StemCell Therapy

In theglobal stem cells marketa sizeable proportion of companies are trying to garner investments from organizations based overseas. This is one of the strategies leveraged by them to grow their market share. Further, they are also forging partnerships with pharmaceutical organizations to up revenues.

In addition, companies in the global stem cells market are pouring money into expansion through multidisciplinary and multi-sector collaboration for large scale production of high quality pluripotent and differentiated cells. The market, at present, is characterized by a diverse product portfolio, which is expected to up competition, and eventually growth in the market.

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Some of the key players operating in the global stem cells market are STEMCELL Technologies Inc., Astellas Pharma Inc., Cellular Engineering Technologies Inc., BioTime Inc., Takara Bio Inc., U.S. Stem Cell, Inc., BrainStorm Cell Therapeutics Inc., Cytori Therapeutics, Inc., Osiris Therapeutics, Inc., and Caladrius Biosciences, Inc.

As per a report by Transparency Market Research, the global market for stem cells is expected to register a healthy CAGR of 13.8% during the period from 2017 to 2025 to become worth US$270.5 bn by 2025.

Depending upon the type of products, the global stem cell market can be divided into adult stem cells, human embryonic stem cells, induced pluripotent stem cells, etc. Of them, the segment of adult stem cells accounts for a leading share in the market. This is because of their ability to generate trillions of specialized cells which may lower the risks of rejection and repair tissue damage.

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Depending upon geography, the key segments of the global stem cells market are North America, Latin America, Europe, Asia Pacific, and the Middle East and Africa. At present, North America dominates the market because of the substantial investments in the field, impressive economic growth, rising instances of target chronic diseases, and technological progress. As per the TMR report, the market in North America will likely retain its dominant share in the near future to become worth US$167.33 bn by 2025.

Investments in Research Drives Market

Constant thrust on research to broaden the utility scope of associated products is at the forefront of driving growth in the global stem cells market. Such research projects have generated various possibilities of different clinical applications of these cells, to usher in new treatments for diseases.Since cellular therapies are considered the next major step in transforming healthcare, companies are expanding their cellular therapy portfolio to include a range of ailments such as Parkinsons disease, type 1 diabetes, spinal cord injury, Alzheimers disease, etc.

The growing prevalence of chronic diseases and increasing investments of pharmaceutical and biopharmaceutical companies in stem cell research are the key driving factors for the stem cells therapeutics market. The growing number of stem cell donors, improved stem cell banking facilities, and increasing research and development are other crucial factors serving to propel the market, explains the lead analyst of the report.

This review is based on the findings of a TMR report, titled, Stem Cells Market (Product Adult Stem Cell, Human Embryonic Stem Cell, and Induced Pluripotent Stem; Sources Autologous and Allogeneic; Application Regenerative Medicine and Drug Discovery and Development; End Users Therapeutic Companies, Cell and Tissues Banks, Tools and Reagent Companies, and Service Companies) Global Industry Analysis, Size, Share, Volume, Growth, Trends, and Forecast 20172025.

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The Stem Cells Market is segmented as below:

Global Stem Cells Market, by Product Type

Global Stem Cells Market, by Source

Global Stem Cells Market, by Application

Global Stem Cells Market, by End Users

Global Stem Cells Market, by Geography

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COVID-19 Impact and Recovery Analysis Stem Cells Market 2017 2025 - Cole of Duty

The 2020 award celebrates outstanding research in rare diseases

NEW YORK & OSAKA, Japan--(BUSINESS WIRE)-- Takeda Pharmaceutical Company Limited (Takeda) (TSE:4502/NYSE:TAK) and the New York Academy of Sciences announced today the Winners of the third annual Innovators in Science Award for their excellence in and commitment to innovative science that has significantly advanced the field of rare disease research. Each Winner receives a prize of US $200,000.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200708005039/en/

The 2020 Winner of the Senior Scientist Award is Adrian R. Krainer, Ph.D., St. Giles Foundation Professor at Cold Spring Harbor Laboratory. Prof. Krainer is recognized for his outstanding research on the mechanisms and control of RNA splicing, a step in the normal process by which genetic information in DNA is converted into proteins. Prof. Krainer studies splicing defects in patients with spinal muscular atrophy (SMA), a devastating, inherited pediatric neuromuscular disorder caused by loss of motor neurons, resulting in progressive muscle atrophy and eventually, death. Prof. Krainers work culminated notably in the development of the first drug to be approved by global regulatory bodies that can delay and even prevent the onset of an inherited neurodegenerative disorder.

Collectively, rare diseases affect millions of families worldwide, who urgently need and deserve our help. Im extremely honored to receive this recognition for research that my lab and our collaborators carried out to develop the first approved medicine for SMA, said Prof. Krainer. As basic researchers, we are driven by curiosity and get to experience the thrill of discovery; but when the fruits of our research can actually improve patients lives, everything else pales in comparison.

The 2020 Winner of the Early-Career Scientist Award is Jeong Ho Lee, M.D., Ph.D, Associate Professor, Korea Advanced Institute of Science and Technology (KAIST). Prof. Lee is recognized for his research investigating genetic mutations in stem cells in the brain that result in rare developmental brain disorders. He was the first to identify the causes of intractable epilepsies and has identified the genes responsible for several developmental brain disorders, including focal cortical dysplasias, Joubert syndromea disorder characterized by an underdevelopment of the brainstemand hemimegalencephaly, which is the abnormal enlargement of one side of the brain. Prof. Lee also is the Director of the National Creative Research Initiative Center for Brain Somatic Mutations, and Co-founder and Chief Technology Officer of SoVarGen, a biopharmaceutical company aiming to discover novel therapeutics and diagnosis for intractable central nervous system (CNS) diseases caused by low-level somatic mutation.

It is a great honor to be recognized by a jury of such globally respected scientists whom I greatly admire, said Prof. Lee. More importantly, this award validates research into brain somatic mutations as an important area of exploration to help patients suffering from devastating and untreatable neurological disorders.

The 2020 Winners will be honored at the virtual Innovators in Science Award Ceremony and Symposium in October 2020. This event provides an opportunity to engage with leading researchers, clinicians and prominent industry stakeholders from around the world about the latest breakthroughs in the scientific understanding and clinical treatment of genetic, nervous system, metabolic, autoimmune and cardiovascular rare diseases.

At Takeda, patients are our North Star and those with rare diseases are often underserved when it comes to the discovery and development of transformative medicines, said Andrew Plump, M.D., Ph.D., President, Research & Development at Takeda. Insights from the ground-breaking research of scientists like Prof. Krainer and Prof. Lee can lead to pioneering approaches and the development of novel medicines that have the potential to change patients lives. Thats why we are proud to join with the New York Academy of Sciences to broadly share and champion their workand hopefully propel this promising science forward.

Connecting science with the world to help address some of societys most pressing challenges is central to our mission, said Nicholas Dirks, Ph.D., President and CEO, the New York Academy of Sciences. In this third year of the Innovators in Science Award we are privileged to recognize two scientific leaders working to unlock the power of the genome to bring innovations that address the urgent needs of patients worldwide affected by rare diseases.

About the Innovators in Science Award

The Innovators in Science Award grants two prizes of US $200,000 each year: one to an Early-Career Scientist and the other to a well-established Senior Scientist who have distinguished themselves for the creative thinking and impact of their research. The Innovators in Science Award is a limited submission competition in which research universities, academic institutions, government or non-profit institutions, or equivalent from around the globe with a well-established record of scientific excellence are invited to nominate their most promising Early-Career Scientists and their most outstanding Senior Scientists working in one of four selected therapeutic fields of neuroscience, gastroenterology, oncology, and regenerative medicine. Prize Winners are determined by a panel of judges, independently selected by the New York Academy of Sciences, with expertise in these disciplines. The New York Academy of Sciences administers the Award in partnership with Takeda.

For more information please visit the Innovators in Science Award website.

About Takeda Pharmaceutical Company Limited

Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan, committed to bringing Better Health and a Brighter Future to patients by translating science into highly-innovative medicines. Takeda focuses its R&D efforts on four therapeutic areas: Oncology, Rare Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted R&D investments in Plasma-Derived Therapies and Vaccines. We are focusing on developing highly innovative medicines that contribute to making a difference in people's lives by advancing the frontier of new treatment options and leveraging our enhanced collaborative R&D engine and capabilities to create a robust, modality-diverse pipeline. Our employees are committed to improving quality of life for patients and to working with our partners in health care in approximately 80 countries. For more information, visit https://www.takeda.com.

About the New York Academy of Sciences

The New York Academy of Sciences is an independent, not-for-profit organization that since 1817 has been committed to advancing science, technology, and society worldwide. With more than 20,000 members in 100 countries around the world, the Academy is creating a global community of science for the benefit of humanity. The Academy's core mission is to advance scientific knowledge, positively impact the major global challenges of society with science-based solutions and increase the number of scientifically informed individuals in society at large. Please visit us online at http://www.nyas.org.

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Takeda and the New York Academy of Sciences Announce 2020 Innovators in Science Award Winners - BioSpace

SHIRLEY, NY, UNITED STATES - Jul 1, 2020 - Recently, exosomes, which have specialized functions and play a key role in different physiological processes and pathological conditions, are attracting increasing attention in their clinical applications for prognosis, diagnosis, drug delivery, and vaccine development. Exosome therapy is also stealing the spotlight in the field of regenerative medicine.

