After years of ethical debates and breakthroughs in the lab, CRISPR has finally made its way to clinical trials. Researchers are now looking at whether the DNA-editing tool, as well as more conventional gene therapies, can effectively treat a wide array of heritable disorders and even cancers.

Theres been a convergence of the science getting better, the manufacturing getting much better, and money being available for these kinds of studies, says Cynthia Dunbar, a senior investigator at the National Heart, Lung, and Blood Institute. Its truly come of age.

CRISPR formally known as CRISPR-Cas9 has been touted as an improvement over conventional gene therapy because of its potential precision. CRISPR (clustered regularly interspaced short palindromic repeats) is a genetic code that, contained in a strand of RNA and paired with the enzyme Cas9, acts like molecular scissors that can target and snip out specific genes. Add a template for a healthy gene, and CRISPRs cut can allow the cell to replace a defective gene with a healthy one.

In April, scientists at the University of Pennsylvania announced they had begun using CRISPR for cancer treatments. The first two patients one with multiple myeloma, the other with sarcoma had cells from their immune systems removed. Researchers used CRISPR to genetically edit the cells in the lab, and then returned them back into their bodies.

On the other side of the country, Mark Walters, a blood and bone marrow transplant specialist at the University of California, San Francisco, Benioff Childrens Hospital in Oakland, is gearing up for trials that will use CRISPR to repair the defective gene that causes sickle cell disease. With CRISPR, once youve made that type of correction, [that cell] is 100 percent healthy, says Walters.

Another team is tackling the same disease using a type of hemoglobin, a protein in red blood cells, thats normally made only in fetuses and newborn babies. Researchers found that some adults continue to produce these proteins throughout their lives, and when those adults also have sickle cell disease, their symptoms are mild. So the international team used CRISPR to disable the gene that interferes with production of this hemoglobin, resuming its production and protecting the adult patients against sickle cell disease.

Several other CRISPR studies are in the works to treat a range of inherited disorders, including hemophilia and SCID-X1 (also known as X-linked severe combined immunodeficiency, the so-called bubble boy disease in which babies are born without a functioning immune system).

At St. Jude Childrens Research Hospital, a gene therapy trial cured Gael Jesus Pino Alva (pictured with his mother, Giannina) of SCID-X1, the bubble boy disease. (Credit: St. Jude Children's Research Hospital/Peter Barta)

The past year also saw success in a handful of experiments on conventional gene therapy. Instead of using CRISPR to repair disease-causing genes, these treatments use hollowed-out viruses to ferry healthy versions of genes into cells. Millions of these altered cells are released into the bloodstream or bone marrow in hopes that enough will land in the right places. But because scientists cant predict where the circulating genes may end up, this shotgun approach has had unintended, sometimes fatal, consequences including, in an earlier study, inadvertently activating leukemia-causing genes in patients treated for SCID-X1.

But in 2019, researchers learned that using a different type of virus one related to HIV to transport the genes may prevent these side effects. In an April study, researchers at St. Jude Childrens Research Hospital in Memphis, Tennessee, and UCSF Benioff Childrens Hospital in Oakland collected bone marrow from eight newborns with SCID-X1. They loaded corrective genes into the disabled HIV-related virus, which carried them into the patients bone marrow stem cells. The infants also received low doses of busulfan, a chemotherapy that gave the doctored stem cells room to grow. So far, we havent seen anything worrisome, says Ewelina Mamcarz, a pediatric oncologist at St. Jude who led the research team. The study recently added its 12th patient.

Gene therapy does have its momentum [back], says Mamcarz, reflecting on the fields setback after the earlier studys leukemia side effects. Theres so much that still needs to be done, and so many questions, she says. [But] this is how medicine evolves. We always want to be better than we were a week ago.

In the future, the hope is that gene therapy technologies will move beyond mending simple genetic mistakes and be used to combat big killers like diabetes or heart disease. [Those diseases are] more challenging, but a lot of them would benefit from knocking out a bad gene, says Dunbar.

For now, though, researchers are optimistic about the progress thats already been made. All of this has been very encouraging, says Dunbar. [And] for sickle cell in the U.S. and hemophilia in the developed world, these diseases may soon be solved.

[This story originally appeared in print as "Gene Therapy Gets Clinical."]

Originally posted here:
Gene Therapies Make it to Clinical Trials - Discover Magazine

Recommendation and review posted by Bethany Smith

For decades, the DNA of living organisms such as corn and salmon has been modified, but Crispr, invented in 2012, made gene editing more widely accessible. Image: YinYang/IStock.com via AFP Relaxnews

In the summer, a mother in Nashville with a seemingly incurable genetic disorder finally found an end to her suffering by editing her genome.

Victoria Grays recovery from sickle cell disease, which had caused her painful seizures, came in a year of breakthroughs in one of the hottest areas of medical research gene therapy.

I have hoped for a cure since I was about 11, the 34-year-old told AFP in an email.

Since I received the new cells, I have been able to enjoy more time with my family without worrying about pain or an out-of-the-blue emergency.

Over several weeks, Grays blood was drawn so doctors could get to the cause of her illness stem cells from her bone marrow that were making deformed red blood cells.

The stem cells were sent to a Scottish laboratory, where their DNA was modified using Crispr/Cas9 pronounced Crisper a new tool informally known as molecular scissors.

The genetically edited cells were transfused back into Grays veins and bone marrow. A month later, she was producing normal blood cells.

Medics warn that caution is necessary but, theoretically, she has been cured.

This is one patient. This is early results. We need to see how it works out in other patients, said her doctor, Haydar Frangoul, at the Sarah Cannon Research Institute in Nashville.

But these results are really exciting.

In Germany, a 19-year-old woman was treated with a similar method for a different blood disease, beta thalassemia. She had previously needed 16 blood transfusions per year.

Nine months later, she is completely free of that burden.

For decades, the DNA of living organisms such as corn and salmon has been modified.

But Crispr, invented in 2012, made gene editing more widely accessible. It is much simpler than preceding technology, cheaper and easy to use in small labs.

The technique has given new impetus to the perennial debate over the wisdom of humanity manipulating life itself.

Its all developing very quickly, said French geneticist Emmanuelle Charpentier, one of Crisprs inventors and the cofounder of Crispr Therapeutics, the biotech company conducting the clinical trials involving Gray and the German patient.

Cures

Crispr is the latest breakthrough in a year of great strides in gene therapy, a medical adventure started three decades ago, when the first TV telethons were raising money for children with muscular dystrophy.

Scientists practicing the technique insert a normal gene into cells containing a defective gene.

It does the work the original could not such as making normal red blood cells, in Victorias case, or making tumor-killing super white blood cells for a cancer patient.

Crispr goes even further: instead of adding a gene, the tool edits the genome itself.

After decades of research and clinical trials on a genetic fix to genetic disorders, 2019 saw a historic milestone: approval to bring to market the first gene therapies for a neuromuscular disease in the United States and a blood disease in the European Union.

They join several other gene therapies bringing the total to eight approved in recent years to treat certain cancers and an inherited blindness.

Serge Braun, the scientific director of the French Muscular Dystrophy Association, sees 2019 as a turning point that will lead to a medical revolution.

Twenty-five, 30 years, thats the time it had to take, he told AFP from Paris.

It took a generation for gene therapy to become a reality. Now, its only going to go faster.

Just outside Washington, at the National Institutes of Health (NIH), researchers are also celebrating a breakthrough period.

We have hit an inflection point, said Carrie Wolinetz, NIHs associate director for science policy.

These therapies are exorbitantly expensive, however, costing up to $2 million meaning patients face grueling negotiations with their insurance companies.

They also involve a complex regimen of procedures that are only available in wealthy countries.

Gray spent months in hospital getting blood drawn, undergoing chemotherapy, having edited stem cells reintroduced via transfusion and fighting a general infection.

You cannot do this in a community hospital close to home, said her doctor.

However, the number of approved gene therapies will increase to about 40 by 2022, according to MIT researchers.

They will mostly target cancers and diseases that affect muscles, the eyes and the nervous system.

Bioterrorism

Another problem with Crispr is that its relative simplicity has triggered the imaginations of rogue practitioners who dont necessarily share the medical ethics of Western medicine.

Last year in China, scientist He Jiankui triggered an international scandal and his excommunication from the scientific community when he used Crispr to create what he called the first gene-edited humans.

The biophysicist said he had altered the DNA of human embryos that became twin girls Lulu and Nana.

His goal was to create a mutation that would prevent the girls from contracting HIV, even though there was no specific reason to put them through the process.

That technology is not safe, said Kiran Musunuru, a genetics professor at the University of Pennsylvania, explaining that the Crispr scissors often cut next to the targeted gene, causing unexpected mutations.

Its very easy to do if you dont care about the consequences, Musunuru added.

Despite the ethical pitfalls, restraint seems mainly to have prevailed so far.

The community is keeping a close eye on Russia, where biologist Denis Rebrikov has said he wants to use Crispr to help deaf parents have children without the disability.

There is also the temptation to genetically edit entire animal species malaria-causing mosquitoes in Burkina Faso or mice hosting ticks that carry Lyme disease in the US.

The researchers in charge of those projects are advancing carefully, however, fully aware of the unpredictability of chain reactions on the ecosystem.

Charpentier doesnt believe in the more dystopian scenarios predicted for gene therapy, including American biohackers injecting themselves with Crispr technology bought online.

Not everyone is a biologist or scientist, she said.

And the possibility of military hijacking to create soldier-killing viruses or bacteria that would ravage enemies crops?

Charpentier thinks that technology generally tends to be used for the better.

Im a bacteriologist weve been talking about bioterrorism for years, she said. Nothing has ever happened.IB/JB

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2019: The year gene therapy came of age - INQUIRER.net

Recommendation and review posted by Bethany Smith

"If it disagrees with experiment, it's wrong. That's all there is to it." So said famed physicist Richard Feynman at a lecture about the scientific method at Cornell University in 1964.

Feynman appears to be only half correct, though. Yes, one's proposed theory is wrong if it doesn't agree with experiment. But that's not all there is to it. With carelessness or outright fraud, you can make it seem that your theory is correct and get it published in a top scientific journal.

Usually, such deception is eventually discovered. This past year was rich in scientific retractions of papers filled with poor processes and, in many cases, blatant fabrications. Here are five from 2019 that made the news in part because they mislead and provide false hope.

God created the Earth 6,000 years ago, according to many Christian creationists. And on the sixth day of creation, God made three species of timber vole with ribonucleotides that would come to demonstrate the shortcomings of the theory of evolution, according to a 1989 paper in the International Journal of Neuroscience.

Russian scientist Dmitrii Kuznetsov, the author of this paper, claimed that each of these three very closely related voles have ribonucleotides enzymes that are the building blocks of DNA and thus DNA repair that are utterly incompatible across the three species. This finding supports "the general creationist concept on the problems of the origin of boundless multitudes of different and harmonically functioning forms of life," Kuznetsov wrote in the paper.

But did Kuznetsov break the commandment about bearing false witness? Swedish biologist Dan Larhammar, who in 2018 became president of the Royal Swedish Academy of Sciences, questioned Kuznetsov's findings in a letter to the journal published way back in 1994. As reported in The Scientist in November 2019, Larhammar claimed that the results were superficially demonstrated and that many of the references couldn't be verified, even after he contacted scientists cited in the paper.

The International Journal of Neuroscience agreed with Larhammar and retracted the paper, albeit 30 years later. Kuznetsov has been accused multiple times of scientific misconduct, including for his analysis of the Shroud of Turin, which scholars claim originated in the Middle Ages but which Kuznetsov suggested could be the 2,000-year-old death shroud of Jesus.

Why the 30-year delay for a retraction? Thirty years in a 6,000-year-old Earth would be equivalent to 20 million years in a 4-billion-year-old Earth. Maybe the journal was hesitant to retype the original title, "In Vitro Studies of Interactions Between Frequent and Unique Mrnas and Cytoplasmic Factors from Brain Tissue of Several Species of Wild Timber Voles of Northern Eurasia, Clethrionomys Glareolus, Clethrionomys Frater and Clethrionomys Gapperi: A New Criticism to a Modern Molecular-Genetic Concept of Biological Evolution."

The vaccine against the human papillomavirus (HPV) has the potential to eliminate most cases of cervical cancer worldwide and save millions of lives. The HPV vaccine can also prevent the majority of vaginal, anal and penile cancers. But that's only if parents vaccinate their children against HPV.

A growing number are opting out over fears that the HPV vaccine is harmful. In Japan, for example, HPV vaccination rates fell from about 70 percent to 1 percent, its current level, in just a few years after unfounded reports of vaccine side effects, according to research published this year in the journal Expert Review of Vaccines.

As such, vaccine proponents are skeptical of any new study purporting problems with the HPV vaccine. Gayle DeLong, an associate professor of economics and finance at Baruch College in New York, learned that quickly. In 2018, she published a paper in the Journal of Toxicology and Environmental Health, Part A, in which she reported a link between the HPV vaccine and infertility. Married women between ages 25 and 29 who had received the HPV vaccine were less likely to have conceived compared with married women who didn't receive the vaccine, DeLong found.

The finding was promoted within anti-vaccination circles, but the study had multiple statistical shortcomings, such as not controlling for birth-control use. Moreover, those women who received the vaccine had a higher educational level. So, it could be that college-educated women who had received the vaccine were delaying childbirth until after age 30, as is the U.S. trend.

The journal retracted the paper in December 2019, noting "serious flaws in the statistical analysis and interpretation of the data in this paper." The World Health Organization has placed the HPV vaccine on its list of essential medicines, right up there with penicillin and acetaminophen, as a sign of its safety and efficacy.

On Nov. 13, 2019, Cao Xuetao, one of China's most prominent scientists, spoke to his fellow countrymen from the Great Hall of People in Beijing about research integrity. Some 6,000 people were in attendance, and the speech was live-streamed to 800,000 college students across the vast nation, mandatory viewing for most.

The topic was a contentious one. Just a year prior, the Chinese Ministry of Science and Technology (MOST) and several other agencies had promulgated a series of punitive measures to be used in cases of scientific misconduct, a sign that the Chinese government was considering the matter seriously. This had come in the wake of numerous scientific scandals in China, such as the retraction of more than 100 papers in 2017 over faked peer review and data manipulation.

Cao is a former president of the Chinese Academy of Medical Sciences, current president of the prestigious Nankai University, leader of several labs and chief research integrity officer for all Chinese research. His accolades are many. But now, Cao's actions are drawing close scrutiny, as he has been accused of scientific misconduct.

As reported on Nov. 22 in the journal Science, a multitude of Cao's papers appear to have doctored images. Science sleuth Elisabeth Bik, based in San Francisco, noticed that several images from a 2009 paper, in particular, looked like repeats. Bik has outed many scientists for data manipulation. Cao's body of work was soon scrutinized; they found examples of charts and images appearing to be repeated and manipulated in dozens of papers, which soon may be retracted.

Cao pledged to look into the matter. As noted, he's the leader of several labs and has a full-time gig as a university president, and he likely relies on postdoctoral fellows and graduate students to conduct actual research. And they likely want to please the boss with superficially good results. The same would apply to other elite scientists in China, which means the problem of scientific misconduct might be difficult to root out.

The cancer research community was ecstatic over a study published in the journal Nature in September 2018 that described a homing system to deliver the powerful anti-cancer chimeric antigen receptor (CAR) T cell therapy to brain cancer cells, which have long been out of reach to drug therapies.

But the researchers who conducted the study, from Baylor College of Medicine in Texas, may not have crossed the bloodbrain barrier, after all, but rather the factfiction barrier.

Within a few weeks of publication, other scientists began homing in on what may be widespread image manipulation. Nearly every image appeared to be fudged and not supportive of the underlying data, according to comments posted on an anonymous post-publication peer-review website called PubPeer.

The journal Nature investigated and retracted the paper in February 2019. The validity of this homing system remains in doubt. Some commenters on PubPeer noted that Nature should have spotted the image manipulation during the peer-review process. Software exists to detect it. It's either that or expect scientists to be honest.

He Jiankui has not been seen publicly since January 2019, just a few months after he infamously announced the birth of twin girls whose DNA was edited using CRISPR. His plan was to make the girls immune to HIV infection by modifying a gene known to offer some protection against the virus.

