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M6P Therapeutics to Host Key Opinion Leader Webinar on Lysosomal Storage Disorders – Yahoo Finance

Posted: July 21, 2021 at 2:22 am

- Webinar on Wednesday, July 28 @ 10 a.m. ET -

ST. LOUIS, July 19, 2021--(BUSINESS WIRE)--M6P Therapeutics ("M6PT" or "the Company"), a privately held life sciences company developing next-generation recombinant enzyme and gene therapies for lysosomal storage disorders (LSDs), today announced that it will host a key opinion leader (KOL) webinar on LSDs on Wednesday, July 28, 2021 at 10:00 a.m. ET.

The webinar will feature a fireside chat with KOLs Gregory Enns, M.D., Lucile Salter Packard Childrens Hospital Stanford School of Medicine, and Mark S. Sands, Ph.D., Departments of Medicine and Genetics at Washington University School of Medicine, who will discuss the current treatment landscape and unmet medical needs in LSDs, including Gaucher disease, Fabry disease, Pompe disease, mucopolysaccharidoses, and mucolipidoses. LSDs are a family of approximately 50 rare, genetic, and life-threatening diseases characterized by a deficiency in a specific lysosomal enzyme.

The event will also feature an update from the M6PT management team on its recombinant enzyme and gene therapy S1S3 bicistronic technology platform for the treatment of LSDs. The Company plans to initiate its first clinical program in 2022.

Dr. Enns, Dr. Sands, and M6PT management will also take questions from the audience.

To register for the webinar, please click here.

Dr. Enns is a Professor of Pediatrics and Genetics at the Lucile Salter Packard Childrens Hospital Stanford School of Medicine. He completed his medical education at the University of Glasgow (1990) in Scotland and completed his residency at the Children's Hospital Los Angeles Pediatric Residency in California. He then went on to complete his fellowship at the UCSF Medical Center in California. He is board certified in Clinical Genetics and Genomics. Dr. Enns research interests include novel means of diagnosing and treating mitochondrial disorders, with an emphasis on antioxidant therapy, lysosomal disorders, and newborn screening by tandem mass spectrometry. His current pursuits include the analysis of glutathione and antioxidant status in patients who have mitochondrial disorders and the development of new techniques for diagnosing and treating these conditions.

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Dr. Sands is a Professor in the Departments of Medicine and Genetics at Washington University School of Medicine in St. Louis. Dr. Sands received his Ph.D. in Molecular Pharmacology from the State University of New York at Stony Brook. He was a postdoctoral fellow at The Jackson Laboratory (Bar Harbor, ME) and at the University of Pennsylvania School of Veterinary Medicine before joining the faculty at Washington University School of Medicine. The goals of Dr. Sands laboratory are to better understand the underlying pathogenesis and developing effective therapies for inherited childhood diseases, specifically LSDs. A major focus of his group is to determine the safety and efficacy of adeno-associated viral gene transfer vectors for the treatment of both the central nervous system (CNS) and systemic manifestations of these diseases. In addition, his group has developed lentiviral-mediated hematopoietic stem cell-directed gene therapy approaches, as well as small molecule drugs, and more recently rational combinations of these approaches. The primary diseases that Dr. Sands studies are mucopolysaccharidosis type VII (MPS VII), Krabbe disease, and Infantile Neuronal Ceroid Lipofuscinosis.

About M6P Therapeutics

M6P Therapeutics is a privately held, venture-backed biotechnology company developing the next-generation of targeted recombinant enzyme and gene therapies for lysosomal storage disorders (LSDs). M6P Therapeutics proprietary S1S3 bicistronic platform has the unique ability to enhance phosphorylation of lysosomal enzymes for both recombinant enzyme and gene therapies, leading to improved biodistribution and cellular uptake of recombinant proteins and efficient cross-correction of gene therapy product. This can potentially lead to more efficacious treatments with lower therapy burden, as well as new therapies for currently untreated diseases. M6P Therapeutics team, proven in rare diseases drug development and commercialization, is dedicated to fulfilling the promise of recombinant enzyme and gene therapies by harnessing the power of protein phosphorylation using its S1S3 bicistronic platform. M6P Therapeutics mission is to translate advanced science into best-in-class therapies that address unmet needs within the LSD community. For more information, please visit: http://www.m6ptherapeutics.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20210719005355/en/

Contacts

Contact us to learn about partnering opportunities with M6P Therapeutics:

M6P Therapeutics: 314-236-9694info@m6ptherapeutics.com

Media: Alex Van Rees, SmithSolve973-442-1555 x111alex.vanrees@smithsolve.com

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Deconstructing the Infectious Machinery of SARS-CoV-2 – Newswise

Posted: July 21, 2021 at 2:22 am

Newswise In February 2020, a trio of bio-imaging experts were sitting amiably around a dinner table at a scientific conference in Washington, D.C., when the conversation shifted to what was then a worrying viral epidemic in China. Without foreseeing the global disaster to come, they wondered aloud how they might contribute.

Nearly a year and a half later, those three scientists and their many collaborators across three national laboratories have published a comprehensive study in Biophysical Journal that alongside other recent, complementary studies of coronavirus proteins and genetics represents the first step toward developing treatments for that viral infection, now seared into the global consciousness as COVID-19.

Their foundational work focused on the protein-based machine that enables the SARS-CoV-2 virus to hijack our own cells molecular machinery in order to replicate inside our bodies.

From structure to function to solutions

It has been remarked that all organisms are just a means for DNA to make copies of itself, and nowhere is this truer than in the case of a virus, said Greg Hura, a staff scientist at Lawrence Berkeley National Laboratory (Berkeley Lab) and one of the studys lead authors. A viruss singular task is to make copies of its genetic material unfortunately, at our expense.

Viruses and mammals, including humans, have been stuck in this battle for millions of years, he added, and over that time the viruses have evolved many tricks to get their genes copied inside us, while our bodies have evolved counter defenses. And although viruses often perform a long list of other activities, their ability to harm us with an infection really does come down to whether or not they can replicate their genetic material (either RNA or DNA, depending on the species) to make more viral particles, and use our cells to translate their genetic code into proteins.

The protein-based machine responsible for RNA replication and translation in coronaviruses and many other viruses is called the RNA transcription complex (RTC), and it is a truly formidable piece of biological weaponry.

