said, but "otherwise she doesnt interact with kids. Her brother will hopefully help her get used to that."

Ashley Cotter, 30 Brians wife and Rubys mom is pregnant with the couples second child, a boy they plan to name Everett Charles.

"We are thinking we might be welcoming him on Christmas," he said.

(The baby was due this past Wednesday, "so she could go into labor at any minute," Brian said. She will be induced if she doesnt give birth naturally by next Thursday, he said.)

Ruby has a rare, potentially fatal disorder called dilated cardiomyopathy, which restricts how blood is pumped to the body and vital organs. The disorder affects at least 1 in 100,000 children. She was born in June 2019 and hospitalized in September at NewYork-Presbyterian Hospital, in upper Manhattan, where she had two heart surgeries; the couple lived in the hospital for months to be with their daughter. She came home in January to Wading River, where the family lived at the time.

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The couple, who have since moved to Shoreham, had discussed last year having more children, Ashley told Newsday last Christmastime, but wanted to do more genetic testing to figure out the odds a sibling of Ruby's could develop the same heart condition.

"I dont want to go through this again," Ashley Cotter said then. "I dont want to put another child through this again."

Brian said earlier this week that the couple did that genetic testing, and learned that the condition isnt in their genes.

"Well, to be honest, this pregnancy was not planned. We lived at the hospital for a long time without privacy and then the whole COVID lockdown happened," Brian said. "We did finish our genetic testing and found out that neither of us carry what caused Rubys condition. So far, our son looks very healthy."

The majority of cases of the disease are idiopathic meaning, arising without a known obvious cause rather than hereditary, according to a 2014 article in the journal Progress in Pediatric Cardiology.

Brian said the family is planning to have Rubys doctors examine their son soon after he is born.

Her parents hoped that she could begin to see people in the spring, but the coronavirus pandemic has meant that the family must stay virtually isolated due to her medication.

"She hasnt met too many other kids or babies, so it might be a shock for her," he said of her little-brother-to-be.

Still, Ruby is aware theres something going on in the family.

"She knows something is happening," Brian said, adding: "She does rub and kiss her moms belly."

Its the second successive Christmastime theres been good news for the Cotters. Just days before Christmas last year, Ruby got the transplant, in time for the holiday.

A GoFundMe account set up in 2019 to raise money for the family's nonmedical expenses food, bills, mortgage, and car payments had raised $114,055 as of this Christmas Eve.

With Rubys immune system medically compromised, the family has been careful about masking and social distance and other precautions. She was able to do outdoor activities when the weather was warmer and once went to a diner a month ago.

"Just her body language the whole time. Sitting in the booth, looking at all the lights. She was just smiling and eating pancakes and eggs. You can tell she appreciated it," he said.

But, Brian said as a second wave of the coronavirus hits the region, "now is not a good time to explore."

Last month, he said, Ruby started walking.

"She says a few words," Brian said. " No is her favorite."

Matthew Chayes, a Newsday reporter since 2007, covers New York City Hall.

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Toddler who received heart transplant due to get baby brother - Newsday

Impact of COVID-19 on Pre-Pregnancy Genetic Testing Market 2027 Expected to reach Highest CAGR – The Courier

Worldwide Market Reports added Pre-Pregnancy Genetic Testing Market to its vast collection of research Databases. The report classifies the Global Pre-Pregnancy Genetic Testing Market in a precise manner to offer detailed insights into the aspects responsible for augmenting as well as restraining market growth.

A comprehensive analysis of the Global Pre-Pregnancy Genetic Testing Market is been done in this intelligence report. It includes the investigations done on past progress, ongoing market scenarios, and future prospects. Accurate data of the products, strategies, and market shares of leading companies in this particular market is mentioned. The report gives in-detailed information across Global regions, including Asia, North America, South America, Middle East, and Africa, Europe, with the sales and revenue data in each of the sub-segments.

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Pre-Pregnancy Genetic Testing market competition by top manufacturers/players, with Pre-Pregnancy Genetic Testing sales volume, price, revenue (Million USD), and market share for each manufacturer/player; the top players including:Illumina (US), Natera (US), Ariosa Diagnostics (US), BGI Health (China), LifeCodexx (Germany)

Note: For a complete company list, please ask for a sample report.

We follow an iterative research methodology model to formulate the report that helps decision-makers take sound investment evaluation. Secondary research is carried out using internal and external sources to obtain qualitative and quantitative information of the market backed by the primary interview of KOLs and SMEs. This model negates any drastic deviation in the market estimation and is used to estimate the Pre-Pregnancy Genetic Testing Market size and forecasts until 2026.

