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Reports of the Death of the C1-C2 Facet Injection have Been Greatly Exaggerated – OrthoSpineNews

April 18th, 2017 7:45 pm

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By Chris Centeno, M.D., CEO at Regenexx April 16, 2017

In 1897, Mark Twain was on a speaking tour in London when an American newspaper started a rumor that he was gravely ill. This was soon followed by an obituary. When asked by an American reporter in London about his death, Twain quipped, The reports of my death have been greatly exaggerated. I feel thesame about C1-C2 facet injections. The radiofrequency mob has been trying hard to kill off cervical facet injections for years and C1-C2 is low hanging fruit, but like Twain, I have to report the death of this procedure has been greatly exaggerated.

Sometime around the turn of this last century, we began to see the use of radiofrequency ablation (RFA) for neck pain due to damaged facet joints take off. What is RFA and what is a damaged facet joint?

You have 14 joints in the back part of your spine (7 on each side). These joints help to control neck motion. These little articulations about the size of a finger joint are commonly called facet joints. They can become injuredor can get arthritis like any other joint in your body. When this happens they can become chronically painful.

While the injection of anti-inflammatory steroid into these joints was the most common way to treat this pain, about 2000 or so we began to see the rise of another form of treatment called RFA. This procedure uses a probe that heats up to burn away nerves around the painful joint. The idea is that once these pain carrying wires are cut, the pain will stop because its no longer being transmitted to the brain. This works pretty well and has been well researched to help chronic neck pain caused by a damagedfacetjoint. However, as you mightimagine, you cant just burn nerves that carry pain signals and not have consequences. This procedure can cause the joint to become more damaged (a Charcot joint) and in my experience can cause a cycle where the patient needs to be treated every 5-18 months forever. In addition, my personal observation is that these patients get more brittle with time. By that, I mean that when their pain returns its worse and easier to provoke than before RFA was begun.

Radiofrequency is a great medical business. Not only do these patients need to come back every so often for a repeat treatment, but insurance companies pay more for RFA than a simple facet injection. In addition, theres a third party vendorwho gets to charge outrageous prices for disposable needles and new RF probes, which means that theres lots of moolaharound to sponsor conferences, pay physician thought leaders, and medical directors. Hence, knowing that money talks in medicine, its not hard to figure out why those thought leaders have been trying to get rid of facet injections (i.e. injecting a substance into the joint rather than burning the nerves around the joint). as the idea competes with RFA. However, with the advent of orthobiologics like PRP and stem cells, everything changes.

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Josh Sandberg has been an executive search consultant focused exclusively on orthopedic and spine start-ups since 2004. He has had a tremendous impact in helping his clients avoid costly hiring mistakes by his deep industry knowledge and network. In 2010, Josh co-founded Ortho Spine Companies, which is the parent company of Ortho Spine Distributors (OSD), Surg.io and Ortho Sales Partners (OSP). OSD a searchable database that helps ease the frustration of finding orthopedic distributors throughout the country. Surg.io is the ultimate distributor toolkit that offers distributors the tools necessary to build the foundation of a scalable and highly functioning sales organization. OSP is an end-to-end solution that helps companies approach the Global Market in a cost efficient way. Our team has hundreds of years of experience and can help you navigate the many challenges present in bringing new technologies to the market.

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Reports of the Death of the C1-C2 Facet Injection have Been Greatly Exaggerated - OrthoSpineNews

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Scientists find evidence that ALS and SMA could be treated with a common drug – Medical Xpress

April 18th, 2017 7:45 pm

April 17, 2017 by Hannah L. Robbins SMN protein (red) is necessary for the survival of spinal cord neurons (motor neurons) responsible for breathing and all movement. Harvard researchers have found a compound that stabilized this protein in mouse and human motor neurons. This may lead to the development of new treatments for motor neuron diseases including Spinal Muscular Atrophy and Lou Gehrigs disease. Credit: Natalia Rodriguez-Muela

Harvard Stem Cell Institute (HSCI) researchers have identified a compound that helps protect the cells destroyed by spinal muscular atrophy (SMA), the most frequent fatal genetic disease in children under 2 years of age.

SMA is a neurodegenerative disease targeting motor neurons, the long nerve cells that relay messages from the brain to the muscles and that are, consequently, responsible for bodily movements, including walking, swallowing, and even breathing. Patients with milder forms of SMA experience muscle wasting that may confine them to a wheelchair, while the more severe forms cause paralysis and death before the second birthday.

About one in 50 people are genetic carriers of the disease.

Because of a dysfunctional gene, many motor neurons in SMA patients are unable to produce adequate amounts of a protein called survival of motor neuron (SMN). The deficiency causes cellular stress and eventually cell death. Rather than fixing the gene, which has been the strategy of many labs looking to develop SMA therapies, the Harvard team has identified a compound that helps stabilize the SMN protein both in human neurons in a dish and in mouse models.

The findings were published in the journal Cell Reports.

"This discovery opens up new lines of drug interrogation," said Lee Rubin, HSCI principal faculty member and the senior author on the study. Rubin's lab, which operates out of in Harvard's Department of Stem Cell and Regenerative Biology, uses induced pluripotent stem cells (iPS cells) to make human models of neurological diseases.

In 2015, Rubin made a variety of neuronal types from the iPS cells of SMA patients in order to determine why motor neurons in particular were targeted, and found they experienced a fatal stress response similar to motor neurons affected by amyotrophic lateral sclerosis (ALS), the late-onset neurodegenerative disease more commonly known as Lou Gehrig's disease.

Additionally, some SMA-affected motor neurons were dying before others, though all of the neurons had the same genetic mutations and were experiencing the same stressful environment.

"Clearly, some motor neurons were surviving, so the next question was whether this is random or if there is a molecular explanation," Rubin said.

Early on in their most recent study, the researchers found that within a single petri dish of motor neurons derived from an SMA patient, some produced up to four times as much SMN protein as their neighbors. Over time, those motor neurons with higher levels of SMN were more likely to survive after exposure to toxic environments and stressors.

When the team analyzed motor neurons derived from ALS patients, they found similar results: Motor neurons with higher levels of SMN were likelier to survive than those with lower levels.

"The surprise was when we looked in a control culture and also saw differences between the individual neurons," Rubin said.

"It is clear that the SMN protein is necessary for all motor neuron survival, not just motor neurons targeted by ALS or SMA," said Natalia Rodrguez-Muela, a postdoctoral fellow in Rubin's lab and co-first author on the paper. The results suggest that if the team could increase the amount of SMN protein in any single motor neuron, they would be able to rescue the cell.

During a cell's life span, proteins are constantly being made and degraded, made and degraded again. To interrupt the process of breaking down the SMN protein, the researchers looked at a family of proteins called Cullins, which act as a part of the cell machinery that regulates protein degradation.

In 2011, the Rubin lab had determined that an enzyme called GSK3b helps control SMN stability. Nearly all proteins degraded by GSK3b are flagged for degradation by a pathway that involves a specific member of the Cullin family. Rubin said the researchers hypothesized that if they could block that Cullin-mediated process, the SMN proteins would not be flagged for degradation and would remain stable longer.

The researchers, led by co-first author Nadia Litterman, then dosed human and murine motor neurons with a compound known to block the specific Cullin and found that exposure to the compound made SMN proteins more stable and more abundant. As a consequence, the compound promoted survival of all motor neurons, both in human cells in the dish and in mouse models.

Additionally, mice with SMA, even the more severe forms of the disease, had some of their symptoms improve after exposure to the compound.

"This process points to an unexplored therapeutic direction that could benefit patients of not one, but two separate diseases," Rubin said.