As a well-known participant in the field of exosome research, Creative Biolabs has been establishing a strong network of academic and industrial collaborators, and has optimized its exosome isolation and profiling services in particular.

In the research and application of exosome, the most important step is to isolate them from a wide spectrum of cellular debris and interfering components. Based on well-established technologies and experienced scientists, Creative Biolabs can efficiently separate high-quality exosomes derived from multiple cell types, such as B cells, dendritic cells and tumor cells and almost any biofluid including plasma, urine, serum, CSF, ascites fluid, and saliva, as well as plants.

Creative Biolabs provides different exosome isolation methods for different projects. For example, differential ultracentrifugation, the gold standard method for exosome isolation, is used to isolate exosomes and membrane particles based on their density and size differences from the fluid phase. Exosome precipitation uses the water-excluding polymers such as polyethylene glycol to tie up water molecules and force less soluble components out of solution. Affinity-based Capture and microfluidics-based isolation are also obtainable at Creative Biolabs.

Since exosomes composed of numerous RNA, proteins, lipids, several large-scale analyses such as proteomics and transcriptomics can often be performed. These vesicles also show potential for cancer diagnostics and determination of other diseases because they transport molecular contents of cells from which they originate. Though the detection and molecular analysis of exosomes is technically challenging, Creative Biolabs has a highly experienced team equipped with advanced platforms to achieve a variety of exosome profiling regarding its contents.

In order to obtain expert data interpretation and technical support, Creative Biolabs offers several exosome profiling platforms for the isolation, purification, quantification, and analysis of required exosomes, covering isolation and profiling of exosomal RNA, exosomal cfDNA and exosomal protein as well as exosome-NGS (RNA next generation sequencing).

We own advanced equipment for exosome profiling, such as flow cytometry, electron microscopy and optical microscopy. Introduced by a senior scientist at Creative Biolabs, thus the transferred information of exosomes can be fully explored with our services.

Creative Biolabs provides the best and comprehensive services covering exosome sampling, analysis, manufacturing, and exosome-based application. Besides, a series of high-quality exosome-related products involving all aspects of exosome research, including exosome isolation and purification, exosome qualification, exosome antibody as well as exosome engineering is also available to facilitate clients project success.

Further information can be reached on https://www.creative-biolabs.com/exosome.

About Creative Biolabs

Empowered by leading technology and years of experience in biomedical science, Creative Biolabs focuses on offering a full range of exosome-related services and products. With more than a decade of exploration and expansion, Creative Biolabs is now known as a famous institute and experienced supplier in the biotech market, accomplishing numerous challenging projects for customers.

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Creative Biolabs Updated Exosome Isolation and Profiling Service to Facilitate Related Research - Bio-IT World

Newswise Scientists focused on finding better treatments or cures for types 1 or 2 diabetes are painfully aware of current limitations, including having to use animal tissue in studies that often dont translate to human trials.

New research published June 29 in Nature Communications could help researchers overcome some of the biggest challenges of taking diabetes research from the lab to human trials and the clinic.

By using a technology first developed at the University of Miami Miller School of Medicine along with a Miller School patented approach to enhance the oxygenation of cultured tissues, researchers will likely be able to conduct real-time regeneration and development studies in the human pancreas.

The finding could lead to treatments that regenerate ones own pancreas without the need for transplantation, according to the studys senior author Juan Domnguez-Bendala, Ph.D., director of stem cell development for translational research and associate professor of Surgery at the Diabetes Research Institute, University of Miami Miller School of Medicine.

Dr. Bendala explained that in people who have type 1 diabetes, the bodys own immune system kills beta cells, or islet cells, in the pancreas that make insulin. Doctors have for years transplanted donor islet cells to replenish those cells.

But there are challenges to the approach. One is a scarcity of donors for organ transplantation. Another is when transplanting the islet cells is possible, the recipients body will likely reject the donor cells unless the recipient is immunosuppressed. Immunosuppression, alone, leads to complications.

The two pillars of our research are to replenish the islet cells that have been lost and then to stop autoimmunity, which is the underlying cause of the disease, Dr. Bendala said. We also are interested in using endogenous regeneration. We have found that there are pancreatic stem cells that we call progenitors because they already have committed to become part of the pancreatic tissue. Ultimately, we want to induce them to replicate and give rise to new insulin-producing cells within the patient, instead of transplanting beta cells from an external source.

Human pancreatic slices are very thin slices of the pancreas that keep together the organs natural architecture, including the much-needed islets.

The islets in these slices are surrounded by acinar cells, which make the digestive juices in the pancreas, and more importantly the ducts, where we have found the progenitor stem cells that can give rise to new beta cells, Dr. Bendala said. Thats why these slices are a very powerful tool to study the organ. Its as if you had a window into the living pancreas.

The problem when studying the regenerative process in human pancreatic slices has been that the tissue lasts only a couple of days before disintegrating and dying.

Dr. Bendala and colleagues determined that the main reason for cell death in the slices was a lack of oxygen. The pancreas is a very vascularized organ, and slicing it cuts off its blood supply.

Dr. Bendala and coauthor on the Nature Communications paper Ricardo Pastori, Ph.D., research professor of medicine, immunology, and microbiology and the director of the Molecular Biology Laboratory at the Diabetes Research Institute, circumvented the problem by placing human pancreatic slices in a culture device they invented that uses a perfluorocarbon (PFC) membrane.

PFC is a compound that is so rich in oxygen that you can breathe it in its liquid form, Dr. Bendala said. We have published on this device and shown that islets survive and function much better when we culture them on PFC. And when we differentiate stem cells into beta cells, the process occurs much more efficiently when you put them in PFC. It was no surprise that when we placed the human pancreatic slices into the PFC membrane that they survived and did much better than controls. We could keep them alive for about 2 weeks, some went as long as 3 weeks, and they were fully functional during that time.

Keeping human pancreatic slices alive for that long is a major breakthrough in diabetes research, especially in the area of islet cell regeneration, he said.

You need a model when you study regeneration. Traditionally we have used the mouse model, and, unfortunately what happens in mice in the lab often doesnt pan out in humans, Dr. Bendala said. This work is revolutionary because using these human pancreatic slices we can witness and monitor regeneration in a human model that resembles a real organ. That was not possible before because the tissue simply didnt live long enough.

The Miller School researchers also tested a molecule called BMP-7, which they have shown in previous studies to act as fuel to stem cells. They showed in this paper that BMP-7 can induce proliferation of pancreatic progenitors in human pancreatic slices.

When we added BMP-7 to human pancreatic slices, we could detect progenitor cells activating, proliferating and then giving rise to new beta cells. We could see that happening before our very eyes, he said.

The fact that the study also included tissue from human type 2 and type 1 diabetic patients makes it more much more likely that the research will facilitate progress to human clinical trials.

I took a step back when I saw this for the first time. This was a living human pancreatic slice from a patient who had passed 10 days ago, he said. I couldnt help but think, imagine if we had done this in the patient if he or she was still alive? Its really powerful.

Dr. Bendala sent PFC-based dishes at no cost to several other centers conducting diabetes research, so they could study the approach and potentially replicate the findings. In the meantime, Dr. Bendala and Miller School colleagues are screening molecules other than BMP-7 to see if they have potential to create new beta cells by inducing progenitors or by inducing the replication of pre-existing beta cells.

The goal is to have a therapy to present to the FDA to produce beta cells within a few years.

These technologies will greatly accelerate our ability to decide what is going to work in clinical trials, he said.

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University of Miami Miller School-led technology paves way for islet regeneration in human pancreas - Newswise

3D Bioprinting Market Size, Growth, Trends and Share Analysis By Technology (Microextrusion Bioprinting, Inkjet 3D Bioprinting, Laser-assisted Bioprinting, Magnetic 3D Bioprinting), Material (Living Cells, Hydrogels, Extracellular Matrices), End-user and Region, Forecast To 2023

Global3D Bioprinting Marketsize is projected to reachUSD 1,923.02 Millionwith expanding at aCAGR of 24.59%By 2023. Currently, the 3D bioprinting is used to print tissues & organs and in the drug discovery. 3D Bioprinting is an emerging technology, which has the potential to transform the medical field with its capacity to bio fabricate living tissues & organs by combining a patients own cells with other biomaterials. Moreover, researchers, innovators, and early adopters are improving the performance of this disruptive technology stepwise, as it grows. The 3D bioprinting market is growing pervasively, mainly due to the burgeoning medical implant market.

The 3D bioprinting majorly involves the creation of simple tissue structures in lab settings. However, in the future, the technology is estimated to participate in the production of complete organs for transplants. It would also be used for swifter and more accurate drug testing. As potential drug compounds could be tested on bio-printed tissue before human trials have begun.

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Global 3D Bioprinting Market Segmentations:

The 3D bioprinting market is segmented by Technique, Application, Material and End User

By Technique the global 3D bioprinting market has been segmented intomicroextrusion bioprinting, inkjet 3d bioprinting, Magnetic 3d bioprinting and laser-assisted bioprinting.