The Pre-Pregnancy Genetic Testing Market report gives a 360-degree holistic view of the market and highlights the key developments, drivers, restraints, and future trends with impact analysis of these trends on the market for short-term, mid-term, and long-term during the forecast period. In addition, Along with an industrial chain, market statistics in terms of revenue, sales, price, capacity, regional market analysis, segment-wise data, and market forecast information are offered in the full study, etc.

Industrial Impact of Covid-19 on Pre-Pregnancy Genetic Testing Industry:

The outbreak of the pandemicCOVID-19changed the market scenario on the global platform. Many of the regions are facing the biggest economic crisis owing to the lockdowns that were implemented due to the outspread of the coronavirus infection. As the only solution that has been found to contracting this disease is social distancing many countries have implemented strong regulations in regards to people gatherings. Owing to this many of the businesses are working with only 30% of its employees thus not able to bring the maximum production.

Thiscan affect the global economy in 3 main ways: by directly affecting production and demand, by creating supply chain and market disturbance, and by its financial impact on firms and financial markets.

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Pre-Pregnancy Genetic Testing Market Report is Segmented as Following-

In the end, the Pre-Pregnancy Genetic Testing report offers a short outline of the dealers, distributors, suppliers. Along with the Pre-Pregnancy Genetic Testingsales channel, analysis findings, conclusions, and results. Finally, provide info regarding new entrants within the Pre-Pregnancy Genetic Testing market. The study suggests a brand new proposition to spice up the Pre-Pregnancy Genetic Testing market price and nurture businesses. Correspondingly explains the current global Pre-Pregnancy Genetic Testing market and the coming development of the business. The Pre-Pregnancy Genetic Testing Market report begins with a basic overview of the industry lifecycle, definitions, classifications, applications, and industry chain structure, and all these together will help leading players understand the scope of the Market, what characteristics it offers, and how it will fulfill customers requirements. The study also covers market status, share, future patterns, development rate, deals, SWOT analysis, channels, merchants, and improvement gets ready for the anticipated year between 2020-2027.

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Impact of COVID-19 on Pre-Pregnancy Genetic Testing Market 2027 Expected to reach Highest CAGR - The Courier

DTC Genetic Testing Market Size By Type, By Application, By Geography, By Top Companies And Forecast To 2027 – LionLowdown

New Jersey, United States: The most recently added report on DTC Genetic Testing Market Insights, Forecast 2020 to 2027, Market Analysis report encourages clients to make strategic business decisions and understand the industry competitive advantage and key players strategies. of the market. The most recently added report on the DTC Genetic Testing Market has qualified and verifiable market insights conducted in the current scenario.

The research report of the DTC Genetic Testing market offers detailed information and overviews of the market for the forecast period 2020 to 2027. The major competitors in the DTC Genetic Testing market and their competitive landscapes are analyzed as they are market leaders and are concerned in the front. The report also takes into account the critical points of the market and offers important solutions for the growth of the market. In addition, the report also examines the raw materials supply chain channels, sales channels, and production flows of the major market players.

DTC Genetic Testing Market: Competitive Landscape

Competitive Analysis is one of the best sections of the report, comparing the progress of leading companies using key metrics like market share, new developments, global reach, local competition, pricing, and production. From the nature of the competition to future changes in the vendor landscape, the report offers an in-depth competitive analysis in the DTC Genetic Testing market.

Major Key Players Operating in the Market:

DTC Genetic Testing Market Segmentation

The report contains the market size with 2019 as the base year and an annual forecast up to 2027 in terms of sales (in million USD). For the forecast period mentioned above, estimates for all segments including type and application have been presented on a regional basis. We implemented a combination of top-down and bottom-up approaches to market size and analyzed key regional markets, dynamics and trends for different applications.

DTC Genetic Testing Market Segment by Type:

DTC Genetic Testing Market Segment by Application:

DTC Genetic Testing Market Regional overview:

In the report, experts analyze and forecast the DTC Genetic Testing market on a global as well as regional level. Taking into account all aspects of the market in terms of regions, the focus of the report is on North America, Europe, Asia Pacific, the Middle East and Africa, and South America. The prevailing trends and various opportunities in these regions are studied that can convince the growth of the market in the forecast period 2020 to 2027.