Seemingly proud of his achievement, He encountered swift worldwide condemnation not merely over the secrecy of the experiment but also for the possible harm that could have been done to the babies, whose genes were manipulated while in an embryonic state. CRISPR is an imperfect technique that can alter DNA in unknown and sometimes harmful ways, as animal studies have demonstrated.

The Chinese government, which may have supported He's efforts, has since suspended all of his research activities and, according to the New York Times, has kept him under guard.

Not much is known about He's procedure. Here's what is known: Scientists have stated that the basic premise of the work altering a gene called CCR5 to prevent HIV infection is shortsighted because this altered gene, found in nature, does not offer uniform HIV protection to those people who carry it. Moreover, the twins were given imperfect versions of this altered gene, and the health consequences are unknown, according to investigative work done by MIT Technology Review.

So, this was an experimental study otherwise suitable only for lab animals, medically unnecessary and poorly executed at that. There was a third gene-edited baby, too, perhaps born in the summer of 2019. Nothing is known of the baby's fate.

At issue is germline gene-editing on embryos. Gene alteration at this early stage ensures that all genetic modifications are copied into every cell in the body, including egg and sperm cells, making the changes inheritable. Otherwise, CRISPR and similar technologies continue to show great promise in curing genetic diseases in children and adults through more isolated and limited gene modification.

Originally published on Live Science.

Go here to see the original:
Take That Back: The Top Scientific Retractions of 2019 - Livescience.com

Recommendation and review posted by Bethany Smith

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Gene Therapy for Ovarian Cancer Market Research Report Analysis And Forecasts To 2025 - Market Research Sheets

Recommendation and review posted by Bethany Smith

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Recommendation and review posted by Bethany Smith

Shares of IVERIC bio (ISEE) have risen by 450% since its name change in April, where the company shed the name of its failed predecessor Ophthotech and refocused efforts on the ocular gene therapy space.

The turnaround has been a long time coming, starting in August 2017 after prior lead asset Fovista failed its phase 3 trial in combination with approved VEGF inhibitors in patients with wet AMD. The focus then shifted to the company's C5 inhibitor Zimura, which was in trials for multiple ocular disease indications. The company entered into various gene therapy pacts, including a global license deal with the University of Florida Research Foundation and the University of Pennsylvania to develop a novel adeno-associated virus gene therapy for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa (NASDAQ:RP). In October 2018, the company acquired privately-held Inception 4, a developer of retinal diseases therapies based on inhibiting a protein called high temperature requirement A serine peptidase 1 protein (HtrA1). In exchange, Ophthotech issued 5.2 million shares of common stock in addition to being on the hook for additional milestone payments. Separately, the company inked an exclusive option agreement with the University of Pennsylvania and University of Florida Research Foundation for novel AAV gene therapy products for the treatment of Best vitelliform macular dystrophy (Best disease), a rare inherited disorder characterized by the progressive degeneration of the retina.

Flash forward to the present, and a strong showing since December's secondary offering provides us the green flag we need to dig deeper. The company priced 6.25 million common shares at $4 per share along with pre-funded warrants to purchase 3.75 million shares at $3.999 per pre-funded warrant for gross proceeds of around $40 million (to my eyes looks like a sweetheart deal to key institutional holders). As the stock currently trades at $7.75, these investors in the secondary offering have done quite well for themselves so far.

Let's take a closer look to determine if this gene therapy pioneer in the ocular disease space is de-risked enough to make it as a "ROTY idea."

Chart

Figure 1: ISEE daily advanced chart (Source: Finviz)

When looking at charts, clarity often comes from taking a look at distinct time frames in order to determine important technical levels to get a feel for what's going on. In the above chart (daily advanced), we can see the stock jump in late October after a positive data readout for the phase 2b study of Zimura in patients with dry age-related macular degeneration (AMD) with geographic atrophy (GA). From there the stock hardly dipped after news of a secondary offering in early December and has experienced much appreciation in the weeks that followed (definitely a green flag). Despite the run-up, at first glance consolidation below the $8 level appears to be offering readers an opportunity to at least initiate a pilot position.

For readers interested in a brief but very insightful overview of the company's operations, management's presentation at Evercore ISI 2nd Annual HealthCONx Conference was a worthwhile listen for me.

CEO and President Glenn Sblendorio starts by stating that during the last three years they've been building a portfolio in inherited retinal diseases with therapeutics (Zimura) as well as a deep gene therapy portfolio. He reminds us that recently they reported positive topline data for Zimura in the first of two pivotal studies (hit its primary endpoint, good safety). Aside from GA secondary to dry AMD, they also are going after Stargardt Disease with Zimura (similar to wet AMD but in younger patients, finished enrollment and expecting data later in 2020). Interestingly enough, this is the largest study in Stargardt patients that has ever been done.

Figure 2: Pipeline (Source: corporate presentation)

As for the preclinical portfolio, the company's HtrA1 inhibitor will be developed for GA secondary to Dry AMD (Genentech recently started a phase 2 study on that same target).

As for the gene therapy portfolio, there are six programs along with some research work. Lead program is in RHO-adRP and should make its way into the clinic next year (11k patients in US and EU5). Best1 related retinal diseases is behind that asset, while the next three programs are in conjunction with the University of Massachusetts medical school using minigene vector (takes large functional protein that is too large to fit into existing AAV vectors, and making it into a smaller protein but keeping the functionality).

Going back to GA secondary to dry AMD, Sblendorio acknowledges the competitor running its own trial (Apellis Pharmaceuticals' APL-2 which binds to a pocket of C3, see Apellis' corporate presentation) and notes that the condition itself is still not well understood. As for pathogenesis, it's pointed out that the complement system is quite complex (over 40 different variables, three different pathways) and management believes both classic and alternative pathways are activated early in the disease of GA.

Figure 3: GA impact on functional vision in daily life (Source: corporate presentation)

As for a development plan, they are taking all comers as opposed to segmenting (could come later on). With Zimura the company is seeking to preserve upstream complement activation while hitting the downstream, as contrasted to Apellis' C3 inhibitor (local suppression). Management states hitting closer to C5 with Zimura could have safety advantages. As for other C5 inhibitors that have been tested in GA and issues experienced in the past, Alexion's C5 inhibitor was administered systemically and had difficulty getting through blood brain barrier (Zimura on the other hand is administered via intravitreal injection). As for Novartis' (NYSE:NVS) monoclonal antibody trial in 99 patients, low dose was inconclusive and higher dose was in seven patients but study was terminated,

As for recent data for Zimura in the phase 2b study, 286 patients were enrolled to three drug arms (1mg, 2mg, 4mg) and the two higher doses hit statistical significance with the primary endpoint (mean rate of change in GA over 12 months measured by fundus autofluorescence at baseline, month 6, and month 12). Dose response (not statistically significant) was observed and safety profile was "very good." Meetings with FDA after the data have resulted in management's plan to run one more trial (to get underway Q1 2020).

Figure 4: Primary efficacy endpoint achieved with 2 mg dose of Zimura versus sham (Source: corporate presentation)

As for Stargardt data next year, here the objective also is to show slowing of disease progression but using a longer time frame (18 month) as Stargardt progresses more slowly than GA.

As for the early stage gene therapy platform, management used a logical selection criteria by choosing programs that are validated and have compelling science. Additionally, these programs are addressing indications with high unmet medical need and are commercially viable. Stargardt and Usher have high prevalence, with the former having 62,000+ patients in the US+EU5 and for the latter 50,000+ patients in US + EU5.

On June 17 IVERIC bio announced that it entered an agreement with Catalent (CTLT) for production and manufacturing of GMP-grade adeno-associated virus (AAV) vector for its gene therapy product candidates, IC-100 for the treatment of rhodopsin-mediated autosomal dominant retinitis pigmentosa and IC-200 for the treatment of BEST1 related retinal diseases. The first of these is expected to enter the clinic in 2020 with IC-200 to follow 1H 2021.

Figure 5: IC-100 proof of concept in canine model shows preservation of retinal function (Source: corporate presentation)

On July 23 the company announced it had exercised an option to enter into an exclusive global license agreement with the University of Massachusetts Medical School for rights to develop and commercialize mutation independent novel AAV gene therapy product candidates for the treatment of Leber Congenital Amaurosis type 10 (LCA10) due to mutations to the CEP290 gene, the most common type of LCA. Apparently, the collaboration resulted in additional research data that supports the plans of moving forward. Separately, IVERIC bio also announced expansion of its gene therapy portfolio by entering into a sponsored research agreement with UMass Medical School and an exclusive option agreement for rights to develop and commercialize novel AAV gene therapy product candidates utilizing a mutation independent minigene therapy approach for the treatment of vision loss in USH2A-related inherited retinal diseases (IRDs).

Figure 6: MiniCEP290 LCA10 early proof-of-concept (Source: corporate presentation)

On Oct. 28 the company announced initial topline data confirming that C5 inhibitor Zimura met its prespecified primary endpoint in reducing the rate of geographic atrophy growth in patients with dry age-related macular degeneration in a randomized, controlled phase 2b clinical trial. Reduction in the mean rate of GA growth over 12 months was 27.38% (p-value = 0.0072) for the Zimura 2 mg group as contrasted to sham control and 27.81% (p-value = 0.0051) for the Zimura 4 mg group as compared to sham control. The drug candidate appeared well tolerated after 12 months of administration with no Zimura-related inflammation or Zimura-related discontinuations (no ocular serious adverse events and no cases of endophthalmitis either). Incidence of choroidal neovascularization (CNV) in the untreated fellow eye was 10 patients (3.5%), three patients (2.7%) in the sham control group, six patients (9.0%) in the Zimura 2 mg group, and eight patients (9.6%) in the Zimura 4 mg group. Most frequently reported ocular adverse events were related to the injection procedure. Keep in mind the significance of this data considering that these patients have no treatment options currently.

Improvement in pre-specified endpoints (mean change in best corrected visual acuity and mean change in low luminance best corrected visual acuity from baseline to month 12) were not as promising (even inferior to placebo in some cases). However, as management pointed out in their presentation above, BCVA improvement is more important in conditions such as wet AMD as opposed to GA where the goal is simply to avoid blindness. Keep in mind that patients in the trial continue to be treated through month 18, so further data collection and readout in 2020 also will prove an important catalyst.

On Oct. 29 the company announced appointment of Abraham Scaria, PhD, to the position of Chief Scientific Officer (served previously at Genzyme, Sanofi and most recently at Casebia Therapeutics, leading multiple ocular gene therapy programs). Dr. Scarias 25-plus years of experience in the gene therapy arena will certainly prove helpful as the company's early-stage programs make their way into the clinic. This was followed up with another appointment in late November in the form of Guangping Gao, PhD, as Chief Strategist, Gene Therapy (has 30 years of research experience in gene-based treatments and is current President of the American Society of Gene and Cell Therapy (ASGCT). Dr. Gao's contributions to the field should not be understated (published 267 research papers, six book chapters and holds 135 patents with 239 additional patent applications pending).

For the third quarter of 2019, the company reported cash and equivalents of $94.9 million compared to net loss of $14.4 million. Research and development expenses rose slightly to $10.4 million, while G&A came in at $4.7 million. At the time, management estimated operational runway into 1H 2021 (not including $40 million of gross proceeds from secondary offering).

As for future catalysts, next year we can expect additional follow up on phase 2b data for the GA program and initiation of enrollment in the second pivotal study in Q1 2020. Data for Zimura in Stargardt disease also is expected at some point in 2020.

Keep in mind that competitor Apellis Pharmaceuticals (APLS) continues to enroll two phase 3 studies (DERBY and OAKS) for GA patients and progress here will be important to monitor as well.

Figure 7: Competitor Apellis' APL-2 FILLY phase 2 data slowed GA growth as well, graph provides point of comparison of mid-stage results (Source: corporate presentation)

On the conference call, management estimated that total expected cost of the second pivotal Zimura trial in GA could range between $30 million to $40 million plus additional external CMC cost for process development validation ranging from $10 million to $20 million (hinted that a partnership is a potential option on the table as well). Regarding market size, AMD is considered the most common cause of visual loss in developed countries with projection of 196 million in 2020 and 288 million in 2040 worldwide. Prevalence of GA in 2020 is estimated to be 1.5 million patients in the US with incidence of around 159,000/year. There are no currently FDA or EMEA approved treatment options available for these patients.

As for institutional investors of note, in December Venrock Healthcare Partners acquired a 5.60% stake in the company. While there has been a history of insider sales, President and CEO Glenn Sblendorio has made a few purchases as well (in May, November and December).

As for management lineup, President and CEO Glenn Sblendorio served prior as president and chief financial officer at The Medicines Company (NASDAQ:MDCO) from 2006 to 2016 and before that as executive vice president/chief financial officer of Eyetech Pharmaceuticals (was sold to OSI Pharmaceuticals for over $900 million in cash and stock deal). Chief Financial Officer David Carroll also came over from the Medicines Company. Chief Clinical Operations Officer also served prior at Eytech Pharmaceuticals as Vice President and Senior Vice President of Clinical Research and Development (played a key role in the development and approval of Macugen for the treatment of wet age-related macular degeneration).

To conclude, there are several elements in an investment here that we look for in ROTY (multiple ways to win via Zimura readouts and progression of gene therapy pipeline, good cash position post secondary, experienced management team, a derisking data set in GA, etc). Looking at prior news flow, I wish I had discovered this one earlier in the year when gene therapy programs were in licensed or even entry post Zimura GA data in October. However, even at the present market capitalization of $340 million (EV of around $200 million if cash is backed out), valuation seems to be on the cheap side relative to prospects in GA with additional indications and gene therapy pipeline giving investors long-term optionality. On a note of caution, burden of proof is on the company in detailed data readout for Zimura as well as with longer follow up to show maintained treatment effect and confirm prior data in the second pivotal trial.

For readers who are interested in the story and have done their due diligence, ISEE is a Speculative Buy and I expect continued upside in 2020 as this is both a revaluation and catalyst idea.

Risks include disappointing data readouts in 2020 for GA and Stargardt, setbacks in the clinic, regulatory setbacks for gene therapy pipeline and competition in certain spaces they are going after. When I think of LCA10 indication (and Usher for that matter), ProQR Theraeputics' (PRQR) sepofarsen and QR-421a come to mind. Allergan and Editas Medicine (EDIT) also are going after LCA10 with a CRISPR-based genome editing medicine (AGN-151587). A former winner mentioned in ROTY and public articles, Nightstar Therapeutics which was acquired by Biogen, also has a highly intriguing Stargardt disease program as well as earlier-stage asset NSR-BEST1 for Best disease. Going back to lead indication of GA for Zimura, keep in mind that multiple attempts with C5 in the past have failed, so burden of proof is on the company to truly show that "this time is different." Keep in mind that competitor APL-2 showed treatment effect maintained through 18 months - if phase 3 data for APL-2 disappoints, it could have an outsized impact on share price as well.

A comparison in valuation to Apellis Pharmaceuticals would be premature and essentially apples to oranges, considering the larger company has a pivotal readout due in PNH where there is rationale for optimism for the prospects of APL-2 as an add-on therapy to Soliris. AIHA and C3G are other indications being explored as well.

Currently Apellis sports a market cap around 6x that of IVERIC bio. One would think that as a revaluation idea alone (in the absence of data catalysts) and given clear signs of accumulation in the smaller company's stock, a revaluation of the latter to $500 million-plus market capitalization would be appropriate.

As for downside cushion and elements of de-risking, as mentioned prior cash position accounts for about a third of market capitalization and GA data for Zimura provides some cushion as well. It would appear that investors purchasing shares presently are getting the gene therapy pipeline essentially for free.

For our purposes in ROTY, again I wish I'd been savvy enough to catch this one earlier when enterprise value was ridiculously cheap (I often try to enter positions early on before a run up has taken place). That said, IVERIC bio still represents an attractive revaluation opportunity and I'm very interested to follow up on an update later in 2020 as lead gene therapy asset IC-100 makes its way into the clinic (would like to see management deliver on timeline projections and let us know when to expect the initial data set). Also, I feel that I have little edge as far as determining how pivotal data for competitor Apellis Pharmaceuticals' GA program will affect shares of IVERIC bio (am optimistic on positive outcome, but a comparison of side effect profiles will be key to determining who has an advantage in addressing this attractive market opportunity).