Explore further: Hope against disease targeting children

More information: Natalia Rodriguez-Muela et al. Single-Cell Analysis of SMN Reveals Its Broader Role in Neuromuscular Disease, Cell Reports (2017). DOI: 10.1016/j.celrep.2017.01.035

Journal reference: Cell Reports

Provided by: Harvard University

This story is published courtesy of the Harvard Gazette, Harvard University's official newspaper. For additional university news, visit Harvard.edu.

Harvard Stem Cell Institute (HSCI) researchers studying spinal muscular atrophy (SMA) have found what they term "surprising similarities" between this childhood disorder that attacks motor neurons and amyotrophic lateral ...

Using a new stem-cell based drug screening technology with the potential to reinvent and greatly reduce the cost of the way new pharmaceuticals are developed, Harvard Stem Cell Institute (HSCI) researchers have found a compound ...

Although only 10 percent of amyotrophic lateral sclerosis (ALS) cases are hereditary, a significant number of them are caused by mutations that affect proteins that bind RNA, a type of genetic material. University of California ...

A puzzling question has lurked behind SMA (spinal muscular atrophy), the leading genetic cause of death in infants.

New research from the Advanced Gene and Cell Therapy Lab at Royal Holloway, University of London has used pioneering stem cell techniques to better understand why certain cells are more at risk of degenerating in spinal muscular ...

Cedars-Sinai scientists are seeking to build an improved stem-cell model of amyotrophic lateral sclerosis (ALS) to accelerate progress toward a cure for the devastating neurological disorder. Their findings demonstrate that ...

Accelerated healing isn't just for superheroes. A new study in Cell Reports suggests a way that mere mortals can potentially speed their recovery from a wide variety of injuries.

Like drag car racers revving their engines at the starting line, stem cells respond more quickly to injury when they've been previously primed with one dose of a single protein, according to a study from the Stanford University ...

A team of scientists from the National Institutes of Health has discovered biological mechanisms that appear to prevent damage to the heart muscle's "power grid," the network of mitochondrial circuits that provide energy ...

Researchers have found a new group of cells in the retina that directly affect the biological clock by sending signals to a region of the brain which regulates our daily (circadian) rhythms. This new understanding of how ...

A new study from the Icahn School of Medicine at Mount Sinai provides important insights into how the body regulates its production of heat, a process known as thermogenesis that is currently intensely studied as a target ...

Cornell University researchers have produced for the first time an image of P2X7, a receptor associated with chronic pain. Visualizing the shape of the receptor has also allowed them to make a second groundbreaking discovery: ...

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Look again: How to fight data blindness – Campaign US

April 18th, 2017 7:45 pm

In the book "Blind Spot: Illuminating the Hidden Value in Business," authors Nathan Shedroff and Stephen Diller tell a story that perfectly dramatizes the problem with todays over-reliance on quantitative data.

Years ago, a team at Levis was researching customer segments and became puzzled over something: While the brand is upscale, many of its customers are not. To find out what was going on, the team took a road trip in Texas and visited people in their homes. One of them was a single mother with two kids, Francine, who was clearly struggling. Yet every year, she bought Levis for her family.

The obvious assumption would be that she was vain and irresponsible. But when they met her, they learned she worked two jobs and was obsessed with her childrens future. Asked why she chose to spend precious dollars on Levis, she replied that she didnt want her children to think they were poor and couldnt achieve more in life.

This story serves as a wake-up call to anyone who thinks that data alone is a sufficient tool to understand human behavior. Not every person fits into a neat category.

Qualitative methodologies can tell you the what (that lower income people buy Levis), but they often fail to tell you why (because theyre aspirational). They cant tell you what motivates the large part of Pradas customer base, which is not affluent. Or why many high-income people shop at big-box discount stores. Is it convenience, or because they dont like overpaying? Only qualitative research will tell.

For decades, however, qualitative research has had a bad rap. It has largely meant focus groups, which can be a costly hassle. You have to recruit respondents, conduct interviews, and travel to different citiesall of which seem time-consuming and antiquated compared to statistical analysis of a rich data set. Product strategists and executives crave insight, but they dont extend that desire to home visits, shop-alongs, and other person-on-the-street work. As a result, in the last 10 years qualitative research facilities have been closing, and quick-turn panels and mobile phone surveys have taken the place of traditional, on-the-ground methods.

But if we want to reach customers in an authentic way, we have to understand the true psychological motivation behind their behaviors. And luckily, we have some new and sophisticated ways to do just that:

Watch what people do, not just what they say. Behavioral economics has opened a new field for understanding human motivation. For example, many behavioral economists stress that quick and effortless, "System 1" thinking dominates the choices we make. The majority of people,most of the time, operate on autopilot. As a result, observing how they actually shop for things can provide deep inspiration for new services that improve store performance. For example, Newsworks award-winning "How People Buy" study literally looked through the eyeglasses of people shopping. It revealed, oddly enough, that many customers do research, not to find the best product, but to ensure that they wont regret buying their preferred brand!

Co-create, dont just evaluate. Research projects typically seek to evaluate concepts and pick a winner. A better idea is to bring people in early, and use their responses to influence design thinking. For example, innovative research firm System 1 Group seeks to improve ideas by putting emotional responses at the heart of their testing methods. This allows their customers (or potential customers) to help build on product concepts, not just evaluate them.

Get outside to understand your category. Person-on-the-street interviews have come a long way in sophistication. Today, production companies such as Snippies offer networks of professional videographers who can generate fast global feedback. Such surveys can give you insight into how people feel about products and brands, helping you move beyond the limitations of traditional tracking surveys and social listening data.

Of course, we know that data big and small isnt going anywhere. With more sources of it and better analytic methodologies, business leaders are finding it easier and easier to extract value from data. But that is only part of the storyand not always the most important part.

Compelling insights and competitive advantage still come from getting out into the world to observe, converse and create with people. While positive results may not be as assured, the insights we can learn are essentialif we want to find out what really matters to our customers.

Brandon Geary is global chief strategy officer of Possible.

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No more PC blindness and appeasement: Trump is the wartime president we needed – Conservative Review

April 18th, 2017 7:45 pm

Under Barack Obama, not only did the world become a more dangerous place, but his lack of will to defeat ISIS, the baloney fed to us by his failed secretaries of state, and his willingness to accept an apparently yet unreached number of American deaths due to the activity of those barbarians actually caused the demise of his partys effectiveness nationwide. Obama was on the wrong side of history.

Many Americans, like my husband and I, finally decided to vote for Donald Trump when the shooting in Orlando happened. Our preferred candidate, Ted Cruz, R-Texas, had pulled out of the race. Seeing a very nasty side of Trump, we were unconvinced he would have a level head and be able to lead the nation. So for about a month, I was sure I could not vote for Trump, nor could I vote for Clinton.

But Orlando did happen, and we agreed with Ted Cruz who believed our nation was already at war with the sickness of ISIS. My husband and I could only see more terror happening in our own country with Clinton. For all of his flaws in the understanding of basic constitutionalism, separation of powers, the proper role of government in the economy, and his tendency to relish in big government, we could see the difference between Trump and Clinton in that respect. He was gonna bomb the shit out of ISIS.

And so he has started. Thank you, President Trump.

Did Obama know that cave formation in Afghanistan Trump recently bombed was being used by ISIS as a hideout? I dont know the answer, but I think rational people could see that it is more than likely that he did. How long was ISIS using that area? What kind of attacks were carried out while that area was used by ISIS? Did the people in the tunnels cheer when Americans were killed in the numerous attacks by their soldiers of ISIS here in America? Why didnt Obama take them out?

