StemCell Therapy

Skyler Simpkins 23

Opinion Editor

When all other options fail, acupuncture is often recommended for those suffering unbearable neuropathy. My father, who was diagnosed with pancreatic cancer last year, developed severe neuropathic symptoms as a side effect of chemotherapy. His doctors recommended that he receive acupuncture after a plethora of other treatments showed no improvement. The appointment was made and my father was optimistic. A short time before the appointment, the therapist called him and cancelled his appointment due to suspicion of coronavirus infection. The only basis the therapist had for cancelling treatment was that my dad had recently traveled to Florida, a coronavirus hotspot. My father was denied life-altering treatment due to mere suspicion. It was at this moment that I saw the effect of coronavirus anxiety on the health of a loved one, and I quickly realized an egregious problem in our modern, pandemic-defined society.

In the age of coronavirus, we have seen the reemergence of infectious disease discrimination. While this discrimination has always existed, it is now more prevalent and apparent than ever. This can be experienced on a daily basis when wefor examplevisit a store or take public transportation. I would believe that most of us would agree with this, as do I, because these are private businesses enforcing their own jurisdiction over their property. Also, many of us would agree that this discrimination is better for the world since it is helping prevent the spread of coronavirus. But what about healthcare institutions like the one mentioned in my example above? Should private healthcare institutions be allowed to discriminate based upon coronavirus suspicion? While legally these institutions have the right to discriminate upon the basis of infectious disease, healthcare professionals have a much higher ethical obligation to the patient that overrides any legal or constitutional argument applicable.

There are two fields of thought to ponder in this argument over the right to discriminate over infectious disease. First, the legal and second, the ethical.

Legally a privately owned American business has the right to discriminate on the basis of infectious disease precaution. As stated above, I wholeheartedly agree with this right as it protects the community (if they choose to disallow those potentially exposed to or with coronavirus) and protects the sanctity of privately-owned business. Its when these private businesses are based around health care that I perceive a startling reality.

The Hippocratic Oath calls upon physicians to swear to uphold ethical standards in regard to their medical practices. This oath holds physicians to do what is good for the patientsand one could assume that this promotes anti-discriminatory practices. While not all medical students and doctors explicitly swear upon the same oath, we could extrapolate the premises of this oath to the plethora of others sworn by medical professionals every year.

When a doctor sees a patient in need, they should treat them as it is their ethical responsibility to do so. Today, many doctorsmostly in private practicesdeny patients out of fear of a coronavirus outbreak. While some may say this is out of caution and for the greater good, the physician denigrates the patient in favor of their own personal safety. Some may argue that the physician is protecting the community as well as themselves; however, if we start to care only for the greater good, we put the most helpless and feeble in danger.

When a healthcare worker enters into their field of work, they accept a formidable taskwhether literally or theoretically. Healthcare workers devote themselves to their patients and those in need. They help without discriminationespecially when its the most helpless. Why, then, do healthcare workers in private institutions neglect these standards when infectious disease is introduced? While I understand physicians are not contractually bonded to these standards, these standards are bound to their work. When physicians deny individualslike my fatherthey lose their perceived higher moral standing in society. These physicians that neglect the individual are no more of an upstanding citizen than the lay people as they care only for themselves when anxiety is high.

If we allow healthcare workers in privatized businesses to neglect their ethical obligations, we permit the societal abandonment of the most needy. We must remind healthcare workers of their obligations and their predecessor Hippocrates who would look down with shame at how these physicians and specialists are conducting their work. We must protect those discriminated against and ensure the care of allunhealthy or wellin these trying times of uncertainty and fear.

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Infectious Disease Discrimination and the Coronavirus - The Trinity Tripod

Childrens Health Defense

Special to Valley News

The law firm of Baum Hedlund Aristei & Goldman filed a lawsuit Wednesday, Sept. 16, against pharmaceutical giant Merck on behalf of a young man, Zachariah Otto, who was allegedly injured by Gardasil, Mercks HPV vaccine. The complaint seeks damages, including punitive damages, for negligence; strict liability or failure to warn; strict liability or manufacturing defect; breach of warranty; common law fraud and violation of Californias unfair competition law.

Otto claimed in the lawsuit that multiple Gardasil injections, which he first received at the age of 16, caused him to develop life-altering injuries, including dysautonomia, postural orthostatic tachycardia syndrome, orthostatic intolerance, small fiber neuropathy, chronic fatigue syndrome, mast cell activation syndrome, autoimmune disease and fibromyalgia, as well as a constellation of other serious health issues. POTS is an autoimmune condition that impacts the autonomic nervous system, which automatically regulates critical bodily functions, and the sympathetic nervous system, which is involved in the fight or flight response. POTS symptoms include fainting, migraine headaches and anxiety among many other serious conditions.

The plaintiff said the Gardasil-induced injuries have made him disabled to a point where he can no longer work and cannot physically attend college. His mother said it was Mercks intense Gardasil marketing campaign that encouraged her to have her son get the shots. Otto and his mother said that had they known of the serious risks associated with this vaccine, they would have never gone forward with the shots.

Merck fast-tracked Gardasil by presenting misleading data to the FDA and fabricating a health crisis, Ottos co-counsel Robert F. Kennedy, Jr. said. They claimed they were filling an unmet medical need but in reality, the only thing Merck was interested in filling was the $6 billion financial hole created by the Vioxx scandal.

Gardasil is racking up a long list of young women and men who were similarly harmed following vaccination with Mercks product. Childrens Health Defense has also been following the case of former athlete and scholar Jennifer Robi, who filed a lawsuit for Gardasil injuries against Merck in 2016. Robi is a 25-year-old woman who has been confined to a wheelchair since receiving her third Gardasil vaccine at age 16. Like Otto, she was diagnosed with POTS after receiving the series of Gardasil shots. Her attorneys alleged that Gardasils amorphous aluminum hydroxyphosphate sulfate adjuvant can over-stimulate the immune systems of vaccine recipients, tipping them into autoimmune conditions in which their redlining immune defenses begin attacking their bodies own organs. The autoimmune process allegedly caused a cascade of illnesses that, in Robis case, resulted in damage and deterioration in diverse organ systems throughout her body.

Colton Berrett, featured in the documentary film Vaxxed II, was another victim of Gardasil injury. Berrett was an active 13-year-old when he received the series of shots as advised by his physician before leaving for Boy Scouts camp in 2014. Two weeks after his third dose of Gardasil, Berrett experienced a sore neck followed by paralysis in his arms and hands. The paralysis continued to other parts of his body ultimately making Berrett completely paralyzed from the neck down and ventilator dependent through tracheostomy. Though he fought hard, he never recovered, and in January 2018, Berrett removed himself from the need of life support or the ventilator.

In this latest Gardasil lawsuit on behalf of Otto, Baum Hedlund accused Merck of knowingly and recklessly placing Gardasils profits ahead of patient safety. The team asked for punitive damages to deter Merck from withholding information on the serious adverse events associated with Gardasil while promoting it as safe and effective.

Most people think Gardasil is for girls, but since 2009, Merck has made billions in profit by marketing the HPV vaccine to the parents of boys and to young men, attorney Nicole K.H. Maldonado said. Through its advertising, Merck sold parents on the idea that Gardasil is a safe and effective tool to stop the spread of HPV and prevent cervical cancer. But Merck knew that Gardasil was neither safe nor effective at preventing cervical cancer, and worse, the company knew that Gardasil could cause a host of serious health issues.

Sign up for free news and updates from Robert F. Kennedy, Jr. and the Childrens Health Defense. CHD is implementing many strategies, including legal, in an effort to defend the health of our children and obtain justice for those already injured.

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Lawsuit filed against Merck on behalf of young man allegedly injured by Gardasil - Valley News

The dramatically falling costs of renewables are now a political, a media, and conversational clich. However, the claim is demonstrably false. Audited accounts show that far from getting cheaper, wind power is actually becoming more expensive. The failure of the British civil service to detect this fact and, hence, to protect the consumer and taxpayer from the consequences of the looming failure of the renewables sector raises important questions about the analytic competence of the Whitehall machine.

If we asked a random sample of broadsheet newspaper readers about the economics of offshore wind, it is practically certain that a majority of those interviewed would say they believed it was now cheap. A similar survey of investment analysts and advisors might return the same answer. Politicians and journalists would be certain about the matter. However, if pressed for evidence none of these groups could do much more than point to secondary sources. Some might remember that the Greenpeace sponsored an extensive advertising campaign in 2017, with full page adverts in the press. Others might point out that official bodies present offshore wind as the cheapest source of electricity. Those in financial circles might also indicate that almost every report or lengthy article on the future role of offshore wind power is accompanied by a chart which claims to show the rapid decline of costs over the last one or two decades, perhaps with forward projections to 2030 or 2040.

Incredible though it may seem, none of this is true. Neither offshore nor onshore wind has become cheaper; indeed, both have become more expensive over the last two decades.

How do we know this? Because one of us, Gordon Hughes, has compiled data from audited accounts on the capital and operating costs of 350 onshore and offshore wind farms in the United Kingdom, a set which covers the majority of the larger wind farms (> 10 MW capacity) built and commissioned between 2002 and 2019. It is the largest study of its kind to date and will be published shortly by the charity Renewable Energy Foundation, which John Constable directs.

In summary, analysis of the data reveals unequivocal findings:

There is an important corollary to these findings. The current set of offshore projects being constructed and planned in North Western Europe are closely akin to speculative property development. They are high risk projects that will only be able to repay lenders and offer a return to equity investors if the average wholesale market prices of power rise to at least three to four times their current level throughout North West Europe. Such a price surge would require either a large and permanent increase in the market price of gas, which experience suggests is very unlikely, or carbon taxation at 8 to 10 times current levels, rising to at least 200 per tonne of carbon dioxide at 2018 prices in 2030. Such a tax would place a heavy burden on the rest of the economy.

This has consequences for financial regulation. To discharge their responsibilities financial regulators ought to impose a heavy risk weighting on loans to offshore wind farm operators, while also advising that green equity investments are too risky for pension funds and small investors. Instead, the chiefs of the European Central Bank (ECB), the Bank of England and other regulators have urged more investment in green assets without acknowledging the risks involved.

This leads to the prospect of what is not so much a car crash as a motorway pile up in the fog of ignorance. The looming crisis will require that those who finance wind power and its related ecosystem of companies are bailed out by either taxpayers or electricity consumers. The scale of the bailout would be large: about 30 billion is at risk in the UK wind sector alone, with significantly more in Germany, the Netherlands and Denmark.