Major Key Points Covered in DTC Genetic Testing Market:

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DTC Genetic Testing Market Size By Type, By Application, By Geography, By Top Companies And Forecast To 2027 - LionLowdown

Breast Cancer Predictive Genetic Testing Market Likely to Experience a Tremendous Growth in Near Future|| Roche, Thermo Fisher Scientific,…

Breast Cancer Predictive Genetic Testing Market 2020: Latest Analysis

Chicago, United States:- Global Breast Cancer Predictive Genetic Testing Market report aims to offer an extensive overview of the Global Breast Cancer Predictive Genetic Testing Market with a broad Market segmentation on the basis of products, services, application, as well as regional overview. The research report on Breast Cancer Predictive Genetic Testing Market offers a comprehensive analysis of the Global Market with in-depth and specialized analysis of the Breast Cancer Predictive Genetic Testing Market. In addition, the Breast Cancer Predictive Genetic Testing Market report also provides a complete analysis of the Global Market Trends that are influencing the Global Market over the forecast period. Moreover, the Global Breast Cancer Predictive Genetic Testing Market is likely to witness a significant growth over the forecast period. Furthermore, the Breast Cancer Predictive Genetic Testing Market report offers a complete analysis of the Global Market, and the report also comprises an extensive study of application and product type with the comprehensive regional scenario. With the objective to offer a complete Market overview the Breast Cancer Predictive Genetic Testing report includes regional competitive landscape for the number of major Market service providers.

Besides a dashboard view of the vendor landscape and important company profiles, the competitive analysis offers an encyclopedic examination of the market structure. The company share analysis included in this study helps players to improve their business tactics and compete well against leading market participants. The intensity map prepared by our analysts helps to get a quick view of the presence of several players in the global Breast Cancer Predictive Genetic Testing market. The report also provides a footprint matrix of key players of the global Breast Cancer Predictive Genetic Testing market. It dives deep into growth strategies, sales footprint, production footprint, and product and application portfolios of prominent names of the industry.

Key players profiled in the report includes: Roche, Thermo Fisher Scientific, PerkinElmer, Quest Diagnostics, Myriad Genetics, Iverson Genetics, Cancer Genetics, OncoCyte Corporation, NeoGenomics, Invitae

The report features unique and relevant factors that are likely to have a significant impact on the Breast Cancer Predictive Genetic Testing market during the forecast period. This report also includes the COVID-19 pandemic impact analysis on the Breast Cancer Predictive Genetic Testing market. This report includes a detailed and considerable amount of information, which will help new providers in the most comprehensive manner for better understanding. The report elaborates the historical and current trends molding the growth of the Breast Cancer Predictive Genetic Testing market.

This report examines all the key factors influencing growth of global Breast Cancer Predictive Genetic Testing market, including demand-supply scenario, pricing structure, profit margins, production and value chain analysis. Regional assessment of global Breast Cancer Predictive 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, scope of NPD in new markets, pricing strategies, innovation possibilities and much more.

Segmentation by Application: HospitalsClinicsOthers

Segmentation by Type: High Penetrant GenesIntermediate Penetrant GenesLow Penetrant Genes

Our exploration specialists acutely ascertain the significant aspects of the global Breast Cancer Predictive Genetic Testing market report. It also provides an in-depth valuation in regards to the future advancements relying on the past data and present circumstance of Breast Cancer Predictive Genetic Testing market situation. In this Breast Cancer Predictive Genetic Testing report, we have investigated the principals, players in the market, geological regions, product type, and market end-client applications. The global Breast Cancer Predictive Genetic Testing report comprises of primary and secondary data which is exemplified in the form of pie outlines, Breast Cancer Predictive Genetic Testing tables, analytical figures, and reference diagrams. The Breast Cancer Predictive Genetic Testing report is presented in an efficient way that involves basic dialect, basic Breast Cancer Predictive Genetic Testing outline, agreements, and certain facts as per solace and comprehension.

Regional Coverage: 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, Colombia etc.), Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

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Table of Contents

Report Overview: It includes major players of the global Breast Cancer Predictive Genetic Testing Market covered in the research study, research scope, and Market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends: This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Breast Cancer Predictive Genetic Testing Market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Breast Cancer Predictive Genetic Testing Market are discussed.

Market Share by Manufacturers: Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type: This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application: Besides an overview of the global Breast Cancer Predictive Genetic Testing Market by application, it gives a study on the consumption in the global Breast Cancer Predictive Genetic Testing Market by application.

Production by Region: Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region: This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles: Almost all leading players of the global Breast Cancer Predictive Genetic Testing Market are profiled in this section. The analysts have provided information about their recent developments in the global Breast Cancer Predictive Genetic Testing Market, products, revenue, production, business, and company.

