StemCell Therapy

Some of the developers behind The Witcher 3, Dying Light, Dead Island, and Cyberpunk 2077 have come together to start up a new studio. Called Starward Industries, its first outing is a sci-fi game with atompunk aesthetics that is inspired by the works of Stanisaw Lem, a prominent novelist who worked within the same genre.Its called The Invincible, and its set in a world wheretechnology has advanced to the point of seamless space exploration, but equipment remains analogue as the digital revolution has not taken place, nor has The Cold War ended. The games been in the works since 2018, and the devs hope to have it out next year.

We got the chance to chat to project leader and CD Projekt Red vet Marek Markuszewsk ahead of the upcoming PC games reveal. So, first things first, what is it about Lem that the studio likes, and what is it about his work that Markuszewsk thinks translates to a videogame?

The most fascinating and inspiring thing about Lems writing is the extent of the boldness of the provided visionary, he tells us. His stories are multi-layered as if written with the intent to be adapted as interactive entertainment. Not everything is trivial, though. We have specifically chosen a novel with quite a deft theme, indeed a straightforward story related to space exploration, yet reaching to the phase which at present is still not easy to be fully pictured.

While Lem was particularly active between 19462005, Markuszewsk reckons the words he wrote still have plenty of meaning and relevance today. Lem has developed several visions of how humanity and societies may be evolving far into the future when space travel and meeting other species will be the norm, he says. Whilst were just beginning space exploration, many prophecies regarding tech innovations indeed came to life, such as the internet, ebook readers, artificial intelligence, genetic engineering, micro-robotics et cetera.

Maybe not always named or working exactly as Lem imagined, but serving precisely the described purposes, rooted in science and psychology. Theres a strong feeling that with the recent trend which includes implants, chips and mental interfaces, were stepping into transhumanism the theory that the human race can evolve beyond its current physical constraints. Lems works are great to reflect on what challenges such developments may bring.

The themes of the game certainly seem bold and interesting, then, but what will The Invincible feel like from moment-to-moment when youre playing it? Markuszewsk says that the atmosphere draws comparisons to Alien: Isolation, whereas communicating through radio comms will put you in mind of Firewatch.

The gameplay is quite diverse, including exploration, navigation, face to face discussions with NPCs, operating various equipment which is all analogue, solving clues, interacting with robots, piloting drones, crunching data, even driving vehicles, Markuszewsk explains to us. A large part of interaction will include radio comms, sometimes dense, even tense at times, often intimate, closely related to the unfolding events in that way The Invincible can remind of Firewatch.

On the other hand, in terms of gameplay and atmosphere, the closest game I can think of is Alien: Isolation. Among tens of games which weve researched while working on The Invincibles concept, these two titles combined perhaps represent the best of what our game is going to offer.

More? Here are the best space games on PC

Markuszewsk hopes to release The Invincible in the second half of 2021, but thats conditional on several factors. Due to the current state of the world with COVID-19 and beyond, its hard to offer a more narrow timeframe. You can wishlist it on Steam if this one sounds like your kind of thing.

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Former Witcher 3 devs are launching a sci-fi novel-inspired game - PCGamesN

News reporting at its best should be nuanced. There are rarely black hats and white hats when it comes to understanding the issues of the day, unless you are 60 Minutes which revels in journalism casting. Life is usually shades of graycomplex. When reporters address controversial topics, its not enough to just get the various elements right; the headline and the editorial thrust should responsibly reflect the multi-dimensionality of a topic; otherwise a story can muddy the understanding of a complex issue and ultimately undermine both science and the publics trust in journalism.

Such is the case for a recent article reporting on a study of Monarch butterfly population declines by an advocacy group, written for Cornell Universitys Alliance for Science, a solid, reputable source of unbiased scientific information.

Why are Monarchs in decline? Its a hotly-debated issue, with many studies with competing conclusions. Anti-biotechnology activist groups have singled out the herbicide glyphosate as a major driver of the decline, so the issue is embedded in a wider, inflamed debate over the controversial weedkiller. Which makes it all the more important that any new science on this issue should be contextualized.

The GLP has addressed this controversy extensively, including providing a dispassionate, science-based analysis in our GMO FAQ resource. We interviewed and sourced a range of scientists on all sides of the issue. Here are two competing quotes, the first from a distinguished, independent scientist discussing the evidence in the Proceedings of the National Academy of Sciences; the second from an activist scientist, representative of activist critics, who happens to be affiliated with an organization known for its endorsements of homeopathy and Chinese medicine addressing the controversy:

Here is what the GLP presented to the public in its GMO FAQ as the science consensus on this issuewhich is accurate today:

There is intense scrutiny over the role that GMO crops (and, by extension, herbicides glyphosate and dicamba) often paired with them play in the health of the Monarch butterfly.

Butterfly population declines are often primarily blamed by activists and some scientists on farmers using herbicides to destroy milkweed a poisonous weed that severely damages crops but is a critical food source for butterfly caterpillars growing near their GMO crops. The issue is complex with researchers differing on the causes of the decline.

The insect is facing problems that appear to be more complex than a single culprit. Research suggests the Monarch faces numerous threats, most of them unrelated to the use of herbicides, including climate change and degradation of their overwintering habitat in Mexico.A review of 116 years of data published in 2019 in the Proceedings of the National Academy of Sciences concluded that agricultural practices, including the use of herbicides, are responsible for less than 20 percent of the monarch decline, blaming most of the declines on deaths during annual migrations to and from Mexico. A2020 study using data compiled by the conservation group Monarch Watch challenges that conclusion, blaming the loss of milkweed on a variety of complex factors,including loss of breeding grounds for weeds due to urbanization and suburbanization, and weed control efforts by organic and conventional farmers.

Thats the science consensus. Which makes it all the more baffling and disappointing when the Cornell Alliance for Science recently posted an article on its well-regarded site with its exaggerated and inflammatory headline and editorial thrust.The articles author, Denmark-based journalist Justin Cremer, opens the articlealready tainted by its headlinewith an exaggerated sentence that contradicts the central conclusion of the study it is reporting.

A new study suggests that extensive agricultural use of glyphosate herbicide is to blame for the decades-long decline in North Americas monarch butterfly population.

Cremer subsequently writes that the study results bolster the milkweed limitation hypothesis. This theory points to the widespread use of glyphosate as the main cause of the population decline.

Heres the problem: This headline and statements contradict the actual study as even Cremer himself acknowledges in an otherwise solidly-reported piece. Also, Cremer does not alert the reader to the source of the data for the study: a Monarch butterfly advocacy group, Monarch Watch. Its standard to inform the reader of potential conflicts of interest.

Milkweed is used exclusively by Monarchs for egg laying on their multi-generational migration from Mexico to Canada and back. As Cremer later points out, the actual study, published in Frontiers in Ecology and Evolution, and headed by University of Kansas emeritus professor (and Monarch expert) Orley Taylor and Iowa State University butterfly authority John Pleasants, is not focused on the glyphosate issue in the main. Its intent, the authors clearly state, is to analyze a popular hypothesis that the severe (more than 90 percent) Monarch population decline over the past few decades is due to losses during the butterflys southern migration.

The study supports an alternative hypothesisthat milkweed supply declines are a driving force, among many other issues, for the decline of these beautiful creatures.And whats behind the milkweed decline? Its not glyphosate directly as the headline asserts; rather, itsland use changes (more on that below).

The worlds most-used weedkiller has long been a popular target of genetic engineering opponents because its used with herbicide-tolerant Roundup Ready (glyphosate) corn and soybean, which now comprise more than 90 percent of all such crops grown in the United States. Previously, these groups blamed the GMO plants themselves for milkweed and Monarch declines. Conservation group Environmental Action summed up the activist case in a recent petition urging individual states to ban glyphosate:

WE NEED TO BAN ROUNDUP TO SAVE MONARCHS.If we want to save the monarch migration, one of natures greatest phenomena, we need to stop the habitat destruction thats been causing their numbers to plummet.A great step that your state can take? Ban Roundup, the weed killer whose active ingredient, glyphosate, decimates the milkweed plant monarchs rely on to survive.

More recently, activist groups have called for home-improvement retailers Lowes and Home Depot to stop selling Roundup (and its generic equivalents) because of its alleged impact on butterflies. Not long after the paper and Alliance for Science story were published, groups like Friends of the Earth and CommonDreams called for a sales ban.

In their pleas, the groups also cited the World Health Organizations (WHO) International Agency for Research on Cancer (IARC) 2015 monograph, which linked glyphosate to certain cancers (a conclusion refuted by every regulatory agency in the world, including the WHO itself), and promoted organic farming methods (which do not exclude pesticides and also target milkweed removal).

There were media groups that contextualized the story, making the Alliance for Science report stand out even more. ScienceDaily handled it well, focusing on what the study was actually about: a refutation of the migratory hypothesis.

Science News concluded: These findings support the conclusion reached by a team of experts that sustaining the monarch migration will require the restoration of over a billion milkweed stems in the Upper Midwest in the coming years.

Even the progressive online magazine DownToEarth handled the headline and the story with appropriate nuance, writing, The findings led researchers to conclude that a billion milkweed stems needed to be restored in the Upper Midwest in the coming years to sustain Monarch migration. It did not single out one weed removal system or product.

This is where things get complicated, and where the author of the Cornell Alliance repot did not do his homework.Taylor told the Genetic Literacy Project that once glyphosate became popular, years before the introduction of GM corn and soy in the mid-1990s, it did almost eliminate milkweed from farmland. But, he added, that effect ended around 2006. Taylor, his co-author Pleasants and others were more concerned in 2000 about the use of GM crops bred to express Bt (Bacillus thuringiensis) Cry toxin, which kills caterpillars, although recent research indicates these insect-resistant plants probably dont pose a risk to butterflies.

In fact, research has shown recent resurgences of Monarch butterflies, though their populations still remain significantly lower than their peak, as the Genetic Literacy Project explains in its FAQ on Monarchs and pesticides:

According to the independent Illinois Butterfly Monitoring Network, the population in 2018 reached the highest levels of the past 25 years, and the fourth highest level since 1993. The number of butterflies heading south to Mexico may reach as many as 250 million over the 2018-19 winter. At its peak in the 1990s, the population reached an estimated 900 million.

Since 2006, corn and soy production have surged, partly due to overall demand but largely because of the 2007 Renewable Fuel Standard (RFS), signed by President George W. Bush, that encouraged the use of corn-based ethanol in gasoline. The RFS subsequently boosted corn production and, according to Taylor, led to 24 million acres of marginal land being converted to corn cropmore than three quarters of this land was grassland that probably once had milkweed. So, politics is the main driver of the rise in the use of milkweed-killing weedkillers. If glyphosate was banned tomorrow, other weedkillers that are more harmful would replace it and butterflies would be no better off.

In other words, the decline is complex. Even a prominent researcher at Monarch Watch, the source of the data, challenged the simplistic glyphosate theory; according to Cremer, Anurag Agrawal, who was not one of the studys researchers, cautioned Cremer that the situation is more complex than the study suggests and said Monarchs are experiencing stress from multiple sources. But that caution is contradicted by the headline opening line and much of the reporting in Cremers piece.

The real issue, as weird as it may sound, is how do we restore weeds, for thats where Monarchs flourish. Weedy areas are targeted by all farmers, organic and conventional. Monarchs fair no better in organic farms, where they are removed through carbon-belching machinery by hand rather than by using glyphosate or dicamba. The main driver in the reduction of weedy areas, as this study and others conclude, is not the use of glyphosate but urbanization and suburbanization, and the removal of wild areas for housing and industrial uses.