By Application 3D bioprinting market has been segmented into Research (regenerative medicine, personalized healthcare, 3D cell culture, others) and Clinical (tissue transplantation, bone grafts, wound care, vascular grafts, others), among other several applications.

By Material3D bioprinting markethas been segmented intoExtracellular Matrices, Cells, Fibrinogen, Alginate, and Hydrogels, among others.

By End-user 3D bioprinting market has been segmented into Academic Institutes and Biotechnology Companies, among others.

Global 3D Bioprinting Market Regional Analysis:

North Americacommands the global market with largest 3D bioprinting market share. The presence players like Organovo Holdings, Inc. & Stratasys Ltd. and well-developed healthcare sectors in the region, drive the North American 3D bioprinting market growth. Besides, high healthcare expenditures, favorable government regulations, and huge patient population for organ transplantation boost the growth of the regional market. With the growing biotech sector, the North American 3D bioprinting market growth is expected to continue with its dominance in the years to come.

Europetakes the second largest global 3D Bioprinting market share. Factors such as the increased research & development activities driven by government support and funds are substantiating the regional 3D Bioprinting market growth. Heading with the increasing per capita healthcare expenditures in Germany, the UK, and France, the region is expected to grow during the forecast period.

TheAsia Pacific3D bioprinting market is emerging as a promising market globally. Vast patient pool and the burgeoning medical treatment market in the region attribute to the growth of the market. Growing 3D bioprinting markets in India and China, backed by the increasing awareness & improved lifestyle, provide impetus to the regional market surge. Besides, the improving economy in the region is expected to create opportunities in the 3D Bioprinting market during the forecast period.

Global 3D Bioprinting Market Competitive landscape

Highly competitive, the 3D bioprinting market appears to be fragmented with several players accounting for a substantial market share. To gain a substantially larger share in the market, these players incorporate strategic initiatives such as acquisitions & mergers, collaboration, expansion, and product & technology launch. Expansion in the emerging market helps them to extend their sales networks. On the other hand, some of the players appear to be reluctant to collaborate as engineering firms & suppliers do not provide CAD drawings/input to clients due to the risk of losing IP.

Major Players:

Players leading the 3D bio-printing market includeCellink AB (Sweden), Organovo Holdings, Inc. (US), Bio3D Technologies (Singapore), Stratasys Ltd. (US), Aspect Biosystems Ltd. (Canada), Fathom (US), Materialise (US), Envisiontec, Inc. (Germany), Allevi (US), Nano3D Biosciences, Inc. (US), 3Dynamic Systems Ltd. (UK), Cyfuse Biomedical KK (Tokyo), REGENHU (Switzerland), and Poietis (France), among others.

Industry/ Innovation /Related News:

CollPlant (the US), a 3D bioprinter material developer, announced the receiving an investment of USD 5.5 MN provided by a group of investors with a special interest in the 3D printing industry and from one its largest shareholder Ami Sagi.

CELLINK (Sweden), a 3D bioprinter and materials developer, launched a new six-printhead bioprinting system named BIO X6. The new six-printhead 3D bioprinting platform allows the combination of multiple materials, cells, and tools, featuring an intelligent exchangeable printhead system and CELLINKs patented Clean Chamber Technology to enhance advanced research & clinical applications.

inkClub AB (Sweden), an online retailer, announced the acquisition of 3D PRIMA (Sweden), an online store for 3D-Printers and filaments. 3D Prima is a fast-growing e-commerce player, and inkClub was one of the first to sell 3D-printing products online. The acquisition is aligned with inkClubs strategic initiative for expansion. InkClub has both the experience and e-commerce expertise, which is essential when 3d Prima, is growing.

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3D Bioprinting Market Size Is expected to Reach USD 1923.02 Million at a CAGR of 24.59% By 2023 - Cole of Duty

The healthcare workers rely on personal protective equipment to protect themselves and their patients from being infected and infecting others. But shortages of such PPE are leaving doctors, nurses and other frontline workers dangerously ill-equipped to care for COVID-19 patients, due to limited access to supplies such as gloves, medical masks, respirators, goggles, face shields, gowns, and aprons. The World Health Organization has warned that severe and mounting disruption to the global supply of personal protective equipment (PPE) caused by rising demand, panic buying, hoarding and misuse is putting lives at risk from the new coronavirus and other infectious diseases. As the number of COVID-19 cases continues to grow worldwide, political leaders are encouraging physical (or social) distancing to slow the rate of transmission. The goal of this practice is to flatten the curve of a new infection, thereby avoiding a surge of demand on the health care system, but the effects of physical distancing may take weeks to appear.

For a detailed analysis of the Healthcare PPE demand during COVID-19 impact browse through:https://univdatos.com/report/global-healthcare-ppe-demand-analysis-covid-19-impact-feb-dec-2020

Healthcare Personal Protective Equipment manufacturers are racing to boost production of the medical PPE required to save the lives of many critically ill COVID-19 patients, but they will not be able to ramp up production quickly enough to meet the demands of the exponentially growing cases of COVID-19. 3M Company, Dowdupont, MSA Safety, Honeywell International, Ansell Limited are among the largest suppliers of medical personal protective equipment, and these are working day and night to meet increased global demand. For instance: Since January, 3M has doubled production of N95 respirators to 1.1 billion per year at its global manufacturing facilities, including in the U.S., Asia and Europe. 3M aims to double its capacity again to 2 billion per year within the next 12 months. In this crisis, 3M is experiencing an unprecedented surge in demand for N95 respirators, and demand will outpace supply for the foreseeable future.

For a detailed analysis of the product type development to cater to the increasing Healthcare PPE demand during COVID-19 impact browse through:https://univdatos.com/report/global-healthcare-ppe-demand-analysis-covid-19-impact-feb-dec-2020

Across the world, frontline medical staff is clamoring for face masks and other personal protective equipment (PPE). In the United States, the new epicentre of the pandemic, shortages are so acute that health workers have taken to social media to appeal for help under the hashtag. Frontline medical staff in many countries say shortages of masks and other equipment have left them vulnerable to catching the virus which forces them into isolation and reduces staff numbers. There are two main kinds of mask: The surgical masks worn routinely on many Asian streets, which can provide some protection; and the higher-standard respirators, often known by designations such as N95 or FFP (filtering facepiece), which are meant for medical procedures to protect workers from the droplets through which the virus spreads. The demand for all of them has skyrocketed. Besides, the government is taking initiatives regarding healthcare PPE production given rising COVID-19 cases across the world. NSW Health is implementing a state-wide strategy to ensure all staff has the personal protective equipment needed to protect them at work by collaborating with the Federal Government to access the national medical stockpile and seeking alternative supply chains. UNICEF Spain has donated 418,000 face masks to the Government of Spain in support of the national response on COVID-19. Announcing Indian Railways foray into another major COVID-19 relief initiative, Minister Piyush Goyal states that it will soon begin large-scale manufacturing of Personal Protective Equipment (PPE) kits to augment their supply amidst a growing demand while at the same time, ensure that Indias medical staff are adequately equipped to fight COVID-19.

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For a better understanding of the Healthcare Personal Protective Equipment, demand trend arises due to COVID-19, a detailed analysis was conducted for the top 10 most affected regions including United States, Canada, Germany, United Kingdom, France, Italy, Spain, Turkey, Iran, and India. The United States currently has the highest number of healthcare personal protective equipment available and is expected to need even more than any other country across the world as the region acquires more than 33% of the global COVID-19 cases alone and the cases are still on the rise. Some of the major players profiled in the Healthcare Personal Protective Equipment demand market study include 3MCompany, Kimberly-Clark Corporation, Ansell Limited, Honeywell International, Alpha Pro Tech, MSA Safety, DuPont Inc., Lakeland Industries, Avanos Medical, and Medline Industries. These industry players are entering into several mergers & acquisitions and partnerships for the expansion of their reach and increasing their hold on the market.

Global HealthcarePPEDemand- COVID-19 Impact, Market Segmentation

Market Insights, by Product Type

Medical Masks

Gowns

Gloves

Goggles

Market Insights, by End-Users

Hospitals

Primary Care Facilities

Others

Market Insights, by Countries

United States

Canada

Germany

United Kingdom

France

Italy

Spain

Turkey

Iran

India

Rest of World

Top Company Analysed

3M Company

Kimberly-Clark Corporation

Ansell Limited

Honeywell International

Alpha Pro Tech

MSA Safety

DuPont Inc.

Lakeland Industries

Avanos Medical

Medline Industries

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Global Healthcare PPE Demand Analysis-COVID-19 Impact reportcan further be customized as per the clients requirements (interested country). Besides this, UMI understands that you may have your own business needs, hence feel free to connect with us to get a report that completely suits your requirements.

Regenerative Medicine Market to represent a significant expansion at CAGR of 31.5% for the period of 2020 to 2026

Frozen Foods Market Industry Analysis, Size, Share, Growth, Trends, and Forecast 2020-2026

Self Service Technology Market Expected to Grow at a CAGR of 10.7% During the Forecast Period 2020-2026

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COVID-19 Impact on Healthcare Personal Protective Equipment (PPE Kits) Market (2020-2026) | Emphasis on Product Type (Medical Masks, Gowns, Gloves,...