Some wind industry players may be aware that specific projects are not performing in line with general expectations there is no lack of examples reported in specialist media. However, until very recently investors have been protected by generous subsidies and operators are likely to blame project-specific factors rather than realising that the entire sector is affected. In addition, the industry in general seems believe its own propaganda, for which basic error they have only themselves to blame.

Government, we suspect, is genuinely confused. On the 24th of August while we were preparing this summary for Briefings for Britain the Department of Business, Energy and Industrial Strategy (BEIS) published its latest set of electricity generation cost estimates, Electricity Generation Costs.[1] It recommits BEIS to the view that the costs of wind power have fallen and that this technology is now amongst the cheapest available.

However, it is not difficult to show that the BEIS analysis is wholly, almost pitifully, inadequate and that it cannot be relied upon. We will discuss it in some detail below because the mistaken view that it gives of wind economics is important in itself. Even more, it provides a graphic illustration of the truly wretched quality of the analytical work that underpins policy decisions with vast implications for the United Kingdom and its people.

Before making more detailed observations, we note two general aspects of the BEIS study. First, it purports to provide estimates or forecasts of electricity generation costs for projects commissioning in 2025, 2030, 2035 and 2040. While costs at the nearest of these dates can be estimated rationally, costs a decade or more in the future are radically uncertain. To attempt even moderately precise costings, as BEIS does, suggests naivety or hubris. Who in 2000 or even in 2010 had any realistic basis for forecasting the capex and opex costs for projects that are being commissioned in 2020?

Furthermore, on examining the accompanying spreadsheet containing the Departments detailed assumptions it turns out that 94 per cent of the model parameters for the various technologies, conventional and renewable, do not change from one period to the next. This is implausible, since it must presume that there is no technological progress in those fields. Where costs do vary they are for either (a) wind and solar, or (b) a range of minor (Geothermal CHP) or novel (wave, biomass with CCS) technologies. This is unreasonable. If there are cost reductions in the renewable sector, why rule out cost reductions in the conventional sector?

Looked at in more detail this underlying bias is quite extraordinary. The rates of decline in capex and opex costs or increases in operating performance for offshore wind now a mature technology are greater and more sustained than the decline for CCGT+CCS a new and potentially critical technology.

Consequently, the BEIS projections of short-term costs are almost trivial, merely generic costs for the middle of the current decade, while the estimates of relative costs of conventional and renewable generation in the medium and longer term are at best meaningless and at worst misleading.

A second general point that should be noted is that the data used in the BEIS model is almost entirely derived from work conducted by or for the department itself. With the exception of a single reference to a National Grid ESO report, all of the sources cited for the data are BEIS publications or BEIS-commissioned reports. No attempt has been made to draw upon the growing academic and policy literature on the actual costs of building and operating various kinds of generation. There is not even a single reference to the extensive studies undertaken by the Energy Information Agency (EIA) in the US and various of the research laboratories funded by the US Department of Energy (DoE) for the example the Lawrence Berkeley National Laboratory (LBNL), the National Renewable Energy Laboratory (NREL) or the Oak Ridge National Laboratory (ORNL). Such a narrow focus is hard to justify, and indeed begins to look like a deliberate blindness in which all data is selected to fit with a pre-determined narrative.

And of course it is also true that BEIS has not made any effort to undertake the empirical investigation of audited accounts that forms the data behind the Hughes study summarised above.

Bearing these general remarks in mind, we will now compare some of the specific assumptions in the BEIS study with the results of the data compiled for this and other studies.

Conveniently BEIS has adopted the same base year (2018) for real prices as the one used for the Hughes database, so there is no need for adjustment. We will start by examining capex costs and then opex costs before looking at load factors and financial parameters. In all cases we will use the BEIS assumptions for projects commissioned in 2025, since, as noted above, the BEIS estimates for later dates are mere speculation. We will focus on onshore wind, offshore wind and large scale solar as those are the primary technologies for which BEIS has updated its assumptions and for which comparisons with actual data from company accounts are possible.

Reviewing the deficiencies of the UK governments latest estimates of generation costs we are left with a puzzle. The assumptions which underpin the BEIS estimates of the cost of generation for wind and solar power are fanciful, and do not withstand even cursory scrutiny; under close analysis they disintegrate and are a disgrace to the civil service and an embarrassment to ministers. Indeed, they are so far from the actual costs incurred by current operators and recorded in audited accounts that they are not worth further consideration, except as evidence for fundamental civil service reform. The review preceding that reform should ask how a heavily funded and staffed government department in a major economy can have strayed so far from the real world in a matter of such importance as energy supply. What on earth is going on?

The behaviour of the commercial entities involved in the renewables sector is also puzzling. If the empirical evidence is so clear, why are large companies committing substantial capital to very large projects that are almost certain to make a loss under anything like current market conditions? There are three factors that may explain this behaviour:

Once economic reality becomes undeniable, there will be a huge lobby to pass on the full costs of offshore wind to either electricity consumers or taxpayers. The obvious instrument is carbon taxation, but the increase required would be very large, and the economic harm would be politically contentious to say the least. Vast bailouts to an industry that has misrepresented its economics, whether knowingly or not, will be extremely unpopular. A government trapped between intense political opposition and the ever-widening ramifications of the financial collapse of the offshore wind sector will behave in ways that cannot be predicted confidently, but investors in renewables should be very nervous.

Gordon Hughes is Professor of Economics at the University of Edinburgh

Dr John Constable is Director of the Renewable Energy Foundation.

[1] BEIS, Electricity Generation Costs (24 August 2020). https://www.gov.uk/government/collections/energy-generation-cost-projections?utm_source=2deef6b5-8bc2-4b0b-a6a7-eecc4f289432&utm_medium=email&utm_campaign=govuk-notifications&utm_content=daily#2020

[2] https://www.gov.uk/government/publications/cost-of-capital-update-for-electricity-generation-storage-and-dsr-technologies

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Excerpt from:
The Costs of Offshore Wind Power: Blindness and Insight - Briefings For Britain - Briefings For Brexit

The season 1 finale of Netflix's hit TV series saw the Atlas crew complete the first half of their mission but with significant complications.

WARNING: The following contains SPOILERS for Away,season 1.

The Netflix Original TV showAwayends with a twist forRussian cosmonautMishaPopov and the situation is likely to get worse as the Atlas crew continues their mission on Mars in season 2.Awaystars Hillary Swank as Emma Green, the NASA astronaut leading humankind's first manned mission to Mars. Emma must lead her international team through multiple challenges during the 3-year trip; one such challenge is the revelation that Misha, the ship's most veteran crew member and an engineer, is rapidly loosing his ability to see.

While Netflix hasn't officially orderedAwayseason 2 yet, viewers can expect a renewal based on the show's enduring popularity.Awayis a drama series that premiered on the streaming platform on September 4, 2020. Since its debut, the show has gained a strong following online, and quickly rose to the top of Netflix's Top 10 charts.

Related:Netflix: Every Movie & TV Show Releasing In September 2020

TheAwayseason 1 finale gave the Atlas crew a much-needed win after 10 episodes of drama, tension, and general adversity. The first half of their journey was fraught with challenges even before the mission began in earnest, Emma was faced with the impossibly-difficult decision of choosing between completing her life's ambition and being present for her family during her husband's medical crisis. Realizing that staying behind would ultimately do more harm than good, she chose to proceed with the mission as planned a decision she grappled with throughout season 1. Like Emma, Misha too faced familial difficulties, but unlike his captain, his career pursuits resulted in him becoming estranged from his daughter. To add salt to the wound, season 1 gradually revealed another unfortunate ramification of his extended bouts in space: Misha has developed space blindness.

Awaymay be a fictional show, but it's based on real science. Nasahas admittedthat deep space travel may cause blindness or visual impairment in astronauts. Astudypublished in 2012 found evidence of eyeball deformities in astronauts who had been in space, and posited that that the microgravity astronauts are exposed to on long-duration missions can cause permanent changes to the optic nerve region in other words, the pressure from space flight gradually flattens the back of the eye, which in turn makes one increasingly far-sighted. This is what happens to Misha in Awayseason 1, who at one point tells fellow astronautVivian Wu that he can no longer see her face, describing it as "like an out-of-focus painting." Given that he is an engineer and previously was responsible for fixing complex machinery, his inability to seeobjectsat a close range is a significant hurdle.

Continue reading here:
Away Season 2: What Misha's Space Blindness Means For The Mars Mission - Screen Rant

This true story of resilience comes as the pandemic creates a need for greater resilience in everyone.

KNOXVILLE, Tenn Growing up in Knoxville, Chad Foster always knew that he had Retinitis Pigmentosa. And he knew the inherited genetic disorder would eventually take away his sight.

But then it actually happened when he was a student at the University of Tennessee.

"A lot of kids are asked a question when they're growing up, what do you want to be when you grow up? And none of them, and I mean none of them, said they want to grow up to be a blind guy," he said.

For a year or so he felt sorry for himself. Then he made a decision.

"I'm not responsible for my blindness, but I have to be accountable for my life and its outcomes," he said. "I have to figure out how to improve upon or how to control what's what I call inside my sphere of influence, how can I change what I can control? How can I paint a picture of my future that includes this unchangeable fact of blindness? How can I take that and then paint the vision for myself? That's something that I can get behind and get inspired to actually chase my dream."

He was 38 years old when his friend, Paul, suggested that Chad try downhill skiing.

"And I said, 'I don't know. That doesn't sound very safe, Paul.' He said, 'no, they actually have guides that can guide you down the mountain. And, you know, safely in quotes, right? That sounds interesting, I'll consider it,'" he said.

To get down the mountain, a guide follows behind him telling Chad which way to turn so he doesn't smash into trees or other skiers.

"And the texture of the voice tells you something, too. So if there's a real severe voice inflection, you know that you're on the razor's edge. So you should probably carve and really dig in to it," he said.

"I feel free. You know, for so many years I've been tethered to either a dog or a cane or something like that and out there on the mountain, you're completely free."

Conquering the slopes is not surprising.

At the University of Tennessee, Chad Foster made straight As and the Deans list and was later honored as a distinguished alumni.

He built a successful career in technology, software innovations, and motivational speaking.

He was the first blind executive to graduate from the Harvard Business School's Leadership Program.

"A lot of people can benefit from the tools and techniques that I've developed in overcoming my personal adversity, my personal adversity of going blind, and then the changes that we've seen in the business world, and the environments that I've worked in," he said. "So I've really tied that together in Blind Ambition to help people learn how to move their mindset from victim to visionary."

The book comes out in February. He's scheduled a ski trip for January. It seems like a natural way to start 2021 for a guy who knows how to pick himself up again.