Market Forecast by Production: The production and production value forecasts included in this section are for the global Breast Cancer Predictive Genetic Testing Market as well as for key regional markets.

Market Forecast by Consumption: The consumption and consumption value forecasts included in this section are for the global Breast Cancer Predictive Genetic Testing Market as well as for key regional markets.

Value Chain and Sales Analysis: It deeply analyzes customers, distributors, sales channels, and value chain of the global Breast Cancer Predictive Genetic Testing Market.

Key Findings: This section gives a quick look at important findings of the research study.

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Breast Cancer Predictive Genetic Testing Market Likely to Experience a Tremendous Growth in Near Future|| Roche, Thermo Fisher Scientific,...

Diversifying the pack: Cross fostering helps Mexican wolf population boost genetic mix – Arizona Daily Star

The center has led the Mexican wolf cross-fostering program that began in 2014. Founded in 1971, it sits on 63 isolated, wooded acres, designed to match the cold, silent and humanless habitat where Mexican wolves live.

Through cross-fostering, 8- to 14-day-old pups born in captivity are placed in a den of similar-aged wild pups in remote areas of the Southwest.

Being able to take puppies from facilities like the Endangered Wolf Center and sneaking them into wild litters is a great way for us to be able to get new genetics out into the wild to help keep that wild population healthier, said Regina Mossotti, director of animal care and conservation at the Endangered Wolf Center.

Mexican wolves breed in April and May, leaving a narrow window for cross-fostering.

To successfully cross-foster a wolf pup, officials must identify a wild wolf that has given birth about the same time that a female wolf in captivity at the center gives birth.

When that does happen, the clock starts ticking.

We have to be able to find a flight, the weather has to work and we have to have enough people to do it, Mossotti said. So all these things, these logistics have to come together to make it happen.

Once the team from the Endangered Wolf Center arrives in Arizona, Game & Fish employees join them on a hike to a specific wolf den, often hidden in the rugged terrain along the Arizona-New Mexico state line.

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Diversifying the pack: Cross fostering helps Mexican wolf population boost genetic mix - Arizona Daily Star

Brief Report Treatment of infertility and menopause in a patient with multiple sclerosis affecting the pituitary stalk: a case report – DocWire News

This article was originally published here

Glob Reprod Health. 2020 Spring;5(1):e36. doi: 10.1097/grh.0000000000000036.

ABSTRACT

BACKGROUND: Multiple Sclerosis (MS) is an immune-mediated inflammatory disease characterized by demyelination of the CNS that affects women in their child-bearing years. There has been no absolute data to suggest infertility in this population; however, women with MS may exhibit decreased fertility due to various etiologies. Furthermore, their transition into menopause presents unique aspects in patient care.

METHODS: We report a case of a 38 year-old female with a diagnosis of MS with subsequent secondary amenorrhea and primary infertility. Multidisciplinary work-up with was consistent with hypothalamic hypogonadism secondary to MS affecting the pituitary stalk. She was treated for infertility in our clinic as well as management of her menopausal symptoms.

RESULTS: The patient conceived triplets after 2 cycles of ovarian stimulation with injectable gonadotropins and intrauterine insemination. She underwent fetal reduction to twins. After completion of childbearing, she was treated for menopausal symptoms with various hormonal therapies and ultimately remained on oral conjugated estrogens with no symptoms.

CONCLUSION: To our knowledge, this is the first report of infertility caused by suspected MS involvement of the pituitary stalk. In this patient population, infertility treatment can be successful with gonadotropins and alleviation of menopausal symptoms can be achieved with hormone replacement.

PMID:33354640 | PMC:PMC7751803 | DOI:10.1097/grh.0000000000000036

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Brief Report Treatment of infertility and menopause in a patient with multiple sclerosis affecting the pituitary stalk: a case report - DocWire News

Prenatal Genetic Testing Market Key Trends, Strategic Indicators, Drivers, SWOT, Key Participants and Global Industry Overview and Key Players Natera…

Prenatal Genetic Testing Market Overview:

Decisive Market Insights publishes detailed report on Global Market. The report computes the market share and size from 2020 2027. According to expert analysis the market is expected to grow at a compound annual growth rate of x% over the next five years and record an estimated value of approximately USD xx billion by 2027, compared to its earlier registered value of xx in 2019. The business has witnessed a growing demand over the last many years because of the expanding market and technological advancement. New tariff laws have eased the accessibility to markets which were limited to even the major players. The COVID 19 has had least impact on the business and is rising momentarily.