Robert Montgomery, MD, DPhil, a pioneering surgeon and director of the NYU Langone Transplant Institute, has been appointed chair of the Department of Surgery. He will assume his new post on September 1. H. Leon Pachter, MD, the George David Stewart Professor of Surgery, who has had a distinguished tenure as chair of the department since 2007, will remain a member of the faculty as chair emeritus.

An internationally renowned surgeon, Dr. Montgomery joined the faculty of NYU Grossman School of Medicine in 2016 from The Johns Hopkins Hospital, where he was part of the team that pioneered a laparoscopic technique for procuring a kidney for live donation that is now standard practice. Under his leadership, the Transplant Institute at NYU Langone has been developing innovative protocols and making significant contributions toward increasing the availability of organs for transplant.

Dr. Montgomery made major headlines himself when, in 2018, the team he assembled performed a heart transplant on him. In yet another example of the game-changing advances he is helping bring about, he accepted a heart that was positive for hepatitis Corgans for which he has strongly advocated for other recipients, including those in the heart, lung, kidney, and liver programs. Thanks to protocols he helped develop, these organs can now be made safe with antiviral medications.

Before joining NYU Langone, Dr. Montgomery developed a system of multiway donor exchanges, also called domino exchanges, facilitating transplants when an intended organ recipient has a donor who is incompatible. He has created techniques such as desensitization therapy to reduce the risk of organ rejection, and has performed groundbreaking research on the possible use of organs from genetically modified animals to address the dire shortages of organs available for transplant.

Dr. Montgomery has made a name for himself in the field of transplant surgery, not only as an innovator and leader, but as a grateful patient, says Robert I. Grossman, MD, dean and CEO of NYU Langone. Under his leadership, the Department of Surgery will continue to push the envelope on behalf of our patients to ensure we continue to provide world-class care.

We thank Dr. Pachter for his leadership of the department, which saw tremendous growthtripling in size during his tenure, says Dr. Grossman. His commitment to patients, trainees, and his faculty embodies the principles of a great leader and outstanding physician.

After graduating magna cum laude with a bachelor of science in biology from St. Lawrence University, Dr. Montgomery graduated with honors from the University of Rochester School of Medicine, and received his doctor of philosophy in molecular immunology from Balliol College at the University of Oxford, England. He completed his general surgical training, postdoctoral fellowship in human molecular genetics, and transplantation surgery fellowship at The Johns Hopkins Hospital.

A prolific researcher and educator, Dr. Montgomery has authored or co-authored more than 275 peer-reviewed publications (cited more than 25,000 times) and given 250 invited or named lectures. In addition to his many academic honors and distinctions, including a Fulbright Scholarship and a Thomas J. Watson Fellowship, in 2019 the Greater New York Hospital Association presented him with the Profile in Courage Award. He appears in the 2010 Guinness Book of World Records for the most kidney transplants performed in one day.

The Department of Surgery at NYU Langone enjoys a distinguished history of discovery and innovation, which has been further enhanced under the exemplary leadership of Dr. Leon Pachter, Dr. Montgomery says. I am extremely excited to accept this new position, and I look forward to this extraordinary opportunity to advance NYU Langones trifold commitment to education, research, and clinical care.

Rob MagyarPhone: 212-404-3500robert.magyar@nyulangone.org

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World-Renowned Transplant Surgeon to Lead Department of Surgery at NYU Langone Health - NYU Langone Health

An inter-disciplinary team of researchers, funded by the University of Torontos Medicine by Design,hasgeneratedfunctional blood vessel cells found in the liver from stem cells a discovery thatoffersan opportunityto study the rolethe cellsplayin liver developmentand diseaseprogression, and which couldlead tonew therapies to treat hemophilia A.

Thestudy, titledGeneration of Functional Liver Sinusoidal Endothelial Cells from Human Pluripotent Stem Cell-Derived Venous Angioblasts,waspublished this week in Cell Stem Cell. Itrepresents a collaborative effort betweenbasic and clinical researchersat U of T and the University Health Network (UHN)with expertise in stem celland computationalbiology,human liver physiology and functionand liver transplantation.

It alsodraws onprevious Medicine by Design-funded research that led to the creationin 2018of the first single-cell map of the human liver.

By combining insights from developmental biology and liver anatomy with thecellatlasof the human liver,we were able to generateand validatefunctional human liver vasculature from stem cells, saysBlair Gage,apost-doctoral researcher at the McEwen Stem Cell Institute at UHNand lead author ofthestudy.Nowwe canmove forwardto use these liver endothelial cells tobetterunderstandtheir role in liver functionand to develop new therapies to treat disorderssuch ashemophilia A.

Theinterdisciplinary researchteam also includes:JeffLiu,research associate atU of TsDonnelly Centrefor Cellular andBiomolecularResearch;Brendan Innes, a PhD candidate at the Donnelly Centre and in thedepartment ofmolecular genetics in the Faculty of Medicine;Sonya MacParland, scientist in themulti-organ transplant program at theToronto General Hospital Research Institute andan assistant professor in U of Ts departments of immunology andlaboratory medicine and pathobiology; Ian McGilvray,senior scientist at themulti-organ transplant program at theToronto General Hospital Research Institute and a professorinU of Ts department of surgery;Gary Bader, professor at the Donnelly Centreandthedepartment ofmolecular genetics; andGordon Keller,director andsenior scientist at theMcEwen Stem Cell Institute at UHNandprofessor in U of Ts department of medical biophysics.

Researchersinthe Keller lab had the goal of generatinga functional liver vasculature cell type known as liver sinusoidal cells (LSECs)fromhuman pluripotent stem cells (hPSCs) cells that can self-renew and have the potential to turn into any other cell type in the human body. LSECs are essential for normal liver function and represent the main source of factor VIII,a blood-clotting protein that is missing or defective in patients with hemophilia A.

However, the teamhad todemonstratethatthecellstheyhadmadein the labhad thesamespecializedgenetic and functionalfeaturesasthose in thehuman liver.So they turned to the work of MacParland, Bader and McGilvray,whoin the first phase ofMedicine by Designs team projectfundingdescribed amolecularmap of the cell types in the adult liver.Thatresearchhascontributed totheHuman Cell Atlasan international effort to create comprehensive reference maps of all human cellsand last yearattracted follow-on funding from the Chan Zuckerberg Initiative.

This paper uses our human liver map as a guide to know if the cells beinggeneratedaretherightones through collaboration with Gary Baders group, says MacParland.The work really highlights thestrengthof MedicinebyDesignin bringingtogether researchers from multiple institutionstofocus on a common goal.

With Bader and Lius help, Keller lab researchers were able to use the MacParlandhuman livermapto show that thehPSC-derivedendothelialcellsthey had generatedshared manyof thefeatures found innormal liver vasculature. The Keller lab team then brought Innes on board toformat thedatafromthehPSC-derived LSECsfor the research communitytoeasilyexplorethe molecular profile of these cells.

This research was supported by Medicine by Design, which receives funding from the federal governmentsCanada First Research Excellence Fundand by theCanadian Institutes of Health Research.

The work continues in a current Medicine by Design-funded team projectled by Kellerthat aims to make other key liver cell types and put together the pieces to get functional tissueswith the goal of developing new cell-based therapies for liver-related diseases.That project is part ofanew $20-million round of team project fundingthat Medicine by Design announced late last year.

Medicine by Designbrings togetherinvestigatorsfromdifferent disciplinesatU of T and its affiliated hospitals to advance new discoveries in regenerative medicine and accelerate them toward clinical impact.Medicine by Designwill host ameeting of the Human Cell Atlass Development and Pediatric Atlasin July 2021in Toronto.

Read more:
Researchers at U of T use stem cells to grow functional blood vessel cells found in liver - News@UofT

Across the globe, approximately 50 million people are living with dementia. The two most common forms are Alzheimers disease and frontotemporal lobar degeneration (FTLD), which develop when neurons in specific parts of the brain stop functioning triggering memory loss and other behavioral or personality changes.

Without a cure, the World Health Organization predicts that number could rise by as many as 10 million cases per year. However, predicting the onset of these diseases is tricky because neurodegeneration can start years before people present any outward symptoms.

An electron microscope shows the myelin sheath in a healthy mouse brain. The myelins fatty tissue insulates neurons and protects them from damage.

Cornell researchers including Fenghua Hu, associate professor in the Department of Molecular Biology and Genetics and member of the Weill Institute for Cell and Molecular Biology, are taking a closer look at the factors that cause Alzheimers, FTLD and similar diseases. Hus latest study, A role of the frontotemporal lobar degeneration risk factor TMEM106B in myelination, was published June 23 in the journal Brain.

I want to have a better understanding of the molecular and cellular mechanisms of neurodegeneration, Hu said. I hope that our research can facilitate therapeutic development of treatment options for patients suffering from neurodegenerative diseases and other brain disorders.

Her team started by investigating a specific gene, called TMEM106B, which had been previously identified as a risk factor for several neurodegenerative diseases, including Alzheimers and FTLD. Researchers also knew that a particular mutation in that gene caused a neurological defect known as hypomyelinating leukodystrophy, which creates a myelin deficit in the brain, leading to the deterioration of both motor skills and mental acuity.