"You're going to fall and if you're trying to do something great whether it's you know achieving what you want in the academic or business world or you know skiing a black diamond, you're probably going to fall in pursuit of that and you have to get comfortable with the idea that eventually I'm going to fall and it might hurt every now and then but I'll be okay," he said.

Visit link:
Knoxville native writes Blind Ambition: How To Go From Victim to Visionary - WBIR.com

On the surface, The Impending Blindness of Billie Scott is simply a coming-of-age story, a sweet and delightful portrait of the wild and wonderful people you can encounter in your early twenties, provided youre amenable. As the title implies, the titular Billie Scott is about to go blind. That would likely panic just about anyone, but Billie has the additional complication of needing to complete ten paintings for a prestigious art gallery before a two-week deadline (imposed by her impending loss of vision) is up. So she forges ahead, out of her comfortable but claustrophobic life in a student flat and out into the world, finding people to paint as she goes.

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Zoe Thorogood, not so far in age from Billie, has created a book thats rich with detail without feeling fussy or overly refined. Theres a panel early on where the reader can see the bottom of Billies coffee mug, which features an intact UPC sticker, the sort of detail that grounds and humanizes a large and sometimes complicated story. The books backgrounds are filled with a cacophony of posters and people and mess, lending Billies adventure a tight and confined feeling, even after shes left the borders of her tiny room. The book is largely in grayscale, with swaths of one or two accent colors that change with the scenes and help set the tone for every interaction. The art is lovely but doesnt shy away from grime or the truly absurd, and the story is stronger for it.

Every character is drawn with a level of detail that tells you a lot about them from the moment they appear, but are still given space to surprise readers with their needs and motivations. Billies sketchbook fills quickly with drawings and observations about each one, guiding the reader to view them through her perspective as a young person who might not be aware of just how vulnerable she really is. Thorogood continues this delicate tightrope walk by giving Billie a supporting cast thats neither completely threatening nor saintly, but simply human. Her roommates are friendly despite her long-term avoidance of them, and her encounters throughout the book run the gamut from warm to awful: Shes embraced by a chaotic group of drunk women at a bachelorette party, but shes also robbed and assaulted. Overall, there are more people willing to come to her aid than want to take advantage of her, which feels honest to the world in which Billie lives.

Image: Zoe Thorogood

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Its clear that her navet and unwillingness to trust people are both hindrances to her safety and progress, and Thorogood navigates this complicated idea very well. Billie is granted space to really screw up and make mistakes, but also given second and third chancesopportunities to not only reevaluate and redefine her goals, but also reach them. Its a touching exploration of what it means to make art and how to find your people, and why both things are important. To quote Billies friend Rachel, its about why you should care.

Theres a period towards the end where the metaphors and imagery Thorogood has used thus far give way to something more explicit, and it veers towards preachiness. Billie herself even makes a joke about how cringe-inducing some of it is, which helps to defuse the awkwardnessbut its definitely not as graceful as the vast majority of the book. It feels like Thorogood doesnt trust the readers, or herself, enough to come to the books conclusions on their own, which is a shame; her storytelling up to that point is far more confident and deft than she seems to believe it was. Given this is her first published book, theres no doubt shell continue to hone her craft and use her skills for future projects that will surpass even this great book.

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The Impending Blindness of Billie Scott tells a poignant story of youth, art, and purpose - The A.V. Club

TipRanks

In the investing game, its not only about what you buy; its about when you buy it. One of the most common pieces of advice thrown around the Street, buy low is touted as a tried-and-true tactic.Sure, the strategy seems simple. Stock prices naturally fluctuate on the basis of several factors like earnings results and the macro environment, amongst others, with investors trying to time the market and determine when stocks have hit a bottom. In practice, however, executing on this strategy is no easy task.On top of this, given the volatility that has ruled the markets over the last few weeks, how are investors supposed to gauge when a name is flirting with a bottom? Thats where the Wall Street pros come in.These expert stock pickers have identified three compelling tickers whose current share prices land close to their 52-week lows. Noting that each is set to take back off on an upward trajectory, the analysts see an attractive entry point. Using TipRanks database, we found out that the analyst consensus has rated all three a Strong Buy, with major upside potential also on tap.Progenity (PROG)Offering clear and actionable genetic results, Progenity specializes in providing testing services. The company started trading on Nasdaq in June and saw its shares tumbling 44% since then. With shares changing hands for $8.11, several members of the Street recommend pulling the trigger before it heats up.Piper Sandler analyst Steven Mah points out that even against the backdrop of COVID-19, PROG managed to deliver with its Q2 2020 performance. We are encouraged by the recovery in late Q2 2020 with 75,000 accessioned tests (~79,000 in Q1 2020), driven by noninvasive prenatal testing (NIPT) and carrier screening, the analyst noted. Expounding on this, Mah stated, Progenity did not provide guidance, but June test volumes of ~28,000 were strong (Q1 2020 monthly average was ~26,000) which we believe showcases the durability of its reproductive tests and the success that Progenity has in co-marketing and attaching carrier screening to the more essential NIPT. Of note, despite the pandemic disruptions, Progenity was able to maintain its leading pre-COVID test turnaround times.Additionally, health insurer Aetna is temporarily extending coverage of average-risk NIPT until year-end as a result of the pandemic, with the American College of Obstetricians and Gynecologists (ACOG) also expected to endorse average-risk in the future given its clinical utility, in Mahs opinion.Reflecting another positive, the fourth generation NIPT (single-molecule counting assay) test was able to measure fetal fraction, a key milestone according to Mah, and will continue to be developed into 2021. As the technology could potentially be applied to DNA, RNA, epigenetic markers and proteins for additional clinical applications such as oncology, the analyst is looking forward to the completion of the preeclampsia verification in Q4 2020 and a possible 2H21 launch. We believe preeclampsia (~2.3 billion serviceable market) is a major differentiator for Progenity, allowing them to cross-sell across the full-continuum of reproductive testing, the analyst added.If that wasnt enough, PROG signed its first GI Precision Medicine partnership agreement with a top-20 Pharma company in August. The Oral Biotherapeutic Delivery System (OBDS), an ingestible drug and device combination designed to precisely deliver biologics systemically through a needle-free liquid jet injection into the submucosal tissues of the small intestine, is set to be utilized as part of the collaboration. Mah commented, We believe Progenity can sign additional Pharma deals and look forward to the newsflow coming out on this front.To sum it all up, Mah said, We believe Progenity shares are undervalued given the robust recovery in the core testing business and multiple upcoming growth catalysts.To this end, Mah rates PROG an Overweight (i.e. Buy) along with a $17 price target. Should his thesis play out, a twelve-month gain of 105% could potentially be in the cards. (To watch Mahs track record, click here)Are other analysts in agreement? They are. Only Buy ratings, 4, in fact, have been issued in the last three months. Therefore, the message is clear: PROG is a Strong Buy. Given the $13.33 average price target, shares could climb 60% higher in the next year. (See PROG stock analysis on TipRanks)Tactile Systems Technology (TCMD)Developing at-home therapy devices, Tactile Systems Technology wants to provide new treatments for lymphedema, which occurs when the lymphatic system is impaired, disrupting normal transport of fluid within the body, and chronic venous insufficiency. Down 52% year-to-date, its $32.67 share price lands close to its $29.47 52-week low. Thus, with business trends improving, the Street is pounding the table.Writing for Canaccord, analyst Cecilia Furlong acknowledges that the pandemic has hampered the company, with COVID-19 weighing on both volumes and sales. In the second half of March, volumes were down 50% compared to the first half of the month, and TCMDs patient volumes in April and May remained challenged. That being said, trends started to improve at the end of May.Going forward, given the vast majority of TCMDs clinician customers practice in outpatient or office-based settings, we remain positive on TCMDs ability to demonstrate better insulation against COVID impacts and likely experience a greater bounce-back relative to overall med-tech volume trends, with TCMD further benefitting from its expanding using of technology to remotely engage with clinicians and support patients, Furlong explained.The analyst added, Furthermore, recent trends among some providers to prescribe Flexitouch (an advanced intermittent pneumatic compression device to self-manage lymphedema and nonhealing venous leg ulcers) earlier along the therapy process, as a means to reduce in-person contact, could provide upside near term, as well as potentially transition to a longer-term tailwind.On top of this, Furlong is also optimistic about new CEO Dan Reuvers and the reprioritization of the companys investment and market development efforts. TCMD will shift focus away from its acquired Airwear product line, with it redirecting investments toward its Flexitouch and Entre (a pneumatic compression device used to assist in the home management of chronic swelling and venous ulcers associated with lymphedema and chronic venous insufficiency) products.Given significant under-penetration in the lymphedema/phlebolymphedema market targeted by Flexitouch alongside the large patient population with limited treatment options today targeted by the firms Head & Neck platform, we view the combination of education and clinical data as key to further developing and penetrating these markets... Going forward, we expect management to continue to compile a broad base of clinical data to support reimbursement and drive broad adoption, Furlong commented.All of this prompted Furlong to keep a Buy rating and $62 price target on the stock. This target conveys her confidence in TCMDs ability to soar 90% in the next year. (To watch Furlongs track record, click here)In general, other analysts are on the same page. With 3 Buy ratings and 1 Hold, the word on the Street is that TCMD is a Strong Buy. The $62.33 average price target brings the upside potential to 91%. (See TCMD stock analysis on TipRanks)uniQure N.V. (QURE)Last but not least we have uniQure, which delivers curative gene therapies that could potentially transform the lives of patients. Even though shares have fallen 44% year-to-date to $40, not much higher than its 52-week low of $36.20, multiple analysts still have high hopes.Representing SVB Leerink, 5-star analyst Joseph Schwartz acknowledges that shares struggled after news broke of its collaboration and licensing agreement with CSL Behring for AMT-061, QUREs gene therapy for Hemophilia B, he argues the shareholder base turnover is likely now complete as investors and QURE shift focus to next-in-line AMT-130, its AAV5 gene therapy for Huntingtons Disease (HD).Schwartz further added, With the M&A premium now out of the stock, we see the QUREs current level as an attractive buying opportunity for those investors interested in the companys up and coming CNS gene therapies, internal manufacturing, and robust intellectual property and knowhow.Looking more closely at the agreement with CSL Behring, QURE will be tasked with the completion of the pivotal Phase 3 HOPE-B trial as well as the manufacturing process validation and manufacturing supply of AMT-061.According to management, 26-week Factor IX (FIX) data from all 54 patients enrolled in the trial remains on track, and topline data from the pivotal trial is still slated to read out by YE20. It should be mentioned that in a Phase 2b dose-confirmation study, QURE reported 41% FIX activity out to one year. Additionally, Schwartz points out that with HOPE-B progressing as planned, QURE has continued its manufacturing process validation work ahead of the anticipated BLA/MAA submissions in the U.S. and EU in 2021.On top of this, as part of the deal, QURE is eligible to receive more than $2 billion including a $450 million upfront cash payment, $1.6 billion in regulatory and commercial milestones and double-digit royalties ranging up to the low-twenties percentage of net product sales.With a strengthened cash position, QURE is well funded to rapidly advance CNS assets including AMT-130 (AAV5 gene therapy for Huntingtons Disease (HD)) and AMT-150 (AAV gene therapy for Spinocerebellar Ataxia Type 3/SCA3)...We continue to believe that as QUREs CNS pipeline assets mature, the company could once again be an attractive partner to larger biopharma companies that have recently acquired many publicly traded gene therapy platforms with substantial manufacturing capabilities, Schwartz noted.Everything that QURE has going for it convinced Schwartz to reiterate an Outperform (i.e. Buy) rating. Along with the call, he attached a $67 price target, suggesting 68% upside potential from current levels. (To watch Schwartzs track record, click here)What does the rest of the Street have to say? 9 Buys and 3 Holds have been issued in the last three months, so the consensus rating is a Strong Buy. In addition, the $69.89 average price target indicates 75% upside potential. (See QURE stock analysis on TipRanks)To find good ideas for beaten-down stocks trading at attractive valuations, visit TipRanks Best Stocks to Buy, a newly launched tool that unites all of TipRanks equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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October Declared as Contact Lens Safety Month by Prevent Blindness to Provide Public with Information on How to Keep Eyes Healthy - Yahoo Finance