When President Trump bombed the Syrian airfield, so many were skeptical. From where I sit, the Russian propaganda machine here in America has been gaining steam for years, as Putin used imbecilic mouthpieces here to fill the void of American leadership. Many pro-Putin Americans continuously praised him as a Western reformer, a real Christian, and just the type of strongman our nation needed. Many of them saw the strength of Trump and figured Putin and Trump would be able to team up to kill ISIS together. But the bombing in Syria and the ridiculous propaganda from Assad and Putin since should crystallize whose side Putin is really on. For those who refuse to admit they have been duped by a superior propaganda campaign from the former KGB agent, well, I guess youre on your own.

Now that the bombings have started, and we are answering a war that was declared on us, regular folks are concerned that President Trump has started WWIII. But it is not possible for President Trump to start a war we are already in. The jihadis received appeasement and Americas other cheek, arm, leg, and throat year after year under Obama. Those attacks on America mentioned in the beginning of this article could have been prevented, had we had a leader who took ISIS seriously, who followed through on ridding Syria of chemical weapons, who didnt blame the Syrian war on the silliness of global warming, and who didnt take every chance he could get to downplay the dangers of radical Islam. Who, instead of acknowledging the violence brought on by fundamentalist radical Islamists, took time rather, to repeat that America cant be at war with a religion, insinuating that it was Americans who didnt understand the threats, when it was him all along.

At the same time, it seems pretty clear Americans dont want to be seriously involved in nation-building. We dont have a reason nor ability to try to make countries that dont understand how civil societies operate into countries that do.

Let the history books show that it was the continued blindness of and appeasement toward radical Islam that caused so many innocent deaths around the world of late. Let history record that America didnt fall asleep after 9/11, but that she was hobbled for eight long years while her enemies grew stronger.

We needed a wartime president, and we got one. Now we need resolve.

Jen Kuznicki is a contributor to Conservative Review, blue collar, wife, mom, political writer, humorist, conservative activist, a seamstress by trade, and compelled to write. Follow her on Twitter @JenKuznicki.

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Overlooking blindness – K24 TV

April 18th, 2017 7:44 pm

Photo: Ochieng during his graduation.

Samuel Ochieng, 37, lost his sight as an infant. However, he has lived his life to the fullest, winning an award while at it

Samuel Ochieng Odawo is the perfect embodiment of the maxim that lack of sight is not lack of vision. He swam against the tide at a time his parents could hardly educate him and his siblings. Now, he is the only child from in home to set foot in a university lecture hall. His mission, to empower persons with disabilities.

He has been vocal in the formulation of disability streaming policies and advocated for the rights of refugees at Daadab. It is what keeps him going; the hope that one day, the blind will lead more useful lives. Things like crossing roads, reading and using technology will be friendlier.

Well, six months after Samuel was born, he developed measles. My late mother told me when I was nine months, my eyes became completely swollen and the doctors said I had lost my sight completely, he narrates. Samuel, the ninenth in a family of 10 says by the time his dad came back from Nakuru, where he worked, it was too late to save his sight.

Challenges

I was bred in Siaya County, Alego and I grew up blind. I didnt know I was blind, I thought that was how life is, until I overheard my mother chatting with her friends about taking me to a special school. However, it did not bother me as much since I was used to my life and didnt know how it is to see, recalls the 37-year-old. He then went on to St Order Primary School for the blind at the age of seven, performed well and later joined Thika School for The Blind. My condition helped me a great deal. My siblings education was cut short whenever they got to class seven, but I had to be kept in school and I excelled, he says.

Also read: My married baby daddy accuses me of trapping him

Despite the lack of fees, hustle to get fare, upkeep and attending school a month to closing day, he passed. After high school in 2000, he was admitted to Kenyatta University in 2002 to pursue a bachelors degree in Special Education and French. I had to find a way to pay my fee. My parents could not raise it at all and so, I looked for well-wishers and donors and that is how I sailed the four years. Being blind in campus was tough, an emotional Samuel says.

He had to sweet talk people into reading for him so that he could catch up with school work. Never in the four years did I present my fee structure to my parents, their position could not even help raise the amount he says.

Breakthrough

With a huge fee arrears after the four years, he failed to graduate and moved to Nakuru. While there, I taught French at a primary and a secondary school. It was tough because most people who see blind people assume they are out to beg. I outgrew Nakuru and decided to relocate to Mombasa in 2007, he says.

Also read: Dennis Mukundi is only at the beginning of his career

While at Nakuru, he was robbed of all of his belongings. The fact that the school needed him to teach more subjects only fanned his desire to relocate. I remember arriving in Mombasa and as I waited for my friend to come and pick me, people were giving me money. They thought I was begging and that just went to show how much people think of the blind in Kenya, says the father of one.

In 2014, he was given the Care Humanitarian Award from Care Canada for his works. The most memorable part of his work was when he was teaching at the Daadab Refugee Camp and his learners with visual impairments got their first classroom.

In 2015, he was helping a friend register for a scholarship and he too applied. I submitted my application on the last day. I was accepted and I attended Birmingham University in the United Kingdom to study a Masters in Management of Special Education in Developing Countries, he beams.

Samuel works as a consultant for special needs education and disability issues at his private firm. I am passionate about empowering persons with disability. Theres a lot of discrimination against peoples with disability in Kenya. A lot needs to be done, Samuel says.

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Genentech’s Lucentis Approved for Blindness-Causing Diabetic Retinopathy – Pharmaceutical Processing

April 18th, 2017 7:44 pm

FDA approves Genentechs Lucentis (ranibizumab injection) for diabetic retinopathy, the leading cause of blindness among working age adults in the United States.

Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration (FDA) approved Lucentis(ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. The most common cause of vision loss in people with diabetes, diabetic retinopathy is the leading cause of blindness among adults aged 20 to 741and affects nearly 7.7 million people in the U.S.2

With this approval, Lucentis becomes the first and only FDA-approved medicine to treat diabetic retinopathy in people who have been diagnosed either with or without diabetic macular edema (DME), a complication of diabetic retinopathy that causes swelling in the back of the eye. In February 2015, Lucentis received FDA approval for the treatment of diabetic retinopathy in people with DME based on data from the pivotal RIDE and RISE Phase III clinical trials.

The FDA granted Lucentis Priority Review for the treatment of diabetic retinopathy without DME based on an analysis of the Diabetic Retinopathy Clinical Research Networks (DRCR.net) Protocol S study. This NIH-funded study compared Lucentis treatment to panretinal laser treatment in diabetic retinopathy patients both with and without DME.

In the analysis that supported this approval, patients with and without DME in the Lucentis group experienced improvements in the severity of their retinopathy. Adverse events were consistent with those seen in previous studies.

Diabetic retinopathy is the leading cause of vision loss among working-aged adults in the U.S. between the ages of 20 and 74. We are very pleased that Lucentis is now FDA-approved to treat retinopathy in people with and without DME, said Sandra Horning, M.D., chief medical officer and head of Global Product Development. In multiple clinical studies, Lucentis demonstrated a significant improvement of patients diabetic retinopathy, and it is the first and only anti-VEGF therapy approved to treat all forms of diabetic retinopathy.

Priority Review Designation is granted to medicines that the FDA has determined to have the potential to provide significant improvements in the safety and effectiveness of the treatment of a serious disease.

The FDA previously granted Lucentis Breakthrough Therapy Designation for diabetic retinopathy in 2014 based on the pivotal RIDE and RISE phase III clinical trials. Breakthrough designation is intended to expedite the development and review of medicines with early evidence of potential clinical benefit in serious diseases and to help ensure that patients receive access to medicines as soon as possible.

Diabetes affects more than 29 million people in the U.S.3The longer a person has diabetes, especially if it is poorly controlled, the higher the risk of developing diabetic retinopathy and vision loss. Diabetic retinopathy occurs when blood vessels in the retina become damaged. This can cause vision loss or distortion when the abnormal vessels leak blood or fluid into the eye.1 ___________________________________________________

References:

1U.S. Centers for Disease Control and Prevention. Common Eye Disorders: Diabetic Retinopathy. Available athttps://www.cdc.gov/visionhealth/basics/ced/index.html. Accessed March 7, 2017.