Myelin is the fatty tissue that wraps around nerve fibers, or axons, in the nervous system. Like insulation, this tissue forms a sheath that surrounds the nerve fibers, protecting them from damage and allowing electrical impulses to be quickly transmitted along the nerve.

Hu wanted to see exactly how that one mutation in TMEM106B could cause so much damage. She also wanted to learn more about how the gene regulates the formation and maintenance of the myelin sheath under normal conditions.

We found that the mutation associated with the disease is a loss-of-function mutation, Hu said.

This distinction is critical since the Hu lab saw that TMEM106B is expressed in the cells that are responsible for forming the protective myelin tissue. Those cells are called oligodendrocytes, and within them, TMEM106B resides in the lysosome a tiny organelle that acts as a cellular recycling center.

Like the stomach, the lysosome must maintain a specific pH to keep its enzymes active. As oligodendrocytes build the myelin sheath, lysosomes remove any extraneous materials. They can also store myelins main membrane protein and deposit it in areas surrounding the nerve fibers.

Hus team discovered that the TMEM106B mutation prevented the gene from regulating both the pH inside the lysosome and the movement of the lysosome itself inhibiting the oligodendrocytes ability to build compact myelin layers.

Using a mouse model, Hu also noticed that an overall TMEM106B deficiency led to abnormal lysosome movement within the oligodendrocytes. This created defects in the myelin sheath, and the team observed behavioral changes, including poor motor coordination.

Additional research will examine the exact mechanism by which TMEM106B regulates lysosome function and will demonstrate how the mutation leads to the known neurological defects.

We want to explore whether the genes regulation of myelination contributes to its association with neurodegenerative diseases, including Alzheimers, FTLD and other age-related dementia, Hu said.

First author on the paper is postdoctoral associate Tuancheng Feng, and co-authors include other members of the Hu lab: Rory Sheng 19, Mohammed Ullah 21, Christina Mendoza 19, Isabel Iscol Katz 21, Daniel Paushter, Ph.D. 18, Peter Sullivan, Ph.D. 17, lab technician Xiaochun Wu, and former students Xiaolai Zhou and Laura Camila Martinez Enriquez.

Collaborators also include Fred Maxfield, professor in the Department of Biochemistry at Weill Cornell Medicine, and his research associate Santiago Domenech.

Hu received funding from the Bluefield project to cure frontotemporal dementia, National Institute on Aging, and National Institute of Neurological Disorders and Stroke.

Jana Wiegand is the editorial content manager for the College of Agriculture and Life Sciences.

See original here:
Gene yields insights into the causes of neurodegeneration | Cornell Chronicle - Cornell Chronicle

- European Investment Bank (EIB) and OpGen, Curetis GmbH and Ares Genetics GmbH enter into Amendment to the EIB Financing Agreement

-Additional EUR 5 Million Tranche With 5-Year Interest Only Period Related to COVID-19 R&D Programs Across Multiple Platforms

-EIB Financing Tranche Available for Draw-Down at Curetis Sole Discretion for a 9-Month Period and Subject to 0.7% Participating Interest in OpGen Equity Value at Maturity

GAITHERSBURG, Md. and HOLZGERLINGEN, Germany, July 09, 2020 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, OpGen), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that its wholly owned subsidiary Curetis GmbH will have access to another EUR 5.0 million debt financing tranche under the amended EIB financing facility.

Under the EIB debt financing facility originally put in place in December 2016, Curetis now stands to receive another EUR 5.0 million tranche of non-dilutive debt financing. This additional tranche is earmarked to co-fund R&D programs across several of the platforms and the entire product portfolio of OpGen group companies Curetis and Ares Genetics as it relates to COVID-19.

This additional tranche, which can be drawn down at the sole discretion of Curetis within nine months from the Effective Date of this amendment, will also have a five-year term to maturity from such draw-down date. All interest payments during that five-year term are compounded and become payable only upon maturity of the principal amount of this tranche. The EIB tranche disbursement will become available subject to typical conditions precedent including a pledge of certain Curetis IP rights as security to EIB. The parties have furthermore agreed on a 0.7% participation percentage interest (PPI). Upon maturity of the tranche, i.e. not before H2-2025 (and no later than early 2027 depending on draw-down date), EIB will be entitled to an additional payment that is equity-linked and equivalent to 0.7% of the then total equity valuation of OpGen. The parties have also adjusted the PPI percentage applicable to the previous EIB tranche of EUR 5.0 million which was funded in June 2019 from its original 2.1% PPI in Curetis N.V.s equity value upon maturity to a new 0.3% PPI in OpGens equity value upon maturity between mid-2024 and mid-2025. This adjustment follows the respective stockholder ownership interest in OpGen following the business combination with Curetis as of April 1, 2020. All other terms and conditions of the EIB financing contract with Curetis remain unchanged.

We are very pleased to see continued strong support and funding commitment from the EIB, said Oliver Schacht, PhD, CEO of OpGen and Managing Director of Curetis GmbH. The additional funding will allow us to continue executing on our R&D programs such as the Unyvero A50 and A30 RQ platforms with a focus on COVID-19 related applications, as well as the Ares Genetics and combined OpGen R&D programs in AI-powered bioinformatics.

About OpGen, Inc.

OpGen, Inc. (Gaithersburg, MD, USA) is a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease. Along with our subsidiaries, Curetis GmbH and Ares Genetics GmbH, we are developing and commercializing molecular microbiology solutions helping to guide clinicians with more rapid and actionable information about life threatening infections to improve patient outcomes, and decrease the spread of infections caused by multidrug-resistant microorganisms, or MDROs. OpGens product portfolio includes Unyvero, Acuitas AMR Gene Panel and Acuitas Lighthouse, and the ARES Technology Platform including ARESdb, using NGS technology and AI-powered bioinformatics solutions for antibiotic response prediction.

For more information, please visit http://www.opgen.com.

Forward-Looking Statements

This press release includes statements regarding the amendment of the EIB financing agreement for purposes of R&D programs related to COVID-19 diagnostic tests by OpGen and its subsidiaries, Curetis and Ares Genetics. These statements and other statements regarding OpGens future plans and goals constitute "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control, and which may cause results to differ materially from expectations. Factors that could cause our results to differ materially from those described include, but are not limited to, our ability to successfully, timely and cost-effectively develop, seek and obtain regulatory clearance for and commercialize our product and services offerings, the rate of adoption of our products and services by hospitals and other healthcare providers, the realization of expected benefits of our business combination transaction with Curetis GmbH, the success of our commercialization efforts, the impact of COVID-19 on the Companys operations, financial results, and commercialization efforts as well as on capital markets and general economic conditions, the effect on our business of existing and new regulatory requirements, and other economic and competitive factors. For a discussion of the most significant risks and uncertainties associated with OpGen's business, please review our filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which are based on our expectations as of the date of this press release and speak only as of the date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

OpGen:Oliver SchachtPresident and CEOInvestorRelations@opgen.com

OpGen Press Contact:Matthew BretziusFischTank PR matt@fischtankpr.com

OpGen Investor Contact:Joe Green Edison Groupjgreen@edisongroup.com

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OpGen Subsidiary Curetis GmbH Secures Access to Additional EUR 5.0 Million Non-Dilutive Debt Financing Tranche from EIB - GlobeNewswire

Since the World Health Organization declared it a pandemic in March 2020, the novel coronavirus SARS-CoV-2 has caused millions of infections and hundreds of thousands of deaths worldwide. Currently there is no cure, and many initial treatments being tested against COVID-19 were designed for other viral infections. Multiple drugmakers are scrambling to find treatments that might help fight off the coronavirus or prevent infections altogetherin a Herculean effort to collapse the typical 1015-year drug development timeline to under a year.

Antiviral human monoclonal antibodies (mAbs) are promising drug candidates for preventing or treating severe viral diseases, but the long timelineson the order of yearsneeded for antibody discovery, functional analysis, preclinical studies, and manufacturing limit their rapid deployment and use as immunotherapeutics. Vanderbilt University Medical Center researchers Robert Carnahan and Pavlo Gilchuk are part of the scientific team attempting to compress the timeline for potent antiviral antibody discovery and characterization by integrating a series of advances in single-cell messenger RNA sequence analysis, bioinformatics, synthetic biology, and high-throughput functional analysis. Their work enabled the rapid discovery of a diverse panel of highly potent antiviral human mAbs against the SARS-CoV-2 Spike protein and the validation of their activity both in vitro and in vivo. These results provide a potential framework for expedited antibody discovery programs against viral pathogens of global concern.

During the webinar, viewers will:

This webinar will last for approximately 60 minutes.

For Research Use Only. Not for use in diagnostic procedures.