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Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Additional disclosure: Disclaimer: Commentary presented is NOT individualized investment advice. Opinions offered here are NOT personalized recommendations. Readers are expected to do their own due diligence or consult an investment professional if needed prior to making trades. Strategies discussed should not be mistaken for recommendations, and past performance may not be indicative of future results. Although I do my best to present factual research, I do not in any way guarantee the accuracy of the information I post. I reserve the right to make investment decisions on behalf of myself and affiliates regarding any security without notification except where it is required by law. Keep in mind that any opinion or position disclosed on this platform is subject to change at any moment as the thesis evolves. Investing in common stock can result in partial or total loss of capital. In other words, readers are expected to form their own trading plan, do their own research and take responsibility for their own actions. If they are not able or willing to do so, better to buy index funds or find a thoroughly vetted fee-only financial advisor to handle your account.

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IVERIC bio: Promising Data In GA, Valuation Still Cheap With Multiple Catalysts In 2020 - Seeking Alpha

Recommendation and review posted by Bethany Smith

Millions of new scientific research papers are published every year, shedding light on everything from the evolution of stars to the ongoing impacts of climate change to the health benefits (or determents) of coffee to the tendency of your cat to ignore you. With so much research coming out every year, it can be difficult to know what is significant, what is interesting but largely insignificant, and what is just plain bad science. But over the course of a decade, we can look back at some of the most important and awe-inspiring areas of research, often expressed in multiple findings and research papers that lead to a true proliferation of knowledge. Here are ten of the biggest strides made by scientists in the last ten years.

The human family tree expanded significantly in the past decade, with fossils of new hominin species discovered in Africa and the Philippines. The decade began with the discovery and identification of Australopithecus sediba, a hominin species that lived nearly two million years ago in present-day South Africa. Matthew Berger, the son of paleoanthropologist Lee Berger, stumbled upon the first fossil of the species, a right clavicle, in 2008, when he was only 9 years old. A team then unearthed more fossils from the individual, a young boy, including a well-preserved skull, and A. sediba was described by Lee Berger and colleagues in 2010. The species represents a transitionary phase between the genus Australopithecus and the genus Homo, with some traits of the older primate group but a style of walking that resembled modern humans.

Also discovered in South Africa by a team led by Berger, Homo naledi lived much more recently, some 335,000 to 236,000 years ago, meaning it may have overlapped with our own species, Homo sapiens. The species, first discovered in the Rising Star Cave system in 2013 and described in 2015, also had a mix of primitive and modern features, such as a small brain case (about one-third the size of Homo sapiens) and a large body for the time, weighing approximately 100 pounds and standing up to five feet tall. The smaller Homo luzonensis (three to four feet tall) lived in the Philippines some 50,000 to 67,000 years ago, overlapping with several species of hominin. The first H. luzonensis fossils were originally identified as Homo sapiens, but a 2019 analysis determined that the bones belonged to an entirely unknown species.

These three major finds in the last ten years suggest that the bones of more species of ancient human relatives are likely hidden in the caves and sediment deposits of the world, waiting to be discovered.

When Albert Einstein first published the general theory of relativity in 1915, he likely couldnt have imagined that 100 years later, astronomers would test the theorys predictions with some of the most sophisticated instruments ever builtand the theory would pass each test. General relativity describes the universe as a fabric of space-time that is warped by large masses. Its this warping that causes gravity, rather than an internal property of mass as Isaac Newton thought.

One prediction of this model is that the acceleration of masses can cause ripples in space-time, or the propagation of gravitational waves. With a large enough mass, such as a black hole or a neutron star, these ripples may even be detected by astronomers on Earth. In September 2015, the LIGO and Virgo collaboration detected gravitational waves for the first time, propagating from a pair of merging black holes some 1.3 billion light-years away. Since then, the two instruments have detected several additional gravitational waves, including one from a two merging neutron stars.

Another prediction of general relativityone that Einstein himself famously doubtedis the existence of black holes at all, or points of gravitational collapse in space with infinite density and infinitesimal volume. These objects consume all matter and light that strays too close, creating a disk of superheated material falling into the black hole. In 2017, the Event Horizon Telescope collaborationa network of linked radio telescopes around the worldtook observations that would later result in the first image of the environment around a black hole, released in April 2019.

Scientists have been predicating the effects of burning coal and fossil fuels on the temperature of the planet for over 100 years. A 1912 issue of Popular Mechanics contains an article titled Remarkable Weather of 1911: The Effect of the Combustion of Coal on the ClimateWhat Scientists Predict for the Future, which has a caption that reads: The furnaces of the world are now burning about 2,000,000,000 tons of coal a year. When this is burned, uniting with oxygen, it adds about 7,000,000,000 tons of carbon dioxide to the atmosphere yearly. This tends to make the air a more effective blanket for the earth and to raise its temperature. The effect may be considerable in a few centuries.

Just one century later, and the effect is considerable indeed. Increased greenhouse gases in the atmosphere have produced hotter global temperatures, with the last five years (2014 to 2018) being the hottest years on record. 2016 was the hottest year since the National Oceanic and Atmospheric Administration (NOAA) started recording global temperature 139 years ago. The effects of this global change include more frequent and destructive wildfires, more common droughts, accelerating polar ice melt and increased storm surges. California is burning, Venice is flooding, urban heat deaths are on the rise, and countless coastal and island communities face an existential crisisnot to mention the ecological havoc wreaked by climate change, stifling the planets ability to pull carbon back out of the atmosphere.

In 2015, the United Nations Framework Convention on Climate Change (UNFCCC) reached a consensus on climate action, known as the Paris Agreement. The primary goal of the Paris Agreement is to limit global temperature increases to 1.5 degrees Celsius over pre-industrial levels. To achieve this goal, major societal transformations will be required, including replacing fossil fuels with clean energy such as wind, solar and nuclear; reforming agricultural practices to limit emissions and protect forested areas; and perhaps even building artificial means of pulling carbon dioxide out of the atmosphere.

Ever since the double-helix structure of DNA was revealed in the early 1950s, scientists have hypothesized about the possibility of artificially modifying DNA to change the functions of an organism. The first approved gene therapy trial occurred in 1990, when a four-year-old girl had her own white blood cells removed, augmented with the genes that produce an enzyme called adenosine deaminase (ADA), and then reinjected into her body to treat ADA deficiency, a genetic condition that hampers the immune systems ability to fight disease. The patients body began producing the ADA enzyme, but new white blood cells with the corrected gene were not produced, and she had to continue receiving injections.

Now, genetic engineering is more precise and available than ever before, thanks in large part to a new tool first used to modify eukaryotic cells (complex cells with a nucleus) in 2013: CRISPR-Cas9. The gene editing tool works by locating a targeted section of DNA and cutting out that section with the Cas9 enzyme. An optional third step involves replacing the deleted section of DNA with new genetic material. The technique can be used for a wide range of applications, from increasing the muscle mass of livestock, to producing resistant and fruitful crops, to treating diseases like cancer by removing a patients immune system cells, modifying them to better fight a disease, and reinjecting them into the patients body.

In late 2018, Chinese researchers led by He Jiankui announced that they had used CRISPR-Cas9 to genetically modify human embryos, which were then transferred to a womans uterus and resulted in the birth of twin girlsthe first gene-edited babies. The twins genomes were modified to make the girls more resistant to HIV, although the genetic alterations may have also resulted in unintended changes. The work was widely condemned by the scientific community as unethical and dangerous, revealing a need for stricter regulations for how these powerful new tools are used, particularly when it comes to changing the DNA of embryos and using those embryos to birth live children.

Spacecraft and telescopes have revealed a wealth of information about worlds beyond our own in the last decade. In 2015, the New Horizons probe made a close pass of Pluto, taking the first nearby observations of the dwarf planet and its moons. The spacecraft revealed a surprisingly dynamic and active world, with icy mountains reaching up to nearly 20,000 feet and shifting plains that are no more than 10 million years oldmeaning the geology is constantly changing. The fact that Plutowhich is an average of 3.7 billion miles from the sun, about 40 times the distance of Earthis so geologically active suggests that even cold, distant worlds could get enough energy to heat their interiors, possibly harboring subsurface liquid water or even life.

A bit closer to home, the Cassini spacecraft orbited Saturn for 13 years, ending its mission in September 2017 when NASA intentionally plunged the spacecraft into the atmosphere of Saturn so it would burn up rather than continue orbiting the planet once it had exhausted its fuel. During its mission, Cassini discovered the processes that feed Saturns rings, observed a global storm encircle the gas giant, mapped the large moon Titan and found some of the ingredients for life in the plumes of icy material erupting from the watery moon Enceladus. In 2016, a year before the end of the Cassini mission, the Juno spacecraft arrived at Jupiter, where it has been measuring the magnetic field and atmospheric dynamics of the largest planet in the solar system to help scientists understand how Jupiterand everything else around the sunoriginally formed.

In 2012, the Curiosity rover landed on Mars, where it has made several significant discoveries, including new evidence of past water on the red planet, the presence of organic molecules that could be related to life, and mysterious seasonal cycles of methane and oxygen that hint at a dynamic world beneath the surface. In 2018, the European Space Agency announced that ground-penetrating radar data from the Mars Express spacecraft provided strong evidence that a liquid reservoir of water exists underground near the Martian south pole.

Meanwhile, two space telescopes, Kepler and TESS, have discovered thousands of planets orbiting other stars. Kepler launched in 2009 and ended its mission in 2018, revealing mysterious and distant planets by measuring the decrease in light when they pass in front of their stars. These planets include hot Jupiters, which orbit close to their stars in just days or hours; mini Neptunes, which are between the size of Earth and Neptune and may be gas, liquid, solid or some combination; and super Earths, which are large rocky planets that astronomers hope to study for signs of life. TESS, which launched in 2018, continues the search as Keplers successor. The space telescope has already discovered hundreds of worlds, and it could find 10,000 or even 20,000 before the end of the mission.

The decade began with a revolution in paleontology as scientists got their first look at the true colors of dinosaurs. First, in January 2010, an analysis of melanosomesorganelles that contain pigmentsin the fossilized feathers of Sinosauropteryx, a dinosaur that lived in China some 120 to 125 million years ago, revealed that the prehistoric creature had reddish-brown tones and stripes along its tail. Shortly after, a full-body reconstruction revealed the colors of a small feathered dinosaur that lived some 160 million years ago, Anchiornis, which had black and white feathers on its body and a striking plume of red feathers on its head.

The study of fossilized pigments has continued to expose new information about prehistoric life, hinting at potential animal survival strategies by showing evidence of countershading and camouflage. In 2017, a remarkably well-preserved armored dinosaur which lived about 110 million years ago, Borealopelta, was found to have reddish-brown tones to help blend into the environment. This new ability to identify and study the colors of dinosaurs will continue to play an important role in paleontological research as scientists study the evolution of past life.

In November 2018, measurement scientists around the world voted to officially changed the definition of a kilogram, the fundamental unit of mass. Rather than basing the kilogram off of an objecta platinum-iridium alloy cylinder about the size of a golf ballthe new definition uses a constant of nature to set the unit of mass. The change replaced the last physical artifact used to define a unit of measure. (The meter bar was replaced in 1960 by a specific number of wavelengths of radiation from krypton, for example, and later updated to define a meter according to the distance light travels in a tiny fraction of a second.)

By using a sophisticated weighing machine known as a Kibble balance, scientists were able to precisely measure a kilogram according to the electromagnetic force required to hold it up. This electric measurement could then be expressed in terms of Plancks constant, a number originally used by Max Planck to calculate bundles of energy coming from stars.

The kilogram was not the only unit of measure that was recently redefined. The changes to the International System of Units, which officially went into effect in May 2019, also changed the definition for the ampere, the standard unit of electric current; the kelvin unit of temperature; and the mole, a unit of amount of substance used in chemistry. The changes to the kilogram and other units will allow more precise measurements for small amounts of material, such as pharmaceuticals, as well as give scientists around the world access to the fundamental units, rather than defining them according to objects that must be replicated and calibrated by a small number of labs.

In 2010, scientists gained a new tool to study the ancient past and the people who inhabited it. Researchers used a hair preserved in permafrost to sequence the genome of a man who lived some 4,000 years ago in what is now Greenland, revealing the physical traits and even the blood type of a member of one of the first cultures to settle in that part of the world. The first nearly complete reconstruction of a genome from ancient DNA opened the door for anthropologists and geneticists to learn more about the cultures of the distant past than ever before.

Extracting ancient DNA is a major challenge. Even if genetic material such as hair or skin is preserved, it is often contaminated with the DNA of microbes from the environment, so sophisticated sequencing techniques must be used to isolate the ancient humans DNA. More recently, scientists have used the petrous bone of the skull, a highly dense bone near the ear, to extract ancient DNA.

Thousands of ancient human genomes have been sequenced since the first success in 2010, revealing new details about the rise and fall of lost civilizations and the migrations of people around the globe. Studying ancient genomes has identified multiple waves of migration back and forth across the frozen Bering land bridge between Siberia and Alaska between 5,000 and 15,000 years ago. Recently, the genome of a young girl in modern Denmark was sequenced from a 5,700-year-old piece of birch tar used as chewing gum, which also contained her mouth microbes and bits of food from one of her last meals.

This decade included the worst outbreak of Ebola virus diseases in history. The epidemic is believed to have begun with a single case of an 18-month-old-boy in Guinea infected by bats in December 2013. The disease quickly spread to neighboring countries, reaching the capitals of Liberia and Sierra Leone by July 2014, providing an unprecedented opportunity for the transmission of the disease to a large number of people. Ebola virus compromises the immune system and can cause massive hemorrhaging and multiple organ failure. Two and a half years after the initial case, more than 28,600 people had been infected, resulting in at least 11,325 deaths, according to the CDC.

The epidemic prompted health officials to redouble their efforts to find an effective vaccine to fight Ebola. A vaccine known as Ervebo, made by the pharmaceutical company Merck, was tested in a clinical trial in Guinea performed toward the end of the outbreak in 2016 that proved the vaccine effective. Another Ebola outbreak was declared in the Democratic Republic of the Congo in August 2018, and the ongoing epidemic has spread to become the deadliest since the West Africa outbreak, with 3,366 reported cases and 2,227 deaths as of December 2019. Ervebo has been used in the DRC to fight the outbreak on an expanded access or compassionate use basis. In November 2019, Ervebo was approved by the European Medicines Agency (EMA), and a month later it was approved in the U.S. by the FDA.

In addition to a preventative vaccine, researchers have been seeking a cure for Ebola in patients who have already been infected by the disease. Two treatments, which involve a one-time delivery of antibodies to prevent Ebola from infecting a patients cells, have recently shown promise in a clinical trial in the DRC. With a combination of vaccines and therapeutic treatments, healthcare officials hope to one day eradicate the viral infection for good.

Over the past several decades, physicists have worked tirelessly to model the workings of the universe, developing what is known as the Standard Model. This model describes four basic interactions of matter, known as the fundamental forces. Two are familiar in everyday life: the gravitational force and the electromagnetic force. The other two, however, only exert their influence inside the nuclei of atoms: the strong nuclear force and the weak nuclear force.

Part of the Standard Model says that there is a universal quantum field that interacts with particles, giving them their masses. In the 1960s, theoretical physicists including Franois Englert and Peter Higgs described this field and its role in the Standard Model. It became known as the Higgs field, and according to the laws of quantum mechanics, all such fundamental fields should have an associated particle, which came to be known as the Higgs boson.

Decades later, in 2012, two teams using the Large Hadron Collider at CERN to conduct particle collisions reported the detection of a particle with the predicted mass of the Higgs boson, providing substantial evidence for the existence of the Higgs field and Higgs boson. In 2013, the Nobel Prize in Physics was awarded to Englert and Higgs for the theoretical discovery of a mechanism that contributes to our understanding of the origin of mass of subatomic particles, and which recently was confirmed through the discovery of the predicted fundamental particle. As physicists continue to refine the Standard Model, the function and discovery of the Higgs boson will remain a fundamental part of how all matter gets its mass, and therefore, how any matter exists at all.

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The Top Ten Scientific Discoveries of the Decade - Smithsonian

Recommendation and review posted by Bethany Smith

For all the flak the pharmaceutical industry has taken for its exorbitant pricing practices, there's no getting around the fact that it's been a pretty stunning decade for medical progress.