2Prevent Blindness America. Diabetic Retinopathy. Available athttp://www.visionproblemsus.org/diabetic-retinopathy/diabetic-retinopathy-definition.html. Accessed March 7, 2017.

3American Diabetes Association. Statistics About Diabetes. Available athttp://www.diabetes.org/diabetes-basics/statistics/. Accessed March 7, 2017.

(Source: Business Wire)

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Answer for why cave animals go blind? – ScienceBlog.com (blog)

April 18th, 2017 7:44 pm

Why do animals that live in caves become blind?This question has long intrigued scientists and been the subject of hot debate.

Clearly, across the animal kingdom, blindness has evolved repeatedly. There are thousands of underground and cave-dwelling species, from naked mole rats to bats, and many have lost their

sense of sight. A well-studied blind cavefish (bottom), the Mexican tetra (Astyanax mexicanus), is a small, docile, pink-hued fish just a few centimeters long that could easily make its home in an aquarium. ASU evolutionary biologist Reed Cartwright chose this Mexican tetra because there is also a surface-dwelling form (top) that has retained its sight. Download Full Image

Charles Darwin originally suggested that eyes could be lost by disuse over time. ButReed Cartwright, an ASU evolutionary biologist in the School of Life Sciences and researcher at the Biodesign Institute,may be proving Darwin wrongin a recent publication in the journal BMC Evolutionary Biology.

We think that blindness in cavefish is indeed Darwinian, but ultimately this disproves Darwins original hypothesis of disuse, Cartwright said. In new research, he explains that eyes are not lost by disuse, but rather a demonstration of Darwins fundamental theory of natural selection at work with blindness selected as favorable and the fittest for living in a cave.

For their work, his research team choose to model a well-studied blind cavefish, the Mexican tetra (Astyanax mexicanus), a small, docile, pink-hued fish just a few centimeters long that could easily make its home in an aquarium.

Its inhabited caves for 2 million to 3 million years, giving it 5 million generations worth of time to evolve blindness. Cartwrights group chose this Mexican tetra because there is also a surface-dwelling form that has retained its sight. And for scientists, this built-in comparative power makes it a good choice for further exploration. They have two populations to study that can interbreed and are polar opposites for physical traits.

So Cartwrights group decided to use computational power to investigate how multiple evolutionary mechanisms interact to shape the fish that live in caves.

The problem we have in these caves is that they are connected to the surface, and fish that can see immigrate into the cave and bring genes for sight with them, Cartwright said. Under these conditions, we dont typically expect to find such a difference in traits between surface and cave populations. Unless selection was really, really strong.

How strong? In their model, the selection for blindness would need to be about 48 times strongerthan the immigration rate for Mexican tetras to evolve blindness in caves. Cartwrights groupestimates that a measure of fitness for blindness, called the selection coefficient, in the tetra is between 0.5 percent and 50 percent.

These coefficients are high enough that laboratory experiments should have detected a difference between surface and cave forms of the fish; however, none have to date.

Cartwrights team turned to a hypothesis going all the way back to a letter to the editor of Nature in 1925 by E. Ray Lankester, that essentially stated that the reason you have blindness in caves is because the fish that can see simply leave.

If sighted fish swim towards the light, the only fish that stay in the cave are blind fish. They arent trying to get to the light anymore because they cant see it. Which actually is a form of selection, and thus, Darwinian evolution in action, Cartwright said.

According to Cartwright, explaining a fitness difference as big as 10 percent between sighted and blind fish may be difficult, Iosing eyes might not give you 10 percent more offspring. However, if 10 percent of your seeing-eye fish leave the cave, the migration rate is reasonably low, and that could be enough.

If over time, enough of the seeing-eye fish are systematically being removed, they will also be removed from the gene pool, and that could be enough to drive the evolutionary process.

It could be this sort of habitat preference that maintains the local blind fish population, and the fish that can see are preferentially moving out of the cave. We found that even a low level of preferential emigration, e.g. 2 percent, would provide a significant boost to local adaptation and the evolution of blindness in caves.

Cartwrights team hopes that field biologists begin to consider Lankesters 90-year old hypothesis when studying cavefish. It would be great if someone could develop a study to test Lankesters hypothesis and whether it is driving the evolution of blindness in caves. That would really help answer one of the questions that have intrigued biologists for over a century.

Cartwrights research was supported by National Science Foundation Advances in Bioinformatics program and Arizona State Universitys School of Life Sciences and Barrett, The Honors College.

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Why Silicon Valley Keeps Getting Biotechnology Wrong – New York Magazine

April 18th, 2017 7:44 pm

Photo: Jamie McCarthy/Getty Images for Glamour

Two years after the $9 billion start-up unicorn Theranos crumbled, Silicon Valley still appears to be struggling to learn its lesson when it comes to health and medical start-ups. Improbable-sounding companies continue to turn up with tens of millions of dollars in funding, no published research to back them up, and nothing but criticism from scientists. Last week, BuzzFeed News examined a new set of start-ups promising to detect cancer early via a simple blood test Freenome, Grail, and Guardant and found them on paths dangerously similar to the one Theranos was on just a few years ago. A year ago, Freenome promised to publish about its product in a scientific journal very soon to Fast Company, and still hasnt. Cancer researchers told BuzzFeed very plainly that such a simple test would be miraculous but seemed improbably advanced beyond our current technology, which was also the case with Theranoss miniature blood tests and Freenome made its lofty promises only months after Theranos started to fall apart. Like a Kickstarter project well over its anticipated delivery date, one begins to wonder if it was all fake.

Silicon Valley has a kind of blind spot when it comes to biotechnology, health-related start-ups, and other medical pursuits. The Theranos hype train was only stopped when The Wall Street Journal surfaced evidence that Theranos had misrepresented how far along it was in its research process to its investors, passing off mediocre test results as much more conclusive than they were. Venture-capital firms insist that the standard that needs to be met for investment is much higher for medical start-ups, which must prove that their technology works with data, not just a pitch. And yet somehow, when these start-ups finally surface to public consciousness, they dont appear to pass even the most basic smell test with literally any experienced researcher in the field.

There are some confounding factors to take into account: venture capitalists invest in ambitious businesses and expect a high failure rate; health start-up failures are highly visible in part because biotechnology businesses are more unusual, and because they tend to be involved with actual life-or-death human experiences. No one really cares about another Uber-alike (just as no one really cared about Uber until it had established itself) but almost everyone has a personal relationship with cancer, and everyone wants a solution to it as soon as possible.

But the fact that we all have bodies, and all need doctors may also be why Silicon Valley seems unable to avoid dabbling in medical technology. The intersection of future tech and health has become crowded with some of the countrys richest hobbyists. They love biohacking (theres even a subscription box). They believe, almost to a man, that the singularity is a question of not if, but when. Elon Musk is very seriously investing in arming biological humans against computers; Peter Thiel takes human growth hormone, a popular practice among transhumanists, and has expressed interested in getting blood transfusions from young people as a way of reversing aging (to his credit, there is some published scientific evidence this might actually work, however fundamentally sinister it sounds). Larry Page, Sergey Brin, Mark Zuckerberg, Sean Parker, and Martine Rothblatt have all sincerely expressed interests in similar pursuits. They often seem less concerned with protecting humanity than their own consciousnesses, designing brain-machine interfaces that will both preserve their own copious knowledge reserves and merge them with the larger internet, turning each tech CEO, investor, and founder into an army of IBM Watsons, but smarter.