To successfully duplicate viral RNA for new virus particles and produce the new particles many proteins, the RTC must: distinguish between viral and host RNA, recognize and pair RNA bases instead of highly similar DNA bases that are also abundant in human cells, convert their RNA into mRNA (to dupe human ribosomes into translating viral proteins), interface with copy error-checking molecules, and transcribe specific sections of viral RNA to amplify certain proteins over others depending on need while at all times trying to evade the host immune system that will recognize it as a foreign protein.

As astounding as this sounds, any newly evolved virus that is successful must have machines that are incredibly sophisticated to overcome mechanisms we have evolved, explained Hura, who heads the Structural Biology department in Berkeley Labs Molecular Biophysics and Integrated Bioimaging Division.

He and the other study leads - Andrzej Joachimiak of Argonne National Laboratory and Hugh M. ONeill at Oak Ridge National Laboratory specialize in revealing the atomic structure of proteins in order to understand how they work at the molecular level. So, the trio knew from the moment they first discussed COVID-19 at the dinner table that studying the RTC would be particularly challenging because multitasking protein machines like the RTC arent static or rigid, as molecular diagrams or ball-and-stick models might suggest. They're flexible and have associated molecules, called nonstructural and accessory proteins (Nsps), that exist in a multitude of rapidly rearranging forms depending on the task at hand akin to how a gear shifter on a bike quickly adapts the vehicle to changing terrain.

Each of these Nsp arrangements give insights into the proteins different activities, and they also expose different parts of the overall RTC surface, which can be examined to find places where potential drug molecules could bind and inhibit the entire machine.

So, following their serendipitous convergence in Washington, the trio hatched a plan to pool their knowledge and national lab resources in order to document the structure of as many RTC arrangements as possible, and identify how these forms interact with other viral and human molecules.

Science during shutdowns

The investigation hinged on combining data collected from many advanced imaging techniques, as no approach by itself can generate complete, atomic-level blueprints of infectious proteins in their natural states. They combined small-angle X-ray scattering (SAXS), X-ray crystallography, and small-angle neutron scattering (SANS) performed at Berkeley Labs Advanced Light Source, Argonnes Advanced Photon Source, and Oak Ridges High Flux Isotope Reactor and Spallation Neutron Source, respectively, on samples of biosynthetically produced RTC.

Despite the extraordinary hurdles of conducting science during shelter-in-place conditions, the collaboration was able to work continuously for more than 15 months, thanks to funding for research and facility operations support from the Department of Energys Office of Science National Virtual Biotechnology Laboratory (NVBL). During that time, the scientists collected detailed data on the RTCs key accessory proteins and their interactions with RNA. All of their findings were uploaded into the open-access Protein Data Bank prior to the journal articles publication.

Of the many structural findings that will help with drug design, one notable discovery is that assembly of the RTC subunits is incredibly precise. Drawing on a mechanical metaphor once more, the scientists compare the assembly process to putting together a spring-based machine. You cant put a spring in place when the rest of the machine is already in position, you must compress and place the spring at a specific step of assembly or the whole device is dysfunctional. Similarly, the RTC Nsps cant move into place in any random or chaotic order; they must follow a specific order of operations.

They also identified how one of the Nsps specifically recognizes the RNA molecules it acts upon, and how it cuts long strands of copied RNA into their correct lengths.

Having the vaccines is certainly huge. However, why are we satisfied with just this one avenue of defense? said Hura. Added Joachimiak: This was a survey study, and it has identified many directions we and others should pursue very deeply; to tackle this virus we will need multiple ways of blocking its proliferation.

Combining information from different structural techniques and computation will be key to achieving this goal, said ONeill.

Due to the similarity of RTC proteins across viral strains, the team believe that any drugs developed to block RTC activity could work for multiple viral infections in addition to all COVID-19 variants.

Reflecting back to the beginning of their research journey, the scientists marvel at the lucky timing of it all. When we started to talk, said Hura, we had no idea that this epidemic would soon become a pandemic that would change a generation.

This study was supported by the DOE Office of Science through the NVBL, a consortium of DOE national laboratories focused on the response to COVID-19, with funding provided by the Coronavirus CARES Act; and by the National Institutes of Health. The Advanced Light Source, Advanced Photon Source, High Flux Isotope Reactor, and Spallation Neutron Source are DOE Office of Science user facilities.

# # #

Founded in 1931 on the belief that the biggest scientific challenges are best addressed by teams, Lawrence Berkeley National Laboratory and its scientists have been recognized with 14 Nobel Prizes. Today, Berkeley Lab researchers develop sustainable energy and environmental solutions, create useful new materials, advance the frontiers of computing, and probe the mysteries of life, matter, and the universe. Scientists from around the world rely on the Labs facilities for their own discovery science. Berkeley Lab is a multiprogram national laboratory, managed by the University of California for the U.S. Department of Energy's Office of Science.

DOE's Office of Science is the single largest supporter of basic research in the physical sciences in the United States, and is working to address some of the most pressing challenges of our time. For more information, please visit energy.gov/science.

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PANAKS PARTNERS ANNOUNCES THE FIRST CLOSING OF ITS NEW PURPLE GLOBAL BIOTECH/ MEDTECH FUND AT 150 MILLION ($180 MILLION) – PharmiWeb.com

Posted: July 21, 2021 at 2:22 am

PANAKS PARTNERS ANNOUNCES THE FIRST CLOSING OF ITS NEW PURPLE GLOBAL

BIOTECH/ MEDTECH FUND AT 150 MILLION ($180 MILLION)

Panaks will use the successful closing of its second Fund to extend its investment activity to biotech, while maintaining its ongoing activity in medtech, the focus of Panaks first fund

Panaks plans to invest the new fund in companies at the forefront of global innovation with the potential to transform patient care, with a focus on Europe, and Italy in particular

Panaks Purple Fund has been backed by the European Investment Fund (EIF), the Fund of Funds managed by CDP Venture Capital SGR, financial institutions and some of the main Italian companies operating in the Life Sciences sector

Milan (Italy), July 20, 2021 - Panaks Partners, the leading Italian venture capital firm in the Life Sciences sector, announces the first closing of its 150 million ($180 million) Purple Fund, the firms second fund.