Commenting on the Alliance for Science article Taylor noted:

The text shows there is a failure to understand that long-term trends in populations are based on long-term trends. The trend here is loss of habitat and not mortality during migration or at other times in the annual cycle.

Andrew Kniss, weed scientist at the University of Wyoming, tweeted shortly after the Alliance for Science article posted. Echoing Taylor, he observed that this was an issue of milkweed habitat losses because of land use, not herbicides.

Glyphosate is better than most herbicides, he wroteand that includes weed control chemicals used by organic farmers. If farmers did not use glyphosate, they would just substitute something elsealmost certainly more toxic and ecologically compromisingand the problem would persist.Knisss perspective that this issue is far more complex than the simplistic glyphosate is harmful chants dovetails with the conclusions of a 2016Cornell University study:

In the face of scientific dogma that faults the population decline of monarch butterflies on a lack of milkweed, herbicides and genetically modified crops, a new Cornell University study casts wider blame: sparse autumnal nectar sources, weather and habitat fragmentation.

In other words, this problem is rooted in the removal of weedy plots and not a glyphosate or even a herbicide issue per se. Both organic farmers and conventional farmers need to remove milkweeds; the method of removal should not be the issue.The CAS article served to legitimize out-of-context attacks on a safe and effective herbicide. Intended or not, it implied that farming systems that rely primarily on synthetic weedkillers are more likely to endanger the Monarch than farming systems using natural chemicals or machines to control weeds. Does anyone really believe that if glyphosate or dicamba or a mechanical tiller was not available, farmers would allow weeds, including milkweed, to inundate their farms?

So, what kind of everyday kindness could improve the fate of the Monarch butterfly?

Monarch Watch and other groups have spent years advocating for accelerated planting of milkweed, especially along the migratory corridors through the US and the Canadian Midwest. If farmers cant do it (or wont, because milkweed is a weed and farming is a precarious business) on their farms, addressing areas could work: public areas, highway medians, federal lands, parks, homes and schools. Taylors paper called specifically for replanting 1.4 million stems of milkweed to return to levels seen 40-50 years ago; where they are replanted is a separate issue.

At Monarch Watch, we now have over 30,000 registered sites with at least twice that number that have been created but not registered, Taylor said. There are plenty of opportunities to provide habitats for monarchs and pollinators in lots of marginal areas around farms and even in suburban and urban environments.

Andrew Porterfield is a Contributing Correspondent to the Genetic Literacy Project. He is a writer and editor, and has worked with numerous academic institutions, companies and non-profits in the life sciences.BIO. Follow him on Twitter@AMPorterfield

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Roundup glyphosate weedkiller responsible for the decline in Monarch butterflies? Media and advocacy groups badly misreport study - Genetic Literacy...

New research report on Bio Vanillin market, which is a detailed analysis of this business space inclusive of the trends, competitive landscape, and the market size. Encompassing one or more parameters among product analysis, application potential, and the regional growth landscape, Bio Vanillin market also includes an in-depth study of the industry's competitive scenario.

Increasing consumer preference towards natural ingredients in food &beverage and personal care formulations will drive global bio vanillin market demand. Natural ingredients have been steadily gaining acceptance with consumers, especially across evolved markets, along with regulatory support for labeling standards. Bio vanillin has been developed as an alternative to the synthetic ingredient, which accounts for over 95% of present global demand.

Food &beverages dominated the application landscape, worth over USD 8 million in 2015. Appeal of new flavors in the industry and strong demand for confectionery and bakery products along with persistent development are key stimulating factors.

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Bio Vanillin Market size is expected to surpass USD 19 million by 2023; according to a new research report

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Biotechnology is also an important route in terms of addressing food waste and natural feedstock issues, permitting low value compound conversions to products of significant commercial interest. However, commercial success of the product will hinge on competitive bio vanillin market price trend.

Synthetic biology vanillin process is likely to lead the biomass removal required for good agricultural soil. Synthetic organisms may also harm the ecology on their escape either intentionally or unintentionally into the environment from a lab which is likely to be a threat for industry growth.

The product is at its initial development stage, while industry participants claim a natural product, there is some ambiguity regarding this classifications, as a few groups have claimed these products are artificial owing to its production from genetic engineering. Naturally derived vanillin from the pod remains in demand, however, a very high price and limited cultivation is unable to meet global demand.

Key insights from the report include:

Major Highlights from Table of contents are listed below for quick lookup into Bio Vanillin Market report

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Bio Vanillin Industry Insights

Chapter 4. Company Profiles

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Bio Vanillin Market Key Growth Factors, development trends, key manufacturers and competitive forecast 2023 - The Research Process

Concepts arent magic but they do focus the mind.

Consider, for example, the new economy: new, high-growth industries that are on the cutting edge of technology (Investopedia). In the 1990s, putting all the changes we were going through together in one phrase helped many people redirect job or career searches and stay in the game.

Here are three new concepts that might help us understand the job market today:

In an internet-dependent culture, attention is a form of currency (money). Your attention is valuable and many people are competing for it. Thats a big change from yesteryear:

For most of human history, access to information was limited. Centuries ago many people could not read and education was a luxury. Today we have access to information on a massive scale. Facts, literature, and art are available (often for free) to anyone with an internet connection.

We are presented with a wealth of information, but we have the same amount of mental processing power as we have always had. The number of minutes has also stayed exactly the same in every day. Today attention, not information, is the limiting factor.

Peoples attention mattered just as much in the past as today but there werent such easy ways of getting it. In the attention economy, specific strategies will probably help us stand out in the right ways when planning or safeguarding a career.

When we are seeking a job we are marketing ourselves, so heres a tip on the importance of niche marketing:

Personalization: Content has been getting increasingly niche over the past 510 years, and this will likely continue. There are marketing blogs, then there are blogs that focus on B2B marketing; Instagram marketing; marketing for artists, pool businesses, bed and breakfasts, and pretty much anything else. Plan on this trend to continue. Theres less and less appetite for generic content, but people will always want specific, personal advice tailored just for them.

Its true. When seeking a new job or career, generalities dont work as well as they used to. We need to focus on how we can meet specific needs. Just for example, in the health care industry for seniors, memory care has become a much bigger concern in recent years. So, a job applicant who can say I have the relevant qualifications to work in a home that provides care for elderly persons might not fare as well as one who can add to that, I have taken three specialist courses in memory care for persons with age-related cognitive issues.

That extra qualification gets attention. But, of course, it means that we need to spot trends and make time to update our education along the way.

A dark store is a warehouse full of groceries where staff called pickers select the goods that have been ordered by an online customer. (The Guardian, January 7, 2014).

It could look like a normal store but all the customers are employees. COVID-19 likely helped that retail style along. Amazon-owned Whole Foods, among others, is joining the trend:

With longer aisles, no salad bar, and missing those checkout candy displays, the store will be used to pack up online orders, which have skyrocketed during the pandemic. Amazon, which owns Whole Foods, says its grocery sales tripled, year over year, for the second quarter of 2020.

But this is not just a pandemic-related reaction. Though six of its stores were temporarily converted to handle only online orders, this new dedicated online-only store had been in the works for more than a year, according to company officials. And its not alone. More retailers are accommodating the shift of shopping from in-store to online by turning their physical locations into so-called dark storesminiature warehouse-like spaces where online orders can be packed for pickup or delivery. Retail experts say this is just the start of a major trend.

If customers are not visiting the physical stores, internet-based media will become much more important in reaching them. A career in retail at any level should include awareness of the new ways in which customers are being reached and served.

The first three industrial revolutions are reckoned to be steam power, electricity, and computing. The fourth is really a function of the internet.

The Fourth Industrial Revolution is a way of describing the blurring of boundaries between the physical, digital, and biological worlds. Its a fusion of advances in artificial intelligence (AI), robotics, the Internet of Things (IoT), 3D printing, genetic engineering, quantum computing, and other technologies.

The attention economy and dark stores are two aspects of the Fourth Industrial Revolution because they both depend on internet-based communication.

To adapt to this technology revolution, we must understand what is happening around us and determine where we fit in. What needs are we are best able to meet? The good news is that the current changes favor individuals with a good idea:

todays machinery the internet- and software-based tools that our knowledge economy businesses are built upon has alleviated the absolute requirement for employees to work together in the same place at the same time. Venture capital has been a leading driver of this trend, turbo-charging the development of the communications, collaboration, and project management tools that have made productive remote-working a reality.

In fact, before Covid-19, the primary barrier to home working was usually organizational reticence or indecision. The pandemic has forced our working practices to catch up to the technology, provoking a decades worth of organizational change overnight as our corporate world has been turned upside down.

Today, there are many new opportunities to make a difference and the challenge is to identify them in the tsunami of the internet.

You may also find worthwhile:

Robot-proofing your career, Peter Thiels way. Jay Richards and Larry L. Linenschmidt continue their discussion of what has changedand what wont changewhen AI disrupts the workplace

Post-Covid: Five ways your job could change. This is a good time to be a creative thinker and innovator.

and

Five possibly unexpected ways the post-Covid office will change. Well all know more about remote working than we ever thought we would.

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Three New Concepts That Can Help You Plan Your Career - Walter Bradley Center for Natural and Artificial Intelligence

Gene Therapy Market - Snapshot

Introduction of new production, availability of reimbursement together with high occurrences of cancer are estimated to propel growth of the global gene therapy market in the years to come. Gene therapy refers to an experimental technique, which utilizes genes for the prevention and treatment of various diseases. It is expected that in the near future, this technology could assist doctors to place a gene into the cells of a patient for the purpose of his treatment. This therapy could be used as an alternative to surgery or drugs. Scientists are examining various approaches to this therapy, which could comprise

Gene therapy has emerged as a promising treatment option for a large number of diseases such as certain viral infections, certain cancers, and inherited disorders. This factor is likely to work in favor of the global gene therapy market in the years to come.

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Progress in Gene-editing and Genomics Tools to Stoke Demand of Gene Therapy

CAR T-cell use has recently garnered considerable attention from the sponsors following the exhibition of its immense promise in the treatment of several diseases. The promising future of CAR T-cell is estimated to amplify the growth opportunities of the global gene therapy market. Sponsors hail CAR T-cell use as a brand new business model of the future.

In the pipeline of pharmaceutical industry, gene therapy account for a considerable share and this trend is likely to continue in the years to come. In addition, significant advancement has been made in the fields of cellular and molecular biology is likely to fuel growth of the global gene therapy market in the years to come. rapid technological progress made in the gene-editing and genomics tools are further estimated to drive the demand for gene therapy.

Global Gene Therapy Market Snapshot

Expanding at a stellar, double-digits CAGR (Compound Annual Growth Rate) of 40% over the forecast period of 2018 to 2026, the global gene therapy market is a dizzying trajectory, marking out a rosy landscape for players operating in the playfield. As per a Transparency Market Research report, based on extensive primary and secondary research, states that over the period states, the market would accrue a worth of USD 5164.03 million a steep and impressive increase from the USD 17 million worth noted in 2017.

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Fixing defective genes via introduction of new and healthy ones to fix severe genetic and chronic disorders is seeing an upward curve in demand for reasons of improved medical outcomes, major leaps in terms of technological advancement and minimal die-effects as compared to alternatives. Some of the most significant alternatives include surgery, and drug use.

Some of the most significant factors that the analysts of the report note include focused efforts towards marketing and commercialization, and a slew of approvals of new products hitting the global gene therapy market. Additionally, there are factors such as growing demand experienced for this treatment by a large pool of patients.