More News24 Sep 2020 | 4:20 PM

Lucknow, Sep 24 (UNI) Havells India Limited, a leading Fast-Moving Electrical Goods (FMEG) company, on Thursday announced its entry into the refrigerator segment under its consumer durable brand - Lloyd.

Kolkata, Sep 24 (UNI) To meet the diverse requirement of its Tier II and III customers, Ujjivan Small Finance Bank with a long term vision to build a better life for its people and communities announced the launch of Small Commercial Vehicle Finance.

(Rptg, correcting slug)Mumbai, Sep 24 (UNI) IndusInd Bank on Thursday slid by 7.24 pc to Rs 489.45 a major loser in 30 scrips of BSE.

Mumbai, Sep 24 (UNI) IndusInd Bank on Thursday slid by 7.24 pc to Rs 489.45 a major loser in 30 scrips of BSE.

Mumbai, Sep 24 (UNI) The BSE Sensex on Thursday slumped by 1114.82 pts to settle at 36,553.60 as selling was seen across the board amid weak Asian Market.

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Why Corneal Blindness Remains a Massive Problem in India - United News of India

The agreed statement of facts offers a template for risk teams seeking to avoid a similar fate.

The complexity of Westpac's IT systems, especially when an upgrade was needed, sits at the heart of its core failures to report millions of "international fund transfer instructions" (IFTIs). These mainly related to just two of its "corresponding banks" offshore banks that Westpac receives money from and sends money to.

The relationships are critical to allow funds to move across borders. But they contain pitfalls, especially ascertaining the identity of the source of funds and customers to which money is being sent.

AUSTRAC CEO Nicole Rose at a press conference on Thursday to discuss the Westpac settlement.Alex Ellinghausen

Westpac's "Australasian Cash Management" (ACM) arrangements allowed its corresponding banks to use Westpac's direct access to the Australian clearing system to process payments. The offshore banks liked this: it reduced costs for them, by allowing them to send "structured", or aggregated, files, which was more efficient than sending payment messages, via a system known as SWIFT, for each and every payment.

When these corresponding banks send money into Australia, they must provide Westpac with an IFTI, which Westpac has to send on to AUSTRAC. In 2010, Westpac was upgrading its systems to ensure it could provide AUSTRAC with the reports in the right format. This became the source of the drama that would unfold a decade later.

The bank failed to match the tech upgrades with different ACM arrangements it had set up for different corresponding banks. Its new systems were not properly configured.

One of these was its financial crime IT system, known as Detica, built by BAE Systems. It was the primary tool for screening customers, conducting risk assessments and reporting suspicious transactions to AUSTRAC.

But to get to AUSTRAC, files received from corresponding banks went through another system, known as WIBS. They were then converted into an IFTI format, passing through Detica via another piece of software known as an integrator, and then being processed again into an IFTI that could be uploaded to AUSTRAC.

Westpac realised it had issues with the process as far back as 2010. AUSTRAC queried its IFTI reporting process in late 2011. Westpac was in regular contact with AUSTRAC in late 2010 and early 2011, as it tried to work out a reporting solution for its "structured files".

The statement of facts suggests the bank for which Westpac failed to report the vast majority of IFTIs fell outside the scope of a technical release relating to the Detica system and this was not picked up.

Then, between August 2011 and August 2012, 15 members of Westpac's IT team left to join ANZ, taking with them the bank's corporate knowledge about the complexity of the reporting system. This prevented it setting up a proper audit process that should have ensured incoming IFTIs for two banks were actually going through to AUSTRAC. The regulator described this as "an absence of appropriate end-to-end reconciliation, assurance and oversight processes for IFTI reporting".

"Westpac did not identify that over 72 per cent of all incoming IFTIs received by Westpac for the period 5 November 2013 to 3 September 2018 had not been reported," the statement says.

"As a result of the failure to file the IFTIs on time, AUSTRAC, the ATO and other law enforcement agencies have been deprived of timely information relating to over $11 billion in international payments."

Frustratingly, there were several chances for these reporting errors to have been caught by Westpac.

For example, in July 2013, AUSTRAC recommended it perform a review of its payment instructions to see if they were not being reported to the regulator. The bank prepared a "group assurance report" but it did not catch the non-reporting.

Then, in 2016, a remediation project also failed to identify the reports were not being sent in to AUSTRAC. When the non-reporting from one of the correspondent banks was identified in 2017 by a team leader, it was not escalated to senior management for action.

It was not until 2018 that the proper level of senior management was made aware of the issues. The bank swung into action but by then, the millions of legal breaches had accumulated in dramatic fashion.

The agreed statement of facts also details the holes in Westpac's due diligence that it was obliged to conduct on its corresponding banks. While it asked them questions via a questionnaire, AUSTRAC said these weren't regular enough for higher-risk banks, while the process failed to respond to new risks emerging from the sale of new products to the corresponding banks until November 2019.

There were also issues with the reporting of outgoing IFTIs, when money was being sent from Westpac abroad. One of the products that tripped up the bank was LitePay, which was set up in August 2016 to send up to $3000 to various countries overseas. Again, a systems upgrade was the root cause of the problem.

In May 2017, a technical issue affected database replication, meaning instructions for some IFTIs were not passed between Westpac systems. Then, in November 2018, another technical issue forced internal IT support teams to manually intervene to set the payment status of each transaction, but this then prevented the automated process for completing the reports which means AUSTRAC did not receive them.

Again, the statement of facts says the bank "did not have appropriate end-to-end reconciliation, assurance and oversight processes in place to identify the IFTI reporting failures relating to the LitePay outgoing IFTIs". The issue was not identified until July last year.

And then there is the failure to heed AUSTRAC's warnings, over a six-year period, about conducting proper due diligence on specific customers showing tendencies of criminal activity.

AUSTRAC published information on child exploitation risks associated with sending frequent, low-value amounts into the Philippines and some other jurisdictions in 2013. The Attorney-General's Department did the same in 2016. Westpac was briefed by AUSTRAC in December 2016 and January 2017, about adopting the new methodology to screen for suspicious payments.

But when it launched LitePay, its detection scenarios for child exploitation risk "did not adequately reflect the guidance, and did not apply to other payment channels". It was not properly implemented until October 2019.

The bank has paid a very heavy price for its failures to action AUSTRAC's requests and its governance failures to audit and proactively identify the issues. AUSTRAC said on Thursday while its contraventions were not the result of any deliberate intention to breach the legislation, "there were opportunities to prevent and detect the non-reporting and, when it was identified, failures to escalate it".

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The tech failures that cost Westpac $1.3b - The Australian Financial Review

WRT the first LTTE today (9/12/20). The concept of white supremacy was not invented; it is a description of the way that some people fantasize about their rightful place in the world. However, this total lack of personal insight often results in similar thinking errors. I wonder if the writer believes that social injustice is also an invention?

The idea that social supremacy is earned by merit, must be similar to the way Pope Urban VIII believed when he cast Galileo into prison. I am confident that his belief that the Earth was the center of the universe helped reinforce his conceit that since he was the head of the church, then he must be the CORE of the center. Such dangerous thinking errors have a long and troubled history in human society. Willful blindness to facts will not help solve our social problems. Some insight might help.

Disclaimer: As submitted to the Arizona Daily Star.

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Letter: Willful Blindness to the Problem of White Supremacy - Arizona Daily Star

BOSTON MAN CHARGED WITH ASSAULT THAT LEFT THE VICTIM BLINDED IN ONE EYE - Andover Leader

September 23, 2020 4:30 pm EDT

It was on September 10th that the police officers responded to a call reporting an unarmed robbery of a 72-year-old man who said he was attacked on Freemont Street in Bostons Mattapan section, police said in a statement Sunday.

During the incident, a male suspect violently punched and kicked a 72-year-old victim, resulting in the permanent loss of vision in the victims left eye, police said.

Adding on to the blindness,The suspect, later identified by police as Willis McGhee, 50, of Boston, was also accused of ripping off the mans pants while trying to steal his wallet from his back pocket, police said.The victim was take to the hospital to be treated for his injuries.

On his arrest,McGhee voluntarily returned to a police station, where he was charged with unarmed robbery, assault and battery of a person over the age of 60, assault and battery by means of a dangerous weapon and mayhem, police said.

McGhee was expected to be arraigned Monday in Dorchester District Court, police said.

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BOSTON MAN CHARGED WITH ASSAULT THAT LEFT THE VICTIM BLINDED IN ONE EYE - Andover Leader

Inherited retinal diseases marketis expected to gain market growth in the forecast period of 2020 to 2027. Data Bridge Market Research analyses the market to account to an annual growth rate of 4.40% in the above-mentioned forecast period.

Inherited Retinal Diseasesmarket research report includes historic data, present and future market trends, environment, technological innovation, upcoming technologies and the technical progress in the allied industry. This market report contains extensive study about miscellaneous market segments and regions, emerging trends, major market drivers, challenges and opportunities in the market. The report has been generated with the comprehensive market insights and analysis that offers superior perspective of the market place. Market segmentation has also been carried out extensively in the Inherited Retinal Diseases Market business report based on a variety of parameters that include applications, verticals, deployment model, end user, and geography.