Panaks Purple Fund is currently the largest venture capital fund actively investing in Italian companies and the most significant fund dedicated wholly to the Life Sciences sector in Italy. The fund will invest in companies at the forefront of innovation, with a focus on Europe, and Italy in particular, which remains underserved in terms of Venture Capital funding.

The Purple Fund is the second venture capital fund dedicated to life sciences launched by Panaks Partners. Panaks first fund, raised in 2016, supported companies in the medtech sector. To-date it has invested in 12 portfolio companies, which have collectively received almost 200 million in funding. Thanks to this financial support, these companies have already brought five innovative medical products to the market and have a further ten products in active clinical trials.

The Purple Fund has been backed by investors from the first fund as well as new investors. The Funds two anchor investors are EIF and the Fund of Funds FoF VenturItaly managed by CDP Venture Capital SGR. The EIF investment is backed under both the InnovFin Equity initiative from the European Commission under Horizon 2020, the Framework Programme for Research and Innovation, as well as the pan-European Guarantee Fund (EGF).

These anchor investors have been joined by several Italian banking foundations and pension funds, as well as numerous Italian companies and family offices in the Life Sciences sector. These include Menarini, the Cogliati family (Elemaster Group), the Colombo family (SAPIO Group), the Rovati family (Rottapharm Biotech), the Petrone family (Petrone Group), the Re family (Digitec Group), the Bassani family (Movi Group) and others.

The Purple Fund will invest mainly in Series A funding rounds, as well as later stage opportunities. The majority of investments will be in companies developing innovative therapeutics and products in the fields of biotechnology, diagnostics, and medical devices.

The fund aims to support the growth of entrepreneurial companies who will reshape healthcare globally by addressing real medical needs, saving lives and providing a better quality of life for patients. By achieving these goals, the fund aims to generate value for both investors and for society as a whole.

We are delighted with the successful first close of our new Purple Fund, and we would like to thank the high-quality investors who have trusted us. Over 500 innovative life science companies have already submitted funding requests to us in the first six months of 2021, said Fabrizio Landi, President of Panaks and a founding partner of the firm alongside Diana Saraceni and Alessio Beverina. The fund will remain open for additional subscribers until the end of the year, with a new target of 180 million. By expanding into the biotech sector, we hope to contribute to the growth of companies active in the development of new therapies and vaccines, concluded Landi.

Panaks has established a strong track record and solid international credibility since it was created a few years ago, also with the support of the CDP Group. commented Enrico Resmini, Chief Executive Officer of CDP Venture Capital SGR. We are delighted to invest in Panaks second fund, as it extends its activity into biotechnology, a sector where long-term planning and the availability of capital is essential to finance the R&D that is expected to lead to the innovative new therapies of tomorrow.

Alain Godard, Chief Executive of the European Investment Fund (EIF/FEI), added: We are happy to once again support Panaks after our previous investment in its first fund. Panaks has managed to build a strong brand in Italy and beyond thanks to its expertise in identifying and investing in novel medtech opportunities. With the extension of its investment strategy into biotech and the resulting growth of the team, Panaks will be able to further support European Life Sciences companies, and particularly those in Italy, which have exceptional R&D but are strongly underserved in terms of Venture Capital funding. We are glad to be able to use both the InnovFin mandate from the European Commission and the direct backing of EU Member States under the European Guarantee Fund to further support this exciting market segment.

To support its expansion into the biotech sector, Panaks intends to recruit three new professionals with significant experience in drug discovery and development in the pharmaceutical industry to its existing team, which is currently made up of 11 professionals. Recently Barbara Castellano has been promoted to the role of Partner, while the management team of the SGR has been strengthened with the arrival of a new CFO, Lorenzo Giordano, and a Financial Assistant, in the person of Andrea Steffanini.

Panaks Advisory Board has also been expanded and strengthened with the appointment of Biotech and Digital Health industry experts Fabio Pammolli, Professor of Economics, Finance, and Management Science at Politecnico di Milano, and Sergio Abrignani M.D. Ph.D. Full Professor at the National Institute of Molecular Genetics (INGM) in Milan.

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PANAKS PARTNERS ANNOUNCES THE FIRST CLOSING OF ITS NEW PURPLE GLOBAL BIOTECH/ MEDTECH FUND AT 150 MILLION ($180 MILLION) - PharmiWeb.com

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Letter to the editor | Why wouldn’t you get vaccinated? – TribDem.com

Posted: July 21, 2021 at 2:21 am

A few years ago, I got the shingles vaccine for $170. What if the COVID-19 shot was $170? The outrage would be completely different from the current kooky conspiracy theories. Im imagining talk of government and big Pharma in cahoots to kill all the poor people by the prohibitive price.

What we have is a biological organism run amok as it rapidly spreads from host to host. Scientists worked overtime to find a solution, and they did. These are among the best brains on the planet.

More than 600,000 Americans have perished from COVID-19. This vaccine is free. Its the governments job to provide for the public health and citizens responsibility to support the common good.

I remember as a young student learning about the black plague that killed millions of people centuries ago and was grateful for living in a time of scientific knowledge.

Im flummoxed as to why people wouldnt want this preventative medicine.

Even mask wearing became controversial. Try telling your doctor that she need not wear a mask while operating on you, as masks dont work. Good luck with your post-op healing. Masks impinging on personal freedom is just selfish.

Go the library and check out The Diary of Anne Frank to find out what a loss of personal freedom is.

The people now getting COVID are almost all unvaccinated and unmasked.

Good for you if you recovered. I wonder how many people you spread the virus to others who did not recover?

Wrap your conscience around that.

Anita LaPorta Altman

Johnstown

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UW School of Medicine and Public Health named as inaugural site for national LGBTQ+ health care fellowship program – University of Wisconsin-Madison

Posted: July 21, 2021 at 2:21 am

The University of Wisconsin School of Medicine and Public Health has been selected by the American Medical Association Foundation as the inaugural institution for theNational LGBTQ+ Fellowship Programaimed at transforming the health equity landscape for the LGBTQ+ community.