It is pertinent to note here that the global gene therapy market is consolidated and is dependent on clinincal research and development of the highest standards in order to chart growth. And, some of the players that operate the market landscape, and are into significant research projects include Gilead Sciences, Inc., Novartis AG, Sibiono GeneTech Co. Ltd., Spark Therapeutics, Inc., CELGENE CORPORATION, and Orchard Therapeutics Limited.

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Yescarta to Dominate Global Gene Therapy Market over the Forecast Period

The global gene therapy market report by TMR is segmented based on type, application, and region. The former includes the only five products that have been approved so far for commercial use. These include Gendicine, Yescarta, Strimvelis, Kymriah, and Luxturna. Riding the first mover benefits, Yescarta helf the dominant position in the market in 2017, and the trend will continue, adding more worth to the sub-segment. This is the product that brought out the initial CAR T therapy in the market for large B-cell lymphoma that relapse.

It is worth noting here that as per the global gene therapy market report, the high incidence of DLBCL and massive commercialization efforts directed towards Yescarta, particularly in Europe, will contribute positively and significantly to the overall growth of the global gene therapy market. The other sub-segment to make a mark over the global gene therapy market landscape will be Luxturna, owing to rising awareness levels and massive efforts towards comercialization.

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Europe to be Ahead of the Global Gene Therapy Market Growth Curve over the Forecast Period

The global gene therapy markets regional segmentation includes incisive growth insights into some of the most significant areas that will shape up the overall growth in the market. These include North America, Europe, and Rest of the World. Researchers involved with the preparation of report claim that a massive chunk of about 40% would be accounted for by Europe over the forecast period. Some of the factors backing-up the market dominance of the region include high incidence of non Hodgkin lymphoma and increase in number of treatment centers into gene therapy.

This growth would be followed by North America region, owing to huge contributions from the United States of America which witnesses about 7500 cases of refractory DLBCL each year. These are ones that qualify for the CAR T therapy.

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Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

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Gene Therapy Market Progress in Gene-editing and Genomics Tools to Stoke Demand of Gene Therapy - BioSpace

It turns out a regulatory delay isnt the only bump on Sareptas road to gene therapy glory.

The biotech is being sued by Regenxbio, which is alleging that its slate of gene therapy programs, including two for Duchenne muscular dystrophy and limb-girdle muscular dystrophy infringes on a patent originally owned by the University of Pennsylvania.

The lawsuit, which was first reported by Bloomberg Law, adds another wrinkle as Sarepta strives to stay in the lead in a race to deliver the first genetic fix for Duchenne muscular dystrophy. After making its name with two antisense drugs neither of which has been proven to have an effect against the crippling disease the Cambridge, MA-based biotech has been viewed as the frontrunner versus Pfizer and trouble-prone Solid Bio. Roche was impressed enough to pay $1.15 billion to acquire ex-US rights to the program.

But Regenxbio wants Sarepta to stop stepping on their patents and pay up. The biotech, which is now based in Rockville, MD, is seeking damages for past, present and/or future infringement equaling no less than a reasonable royalty.

At the center of the dispute is US Patent No. 10,526,617. Jim Wilson, the gene therapy luminary who co-founded Regenxbio, was cited as an inventor on that patent, granted this January.

As it covers a cultured host cell containing a recombinant nucleic acid molecule encoding the capsid protein, the technology can be used to create adeno-associated vectors both in animal studies and for delivering a transgene into humans.

The vectors made using the claimed subject matter of the 617 Patent have unique properties, e.g., an ability to target certain types of cells in the body, the lawsuit states.

Specifically, Regenxbio alleges, Sareptas Duchenne program SRP-9001 is manufactured by a process that includes making and using a cultured host cell a recombinant nucleic acid molecule encoding an AAVrh74 vp1 capsid protein. The same capsid protein is also integral to SRP-9003, the limb girdle candidate, and a host of other follow-on gene therapies.

Regenxbio is suing as Sarepta is sorting out a new request from regulators that can push back its pivotal study for Duchenne. While CEO Doug Ingram assured investors that quality control issues such as this are not uncommon and pinned the delay on an overburdened FDA, he stopped short of promising concrete timelines.

Focused on retinal, metabolic and neurodegenerative diseases for its internal pipeline, Regenxbio is perhaps more accomplished as a gene therapy tech provider. Novartis and Abeona have both licensed its NAV tech platform.

It also doesnt shy away from legal actions. In its most recent quarterly report, Regenxbio disclosed that Abeona failed to make a $8 million payment due in April, effectively terminating their licensing agreement. In response to an arbitration claim Abeona filed in May alleging we breached certain responsibilities to communicate with Abeona regarding our prosecution of licensed patents, Regenxbio filed a counterclaim to ask for $28 million including $20 million that would have been owed under the pact.

Last November Regenxbio challenged the FDAs arbitrary and capricious decisions to issue a full clinical hold on its diabetic retinopathy trial and a partial hold on wet age-related macular degeneration. The company had withdrawn the IND for diabetic retinopathy, and the FDA lifted the partial hold for wet AMD two months later.

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Sarepta faces another gene therapy hiccup as Regenxbio sues over Jim Wilson's patent - Endpoints News

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Pfizer has spent $800 million to build the leading production platform for gene therapies, the company said on Tuesday in its second day of talks to show how it plans to become a fast-growing innovator. Within three years, the drug giant hopes to launch three potential cures for hemophilia and muscular dystrophyworth as much as $4 billion in annual revenue.

We are in an unrivaled position to go to market, said the head of Pfizers rare-disease business, Suneet Varma, in his Tuesday morning presentation. In another Tuesday talk, the companys immunology leaders highlighted coming breakthroughs for the tens of millions who suffer miserable autoimmune skin disorders.

Pfizer (ticker: PFE) is eager to recast itself as a high-multiple growth stock. By year-end, its slower-selling products will be spun off into a business run by Mylan (MYL). From that point, Pfizer thinks it can boost revenue by 6% a year, despite the patent expirations of nearly $20 billion worth of its products in the latter part of this decade. The expected growth will be fired up by 25 product launches, which Pfizer is explaining in two days of online talks.

After rising Monday, Pfizer stock was down 0.3%, at $36.91, in recent trading. The S&P 500 was up 0.4%.

A rare disease may affect only a few hundred thousand people, but there are a lot of these diseases. Cumulatively, they add up to 400 million people worldwide, said Varma, with fewer than 5% having approved treatments. Pfizer believes the rare-disease market will grow at a double-digit annual rate.

Clinical trials are under way for treatments for the bleeding disorders known as hemophilia A and hemophilia B. After treatment, none of the enrolled patients have had bleeding problems, including some in which more than a year has passed since dosing.

Pfizer hopes for approval and launch of its hemophilia B treatment in 2022. Peak annual sales could hit $500 million to $1 billion, says the company. The hemophilia A launch could happen in 2023 and eventually exceed $1 billion in annual sales.

The gene-therapy treatments can require a short hospital stay. But the possibility of a cure will inspire 30% to 40% of hemophilia patients to seek treatment, Pfizer predicts.

A rival in hemophilia A gene therapy, BioMarin Pharmaceutical (BMRN), had a head start over Pfizer in clinical trials. But last month, the U.S. Food and Drug Administration rebuffed BioMarins application for approval and demanded additional follow-up of its patients for a period that will extend through the end of 2021.

The FDA hasnt asked Pfizer to change its design for the hemophilia A trial that the company will begin in a few weeks, said the chief medical officer of the rare-disease unit, Brenda Cooperstone,

There were some worrisome immune reactions among boys in the continuing clinical trial for Pfizers gene therapy for Duchenne muscular dystrophy. But after adjustments in the trials preparatory regime, Pfizer says there have been no more of those events. The treatment showed promising efficacy in early phase trials.

The pivotal Phase 3 muscular dystrophy trial will begin within weeks, with the first data expected in 2022. Pfizer hopes for a launch in 2023 of a muscular dystrophy therapy that would be used by 30,000 people a year in the U.S. and Europe, generating over $2 billion in annual revenue. to reach that goal, Pfizer is racing with Sarepta Therapeutics (SRPT).

In addition to its rare-disease treatments, Pfizer plans to launch four products for autoimmune disorders by 2025. Two of the products would treat atopic dermatitis, which causes painful itching in up to 30 million Americans. Only a portion of those patients get any treatment today.

Based on successful clinical trials, sufferers of the skin disease can look forward to breakthrough treatments, similar to those launched in recent years for psoriasis, says Pfizers inflammation and immunology business head, Richard Blackburn.

Corrections & Amplifications

Pfizers gene-therapy treatments can require short hospital stays. An earlier version of this article incorrectly said the treatments are like bone-marrow transplants, which require months of grueling hospital care.

Write to Bill Alpert at william.alpert@barrons.com

Read this article:
How Pfizer Plans to Lead the Industry in Gene Therapies - Barron's

China is predicted to continue its rapid bio growth rates, with more than 10 new mAbs

CPhI Annual Report has launched ahead of the firstCPhI Festival of Pharma(5-16 October 2020), the worlds largest digital pharma Expo that predicts dramatic growth of new mAb production in China, capacity shortages for cell and gene therapies in the USA, and the widespread global adoption of single-use technologies, but only limited continuous bioprocessing.

Three CPhI experts from BioPlan Associates Vicky Qing XIA, Leo Cai Yang and Eric Langer explore the rapidly changing global biologics markets, with special reference to the implications for contract outsourcing and Chinas continued emergence as a hub for both bio innovation and contract services.

Remarkably, China is predicted to continue its rapid bio growth rates, with more than 10 new mAbs predicted to be launched per year in the country by 2025. In fact, the total market size will quadruple by 2025, reaching 120bn RMB, and rising further to 190bn RMB by 2030.

According to the CPhI report, bioprocessing outsourcing in China is currently highly stratified with four tiers and just one domestic company intierone WuXi Biologics and a number of international CDMOs including BI, Lonza and Merck. However, by 2025 it is anticipated that as many as five more domestic CDMOs may have reached tier one status, with FDA and EU facility approvals.

Single Use Systems (SUS) are now far and away the leader at both pre-clinical and clinical stages, with nearly 85% now involving a substantial SUS component. Yet whilst its usage continues to grow, continuous bioprocessing is not anticipated to be in mainstream usage by 2025.

The report also suggested that in the US and Europe there is likely to be a cell and gene therapy capacity crunch by 2025, with CDMOs investing in this area already expanding to try and meet the pipelines demand.

Read the original post:
2025 will see cell & gene therapy capacity shortages in US: CPhI report - BSA bureau

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Chapter 1 Gene Therapy for Age-related Macular Degeneration Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Production, Revenue (Value) by Region

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Technological advancements have blurred the borders of natural biological processes by giving humans more control. One such area is that of gene editing that allows us to modify the childs genetic make up to not only prevent diseases, and lead to a healthier life, but also personality traits for a more fulfilling life. However, this raises question on ethics, consent of the child and rights of parents. RAGHAV AHOOJA,addresses this issue with the lens of state involvement in controlling the private realm.

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WE are at crossroads wherein we may be able to customize and design the futures of our future generations. Lawmakers, thus, need to solve the ethical dilemmas brought about by such giant scientific leaps.

Even though it may sound like science fiction, the future is here.

Gene editing for therapeutic purposes (namely gene therapy) is being conducted for the removal of diseases in humans and foetuses both. When changes are made to the somatic cells, the modifications arent hereditary. However, when the changes are made to the sperm, egg, or embryo, the modifications are transferred on to the next generation. It is done through a process called germline gene editing.

It seems like German philosopher Neitzsches post-human concept of bermensch (translated as beyond-man or superman) might become real. Using a technology known as CRISPR, one can not only treat diseases but also customize a baby in terms of intelligence, athleticism, and so on. This can permanently enhance the lineage of the family.