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The major players covered in the inherited retinal diseases market report are American Society of Gene & Cell Therapy, Spark Therapeutics, Inc., Invitae Corporation., The Choroideremia Research Foundation Inc, American Council of the Blind, Foundation Fighting Blindness, Guide Dogs for the Blind, Inc., Fighting Blindness, FIGHTING BLINDNESS CANADA, Lighthouse Guild, The RDH12 Fund For Sight, Sofia Sees Hope, Retina International, Usher Syndrome Coalition, VisionServe Alliance among other domestic and global players. Market share data is available for global, North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South America separately. DBMR analysts understand competitive strengths and provide competitive analysis for each competitor separately.

Europe is assumed to be the most lucrative inherited retinal disease market due to a relatively bigger prevalence of acquired retinal complications copulated with a higher treatment-seeking rate.

Global Inherited Retinal Diseases Market Scope and Market Size

Inherited retinal diseases market is segmented on the basis of type, treatment type and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries, and provide the users with valuable market overview and market insights to help them in making strategic decisions for identification of core market applications.

Based on type, inherited retinal diseases market is segmented into leber congenital amaurosis (LCA), retinitis pigmentosa, choroideremia, stargardts disease, and achromatopsia.

Inherited retinal diseases market has also been segmented based on treatment type such as gene therapy treatment, and symptomatic treatment.On the basis of distribution channel, the inherited retinal diseases market is segmented into hospital pharmacies, and retail pharmacies.

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Global Inherited Retinal Diseases Market Drivers:

he growing awareness amongst the physicians and patients regarding the benefits associated with the usage of inherited retinal diseases has been directly impacting the growth of inherited retinal diseases market.

The swelling prevalence of the acquired retinal disorders is foreseen to push the growth of inherited retinal diseases treatment market. Expanding knowledge and treatment-seeking flow is anticipated to feed the germination of the inherited retinal diseases therapy business. Emphasizing knowledge of the inherited retinal disease surgery options and analysis of the condition is moreover awaited to magnify the growth of the inherited retinal disease surgery market.

The production businesses in the inherited retinal diseases market is moreover concentrating on the gene mutation-specific way for developing innovative outputs which is anticipated to accelerate the growth of inherited retinal diseases market. Numerous companies are contracting in collaborations, businesses to perform clinical experiments to promote acquired retinal disorder medication alternatives more efficiently. These certain mentioned factors are expected to drive the market growth in the forecasted period of 2020 to 2027.

TOC of Inherited retinal diseases Market Report Contains:

To know more about the study,https://www.databridgemarketresearch.com/reports/global-inherited-retinal-diseases-market

About Data Bridge Market Research

An absolute way to forecast what future holds is to comprehend the trend today!Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.Data bridge is an aftermath of sheer wisdom and experience which was formulated and framed in the year 2015 in Pune. We ponder into the heterogeneous markets in accord with our clients needs and scoop out the best possible solutions and detailed information about the market trends. Data Bridge delve into the markets across Asia, North America, South America, Africa to name few.Data Bridge adepts in creating satisfied clients who reckon upon our services and rely on our hard work with certitude. We are content with our glorious 99.9 % client satisfying rate.

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Global Inherited Retinal Diseases Market with Analysis, Trends-Industry Share, Size, Top Manufactures and Forecast Report 2020 to 2027||Invitae...

Nanoscience has made an impact on a range of industries. With continuous developments, it will only get more exciting for investors.

Through nanotechnology, nanoscience has undeniably impacteda range of industries, from energy to medicine. In the face of continuous nanotechnology research and development, experts are promising an exciting future for the industry.

The terms nanoscience and nanotechnology have been around for a long time, and its common for them to be used interchangeably. However, its important to note that they are not the same.

According toErasmus Mundus, the European Unions higher education program, nanoscience refers to the study, manipulation and engineering of particles and structures on a nanometer scale. For its part, nanotechnology is described as the design and application of nanoscience.

In simple terms, nanoscience is the study of nanomaterials and properties, while nanotechnology is using these materials and properties to create a new product.

Here the Investing News Network provides a comprehensive look at nanoscience investing and nanomaterials, with an overview of the subjects and where they are headed in the future.

The University of Sydneys Nano Institute describes nanoscience as the study of the structure and function of materials on the nanometer scale.

Nanometers are classified as particles that are roughly the size of about 10 atoms in a row. Under those conditions, light and matter behave in a different way as compared to normal sizes.

These behaviours often defy the classical laws of physics and chemistry and can only be understood using the laws of quantum mechanics, the universitys research page states.

The Institute of Nanoscience of Aragon identifies carbon nanotubes (CNTs) as one example of a component that is designed at the nanoscale level. These structures are stronger than steel at the macroscale level. CNT powders are currently used in diverse commercial products, from rechargeable batteries to automotive parts to water filters.

Scientists, researchers and industry experts are enthusiastic about nanoscience and nanoparticles.

As noted in a study published by Jeffrey C. Grossman, a University of California student, quantum properties come into play at the nanoscale level. In simple terms, at the nanoscale level, a materials optical properties, such as color, can be controlled.

Further, the paper states that the surface-to-volume ratio increases at the nano size, opening up new possibilities for applications in catalysis, filtering, and new composite materials, to name only a few.

In other words, the opening up of surface area, which adds new possibilities, can have drastic effects on industries such as manufacturing. New applications in catalysis can allow manufacturing to be sped up, while new composite materials can add more dimension to an end product.

Nanoscale developments could also lead to increased resources and could play a role in the energy sector by increasing efficiency.

As the Royal Society putsit, the aim of nanoscience and nanotechnologies is to produce new or enhanced nanoscale materials.

Nanomaterials are formed when materials have their properties changed at the nanoscale level. Nanomaterials involve elements that contain at least one nanoscale structure, but there are several subcategories of nanomaterials based on their shape and size.

According to the Royal Society, nanowires, nanotubes and nanoparticles like quantum dots, along with nanocrystalline materials, are said to be nanomaterials.

While these are broader classifications of nanomaterials, each of them has several submaterials. Graphene is one popular submaterial and is an example of a nanoplate.

The Integrated Nano-Science & Commodity Exchange, a self-regulated commodity exchange, includes a wide range of nanomaterials and related commodities and lists more than 1,000 nanomaterials.

The exchange states that its entire product range is in excess of 4,500 products, including CNTs, graphene, graphite, ceramics, drug-delivery nanoparticles, metals, nanowires, micron powders, conductive inks, nano-fertilizers and nano-polymers.

As can be seen, nanoscience and nanotechnology are used in a variety of applications across diverse fields, from energy to manufacturing. The University of Sydneys Nano Institute highlights how nanoscienceimpacts manufacturing, energy and the environment through the continuous development of new nano and quantum materials.

With the advancement of materials science and technology, solutions are being worked on for the health and medicine fields, with nanobots gaining popularity in the medical field.

Similarly, nanomaterials like graphene are having a major impact in the technology field graphene is used for various purposes, including in cooling and in batteries.

According to IndustryARC, the global nanotechnology market is projected to reach US$121.8 billion by 2025, growing at a compound annual growth rate of 14.3 percent between 2020 and 2025.

In the US, the National Nanotechnology Initiative, a US government research and development initiative that involves 20 federal and independent agencies, has received cumulative funding of US$27 billion since 2001 to advance research and development of nanoscale projects.

With growth predicted across multiple areas and industries, and with researchers and institutes working on developing the nanoscience field, investors have a slew of nanotechnology stocks to consider.

One popular investment avenue is via graphene, with companies in the space including Applied Graphene Materials (LSE:AGM,OTC Pink:APGMF) and Haydale Graphene Industries (LSE:HAYD). Meanwhile, nanotech stock options include firms such as NanoViricides (NYSE:NNVC), Nano Dimension (NASDAQ:NNDM) and Sona Nanotech (CSE:SONA).

This is an updated version of an article first published by the Investing News Network in 2019.

Dont forget to follow us @INN_Technology or real time updates!

Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.

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What is Nanoscience? | Outlook and How to Invest | INN - Investing News Network

Bioengineering professor Andrew Tsourkas leads the TITAN Lab. (Photo from Andrew Tsourkas)

The National Institutes of Health awarded a Penn Engineering lab and Penn-based startup $667,000 to improve COVID-19 detection technology.

Led by Bioengineering professor Andrew Tsourkas, the Targeted Imaging Therapeutics and Nanomedicine (Titan) Lab partnered with AlphaThera, a startup located at the Pennovation Center, to improve the ELISA technology, which is widely used to detect COVID-19 infections. ELISA, also known as enzyme-linked immunosorbent assay, is used to detect antibodies, proteins the body makes to fight an infection like COVID-19.

By improving ELISA technology, the Titan lab and AlphaThera will enable faster and more sensitive antibody tests for COVID-19 patients. According to the Centers for Disease Control and Prevention, antibody tests may allow patients to determine if they have previously been infected with COVID-19, but do not detect a current COVID-19 infection.

James Hui, who founded AlphaThera alongside Tsourkas, said the company has been working on reducing the time it takes to complete an ELISA assay in detecting antibodies for COVID-19.

These assays can take anywhere between three hours to six hours, but we can do these ELISA assays about probably half the time if not more," said Hui, who received a Ph.D. in Bioengineering from Penn in 2015 and Doctor of Medicine from the Perelman School of Medicine in 2017.

AlphaThera is responsible for developing the ELISA assays, while Tsourkas lab conducts pre-clinical testing for further development of the technology before testing on human samples. After AlphaThera's assays have been validated with the test samples, the team will begin clinical trials in Ping Wang lab at Penn Medicine on about 80 human samples from both COVID-19 and non-COVID-19 patients, Tsourkas said.

The main benefit for the lab is that it shows a practical application for some basic technology we developed in the lab, Tsourkas said. It's always nice to see something turned into a product and be useful for laboratories beyond our own.

Tsourkas said his lab's research also focuses on improving ELISA's sensitivity to detect antibodies, which will help healthcare workers identify a greater number of patients who were previously infected with the virus.

We have some cool antibody labeling technologies that we think will give us a significant boost in sensitivity and how rapid we can read out whether the patient has those antibodies in their serum, he said.

Their goal is to have the technology's validation studies be completed and for kits to be made available to the public within a year, Tsourkas said.

Vaccines imitate an infection while almost never causing illness, prompting the body to produce antibodies and white blood cells that will remember how to fight the disease in the future. Tsourkas said, therefore, fast antibody tests to determine whether a vaccine has prompted the body to produce antibodies will become more important as vaccine development progresses.