There is a pervasive sense in Silicon Valley, bolstered by ten years of world-conquering success, that any sufficiently intelligent, sufficiently driven person can will what they want. The only thing slowing the unrelenting forward march of medical tech is funding. Solutions are an inevitability, and the realities of the human body are simply a set of inefficiencies that can, with enough time and attention, be brought to heel. The culture of Silicon Valley meritocracy affords its practitioners cynicism when confronted with realities other than their own: If you were dumb enough to trust new tech, or too poor to have more options, you deserve what you had coming.

Health tech is certainly valuable and ripe for profit. Machines and medical tests used in hospitals for treatment and diagnosis are wildly expensive, but their cost is determined both by demand (high; no one wants to die, and enough people have insurance) and research (expensive, very costly to get right and get through all the hoops of being brought to market). For further evidence, look at the pharmaceutical industry. Investors who sense a rich potential for profit if only they can insert themselves at the right place in the process are not wrong, in that sense.

But the move fast and break things mantra that has helped Silicon Valley disrupt countless industries over the last two decades is more dangerous when applied to medical science. The roadblocks that health tech companies run into are not qualitatively different from the ones that all tech companies run into. But when Uber or Airbnb run afoul of their respective laws, the result is abstracted lost money out of someones pocket the government, independent contractors, independent businesses, other segments of the market. When Airbnb keeps viable apartments off the market so they can be rented short-term to its users, the money can theoretically be remanded if someone determines that Airbnb is doing something wrong. The things being broken by the current generation of unicorns are regulatory regimes. (Valuable, useful regulatory regimes, to be sure.) The things being broken by health start-ups are laws of science and ironclad guidelines for research. When a health start-up moves fast and breaks things, it can directly result in the death, dismemberment, and injury of real people. You cant un-kill someone who died thanks to a bad diagnosis (at least, theres no start-up hawking that yet).

Theres always room to be wrong in business. But theres less of that room when it comes to medical treatment. That it appears all the same to even the highest-profile venture capitalists actually turns out to make a lot of sense.

The Snapchat 101: The Best, Coolest, Smartest, Weirdest Accounts on the Hottest Social Network on Your Phone

F**k.

The News Feeds enormous audience wont solve its waning relevance.

If Snapchat wants to be the Apple of augmented reality, Facebook is more than happy to be its Microsoft.

We give it three months before Facebook rips off the idea.

Move fast and break things doesnt work when those things are research procedures, laws of science, and human bodies.

A day in the life of YouTubes reigning teen queen.

Cabana lets you watch videos with your friends in real time.

You may be able to give a five-star review, and tip a dollar or two, at the end of an Uber ride in the near future.

Cant keep a good content farm down.

F**k.

How Robert Taylor, who passed away Thursday at the age of 85, essentially created the internet as we know it.

It is kind of contagious, the optimism. I guess it just becomes a part of you.

Add a little pinch of electoral participation.

As YouTube becomes big business for families willing to film everything, are the kids adequately protected?

This is bad news for a lot of PC owners.

Some assembly required.

Everything you need to make the best slime at home.

Lemme up there to hang out with these good boys.

True art takes courage.

When product placement goes wrong.

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Investor Radar: Taking a Closer Look at Puma Biotechnology, Inc. (NASDAQ:PBYI) – Davidson Register

April 18th, 2017 7:44 pm

Active investors may be taking a second look at shares of Puma Biotechnology, Inc. (NASDAQ:PBYI). Checking in on some levels, the six month price index is currently at 0.68164. The six month price index is measured by dividing the current share price by the share price six months ago. A ratio above one indicates an increase in the stock price over the six month time frame. A ratio under one signals that the price has lowered over that same time frame.

We can also take a look at some stock volatility data on shares of Puma Biotechnology, Inc. (NASDAQ:PBYI). The 12 month volatility is currently 85.067900. The 6 month volatility is noted at 83.631200, and the 3 month is recorded at 75.587900. When following the volatility of a stock, investors may be challenged with trying to decipher the correct combination of risk-reward to help maximize returns. As with any strategy, it is important to carefully consider risk and other market factors that might be in play when examining stock volatility levels.

Investors may be looking at the Piotroski F-Score when doing value analysis. The F-Score was developed to help find company stocks that have solid fundamentals, and to separate out weaker companies. Piotroskis F-Score uses nine tests based on company financial statements. Puma Biotechnology, Inc. (NASDAQ:PBYI) currently has a Piotroski F-Score of 2. One point is given for piece of criteria that is met. Typically, a stock with a high score of 8 or 9 would be seen as strong, and a stock scoring on the lower end between 0 and 2 would be viewed as weaker.

Shifting gears, Puma Biotechnology, Inc. (NASDAQ:PBYI) has an FCF quality score of -6.273255. The free quality score helps estimate the stability of free cash flow. FCF quality is calculated as the 12 ltm cash flow per share over the average of the cash flow numbers. When reviewing this score, it is generally thought that the lower the ratio, the better. Presently, Puma Biotechnology, Inc. has an FCF score of 0.359983. The FCF score is determined by merging free cash flow stability with free cash flow growth. In general, a higher FCF score value would represent high free cash flow growth. Monitoring FCF information may help provide some excellent insight on the financial health of a specific company.

Investors might want to take a look at shares of Puma Biotechnology, Inc. (NASDAQ:PBYI) from a different angle. Lets take a peek at the current Q.i. (Liquidity) Value. Puma Biotechnology, Inc. (NASDAQ:PBYI) has a Q.i. value of 84.00000. This value ranks stocks using EBITDA yield, FCF yield, earnings yield and liquidity ratios. The Q.i. value may help identify companies that are undervalued. A larger value would indicate low turnover and a higher chance of shares being priced incorrectly. A lower value may show larger traded value meaning more sell-side analysts may track the company leading to a lesser chance that shares are priced improperly.

By DR Staff Writer

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Can Lilly Survive Rheumatoid Arthritis Flop With Breast Cancer Drug? – Investor’s Business Daily

April 18th, 2017 7:44 pm

AbbVie (ABBV) will get some breathing room in rheumatoid arthritis after Eli Lilly (LLY) and Incyte's (INCY) drug was hit with delays by the Food and Drug Administration over the weekend, leaving Lilly to instead focus on a Pfizer (PFE)-rivaling breast cancer med.

On Friday, theFDA asked for more dosing information for Lilly and Incyte's rheumatoid arthritis drug, baricitinib, causing what could be a lengthy delay in its release. So Lilly'sbreast cancer drug known as abemaciclib is now especially important for Lilly, Leerink analyst Seamus Fernandez said.

Abemaciclib could compete against Pfizer's Ibrance and Novartis' (NVS) Kisqali in the CDK4/6 inhibitor market. These drugs aim to inhibit a specific set of enzymes thought to be tied to breast cancer.

"In our Lilly model, we are currently forecasting $1.5 billion global sales of abemaciclib by 2026 with the overall CDK4/6 market reaching more than $10 billion," Fernandezwrote in a note to clients.

Fernandez said abemaciclib could be the next major catalyst for Lilly's stock. Phase 3 data on abemaciclib is expected in June.

"We believe abemaciclib's ability to dose continuously together with a safe and manageable tolerability profile likely will make abemaciclib highly competitive with Novartis' Kisqali and provide opportunities to differentiate from Pfizer's Ibrance on secondary efficacy measures like response rate," Fernandez said.

The analyst kept his outperform rating and 91 price target on Lilly stock.

Lilly shares toppled as much as 5.6% on the stock market today, closing down 4.1% to 82.38, below its 50-day ling and a 83.34 buy point. Incyte stock tumbled 10.5% to 126.07.The delay on baricitinib means it likely won't get FDA approval until 2018 and launch until 2019. That removes a near-term rival for AbbVie's Humira. It also puts Lilly/Incyte seven to eight years behind Pfizer's Xeljanz, and more in line with generic-like competition.