Believe it or not, the future is here.

Somatic gene editing has been approved in countries like the United States, although with restrictions. It is for the Courts and lawmakers to decide whether this right to enhance children for their own welfare falls within the right to privacy of the parents, or whether the state has a right to curtail such an action.

According to American jurisprudence, there is a private realm of family life which the state cannot enter. Yet time and again the state has entered this realm, claiming a legitimate interest in regulating the family, especially for the welfare of the child. Thus, whilst there exists a right to privacy under the Fourteenth Amendment, it is not absolute.

In the famous case of Roe v. Wade, the United States Supreme Court held that the right to abortion is embedded in the right to privacy of the parent bearing the child. While the judgment was pro-choice, gene editing doesnt quite fit the bifurcated and antagonistic pro-choice v. pro-life debate. It gives parents the choice to genetically edit their children, and the aim of such editing inter alia is to eradicate disease and enhance children for their own welfare.

(Credit: Edward Jenner, Source: Pexels)

Germany, as opposed to the US, recognises the unborn as an individual with a genetically determined identity, which is unique and inseparable. According to German courts, as the unborn baby grows, it does not only develop into a human being but develops as a human being and is worthy of human dignity. Such human dignity would also include the right to live a dignified life, which is free of disease. Therefore, a blanket ban on gene editing would be violative of human dignity.

It is quite clear that therapeutic gene editing is not violative of human dignity, insofar its aim is to eradicate disease. However, such human dignity also includes the right to free development of personality.

It is quite clear that therapeutic gene editing is not violative of human dignity, insofar its aim is to eradicate disease. However, such human dignity also includes the right to free development of personality.

A plain reading of the German constitutional text would suggest that non-therapeutic editing for personality factors is violative of human dignity. But to the contrary, heritable gene editing for purposes such as personality building will be permissible for strengthening the autonomy of the child. Furthermore, it must be for the welfare of the child and must not restrict the free development of their personality. A thumb rule could be whether the child would subsequently consent to such a modification.

Thus, there is a tripartite relationship of the right of the parents to choose the genetic makeup of their children, the right of the state to regulate such an act, and the right of the unborn baby to consent to such editing.

In India, guidelines permitting development of therapeutic gene editing products were introduced. Currently, heritable gene editing can only be done for purposes of experimentation and the embryo cannot have a life beyond 14 days. Thus, heritable gene editing is yet not fully permitted in India. However, there is scope as the Indian Supreme Court in K.S. Puttaswamy (2017) recognised that the right to privacy encompasses family affairs and childrearing. This would possibly entail the parents right to enhance their child as an extension of their right to choose.

It is an established position in law that technology mustnt be prohibited due to a mere possibility of harm. Rather, a positivist approach must be adopted so as to do the greatest good to the greatest number. In fact, a recent report by a German government-appointed council of experts stated that heritable gene editing is not violative of human dignity.

Further, a joint statement by the councils of the United Kingdom, France, and Germany stated that heritable gene editing is permissible. However, there must be a risk assessment and the risk must be brought down to a minimum acceptable level.

And that at the heart of this liberty lies the right to define ones own concept of existence, of meaning, of the universe, and of the mystery of human life, without the interference of the state.

The question, when looked at more deeply, is whether the personality and well-being of future generations ought to be subjected to medical decisions or not.

Thus, there is a tripartite relationship of the right of the parents to choose the genetic makeup of their children, the right of the state to regulate such an act, and the right of the unborn baby to consent to such editing.

The American Supreme Court in Planned Parenthood v. Casey has reiterated that the matters involving the intimate choices of a person are central to dignity and autonomy protected under liberty enshrined in the American Constitution. And that at the heart of this liberty lies the right to define ones own concept of existence, of meaning, of the universe, and of the mystery of human life, without the interference of the state.

(Credit: Ian Panelo, Source: Pexels)

Ultra-modern technologies such as artificial wombs make one think whether a birth is really an event, or a process, and if so then where does the process begin?

Partial ectogenesis (the growth of a baby outside the womb) is already happening. But in time, we might be able to carry out full ectogenesis. As the reliability of such technologies increases, so does their capability. The potential to live outside the mothers womb as opposed to the usual 24 weeks would begin right from the stage of development of the foetus, which is at 8 weeks. Further, with the help of biotech, the ability of an unborn baby to live outside the mothers womb might begin right at fertilisation.

Do we fast forward using techno solutionism or do we let evolution do its thing?

The American Courts have held that an individual whether single or married has the right to privacy which the state cannot infringe. Thus, even a single parent, out of wedlock, can bear such a child and the right to genetically edit unborn babies would be extended to them. The mother and father would be on an equal footing while deciding whether to genetically edit the baby or not.

The aim of the process of childrearing is to produce children with favourable traits and personality and allow them to have a dignified life.

In the first such successfully germline edited babies, scientists predict that it might have actually led to having enhanced their ability to learn and form memories. In another case of successful gene therapy, young children were saved from potentially deadly diseases and lives of isolation.

Therefore, the moot question is: Do we fast forward using techno solutionism or do we let evolution do its thing? Where do we draw the line? Should one circumscribe the limits of technology, or let it take a well-designed course?

Believe it or not, the future is here.

Where does that leave us?

It is for us to decide.

(Raghav Ahooja is a final year student at Rajiv Gandhi National Law University, Punjab. Views are personal.)

Excerpt from:
Gene Editing: Do We Have The Right to Genetically Enhance Our Children? - The Leaflet

New York, Sept. 18, 2020 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Advanced Therapy Medicinal Products Market Research Report by Therapy Type - Global Forecast to 2025 - Cumulative Impact of COVID-19" - https://www.reportlinker.com/p05953100/?utm_source=GNW

The Global Advanced Therapy Medicinal Products Market is expected to grow from USD 2,946.38 Million in 2019 to USD 6,524.94 Million by the end of 2025 at a Compound Annual Growth Rate (CAGR) of 14.16%.

Market Segmentation & Coverage:This research report categorizes the Advanced Therapy Medicinal Products to forecast the revenues and analyze the trends in each of the following sub-markets:

Based on Therapy Type , the Advanced Therapy Medicinal Products Market studied across CAR-T Therapy, Cell Therapy, Gene Therapy, and Tissue Engineered Product. The Cell Therapy further studied across Non-stem Cell Therapy and Stem Cell Therapy.

Based on Geography, the Advanced Therapy Medicinal Products Market studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas region surveyed across Argentina, Brazil, Canada, Mexico, and United States. The Asia-Pacific region surveyed across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, South Korea, and Thailand. The Europe, Middle East & Africa region surveyed across France, Germany, Italy, Netherlands, Qatar, Russia, Saudi Arabia, South Africa, Spain, United Arab Emirates, and United Kingdom.

Company Usability Profiles:The report deeply explores the recent significant developments by the leading vendors and innovation profiles in the Global Advanced Therapy Medicinal Products Market including AveXis, Inc., Bluebird Bio, Inc., Celgene Corporation, Gilead Lifesciences, Inc., JCR Pharmaceuticals Co., Ltd., Kolon TissueGene, Inc., MEDIPOST, Novartis AG, Organogenesis Inc., PHARMICELL Co., Ltd, Spark Therapeutics, Inc., UniQure N.V., and Vericel Corporation.

FPNV Positioning Matrix:The FPNV Positioning Matrix evaluates and categorizes the vendors in the Advanced Therapy Medicinal Products Market on the basis of Business Strategy (Business Growth, Industry Coverage, Financial Viability, and Channel Support) and Product Satisfaction (Value for Money, Ease of Use, Product Features, and Customer Support) that aids businesses in better decision making and understanding the competitive landscape.

Competitive Strategic Window:The Competitive Strategic Window analyses the competitive landscape in terms of markets, applications, and geographies. The Competitive Strategic Window helps the vendor define an alignment or fit between their capabilities and opportunities for future growth prospects. During a forecast period, it defines the optimal or favorable fit for the vendors to adopt successive merger and acquisition strategies, geography expansion, research & development, and new product introduction strategies to execute further business expansion and growth.

Cumulative Impact of COVID-19:COVID-19 is an incomparable global public health emergency that has affected almost every industry, so for and, the long-term effects projected to impact the industry growth during the forecast period. Our ongoing research amplifies our research framework to ensure the inclusion of underlaying COVID-19 issues and potential paths forward. The report is delivering insights on COVID-19 considering the changes in consumer behavior and demand, purchasing patterns, re-routing of the supply chain, dynamics of current market forces, and the significant interventions of governments. The updated study provides insights, analysis, estimations, and forecast, considering the COVID-19 impact on the market.

The report provides insights on the following pointers:1. Market Penetration: Provides comprehensive information on the market offered by the key players2. Market Development: Provides in-depth information about lucrative emerging markets and analyzes the markets3. Market Diversification: Provides detailed information about new product launches, untapped geographies, recent developments, and investments4. Competitive Assessment & Intelligence: Provides an exhaustive assessment of market shares, strategies, products, and manufacturing capabilities of the leading players5. Product Development & Innovation: Provides intelligent insights on future technologies, R&D activities, and new product developments

The report answers questions such as:1. What is the market size and forecast of the Global Advanced Therapy Medicinal Products Market?2. What are the inhibiting factors and impact of COVID-19 shaping the Global Advanced Therapy Medicinal Products Market during the forecast period?3. Which are the products/segments/applications/areas to invest in over the forecast period in the Global Advanced Therapy Medicinal Products Market?4. What is the competitive strategic window for opportunities in the Global Advanced Therapy Medicinal Products Market?5. What are the technology trends and regulatory frameworks in the Global Advanced Therapy Medicinal Products Market?6. What are the modes and strategic moves considered suitable for entering the Global Advanced Therapy Medicinal Products Market?Read the full report: https://www.reportlinker.com/p05953100/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Advanced Therapy Medicinal Products Market Research Report by Therapy Type - Global Forecast to 2025 - Cumulative Impact of COVID-19 - GlobeNewswire

The CDC estimates that sickle cell disease affects well over 100,000 Americans, with the disease occurring most often in African Americans. September has been designated as National Sickle Cell Awareness month designed to focus attention on the ongoing research in this field and the need for new treatments. The sector can certainly point to the significant progress that has taken place during the past few years, with new medicines reaching the market and several novel therapeutics with new mechanisms of action advancing in the pipeline.

Ted Love, president and CEO of Global Blood Therapeutics Inc. (GBT), said 2019 was a landmark year with the FDA approval of two new novel therapies to treat sickle cell disease. He was speaking at the virtual annual Sickle Cell Disease (SCD) Therapeutics Conference this week. His company, together with the Sickle Cell Disease Association of America, was hosting the one-day event featuring discussions on the latest advances and future trends.

Approvals

The key manifestation of the inherited blood disorder is that red blood cells (RBCs) are abnormally shaped (crescent), which restricts their flow in blood vessels and limits oxygen delivery to the bodys tissues, leading to severe pain and organ damage. The condition is also characterized by severe chronic inflammation that results in vaso-occlusive crisis (VOC) where patients experience episodes of extreme pain and organ damage.

Late November, GBT gained accelerated approval for its Oxbryta (voxelotor) tablets for the treatment SCD in adults and pediatric patients 12 and older. The agencys green light came less than two weeks after it gave the go-ahead to Novartis AG for Adakveo (crizanlizumab) to reduce the frequency of VOCs in adult and pediatric patients ages 16 and older with SCD.

According to Love, Oxbryta is a new class of therapy binding to hemoglobin and stabilizing RBCs in an oxygenated state and inhibiting deoxygenated sickle hemoglobin polymerization, making cells less likely to bind together and form the distinctive sickle shape.