As vaccines are being developed now, we need to check to see whether they're working and to see how much of the population was really exposed [to the virus]," Tsourkas said.

Get our newsletter, Dear Penn, delivered to your inbox every weekday morning.

Tsourkas' research can also be applied to other antibody-detecting assays already on the market to improve their speed and sensitivity, he said.

While AlphaThera has been working to make the technology commercially viable and competitive in the market, Hui said their priority is to ensure the assays' speed and sensitivity in detecting antibodies.

We're not trying to be the first to roll off the market and try to get as much sales as possible, he said. Ultimately, we are a technology company [that is] more interested in developing a better product.

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Penn lab and startup awarded $667000 NIH grant to improve COVID-19 antibody testing - The Daily Pennsylvanian

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that recent new contracting with partners and investments in manufacturing capacity have contributed to its Captisol business operating at the highest levels in the history of the technology and position Captisol for major growth. Significant new clinical and regulatory developments with Evomela and Kyprolis, among other drugs, are reinforcing the role the proprietary technology serves in enabling important medicines. During 2020, Ligand has facilitated the successful installation of equipment to allow production at significantly higher levels to support anticipated demand. In addition to manufacturing at partner Hoviones facilities in Ireland and Portugal, Ligand has now added final step processing capacity for Captisol in both the United States and England. Ligand also introduces guidance for 2021 Captisol material sales of approximately $200 million.

The global medical need for Captisol-enabled drugs has never been higher, said John Higgins, Chief Executive Officer of Ligand. Our recently expanded operating team has successfully positioned our Captisol technology for the substantial growth we now expect in 2021 and beyond. There is significant ongoing investment by our partners for over 30 Captisol-enabled medicines in clinical development. We have entered into more contracts this year than any other year and are proud to be working closely with Gilead under our recently extended 10-year supply contract. We continue to be pleased with the momentum relating to Captisol, as it is a critical component in multiple life-saving medicines.

Recent Captisol technology business highlights include the following:

Ligands forecast for 2021 Captisol material sales of approximately $200 million is based on information it has on anticipated demand from its major partners given growth in existing and new markets, clinical requirements for Captisol-enabled development programs and binding orders from certain commercial or pre-commercial partners. The 2021 Captisol outlook compares with the Companys guidance for 2020 Captisol material sales of approximately $90 million.

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gileads VEKLURY, Amgens KYPROLIS, Baxter Internationals NEXTERONE, Acrotech Biopharma L.L.C.s and CASI Pharmaceuticals EVOMELA, Melinta Therapeutics BAXDELA and Sage Therapeutics ZULRESSO. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including 37 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.

About Ligand Pharmaceuticals

Ligand is a revenue-generating biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligands OmniAb technology platform is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. The Captisol platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. The Vernalis Design Platform (VDP) integrates protein structure determination and engineering, fragment screening and molecular modeling, with medicinal chemistry, to help enable success in novel drug discovery programs against highly challenging targets. Ab Initio technology and services for the design and preparation of customized antigens enable the successful discovery of therapeutic antibodies against difficult-to-access cellular targets. Icagen has established deep biological expertise focused on ion channels and transporters and has a strong track record in ion channel drug discovery from screening to lead optimization. Ligand has established multiple alliances, licenses and other business relationships with the worlds leading pharmaceutical companies including Amgen, Merck, Pfizer, Sanofi, Janssen, Takeda, Servier, Gilead Sciences and Baxter International. For more information, please visit http://www.ligand.com.

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Forward-Looking Statements

This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as plans, believes, expects, anticipates, and will, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligands expectation that Captisol demand will increase significantly in 2021 and beyond (particularly for sales to Gilead and to partners in Gileads consortium) and Ligands ability to supply Captisol to Gilead and other partners, including Ligands ability to increase supply capacity; the timing of initiation, enrollment and expected results with respect to the planned clinical trial of CE-Iohexol; and guidance regarding Ligands 2020 and 2021 Captisol material sales. Actual events or results may differ from Ligand's expectations due to risks and uncertainties inherent in Ligands business, including, without limitation: Ligand may not receive expected revenue from Captisol sales; the COVID-19 pandemic has disrupted Ligands and its partners business, including delaying manufacturing, preclinical studies and clinical trials and product sales, and impairing global economic activity, all of which could materially and adversely impact Ligands results of operations and financial condition; Ligand may not achieve its Captisol material sales guidance for 2020 and/or 2021; remdesivir may be later shown to not be effective or safe for the treatment of COVID-19 and/or the FDA (and/or equivalent agencies in other countries) may revise or revoke its emergency use authorization for remdesivir for the treatment of COVID-19 in patients hospitalized with moderate or severe disease if the FDA (and/or another such agency) determines that authorization no longer meets the statutory criteria for issuance; alternative COVID-19 therapies or vaccines may be approved or the risk of coronavirus infection could significantly diminish, any of which could materially and adversely affect the commercial opportunity for remdesivir; Gilead may terminate the supply agreement without cause upon 30 days prior written notice; Ligand may be unable to scale-up the supply of Captisol or at acceptable prices; Ligand is currently dependent on Hovione as a single source sole supplier for certain Captisol manufacturing functions and failures by such supplier may result in delays or inability to meet the Captisol demands of its partners; Amgen, Acrotech Biopharma or other Ligand partners may not execute on their sales and marketing plans for marketed products for which Ligand has an economic interest; Ligand or its Captisol partners may not be able to protect their intellectual property and patents covering certain products and technologies may be challenged or invalidated; Ligand's Captisol partners may terminate agreements or development or commercialization of products; Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements; Ligand and its Captisol partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for product candidates, or significant issues regarding the adequacy of clinical trial designs or the execution of clinical trials, which could result in increased costs and delays, or limit the ability to obtain regulatory approval; unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's or its Captisol partners product(s) could delay or prevent regulatory approval or commercialization; and ongoing or future litigation could expose Ligand to significant liabilities and have a material adverse effect on the company. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at http://www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at http://www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

a Monahan, et al. Biology of Blood and Marrow Transplantation, September 2020

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Ligand Announces its Captisol Business is Positioned for Major Growth and Forecasts 2021 Captisol Material Sales of $200 Million - Business Wire

Editor's note: Life can be stressful, and many of us have a hard time administering self-care. The current world situation ripe with conflicts, shortages and a pandemic makes things even harder. Dr. Amit Sood, formerly of Mayo Clinic and now head of the Global Center for Resiliency and Wellbeing, is the author of books including "The Mayo Clinic Handbook for Happiness" and "SMART with Dr. Sood, and creator of the mobile app Zizo: Your Resilience Pal. Now, he is writing a weekly column answering readers' questions on these topics. See the tagline to learn how to send him your questions, and he will answer in future columns.

Dear friend,

Of the hundreds of ice-creams I have eaten so far, the only one I remember is the ice-cream I never ate.

That was in 1993. My wife Richa and I were sitting outside a shop in the sweltering New Delhi. We had just bought an ice cream to cool down. From the corner of my eye, I saw a little boy who could use a few calories. I walked up to him and offered my cone that he gladly took. I have savored the gleam I saw in his eyes at least a dozen times since then.

In a very interesting study, researchers looked at the genetic fingerprint of the two types of happiness hedonistic (self-centric) and eudaimonic (other-centric). People who were hedonistically happy had a higher inflammatory and lower anti-viral gene expression. It was just the opposite for the eudaimonic ones. With many illnesses caused by inflammation, you can see why this is so important for our health.

My take on this research is that our genes and the immune system know what is right for us and society. In the current times when a healthy immune system is extremely important for us, promoting kindness is imperative.

Kindness, research shows, pays three times over. Your kind words and actions enhance your health and wellbeing, help others, and the memory of kind actions by itself enhances your wellbeing. A very simple way to enhance your self-worth and happiness today is to count your previous kind actions.

I suggest take out a pen and paper and write the three most selfless things you have done in your life. If you feel up to it, share your experience with someone. Just counting previous acts of kindness can enhance your self-worth and bring happiness to others (you guessed it right witnessing or hearing about others kind actions also increases happiness).

In kindness,

Amit

Dr. Amit Sood answers your questions about stress, resilience, happiness, relationships, and related topics in his column. Email dearfriend@postbulletin.com.

Original post:
Our genes know kindness is the best medicine - Brainerd Dispatch

dnaPower Inc, a biotechnology company that offers DNA testing for health and wellness, announces their partnership with Inagene Diagnostics. Inagene Diagnostics is a DNA testing company that uses genetic information to predict response to medications commonly used to treat pain and mental health conditions. These two Canadian DNA testing companies have joined forces to crack the code on personalized healthcare, empowering people to take control of their health and live their best lives.

dnaPower is committed to helping people make better data-driven decisions about their day to day health using genetics. We are delighted to be partnering with Inagene, a strong female-led, Canadian DNA company to include their pharmacogenetic testing.In addition to providing tailored health solutions for your diet, exercise and lifestyle, we can now add the ability to identify the medications best suited for your body to keep you safe and get the best health outcome. Dr. Lois Nahirney, CEO, dnaPower Inc.

Through their partnership, dnaPower and Inagene offer a suite of tailored health solutions for anyone looking to maximize insights to optimize their health. Comprehensive DNA testing is available for preventative health and medical treatment optimization. Personalized insights include tailored diet, exercise, lifestyle recommendations, and medications to optimize ones treatment plan based on their genetic information. Together, these powerful genetic insights act as a biological roadmap to help individuals navigate their best health.

Advancements in technology have opened up a world of opportunities to personalized healthcare in ways never seen before. There is no one size fits all solution when it comes to health. Unique genes can respond differently to foods, types of exercise, and medications. Spending years through trial and error to find the best diet, exercise, and medication is a way of the past. Individuals can now enjoy the ability to take control of their health without the guesswork through genetic testing.

We are excited and proud to partner withdnaPower another leading-edge Canadian company! Our teams care deeply about helping clients and are passionate about bringing innovation and personalized medicine to consumers. Helping individuals and their healthcare providers determine which drug and dose will work best, with less trial and error, is just part of the equation; the opportunity to learn what diet and exercise regimen works best for you, further enhances the client experience. Nancy White, CEO, Inagene Diagnostics.

To celebrate their partnership, dnaPower and Inagene are offering a combined special on their DNA tests. The Ultimate Insights Package includes the suite of dnaPower and Inagene DNA tests at the incredible price of $648 (retail value $1495). See this special offer.

Together, dnaPower and Inagene are passionate about empowering individuals to control their health with genetic testing, sharing a unified principle that knowledge is power.