Multiple new categories of medicines have moved from dreams and lab benches into the market and peoples lives, and investors who came along for the ride often reaped extraordinary profits. The Nasdaq Biotech Index is up 360% over the last 10 years to the S&P 500's 190%. And thats without mentioning the hundreds of billions of dollars in takeovers that rewarded shareholders with windfalls.

As 2020 approaches, it's worth highlighting how far we've come in the past 10 years in developing new therapies and approaches to treating disease, even as politicians grapple with how to rein in health-care costs without breaking an ecosystem that incentivizes the search for new discoveries. Here are some of the decades biggest medical breakthroughs:

Cell therapies: First approved in the U.S. two years ago, these treatments still sound like science fiction. Drugmakers harvest immune cells from patients, engineer them to hunt tumors, grow them by the millions into a living drug, and reinfuse them. Yescarta from Gilead Siences Inc. and Novartis AGs Kymriah the two treatments approved so far can put patients with deadly blood cancers into remission in some cases. At the beginning of the decade, academics were just beginning early patient tests.

Its still early days for the technology, and some issues are holding these drugs back. There are significant side effects, and the bespoke manufacturing process is expensive and time-consuming. That has contributed to a bruising price tag: Both of the approved medicines cost over $350,000 for a single treatment. And for now, cell therapy is mostly limited to very sick patients who have exhausted all other alternatives.

Luckily, more options are on their way. Some drugmakers are focused on different types of blood cancers. Others hope to mitigate side effects or create treatments that can be grown from donor cells to reduce expenses and speed up treatment. In the longer run, companies are targeting trickier solid tumors. Scientists wouldn't be looking so far into the future without this decades extraordinary progress.

Gene therapies: Researchers have spent years trying to figure out how to replace faulty DNA to cure genetic diseases, potentially with as little as one treatment. Scientific slip-ups and safety issues derailed a wave of initial excitement about these therapies starting in the 1990s; the first two such treatments to be approved in Europe turned out to be commercial flops.

This decade, the technology has come of age. Luxturna, a treatment developed by Spark Therapeutics Inc. for a rare eye disease, became the first gene therapy to get U.S. approval in late 2017. Then in May came the approval of Novartis AGs Zolgensma for a deadly muscle-wasting disease. The drugs have the potential to stave off blindness and death or significant disability with a single dose, and, unsurprisingly, Big Pharma has given them a substantial financial endorsement. Roche Holding AG paid $4.7 billion to acquire Spark this year, while Novartis spent $8.7 billion in 2018 to buy Zolgensma developer Avexis Inc.

Dozens of additional therapies are in development for a variety of other conditions and should hit the market in the next few years. They offer the tantalizing potential not just to cure diseases, but to replace years of wildly expensive alternative treatment. If drugmakers can resist the temptation to squeeze out every ounce of value by doing things like charging $2.1 million for Zolgensma, theres potential for these treatments to save both lives and money.

RNA revolution: The above treatments modify DNA; this group uses the bodys messaging system to turn a patients cells into a drug factory or interrupt a harmful process. Two scientists won a Nobel Prize in 2006 for discoveries related to RNA interference (RNAi), one approach to making this type of drug, showing its potential to treat difficult diseases. That prompted an enormous amount of hype and investment, but a series of clinical failures and safety issues led large drugmakers to give up on the approach. Sticking with it into this decade paid off.

Alnylam Inc. has been working since 2002 to figure out the thorny problems plaguing this class of treatments. It brought two RNAi drugs for rare diseases to the market in the past two years and has more on the way. The technology is also moving from small markets to larger ones: Novartis just paid $9.7 billion to acquire Medicines Co. for its Alnylam-developed drug that can substantially lower cholesterol with two annual treatments.

Ionis Pharmaceuticals Inc. and Biogen Inc. collaborated on Spinraza, a so-called antisense drug that became the first effective treatment for a deadly rare disease. It was approved in late 2016 and had one of the most impressive drug launches of the decade. And Moderna Therapeutics rode a wave of promising messenger RNA-based medicines to the most lucrative biotechnology IPO of all time in 2018. From pharma abandonment to multiple approvals and blockbuster sales potential in under 10 years. Not bad!

Cancer immunotherapy: Scientists had been working on ways to unleash the human immune system on cancers well before the 2010s without much luck. Checkpoint inhibitors drugs that release the brakes on the body's defense mechanisms have since produced outstanding results in a variety of cancers and are the decades most lucrative turnaround story.

Merck got a hold of Keytruda via its 2009 acquisition of Schering-Plough, but it was far from the focus of that deal. Once Bristol-Myers Squibb & Co. produced promising results for its similar drug, Opdivo, Merck started a smart development plan that has turned Keytruda into the worlds most valuable cancer medicine. Its now available to treat more than 10 types of the disease, and has five direct competitors in the U.S. alone. Analysts expect the category to exceed $25 billion in sales next year.

If anything, the drugs may have been too successful. Copycat efforts are pulling money that could fund more innovative research. There are thousands of trials underway attempting to extend the reach of these medicines by combining them with other drugs. Some are based more on wishful thinking than firm scientific footing. Still, the ability to shrink some previously intractable tumors is a considerable advance. If drugmakers finally figure out the right combinations and competition creates pricing pressure that boosts access, these medicines will do even more in the years to come.

Conquering hepatitis C: From a combined economic and public-health standpoint, a new group of highly effective hepatitis C medicines may outstrip just about anything else on this list so far. Cure rates for earlier treatments werent especially high; they took some time to work and had nasty side effects. The approval of Gileads Sovaldi in 2013, followed in time by successor drugs such as AbbVie Inc.s Mavyret, have made hepatitis C pretty easily curable in a matter of weeks. For Gilead, getting to market rapidly with its drug proved enormously profitable; it raked in over $40 billion in revenue in just three years.

Hepatitis C causes liver damage over time that can lead to transplants or cancer. The existence of a rapid cure is a significant long-term boon even if the initial pricing on the drugs made them, in some cases, prohibitively expensive. Sovaldi notoriously cost $1,000 per pill at launch and over $80,000 for a course of treatment. The good new is, treatments have become a lot more affordable, which should allow this class of drugs to have a broad and lasting positive health impact.

Hepatitis C is one of the relatively few markets where the drug-pricing system has worked well. As competing medicines hit the market, the effective cost of these treatments plummeted. That, in turn, made the drugs more accessible to state Medicaid programs and prison systems, which operate on tight budgets and care for populations with higher rates of hepatitis C infection. Louisiana has pioneered the use of a Netflix model, under which the state paid an upfront fee for unlimited access to the drug. Its an arrangement that will help cure thousands of patients, and other states are likely to follow its lead.

Many of the medicines highlighted in this column have list prices in the six figures, a trend thats helped drive up Americas drug spending by more than $100 billion since 2009. Building on this decades medical advances is going to lead to even more effective medicines that will likely come with steeper prices. Id like to hope that policymakers will come up with a solution that better balances the need to reward innovation with the need to keep medicines accessible. That would really be a breakthrough.

Max Nisen at mnisen@bloomberg.net

@2019Bloomberg

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Gene therapy to conquering hepatitis C: A decade of medical breakthroughs - Business Standard

Recommendation and review posted by Bethany Smith

NEW YORK, Dec. 31, 2019 /PRNewswire/ --

Global Heart Transplantation Therapeutics Market: About this market This heart transplantation therapeutics market analysis considers sales from immunosuppressants and supplementary medications products. Our study also finds the sales of heart transplantation therapeutics in Asia, Europe, North America, and ROW. In 2019, the immunosuppressants segment had a significant market share, and this trend is expected to continue over the forecast period. Factors such as mechanism of actions (MoA) of these drugs to treat and prevent organ rejection will play a significant role in the immunosuppressants segment to maintain its market position. Also, our global heart transplantation therapeutics market report looks at factors such as rising prevalence of cardiovascular diseases and heart failures, availability of drugs in multiple dosage forms, and high dependency of immunosuppressants for heart transplantation. However, adverse effects of immunosuppressants, demand-supply imbalance for organ transplantation, and long-term complications associated with heart transplantation may hamper the growth of the heart transplantation therapeutics industry over the forecast period.

Read the full report: https://www.reportlinker.com/p05835627/?utm_source=PRN

Global Heart Transplantation Therapeutics Market: Overview High dependency on immunosuppressants for heart transplantation Various advances in surgical techniques, especially organ transplants and the prevalence of severe coronary artery disease and dilated cardiomyopathy are leading to an increase in the need for heart transplantation surgeries. However, heart transplantation can lead to several types of heart transplant rejection such as acute cellular rejection, acute antibody rejection, and coronary artery vasculopathy chronic rejection. This is driving the need for heart transplantation therapeutics to prevent transplant rejection. Immunosuppressants are used to prevsent transplant rejection caused by immune system. Thus, the high dependency on immunosuppressants for heart transplantation will lead to the expansion of the global heart transplantation therapeutics market at a CAGR of almost 3% during the forecast period. Advent of techniques for organ transplantation The number of heart transplantation procedures is substantially high, especially in developed countries, due to the high prevalence of risk factors for heart impairment. Currently, the market is witnessing rapid development in the field of regenerative therapies, such as cell therapy, gene therapy, and tissue engineering, which also involve the development of heart and/or other organs. The introduction of novel approaches for heart regeneration and transplantation is one of the key heart transplantation therapeutics market trends. Organ printing is a modern technology, which is a layer-by-layer additive robotic bio-fabrication of 3D functional living macro tissues and organ constructs using tissue spheroids as building blocks. This development is expected to have a positive impact on the overall market growth.

Competitive Landscape With the presence of several major players, the global heart transplantation therapeutics market is fragmented. This robust vendor analysis is designed to help clients improve their market position, and in line with this, this report provides a detailed analysis of several leading heart transplantation therapeutics manufacturers, that include AbbVie Inc., Astellas Pharma Inc., Cadila Healthcare Ltd., F. Hoffmann-La Roche Ltd., Mylan NV, Novartis AG, Pfizer Inc., Sun Pharmaceutical Industries Ltd., Teva Pharmaceutical Industries Ltd., and Veloxis Pharmaceuticals A/S. Also, the heart transplantation therapeutics market analysis report includes information on upcoming trends and challenges that will influence market growth. This is to help companies strategize and leverage on all forthcoming growth opportunities.

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The global heart transplantation therapeutics market at a CAGR of almost 3% during the forecast period - PRNewswire

Recommendation and review posted by Bethany Smith

As Newtons famous quote, standing on the shoulders of giants, this year, science has made considerable advances, building on many feats achieved in the past years. New discoveries, insights and inventions in the areas of astronomy, biology, medicine, paleontology and physics marked the year. Here is a selected pick of ten such breakthroughs in science witnessed in 2019.

1. Detailing the Denisovans

An early sketch of a Denisovan teen [Image Credits: Maayen Harel]

This year revealed some fantastic facts about our ancient ancestors, the Denisovans, who lived about 100,000 years ago. So far, we knew about them through scrap fossils from the Denisova Cave in Siberia, Russia. This year, researchers found a fossilised jawbone in the Tibetian plateau, which on DNA analysis showed that it belonged to the Denisovans, who were the regions first hominin inhabitants. It was also believed earlier that Denisovans were closely related to Neanderthals than to present-day humans. On the contrary, genomic analysis of the fossils from the Denisova Cave showed that they were closer to humans than to Neanderthals. But, how did our ancestors look like? Based on patterns of chemical changes in their DNA, researchers have reconstructed the anatomy of Denisovans. The findings reveal that some traits, like a sloping forehead, long face and large pelvis resemble Neanderthals, while others, like a large dental arch and very wide skull, are unique. Based on these findings, they even reconstructed the face of a teenage Denisovan girl.

2. An elusive cure to Ebola

Electron micrograph of an Ebola virus virion [Image Credits: CDC/Cynthia Goldsmith]

Ebola, a deadly viral disease that shook the African continent, affects humans and other primates and a cure for this disease has eluded science so far. Although an experimental vaccine is being developed, without a therapeutic cure, those infected are doomed to die. This year, two drugs that were tested during an outbreak in the Democratic Republic of the Congo may have hopes as they dramatically increased patients chances of survival. The two drugs, named REGN-EB3 and mAb-114, contain a cocktail of antibodies that are injected into the bloodstream of those infected. These drugs have shown a success rate of about 90% , bringing hopes to those battered by the disease.

3. The first image of a blackhole

The first captured image of a black hole [Image Credit: Event Horizon Telescope Collaboration]

Black holes, the most dense objects of our Universe, have been awe-inspiring for a century. However, we did not even know how they lookedbut all that changed this year. Scientists used a combination of telescope observations around the globe to reveal the first ever photograph of a supermassive black hole present at the heart of the distant galaxy Messier 87 in the Virgo constellation. The image, which captures the shadow of the black hole, shows a black hole that is 55 million light-years from Earth and has a mass of 6.5 billion times that of the Sun. Researchers believe that this epic photograph opens a new window into the study of black holes, their event horizons, and gravity.

4. Conquering Quantum Computing

Photograph of the Sycamore processor. [Image Credits: Erik Lucero, Research Scientist and Lead Production Quantum Hardware, Google]

Although physicists have been working on realising the concept of quantum computing for over three decades, it wasnt until this year that there was something tangible. Physicists and Engineers at Google claim to have developed the first functional quantum computer that can perform a set of computations in 200 seconds, which would have otherwise taken the worlds fastest supercomputer 10,000 years! This quantum computer has a 54-qubit processor, named Sycamore, which is comprised of quantum logic gates.

5. Beating malnutrition in the gut

Escherichia coli, a common bacteria found in the human gut [Image Credits: Photo by Eric Erbe, digital colorization by Christopher Pooley, both of USDA, ARS, EMU]

While it was long known that microbes in our gut played a vital role in our health and well-being, two studies published during the year showed how they could be used to address malnutritiona condition that affects millions of children around the world. The researchers analysed the types of microbes present in the gut of healthy and malnourished children and focused on boosting crucial gut microbes in the children using affordable, culturally acceptable foods.

6. Pushing the limits of gene editing

The DNA Double Helix [Image Credits: Image by Arek Socha from Pixabay]

After tasting success and controversies last year for genetically editing babies, researchers in China this year reported to have cloned five genetically edited macaques for research purposes for the first time. These monkeys have reduced sleep, increased movements in the night, increased anxiety and depression, and schizophrenia-like behaviors. Although it raises ethical questions, the researchers believe that cloned monkeys could replace the wild monkeys used in laboratories today. In the UK, scientists used gene therapy to arrest a form of age-related blindness and in the US, CRISPR, the gene editing software, was used to treat cancer.

7. The rampant loss of worlds ice

Meltwater on the ice shelf next to McMurdo Station, Antarctica.[Image Credit: Nicholas Bayou, UNAVCO]

With the rising global temperature, ice on the Earths surface is melting at a rapid rate. In Greenland, the ice sheets are melting seven times faster than they did in the 90s. Greenland has lost 3.8 trillion tonnes of ice since 1992, a quantity - enough to push global sea levels up by 10.6 millimetres. In Antartica, studies have detected significant changes in the thickness of the floating ice shelves, which hold the land-based ice in place. As a result, there could be more ice moving from the land into the sea. Similar loss of ice has been reported in the Alps and the Himalayas. The rising sea levels are estimated to displace 300 million people all over the world, affecting coastal cities and their livelihoods.

8. Taking a closer look at the Moon

The far side of the moon that is invisible to Earth [ Image Credits: NASA Apollo 16 photograph AS16-3021]

This year, China's National Space Administration (CNSA) achieved the first soft landing on the far side of the Moon with its Chang'e 4 mission. This mission will attempt to determine the age and composition of an unexplored region of the Moon. India also launched its second lunar mission, Chandrayaan 2, to map and study the variations in the lunar surface composition, and the location and abundance of water. The mission consisted of an orbiter, the Vikram lunar lander and the Pragyan rover. However, Vikram crashed during landing, in its attempt to land closer to the lunar south pole.

9. Biodiversity on the brink of extinction

A frog from the Western Ghats

This year, an extensive report from the United Nations Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES) found that of the estimated 8 million species of animals and plants on the planet, about a million face the threat of extinction, many within decades. About 40% of amphibians, a third of marine life and about 10% of the insects are at the brink of extinction. The report mentions that changes in land and sea use, exploitation of organisms; climate change, pollution and invasive alien species as primary reasons behind this situation.