Sara Benzel608-852-2605sbenzel@uwhealth.org

The ultimate goal of the program is to ensure that all LGBTQ+ patients receive the highest standards of care, according to Dr. Elizabeth Petty, senior associate dean for academic affairs at the UW School of Medicine and Public Health, and the principal investigator and program director for the interdisciplinary fellowship program.

This funding provides a very exciting and critically important opportunity to integrate primary care and public health in highly innovative ways that will significantly accelerate needed change to optimize the health of LGBTQ+ and gender expansive individuals, she said.

The program, which will be housed in the schools Department of Family Medicine and Community Health, will build on the school and health systems existing foundations of diversity, equity, and inclusion strategies that support affirming LGBTQ+ services and will accelerate education, research and clinical initiatives.

The first fellow will be recruited to begin their training for the year-long clinically focused academic program in July 2022. Fellows will have opportunities to extend their training beyond one year to do additional scholarship to advance LGBTQ+ health equity. The program will accept one fellow each year thereafter, with a goal of recruiting three fellows per year annually by the fifth year.

Physician fellows will undergo clinical and classroom training in LGBTQ+ health care and will engage in research, teaching, mentoring, community collaborative partnership efforts and other scholarly endeavors.

We envision a future where LGBTQ+ and gender diverse patient populations experience optimal health and feel accepted and supported by health care providers who are well-versed in both general and unique medical needs of LGBTQ+ patients, Petty said. We have much ground to cover before we reach this goal, as far too many LGBTQ+ patients in our society currently experience oppression, stigma, lack of support, lack of medical understanding, and discrimination when seeking care, which leads to unacceptable and life-threatening health disparities. Our team is deeply committed to changing that narrative.

Several studies show that LGBTQ+ individuals experience higher rates of depression, increased suicide risk and reduced access to appropriate and timely preventative health care for chronic diseases such as cancer and heart disease. The programs focus is to train the next generation of physicians to provide high-quality, evidence-based, affirming patient-centered care to urgently address these disparities and to optimize health outcomes, Petty said.

The award marks the first chapter in the foundations nationwide effort to train hundreds of fellows and to foster development of multi-disciplinary standards of care for LGBTQ+ individuals. The goal is to establish a workforce of physicians fluent in LGBTQ+ health care as well as a rich body of medical knowledge about best practices in caring for LGBTQ+ patients that can be disseminated throughout the academic medicine community.

Our strong partnerships with many talented individuals at UW Health, UWMadison, and across communities in Wisconsin and beyond will greatly enhance our ability to transform the national landscape to promote health and advance health equity both for LGBTQ+ and gender expansive individuals and for diverse individuals more broadly, Petty said. Through innovative programmatic efforts, we aim to help health care providers recognize and address the diverse, multi-dimensional uniqueness of all individuals in affirming, supportive ways.

In a stringent peer-reviewed process, the AMA Foundation selected the University of Wisconsin School of Medicine and Public Health for the award due to its extensive multidisciplinary network of institutional and community leaders with expertise in LGBTQ+ health.

I am deeply grateful to the AMA Foundation for their recognition of the urgent need to address these important health equity issues, Petty said. I look forward to working with them as well as our amazing team of champions for LGBTQ+ health equity in Wisconsin and beyond.

This program is the AMA Foundations response to the urgent need to address the growing health inequities and lack of quality medical care for LGBTQ+ patients, according to John D. Evans, chairman of the AMA Foundation Fellowship Commission on LGBTQ+ Health.

The LGBTQ+ community is widely diverse, and for those members of the community who are also members of other marginalized groups such as people of color, people with disabilities and those living in rural communities the outcomes are exponentially worse, he said. The COVID-19 pandemic further highlighted the health care inequities for LGBTQ+ people of color and other marginalized communities as those groups received inconsistent and inadequate care and representation throughout the pandemic.

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Covenant Childrens to host COVID-19 vaccine clinic at the South Plains Mall – KLBK | KAMC | EverythingLubbock.com

Posted: July 21, 2021 at 2:21 am

LUBBOCK, Texas (PRESS RELEASE) The following is a press release from the Covenant Health System:

In a joint effort to encourage our community to get the COVID-19 vaccine, Covenant Childrens is partnering with South Plains Mall to host a pediatric vaccine clinic on Saturday of Tax-Free Weekend.

Kids age 12 and over will be able to receive their vaccine from 10 a.m. to 4 p.m. on Saturday, August 7.

Patients will receive their first dose of the Pfizer vaccine, the only vaccine currently approved for children under the age of 18. The clinic will provide vaccines for those parents, grandparents, and other family members who also wish to be vaccinated.

Today, the U.S. is experiencing a rapid rise in COVID-19 cases and hospitalizations, mostly in unvaccinated individuals, Covenant Childrens Chief Medical Officer Dr. David Gray said. The current surge is driven by the more infectious delta variant, from which our current vaccines provide protection. As kids return to school, the crowding and close proximity will increase potential for the virus to spread. This risk can be dramatically decrease by vaccinating eligible kids as soon as possible.

South Plains Mall prides itself on being a town center for the Lubbock community, said General Manager Beth Bridges. We cant imagine a better opportunity to serve our community than to partner with Covenant Childrens to provide access to vaccinations for children and families.

The clinic will be held in the west concourse between Womens Dillards and Premiere Cinemas, on the north side of the mall.

Covenant Childrens will return to South Plains Mall on Saturday, August 28 to provide the second dose of the vaccine.

About Covenant Health:Covenant Childrens is the only independently licensed, freestanding, childrens hospital in West Texas and eastern New Mexico and is one of only eight members of the Childrens Hospital Association of Texas and is the only one in our region.

As a faith-based health care system, it is Covenant Healths vision to create Health for a Better World. As the Best Hospital in the Panhandle Plains region as voted by U.S. News and World Report, Covenant Health has consistently provided exceptional health care to West Texas, and eastern New Mexico for more than 100 years. Our clinically integrated health network of eight hospitals, and more than 6,000 caregivers allows us to provide our patients with better access to care using more innovative technology and procedures, while focusing on new age approaches to health care like education and preventative medicine. To learn more about Covenant Health, please visit covenanthealth.org or our Facebook, LinkedIn, or Twitter, pages

(Press release from Covenant Health System)

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FDA approval of new Alzheimer’s drug Aduhelm, developed in part by Brown researchers, mired in controversy – The Brown Daily Herald

Posted: July 21, 2021 at 2:21 am

The Food and Drug Administration approved a new drug Aduhelm for the treatment of Alzheimers disease June 7 through its accelerated approval pathway. While some patient advocacy groups and creators of the drug including several University researchers see the drugs approval as a step forward, Aduhelms price and approval against the recommendations of advisors have garnered nationwide criticism and sparked a federal investigation into the communications between FDA staff and Biogen, the biotechnology company that developed the drug.