The launch of the drug has gone well since it was approved, he said in the companys second-quarter financial report and business update, despite the impact of COVID-19. Net sales in the period reached $31.5 million, well ahead of the Streets expectations. Going forward, the company is planning to expand the potential use of Oxbryta for the treatment of SCD in children as young as 4 years old and also seek marketing authorization in Europe for Oxbryta to treat hemolytic anemia in SCD patients ages 12 and older with a marketing authorization application being submitted to the EMA by the middle of next year.

Pipeline progress

Cambridge, Mass.-based Agios Pharmaceuticals Inc. is working on mitapivat (AG-348), an investigational, oral, small-molecule allosteric activator of wild-type and a variety of mutated pyruvate kinase-R (PKR) enzymes, in patients with SCD. The compound has been shown to decrease 2,3-diphosphoglycerate (2,3-DPG) and increase adenosine triphosphate (ATP), and through that mechanism, it may reduce hemoglobin (Hb) S polymerization and red blood cell sickling. In June, the company reported that clinical proof of concept had been established based on a preliminary analysis in a phase I trial being conducted in collaboration with the U.S. NIH as part of a cooperative research and development agreement.

The ongoing study had enrolled nine patients, with eight completing all planned dose levels of mitapivat. Seven of eight patients who completed all dose levels experienced a Hb increase, with five of eight patients (63%) achieving a hemoglobin increase of 1 g/dL from baseline (range 1-2.7 g/dL). All five patients who achieved a hemoglobin increase of 1 g/dL did so at doses of 50 mg BID or lower. Decreases in 2,3-DPG and increases in ATP levels were observed, consistent with the proposed mechanism of action and comparable to that observed in healthy volunteer studies with mitapivat.

The company said it expects to report data from ACTIVATE and ACTIVATE-T, its two global pivotal trials for mitapivat in adults with pyruvate kinase deficiency, between the end of 2020 and mid-2021.

Watertown, Mass.-based Forma Therapeutics Holdings Inc., which made its public debut this year, also has a selective RBC pyruvate kinase-R activator in its pipeline for treating SCD. FT-4202 is being evaluated in a phase I trial in SCD patients ages 12 and older and has been granted fast track, rare pediatric and orphan drug designations. The compound is a potent activator of pyruvate kinase-R designed to improve RBC metabolism, function and survival by decreasing 2,3 DPG and increasing ATP, potentially resulting in both increased hemoglobin levels and reduced VOCs.

Olinciguat, an oral guanylate cyclase (sGC) stimulator, being developed by Cyclerion Therapeutics Inc., has completed the treatment period in its STRONG-SCD study with a total of 70 patients randomized. The placebo-controlled, dose-ranging study is designed to evaluate safety, tolerability and pharmacokinetics, as well as to explore effects on daily symptoms and biomarkers of disease activity when dosed over a 12-week treatment period. Top-line results are expected this year. Olinciguat is a compound that aims to stimulate sGC production, leading to the production of a signaling molecule called cyclic guanosine monophosphate (cGMP). High levels of cGMP help reduce inflammation in blood vessels, decrease adhesion between RBCs, and allow for improved blood flow by increasing the availability of nitric oxide.

Boston-based Imara Inc. is developing IMR-687, a small-molecule inhibitor of PDE9 that degrades cyclic guanosine monophosphate (cGMP), an active signaling molecule that plays a role in vascular biology. The company said that lower levels of cGMP are often found in people with SCD and beta-thalassemia and are associated with impaired blood flow, increased inflammation, greater cell adhesion and reduced nitric oxide-mediated vasodilation. Blocking PDE9 acts to increase cGMP levels, which are associated with reactivation of fetal hemoglobin.

In August, the company dosed the first patient in its Ardent phase IIb trial of IMR-687 for adult patients with SCD. The planned primary efficacy objective is to evaluate the proportion of all patients with fetal hemoglobin (HbF) response, defined as an increase of 3% in HbF from baseline to week 24, compared to placebo.

Gene therapy/gene editing

Since SCD is a monogenic disease condition, researchers believe that it would be a good candidate for gene therapy therapeutic approaches. For example, significant progress is being made by Cambridge, Mass.-based Bluebird Bio Inc. with lentiglobin, its lentiviral-based gene therapy that inserts an anti-sickling beta-globin variant into CD34-positive cells, progenitors of red blood cells.

At the virtual European Hematology Association (EHA) meeting in June, it reported new data from its ongoing phase I/II study involving adult and adolescent patients with SCD that showed a near-complete reduction of serious VOCs and acute chest syndrome. The company expects to submit a BLA to the FDA for the gene therapy next year.

Crispr Therapeutics AG and Vertex Pharmaceuticals Inc. are progressing CTX-001, an investigational, autologous, CRISPR/Cas9 gene-edited hematopoietic stem cell therapy being evaluated for patients suffering from severe hemoglobinopathies. At EHA, the companies reported that in the phase I/II Climb-121 study, at nine months after CTX-001 infusion, the first treated patient was free of VOCs, was transfusion independent and had total hemoglobin levels of 11.8 g/dL, 46.1% fetal hemoglobin and F-cells (erythrocytes expressing fetal hemoglobin) of 99.7%.

Last month, Cambridge, Mass.-based Editas Medicine Inc., a genome editing company, reported that the FDA had granted rare pediatric disease designation for EDIT-301, an experimental, autologous cell medicine, being developed as a potentially best-in-class, durable medicine for SCD. The company plans to file an investigational new drug application for EDIT-301 by the end of this year. EDIT-301 comprises sickle patient CD34+ cells genetically modified using a hCRISPR/Cas12a (also known as Cpf1) ribonucleoprotein to edit the HBG1/2 promoter region in the beta-globin locus. Red blood cells derived from EDIT-301 CD34+ cells demonstrate a sustained increase in fetal hemoglobin (HbF) production.

In its second-quarter financial report and business update, Beam Therapeutics Inc. announced the nomination of its first two adenine base editing development candidates, BEAM-101, targeting patients with hereditary persistence of fetal hemoglobin, and BEAM-102 (Makassar variant), both aimed at correcting SCD.

New Initiative

The NIH, which reports it spends approximately $100 million on sickle cell disease research, announced that is has launched The Cure Sickle Cell Initiative designed to speed the development of cures for the disease. It will take advantage of the latest genetic discoveries and technological advances to progress the most promising genetic-based curative therapies safely into clinical trials within five to 10 years.

Aided by research partners, the initiative will establish a national data warehouse of genetic therapies for sickle cell disease and conduct comparative analyses of therapeutic approaches to assess both clinical and cost effectiveness. National networks will also be created to make it easier for patients and providers to interact with the research, clinical trials, and other activities.

Read this article:
New medicines in the pipeline to treat sickle cell disease - BioWorld Online

With September being Sickle Cell Disease Awareness Month, Loma Linda University Childrens Health wants to help educate the community about SCD one of the most common yet overlooked genetic disorders in the world.

Each year, approximately 1,000 babies in the U.S. and 500,000 worldwide are born with the disease, according to the Sickle Cell Disease Association of America.

Akshat Jain, MD, MPH, a global sickle cell disease expert at Childrens Hospital, is passionate about establishing awareness and proper care for children suffering from SCD and Sickle Cell Trait, especially the diverse patient population in San Bernardino County.

There are many barriers to receiving care for those with SCD in our community, Jain says. One barrier specifically is lack of awareness surrounding the disease coupled with lack of awareness surrounding the treatment options available at Childrens Hospital.

In sickle cell disease, a persons red blood cells have an irregular cell shape, Jain says. Instead of round discs, theyre in a crescent or sickle shape.

Due to their shape, texture and inflexibility, the cells become clumped together. This grouping causes a blockage in a childs blood vessels, hindering blood-flow. This blockage may cause varying levels of pain and potentially organ damage long-term.

Jain says some of the signs and symptoms of SCD include:

Jain says that many children with SCD develop symptoms in their first year of life. SCD is commonly diagnosed during newborn screening tests, which check for the abnormal hemoglobin found in SCD. Additionally, if both parents of a child are known carriers of a SCD trait, their child will have a 25% chance of having the disease, Jain says.

Some of the emergent issues needing immediate medical care in kids with SCD disease include:

Treatments for SCD include pain medicines for pain management, adequate hydration, blood transfusions, vaccines and antibiotics, and some medicines. Currently, stem cell transplant from bone marrow is the recognized cure for SCD.

Childrens Hospital, with Jain working as a lead on the team, performed the institutions first stem cell transplant in 2019, curing a then 11-year-old girl who had suffered from SCD since birth. Since then, the team has successfully performed the transplant on several pediatric patients.

Patients with SCD at Childrens Hospital are placed into a treatment and care program where Jain and his team offer non-traditional services such as individualized patient treatment plans and direct access to the care team in case of an emergent event. Additionally, the program is working toward offering curative gene therapy for both sickle cell and hemophilia patients.

The bottom line is children and families suffering from this disease need to know that theyre not alone, Jain says. Here at Childrens Hospital, we are here to manage and fight this disease alongside of you.

Learn more about our treatments for sickle cell disease at our Specialty Team Centers.

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Here's what to know about Sickle Cell Disease in kids - Loma Linda University Health

NEW YORK--(BUSINESS WIRE)--As part of a two-day virtual Investor Day, Pfizer Inc. (NYSE: PFE) provided an extensive overview of pipeline advances and shared updates on the Companys efforts to battle the COVID-19 pandemic on multiple fronts, including new data on the BNT162b2 vaccine candidate being developed in collaboration with BioNTech SE. The pipeline updates contribute to the Companys expectation of at least a 6% revenue CAGR over the next five years, as well as delivery of longer-term topline growth beyond that period.

Pfizers goal of delivering up to 25 breakthroughs to patients by the year 2025 has 38 such opportunities to draw from as of today, including the companys 20-valent pneumococcal conjugate vaccine candidate (20vPnC). On a non-risk adjusted basis, these opportunities collectively represent more than $15 billion (excluding 20vPnC) in potential incremental revenue for Pfizer from 2020 to 2025, as well as aggregate peak annual sales potential of $35 billion to $40 billion (including 20vPnC). If successful, the Companys COVID-19 programs would be incremental to these estimates.

Pfizers purpose Breakthroughs that change patients lives has never been more relevant, and our R&D pipeline has never been more dynamic, said Dr. Albert Bourla, Pfizer Chairman and CEO. I am proud of the truly transformational science that our research and clinical teams are bringing to the fight against disease, as well as the unprecedented speed with which we are advancing our clinical programs in the battle against COVID-19. In the coming months and years, I look forward to the new Pfizer continuing to demonstrate the agility and innovative spirit of a biotech combined with the scale of Big Pharma. With the depth and breadth of our current portfolio, the tremendous potential of our pipeline and scientific engine, and the power of our culture of innovation, we are poised to continue delivering meaningful value to patients by addressing some of the worlds most difficult health challenges.

UPDATES ON COVID-19 DEVELOPMENT PROGRAMS

Pfizer announced several key advances in its efforts to protect humankind from the COVID-19 pandemic and prepare the pharmaceutical industry to better respond to future global health crises.

BNT162 mRNA-based Vaccine Program

Pfizer and BioNTech shared several updates from their BNT162 mRNA-based vaccine program against SARS-CoV-2, the virus that causes COVID-19 disease, including:

Protease Inhibitor Program

The company announced the initiation of its Phase 1b clinical trial to evaluate the safety of a novel investigational therapeutic for COVID-19, PF-07304814. Of note,

THERAPEUTIC AREAS OF FOCUS

Pfizer shared significant research advances across its various therapeutic areas including candidates with blockbuster potential expected to launch by 2025.