Vanderbilt Vaccine CenterNashville, TN

Dr. Pavlo Gilchuk received his M.S. in biochemistry and his doctorate in biotechnology from Taras Shevchenko National University of Kyiv, Ukraine. His work there was largely focused on single-chain antibody design and discovery. From 2002 to 2009, he was employed by Phage Biotechnology Corporation in San Diego, California, where he advanced from engineer biologist to research group manager. Dr. Gilchuk also held the position of staff scientist at the Institute of Molecular Biology and Genetics, National Academy of Sciences of Ukraine (Kyiv), and served as laboratory head at the State Institute of Genetic and Regenerative Medicine, Academy of Medical Sciences of Ukraine (Kyiv). Upon transitioning to the Vanderbilt University Medical Center in Nashville, Tennessee, his initial research was directed to large-scale vaccinia virusderived T cell epitope discovery, elucidation of immunological features of lung-resident memory CD8+ T cells, and development of platforms for T celltargeted mucosal vaccination. Dr. Gilchuk is now a senior staff scientist in the laboratory of James E. Crowe, Jr. at the Vanderbilt Vaccine Center (VVC) and leads antibody-discovery technology development and evolution within this large academic team. In addition, he is currently working on methods development for rapid identification of therapeutic antibodies against viral diseases (the Defense Advanced Research Projects Agency [DARPA] Pandemic Prevention Platform program).

Vanderbilt Vaccine CenterNashville, TN

Dr. Robert Carnahan is associate director of the Vanderbilt Vaccine Center at Vanderbilt University Medical Center and an associate professor in pediatrics and radiology. He has a high level of experience with monoclonal antibodies and antibody engineering. He directed the Vanderbilt Antibody and Protein Resource (VAPR) for over 10 years. The facility grew to the point of conducting an average of 150 antibody projects per year, comprising more than 70 unique Vanderbilt investigators as well as several academic and industry partners from across the country (e.g., the University of California, Los Angeles; the Fred Hutchinson Cancer Research Center; Purdue University; Kolltan Pharmaceuticals; Becton Dickinson). Both academic and industry projects focused increasingly on therapeutic targets (cancer, viral pathogens, autoimmunity, diabetes, etc.), with work in the lab ranging from discovery to preclinical activities. Dr. Carnahan has brought this focus on innovation applied to antibody generation and detailed characterization to the Crowe Lab and the Vanderbilt Vaccine Center. During this time, he has also held numerous regional and national leadership roles within the Association of Biomolecular Resource Facilities (ABRF), to develop advances in methodologies and technical standards, oversee collaborative studies, and implement training opportunities for lab directors and personnel. Furthermore, he is also a national leader in the design and implementation of Lean management systems for biological laboratories.

Science/AAASWashington, D.C.

Dr. Oberst did her undergraduate training at the University of Maryland, College Park, and her Ph.D. in Tumor Biology at Georgetown University, Washington D.C. She combined her interests in science and writing by pursuing an M.A. in Journalism from the Philip Merrill College of Journalism at the University of Maryland, College Park. Dr. Oberst joined Science/AAAS in 2016 as the Assistant Editor for Custom Publishing. Before then she worked at Nature magazine, the Howard Hughes Medical Institute, The Endocrine Society, and the National Institutes of Mental Health.

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Racing against time: Rapid, high-throughput discovery of antibody therapeutics for SARS-CoV-2 - Science Magazine

Model suggests ACER-001, Acers taste-masked, immediate release formulation of sodium phenylbutyrate, may offer improved disease management in patients with Urea Cycle Disorders compared to current treatments

Anticipate submitting ACER-001 NDA in H1 2021 assuming successful completion of additional nonclinical work and long-term stability data, and subject to additional capital

NEWTON, Mass., July 08, 2020 (GLOBE NEWSWIRE) -- Acer Therapeutics Inc. (Nasdaq: ACER), a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs, today announced data from a food effect study in healthy volunteers showing that administration of ACER-001 in a fasted state increased systemic exposure of phenylbutyrate (PBA), phenylacetate (PAA) and phenylacetylglutamine (PAGN) levels compared to fed state, and therefore based on modeling data may improve disease management in patients with urea cycle disorders (UCDs) when compared to currently approved treatments requiring administration with food.

Results from Part B of the ACER-001 bioequivalence (BE) trial in healthy volunteers (n=36) announced in February 2020 showed that ACER-001 was bioequivalent to BUPHENYL (sodium phenylbutyrate) and were within the parameters recommended by the FDAs Guidance for Industry, Statistical Approaches to Establishing Bioequivalence. The BE trial included a food effect study, which evaluated the pharmacokinetics (PK) of sodium phenylbutyrate (NaPBA) showing that administration of ACER-001 in a fasted state achieved more than two times the maximum concentration (Cmax) of PBA compared to administration of the same dose of ACER-001 in a fed state. These results are consistent with previously published data by Nakano, et al1 that evaluated PK of NaPBA in patients with progressive familial intrahepatic cholestasis, also demonstrating that administration of NaPBA in a fasted state significantly increased PBA peak plasma concentration compared to administration of NaPBA in a fed state.

Currently approved therapies for UCDs, including BUPHENYL2 and RAVICTI3 (glycerol phenylbutyrate), are required to be administered with food. BUPHENYL is required to be administered in a fed state due to its aversive odor and taste, with side effects including nausea, vomiting and headaches, which often lead to discontinuation of treatment.4 Additionally, prescribing information states that BUPHENYL food effect is unknown. RAVICTI PK and pharmacodynamic (PD) properties were determined to be indistinguishable in fed or fasted states.5 ACER-001 is uniquely formulated with its multi-particulate, taste-masked coating to allow for administration in a fasted state, while still allowing for rapid systemic release.

Based on the results from the food effect study within the ACER-001 BE trial, Acer commissioned Rosa & Co. LLC to create a PhysioPD PK model to evaluate the potential food effect on exposure, tolerability and efficacy of ACER-001 in UCDs patients. Results from this in silico model suggest that administration of ACER-001 in a fasted state required approximately 30% less PBA to achieve comparable therapeutic benefit in a fed state. In addition, the model predicted that administration of ACER-001 in a fasted state compared to administration of BUPHENYL or RAVICTI (same amounts of PBA) in their required fed states is expected to result in higher peak blood PBA, PAA and PAGN concentrations, predicting a 43% increase in urinary PAGN levels (a negative correlation between blood ammonia area under the curve and 24-hour urinary PAGN amount has been demonstrated6).

For nearly a quarter century, phenylbutyrate has been prescribed to UCD patients with food while its effect on phenylbutyrate absorption was never determined. The results of the ACER-001 food effect study, published literature and in silico modeling suggest that ACER-001 administered in a fasted state, and likely just 10 minutes prior to meals, could offer UCD patients a safe and better disease management option compared to currently approved products that are required to be taken with food, said Chris Schelling, CEO and Founder of Acer. We formulated ACER-001 to specifically improve palatability and tolerability, and we expect that this formulation should allow ACER-001 to be successfully administered without food. We look forward to discussing these findings with the FDA later in the third quarter. Schelling continued Interestingly, the increased exposure seen under fasted conditions may have benefit in other patient populations we intend to study, such as Maple Syrup Urine Disease (MSUD), where the Cmax of phenylbutyrate is the active moiety.

About UCDsUCDs are a group of disorders caused by genetic mutations that result in a deficiency in one of the six enzymes that catalyze the urea cycle, which can lead to an excess accumulation of ammonia in the bloodstream, a condition known as hyperammonemia. Acute hyperammonemia can cause lethargy, somnolence, coma, and multi-organ failure, while chronic hyperammonemia can lead to headaches, confusion, lethargy, failure to thrive, behavioral changes, and learning and cognitive deficits. Common symptoms of both acute and chronic hyperammonemia also include seizures and psychiatric symptoms.7,8

The current treatment of UCDs consists of dietary management to limit ammonia production in conjunction with medications that provide alternative pathways for the removal of ammonia from the bloodstream. Some patients may also require individual branched-chain amino acid supplementation.

Current medical treatments for UCDs include nitrogen scavengers RAVICTI and BUPHENYL in which the active pharmaceutical ingredients are glycerol phenylbutyrate (GPBA) and sodium phenylbutyrate (NaPBA), respectively. According to a 2016 study by Shchelochkov et al., published in Molecular Genetics and Metabolism Reports, while nitrogen scavenging medications can be effective in helping to manage ammonia levels in some patients with UCDs, non-compliance with treatment is common. Reasons given for non-compliance include the unpleasant taste associated with available medications, the frequency with which medication must be taken, the number of pills, and the high cost of the medication.9

About ACER-001ACER-001 is a taste-masked, immediate-release proprietary formulation of sodium phenylbutyrate developed by Acer using a microencapsulation process. ACER-001 is being developed for the treatment of various inborn errors of metabolism, including UCDs and Maple Syrup Urine Disease (MSUD). ACER-001 microparticles consist of a core center, a layer of active drug, and a taste-masking coating that quickly dissolves in the stomach, allowing taste to be neutralized while still allowing for rapid systemic release. This taste-masked formulation may result in better patient tolerability allowing for administration in a fasted state, and likely prior to a meal. Acer has been granted orphan drug designation by the FDA for the MSUD indication. ACER-001 is under clinical investigation and its safety and efficacy have not been established. There is no guarantee that this product will receive FDA approval or become commercially available for the uses being investigated.

About Acer Therapeutics Inc.Acer is a pharmaceutical company focused on the acquisition, development and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Acers pipeline includes four clinical-stage candidates: emetine hydrochloride for the treatment of patients with COVID-19; EDSIVO (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (vEDS) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (UCDs) and Maple Syrup Urine Disease (MSUD); and osanetant for the treatment of induced Vasomotor Symptoms (iVMS) where Hormone Replacement Therapy (HRT) is likely contraindicated. Each of Acers product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation and/or accelerated paths for development through specific programs and procedures established by the FDA. For more information, visit http://www.acertx.com.