More than six million Americans suffer from Alzheimers disease, a form of slowly-progressing dementia for which there is no cure. Existing drugs that treat Alzheimers mediate symptoms of the disease but do not slow down or reverse the disease process. Since the approval of the last AD drug 18 years ago, patients and healthcare workers alike have waited for stronger treatment options to combat this devastating disease.

As the Baby Boomer generation enters the prime age range susceptible to the disease, the development of effective treatments is imperative, said University Professor of Neurology Brian Ott, who served as a principal investigator on several of the Aduhelm trials.

Stephen Salloway, professor of neurology at the Warren Alpert Medical School, also served as a principal investigator for Aduhelm phase one and phase three trials at Butler Hospital.

The new drug Aduhelm consists of monthly intravenous injections of aducanamab, an antibody molecule that fights off the build-up of amyloid beta proteins in the brain a hallmark feature of AD. Aduhelm is the first drug on the market to directly target these plaques with the goal of slowing disease development in its early stages.

Aduhelm really represents a turning point in how we approach the treatment of Alzheimers disease, Ott said. This is the first time that physicians will be able to prescribe a disease-modifying drug for Alzheimers.

Salloway said that the development of the drug opens a new treatment era for Alzheimers.

But the FDAs decision to approve the drug has raised a wave of concerns about its effectiveness, cost and the legitimacy of the FDAs approval process.

FDA Approval and Backlash

In November 2020, Aduhelm was brought to the FDA Peripheral and Central Nervous System Drugs Advisory Committee, which consists of experts in this area that advise the FDA upon assessment of a proposed drug, where it was almost unanimously rejected.

The panel evaluated data from two Biogen clinical trials designed to test the drugs effectiveness in treating AD. Although both of these trials were terminated early when Biogen determined that the drug was unlikely to be effective, a retrospective analysis found that one of two trials did produce positive results.

The advisory committee did not believe there was sufficient evidence that the drug would improve clinical outcomes given the conflicting results between trials, wrote Joel Perlmutter, professor of neurology at Washington University in St. Louis and a former member of the FDA advisory committee who resigned after Aduhelms approval, in a written statement provided to The Herald. Additionally, the committee expressed concern about brain swelling and bleeding, a side effect observed in approximately 40% of trial participants, Perlmutter wrote.

None of the committee members voted in favor of the drug ten of the 11 members voted against Aduhelms approval, with the last member voting that they were uncertain. Despite the negative recommendation by the committee, Aduhelm was approved through the FDAs Accelerated Approval Program.

The program allows the FDA to evaluate the efficacy of a drug based on its ability to reach a surrogate endpoint an outcome that predicts clinical benefit rather than directly measuring clinical benefit. The intention is to expedite the approval process of drugs they feel should be made available to the public urgently by forgoing expensive and time-consuming clinical trials.

By using amyloid plaque reduction in the brain as the surrogate endpoint for Aduhelm, the FDA determined that the drug was effective.

As part of the Accelerated Approval process, Biogen is required to conduct a post-approval study but does not have to produce results for another nine years. The FDA can reverse its decision based on the results of this study, but does not have to.

In all studies in which it was evaluated, Aduhelm consistently and very convincingly reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion. It is expected that the reduction in amyloid plaque will result in a reduction in clinical decline, the FDAs director of the Center for Drug Evaluation and Research, Patrizia Cavazzoni, wrote in the FDAs press release.

But there is little evidence so far to support the idea that clearing amyloid plaques will relieve AD symptoms, according to Perlmutter. He wrote that many studies on experimental drugs targeting these plaques have not shown a clinical benefit for people with non-genetic forms of AD.

We know that the drug does reduce plaques in the brain, based on the evidence, Ott said. But does that make a real difference on the clinical outcomes and patient functionality? Thats still up in the air, and another trial needs to be done.

I am extraordinarily disappointed that our unbiased advisory committee review was not valued, Perlmutter wrote in his statement. He resigned from the FDA panel in protest, along with two other committee members, including Mayo Clinic neurologist David Knopman.

Knopman wrote in his resignation letter to the FDA that justifying approval through the reduction of the plaques in the absence of consistent clinical benefit after 18 months of treatment is indefensible, and that the approval made a mockery of the advisory committees role, as reported by The New York Times.

On July 8, the FDA revised Aduhelms usage from treating all patients with AD to patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials, thereby narrowing the population the drug is available to.

In separate emails to The Herald, Salloway and Ott wrote that they approve of this change because it is more consistent with the evidence from the clinical trials. Salloway added that it is highly recommended that patients being offered this treatment have a positive amyloid

Additionally, on July 9, the Acting Commissioner of the FDA Janet Woodcock requested an independent investigation by the Office of Inspector General into the interactions between Biogen representatives and FDA members leading up to the approval.

Ramifications of Aduhelms unconventional approval

Aduhelms approval has serious potential to impair future research into new treatments that may be effective at treating AD, Perlmutter wrote. Enthusiasm (from either potential volunteer participants or funders) for new treatments may wane due to thinking that we already have an effective treatment, when in fact we do not.

There is also concern that Aduhelms unconventional approval may set a precedent that leads to a less stringent approval process for future drugs, noted Harvard Professor of Medicine Aaron Kesselheim, the third committee member who resigned, as reported by CBSnews.

Biogen has listed Aduhelm at a price of $56,000 a year per patient, but other sources claim that the price will be closer to $61,000 to $62,000 per year when factoring in the average AD patients weight, which is greater than the number used for Biogens approximation. Biogens listed price does not include doctors visits, amyloid plaque diagnostic testing and MRIs that will be necessary to monitor for side effects.

For many, this price will pose an insurmountable barrier to access, wrote the Alzheimers Association in a statement in favor of the drugs approval but calling for more affordability of the drug. It complicates and jeopardizes sustainable access to this treatment, and may further deepen issues of health equity.