Vaccines

In addition to the COVID-19 vaccine program, Pfizer aims to deliver five innovative vaccines by 2025, subject to clinical success and regulatory approval. Updates on these late-stage clinical development programs include:

Rare Disease

Pfizers Rare Disease late-stage pipeline currently includes three gene therapy programs that, if successful, are expected to gain regulatory approval by the end of 2023, with an additional pipeline of 10 preclinical initiatives that are at various stages of maturity. Key updates include:

Oncology

Pfizers Oncology pipeline has the potential to deliver up to 14 approvals expected by the end of 2025 and the potential for 24 new molecular entities in the clinic by the end of 2021. Key updates included, for the first time, early-stage opportunities obtained from the 2019 acquisition of Array BioPharma:

Inflammation and Immunology

The Inflammation & Immunology pipeline is focused on patients with autoimmune and chronic inflammatory diseases across rheumatology, gastroenterology and dermatology, with five distinct immuno-kinases, in oral and topical formulations, studied for potential treatment of 10 diseases, and three additional novel biologics in Phase 2 studies. Key updates included:

Internal Medicine

The Internal Medicine pipeline addresses the increasing global burden of cardiometabolic disease, with nine investigational medicines in active clinical studies and additional therapies in the pre-clinical pipeline. Key updates included:

To access a replay of the webcast, including audio, video and presentation slides, visit our web site at http://www.pfizer.com/investors.

About Pfizer: Breakthroughs That Change Patients Lives

At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at http://www.Pfizer.com. In addition, to learn more, please visit us on http://www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer.

Disclosure Notice: The information contained in this release is as of September 15, 2020. Pfizer assumes no obligation to update forward-looking statements contained in this release or the webcast as the result of new information or future events or developments.

This release and the webcast contain forward-looking information about Pfizers anticipated operating and financial performance, business plans and prospects, Pfizers pipeline portfolio (including anticipated regulatory submissions, data read-outs, study starts, approvals, revenue contributions and market opportunities), and our efforts to respond to COVID-19, including our investigational vaccine candidate against SARS-CoV-2 and our investigational protease inhibitor, including their potential benefits, among other things, that are subject to substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizers product candidates; whether and when any such applications that may be filed for any of Pfizers product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizers product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; uncertainties regarding the ability to obtain recommendations from vaccine technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on Pfizers business, operations and financial results; and competitive developments.

A further description of risks and uncertainties can be found in Pfizers Annual Report on Form 10-K for the fiscal year ended December 31, 2019 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned Risk Factors and Forward-Looking Information and Factors That May Affect Future Results, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at http://www.sec.gov and http://www.pfizer.com.

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Pfizer Investor Day Features Significant Number of Pipeline Advances for COVID-19 Programs and Across Numerous Therapeutic Areas - Business Wire

Here are the top biotech companies you will find in Oxford, a city with an old scientific tradition and an enormous output of biotech applications.

Oxford is well known for its university, one of the oldest in Europe and considered to be one of the best in the world. Recently, the University of Oxford has been the center of attention thanks to an experimental Covid-19 vaccine that the university is developing in partnership with big pharmaceutical companies. If successful, the vaccine, already in phase III testing, could be one of the first to get approval for this new disease.

The University of Oxford has hosted thousands of bright minds over the years. Thanks to its emphasis on technology transfer, the university has also helped a large number of them turn their ideas into successful spinout companies. The environment created around the university has also attracted many talents and businesses to the city, making it the ideal melting pot for new and promising ideas.

Biotech is one of the fortes of the innovation seen in the city of Oxford. So we consulted with local experts to put together a list of the most remarkable companies in the city, be it for their size, innovation, or influence in the sector.

Founded in 2008, Immunocore is one of just a few private biotech companies in Europe that are estimated to be worth over 1B. The company is tackling multiple forms of cancer as well as infectious and autoimmune diseases using T-cell receptor (TCR) technology. TCRs are proteins on the surface of immune T cells that are responsible for identifying a threat that must be destroyed, such as cancerous or infected cells. Immunocore aims to patients with engineered TCRs to circumvent the mechanisms by which these threats evade the immune system, restoring its ability to fight disease.

The company is collaborating on several projects with Genentech, AstraZeneca, Eli Lilly, and GSK. Its most advanced program is a treatment for uveal melanoma that is currently in phase III trials. Other programs target solid tumors, hepatitis, HIV, and type 1 diabetes.

Adaptimmune Therapeutics was founded at the same time as Immunocore with the goal of exploiting TCR technology in the form of T-cell therapy. The company engineers the TCRs naturally present on the patients own immune T cells to improve their ability to identify cancerous cells.

Adaptimmune is now getting ready to start late-stage clinical trials in multiple cancer types. Thanks to a deal with Astellas Pharma, the company is also gearing up to start clinical testing of a version of its T-cell therapy that doesnt require engineering each dose individually for each patient, using donor cells instead. Adaptimmune also has several partnerships with companies including GSK, Noile-Immune Biotech, and Alpine Immune Sciences.

Oxford Biodynamics was spun out of Oxford University in 2007 with the goal of developing liquid biopsy tests that can perform a diagnosis from just a drop of blood. The company specializes in epigenetics, that is changes to the structure of our DNA that determines which genes are switched on or off.

Oxford Biodynamics works in a wide range of indications, including cancer, diabetes, Alzheimers, multiple sclerosis, and rheumatoid arthritis among many others. The tests are not only designed to diagnose a disease; they can also be made to determine which patients are going to benefit the most from a specific drug, and how likely the disease is to progress faster or relapse.

With these tests, the company is supporting the development of personalized medicine approaches and helping drug developers increase their chances of succeeding in clinical trials. Partners include big pharma such as Pfizer and EMD, as well as universities and research institutes.

Chronos Therapeutics started out in 2009 as a spinout of the University of Oxford with the goal of developing drugs for age-related conditions. The companys lead program targets amyotrophic lateral sclerosis (ALS), the most common motor neuron disease, for which there are no treatments able to stop its progression.

Over time, the company has expanded its portfolio into other indications, particularly those that affect the brain, by acquiring assets from third parties. They include programs targeting fatigue caused by multiple sclerosis, addictive behaviors such as binge eating and alcohol use disorder, and post-traumatic stress disorder.

Evox Therapeutics is developing a drug delivery technology based on exosomes nanoparticles that our bodies naturally use to transport molecules. The company engineers exosomes to carry different types of drugs, such as proteins, RNA, or small drugs. The key advantage is that these natural carriers are able to reach targets that conventional drug delivery systems cant, such as the brain.

Founded in 2016, the company has signed big deals with Takeda and Eli Lilly. Its programs are all in preclinical testing and mostly target rare diseases. One of them targets the rare liver disorder argininosuccinic aciduria and is scheduled to enter clinical trials in 2021.

Exscientia is a pioneer in the application of artificial intelligence to drug discovery. The company uses AI to identify potential drug candidates and optimize their structure to maximize their chances of success in clinical trials. The goal is to speed up and reduce the costs of the drug discovery process.

Earlier this year, the companys drug candidate for obsessive-compulsive disorder became one of the first AI-designed drugs to enter clinical trials. While a drug typically takes five years from identification until clinical trials, this one did so in just a year.

Exscientia is partnered with Bayer, BMS, Sanofi, and GSk among others. In the wake of the Covid-19 pandemic, the company set out to go through a database of 15,000 approved and investigational drugs that had already passed safety testing to find candidates that can then be fast-tracked to clinical testing in Covid-19 patients.

Oxford Biomedica was set up in 1995 as a developer and provider of lentiviral vectors for gene and cell therapy. These vectors allow the permanent introduction of a desired DNA sequence into a target cell, be it in the test tube or directly in the patients body.

The technology of Oxford Biomedica is regularly used by companies such as Novartis, Sanofi, Boehringer Ingelheim, Imperial Innovations, and Orchard Therapeutics. Notably, the vectors developed by the company are used in Novartis Kymriah, the first CAR T-cell therapy approved in Europe and the US as a cancer treatment.

Oxford Biomedica also has a preclinical pipeline of proprietary programs in a wide range of applications, including cancer, eye disease, ALS, and liver disease. Last year, the company struck a deal with Microsoft to reduce the complexity and costs of gene and cell therapy manufacturing using artificial intelligence.

Founded in 2016, Arctoris aims to bring the benefits of automation to cancer research. Through the companys services, a researcher could just order an experiment online and spend their valuable time designing experiments and analyzing results rather than performing the repetitive tasks needed to complete them.

Arctoris aims to contribute to reducing the costs of drug discovery, which are increasing every year as treatments become personalized and results more difficult to replicate. In the context of the Covid-19 pandemic, Arctoris has established assays that allow scientists the possibility of running Covid-19 experiments remotely.

Founded in 2015, Orbit Discovery is a drug discovery company focusing on the identification of peptide drugs. The company has developed a technology that significantly improves on conventional methods of drug screening such as phage display or mRNA display.

The technology consists of fusing peptides to the DNA sequence encoding them and presenting them to live cells. This method allows the screening of peptide targets that were previously missed by other technologies, and to study their effect on live cells to better predict their function.

The company has already identified several candidates in the areas of cardiology, immunology, and cancer, and is working with partners such as Zealand Pharma in their preclinical development.

OxStem is a drug discovery company with an unusual approach to stem cell treatments. Instead of using stem cells as a therapy, the firm focuses on developing small molecule drugs that can reprogram the patients own stem cells to treat a wide range of diseases related to aging, including cancer and diabetes as well as neurological, cardiovascular, and ocular conditions.

Founded in 2013, the strategy of OxStem is to spin out companies that specialize in each disease area to focus on the development of the drugs found by the parent company, with five subsidiaries set up so far.

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The Top 10 Biotech Companies Brewing at... - Labiotech.eu

"Hey, baby!" my wife Caron said, smiling her way into the room. "The Health Departmentis doing free COVID tests on the church parking lot! Would you like to get one?"

What I thought:Isn't the best place to catch COVID a test site where people go to see if they have COIVD and be tested by people who test people for COVID all day? I'd rather attend a Trump rally in Alabamawearing my Huey P. Newton T-shirt and carrying a Black Lives Matter picket sign.

What I said:"I mean, we don't have any symptoms. I don't really wanna be around a bunch of people. But we can go if you want, baby."

"We'll go early on Friday!" she said, exiting with the same smile.

The old me would never voluntarily go and get a COVID test when I felt fine. I'd wait until my body performed each and every symptom across the board,from the feverand the shortness of breathto the inability to taste food. One or two symptoms wouldn't be good enough, either I'd have to have them allat the same time. Only then would I seek treatment.

This is how I was raised.I come from the school of you don't go to the hospital unless you're dying, even if you do have insurance. You could getshot, break a leg, or have your index finger swallowed by a lawnmower, doesn't matter: just drink some water or some ginger ale, take a nap and you'll be good in the morning.But I'm trying to be better now, and I'm encouraging the men around me to do the same.

By trying, I mean I havea primary care physician so I'm no longer playing Russian Roulette in the ER when I feel bad. I getannual physicals. Iaim to hit the dentist twice a year, when the pandemic isn't stopping me. And I actually listen to what these professionals say, keeping all of my self-diagnoses and Googled explanations for what's happing to my body to myself.

I also ride about 13 miles a day on my Peloton bike. I'm all in:wearingmy Peloton T-shirt, learning from my instructors, adopting their breathing techniques andpositive outlooks, reciting their motivational quotes with religious intensity.When confronted with life's annoying hurdles like systemic racism, I tell myself,"if you can conquer this 45-minute Hip Hop Arms and Intervals ride, you can conquer anything!"