Analysts expect the drug to be delayed at least a year, and shares of Lilly and Incyte toppled early Monday. Baricitinib already has been approved for use in Europe.

While baricitinib is likely delayed, Fernandez expects $1.7 billion in peak U.S. sales when it is approved. And Lilly still benefits from sales in Europe where the drug has attained approval.

IBD'S TAKE:IBD's 43-company Ethical-Drugmakers industry group has risento No. 150 out of 197 groups tracked from No. 184 just four weeks ago. Head to IBD Stock Checkup for a list of the top-rated drugmakers.

Other analysts agreed on the one-year delay for baricitinib, but were more cautious on Lilly's breast cancer drug. BMO analyst Alex Arfaei called abemaciclib "the biggest remaining uncertainty for Lilly in 2017."He sees the data as likely to disappoint.

"We still have not seen much data that would indicate CDK4/6 inhibitors are meaningfully differentiated," he wrote in a report. "Data from (the American Association for Cancer Research) 2017 suggests abemaciclib is not as selective as ribociclib (Kisqali) and Ibrance."

Arfaei cut his price target on Lilly stock to 71 from 73, though he maintained his forecast for 5% sales growth for Lilly in 2017 on its diabetesdrugs Trulicity, Jardiance and Basaglar, and psoriasis drug Talz.

These drugs "should offset the decline of mature franchises," he wrote. "However, from 2015-20, we forecast revenue compound annual growth rate of 4%, below Lilly's guidance of 5% partly because more conservative assumptions for the mature franchises."

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Eli Lilly could do better than its rivals in diabetes drug sales. (Jonathan Weiss/Shutterstock.com)

4:36 PM ET Eli Lilly is set to outperform bigger drugmakers Novartis and Sanofi in terms of first-quarter diabetes sales.

4:36 PM ET Eli Lilly is set to outperform bigger drugmakers Novartis and...

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UA softball coach pitches in for arthritis center fundraiser – Arizona Daily Star

April 18th, 2017 7:44 pm

UA softball Coach Mike Candrea hopes to hit a home run in support of the University of Arizona Arthritis Center and its research efforts at the 2017 Bear Down Luncheon on April 26.

The affiliation between Wildcat athletics and the UAAC is a long-standing tradition that goes back to the early days of Lute Olson. Supporting the UAACs mission and efforts to defeat arthritis as a debilitating disease is a privilege for me, said Candrea, featured speaker at the event.

An eight-time NCAA champion who will be inducted into the coaching Hall of Fame this October, Candrea will share anecdotes and insights gleaned during 32 seasons. Candreas talk is sure to be unforgettable, said Paul Cicala, sports director at KVOA, who will serve as master of ceremonies.

I feel honored to be able to introduce Mike Candrea, who has had an amazing coaching career: He is a UA standout and he is going out of his way, along with doctors at the UAAC, to help others, said Cicala, one of the more than one million Arizonans battling arthritis.

Cicala, who has psoriatic arthritis, said he is proof arthritis impacts those of every age, including children and young adults. Psoriatic arthritis is a chronic inflammatory disease that occurs when the immune system mistakenly begins attacking healthy joints and skin.

I was in my mid-20s and in the best shape of my life. I could still dunk a basketball and I was lifting weights every day when I started having sharp pains in my legs that spread to the rest of my body. My digits on my hands and feet started swelling and they tested me for multiple sclerosis and many other ailments, but they never considered psoriatic arthritis, said Cicala.

Cicalas condition deteriorated rapidly. Walking caused extreme pain, he was unable to open jars or complete simple household tasks and it became increasingly difficult to work. When he was finally diagnosed with psoriatic arthritis, Cicala said the medications Enbrel and Methotrexate saved his life.

I am almost back to being the person I used to be and I am so thankful to the UAAC and all of the fine doctors who continue to do research to find treatments for arthritis. To this day I dont take walking for granted; I take pride in walking when I run errands, walking up A Mountain or Tumacoc Hill and doing other things I thought were taken away forever, he said.

Dr. C. Kent Kwoh, arthritis center director, said the center offers specialized care for patients who are living with cutaneous autoimmune diseases such as psoriatic arthritis, lupus, and scleroderma.

Kwoh said the centers multi-disciplinary approach, which includes bench-to bedside research, also utilizes specialists in orthopedic surgery, geriatrics, immunology, medical imaging, pharmacology, integrative medicine, epidemiology, public health, exercise, nutritional sciences, podiatry and biomechanics.

The list of specialists is expanding with the recruitment of new physicians and the centers ongoing distinction as Arizonas only rheumatology training program for medical students, medical residents and fellows. Kwoh attributes many positive developments to the partnership between Banner and University Medical Center and the continued support of the community and institutions such as the UA Department of Athletics.

There is a shortage of rheumatologists nationwide and here in Tucson. We want to continue to expand our programs to try to meet the need for caring for patients with arthritis in clinics where different specialties can practice together to provide specialized care in an academic medical center. This allows patients to see a number of specialists at the same time or on the same day, which is particularly important for patients with arthritis because these are multi-system diseases, Kwoh said.

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Ask the Doctor: Keloids, arthritis, ankle tenderness – WNDU-TV

April 18th, 2017 7:44 pm

Each Tuesday, Doctor Rob Riley joins us to answer viewers' medical questions. Here are the questions he addressed on April 18.

"I had a total thyroidectomy back in August. My scar turned into a keloid. What can I do to make the keloid go away?"

Dr. Riley: Keloids are thickened scars. When most people have surgery, the scar that forms can be pretty thin and flat and tends to fade over time. But some of us, due to our genetics, form big, thick keloids instead. They don't generally do harm, but understandably, people don't like the way they look. Silicone sheets can be obtained at the drug store without a prescription and may help keloids to flatten over time. In the office, we can inject these keloids with a cortisone-like preparation which is often effective. There's some evidence to suggest that freezing keloids in the office may be helpful, too. Unfortunately, surgically cutting the keloid out usually results in a new keloid forming, so that's usually tried as a last resort.

"I just found out I have arthritis so bad in my one knee it's bone on bone. I am taking meloxicam and starting therapy soon. Any other over-the-counter meds that will help this?"

Dr. Riley: Meloxicam is an anti-inflammatory medicationlike ibuprofen or naproxen. Some people find they do just as well or better with these over-the-counter meds as they do with the prescription versions. There's also something called capsaicin, which comes as a cream or gel, which can be applied directly over the painful joint several times daily, and some people get some relief from that. When things get to the bone on bone point, we certainly try all the medications possible plus physical therapy, but often times that's when we start to have the conversation about considering knee replacement surgery.

"I have a tender spot on the back of my right ankle that only hurts when I wear tennis shoes. What could that be?"

Dr. Riley: The most common causes of pain in that location are irritation of the Achilles tendon and bursitis from pressure on the little sac that sits just beneath the Achilles tendon. The tendon tends to hurt when the person is using that big calf muscle on the back of their leg, while the bursa is often tender to direct pressure in the area. Both of these are overuse issues, though, so the best initial approach is to back off on painful activity somewhat and give things a chance to heal. If a certain pair of shoes seems to make things worse, then probably the shoes are applying too much pressure in that area and should be avoided. If the simple things aren't taking care of things, a visit to the doctor may be in order. Some medications, some home exercises, and working with a physical therapist may all be effective for this problem.

Dr. Riley joins us from Memorial Family Medicine.

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Incyte, Eli Lilly Tumble As FDA Delays Arthritis Drug Approval – Barron’s (blog)

April 18th, 2017 7:44 pm

By Teresa Rivas

Incyte Corp. (INCY) and Eli Lilly (LLY) are both falling Monday, on news that the FDA issued a complete response letter concerning its rheumatoid arthritis treatment baricitinib, delaying approval.