At the moment, the Centers for Medicare and Medicaid Services has not said whether the drug will be covered under Medicare and Medicaid. But even with Medicare coverage, patients and their families would have to pay about $11,500 in co-insurance annually, since Medicare does not cover the entire cost.

According to an analysis by the Kaiser Family Foundation, Aduhelm would cost patients and taxpayers more than $29 billion per year. This estimate only accounts for one fourth of the Medicare population currently prescribed Alzheimers medication the real cost would likely be higher. This far exceeds the money spent on any other drug to treat any disease covered by Medicare Part B or Part D.

In this case, we have a new medication that costs a lot. And what were getting in return is not entirely clear, said Eric Jutkowitz, assistant professor of Health Services, Policy and Practice. We dont want to be spending money on something that doesnt work.

Spending on Aduhelm would take away from Medicaid and Medicare funds that would otherwise go towards underfunded services like long-term care or the development and testing of new AD treatments, Jutkowitz said.

Future plans for Alzheimers research

Still, Aduhelms approval has been celebrated by AD advocacy groups who have long-awaited new treatment options.

Aduhelm is certainly not a cure, but, at long last, it provides many with Alzheimers disease and their families an effective treatment, the Alzheimers Association wrote in a statement. They hope this drug will help close the vast unmet need of the Alzheimers community.

Salloway said that the FDA approval was a very wise decision and very much pro-patient in an interview with The Herald.

Though he understands the concerns voiced by critics of the drug, the totality of evidence amassed by the researchers including the drugs ability to reduce amyloid beta plaques, the positive phase three clinical trial and the clinical benefits observed in the phase two trial as well as the strong need for innovative Alzheimers treatments support the FDAs decision.

Contrary to the idea that the approval of Aduhelm will quench efforts to develop new drugs, Salloway said that he believes the presence of Aduhelm as a treatment could spur new drug development for Alzheimers by creating demand for new screening and preventative technologies.

Theres so much that needs to be done and there is no time to waste, he said. For instance, Salloway cited the ongoing need for new inexpensive diagnostic tools to test for amyloid beta plaque build-up in the brain, and the development of new combination treatments, which incorporate multiple medications and lifestyle changes to not only treat AD once it develops but also help prevent it.

Salloway and Ott hope that through a strong partnership with primary care, continued research and a focus on early and preventative treatment, clinicians will develop new care models to better care for Alzheimers patients.

With additional reporting by Gabriella Vulakh

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COVID cases surge in 43 states as new cases per day DOUBLE over the past three weeks – Texasnewstoday.com

Posted: July 21, 2021 at 2:21 am

The number of COVID-19 cases has started to surge in the United States after months of decline, with the number of new cases per day doubling over the past three weeks.

Doctors and public health officials have said that the surge, in 43 out of the countrys 50 states, comes amid a rise in the Delta variant of the SARS-CoV-2 virus and stagnating vaccination numbers.

Health experts warn that the worrying increase in cases is linked to the Indian Delta variant, which accounts for as many 97 percent of infections in some states.

Centers for Disease Control and Prevention data updated last week shows that the Delta variant, also known as B.1.617.2, makes up 51.7 percent of all new infections making it the dominant form of the virus in the United States.

The Delta variant has been detected in all 50 states and accounts for more than 80 percent of new infections in Midwestern states such as Iowa, Kansas and Missouri, where vaccination rates are lagging.

In the United States, 59 percent of adults are fully vaccinated while 68 percent have at least one shot, according to CDC data.

U.S. Surgeon General Vivek Murthy said the number of new infections are coming as people refuse to get tested or vaccinated against COVID-19

Dr. Chris Pernell, a fellow at the American College of Preventative Medicine, called it a pandemic of the unvaccinated in an interview on Tuesday

Just a quarter of children aged 12-15 have received the vaccine, it has been reported

Dr. Chris Pernell, a fellow at the American College of Preventative Medicine, called it a pandemic of the unvaccinated in an interview with CNN on Tuesday.

This is primarily a pandemic of the unvaccinated. And we need to be very clear about that message, Dr. Pernell said.

She also hit out at states like Florida, Alabama, Arkansas, Indiana, Montana, Oklahoma, and Utah that have blocked COVID-19 vaccine requirements in schools.

To flat out prohibit COVID-19 vaccination is not in anyones best interest. When states make that move, they get in the way of good and effective public health, she said.

U.S. Surgeon General Vivek Murthy said the number of new infections are coming as people refuse to get tested or vaccinated against COVID-19.

Many people are thinking COVID is over. Why do I really need to get tested? and this is particularly happening in areas, unfortunately, where the vaccination rates are low which is exactly where we want to be testing more, he said.

He also voiced support for vaccine mandates in hospitals, adding: Healthcare workers have a responsibility to protect the patients.

Confirmed infections climbed to an average of about 23,600 a day on Monday, up from 11,300 on June 23, according to Johns Hopkins University data.

A chart shows the number of deaths from the coronavirus per day in the United States for the months of June and July

A chart shows that there have been a total of 607.577 coronavirus deaths in the United States

A chart shows the number of coronavirus infections per day in the United States for the months of June and July

A chart shows that there have been 33,898,168 coronavirus infections in the United States since the onset of the pandemic

Even states with high vaccination rates, such as California, Illinois, New York and Vermont are seeing cases rise. All but two states Maine and South Dakota reported that case numbers have gone up over the past two weeks.

It is certainly no coincidence that we are looking at exactly the time that we would expect cases to be occurring after the July Fourth weekend, said Dr. Bill Powderly, co-director of the infectious-disease division at Washington Universitys School of Medicine in St. Louis.

At the same time, parts of the country are running up against deep vaccine resistance, while the highly contagious mutant version of the coronavirus that was first detected in India is accounting for an ever-larger share of infections.

Nationally, 55.6% of all Americans have received at least one COVID-19 shot, according to the Centers for Disease Control and Prevention.

The five states with the biggest two-week jump in cases per capita all had lower vaccination rates: Missouri, 45.9%; Arkansas, 43%; Nevada, 50.9%; Louisiana, 39.2%; and Utah, 49.5%.