10. Chronicling the final moments of dinosaurs

Image by enriquelopezgarre from Pixabay

It is well known that the dinosaurs, giant reptiles that once ruled the planet, went extinct about 66 million years ago when an asteroid crashed into Earth at the Chicxulub crater in Mexico. This year, scientists detailed fallouts of the impact that resulted in a mass extinction by examining the topography of the centre of the crater. When the asteroid struck, the melt rocks and breccia deposited at the bottom of the crater within minutes and over a few hours, another 90 metres were deposited. There was also a tsunami and a wildfire that followed the impact, which emitted sulphur aerosols that cooled the earth and blocked much of the sunlight.

See more here:
The Best of Science in 2019 - Research Matters

Recommendation and review posted by Bethany Smith

Gene Therapy market analysis report speaks about the manufacturing process. The process is analysed thoroughly with four points Manufacturers, regional analysis, Segment by Type & Applications and the actual process of whole Gene Therapy industry.

A complete analysis of the competitive landscape of the Gene Therapy Market is provided in the report. This section includes company profiles of market key players. The profiles include contact information, gross, capacity, product details of each firm, price, and cost of Gene Therapy Industry are covered.

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Gene Therapy Market Description: Gene therapy is an experimental treatment that involves introducing genetic material into a persons cells to fight or prevent disease. Researchers are studying gene therapy for a number of diseases, such as severe combined immuno-deficiencies, hemophilia, Parkinsons disease, cancer and even HIV, through a number of different approaches. A gene can be delivered to a cell using a carrier known as a vector. The most common types of vectors used in gene therapy are viruses. The viruses used in gene therapy are altered to make them safe, although some risks still exist with gene therapy. The technology is still in its infancy

Gene Therapy Market Segment by Manufacturers, this report covers

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Scope of the Report:

Today, Gene Therapy is used for Cancer Diseases, Hematological Disease and Hereditary Disease. Cancer Diseases is the largest application of Gene Therapy and its market share exceed 78% in 2018.The global Gene Therapy market is valued at xx million USD in 2018 and is expected to reach xx million USD by the end of 2024, growing at a CAGR of xx% between 2019 and 2024.The Asia-Pacific will occupy for more market share in following years, especially in China, also fast growing India and Southeast Asia regions.North America, especially The United States, will still play an important role which cannot be ignored. Any changes from United States might affect the development trend of Gene Therapy.Europe also play important roles in global market, with market size of xx million USD in 2019 and will be xx million USD in 2024, with a CAGR of xx%.This report studies the Gene Therapy market status and outlook of Global and major regions, from angles of players, countries, product types and end industries; this report analyzes the top players in global market, and splits the Gene Therapy market by product type and applications/end industries.

Gene Therapy Market Segment by Regions, regional analysis covers

Gene Therapy Market report provides application, type impact on market. Also research report covers the present scenario of Gene Therapy Market Consumption forecast, by regional market, type and application, with sales and revenue, from 2019 to 2024.

Gene Therapy Market Segment by Type, covers

Gene Therapy Market Segment by Applications, can be divided into

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Gene Therapy Market 2020 Business Revenue, Future Growth, Trends Plans, Top Key Players, Business Opportunities, Industry Share, Global Size Analysis...

Recommendation and review posted by Bethany Smith

The JB Angus annual production sale will be at Stockmen's Livestock, Dickinson, at 1 p.m. MST Wednesday, Jan. 29. Bobby and Erika Kubas will be selling 30 select yearlings and two-year-old bulls.

JB Angus is a family owned and operated ranch located near Belfield. It is operated by Bobby and Erika Kubas along with their four children, Conner, Jaden, Matthew, and Kasey.

The Kubas family has been farming and ranching in the area for five generations. In 2013, Bobby and Erika Kubas took over Tuhy Angus and established JB Angus. Their primary focus is raising seed stock for commercial cattlemen. The registered cows receive no special treatment and must maintain their place in the herd, making them structurally sound and acclimated to hard winters. Good maternal genetics are essential, and a lot of selection pressure is placed on the bulls. Cattle must have structural correctness, a calm disposition, and "real world genetics," such as promoting a live calf at birth, producing a calf that gains well on grass and milk, and one that will become a top replacement female. Profitability is a huge factor in a successful operation and our genetic selection, as well as 40 years of genetic selection from Tuhy Angus will provide producers the genetics they need to maximize their investment.

"The foundation of our herd is our well-rounded mother cows. These females have been selected over many years for a moderate frame, calving ease, calm disposition, and a quality udder. We make our cows work for us; they must calve on their own and raise a calf on the North Dakota prairie without any creep feed. If they cannot raise a nice calf, they are down the road. One of the most prominent traits we emphasize in our cow herd is docility. Calm cattle are easier and safer to handle, especially when children or outside help is on the farm. We strive to handle our cattle in a way that will provide a docile disposition not only in our herd but in all of our customer's herds," explained Bobby.

JB Angus females are backed by some of the best sires in the breed. Many of their pedigrees include sires such as Sitz Upward 307R, SAV Traveler 004, Kesslers Frontman R001, Connealy Final Product, GDAR Game Day 449, HA Image Maker 0415, and Mytty IN Focus.

"In our business, we try to focus especially hard on customer service; 100% satisfied customers after every breeding season is our main goal. If a problem arises before, during, or after our sale, we will do whatever we can to make sure that the customer has had a positive experience with JB Angus," said Bobby.

JB Angus looks forward to establishing long-lasting relationships with their customers, one that will last long after the stock trailer gate closes. For more information, visit their website at http://www.jbangus.com or call 701-590-9814.

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JB Angus To Hold Annual Production Sale Jan. 29 - The Roundup

Recommendation and review posted by Bethany Smith

To grow hemp, or not to grow hemp? That is the question. The Texas Hemp Growers Association sponsored a seminar at the recent Amarillo Farm Show where experts gave producers enough information to try to help them determine the answer to this question.

Dion Oaks, co-owner of Wright-Oaks LLC near Del Norte, Colorado, started growing hemp on his operation six years ago. He shared how his farm handles and crop and challenges and benefits they have seen from it. (Journal photo by Lacey Newlin.)

Dion Oaks, co-owner of Wright-Oaks LLC near Del Norte, Colorado, started growing hemp on his operation six years ago. They began with a few hundred plants, growing them indoors. The next year they went to 30 acres, then 300 acres, then 600 acres and this year they planted 2,500 acres. Oaks says they grow industrial hemp for cannabidiol or CBD, grain and fiber. Other than hemp, they grow potatoes, wheat, alfalfa and barley.

We swath everything and take off the top of the industrial hemp, if were going for strictly grain, he said.

Oaks says his operation is getting more into no-till with their hemp. He says the main reason he decided to go into growing hemp was for water savings, but hemp also provides soil health benefits for the other crops they produce. For instance, with the potato and corn crops, nematodes are often a challenge, but hemp alleviates a lot of this pest problem.

Oaks says in the last four to five months the CBD market has dropped dramatically for multiple reasons. He says it has declined 70 to 80% since April.

However, the hemp industry is ever changing and new developments will improve the success of the crop. Hemp crop insurance will be available next season, but the Farm Service Agency wants to learn more about it so administrators can create programs to help farmers. It is also important to remember crop insurance will not cover a crop with high Tetrahydrocannabinol, or THC. Additionally, Oaks says the American Bankers Association recently sent out a notice to all Federal Deposit Insurance Corp. banks telling them to start treating hemp as a regular agricultural crop.

What is this cannabis stuff everyone is talking about?

There are two different types of hemp. CBD hemp, which is in the pharmaceutical products sold on just about every corner these days, and then there is industrial hemp, used for paper, textiles, fuel and biodegradable plastics.

CBD oil is made from the flower and the trichomes, Oaks said. Hemp can be very brittle and difficult to harvest while keeping the combs intact.

Corbett Hefner, vice-president of research and development for Formations Ag, spoke about harvesting hemp and the importance of drying the crop properly. (Journal photo by Lacey Newlin.)

Corbett Hefner, vice president of research and development for Formations Ag, says keeping the trichomes unharmed is one of the drivers for the designs of the equipment his company develops. He says in some cases producers can lose between 50 and 90% of their crop at harvest due to equipment that destroys the trichomes.

If you intend to grow for CBD, buying the proper equipment is key to success with this crop. There are multiple ways to harvest, including combines, whole plant harvesters and balers.

For industrial hemp, the grain is the seed that is produced inside the flower material after it has been pollinated.

With industrial hemp, you are looking at the grain, fiber and flower and it could possibly be a dual or tri-crop, Oaks explained.

The fiber and hurd, or the inner woody cored of hemp, is a secondary part of the industry and the market needs more time to develop. Once hurd is mixed with lime and water it becomes fire resistant and great for insulation. It can also be used in bedding, plastics, biochar and loss circulation material.

The woody material of hemp is very versatile as far as temperature, durability and ability to maintain strength under harsh environmental conditions, said Calvin Trostle, professor and Extension specialist at Texas A&M University. Thats one reason why its valuable for so many products.

With hemp recently becoming legal in Texas, Calvin Trostle, professor and Extension specialist at Texas A&M University, is beginning to learn how hemp grows in Texas and how he can best advice Texas farmers about this crop. (Journal photo by Lacey Newlin.)

Trostle said he has heard a lot of people comparing the hemp craze to the emu market in the 1990s, however he says there is a key difference between them.

My assertion is that hemp, CBD or other cannabinoids, grain and fiber each have inherent value in a way that emu meat and oil never achieved.

One myth Trostle says is a common misconception is hemps water usage. He said he keeps hearing that hemp uses one half the amount of water that cotton uses, but in reality he believes it will require more moisture. Another comparison he had been given from a hemp producer is that hemp could be grown on about 40% less water than corn.

If youre growing for CBD or you have such a high investment in that crop, I do not foresee any dryland production in the Texas High Plains, Trostle said. In fact, I think the combination of rainfall during the cropping season and acclimated soil moisture need to be at least 15 inches if you are going to go without irrigation. The bottom line is you cannot start a crop into profitability, so prospective producers must take water requirements into account.

However, he believes hemp fiber production on dry land in West Texas might be a viable opportunity. Trostle also views hemp as a reasonable rotation crop. Most of the established producers he has talked to in the Texas High Plains see one to two years of possibility of CBD production, but their interest long-term is fiber.

The right seed at the right price is crucial

Where to buy seed is one of the biggest dilemmas in the hemp industry. Oaks says there are a lot of lawsuits right now relating to seed quality and seed type. The pricing is all over the place and can make a big difference when the plant is harvested and sold. Growers must decide what kind of hemp they want to grow and properly vet the seed source to protect their investment.

Genetics for a grain or fiber crop are totally different from a CBD crop, Oaks said. There are seed genetics that overlap between the two types of hemp, but for the most parts, if youre looking at CBD percent, fiber quality or seed yield per acres, there are a lot genetics to pay attention to and decide which avenue you want to take.

Similarly to watermelon, hemp has both male and female plants.

A strong majority of people assume you need a zero tolerance policy to any male plants in the field for CBD production, although they say for fiber it does not matter, said Trostle. The standard thinking is if you have males in the field, it makes pollen available so seeds develop and it will reduce CBD levels and that crop will produce less high quality material for CBD extraction.

Trostle says there is feminized seed available for purchase that will produce almost all female seeds.

Feminized seed can be $1 per seed, and imagine planting 1,500 of those per acre. Ever had any cotton or corn seed cost about $1,500 per acre? Of course not. That might be one of the first things to consider about hemp.

However, Oaks says his operation grows male and female plants together in the same field for CBD.

Were looking for anywhere from six to eight CBD percentageso were not going for super high grade, he said. That also cuts down the risk because high CBD genetics are on a really tight curve with the 0.3% THC that youre allowed legally. Having a higher CBD percent means a higher THC percentage.

Trostle says if the THC percentage is above that level, the crop will be treated like marijuana and will have to be disposed of.

The first thing to do with harvesting is start planning right now, Hefner said. You cannot believe the number of people who will call right before harvest and say Ive got 1,000 acres. What do I do with it?

Facilities that will take harvested hemp are limited in the states it is legal in, so always have a destination for the crop prior to planting. Trostle says let the buyers available to you determine the type and quality of hemp you decide to grow.

Its not a crop you can grow and just take to the elevator once harvested, Oaks added. You really have to decide what youre growing for and find a buyer. Be careful with buyers, question their intentions and always read the fine print.

Hefner says harvested hemp is quite bulky because it is light, so producers have to have a lot of space to store it. He says in some climates producers are able to field dry hemp, but there are risks such as excessive moisture after cutting, which could lead to a mold problem. Some growers air dry in facilities by hanging plants from cables. However, Hefner warns it takes roughly 44,000 cubic feet to hang dry an acre. He says hemp can be dried on the ground with air flown underneath it, but it takes about 18,000 cubic feet.

You have almost exactly two hours to get some kind of air under the crop before it will start to get hot, Hefner cautioned.

Trostle wants perspective growers to be realistic about yields.

Anything that we grow, we do not shoot for maximum yield, he said. There are very rare instances where that might be possible, but maximum yield is not maximum economic profitability. Input costs are just too high to produce maximum yield.

According to Trostle, one Colorado farmer says his costs are about $13,000 an acre. The United States Department of Agriculture reported an average farmer spends about $19,000 an acre. However, costs should come down with economies of scale.

Dont risk more than you can plow under, Oaks explained.

The take away is hemp can be a successful crop if farmers plan ahead, are cautious of who they do business with, go into it with reasonable expectations and do not bet the farm on incredible yields.

This is a chance for you to be an entrepreneur, create demand for a product and really help your bottom line, Hefner said. You can be as creative as you want and the opportunities here are endless. The advocates will tell you there is 25,000 uses for it and theres ways to make money in this thing whether its small scale or large scale.

Link:
The truth about hempgrowers have to weigh options - High Plains Journal

Recommendation and review posted by Bethany Smith

Credit...Christoph NiemannJanuary

1. In 2014, James D. Watson, who shared a 1962 Nobel Prize for describing the double-helix structure of DNA, became the first living Nobelist to sell his medal.James Watson Had a Chance to Salvage His Reputation on Race. He Made Things Worse.

2. Child abandonment was once routine; in ancient Rome, 20 percent to 40 percent of babies were left to die of exposure.Raising Kids Isnt Easy. Parenting Advice Often Makes It Harder.

3. Among the most notorious Malaysian royals was King Mahmood Iskandar of Johor, who was accused in the 1980s of fatally beating a golf caddy who had laughed at his putt. (He was immune from prosecution.)Malaysias King, an Unusual Monarch, Abruptly Leaves His Job

4. Everyone who works at Ben & Jerrys headquarters in Burlington, Vt., is entitled to three free pints of ice cream for each day of work.There Is a Free Lunch, After All. Its at the Office.

10. The National Hockey League player Andy Hebenton, who never missed a game during eight seasons with the New York Rangers, lost seven teeth on the ice in a two-week period in January 1961.Andy Hebenton, N.H.L. Ironman with 630 Consecutive Games, Dies at 89

11. The artist who now goes by the name Pope.L has belly-crawled the length of Manhattan, ingested entire issues of The Wall Street Journal, and created odoriferous installations from baloney and Pop-Tarts.MoMA, the New Edition: From Monumental to Experimental

12. Elizabethan preachers condemned coal as literally the Devils excrement.A Sensible Climate Change Solution, Borrowed From Sweden

13. The genome of the axolotl, sometimes called the Mexican walking fish, which can regenerate almost any body part, is 10 times as large as the human genome.Seeking Superpowers in the Axolotl Genome

14. The Electronic Numerical Integrator and Computer, or Eniac, was the first programmable digital computer in the United States. It weighed more than 30 tons and included 17,468 vacuum tubes.The Secret History of Women in Coding

15. The McRib sandwich was introduced in 1981 as a way to give McDonalds another unique menu item after the smash success of Chicken McNuggets resulted in a chicken shortage for the chain.My Lifelong Obsession With the McRib

16. The fashion designer Karl Lagerfeld had 300 iPods.The Last Designer

17. Tyrannosaurus rex strutted around on legs that were about 12 feet long, and weighed more than 10,000 pounds.Tiny Tyrannosaur Hints at How T. Rex Became King

18. Common animal-derived ingredients found in beauty products include squalene (shark liver oil), carmine (crushed-up beetles), allantoin (cow urine), ambergris (whale vomit) and placenta (sheep organs).Why You Should Care About Vegan Beauty

19. Harry Houdini left precise instructions with his wife and friends as to just how he would reach out, if it were possible, after his death.Inside the Secret Sting Operations to Expose Celebrity Psychics

20. King Kong Bundy, a professional wrestler who in his prime stood about 6 feet 4 inches tall and was said to weigh 450 pounds, was called a walking condominium by his fellow wrestler Gorilla Monsoon.King Kong Bundy, Gargantuan Professional Wrestler, Dies at 63

21. From 1977 to 2002, the number of Americans eating three or more snacks per day increased to 42 percent, from 11 percent.At Start-Ups, the Free Lunch Is Yours for the Making

22. Meghan Markle, the Duchess of Sussex, undertook a campaign as an 11-year-old lobbying Procter & Gamble to withdraw an advertisement, for dishwashing liquid, that she thought was sexist.Meghan Markle Moved the Dial for British Royal Family in Womens Day Talk

23. For every one million people in India, there are only 11 eye doctors, according to the International Council of Ophthalmology.India Fights Diabetic Blindness With Help From A.I.