The FDA didnt kill the drug, but it didnt approve it either, saying that more clinical trials would be needed to determine the correct dosage. Of course, more trials will increase the time and money that the companies will have to spend on baricitinib before its approval. Incyte and Lilly both said they are committed to working with the agency to get approval.

Plenty of analysts are weighing in on the stocks today.BMO Capital Markets M. Ian Somaiya reiterated an Outperform rating but cut his price target on Incyte to $144 from $170:

We are pushing out U.S. launch timelines for baricitinib by three years following CRL where FDA cited need for additional dosing and safety data, implying need for new trials. In our conversation, management suggested that the issue in the CRL was not raised previously by the FDA, nor was it the reason for the recent data submission. Our review of published data suggests that the issue could be related to increase in creatinine phosphokinase (CPK), which can be causing drug-induced myopathy (i.e., alectinib) and addressed via a REMS.

SunTrust Robinson Humphreys Peter Lawson reiterated a Buy rating but cut his price target from $160 to $145:

On Friday the FDA issued a complete response letter (CRL) for the NDA for baricitinib in moderate-to-severe rheumatoid arthritis (RA). This was unexpected considering the strength of the data which was published in highly respected medical journals, and the recent EU approval. The FDA is seeking additional clinical data to determine dose, and to further characterize safety. While still early, we have re-assessed our model, we have assumed a conservative 2 year delay in filing, lowered the probability of success in the U.S, and removed milestone payments.

Raymond Jamess Reni Benjamin reiterated a Market Perform rating on Incyte:

While the timing of the FDAs decision was on the PDUFA date, the CRL certainly came as a surprise to us and, we expect, many other investors given the recent approval of the drug by the European agency as well as the multiple positive phase III results generated during clinical development. Whats more surprising and concerning to us is the agencys request for additional clinical data to determine the appropriate doses and further address the safety concerns associated with the drug, a decision that both companies plan to appeal.

As for Eli Lilly, Credit Suisses Vamil Divan reiterated an Outperform rating but lowered his price target by $1 to $87:

While we like LLY for its diversified new product story, baricitinib is a key component of the story and the press release reads ominously to us. The FDA is requesting additional clinical data to determine the most appropriate doses and also to characterize safety concerns across various treatment arms. The timing of a resubmission is still to be determined but for now we assume it will take at least 12 months, pushing back a US launch to potentially 2019 or later. It will likely also limit the peak potential of the product given the competitive nature of the rheumatoid arthritis market and the fact that we expect PFEs Xeljanz will lose it US patent exclusivity by 2025, opening the door for generic oral JAK inhibitors to enter the US marketOur updated baricitinib estimates, including a 2019 US launch and peak 2025 sales of $1.2Bn in the US and $2.1Bn globally, led to our LLY target price reduction to $87 (from $88).

Incyte is down 11.2% to $125.03 in recent trading, while Eli Lilly is down 3.9% to $82.52.

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Supreme Court , including Gorsuch, to hear church-state case – WJLA

April 17th, 2017 11:44 am

by MARK SHERMAN and MARIA DANILOVA, Associated Press

In this photo taken Jan. 26, 2016, the empty playground at Trinity Lutheran Church in Columbia, Mo. Justice Neil Gorsuch's first week hearing Supreme Court arguments features a case that's giving school choice advocates hope for an easier use of public money for private, religious schools in dozens of states. The long-delayed argument Wednesday, April 19, 2017, deals with whether Missouri should pay for a soft surface at the church playground. (Annaliese Nurnberg/Missourian via AP)

WASHINGTON (AP) Justice Neil Gorsuch's first week on the Supreme Court bench features an important case about the separation of church and state that has its roots on a Midwestern church playground. The outcome could make it easier to use state money to pay for private, religious schooling in many states.

The justices on Wednesday will hear a Missouri church's challenge to its exclusion from a state program that provides money to use ground-up tires to cushion playgrounds. Missouri is among roughly three dozen states with constitutions that explicitly prohibit using public money to aid a religious institution, an even higher wall separating government and religion than the U.S. Constitution erects.

Trinity Lutheran Church of Columbia, Missouri, says its exclusion is discrimination that violates its religious freedoms under the U.S. Constitution.

If the justices agree, "the decision could have implications far beyond scrap tires and playgrounds," said Michael Bindas of the Institute for Justice, which is backing the church. "It has the potential to remove one of the last legal clouds hanging over school choice."

That prospect worries groups of public school teachers and others who oppose vouchers and other forms of public aid for private schooling.

Adding to the intrigue is the long delay between when the Supreme Court agreed to hear Trinity Lutheran's appeal, a month before Justice Antonin Scalia died in February 2016, and the argument. The span of more than 15 months suggests the justices were concerned they might divide 4-4. Indeed, the case wasn't scheduled for argument until after President Donald Trump nominated Gorsuch for the seat.

The timing of the argument "heightened our concern that the court has held this case for so long," said Alice O'Brien, general counsel of the National Education Association, which opposes state aid to private schools.

Missouri's new governor, Republican Eric Greitens, injected some uncertainty into the high court case on Thursday, when he directed state agencies to allow religious groups and schools to receive taxpayer money for playgrounds and other purposes. The court on Friday asked both the church and the state to tell it whether the governor's announcement affects the case.

A lawyer for the church said in an interview with The Associated Press that the case would be unaffected because Greitens' policy change does not resolve the legal issue. But a top aide to state Attorney General Josh Hawley told the AP that state lawyers were evaluating whether the new policy would affect the case.

Should the court decide to go forward, Gorsuch's votes and opinions in religious liberty cases as a judge on the federal appeals court in Denver would seem to make him more inclined to side with the church, and potentially provide the decisive, tie-breaking vote if the rest of the court is divided between liberals and conservatives, Bindas said.

The case arose from an application the church submitted in 2012 to take part in Missouri's scrap tire grant program, which reimburses the cost of installing a rubberized playground surface made from recycled tires. The money comes from a fee paid by anyone who buys a new tire. The church's application to resurface the playground for its preschool and daycare ranked fifth out of 44 applicants.

But the state's Department of Natural Resources rejected the application, pointing to the part of the state constitution that says "no money shall ever be taken from the public treasury, directly or indirectly, in aid of any church, sect or denomination of religion."

A recycled scrap tire is not religious, the church said in its Supreme Court brief. "It is wholly secular," the church said.

Leslie Hiner, vice president of programs at Ed Choice, a school voucher advocacy group said, "It is difficult to understand that a little school could not participate in a safety measure determined by the state because somehow safety of children is conflated with religious purpose."

But the question of where the dividing line should be between church and state is complicated, said the NEA's O'Brien.

The Supreme Court has upheld some school voucher programs and state courts have ratified others. But "in many instances challenges to voucher programs have succeeded based on state court views that their constitutions draw a different line than does the federal constitution," O'Brien said.

Thirty states and the District of Columbia have some form of school choice, including vouchers, tax credits and education savings accounts, according to Ed Choice.

The justices could themselves draw a line that decides the case in Missouri without saying anything more broadly about school choice.

But that issue already is looming at the high court in appeals from a Colorado Supreme Court ruling that blocked the nation's first county-initiated voucher program in Douglas County, Colorado.

The Missouri church and some of the groups backing it have invoked what they describe as anti-Catholic bias that motivated the adoption of the Missouri provision and similar measures in other states in the late 1800s. They are similar to the proposed 1875 Blaine Amendment to the U.S. Constitution that would have prohibited the allocation of public school funds to religious institutions.