A total of 43 states and the District of Columbia are seeing their numbers of COVID-19 infections increase, according to data from John Hopkins University

Health experts blame the spread of the Indian Delta variant, which makes up more than half of all new infections in the country and up to 97% in some states

Even with the latest surge, cases in the U.S. are nowhere near their peak of a quarter-million per day in January. Deaths are running at under 260 per day on average after topping out at more than 3,400 over the winter a testament to how effectively the vaccine can prevent serious illness and death in those who become infected.

Still, amid the rise, health authorities in places such as Los Angeles County and St. Louis are begging even immunized people to resume wearing masks in public. And Chicago officials announced Tuesday that unvaccinated travelers from Missouri and Arkansas must either quarantine for 10 days or have a negative COVID-19 test.

Meanwhile, the Health Department in Mississippi, which ranks dead last nationally for vaccinations, began blocking posts about COVID-19 on its Facebook page because of a rise of misinformation about the virus and the vaccine.

Mississippi officials are also recommending that people 65 and older and those with chronic underlying conditions stay away from large indoor gatherings because of a 150% rise in hospitalizations over the past three weeks.

In Mississippi, COVID-19 infections have spiked by 57 percent from 192 cases recorded on June 28 to an average of 303 per day on July 12.

Additionally, the number of residents hospitalized with COVID-19 has increased 65percent between July 4 and Sunday, July 11, according to state data.

Only 33.4 percent of the population in Mississippi is fully vaccinated, CDC data shows.

We have a lot more vulnerability than we should, said Mississippi State Health Officer Dr. Thomas Dobbs during a livecast of the Mississippi State Medical Association on Friday, according to Mississippi Free Press.

We are way undervaccinated as a state. We have a vast pool of unimmunized people who are a perfect breeding ground for Delta variant, and its gonna kill folks. And its already killing folks.

Some neighborhoods in the Big Apple are witnessing a rise in cases in what health officials blame on low vaccination rates and more transmissible variants like the Delta variant

People check in for their COVID-19 vaccine at a mobile clinic in an East Los Angeles neighborhood which has shown lower vaccination rates especially among the young

Louisiana also has one of the nations lowest vaccination rates.State health officials said cases of the coronavirus are surging, largely among nonvaccinated people.

New Orleans officials said on Tuesday they are likely to extend virus-mitigation efforts currently in place at large sporting and entertainment gatherings until fall.

Those efforts include mask mandates or requirements that attendees be vaccinated or have a negative COVID-19 test.

In Louisiana, cases have increased by 115 percent from a seven-day rolling average of 389 per day on June 28 to 840 per day on July 12, according to Johns Hopkins data.

Just 35.8 percent of the state is fully vaccinated.

I do think were in it. We are seeing what is likely the beginning of increases, Dr Joe Kanter, Louisiana state health officer, told The Advocate.

But the political will may not be there in many states fatigued by months of restrictions.

In Michigan, Democratic Gov. Gretchen Whitmer is facing a drive to repeal a law that she used to set major restrictions during the early stages of the pandemic.

And Republican Gov. Kay Ivey of Alabama pushed back against the idea that the state might need to reimpose preventive measures as vaccinations lag and hospitalizations rise.

Alabama is OPEN for business. Vaccines are readily available, and I encourage folks to get one. The state of emergency and health orders have expired. We are moving forward, she said on social media.

In many states cases have doubles such as Louisiana, where just 35.8% are fully vaccinated. Cases have increased by 115% from a seven-day rolling average of 389 per day on June 28 to 840 per day on July 12

In Mississippi, with just 33.4% of residents fully vaccinated, COVID-19 infections have spiked by 57% from an average of 192 cases recorded on June 28 to an average of 303 per day on July 12

Dr. James Lawler, a leader of the Global Center for Health Security at the University of Nebraska Medical Center in Omaha, said bringing back masks and limiting gatherings would help.

But he acknowledged that most of the places seeing higher rates of the virus are exactly the areas of the country that dont want to do any of these things.

Lawler warned that what is happening in Britain is a preview of whats to come in the U.S.

The descriptions from regions of the world where the delta variant has taken hold and become the predominant virus are pictures of ICUs full of 30-year-olds. Thats what the critical care doctors describe and thats whats coming to the U.S., he said.

He added: I think people have no clue whats about to hit us.

President Joe Biden is putting a dose of star power behind the administrations efforts to get young people vaccinated. Eighteen-year-old actress, singer and songwriter Olivia Rodrigo will meet with Biden and Dr. Anthony Fauci on Wednesday.

While the administration has had success vaccinating older Americans, young adults have shown less urgency to get the shots. CNN reported on Tuesday that just a quarter of children aged 12-15 have received the vaccine.

Some, at least, are heeding the call in Missouri after weeks of begging, said Erik Frederick, chief administrative officer of Mercy Hospital Springfield.

Frederick tweeted that the number of people getting immunized at its vaccine clinic has jumped from 150 to 250 daily, saying it gives him hope.

Scientists had warned about the rise of the Delta variant in February.

The B.1.526 variant, which first appeared in samples collected in New York City in November, made up about 27 percent of viral sequences deposited into a database shared by scientists called GISAID, The New York Times reported in February.

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Prices are going up on almost everything. Here’s why – kuna noticias y kuna radio

Posted: July 21, 2021 at 2:21 am

By Moira Ritter, CNN Business

You mightve heard that everything is getting more expensive.

Well, thats mostly true. It wasnt easy, but we found a handful of items that are still cheaper than when the pandemic started last year.

Here are some of the things that are cheaper than they were in February 2020.

As the shift to remote work took hold at the start of the pandemic, the typical Americans closet shifted, too. Goodbye, suits and dresses. Hello, sweatpants and T-shirts.

Now that offices, restaurants and the rest of the world are starting to reopen, it might be a good idea to prepare your wardrobe. Fortunately, some clothing is still cheaper than it was pre-pandemic.

Both mens and womens apparel broadly are less expensive than pre-pandemic. Mens apparel has dropped 7.2%, while womens apparel has decreased 5.9% since February 2020, according to the Bureau of Labor Statistics.

Womens dress prices have fallen 12.1% during the pandemic. Mens suits and sports coats have decreased even more significantly. Suits are now 21.5% cheaper than they were in February 2020.