References

Forward-Looking StatementsThis press release contains forward-looking statements that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this press release regarding strategy, future operations, timelines, future financial position, future revenues, projected expenses, regulatory submissions, actions or approvals, cash position, liquidity, prospects, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to the potential for our product candidates to safely and effectively treat diseases and to be approved for marketing; the commercial or market opportunity of any of our product candidates in any target indication and any territory; our ability to secure the additional capital necessary to fund the ACER-001 program; the adequacy of our capital to support our future operations and our ability to successfully initiate and complete clinical trials and regulatory submissions; the ability to protect our intellectual property rights; our strategy and business focus; and the development, expected timeline and commercial potential of any of our product candidates. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Such statements are based on managements current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, risks and uncertainties associated with the ability to project future cash utilization and reserves needed for contingent future liabilities and business operations, the availability of sufficient resources to meet our business objectives and operational requirements, the fact that the results of earlier studies and trials may not be predictive of future clinical trial results, the protection and market exclusivity provided by our intellectual property, the substantial costs and diversion of managements attention and resources which could result from pending securities litigation, risks related to the drug development and the regulatory approval process, including the timing and requirements of regulatory actions, and the impact of competitive products and technological changes. We disclaim any intent or obligation to update these forward-looking statements to reflect events or circumstances that exist after the date on which they were made. You should review additional disclosures we make in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K. You may access these documents for no charge at http://www.sec.gov.

Investor Contact:Hans VitzthumLifeSci AdvisorsPh: 617-430-7578hans@lifesciadvisors.com

Jim DeNikeAcer Therapeutics Inc.Ph: 844-902-6100jdenike@acertx.com

Continued here:
Acer Therapeutics Announces Administration of ACER-001 in a Fasted State Increased Systemic Exposure of Phenylbutyrate in Healthy Volunteer Food...

This report provides statistics on the market situation, size, regions and growth factors. Emerging Gene Therapies Market report contains emerging players analyze data including competitive situations, sales, revenue and market share of top manufacturers.

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Scope of Emerging Gene Therapies Market Report- What are the key emerging products within the gene therapy landscape? Which companies have the strongest pipeline of innovative products? How will gene editing disrupt existing gene therapy products? What are the regulatory trends for emerging gene therapies? What are the interests of pharmaceutical companies within the field?

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Reasons to accessthis Report- Achieve an up-to-date understanding of the area, with a comprehensive reference of key products within the gene therapy landscape, compared across technology-specific relevant characteristics such as editing mechanism and delivery vector. Conduct competitive analysis using indication-specific, side-by-side comparisons of the latest data for key gene therapy products in the strategically relevant areas of eye, blood, and liver. Conduct strategic analysis using an overview of gene therapy specific considerations for evaluating and developing gene therapy products the CRISPR patent space, emerging regulatory trends, innovation leaders and the interests of pharma in gene therapy.

Table of Contents in this Report-1 Table of Contents 51.1 List of Tables 71.2 List of Figures 82 Introduction 102.1 Gene Therapy Definitions 102.2 Report Coverage the Emerging Gene Therapy Pipeline 112.3 History of Gene Therapy 122.4 Limitations of Gene Transfer 132.5 The Development of Targeted Gene Editing 132.6 Overview of Gene Editing Platforms 132.6.1 Zinc Fingers (1996) 132.6.2 Transcription Activator-Like Effectors (2011) 142.6.3 The CRISPR/Cas System (2013) 152.6.4 Effectors for Targeting Domains 192.6.5 Comparison of Gene Editing Systems 192.6.6 Summary of Gene Editing Systems 192.7 Overview of In Vivo Gene Therapy 212.7.1 Editing is Dependent on Cell Type, Stage, and Repair Pathway 212.7.2 Delivery 212.7.3 Emerging Safety Concerns with Editing Platforms 242.7.4 Editing Products are Reliant on the Target Cells Cycle Stage and DNA Repair Machinery 272.7.5 Advantages of Gene Editing over Gene Transfer 282.7.6 Integration into Safe Harbor Sites 282.7.7 The Increasing Complexity of Gene Therapy 302.7.8 Summary of In Vivo Gene Therapy 313 Gene Therapy Near Term Product Pipeline 333.1 Leber Congenital Amaurosis 333.1.1 Unmet Need 333.1.2 Molecular Genetics 333.1.3 Luxturna (Voretigene neparvovec) 333.1.4 Editas Medicine: EDIT-101 353.1.5 Trial Design 363.1.6 EDIT-101 and Off-Target Effects 373.1.7 The Potential Advantage of EDIT-101 is the Longevity of its Therapeutic Effect 373.1.8 Summary LCA 383.2 Choroideremia 383.3 Hurler Syndrome (MPS I) 393.3.1 Key Clinical Studies 403.3.2 Regenex: RGX-111 403.3.3 Sangamo Therapeutics: SB-318 403.4 Hunter Syndrome (MPS II) 413.4.1 Unmet Need 413.4.2 Sangamo Therapeutics: SB-913 413.4.3 Immusoft Corporation: Cell Therapy 433.5 Sanfilippo Syndrome (MPS III) 433.5.1 Lysogene: LYS-SAF302 433.6 Summary MPS Disorders 443.7 Hemophilia 443.7.1 Hemophilia A 463.7.2 Summary Hemophilia A 503.7.3 Hemophilia B 513.7.4 Summary Hemophilia B 533.8 Hemoglobinopathies 543.8.1 Beta Thalassemia: Unmet Need 543.8.2 Beta Thalassemia: Molecular Genetics 553.8.3 Sickle Cell Disease: Unmet Need 563.8.4 Sickle Cell Disease: Molecular Genetics 563.9 Cellular Therapies for Hemoglobinopathies 573.9.1 Blue Bird Bio: BB-305 (LentiGlobin) 573.9.2 Sangamo: ST-400 603.9.3 CRISPR Therapeutics: CTX-001 613.9.4 Summary: Cellular Therapies for Hemoglobinopathies 623.10 Duchenne Muscular Dystrophy 633.10.1 Unmet Need 633.10.2 Molecular Genetics 633.10.3 ExonDys 51 Sarepta Therapeutics 643.10.4 Solid BioSciences: SGT-001 663.10.5 Exonics Therapeutics: CRISPR Approach 673.10.6 Summary Duchenne Muscular Dystrophy 684 Competitive Landscape 694.1 Regulatory Considerations for Developing Gene Therapy Products 694.1.1 Product Characteristics 694.1.2 Clinical Study Design for Gene Therapy Products 694.1.3 Disease specific guidance 704.1.4 Reimbursement and Payment 714.1.5 Summary Regulatory Considerations 724.2 Intellectual Property CRISPR/Cas 724.2.1 Licensing, Exploitation, and MPEG Pool 744.3 Company Analysis: Gene Editing Companies 754.3.1 Sangamo Therapeutics 754.3.2 CRISPR Therapeutics 794.3.3 Casebia Therapeutics 814.3.4 Editas Medicine 824.3.5 Intellia Therapeutics 844.3.6 Homology Medicines 864.4 Company Analysis: Pharma 874.4.1 Amgen 874.4.2 Gilead Sciences 874.4.3 Novartis 874.4.4 Sanofi 884.4.5 GlaxoSmithKline 884.4.6 Pfizer 885 Appendix 895.1 References 895.2 Report Methodology 98

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Current research: 2020 Emerging Gene Therapies Market Report - WhaTech Technology and Markets News

SALT LAKE CITY, July 07, 2020 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular diagnostics and precision medicine, announced today two recent publications validating the polygenic risk score (PRS) component of Myriad’s breast cancer risk stratification tool riskScore®. The publications clinically validate both the ability of the PRS component of riskScore to predict breast cancer risk in asymptomatic women and modify risk estimations for patients identified with pathogenic mutations.

Historically we’ve considered breast cancer risk most significant for women diagnosed with pathogenic mutations in hereditary cancer genes. These studies demonstrate clearly that other genetic factors evaluated through Myriad’s riskScore test can dramatically alter breast cancer risk both independent of, and in combination with, gene mutations,” said Nicole Lambert, president of Myriad International, Oncology and Women’s Health. This information can dramatically change patient clinical management and Myriad is currently working diligently to provide access to this important information for all women.”

The first study published in JCO Precision Oncology described the PRS component of riskScore in over 150,000 women. It showed that independent of other hereditary breast cancer gene mutations (e.g., BRCA1), Myriad’s polygenic risk score can add great value and precision to breast cancer risk estimates. The PRS was highly associated with breast cancer risk with an odds ratio of 1.47 (95% confidence interval 1.45 to 1.49) per unit standard deviation in the PRS. This translated to women in the top PRS percentile having a three-fold higher risk of breast cancer than an average risk patient.