24. Before its atomic red, extremely sweet bouquet came to dominate school cafeterias and birthday parties nationwide, Hawaiian Punch was sold as a cocktail mixer for adults and came in two flavors.How Big Tobacco Hooked Children on Sugary Drinks

25. The 20 warmest years on record have all come in the past 22 years.Pictures From Youth Climate Strikes Around the World

26. Since the Civil War, only four minor-party candidates for president have mustered at least 10 percent of the vote: Ross Perot, George Wallace, Robert La Follette and Theodore Roosevelt.For Clues to Howard Schultzs Leadership, Look Beyond Starbucks

27. In 1969, the sculptor Siah Armajani wrote a Fortran program to plot the dimensions of a tower large enough to cast a shadow over the entire state of North Dakota. (If constructed, the tower would have been 18 miles tall.)Fraught and Fabulous: Art That Shows a Passion for Democracy

28. In November 2016, after the election of President Trump, immigration officials in New Zealand received 17,000 registrations from Americans. New Zealand typically receives 3,000 expressions of interest from United States citizens each month.After New Zealand Attacks, More People Registered to Move There

34. NASA engineers, in the 1980s, once guessed that Sally Ride would need 100 tampons for a week in space.Toxic Men Get All the Attention. But Not in These Plays.

35. Penn Station is today the busiest transit hub in the Western Hemisphere, through which more than 600,000 commuters pass each day.When the Old Penn Station Was Demolished, New York Lost Its Faith

36. In 2018, injections of Botox the No. 1 aesthetic procedure since 1999, according to the American Society of Aesthetic Plastic Surgery were up 16.3 percent from the year before.Are You Ready for Drive-Thru Botox?

37. Nearly 10 horses a week, on average, died at American racetracks in 2018, a rate that is anywhere from two and a half to five times greater than in the rest of the racing world.At the Kentucky Derby, Prayers for a Safe Race

38. When Napoleon III of France declared war on Prussia in 1870, he dressed his soldiers to look like the army that his much more famous uncle, Napoleon Bonaparte, had led decades before.To Stand Out, the Army Picks a New Uniform With a World War II Look

54. Slightly more than two-thirds of cancer patients treated in the United States are cured.Cancer Treatment at the End of Life

55. Franz Kafka had instructed his close friend and literary executor Max Brod to burn his manuscripts, letters and papers after his death. Instead, Mr. Brod published many of the writers most monumental, if incomplete, works.A Yearslong Battle Over Kafkas Legacy Ends in Jerusalem

56. Until the 20th century, there was little fanfare around the Mona Lisa. Her theft in 1911, and a trip to the Met in New York and the National Gallery in Washington in 1962-3 made her a global media sensation.Want to See the Mona Lisa? Get in Line

57. The longest of the dashes roughly the length of the letter M the em dash is still largely undefined.The Em Dash Divides

58. Before 1920, when the 19th Amendment was ratified, 15 states, mainly in the West, already had full female suffrage, while others granted women partial voting rights.The Complex History of the Womens Suffrage Movement

59. In 1971, the average 19-year-old man weighed 159.7 pounds, according to the National Center for Health Statistics, and the average woman 131. Today, the average man weighs 14 pounds more, and the average woman 20 pounds more.Naked Came the Strangers

60. In the past, books were more often borrowed than bought, even among middle-class Victorians, who would pay to join for-profit circulating libraries so that they could rent books and get rid of them after reading.Recalling a Time When Books Could Give You Indigestion

61. As recently as the 1950s, doctors considered exercise dangerous for people over age 40; for heart disease, which was then killing a record number of Americans, they prescribed bed rest.How Many Steps Should You Take a Day?

62. The floor in a public restroom has around two million bacteria per square inch. A toilet seat, on the other hand, has an average of about 50 per square inch.Should You Take Your Shoes Off at Home?

63. More than 90 percent of the heat trapped by greenhouse gas emissions is being stored in the ocean.How Has Climate Change Affected Hurricane Dorian?

64. One in four cowboys during what is known as the Pioneer Era, which began following the Civil War in 1865 and ended around 1895, were black, according to historians.Restoring Black Cowboys to the Range

65. The advantage for STEM (science, technology, engineering and mathematics) majors fades steadily after their first jobs, and by age 40 the earnings for majors like social science or history have caught up.In the Salary Race, Engineers Sprint but English Majors Endure

71. The Office is Netflixs most-watched show. It clocked 45.8 billion viewing minutes last year, according to Nielsen.The Office Ladies Return to Dunder Mifflin

72. The data marketing company Epsilon Data Management claims on its website to have insights on virtually every U.S. consumer.Ad Giant Wins Over Disney With Big Data Pitch

73. The word Sioux refers to a coalition of seven allied and related nations, including the Lakotas, but the word itself is a French corruption of Nadouessioux, an Ojibwe word meaning snake or enemy.Lakota America Puts the Tribe of Sitting Bull and Crazy Horse Front and Center

74. In a survey published in October by a respected French polling firm, in The Journal du Dimanche, 61 percent of respondents said that Islam was incompatible with the values of French society, an increase of 8 percent over February.How ISIS Changed France

75. Kissing, according to one study, transfers up to one billion bacteria from one mouth to another, along with 0.2 micrograms of food bits.Your Body Is a Wonderland

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79 of Our Favorite Facts of 2019 - The New York Times

Recommendation and review posted by Bethany Smith

In 2004, when the year 2020 sounded futuristic, the Guardian predicted it would by now be very hard to talk about a typical family. Domestic units would be formed in myriad ways and children living with both their biological parents in the same household would be in the minority.

This hasnt quite panned out. In the UK today, 84% of babies are born to parents who are married, in a civil partnership or co-habiting, although the statistics dont reveal all the real-life complexities (many of the parents will be starting second families, for instance). In 2019, 61% of families with dependent children have married or civil-partnered parents (the children may not be biologically related to both). In the US, fewer than half of children are living with two biological parents who are in their first marriage.

We correctly predicted that, in heterosexual couples, an increasing number of women would be the breadwinner, but dont imagine these are all high-earning women easily carrying the financial burden; most are low-earners, and the figures include single mothers. And we said that financial pressures on young adults would lead to people staying at home for longer. There has been a 46.3% increase in the number of young adults living with their parents in the two decades to 2019.

But we overstated the attention we would be giving to the issue of how to care for an ageing population. By 2020, we predicted, we will be in the middle of the debate on the care deficit. The crisis is still there, and growing, but it is one of those issues that has been overshadowed, and exacerbated, by Brexit (there are 104,000 EU citizens working as carers in the UK). And we understated the extent to which we would invite technology into our family lives. Webcams might by 2020 be playing the role the telephone did in the 20th century, a vital communication link for families who might live hundreds of miles apart, we predicted in 2004. This wasnt wrong, but the quaint idea of webcams this was three years before Apple launched its iPhone, and everyone started uploading photographs of their children to a new site called Facebook doesnt quite describe the proliferation of tech in everyday life.

Its certainly true that the family has changed immensely over the past few decades, and those trends are continuing. The number of people living alone is increasing, as is the number of women choosing not to have children, and we are having fewer children than before, too. A key change in family structure since the 1980s has been the rise of childbearing within cohabitation, says Ann Berrington, professor of demography and social statistics at the University of Southampton. The proportion of births that take place in England and Wales outside marriage has doubled from around a quarter in 1988 to just under half today. Cohabiting families with and without children are the fastest-growing type of family in England and Wales. Evidence from qualitative research that we have undertaken suggests that while marriage is being rejected by a minority as an outdated, patriarchal institution, most people still view it in a positive light and as an ultimate goal. The number of same-sex couples has also risen, she says: An increase of 53%, from 152,000 in 2015 to 232,000 in 2018. It seems likely that this diversity in family life will continue to increase in the coming decade, along with complex families for example, stepfamilies resulting from repartnering.

There have been developments in reproductive technology alongside changing social attitudes. Certainly, since the turn of this century, the two have come together to create family types that just wouldnt have been possible before, says Susan Golombok, the director of the Centre for Family Research at Cambridge University, and author of the forthcoming book We Are Family. But, she adds: Its hard to tell whether they are going to explode into something or not. One thing that we are studying is a small but growing number of people who are meeting each other over the internet in order to have children together, without a romantic relationship. We dont know how that works out for them or for the children yet, but its certainly happening.

Over the past couple of decades, weve seen quite a rise in the number of single mothers by choice the single women who decide to go it alone and have children, through donor insemination but were now beginning to see single fathers by choice. Its a very small group, but they do exist. Some of them are gay men, so that, in a way, is more obvious, but there are also single heterosexual men having children through surrogacy and egg donation. Thats something that may grow.

There is also a rise in the number of transgender parents. Until very recently, transgender parents had children and then transitioned afterwards, but because of developments in assisted reproduction and people being able to preserve eggs and sperm, more transgender people are having children after their transition. She says this is likely to increase in the coming decades.

Advances in technology will create ever-bigger ethical debates. So-called designer babies are already a reality, with parents able to select embryos to screen out inherited diseases and conditions. But by 2050, prospective parents could pay to select not only for good health but for traits such as intelligence, attractiveness or athleticism the babies of rich parents could be genetically superior to those born to lower-income families.

Artificial eggs and sperm are on the horizon, says Golombok, which will not just be helpful for infertile heterosexual couples but will allow same-sex couples to both be the biological parents of their children, because that will mean men can produce eggs and sperm, and so can women. For single people who want to have children, it would even be possible for them to produce eggs and sperm.

Genetic testing will become more popular, and it will be harder for parents to keep secret from their children that they were conceived using donated eggs or sperm (although disclosure is widely considered to be a good thing). Ancestry websites will be used to discover genetic half-siblings. But genetics are not all-important to the concept of family. Family is no longer necessarily about biological relatedness that is something that has changed a lot, says Golombok.

We are already seeing uterus transplants, but by 2050, we may be relying on artificial wombs to grow our babies. They are being developed at the moment initially to help with very premature babies to replicate, as far as possible, the human uterus. But eventually its possible that artificial wombs will be used instead of pregnancy. That could free up women for whom pregnancy and its related physical and psychological toll, as well as the financial hit they take when taking time out from their careers is something to be endured, rather than enjoyed. I think first it will probably be used for women who dont have their own wombs the women who might, at the moment, turn to surrogacy, says Golombok. But actually, anybody could do this, so it could be quite liberating in some ways for women. Some women wouldnt like the idea at all. Also, I can see ways in which it could be used in a rather worrying way, almost like baby farms.

A growing number of women are freezing their eggs, and the age at which women have their first child is also rising. In 2050, will it be more normal for women in their 50s, or even 60s and beyond, to become mothers? It is technically possible, says Golombok. Whether many women would actually want to do that seems unlikely to me. But, generally, there will certainly be more women having babies in their 40s, unless there is a huge change in mindset. Experts have already called for children to be educated about natural fertility decline, which could mean future generations decide to have children earlier. But society isnt set up to support that, Golombok points out from the price of education to the lack of state support, and the cost of housing. The age at which women are having children is going up and up, and I cant really see an end to that.

Will we have men travelling abroad for work? What will happen to their skills as dads?

Brexit with prolonged trade negotiations and predicted economic decline will affect families in the coming decades. Economic insecurity is associated with an increased preference for cohabitation as opposed to marriage, says Berrington. Furthermore, economic hardship is related to increased risks of family breakdown.

Berrington points out that families have become more transnational, especially since women have made up an increasingly large proportion of migrants. In previous decades, migrants to the UK from South Asia often migrated for the purpose of family formation or reunification. Today, migration to the UK is more often for purposes of education and work. So the future link between international migration and family formation is unclear. This is particularly so as policies around migration are tightened up.

If the economy suffers post-Brexit, as numerous economists warn, increasing numbers of British people may seek work abroad and this could disproportionately mean men. Fathers have become more engaged with their children in recent years, with the number of stay-at-home dads rising (although in 93% of heterosexual couples, the bulk of the housework, including caring responsibilities, still falls to women). Will we have men travelling to the Commonwealth, Europe and the like to work? And if they do, what will happen to their skills as dads? asks Charlie Lewis, a professor of psychology at Lancaster University who researches fatherhood.

Thirty years ago when I started working on fathers, all the trends were for women to enter the professions, he says, but theres no good evidence that there will be this [female] takeover of the workplace. Work is still a largely hostile environment for family life. And its going to be much more volatile in future years. Policies such as a four-day week would allow the family to balance better.

Women will continue to make strides in the workforce, but this will put pressure on childcare, which still disproportionally falls to mothers. In the UK, we dont have the extensive childcare to match what happens in Germany and northern Europe, says Lewis. We dont think carefully about protecting the next generation.

Stay-at-home dads are still a minority, but Lewis says he remains surprised by the still-small number of fathers who are the resident parent after family breakdown, even if they have been the main carer prior to that. Will that change by 2050? Not if the past few decades are anything to go by. It hasnt changed much since the early 70s. We think that 40 or 50 years ago was a time when the children always went to the mother, but a government report in 1974 documented that 10% of children lived with their dads, and its not much more than 10% now.

Inherited advantage will entrench the privilege of some families at the expense of everyone else. The inequality that we currently see between families will only continue to grow, says Jessica Calarco, associate professor of sociology at Indiana University. We know that affluent white families hoard opportunities and often demand new opportunities to give them access to even more resources. That cycle perpetuates itself over time and inequalities grow. It starts with early education, but quickly escalates, as children from well-off families are funnelled into the right universities and jobs. Without some policy interventions, we will see affluent white families continuing to have power over schools and workspaces, says Calarco, even as the demographics of society change in terms of white people becoming a smaller share of the population.

We are an ageing population. By 2035, there will be 44% more people over the age of 65 than there were in 2017. Age UK estimates around 650,000 extra care jobs will be needed. In October, the government announced a 34m investment programme to try to teach robot carers to be more empathetic to their humans, making it more likely that by 2050, robots will as has long been predicted be one answer to the growing social care crisis. Will they also provide childcare? This has long been more controversial than elder care, but nurseries in Japan have already trialled the use of robots to help out.

The birth of social media has provided a new view of what perfect parenting is supposed to look like. We are encouraged to compare ourselves with others, and we are also, says Thomas Curran, a social psychologist at the London School of Economics, becoming more perfectionist. Parenting has changed in recent years. Parents are more expectant, and are becoming more critical. That is because they are passing down pressures that they feel from society. Things have become tough, the job market has become more precarious, educational achievement has become very important for I hate to put it in these terms their childrens future market price. Theres a lot of pressure on parents now to ensure they raise successful children.

This will become more acute, he believes, at least in the shorter term. By 2050, it could have reversed. This current generation of young people, as they become parents themselves, my sense is that they will do things differently. They are pushing back against societal pressures. In terms of social media, they may not share endless photographs of their children, or do the kind of performative parenting that now often plays out online. I think they will be much better at educating and building awareness in their own children about [how manufactured] social media is.

The family in 2050 will be subject to external pressures nobody I speak to wants to confidently predict; the only certain thing is how diverse families will be in the coming decades. The moral panic about the rapid decline of the nuclear (heterosexual) family hasnt proved justified. What were finding is that family structure is actually less important for children than the quality of relationships within families, says Golombok. And also the social acceptance of their family in the wider world. Families are changing and its not necessarily a bad thing for children or parents.