Another change that came with staying home: No more mass transit. Now that many Americans are vaccinated, trains and buses are gaining steam and becoming the norm once again.

Luckily, intracity mass transit is about 2.9% cheaper than it was last February.

If youre enjoying a night (or day) out this weekend, although your meal or drink might be more expensive than usual, you can take comfort in the fact that your ride was cheaper than it would have been 16 months ago.

Its baseball season, and what better way to celebrate summer and vaccination than joining a stadium full of other people and watching a game in person?

Sporting event admissions are 1.8% cheaper than before the pandemic. Although not the most monumental difference, its important to take our wins where we can, and even the smallest difference in price is a big deal when (almost) everything else is getting more expensive.

The demand for pets and pet supplies skyrocketed during the pandemic as Americans spent time stuck at home.

As we re-enter the world, though, you might consider restocking your pets toy basket once more, because pet supply prices are still lower than they were pre-pandemic.

Pets and pet product prices are 1.8% cheaper than they were in February 2020. Pet supplies and accessories are down 3.8% since the start of the pandemic.

During the pandemic, health care became even more important than before. So how has medical care dodged inflation? Preventative doctors visits and healthcare were moved to the back burner last year as people stayed home during the pandemic.

Since February 2020, medical care commodities, which include all medicinal drugs and other medical supplies, have gotten 2.3% cheaper.

Broken down into more specific categories, prices of medicinal drugs, which encompass both prescription and over-the-counter medicine, saw a 2.2% decrease. Prescription drug prices alone are down 2.9% over the past year and a half.

Medical equipment and supplies, which includes items like dressings, contraceptives, heating pads and wheel chairs, saw the biggest change with a 5.8% drop in price since before the pandemic.

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Even before coronavirus, almost half of adults in rural areas went without dental care – North Carolina Health News

Posted: July 21, 2021 at 2:21 am

Rural adults are less likely than their urban peers to see a dentist for preventative treatments, according to the CDC.

Millions of rural residents have not seen a dentist in over a year, a recent CDC report reveals.

In 2019, before the coronavirus pandemic forced dentists to shut down, 42 percent of adults in rural areas did not receive dental care, according to the survey. In urban areas, roughly a third of adults did not see a dentist that year.

In both groups, people of color and low-income residents were less likely to have seen a dentist in 2019. These disparities were wider in rural areas, where issues such as transportation barriers, dentist and dental hygienist shortages and lack of health insurance are more common. The coronavirus pandemic has likely exacerbated the need, especially for low-income patients, the report says.

The things that really went by the wayside [with the pandemic] are the maintenance, the routine exams and the cleanings things that keep people healthy, said Katherine Jowers, who oversees oral health programs at the Asheville-based Mountain Area Health Education Center. Were still dealing with very old treatment plans for patients we havent seen in two years. Nothing was on fire so they didnt come, and now all of their plans are completely disrupted and we have to start from scratch.

Since cavities and other dental problems dont resolve on their own, what might have been small areas of decay that could have been addressed with a filling have likely advanced to more extensive decay that requires a root canal or even extraction.

Lower-income patients are already predisposed to forgoing preventative dental treatment because of cost, especially if they arent in pain, said Anahita Shaya, a dentist at the Brunswick County Health Department.

People are having to choose between the necessities of life, she added. If theyre having to pay for fillings and a cleaning out of their pocket and thats against having to pay their electric bill or mortgage or rent, [preventative dental care] is not always at the top of the list.

Oral health is an important part of overall wellness and if left untreated, tooth decay can lead to a whole host of other complications. Cavities have been linked to heart disease, pneumonia and sepsis, for example. Pregnant women with poor oral health have been found to have a higher risk of premature births and other complications.

Shaya sees some of these complications in her own practice, with patients turning to the emergency department for dental abscesses.

The same is true for communities nationwide. Dental abscesses accounted for 3.5 million visits between 2008 and 2014 and cost a collective $3.4 billion, research shows. Uninsured people and Medicaid beneficiaries accounted for the bulk of these emergency visits.

Though receiving antibiotics at the ER can cost $1,000 or more out of pocket, Blake Gutierrez, a dentist at MAHEC, said patients go there because they dont think there are other options. In most cases, however, emergency departments cant fully address a dental issue. At most, emergency providers can administer antibiotics and painkillers, but without dental treatment, the source of infection remains and can flare up again.

Even after an ER visit, patients may still be hesitant to seek dental care because of cost. Care Credit, a company that provides financing for dental and other health procedures, estimates that an extraction, the cheapest option for advanced tooth decay, can cost anywhere from $130 to $500, depending on the complexity of the extraction. Root canals, another common treatment, can cost $1,000 or more.

Rural North Carolinians have another significant challenge to deal with when seeking care: lack of dentists. Most dental providers congregate in urban areas, according to data from the Sheps Center for Health Services Research at the University of North Carolina at Chapel Hill. Some rural counties, including Hyde, Tyrrell and Gates, did not have an active dentist in 2019, the data shows.

Greg Chadwick, dean of the East Carolina University School of Dental Medicine, keeps close tabs on that data. By his calculation, the state has roughly 5,600 active dentists, and most of them over 4,500 work in cities. The remaining 1,400 serve North Carolinas 80 or so rural counties.

A study published this year by the American Dental Association notes North Carolina has about 54 dentists per 100,000 residents, behind the national average of about 61 dentists per 100,000. Based on a 2015 analysis generated by the federal Health Resources and Services Administration, North Carolina is likely to remain a state with not enough dentists to meet the demand into the future.

That math alone makes it so patients in rural areas have to travel farther for care, he added, something that many residents struggle with. The only way to address these disparities is to make dental care more accessible, perhaps by coupling it with primary care as many community health centers do across the state.

These health centers arent always enough. MAHECs dental clinic, for instance, has a two-month wait for a cleaning and general exam. Another provider, CommWell Health a community health center with locations in Sampson and surrounding counties has seen a similar trend.

Time, said MAHECs Jowers, isnt on rural patients side, especially since the pandemic delayed care for so many of them.

Youre not addressing needs that were minor needs two years ago, she said. [Dentistry] is the type of health care where if you dont address the problem, it doesnt get better by itself.

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