About Inagene Diagnostics

With over two decades of experience in genetic research and diagnostics, combined with over 30 years of commercial health experience, Inagene has witnessed and been a part of the growing technology that now makes personalized healthcare possible. Inagene believes patients are not simply seeking more information, but practical and individualized information they can use to help make the best decisions about their health. Inagene Personalized InsightsTM makes it easy for patients and health care practitioners to navigate to the safest and most effective treatment options for medications used for pain and mental health conditions, and steer clear of those that arent.

About dnaPower Inc

dnaPower was one of the first in the world to offer DNA health testing, launching in 2008. They saw enormous potential for new DNA technology to help support peoples health and wellness, particularly in diet and fitness. dnaPower was a pioneer in applying leading-edge gene research to develop targeted gene panels. Since then, they have been providing personalized testing and professional support to help people like you make better, data-driven decisions about your health. With years of experience, dnaPower provides clear results and specific recommendations to help you take proactive and positive action for your unique body.

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Cracking the code to live your best life: Canadian DNA testing companies, dnaPower and Inagene, partner to unlock true personalized health through...

(UroToday.com) Since 2015, multiple studies together have suggested that approximately a quarter of metastatic castration-resistant prostate cancer (mCRPC) tumors have mutations in DNA damage repair (DDR) genes. These alterations, especially those in genes for homologous recombination repair (HRR), are associated to varying degrees with response to PARP inhibitor therapy. Two PARP inhibitors are now approved for the care of patients with mCRPC and mutations in certain HRR genes: olaparib (based on PROfound trial) and rucaparib (based on TRITON2 trial). Given the significance of alterations in HRR genes in mCRPC, genomic testing for HRR alterations has been included in mCRPC treatment guidelines with the purpose of guiding genetic counseling and therapy selection.

In this poster, Dr. Neal Shore and colleagues describe real-world patterns and predictors of tissue testing for alterations in HRR genes. They focused on the community cancer care setting. Data were collected from the Flatiron Health Electronic Health Record derived database that was collected between 2013 and March 2019, prior to the approval of PARP inhibitor therapy in mCRPC, and focused on testing for alterations in BRCA1, BRCA2, ATM, CDK12, FANCA, and PALB2). The Flatiron database contains information on patient demographics, prostate cancer characteristics, and treatment, as well as genetic testing results.

From the Flatiron database, 5,213 patients with mCRPC were identified, 91% of which were managed at community oncology care centers. Of these patients, 674 (12.9%) underwent testing for the specified HRR gene alterations. Patient characteristics are shown below.

The breakdown of the 674 patients by testing method and number of genes tested is shown below.

BRCA1 and BRCA2 were the most commonly tested genes. A substantial portion of patients underwent only blood/saliva testing (40.5%, capable of detecting germline or circulating tumor DNA) or tumor-tissue testing only (42.1%, capable of detecting germline or tumor tissue DNA alterations). Only 1.8% of patients undergoing blood/saliva testing were tested for all 6 HRR genes, and 69% of tumor-tissue testing covered all 6 genes. Amongst the 286 patients who had negative blood/saliva testing, only 12.6% underwent tumor-tissue profiling, and 5 of these patients (13.9%) had an HRR alteration found.

The most common testing platform utilized was Foundation Medicine, followed by Guardant. Testing rates and the inclusion of more genes increased with time.

The prevalence of HRR alterations found is shown below.

Treatment at an academic medical center or having received multiple prior lines of therapy was associated with a higher likelihood of having HRR mutational profiling. Older age and higher PSA value at diagnosis of mCRPC were significantly associated with a lower likelihood of HRR mutation profiling.

The poster concludes that rates of HRR mutational testing did not increase dramatically with changes to the NCCN guidelines recommending this testing in 2017. Increased awareness of recommendations for testing, especially with the approval of two therapeutic agents contingent upon the presence of HRR alterations, is critical for the care of patients with mCRPC.

Presented by: Neal Shore, MD FACS, Urologist, and Director of the Carolina Urologic Research Center, Myrtle Beach, South Carolina

Written by: Alok Tewari, MD, Ph.D., Medical Oncologist at the Dana-Farber Cancer Institute, at the 2020 European Society for Medical Oncology Virtual Congress (#ESMO20), September 19th-September 21st, 2020

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ESMO Virtual Congress 2020: Real-World Patterns of Genomic Testing in Patients with Metastatic Castration-R... - UroToday

BOSTON--(BUSINESS WIRE)--Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that data from the companys portfolio of cystic fibrosis (CF) medicines will be presented at the 43rd European Cystic Fibrosis Digital Conference (ECFS) held September 24-25, 2020 and the 2020 North American Cystic Fibrosis Virtual Conference (NACFC) taking place October 7-23, 2020. An oral presentation at the ECFS Digital Conference will highlight, for the first time, interim results from the TRIKAFTA open-label extension study, which showed safety and efficacy consistent with the results of the Phase 3 pivotal studies in patients with CF ages 12 and older with F508del/Minimal Function (F/MF) or F508del/F508del (F/F) genotypes. Four additional scientific abstracts for ORKAMBI and TRIKAFTA were published in the Journal of Cystic Fibrosis as part of the ECFS conference. In addition, six scientific presentations will occur at NACFC regarding KALYDECO, ORKAMBI and TRIKAFTA, including new data from KALYDECO in infants ages 4 to less than 6 months old.

As we continue to reach additional people with CF with our medicines, gaining a better understanding of their long-term and real-world impact becomes even more important, said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex. We are pleased to report the first longer-term data for TRIKAFTA which show the significant benefits seen early are maintained through one year of treatment.

Data highlighting interim results from the ongoing TRIKAFTA open-label extension (OLE) study to evaluate long-term safety and efficacy in people with CF ages 12 and older with F508del/Minimal Function (F/MF) or F508del/F508del (F/F) genotypes who completed pivotal studies will be presented at the ECFS Digital Conference. In the interim analysis, TRIKAFTA was generally well-tolerated, with no new safety concerns. The data show that the marked improvements observed in the prior pivotal studies across multiple efficacy endpoints, including, percent predicted forced expiratory volume in 1 second (ppFEV1), sweat chloride (SwCl), Cystic Fibrosis Questionnaire Revised (CFQ-R) respiratory domain score, and body mass index (BMI), were sustained with continued treatment with TRIKAFTA.

A full listing of Vertex scientific presentations at ECFS and NACFC are below:

Abstract Title

PresentationType

PresentingAuthor

Date/ Time

ELX/TEZ/IVA

A phase 3, open-label extension study of elexacaftor/tezacaftor/ivacaftor: interim analysis of safety and efficacy in people with cystic fibrosis and F508del/minimal function or F508del/F508del genotypes

ECFS Oral Presentation

Professor Griese

September 24, 2020

11:21-11:45 a.m. CET

Impact of elexacaftor/tezacaftor/ivacaftor triple combination therapy on health-related quality of life in people with cystic fibrosis heterozygous for F508del and a minimal function mutation: results from a phase 3 clinical study

ECFS published abstract: Journal of Cystic Fibrosis 19S2 (2020) S55S168, P221

NACFC Poster Presentation #447

Professor Fajac

Oct 7 Oct 23, 2020

Impact of elexacaftor/tezacaftor/ivacaftor triple combination therapy on health-related quality of life in people with cystic fibrosis homozygous for F508del: results from a phase 3 clinical study

ECFS published abstract: Journal of Cystic Fibrosis 19S2 (2020) S1S36, WS19.6

NACFC Poster Presentation #478

Professor Majoor

Oct 7 Oct 23, 2020

IVA

An observational study of ivacaftor in people with cystic fibrosis and selected non-G551D gating mutations: outcomes from the third interim analysis of the VOCAL study

NACFC Poster Presentation

#466

Professor Kors van der Ent

Oct 7 Oct 23, 2020

Ivacaftor in 4 to < 6-month-old infants with a gating mutation: results of a 2-part, single-arm, phase 3 study

NACFC Poster Presentation

#415

Dr. Rosenfeld

Oct 7 Oct 23, 2020

Real-world outcomes in children aged 2-5 with CF treated with ivacaftor

NACFC Poster Presentation

#141

Dr. Volkova

Oct 7 Oct 23, 2020

LUM/IVA

Long-term safety of lumacaftor/ivacaftor in persons with cystic fibrosis aged 2-5 years homozygous for the F508del-CFTR mutation (F/F)

ECFS Published abstract:

Journal of Cystic Fibrosis 19S2 (2020) S1S36, WS19.2

Disease progression in F508del homozygous (F/F) persons with cystic fibrosis treated with lumacaftor/ivacaftor (LUM/IVA): interim results of a long-term safety study using data from the US Cystic Fibrosis Foundation Patient Registry (CFFPR)

ECFS Published abstract:

Journal of Cystic Fibrosis 19S2 (2020) S1S36, WS13.1

NACFC Poster Presentation

#190

Dr. Bower

Oct 7 Oct 23, 2020

About Cystic Fibrosis

Cystic Fibrosis (CF) is a rare, life-shortening genetic disease affecting approximately 75,000 people worldwide. CF is a progressive, multi-system disease that affects the lungs, liver, GI tract, sinuses, sweat glands, pancreas and reproductive tract. CF is caused by a defective and/or missing CFTR protein resulting from certain mutations in the CFTR gene. Children must inherit two defective CFTR genes one from each parent to have CF. While there are many different types of CFTR mutations that can cause the disease, the vast majority of all people with CF have at least one F508del mutation. These mutations, which can be determined by a genetic test, or genotyping test, lead to CF by creating non-working and/or too few CFTR proteins at the cell surface. The defective function and/or absence of CFTR protein results in poor flow of salt and water into and out of the cells in a number of organs. In the lungs, this leads to the buildup of abnormally thick, sticky mucus that can cause chronic lung infections and progressive lung damage in many patients that eventually leads to death. The median age of death is in the early 30s.

INDICATION AND IMPORTANT SAFETY INFORMATION FOR KALYDECO (ivacaftor), TRIKAFTA (elexacaftor/tezacaftor/ivacaftor and ivacaftor), and ORKAMBI (lumacaftor/ivacaftor)

What is KALYDECO?KALYDECO is a prescription medicine used for the treatment of cystic fibrosis (CF) in patients age 6 months and older who have at least one mutation in their CF gene that is responsive to KALYDECO. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if KALYDECO is safe and effective in children under 6 months of age.

What is TRIKAFTA?TRIKAFTA is a prescription medicine used for the treatment of CF in patients aged 12 years and older who have at least one copy of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. Patients should talk to their doctor to learn if they have an indicated CF gene mutation. It is not known if TRIKAFTA is safe and effective in children under 12 years of age.