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The family in 2050: artificial wombs, robot carers and the rise of single fathers by choice - The Guardian

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TORONTO , Dec. 31, 2019 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (HLS.TO), a specialty pharmaceutical company focusing on central nervous system and cardiovascular markets, is pleased to announce that Health Canada has approved the use of Vascepa (icosapent ethyl) to reduce the risk of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with elevated triglycerides, who are at high risk of cardiovascular events due to established cardiovascular disease, or diabetes, and at least one other cardiovascular risk factor. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (AMRN) in 2017.

"Cardiovascular disease is the leading cause of death worldwide and Vascepa provides a new treatment option for healthcare practitioners to enhance cardiovascular protection for the many Canadians at risk of a cardiac event," said Dr. Jean-Claude Tardif , Cardiologist and Director, Montreal Heart Institute Research Centre.

In the global REDUCE-IT cardiovascular outcomes study, approximately 28 percent of patients in the control arm treated with statins and other contemporary therapy but not treated with Vascepa experienced a major adverse cardiovascular event (MACE), defined as the first occurrence of either myocardial infarction (heart attack), stroke, coronary revascularization, unstable angina requiring hospitalization or cardiovascular death.2As evidenced by this MACE occurrence, there is a group of patients who, despite controlling their cholesterol on statin therapy, continue to have a high need for additional preventative cardiovascular care. For those adult patients in this group who have elevated serum triglycerides (TG) levels (1.5mmol/L and < 5.6mmol/L) and established cardiovascular disease or diabetes and at least one additional risk factor for cardiovascular disease, Vascepa showed a 25% risk reduction in the first occurrence of major adverse cardiovascular events and is the first drug approved to help reduce this persistent cardiovascular risk in that specified population.

"As approved by Health Canada, Vascepa is intended to address a serious, life-threatening condition for which no drug is currently marketed in Canada , and for which there is substantial evidence of clinical effectiveness of the treatment. These factors led to Health Canada's priority review of the product and now serve as the foundation for Vascepa to be a transformative product for HLS," said Greg Gubitz , CEO of HLS. "Looking ahead, we are now in the final phase of preparation for the commercial launch of Vascepa in Canada , which we expect will take place in the mid-February 2020 timeframe."

Vascepa is the subject of numerous Canadian issued patents and pending patents with expiration dates which could extend to 2039. The eligible patents will be added to Health Canada's Patent Register following receipt of NOC and in accordance with Health Canada's process.

The approval of Vascepa is supported by data from REDUCE-IT2, an 8,179-patient cardiovascular outcomes study that was completed in 2018. REDUCE-IT was the first multinational cardiovascular outcomes study that evaluated the effect of pure and stable EPA therapy as an add-on to statins in patients with high cardiovascular risk who, despite stable statin therapy, had elevated serum triglyceride levels (1.5mmol/L and <5.6mmol/L). A large portion of the male and female patients enrolled in this outcomes study were diagnosed with type 2 diabetes. REDUCE-IT studied Vascepa at four grams/day as compared to placebo. The U.S. Food and Drug Administration (FDA) approved the use of Vascepa(icosapent ethyl) capsules to reduce cardiovascular risk in December 2019 . More information on the REDUCE-IT study results can be found at https://www.nejm.org/doi/full/10.1056/NEJMoa1812792

HLS paid Amarin $5.0 million to in-license the exclusive Canadian rights to Vascepa in 2017 and a further $2.5 million on the successful REDUCE-IT trial results in 2018. As a result of this approval by Health Canada, HLS will pay a further $2.5 million milestone payment. All amounts are in U.S. dollars.

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ABOUT CARDIOVASCULAR DISEASE Worldwide, cardiovascular disease (CVD) remains the #1 cause of mortality of men and women.

Multipleprimary and secondary preventiontrials have shown a significant reduction of 25% to 35% in the risk ofcardiovascular eventswithstatintherapy, leaving significant persistent residual risk despite the achievement of target LDL-C levels.3

Beyond the cardiovascular risk associated with LDL-C, genetic, epidemiologic, clinical and real-world data suggest that patients with elevated triglycerides (TG) (fats in the blood), and TG-rich lipoproteins, are at increased risk for cardiovascular disease.4, 5, 6, 7

ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES Vascepa (icosapent ethyl) capsules are a single-molecule prescription product consisting of the omega-3 acid commonly known as EPA in ethyl-ester form (known as icosapent ethyl or IPE). Vascepa is derived from fish through a stringent and complex FDA-regulated manufacturing process designed to effectively eliminate impurities and isolate and protect the single molecule active ingredient icosapent ethyl from degradation. Amarin has been issued multiple patents internationally based on the unique clinical profile of Vascepa, including the drug's ability to lower triglyceride levels in relevant patient populations without raising LDL-cholesterol levels.

ABOUT HLS THERAPEUTICS INC.Formed in 2015, HLS is a specialty pharmaceutical company focused on the acquisition and commercialization of late stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: http://www.hlstherapeutics.com

FORWARD LOOKING INFORMATIONThis release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated April 1, 2019 , which has been filed on SEDAR and can be accessed at http://www.sedar.com. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

REFERENCES1 https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death2 Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med2019;380:11-22.3Ganda OP, Bhatt DL, Mason RP, et al. Unmet need for adjunctive dyslipidemia therapy in hypertriglyceridemia management. J Am Coll Cardiol. 2018;72(3):330-343.4Budoff M. Triglycerides and triglyceride-rich lipoproteins in the causal pathway of cardiovascular disease. Am J Cardiol. 2016;118:138-145.5Toth PP, Granowitz C, Hull M, et al. High triglycerides are associated with increased cardiovascular events, medical costs, and resource use: A real-world administrative claims analysis of statin-treated patients with high residual cardiovascular risk. J Am Heart Assoc. 2018;7(15):e008740.6Nordestgaard BG. Triglyceride-rich lipoproteins and atherosclerotic cardiovascular disease - New insights from epidemiology, genetics, and biology. Circ Res. 2016;118:547-563.7Nordestgaard BG, Varbo A. Triglycerides and cardiovascular disease. Lancet. 2014;384:626635.

SOURCE HLS Therapeutics Inc.

View original content: http://www.newswire.ca/en/releases/archive/December2019/31/c3447.html

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HLS Therapeutics Announces Health Canada Approval for Vascepa to Reduce the Risk of Cardiovascular Events - Yahoo Finance

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The U.S. Department of Defense circulated a memo warning troops against using inexpensive home genetic testing kits. The memo cited the possibility of troops getting incorrect information about their genetic medical history but also the possibility that unknown parties could use the information to create security consequences that pose a risk to military operations.

According to an exclusive by Yahoo News, the memo warns soldiers, sailors, Marines and airmen that, [direct-to-consumer] genetic tests are largely unregulated and could expose personal and genetic information, and potentially create unintended security consequences and increased risk to the joint force and mission. The memo does not explain what those unintended security consequences are.

The genetic testing industry promises to unlock the secrets of your genetic past, presenting customers with a full genetic breakdown that includes family history and genetic predispositions to certain diseases and disorders. One issue is that the industry is largely unregulated. Although some companies have strict privacy concerns, others have been known to share information with law enforcement and others without the direct consent of their customers.

Typically genetic testing companies share anonymized datadata stripped of personal information. But in February 2019, FamilyTreeDNA revealed it regularly gave the FBI access to its database, allowing it to compare crime scene DNA against the genetic information of its customers. Such testing has provided key evidence in many unsolved crime cases, including the investigation that eventually caught the Golden State Killer.

The Pentagon isnt concerned about that sort of sharing. Instead, its likely more concerned about what happens if a potentially hostile foreign government gains access to genetic testing databases. For example, foreign governments could use the data to gather compromising information on individual military personnel, using it blackmail people into committing acts of espionage...or worse.

The total U.S. military population is 3.5 million, with several million more spouses and dependents. Thats a big chunk of the genetic testing pool suddenly off-limits to testing companies. The Pentagons warning, while seemingly premature, could lead to industry-wide reforms in the genetic testing business. That could lead to a better consumer experience for all Americans seeking to learn more about their genetic historywhile preventing adversaries from using the same for nefarious purposes.

Source: Yahoo News

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If You're in the Military, Maybe Don't Take That Home Genetic Test - Popular Mechanics

Recommendation and review posted by Bethany Smith

NEW YORK, Dec. 30, 2019 /PRNewswire/ --

The Asia Pacific prenatal and newborn genetic testing market is expected to reach US$ 1,679.956 Mn in 2027 from US$ 630.914 in 2018. The market is estimated to grow with a CAGR of 11.6% from 2019-2027.

Read the full report: https://www.reportlinker.com/p05833588/?utm_source=PRN

The key factors responsible for the growth of the market in Asia Pacific are rising burden of genetic diseases among infants, increasing fertility rates and developing healthcare scenario with rising awareness among populace regarding the benefits of prenatal testing.On the other hand, use of digital microfluidics in newborn testing is likely to be a prevalent trend in the future years.

Soaring birth rates among developing economies are responsible for fueling global baby boom.However, the rising birth rate also contributes to rising birth defects and infants suffering from several genetic diseases.

According to a report published by Bill and Melinda Gates Foundation in 2018, there are almost 250 babies born every minute around the globe. Moreover, according to the Centers for Disease Control and Prevention, the fertility rates for Hispanic women was highest in 2017 among Hispanic women with 67.1 births per 1,000 women.Asian countries such as India and China also have high fertility rates due to factors such as effects of religion, inadequate supply of family welfare services, poverty, and others. According to the World Bank in 2016, the fertility rates in India were reported to be 2.23 births per women as compared to 1.80 in the United States and 1.62 in China. Moreover, neighboring countries, such as Pakistan also have alarming rates of fertility. In 2016, the birth rate in Pakistan was reported to be 3.48 births per woman as per the World Bank data. However, the birthrate in India has successfully reduced its high fertility rate, but still is high as compared to other developed nations. According to the United Nations (UN) report published on June 2019, the fertility rate has reduced to 2.1. Therefore, by 2050 additional 273 million people will be added to India's population. The increasing number of parturient women across the world are thus likely to create increasing demand for prenatal and newborn genetic tests across the globe leading to the growth of the market.The Asia Pacific prenatal and newborn genetic testing market, based on the disease indication was segmented into cystic fibrosis, sickle cell anemia, downs syndrome, phenylketonuria, recurrent pregnancy loss, and Antiphospholipid syndrome, and other diseases.In 2018, Down syndrome segment held the largest share of the market, by disease indication.

The highest share of Down syndrome attributes to the high prevalence of this genetic abnormality among fetuses and availability of multiple tests for its screening and diagnostics. However, the sickle cell anemia segment is expected to grow at the fastest rate during the coming year.Some of the major primary and secondary sources for prenatal and newborn genetic testing included in the report are Food & Drug Administration (FDA), Indian Institutes of Technology (IITs), International Trade Administration (ITA), Japan Society of Obstetrics and Gynecology (JSOG), Council of Scientific and Industrial Research (cSIR), Pakistan Down Syndrome Association (PDSA) and others.

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The Asia Pacific prenatal and newborn genetic testing market is expected to reach US$ 1,679.956 Mn in 2027 from US$ 630.914 in 2018 - PRNewswire

Recommendation and review posted by Bethany Smith

What Can Genes Tell Me About My Cancer Risk?

Before pursuing any kind of genetic testing, it is important to understand that the majority of cancers are not the direct result of genes passed down from your parents. Inherited gene changes sometimes called mutations or variants contribute to somewhere between 5 and 10 percent of all cancers. For that reason, genetic testing and counseling is typically recommended only for people who have had certain types of inherited cancer or who have histories of cancer within their family.

Genetic testing allows healthcare providers to look for inherited gene mutations associated with increased cancer risk, such as BRCA1 and BRCA2 gene changes that have a clear tie to breast and ovarian cancer. For example, women in the general population have roughly a 12 percent chance of developing breast cancer in their lifetime; for women with BRCA mutations, it is closer to 70 percent, according to the NCI. Understanding that risk can help a woman and her healthcare providers plan prevention strategies.

RELATED: My Genetic Test Came Back BRCA Positive. Now What?

Medical-grade genetic cancer testing is typically ordered by your doctor or a specialist, such as a genetic counselor. The tests are noninvasive and typically use a blood or saliva sample.

"Medical-grade testing is developed and approved to answer medical questions [such as]: 'Do I carry a mutation in one of these hereditary cancer genes?'" says Ellen Matloff, the president and CEO of My Gene Counsel, a company that helps clients better understand their genetic testing results, and the former director of the cancer genetic counseling program at Yale University School of Medicine in New Haven, Connecticut. "At-home testing kits are for entertainment and are not developed, or approved, to answer medical questions."

There are several reasons for that. Medical-grade testing is far more thorough, Matloff says. For example, medical-grade testing for BRCA gene mutations analyzes thousands of gene variant options, whereas one leading at-home kit considers just three.

There are also differences in accuracy. A study published in March 2018 in the journal Genetics in Medicine found that 40 percent of gene variants reported in direct-to-consumer tests were false positives and that some of the variants companies told users meant they were at increased risk for certain health conditions are actually considered common gene variants by clinical labs.

An unpublishedstudy presented in October 2019 by Invitae, a medical-grade genetic testing company, found that an individual's ethnicity may have a significant impact on whether their at-home test results are accurate. MUTYH gene mutations, for example, would have been missed in 100 percent of Asian and 75 percent of African American test takers, but only 33 percent of Caucasian individuals.

"Medical-grade testing uses laboratory techniques and validation methods not used by most at-home testing kits," Matloff explains. "So those results are generally more accurate."

Health insurance plans will often cover genetic testing which can cost thousands of dollars but not always, according to the U.S. National Library of Medicine and Breastcancer.org. Direct-to-consumer genetic cancer risk tests tend to be less expensive, so they can be a good starting point for people who are worried about their family history and who do not want to spend too much.

"There are some at-home genetic cancer testing kits that are good, reasonably priced, and convenient for people who do not meet insurance criteria for coverage of traditional medical-grade testing and prefer to pay out of pocket and have the test delivered to their house," Matloff says.

But it is important to remember that everyone from the American Cancer Society to the U.S. Food and Drug Administration (FDA) caution that the tests may provide incomplete or inaccurate information, and urge individuals to talk to their doctors before making any health-related decisions on the basis of those tests.

Read more:
What to Know Before You Buy an At-Home Genetic Cancer Risk Test - Everyday Health

Recommendation and review posted by Bethany Smith

Private Letter Rulings from the IRS provide useful guidance on how they view and will handle certain situations, even if identifying information is redacted from the letter. A recent redacted ruling focused on ancestry genetic testing and whether those costs are payable by a Health Flexible Spending Account (FSA). The IRS found that at least a portion of the test could be covered by funds from a Health FSA, as the testing is medical care.

Deducting Expenses for Medical Care

The IRS allows taxpayers to deduct medical expenses if they exceed 10% of the individuals adjusted gross income. This includes expenses for the diagnosis, cure, mitigation, treatment, and prevention of illness and disease and includes medical and other diagnostic services. Expenditures that are for the general health of a person, such as menstrual products, are not considered medical care. The IRS already allows individuals to break out fees where some portion of the fee covers medical care. This includes, for example, lump sum student services fees where part of the fee is for medical care.

Similarly, a diagnosis includes determination on whether a disease is present and includes tests that show the disease is not present and tests of changes in bodily function. Pregnancy tests, full-body scans, and other diagnostic tests performed without a physicians recommendation are still considered medical care and can be reimbursed from a Health FSA.

IRS Private Ruling

While much of the information in the letter was redacted, we do know that the question concerned whether a taxpayer with an FSA could use the FSA to purchase a genetic testing service that includes a report on the taxpayers ancestry and health. The kit collects a DNA sample which is sent to the testing service. The testing service then sends the sample to a third party laboratory for genotyping. The results from the lab are sent back to the testing service for analysis.