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Market Report Summary

The report covers a wide range of areas for better insights of the global market and industry trends and forecasts. The report covers market trends based on product types, application areas and key geographies. Market influencing factors such as drivers, restrains and investment opportunities has been carefully detailed in this report. The examination of the market trends, analysis and forecast has been done both at the macro and micro level perspective. It further gives a complete idea of the strategies adopted by major competitors in the business. Other significant factors, which works at the regional and international level to impact the market trends has been included. These influencing factors are socio-political scenario, environmental conditions, demography, legal agencies, and competitive environment of the region.

Based on the type of product, the global Prenatal Genetic Testing market segmented intoDiagnostic TestChorionic Villi Sampling (CVS)AmniocentesisPlacental BiopsyCordocentesisFetal BiopsyScreening TestCarrier ScreeningSequential ScreeningMaternal Serum Quad Screening

Based on the end-use, the global Prenatal Genetic Testing market classified intoHospitalsClinicsDiagnostic Centers

Based on geography, the global Prenatal Genetic Testing market segmented intoNorth America [U.S., Canada, Mexico]Europe [Germany, UK, France, Italy, Rest of Europe]Asia-Pacific [China, India, Japan, South Korea, Southeast Asia, Australia, Rest of Asia Pacific]South America [Brazil, Argentina, Rest of Latin America]Middle East & Africa [GCC, North Africa, South Africa, Rest of Middle East and Africa]

And the major players included in the report areSequenom LaboratoriesIlluminaNateraAriosa DiagnosticsBGI HealthNateraLifeCodexx

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Market Segmentation: Product, Application and Key Geographies

The geographical division based on product types and application areas are categorized as North America, Europe, Asia Pacific and the Rest of the World (RoW).

These geographical regions are further sub-divided into:

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Class action launched against Monash IVF over non-invasive embryo testing – ABC News

A heartbroken woman has launched a multi-million-dollar class action against one of Australia's leading IVF clinics, saying her chances of falling pregnant have been scuttled after a controversial genetic test labelled her embryos as "abnormal".

Danielle Bopping, of Canberra, has launched a class action in Victoria's Supreme Court accusing Monash IVF of breaching its duty of care by failing to tell her and others about the pitfalls of non-invasive pre-implantation genetic testing, which was being trumpeted by the fertility specialist.

She has since learned the testing can produce false-positives.

Her lawyer, Michel Margalit, said more than 100 people had already expressed interest in joining the suit and she was expecting up to 1,000.

"Danielle's in her 40s now and had she known at the time that this technology was not accurate in the manner she believed, she could have taken a different course," Ms Margalit said.

"I think that there is a real possibility that many, many people will question whether or not they have lost their ability to have children because of this inaccurate testing."

If successful, the class action could reap millions of dollars in compensation.

"This will be one of the largest class actions ever brought against a fertility provider," Ms Margalit said.

"We will be fighting for the rights of these women who have placed their trust in the hands of a medical provider and unknowingly have had devastating consequences."

The class action centres on the way in which Monash IVF conducted genetic testing on embryos to uncover abnormalities.

There are two ways to conduct such testing: the first method is through a biopsy, which involves taking a tissue sample from an embryo, a method that is considered invasive.

The second method is called non-invasive pre-implantation genetic testing and involves collecting DNA from the culture that the embryo has been growing in while in the laboratory.

According to court documents, lawyers alleged that Monash IVF told patients including Ms Bopping that the two tests were "identical" in 95 per cent of cases.

In November 2019, Ms Bopping had the non-invasive testing done on an embryo and was informed that the results were "abnormal".

As a result, she decided not to pursue inserting the embryo.

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Her lawyers now say she was the victim of "false, misleading and deceptive" behaviour because she was not told that the non-invasive type of testing could return a false-positive.

Monash IVF has since suspended the non-invasive testing.

Ms Margalit said the decision her client made that was based on the test results had whittled away crucial time.

She has since been unable to find anyone willing to insert her embryo because it has already been labelled abnormal.

"Every week and month counts when you're in your 40s," Ms Margalit said.

"Some people fear that they've lost their last chance to produce their own genetically-related children."

Others, she said, had since made life-altering decisions based on those testing results.

"Other people have gone on to use donor embryos and many women are now questioning their decision to cease treatment. So, there really will be lifelong consequences," she said.

Monash IVF has been contacted for comment.

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Class action launched against Monash IVF over non-invasive embryo testing - ABC News

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