What is ORKAMBI?ORKAMBI is a prescription medicine used for the treatment of CF in patients age 2 years and older who have two copies of the F508del mutation (F508del/F508del) in their CFTR gene. ORKAMBI should only be used in these patients. It is not known if ORKAMBI is safe and effective in patients under 2 years of age.

Patients should not take KALYDECO or TRIKAFTA if they take certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; seizure medicines such as phenobarbital, carbamazepine, or phenytoin; or St. Johns wort.

Patients should not take ORKAMBI if they take certain medicines or herbal supplements, such as: the antibiotics rifampin or rifabutin; the seizure medicines phenobarbital, carbamazepine, or phenytoin; the sedatives and anti-anxiety medicines triazolam or midazolam; the immunosuppressant medicines cyclosporine, everolimus, sirolimus, or tacrolimus; or St. Johns wort.

Before taking KALYDECO, TRIKAFTA, or ORKAMBI, patients should tell their doctor about all of their medical conditions, including if they: have or have had liver problems; have kidney problems; have had an organ transplant; are pregnant or plan to become pregnant because it is not known if KALYDECO, TRIKAFTA, or ORKAMBI will harm an unborn baby; or are breastfeeding or planning to breastfeed because it is not known if KALYDECO, TRIKAFTA, or ORKAMBI passes into breast milk. Before taking ORKAMBI, patients should tell their doctor if they are using birth control as hormonal contraceptives, including oral, injectable, transdermal, or implantable forms should not be used as a method of birth control when taking ORKAMBI.

KALYDECO, TRIKAFTA, or ORKAMBI may affect the way other medicines work, and other medicines may affect how KALYDECO, TRIKAFTA, or ORKAMBI work. Therefore, the dose of KALYDECO, TRIKAFTA, or ORKAMBI may need to be adjusted when taken with certain medications. Patients should especially tell their doctor if they take antifungal medications such as ketoconazole, itraconazole, posaconazole, voriconazole, or fluconazole; or antibiotics such as telithromycin, clarithromycin, or erythromycin.

KALYDECO or TRIKAFTA can cause dizziness in some people who take it. Patients should not drive a car, use machinery, or do anything that needs them to be alert until they know how KALYDECO or TRIKAFTA affects them.

When taking ORKAMBI, patients should tell their doctor if they stop taking ORKAMBI for more than 1 week as their doctor may need to change the dose of ORKAMBI or other medicines the patient is taking.

Patients should avoid food or drink containing grapefruit or Seville oranges while taking KALYDECO. Patients should avoid food or drink containing grapefruit while taking TRIKAFTA.

KALYDECO, TRIKAFTA, and ORKAMBI can cause serious side effects, such as:

High liver enzymes in the blood have been reported in patients receiving KALYDECO, TRIKAFTA, or ORKAMBI. The patient's doctor will do blood tests to check their liver before starting treatment with KALYDECO, TRIKAFTA, or ORKAMBI; every 3 months during the first year of treatment; and every year while on treatment. For patients who have had high liver enzymes in the past, the doctor may do blood tests to check the liver more often. Patients should call their doctor right away if they have any of the following symptoms of liver problems: pain or discomfort in the upper right stomach (abdominal) area; yellowing of their skin or the white part of their eyes; loss of appetite; nausea or vomiting; or dark, amber-colored urine.

Breathing problems such as shortness of breath or chest tightness in patients when starting ORKAMBI, especially in patients who have poor lung function. If a patient has poor lung function, their doctor may monitor them more closely when starting ORKAMBI.

An increase in blood pressure in some people receiving ORKAMBI. The patients doctor should monitor their blood pressure during treatment with ORKAMBI.

Abnormality of the eye lens (cataract) in some children and adolescents treated with KALYDECO, TRIKAFTA, or ORKAMBI. If the patient is a child or adolescent, their doctor should perform eye examinations before and during treatment with KALYDECO, TRIKAFTA, or ORKAMBI to look for cataracts.

The most common side effects of KALYDECO include headache; upper respiratory tract infection (common cold), which includes sore throat, nasal or sinus congestion, and runny nose; stomach (abdominal) pain; diarrhea; rash; nausea; and dizziness.

The most common side effects of TRIKAFTA include headache, diarrhea, upper respiratory tract infection (common cold) including stuffy and runny nose, stomach (abdominal) pain, inflamed sinuses, increase in liver enzymes, increase in a certain blood enzyme called creatine phosphokinase, rash, flu (influenza), and increase in blood bilirubin.

The most common side effects of ORKAMBI include breathing problems, such as shortness of breath and chest tightness; nausea; diarrhea; fatigue; increase in a certain blood enzyme called creatinine phosphokinase; rash; gas; common cold, including sore throat, stuffy or runny nose; flu or flu-like symptoms; and irregular, missed, or abnormal periods (menses) and increase in the amount of menstrual bleeding. Additional side effects seen in children include: cough with sputum, stuffy nose, headache, stomach pain, and increase in sputum.

These are not all the possible side effects of KALYDECO, TRIKAFTA, or ORKAMBI. Please click product link to see the full Prescribing Information for KALYDECO, TRIKAFTA, or ORKAMBI.

About Vertex

Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has multiple approved medicines that treat the underlying cause of cystic fibrosis (CF) a rare, life-threatening genetic disease and has several ongoing clinical and research programs in CF. Beyond CF, Vertex has a robust pipeline of investigational small molecule medicines in other serious diseases where it has deep insight into causal human biology, including pain, alpha-1 antitrypsin deficiency, and APOL1-mediated kidney diseases. In addition, Vertex has a rapidly expanding pipeline of genetic and cell therapies for diseases such as sickle cell disease, beta thalassemia, Duchenne muscular dystrophy and type 1 diabetes mellitus.

Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is in London, UK. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia and Latin America. Vertex is consistently recognized as one of the industry's top places to work, including 10 consecutive years on Science magazine's Top Employers list and top five on the 2019 Best Employers for Diversity list by Forbes. For company updates and to learn more about Vertex's history of innovation, visit http://www.vrtx.com or follow us on Facebook, Twitter, LinkedIn, YouTube and Instagram.

Special Note Regarding Forward-looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, statements made by Dr. Carmen Bozic in this press release, statements regarding the potential benefits, safety and efficacy of TRIKAFTA, KALYDECO and ORKAMBI, and our plans to present data at the ECFS and the NACFC, including data from our TRIKAFA open-label extension study, scientific abstracts for ORKAMBI and TRIKAFTA, and scientific presentations regarding KALYDECO, ORKAMBI and TRIKAFTA. While Vertex believes the forward-looking statements contained in this press release are accurate, these forward-looking statements represent the company's beliefs only as of the date of this press release and there are a number of risks and uncertainties that could cause actual events or results to differ materially from those expressed or implied by such forward-looking statements. Those risks and uncertainties include, among other things, that data from the company's development programs may not support registration, approval or further development of its compounds due to safety, efficacy or other reasons, risks related to approval and commercialization of our medicines, and other risks listed under Risk Factors in Vertex's most recent annual report and subsequent quarterly reports filed with the Securities and Exchange Commission and available through the company's website at http://www.vrtx.com. You should not place undue reliance on these statements, or the scientific data presented. Vertex disclaims any obligation to update the information contained in this press release as new information becomes available.

(VRTX-GEN)

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Vertex to Present New Data at European and North American Virtual Cystic Fibrosis Conferences Highlighting Long-Term Use of CFTR Modulators - Business...

MIAMI, Sept. 22, 2020 /PRNewswire/ -- The Victor Center for the Prevention of Jewish Genetic Diseases, which offers preconception screening and genetic counseling for prospective parents, has recently expanded services to offer genetic screening and virtual clinical consults to couples and individuals in New York, New Jersey and Maryland.

The center, which also serves Florida, Massachusetts and Pennsylvania, helps future parents identify whether they are at risk of passing on genetic diseases, including those common among people of Jewish ancestry.

"Not everyone knows their full ancestral heritage, so we encourage anyone planning to start a family and their partner to undergo screening," said Debbie Wasserman, Outreach Coordinator/Genetic Counselor for the Victor Center.

Jewish genetic diseases are a group of recessive, inherited disorders that occur with significant frequency in the Ashkenazi Jewish community (those of eastern or central European descent). Individuals of Ashkenazi descent have higher carrier rates for diseases such as Tay-Sachs, Canavan, familial dysautonomia, and Gaucher. Many of the diseases are severe, and some are fatal in childhood.

One in two of those of Ashkenazi descent is a carrier for at least one Jewish genetic condition, and Sephardic and Mizrachi Jews are also at increased risk for certain genetic disorders. More than half of participants in the Victor Center screening program are carriers for one or more of the 225 plus conditions on the expanded screening panel, which also includes disorders found in other ethnicities.

The Victor Center offers a convenient screening process during this time of social distancing. Upon request, a genetic counseling session is scheduled and a screening kit is mailed to the home. Recipients provide saliva samples and return the kit to a lab for processing. Once results are available, a video consult is coordinated to convey understanding and address questions.

There is a fee for Victor Center screening services. However, most medical insurance plans cover the service. For more information, please call 786-897-9587 or visit http://www.victorcenter.org

About the Victor Center The Victor Center was founded in 2002 by Lois B. Victor in partnership with Einstein Healthcare Network in Philadelphia. Ms. Victor lost two children to a Jewish genetic disease before a test for the disorder became available. The experience galvanized her commitment to ensuring that no family endures the heartache of a preventable illness by making certain that Jews of childbearing age are screened and get the information they need to have healthy children. Nicklaus Children's Hospital was appointed the National Office for the Victor Center in 2017. The Nicklaus Children's Hospital Victor Center maintains the nation-wide collaborative work of the center in promoting education related to preconception screening while increasing knowledge, awareness, and access to genetic services.

About Nicklaus Children's HospitalFounded in 1950 by Variety Clubs International, Nicklaus Children's Hospital is South Florida's only licensed specialty hospital exclusively for children, with nearly 800 attending physicians and more than 475 pediatric subspecialists. The 309-bed hospital, known as Miami Children's Hospital from 1983 through 2014, is renowned for excellence in all aspects of pediatric medicine with several specialty programs routinely ranked among the best in the nation by U.S. News & World Report since 2008. The hospital is also home to the largest pediatric teaching program in the southeastern United States and has been designated an American Nurses Credentialing Center (ANCC) Magnet facility, the nursing profession's most prestigious institutional honor. For more information, please visit http://www.nicklauschildrens.org.

For more information: Nicklaus Children's Hospital Rachel Bixby, 305-663-8476

SOURCE Nicklaus Childrens Health System

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