"Both the Colorado and Missouri Blaine Amendments share discriminatory, anti-Catholic origins that make their contemporary use to compel religious discrimination particularly unacceptable," lawyer Paul Clement wrote on behalf of the Colorado county.

But 10 legal and religious historians said in a separate court filing that there is no evidence that "anti-Catholic or anti-religious animus" played a role in the adoption of the Missouri constitutional provision. And they said anti-Catholicism was a minor factor behind the Blaine Amendment. The broader debate was about the future of American education, they said.

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Book Review: Notes On Blindness: A Journey Through The Dark by John Hull – Press and Journal

April 17th, 2017 11:44 am

If you are a sighted person and wonder what it might be like to lose the visual world, the gripping Notes On Blindness will challenge your preconceptions about the condition and leave you reeling at the complexities of a life deprived of sight.

Writing movingly of how he finally came to identify as a blind person and relinquish those things every sighted person takes for granted, the academic Hull who died in 2015 has a flair for evoking the sensations, ironies and even moral quandaries of the blind (how to escape tedious conversations at parties when you cant see a friend to head for?).

First published in 1990 under the title Touching The Rock, this edition ties in with its BAFTA-nominated cinematic namesake, and contains an introduction by Cathy Rentzenbrink.

As an account of dealing with disability, it remains as visceral and lucid as it did when first published.

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Puma Biotechnology Announces FDA Advisory Committee to … – Business Wire (press release)

April 17th, 2017 11:43 am

LOS ANGELES, Calif.--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on May 24, 2017. Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen.

ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.

Puma Biotechnology announced on September 20, 2016 that the FDA had accepted for filing the NDA for neratinib. The NDA for neratinib is based on results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements: This press release contains forward-looking statements, including statements regarding the ODACs scheduled review of the NDA for neratinib. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

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M3 Biotechnology Raises $1.4M in Second Funding Round – FinSMEs (blog)

April 17th, 2017 11:43 am
M3 Biotechnology Raises $1.4M in Second Funding Round
FinSMEs (blog)
M3 Biotechnology, a Seattle, WA-based therapeutics company, raised $1.4m in a second funding round. Backers included Dolby Family Ventures and the Alzheimer's Drug Discovery Foundation (ADDF). The company, which has raised $14M in total financing ...

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M3 Biotechnology Raises $1.4M in Second Funding Round - FinSMEs (blog)

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Home Market Research Worldwide Biotechnology Separation Systems Market Projected to reach USD XXXX million at… – Edition Time

April 17th, 2017 11:43 am

Market.Biz: Research Report on Biotechnology Separation Systems Industry 2016 provides the analytical view of the Biotechnology Separation Systems industry globally, focusing on main regions like North America, Europe, and Asia. Amongst these continental Biotechnology Separation Systems market, the report focuses on Biotechnology Separation Systems market by countries like United States Biotechnology Separation Systems market, Germany Biotechnology Separation Systems market, Japan and China Biotechnology Separation Systems market.

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1) Report on Biotechnology Separation Systems industry covers growth rate (forecast). 2) Worldwide Biotechnology Separation Systems market 2017 estimated at USD XXXX in 2016. 3) Global Biotechnology Separation Systems industry 2017 projected to reach USD XXXX million at forecast period. 4) Worldwide Biotechnology Separation Systems market projected to grow at CAGR XXXX % During forecast period. 5) Continental Biotechnology Separation Systems Market: (North America, Europe and Asia) Biotechnology Separation Systems market expected to grow at CAGR of XXXX % over the forecast period. 6) 2017 Biotechnology Separation Systems Market Segment by Manufacturers, which covers all details related Biotechnology Separation Systems industry Manufacturers/Companies.

Lastly, 2017 Biotechnology Separation Systems industry report adds the feasibility study related to the futuristic Biotechnology Separation Systems market scenario, SWOT analysis of Biotechnology Separation Systems industry and investment return analysis. The report introduced Biotechnology Separation Systems new project SWOT analysis, investment feasibility analysis, and Biotechnology Separation Systems industry investment return analysis and Biotechnology Separation Systems growth aspects of the industry.

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This Biotechnology Separation Systems market study consists of 6 parts, in the 1st part the basic information about Biotechnology Separation Systems , in the 2nd part analysis of the Asia Biotechnology Separation Systems industry; in the 3rd part analysis of North America Biotechnology Separation Systems industry is done; in the 4rth part analysis of the Europe Biotechnology Separation Systems industry is done; 5th part does the analysis of feasibility study and scope of Biotechnology Separation Systems market future investment; in 6th part research conclusions are offered.

Thus, this research report on Biotechnology Separation Systems industry provides the insightful knowledge on current Biotechnology Separation Systems market trends.

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Home Market Research Worldwide Biotechnology Separation Systems Market Projected to reach USD XXXX million at... - Edition Time

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iShares NASDAQ Biotechnology Index (IBB) Upgraded at Vetr Inc. – Markets Daily

April 17th, 2017 11:43 am
iShares NASDAQ Biotechnology Index (IBB) Upgraded at Vetr Inc.
Markets Daily
iShares NASDAQ Biotechnology Index logo Vetr upgraded shares of iShares NASDAQ Biotechnology Index (NASDAQ:IBB) from a hold rating to a buy rating in a research note released on Wednesday. They currently have $301.57 target price on the stock.

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Lilly and Incyte Fall After FDA Rejects Potential Blockbuster for … – TheStreet.com

April 17th, 2017 11:42 am

Eli Lilly & Co. (LLY) and Incyte (INCY) chose to disclose the FDA rejection of their rheumatoid arthritis pill baricitinib on Friday, a market holiday, so the repercussions from the regulatory setback are hittingboth stocks Monday.

Lilly shares were down just over 4% to $ 82.33through mid-morningtrading, while Incyte shares were down just over 11% to $125.09

Baricitinib was expected to secure U.S. approval and deliver $2 billion or more in peak sales as the most effective, once-daily oral JAK inhibitor for rheumatoid arthritis, supplanting Pfizer's (PFE) Xeljanz.

Those plans are now on hold indefinitely. In a statement, Lilly said the FDA's complete response letter included a request for additional clinical data to determine appropriate doses of baricitinib. The FDA also asked for more safety data.

Lilly and Incyte said they disagree with the FDA's conclusions and plan to resubmit baricitinib for another shot at approval. A timeline for resubmission was not provided.

The European Medicines Agency approved baricitinib for the treatment of rheumatoid arthritis in February. The drug is marketed there under the brand name Olumiant.

Piper Jaffray analyst Josh Schimmer downgraded Incyte to neutral and cut his price target to $124 from $140. "Incyte has a differentiated flagship product in Jakafi, a leading management team, a strong R&D engine and strategic sense, and still strong growth prospects. But baricitinib in the U.S. was an important part of the valuation and outlook for us," Schimmer wrote, in his downgrade note.

Leerink analyst Michael Schmidt said baricitinib contributes 18%, or $25, to his Incyte $141 price target. "We expect Incyte shares to be weak on Monday given that approximately one-year U.S. approval delay now seems likely in our view, in a best case scenario," Schmidt said in a research note.

Lilly licensed baricitinib from Incyte in 2009. The pharma giant took the lead on the drug's development, conducting all the clinical trials and handling regulatory duties. Lilly retains the bulk of baricitinib's sales under the Incyte licensing deal, so the FDA rejection hits the pharma giant -- desperate for new blockbuster drugs -- particularly hard.

Lilly reiterated 2017 earnings guidance but has not said how the baricitinib setback will impact its 2018 financial outlook.

Why FDA turned away baricitinib is not entirely clear, although analysts speculate regulators picked up a concerning safety signal with the higher 4 mg dose. Pfizer faced the same problem with Xeljanz before FDA ultimately approved a lower dose.

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