I have not been perfect. I need to do better;we all do.But when news of Chadwick Boseman's death flashed across thescreen,I dropped my phone. The "Black Panther" star a manliterally built like a superhero was only 43, at the height of his career, and gone in the blink of an eye due to colon cancer.

Obviously thePeloton lifestyleisn't going to prevent me from getting coloncancer. But most of the men I know aren't being tested regularly, if they're even going in for check-ups at all. For men who were raised not to seek professional treatmenteven when they can feel or see something's wrong, preventative medicine often isn't even on the radar.We don't evenget the opportunity to fight these deadly illnesses before it's too late.

* * *

On the way to the testing site I thought about the ways I would respond if I tested positive for COVID or if my wife did. What if our baby was sick? What would that nightmare look like?The more I thought about it, the less I wanted to go.A test had the power to make a hypotheticalreal. Images of infants strapped to ventilators spiraled through my head as we pulled into the parking lot. I tried to calmmyself by remembering that we had no symptoms, even though there are asymptomatic people out right now spreading the virus around the world.

"Let me go first?" I asked my wife. "You can stay in the car with the baby. I'll get a feel for the test and tell you if it's weird or not."

She agreed. I put on my mask, flooded my hands and forearms with enough sanitizer to sting, exited our truck and took my place on line with the rest of the COVID-curious.

* * *

My distrust of medicine didn't come out of left field. I know how Black people have been treated since the beginning of American medicine. We'vebeen used as guinea pigs throughout its history, from Dr. James Marion Sims' brutal treatment ofenslaved womenduringthe invention of the vaginal speculum and the neonatal tetanus experiments he performedon enslaved babies, in which he beat holes into their heads with a shoemaker's awl,to the "Tuskegee Study of Untreated Syphilis in the Negro Male," in which white scientists lied to Black men saying that they were treating them for"bad blood" when they were actually watching them suffer. I carry that history with me into every exam room.

Many Black people see going to be tested or treated for COVID-19 as a death sentence, since conditions like asthma, which we are most likely to have because the air quality in our neighborhoods is poorer, and diabetes, which we are more likely to have because Black Americanshistorically have not had equal access tohealthy food, puts us more at risk for developing potentially fatal cases.

My college friend Cliff often posted on Facebook about poverty, inequality, and how Black people are treated in America. Cliff died from COVID-19."In poverty, there is a lack of access," Cliff wrote in response to a friend the day before he passed. "I grew up and live in West Baltimore. How many hospitals do we have? Two. Think of that. Two hospitals (Sinai and Bon Secours) for the ENTIRE West Baltimore. So, when you look at things like testing and treatment and combine them with things like access, you can clearly see how poverty plays a factor into who gets treated and who doesn't."

The increased likelihood ofcomplicating health factors and a systemic lack of access to quality care make Black people especially vulnerable to the coronavirus. But somany can't just chill in quarantine and #StayAtHome because they have to go to work in jobs designatedas "essential," which comes with an increasedlikelihood of contact with the virus. (The irony here is that America certainly doesn't treat Black people like we are "essential," as in "worth protecting.")All of the mail carriers, Amazon delivery drivers, and app courierswhose services help me stay at home to ride my Peloton and worry about my missed dentist appointment are Black.As usual, Black people are on the frontlines fighting for a country that kills us in multiple ways.

* * *

"Sir, fill this form out, front and back," a bubbly woman dressed in scrubs said, passing me a pen and a clipboard.

The line moved fast, with only about fivepeople in front of me. By the time I finished completing the form, another woman wearing a different color of scrubs walked toward me with a long Q-tipaimed at my nostril. Slowly, she inserted the Q-tip deep into my nose, swabbed around, then placed it into a bag and told me to have a good day. I watched her walk off because I wanted to see what she did with my sample. The woman laughed her way over to a sample collector insidea huge van that looked like a clinic on wheels, and then I watched her prepare for testing the next person by pouring hand sanitizer on her hands without removing the gloves she wore while testing me.

I flippedout.

It's called hand sanitizer, not latex glove sanitizer!I panicked.All of the residual distrust of medicine and health care and doctors and hospitals flooded back into my brain.She probably just gave me COVID!

I wanted to walk over to her and yell, "That is the nastiest, most unsanitary display of carelessness I ever saw in my life!"

But I remembered my breathing techniques, my positive outlook.I tapped into the new healthy me.

"Shut ya mouth, D. Watkins,"I mumbled instead on the way back to our truck. "Asking her why she didn't change gloves and not getting a satisfying response will only ruin your day."

The new healthy me had taken COVID-19 more seriously than anyone I knew. "Prepare for a lockdown! Load up on canned goods and Lysol wipes!" I had ranted to my friends and family like a maniacas quarantine approached.I just knew we were headed straight toward crazy times.

Before coronavirus, we had family and friends over daily.But six months ago we shut everything down anddecided to stay away from everyone. My daughter Cross was only three months old at the time, which means she can't say "my chest hurts" or "I'velost my sense of taste," so we took every precaution in our household, even breaking family members' hearts by telling them they couldn't see the baby until this is over.

Happy-go-lucky neighbors who intruded our six-foot imaginary bubble were told to get the f**k back.Groceries and other packages were disinfected as soon as they hit our doorsteps. We left the house only to take car rides.No meet-ups, no house parties, no quick visits to anywhere. And now I can't even trust the results of a test I didn't want to go take.

"What's wrong with you?" my wife asked. "Why you'd stand there like that?"

I inhaled, then exhaled, and calmly said, "CAN YOU BELIEVE THEY ARE NOT CHANGING THEIR $*%& GLOVES!"

"The health department is in charge of this," my wife said.

Was that supposed to make me feel better or worse?

"They should know better!" she said.

Then Caron morphed into full Karen mode. She was going to take the test, investigate, check their glove strategy, make sure they were clean and doing their jobs. And if they failed to meet what she thought the standard should be, then she was going to deliver the most devastating blow an agency could face from a person like her: My wife was going to write a letter.

She hopped out of the truck and marched toward the testing site. I looked at Crosssitting snug in her car seat and said, "Mommy is on a mission. They're in trouble now!"

Caron marched back to the truck about five minutes later looking as unhappy as I was. "The woman told me that they sanitize their gloves, and then double-glove for extra safety."

Double-glove?! I took a huge 45-minute Hip Hop Cycling inhale anda smooth 20-minute Rhythm & Blues exhale.

Then I directed my anger toward the health departmentfor allowing such sloppy practices at a community testing site. And thought about Cliff, and the new healthy me, all of my work-outs andsalads and dental appointments, and how we live in a country that claims it's a superpower even though our so-called leader shows no remorse for the 190,000 people who died of COVIDunder his watch. I thought of those 190,000 people too. Maybe a new healthy me doesn't even matter maybe my race and social context have already sealed my fate, my family'sfate.

I imagine Caron was already drafting the letter inside of her head as we headed home.

"I'm not worried," I reassured her. "You shouldn't be worried.We don't have any symptoms.I'm fine, you're fine, the baby will be fine. We will not let them ruin our weekend."

And it didn't. We had a pretty good weekend Idid my daily digital bike ride and forgot about the test until the following Monday.

We were having a classic clichd Black American Labor Day:Caron on the deck grilling, baby Cross in her tiny inflatable pool, and me eating crabs with my parents, trying to explain to my mom why Jay-Z's music is so much better and more important than all of the Luther Vandrossand Mahalia Jacksonsongs together.

Then Caron got the call from an unfamiliar number that turned out to be the health department. "Call us back," the voicemail said."We have very important information about your health."

When we filled out our forms, we elected to be notified by text for negative results, not letter or phone call. If they were calling us on a holiday, it had to be bad news.

"What do you think we should do?" Caron asked.

Then I noticed I had a missed call, too. Same number, same woman's voice, same message. I dialed it back and the call went straight to voicemail. I called back, then again, and again I might have redialed like 16 times only to get the same result.

"Should we ask your parents to leave?" Caron asked me. "This is really anxiety provoking."

Both of my parents are high-risk for COVID.They fitinto those preexisting conditions categories, especially my dad who recently received a kidney transplant. Before that, hehad his gallbladder removed, and before that, a piece of his liver removed, and something was done to his spleen before that all while juggling high blood pressure and diabetes.

But myparents weren't worried.We continued with our day, even though that terrible message from the health department festered inside both of our heads for the rest of the night. We receivedanother round of voicemails later that evening, too, putting us both on edgeuntil the next morningwhenwe finally got the health department on the phone and were informed that we had both tested negative.

Emotions soared. I thanked God and Peloton.

"Why did you decide to get a Covid test, Mr. Watkins?" the woman from the Health Department asked me.

I hung up on her.

Caron was already working on her letter.

Apparently my precautions areworking,so I'll continue to mask up,wash my hands every two minutes and encourage others to do the same. Realizing that I can calm myself down and work to keep my coolthrough this stressful period has been an unexpected reward.I can't imagine what my reaction would have been if we had tested positive, but I hope it would have been to keep doing what's right. The new healthy me is worthless if I only focus on my body and ignore my mindset, my outlook on life and the way that I treat other people, especially in times of crisis.

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The new healthy me is still Black in COVID's America - Salon

With a lack of certainty surrounding the future, being and feeling healthy may help bring the security that you need during these unpredictable times.

When it comes to your health, there is a direct relationship between nutrition and physical activity that play an enormous part in physical, mental, and social well-being. As COVID-19 continues to impact almost every aspect of our lives, the uncertainty of the future may seem looming. Sometimes improvisation is necessary, and understanding how to stay healthy and fit can significantly help you manage your well-being during these times.

Gyms, group fitness studios, trainers, and professionals can help you to lay out a plan that will either keep you on track through all of the changes and restrictions or help you to get back on the ball so that all of your health objectives are met.

Most facilities and providers are setting plans to provide for their clients and customers to accommodate the unpredictable future. The key to remaining consistent is to have solid plans in place. This means setting a plan A, plan B, and perhaps even a plan C. An enormous amount is on the table for this coming fall and winter; if your gym closes again, what is your plan? If outdoor exercising is not an option due to the weather, what is your plan? Leaving things to chance will significantly increase your chances of falling off of your regimen and will make consistency a big problem.

The key to remaining consistent is to have solid plans in place. This means setting a plan A, plan B, and perhaps even a plan C.

The rise of stress and anxiety as a result of the uncertainty around COVID-19 has affected everyone in some way. Staying active by exercising helps alleviate stress by releasing chemicals like serotonin and endorphins in your brain. In turn, these released chemicals can help improve your mood and even reduce risk of depression and cognitive decline. Additionally, physical activity can help boost your immune system and provide long term health benefits.

With the new work-from-home norm, it can be easy to bypass how much time you are spending sedentary. Be aware of your sitting time and balance it with activity. Struggling to find ways to stay active? Start simple with activities like going for a walk outside, doing a few reps in exchange for extra Netflix time, or even setting an alarm to move during your workday.

If you, like many others during the pandemic shift, have taken some time off of your normal fitness routine, don't push yourself to dive in head first, as this may lead to burnout, injury, and soreness. Plan to start at 50 percent of the volume and intensity of prior workouts when you return to the gym. Inactivity eats away at muscle mass, so rather than focusing on cardio, head to the weights or resistance bands and work on rebuilding your strength.

Be aware of your sitting time and balance it with activity.

In a study published earlier this year, researchers found drug-resistant bacteria, the flu virus, and other pathogens on about 25 percent of the surfaces they tested in multiple athletic training facilities. Even with heightened gym cleaning procedures in place for many facilities, if you are returning to the gym, ensuring that you disinfect any surfaces before and after using them is key.