The stated goal of the genetic testing was to get individuals to provide genetic information to their healthcare providers. Individuals could not purchase the health-related services from the testing company without also purchasing the ancestry services. However, in order to use a Health FSA to cover genetic testing, the testing must be defined as medical care. The IRS ruled that portions of the testing, such as genotyping and ancestry reports, are not medical care, but other services offered by the service would be considered medical care. The taxpayer is left to allocate the cost between these non-medical services and the medical services provided. The taxpayer must use a reasonable method to allocate value between the services provided. The testing service, however, is not required to provide this data to the taxpayer.

Read more:
IRS Deems Portion of Ancestry Genetic Testing Payable by Health FSA - Lexology

Recommendation and review posted by Bethany Smith

It was quite a year for the Jews of the Bay Area. From TV shows to Barbie Death Camp to white supremacists to racial diversity in the Jewish community, here are the 10 stories our online readers clicked on the most in 2019.

It was a big year for Israeli TV in America. One show in particular, Shtisel, became an unlikely crossover hit among American viewers when the 2013-2016 series about the travails of a haredi family in Jerusalem hit Hulu late last year. As our TV reviewer Esther D. Kustanowitz wrote in January, there are some universal themes about family, community and change that kept mainstream audiences fascinated by the show:

In September, we brought you perhaps the strangest piece of news we covered this year: the curious case of Burning Mans Barbie Death Camp display. Heres how reporter Gabe Stutman described it: A sea of nude Barbies is seen moving toward three full-size kitchen ovens. Some are crucified on bright pink crosses. Other photos show toy soldiers with semi-automatic rifles marching the Barbies from the rear. A banner strapped to an RV proclaims the Barbie Death Camp the friendliest concentration camp at Burning Man. Another reads arbeit macht plastik frei, a reference to the message over the Auschwitz gate meaning work makes you free.

Some might say its the least Jewish story we wrote this year, but I beg to differ. My visit to the recently remodeled Church of Jesus Christ of Latter-day Saints Temple in Oakland was a personal highlight of the year. It was the first time it had been open to the public in over 50 years, and the visit did not disappoint. As I wrote at the time: I was there out of my love of religious architecture and because Id heard that [Mormon temples] include architectural references to the Mishkan (the portable sanctuary used by the Israelites as they wandered in the desert), as well as the ancient Temples that stood on Jerusalems Temple Mount.

No one article about him truly topped the list, but weve been covering the story since the 24-year-old Concord man was arrested in June and accused of plotting online to shoot Jews. Police found a weapons cache and Nazi literature in his home. He has been in and out of court and jail since then. Last month, a federal charge was added: In 2017, he falsified an application to join the Army by lying about his mental health history, according to the FBI. His bail has been revoked and he remains in custody as his case progresses.

This profile of iconoclastic billionaire Craig Newmark, founder of Craigslist, was the first in-depth interview he has given about his Jewish upbringing and values. More and more Im conscious of the notion of treating people like I want to be treated, and more and more Im conscious of the notion that I got lucky financially and I should share that in ways that mean something, he told our late colleague Rob Gloster in April.

The 2018 Portrait of Bay Area Jewish Life and Communities revealed that one-quarter of local Jewish households include at least one person of color. In our Jan. 25 editorial, we wrote: Its time we acknowledge not only the tendency to make Jews the other in broader society, but the equally pernicious tendency to other Jews of color right here within our own community. Our cover story is replete with stories from Jews of color being stared at or questioned when they show up in synagogue, and being passed over for leadership positions. But we also highlighted ways in which the situation is changing for the better.

Remember this years middling Netflix film The Red Sea Diving Resort, based on the secret Israeli plan to extract Ethiopian Jews through Sudan in the early 80s? Yeah, theres no reason you should. Much more interesting is the real-life story of one of the Israeli naval commandos who took part in the operation. Nir Merry lives in Mountain View today, and as he told editorial assistant Gabriel Greschler, during the operation he spent nights picking up Ethiopian Jews who had hiked for days, sometimes weeks, to reach the rendezvous point. He recalled avoiding armed Sudanese patrols on the coastline and ferrying the refugees to a disguised Israeli Navy ship in the Red Sea. We were tired but really excited, Merry said. I remember picking [up] an [Ethiopian] lady and you could hear little squeaks. And I realized it was a baby tucked in her dress close to her body.

Just last week, Adam Eilath, head of school at Ronald C. Wornick Jewish Day School in Foster City, registered his dismay at the Hanukkah-themed episode of the Disney series Elena of Avalor. In his opinion piece he wrote, As a Sephardic Jew raising two small daughters in an American Jewish community whose default is almost always Ashkenazi. I was excited that the episode would feature Princess Rebekah from a Latino (Ladino) Jewish kingdom. But, he continued, As usual, the only way that Sephardic culture gets represented in this episode is by incorporating Sephardic food.

This story was part of a three-part series on the rise of home genetic testing and the ease of doing genealogical research from the comfort of your home computer. One woman we spoke with grew up Catholic, but found out that she was 50% Asheknazi Jewish from a 23andMe home genetic test. But, as reporter Maya Mirsky asks, what does that really mean? The question itself is a new wrinkle in the age-old debate of just what it means to be Jewish, which has been given a kick in the pants from the commercialization of a field of science that says it can tell you something new: For a price, you can now choose from one of seven commercial genetic tests to find out just how Jewish you are.

In October we reported on a Nazi flag seen hanging inside a state parole office in Sacramento. How did it get there? And why was it hanging in a government building? The California Department of Corrections and Rehabilitation told us in an email that they have a zero tolerance policy for the display of objects that are derogatory in nature, but they pointed out that their officers deal with gang members and high-risk sex offenders, [so] we will come into contact with items that may be considered objectionable. However, the email continued, We take this issue seriously and have removed the item and are looking into the circumstances for why the flag was displayed in potential view of the public. No word yet on what they found out.

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Our 10 most read stories of 2019: genetics, TV, 'Barbie Death Camp' and more - The Jewish News of Northern California

Recommendation and review posted by Bethany Smith

The global Preimplantation Genetic Testing market study presents an all in all compilation of the historical, current and future outlook of the market as well as the factors responsible for such a growth. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities and threats of each Preimplantation Genetic Testing market player in a comprehensive way. Further, the Preimplantation Genetic Testing market report emphasizes the adoption pattern of the Preimplantation Genetic Testing across various industries.

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The business intelligence study of the Preimplantation Genetic Testing market covers the estimation size of the market both in terms of value (Mn/Bn USD) and volume (x units). In a bid to recognize the growth prospects in the Preimplantation Genetic Testing market, the market study has been geographically fragmented into important regions that are progressing faster than the overall market. Each segment of the Preimplantation Genetic Testing market has been individually analyzed on the basis of pricing, distribution, and demand prospect for the following regions:

The key players in the global Preimplantation Genetic Testing market report consist of

The Preimplantation Genetic Testing market report examines the operating pattern of each player new product launches, partnerships, and acquisitions has been examined in detail.

Each market player encompassed in the Preimplantation Genetic Testing market study is assessed according to its market share, production footprint, current launches, agreements, ongoing R&D projects, and business tactics. In addition, the Preimplantation Genetic Testing market study scrutinizes the strengths, weaknesses, opportunities and threats (SWOT) analysis.

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What insights readers can gather from the Preimplantation Genetic Testing market report?

The Preimplantation Genetic Testing market report answers the following queries:

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Preimplantation Genetic Testing Market Offered in New Research Forecasted through 2022 - News Cast Report

Recommendation and review posted by Bethany Smith

GlobalDirect-to-Consumer Genetic Testing (DTC-GT)Market Growth 2019-2024presents key insights on market-related factors such as market size, latest & future trends, competition, forecasts from 2019 to 2024. The data served in this report has been carefully analyzed in the various models. The report covers theDirect-to-Consumer Genetic Testing (DTC-GT)market overview, summary, market dynamics, major leading players, competitive analysis, and leading players various strategies as well as shows the status of regional development, consisting of market value, volume, size, and price data. The research study contains includes analysis of the impact of current market trends and conditions that analysts use to make predictions on future market expansion.

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Market Overview In Brief:

Moreover, the report gives an extensive analysis of key drivers, opportunities, challenges, restraints, trends, leading market players, key segments, and regions. Additionally, the performance of each player active in the globalDirect-to-Consumer Genetic Testing (DTC-GT)market has been analyzed. Apart from this, a comprehensive analysis of consumption, market share, and growth rate of each application is presented in this report. With the help of charts, tables, figures, numbers, and graphs, the study provides a detailed study of the growth rate of every segment of this market. Key players have been studied depending on product portfolio, company profile, capacity, price, price, and earnings.

Key players mentioned in the market research report:EasyDNA, Ancestry.com LLC, 24Genetics, Genebase, Dante Labs, MyHeritage, Atlas Biomed, Mapmygenome, Family Tree DNA

Market By Regional Segments:

The chapter on regional segmentation details the regional aspects of the globalDirect-to-Consumer Genetic Testing (DTC-GT)market. This section explains the regulatory framework that is likely to impact the overall market. This research report consists of the worlds crucial region market share, size (volume), trends including the product profit, price, value, production, capacity, capability utilization, supply, and demand and industry growth rate.

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The region covered according to the growth rate:

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Global Direct-to-Consumer Genetic Testing Market Report 2019 Technology Development, Research Study and Forecasting 2024 - The Picayune Current

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Stem Cell Assay Market: Snapshot

Stem cell assay refers to the procedure of measuring the potency of antineoplastic drugs, on the basis of their capability of retarding the growth of human tumor cells. The assay consists of qualitative or quantitative analysis or testing of affected tissues and tumors, wherein their toxicity, impurity, and other aspects are studied.

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With the growing number of successful stem cell therapy treatment cases, the global market for stem cell assays will gain substantial momentum. A number of research and development projects are lending a hand to the growth of the market. For instance, the University of Washingtons Institute for Stem Cell and Regenerative Medicine (ISCRM) has attempted to manipulate stem cells to heal eye, kidney, and heart injuries. A number of diseases such as Alzheimers, spinal cord injury, Parkinsons, diabetes, stroke, retinal disease, cancer, rheumatoid arthritis, and neurological diseases can be successfully treated via stem cell therapy. Therefore, stem cell assays will exhibit growing demand.

Another key development in the stem cell assay market is the development of innovative stem cell therapies. In April 2017, for instance, the first participant in an innovative clinical trial at the University of Wisconsin School of Medicine and Public Health was successfully treated with stem cell therapy. CardiAMP, the investigational therapy, has been designed to direct a large dose of the patients own bone-marrow cells to the point of cardiac injury, stimulating the natural healing response of the body.

Newer areas of application in medicine are being explored constantly. Consequently, stem cell assays are likely to play a key role in the formulation of treatments of a number of diseases.

Global Stem Cell Assay Market: Overview

The increasing investment in research and development of novel therapeutics owing to the rising incidence of chronic diseases has led to immense growth in the global stem cell assay market. In the next couple of years, the market is expected to spawn into a multi-billion dollar industry as healthcare sector and governments around the world increase their research spending.

The report analyzes the prevalent opportunities for the markets growth and those that companies should capitalize in the near future to strengthen their position in the market. It presents insights into the growth drivers and lists down the major restraints. Additionally, the report gauges the effect of Porters five forces on the overall stem cell assay market.

Global Stem Cell Assay Market: Key Market Segments

For the purpose of the study, the report segments the global stem cell assay market based on various parameters. For instance, in terms of assay type, the market can be segmented into isolation and purification, viability, cell identification, differentiation, proliferation, apoptosis, and function. By kit, the market can be bifurcated into human embryonic stem cell kits and adult stem cell kits. Based on instruments, flow cytometer, cell imaging systems, automated cell counter, and micro electrode arrays could be the key market segments.

In terms of application, the market can be segmented into drug discovery and development, clinical research, and regenerative medicine and therapy. The growth witnessed across the aforementioned application segments will be influenced by the increasing incidence of chronic ailments which will translate into the rising demand for regenerative medicines. Finally, based on end users, research institutes and industry research constitute the key market segments.

The report includes a detailed assessment of the various factors influencing the markets expansion across its key segments. The ones holding the most lucrative prospects are analyzed, and the factors restraining its trajectory across key segments are also discussed at length.

Global Stem Cell Assay Market: Regional Analysis

Regionally, the market is expected to witness heightened demand in the developed countries across Europe and North America. The increasing incidence of chronic ailments and the subsequently expanding patient population are the chief drivers of the stem cell assay market in North America. Besides this, the market is also expected to witness lucrative opportunities in Asia Pacific and Rest of the World.

Global Stem Cell Assay Market: Vendor Landscape

A major inclusion in the report is the detailed assessment of the markets vendor landscape. For the purpose of the study the report therefore profiles some of the leading players having influence on the overall market dynamics. It also conducts SWOT analysis to study the strengths and weaknesses of the companies profiled and identify threats and opportunities that these enterprises are forecast to witness over the course of the reports forecast period.

Some of the most prominent enterprises operating in the global stem cell assay market are Bio-Rad Laboratories, Inc (U.S.), Thermo Fisher Scientific Inc. (U.S.), GE Healthcare (U.K.), Hemogenix Inc. (U.S.), Promega Corporation (U.S.), Bio-Techne Corporation (U.S.), Merck KGaA (Germany), STEMCELL Technologies Inc. (CA), Cell Biolabs, Inc. (U.S.), and Cellular Dynamics International, Inc. (U.S.).

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Stem Cell Assay Market Expected to Witness a Sustainable Growth over 2025 - Filmi Baba

Recommendation and review posted by Bethany Smith

Cardiac rhythm management refers to a process of monitoring functioning of the heart through devices. Cardiac rhythm management devices are used to provide therapeutic solutions to patients suffering from cardiac disorders such as cardiac arrhythmias, heart failure, and cardiac arrests. Cardiac disorders lead to irregular heartbeat. Technological advancements and rise in the number of deaths due to increasing incidences of heart diseases and increasing aging population are some of the major factors driving the cardiac rhythm management market. Heart disease is one of the primary causes of death in the U. S. Excess of alcohol consumption; smoking, high cholesterol levels, and obesity are some of the major causes of heart diseases.

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Cardiac rhythm management is conducted through two major devices: implantable cardiac rhythm devices and pacemakers. Implantable cardiac rhythm devices treat patients with an improper heartbeat. Based on the device, the cardiac rhythm management market can be segmented into defibrillators, pacemakers, cardiac resynchronization therapy devices, implantable defibrillators, and external defibrillators. Pacemakers are used to treat patients with a slow heartbeat. Based on the end user, the cardiac rhythm management market can be segmented into hospitals, home/ambulatory, and others.

North America has the largest market for cardiac rhythm management due to improved healthcare infrastructure, government initiatives, rise in incidences of cardiac disorders, growing number of deaths due to cardiovascular diseases,and increasing healthcare expenditure in the region. The North America market for cardiac rhythm management is followed by Europe. Asia is expected to witness high growth rate in the cardiac rhythm management market in the next few years due to increasing incidences of cardiovascular diseases, growing disposable income, rise in awareness regarding heart disorders and relevant treatments, and improving healthcare infrastructure in the region.

Increasing the prevalence of cardiovascular diseases, technological advancements, rise in life expectancy, increasing awareness regarding cardiac disorders, and government initiatives are some of the major factors that are expected to drive the market for cardiac rhythm management. In addition, factors such as a rise in disposable income, increasing aging population, and high cost associated with heart disease treatment are expected to drive the market for cardiac rhythm management. However, economic downturn, reimbursement issues, the importance of biologics and stem cells, and inappropriate use of the devices are some of the factors restraining the growth of the global cardiac rhythm management market.

Growing population and economies in the developing countries such as India and China are expected to drive the growth of the cardiac rhythm management market in Asia. In addition,factors such as innovations along with technological advancements such as miniaturization, introduction of MRI pacemakers, biocompatible materials and durable batteries, and continuous rise in aging population and increasing cardiovascular diseases such as arrhythmias, stroke, and high blood pressure are expected to create new opportunities for the global cardiac rhythm management market. An increasing number of mergers and acquisitions, rise in the number of collaborations and partnerships, and new product launches are some of the latest trends in the global cardiac rhythm management market. Some of the major companies operating in the global cardiac rhythm management market are

Other companies with significant presence in the global cardiac rhythm management market include

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Key geographies evaluated in this report are:

Key features of this report

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Cardiac Rhythm Management Market Development, Key Opportunity and Analysis of Leading Players to 2015 To 2021 - Info Street Wire

Recommendation and review posted by Bethany Smith