When spraying disinfectant, wait a few minutes to kill the germs before wiping down the equipment. Also, don't forget to wash your hands frequently. In an enclosed space where many people are breathing heavier than usual, this can allow for a possible increase in virus droplets, so make sure to wear a mask and practice social distancing. Staying in the know and preparing for new gym policies will make it easy to return to these types of facilities as protocols and mutual respect can be agreed upon.

From work to working out, many routines have faltered during the COVID pandemic. If getting back into the routine seems daunting, investing in a new exercise machine, trainer, or small gadget can help to motivate you. Whether it's a larger investment such as a Peloton, a smaller device such as a Fitbit, or simply a great trainer, something new and fresh is always a great stimulus and motivator.

Make sure that when you do wake up well-rested, you are getting out of your pajamas and starting your day with a morning routine.

Just because you are working from home with a computer available 24/7 doesn't mean you have to sacrifice your entire day to work. Setting work hours, just as you would in the office, can help you to stay focused and productive.

A good night's sleep is also integral to obtaining and maintaining a healthy and effective routine. Adults need seven or more hours of sleep per night for their best health and wellbeing, so prioritizing your sleep schedule can drastically improve your day and is an important factor to staying healthy. Make sure that when you do wake up well-rested, you are getting out of your pajamas and starting your day with a morning routine. This can help the rest of your day feel normal while the uncertainty of working from home continues.

In addition to having a well-rounded daily routine, eating at scheduled times throughout the day can help decrease poor food choices and unhealthy cravings. Understanding the nutrients that your body needs to stay healthy can help you stay more alert, but they do vary from person to person. If you are unsure of your suggested nutritional intake, check out a nutrition calculator.

If you are someone that prefers smaller meals and more snacks throughout the day, make sure you have plenty of healthy options, like fruits, vegetables and lean proteins available (an apple a day keeps the hospital away). While you may spend most of your time from home, meal prepping and planning can make your day flow easier without having to take a break to make an entire meal in the middle of your work day. Most importantly, stay hydrated by drinking plenty of water.

While focusing on daily habits and routines to improve your physical health is important, it is also a great time to turn inward and check in with yourself. Perhaps your anxiety has increased and it's impacting your work or day-to-day life. Determining the cause and taking proactive steps toward mitigating these occurrences are important.

For example, with the increase in handwashing, this can also be a great time to practice mini meditation sessions by focusing on taking deep breaths. This can reduce anxiety and even lower your blood pressure. Keeping a journal and writing out your daily thoughts or worries can also help manage stress during unpredictable times, too.

While the future of COVI9-19 and our lives may be unpredictable, you can manage your personal uncertainties by focusing on improving the lifestyle factors you can controlfrom staying active to having a routine and focusing on your mental healthto make sure that you emerge from this pandemic as your same old self or maybe even better.

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5 Most Desirable Medical Specialities Around the Globe - SWAAY

Doctors and experts say that improved medical tactics and earlier treatment are helping improve the outcomes for very sick patients, said Andrew Badley, head of Mayo Clinics Covid Research Task Force.

Health-care preparedness today is much better than it was in February and March, Badley said in an interview. We have better and more rapid access to diagnosis. We have more knowledge about what drugs to use and what drugs not to use. We have more experimental treatments available. All of those contribute to possible improvements in the mortality rate.

One study looked at 4,689 Covid-19 hospitalizations from March to June in New York, adjusting patients mortality rate for factors such as age, race, obesity and any underlying illnesses they might have had. In the first half of March, the mortality rate for hospitalized patients was 23%. By June, it had fallen to 8%. The research hasnt yet been peer-reviewed, a process through which other experts examine the work.

Despite the gains, the U.S. will soon pass 200,000 deaths, and tens of thousands of Americans are confirmed infected each day. The number killed by the disease is still in large part a factor of how many are infected in the first place -- the more people who get sick, the more die. The Centers for Disease Control and Prevention has emphasized that a mask is still the best available protection from the virus for most people. And experts warn that the virus is still very dangerous and can kill even seemingly healthy individuals.

Even with these improvements, this is not a benign disease, said Leora Horwitz, an associate professor of population health and medicine at New York Universitys Grossman School of Medicine who conducted the New York study of Covid-19 hospitalizations. This does not mean that coronavirus is now a non-dangerous disease. It remains a very serious threat to public health.

Public-health officials, epidemiologists, amateur observers and others have watched as the pandemic has unfolded, looking for how to measure the viruss deadliness. Tallying deaths as a percentage of the greater population sheds light on the scope of the pandemic. Excess mortality compares fatalities to what the death rate is expected to be. But neither method offers insight into whether the virus is becoming more or less deadly for an individual with a severe case.

Even looking at deaths per the number of confirmed cases can be misleading as the result is largely a function of testing, experts say. If many mild or asymptomatic cases are captured, mortality rates will be skewed lower. In Europe, for example, there are anecdotal signs of a similar trend, though much of the lower death rate may be because of more cases being found in younger, healthier people. More infections in young people are being found in the U.S., as well.

You have to understand who youre testing and then what the real fatality rate is for that demographic, said Aaron Glatt, chief of infectious diseases at Mount Sinai South Nassau hospital.

There is even a hypothesis that public health-measures like mask-wearing and distancing can help decrease the amount of virus people are getting infected with, leading to less severe cases because the body isnt overwhelmed with a large dose of virus at once.

Even though theyre getting infected with the virus, perhaps they are getting less of a dose of the virus and so theyre just getting less sick from it, Horwitz said.

In New York, the first major U.S. city hit hard by the virus, knowledge among doctors was limited as cases poured into emergency rooms this spring. There have been more than 27,000 confirmed and probable Covid-19 deaths in the city, the bulk of them at the peak of the outbreak there in March and April.

As the outbreak moved on to other parts of the country, such as Texas, health-care workers had more time to prepare and learn what works.

We kind of had a play book before we even started seeing any patients in Texas, said Robert Hancock president of Texas College of Emergency Physicians. We understand the things that work at this point with Covid much better.

Since March, doctors have learned valuable lessons, not only about how to ensure hospitals dont run out of ICU beds and ventilators, but also that flipping a patient onto their stomach, known as prone positioning, can help. Giving patients steroids early on and treating them with blood thinners can also improve someones prognosis.

Now that we know that we might need to start these patients on blood thinners and Heparin pretty quickly, thats helping, said Diana L. Fite, president of the Texas Medical Association. A lot of these deaths from Covid are because of the blood coagulation; the blood clots ruin their organs.

Though there is still no cure for the coronavirus, all of the improvements in treatment and preventative measures combined contributes toward an improved prognosis for patients, Fite said. In Texas, there have been at least 14,590 deaths from the virus, according to the Texas Department of State Health Services.

Even if these things arent cures, they help a small percentage do better, Fite said. You add several of those things up and youve got a better outcome overall.

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COVID-19 grows less deadly as doctors gain practice and drugs improve - The Boston Globe

Eli Lilly said it planned to discuss with regulators the possible emergency use of baricitinib for hospitalized patients. Other news is about early research on an antibody that might neutralize COVID and how the virus controls the brain, as well.

AP:Anti-Inflammatory Drug May Shorten COVID-19 Recovery TimeA drug company says that adding an anti-inflammatory medicine to a drug already widely used for hospitalized COVID-19 patients shortens their time to recovery by an additional day. Eli Lilly announced the results Monday from a 1,000-person study sponsored by the U.S. National Institute of Allergy and Infectious Diseases. The study tested baricitinib, a pill that Indianapolis-based Lilly already sells as Olumiant to treat rheumatoid arthritis. (Marchione, 9/14)

The Hill:Drugmaker Says Anti-Inflamatory Medicine May Shorten COVID-19 Recovery TimeThe use of Baricitinib, arheumatoidarthritis drug from Eli Lilly, led to a one-day reduction in recovery time for patients when combined with Remdesivir compared to patients who only took Remdesivir, according to a trial. The finding was statistically significant, Eli Lilly said in a statement. The company did not release the full results of the study but stated the National Institute of Allergy and Infectious Diseases (NIAID) is expected to publish full results in peer-review studies and that additional analyses are ongoing to understand clinical outcome data, including safety and morbidity data. (9/14)

In other scientific developments

Fox News:University Of Pittsburgh Scientists Discover Antibody That 'neutralizes' Virus That Causes CoronavirusScientists at the University of Pittsburgh School of Medicine have isolated the smallest biological molecule that completely and specifically neutralizes SARS-CoV-2, the virus that causes the novel coronavirus. The antibody component is 10 times smaller than a full-sized antibody, and has been used to create the drug Ab8, shared in the report published by the researchers in the journal Cell on Monday. The drug is seen as a potential preventative against SARS-CoV-2. (Deabler, 9/14)

Fox News:Coronavirus Can 'Hijack' Brain Cells To Replicate Itself, Yale Researchers DiscoverThe coronavirus can affect the brain and hijack brain cells to replicate itself, Yale University researchers have discovered. A new study from Yale University, on BioRXiv, which is awaiting peer review, found that the brain is another organ susceptible to an attack by the novel coronavirus. (McGorry, 9/14)

Stat:23andMe Research Finds Possible Link Between Blood Type And Covid-19A forthcoming study from genetic testing giant 23andMe shows that a persons genetic code could be connected to how likely they are to catch Covid-19 and how severely they could experience the disease if they catch it. Its an important confirmation of earlier work on the subject. People whose blood group is O seemed to test positive for Covid-19 less often than expected when compared to people with any other blood group, according to 23andMes data; people who tested positive and had a specific variant of another gene also seemed to be more likely to have serious respiratory symptoms. (Sheridan, 9/14)

Originally posted here:
Drug Company Touts Anti-Inflammatory Drug's Role In Shortening COVID Recovery - Kaiser Health News

Interview by Nicole Aschoff

For the better part of a year the world has battled SARS-CoV-2, a novel coronavirus that has killed nearly a million people and sickened tens of millions. In the United States the virus has wreaked havoc, particularly on older members of the population. Americans aged fifty-five and older account for more than 90 percent of the nearly two hundred thousand US COVID-19 deaths, while roughly 0.2 percent were people under twenty-five.

Efforts to quell the virus have brought additional pain. As of late August, roughly nineteen million Americans were out of work as a result of the pandemic, and food and housing insecurity has increased dramatically. But the pain caused by lockdowns has not been shared equally.

Elites have seen their stock portfolios balloon in value, and many professionals have been able to keep their jobs by working from home. It is the countrys poor and working-class households, particularly those with children, who have borne a disproportionate share of the burden. Lower-income Americans were much more likely to be forced to work in unsafe conditions, to have lost their livelihoods due to business and school shutdowns, or to be unable to learn remotely.

Jacobin editorial board member Nicole Aschoff sat down with two public health experts to discuss the challenge of keeping Americans safe without forcing working people to bear the lions share of pain and risk.

Katherine Yih is a biologist and epidemiologist at Harvard Medical School where she specializes in infectious disease epidemiology, immunization, and post-licensure vaccine safety surveillance. Yih is also a founding member of the New World Agriculture and Ecology Group, a former and current member of Science for the People, and a long-time activist in farm labor and anti-imperialist struggles.

Martin Kulldorff is a professor of medicine at Harvard Medical School. Kulldorff has developed methods for the detection and monitoring of infectious disease outbreaks which are used by public health departments around the world. Since April, he has been an active participant in the COVID-19 strategy debate in the United States, his native Sweden, and elsewhere. This interview has been lightly edited for clarity.

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We Need a Radically Different Approach to the Pandemic and Our Economy as a Whole - Jacobin magazine