The second study published in the Journal of the American Medical AssociationNetwork Open demonstrates the ability of Myriad’s polygenic risk score to improve breast cancer risk stratification in women diagnosed with pathogenic mutations in common breast cancer genes. The study evaluated over 150,000 patients and approximately 10,000 patients who were carriers of pathogenic mutations in the BRCA1, BRCA2, CHEK2, ATM and PALB2 genes who were tested at Myriad. The study demonstrated that patients with high penetrant genes such as BRCA1 and BRCA2 did not warrant changes in clinical management; however, breast cancer risks in patients with moderate penetrant genes such as CHEK2, ATM, and PALB2 could vary significantly, warranting different clinical management considerations. For example, patients with a PALB2 mutation historically have been assessed to have an approximately 50 percent lifetime risk for breast cancer. However, after incorporating the data from Myriad’s 86 single nucleotide polymporphism (SNP) riskScore test, patient risks varied between 26 percent to 79 percent (see Graph 1 below).

To view Graph 1: PRS Significantly Modifies Lifetime Breast Cancer Risk in Mutation Carriers please visit the following link: https://www.globenewswire.com/NewsRoom/AttachmentNg/11ac3a62-dd7e-417a-9f08-a3a3110e01db

These are some of the largest polygenic risk score studies ever published. Patient medical management can vary dramatically depending on where patients with and without pathogenic mutations fall within the risk spectrum,” said Thomas P. Slavin M.D., senior vice president for Medical Affairs in Oncology at Myriad Genetic Laboratories. This information will help empower patients and clinicians to make more informed decisions based upon the most precise breast cancer risk estimates availiable.”

About riskScore® riskScore is a new clinically validated personalized medicine tool that enhances Myriad’s myRisk® Hereditary Cancer test. riskScore helps to further predict a women’s lifetime risk of developing breast cancer using clinical risk factors and genetic-markers throughout the genome. The test incorporates data from more than 80 single nucleotide polymorphisms identified through 20 years of genome wide association studies in breast cancer and was prospectively validated in our laboratory to predict breast cancer risk in women of European descent. This data is then combined with a best-in-class family and personal history algorithm, the Tyrer-Cuzick model, to provide every patient with individualized breast cancer risk.

About Myriad Genetics Myriad Genetics Inc., is a leading personalized medicine company dedicated to being a trusted advisor transforming patient lives worldwide with pioneering molecular diagnostics. Myriad discovers and commercializes molecular diagnostic tests that: determine the risk of developing disease, accurately diagnose disease, assess the risk of disease progression, and guide treatment decisions across six major medical specialties where molecular diagnostics can significantly improve patient care and lower healthcare costs. Myriad is focused on three strategic imperatives: transitioning and expanding its hereditary cancer testing markets, diversifying its product portfolio through the introduction of new products and increasing the revenue contribution from international markets. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com.

Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice CDx, Vectra, Prequel, Foresight, GeneSight, riskScore and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. or its wholly owned subsidiaries in the United States and foreign countries. MYGN-F, MYGN-G.

Safe Harbor Statement This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to providing access to this important information for all women; and the Company’s strategic directives under the caption "About Myriad Genetics." These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: uncertainties associated with COVID-19, including its possible effects on our operations and the demand for our products and services; our ability to efficiently and flexibly manage our business amid uncertainties related to COVID-19; the risk that sales and profit margins of our molecular diagnostic tests and pharmaceutical and clinical services may decline; risks related to our ability to transition from our existing product portfolio to our new tests, including unexpected costs and delays; risks related to decisions or changes in governmental or private insurers’ reimbursement levels for our tests or our ability to obtain reimbursement for our new tests at comparable levels to our existing tests; risks related to increased competition and the development of new competing tests and services; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and pharmaceutical and clinical services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and pharmaceutical and clinical services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and pharmaceutical and clinical services and any future tests and services are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with operating our laboratory testing facilities and our healthcare clinic; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of the healthcare system or healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; risks related to our projections about our business, results of operations and financial condition; risks related to the potential market opportunity for our products and services; the risk that we or our licensors may be unable to protect or that third parties will infringe the proprietary technologies underlying our tests; the risk of patent-infringement claims or challenges to the validity of our patents or other intellectual property; risks related to changes in intellectual property laws covering our molecular diagnostic tests and pharmaceutical and clinical services and patents or enforcement in the United States and foreign countries, such as the Supreme Court decisions in Mayo Collab. Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012), Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), and Alice Corp. v. CLS Bank Int’l, 573 U.S. 208 (2014); risks of new, changing and competitive technologies and regulations in the United States and internationally; the risk that we may be unable to comply with financial operating covenants under our credit or lending agreements; the risk that we will be unable to pay, when due, amounts due under our credit or lending agreements; and other factors discussed under the heading "Risk Factors" contained in Item 1A of our most recent Annual Report on Form 10-K for the fiscal year ended June 30, 2019, which has been filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.

Graph 1

PRS Significantly Modifies Lifetime Breast Cancer Risk in Mutation Carriers

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Myriad Announces New Studies Validating the Ability of Myriad's riskScore Test to Modify Breast Cancer Risk Prediction | 2020-07-07 | Press Releases -...

STONY BROOK, N.Y.--(BUSINESS WIRE)-- Applied DNA Sciences Inc. (NASDAQ: APDN) (Applied DNA or the Company) a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing that enables in vitro diagnostics, and pre-clinical nucleic acid-based therapeutic drug candidates, today announced the formation of a wholly-owned subsidiary, Applied DNA Clinical Labs, LLC (ADCL), dedicated to the commercial development of its tests in Virology, for the detection of COVID-19, and in Oncology, for the detection and enumeration of invasive Circulating Tumor Cells (iCTCs). With the formation of ADCL, the Company is executing on a strategy to expand its market reach through value-added services complementary to a growing portfolio of diagnostic assays attractive to a broader number of qualified labs. ADCL allows Applied DNA to be a direct beneficiary of its own diagnostics development beyond the sales of kits to qualified laboratories, and provides the clinical sampling framework necessary to obtain the data required by State and Federal regulatory authorities to develop and improve diagnostics and vaccines in the face of a pandemic with rapidly shifting genetics and infectious behavior.

In mid-May, Applied DNA received Emergency Use Authorization (EUA) for a high sensitivity, high-throughput complex molecular test for SARS-CoV-2, the coronavirus that causes COVID-19. The Linea COVID-19 SARS-CoV-2 Assay Kit is a real-time polymerase chain reaction (RT-PCR) test for the qualitative detection of SARS-CoV-2 RNA in respiratory specimens. It provides a high-throughput solution to help laboratories address the urgent need for patient testing during the Coronavirus pandemic.

The Company also announced that the amendment of its EUA was approved by FDA to include extraction and concentration of the viral RNA by a magnetic method of nucleic acid extraction that lends itself easily to high throughput scaling with robotics and diversifies the two extraction methods already covered by the existing EUA. A series of EUA amendments are planned to introduce automation for increased throughput and accuracy, gain approval for additional RNA extraction methods and PCR devices to expand the footprint where our EUA assay can be used, develop point-of-care testing and simplify sample acquisition from patients.

Commenting on the amendment, Dr. James Hayward, president and CEO of Applied DNA, said, We are extremely grateful to our collaborators at Stony Brook University Hospital and to the FDA for their guidance during the development and validation of our Linea COVID-19 Assay Kit. Our goal is to service the COVID-19 patient community and their families, and to facilitate the reopening of universities and businesses with reliable, well-tested science. The demand for COVID testing is diverse, from asymptomatic patients and those in the early stages of disease, to the commercial imperative to operate.

The Company believes that as the demand for testing grows and diversifies, the existing approval of the Companys Linea COVID-19 Assay Kit for use with anterior nasal swabs will facilitate uptake by certified testing labs. As opposed to nasopharyngeal swabs, anterior nasal swabs only enter less than 1 inch into the nose, allowing for sampling with minimal irritation or discomfort. Additionally, anterior nasal swabs may be self-collected at a healthcare location or collected by a healthcare worker.

Dr. Hayward continued, With anterior nasal swabs, we believe patient compliance is not an issue. This is a simple approach to early testing, repetitive testing if begun early in infection, or high-frequency testing, such as in schools, universities, government office, and companies struggling with reopening. When combined with our high-sensitivity and high-throughput Linea COVID-19 Assay Kit, we believe the combined platform to be well suited to combat both the healthcare and economic challenges of the pandemic.

ADCL, the Companys new subsidiary was formed to enable clinical testing of patient specimens using methods developed by the Companys research teams. Access to clinical specimens will also facilitate more rapid development of improvements and new assays. All of these continuous improvements are designed to help drive sales to other approved testing labs.

ADCL was also formed to facilitate the use and development of the Companys Liquid Biopsy platform for detecting iCTCs in the blood of cancer patients, far simpler and safer than surgical or needle biopsies, and is already in use under contract in a Phase III clinical trial of a promising drug for the treatment of Stage IV pancreatic cancer. The trial involves 3,000 samples and the quantification of metastatic cancer cells in the blood. Dr. Hayward continued, Eventually, with the utility of ADCL, we plan to seek regulatory approval for our iCTC assay and add it to the tools used in modern oncology to ensure better patient outcomes.

The Company has obtained its Permanent Facility Identifier for ADCL, has hired a New York State Licensed Clinical Laboratory Director for Oncology and Virology and Certified Laboratory Scientists, and has applied for a license from the New York State Department of Health.

There can be no assurance that this license will be obtained, or that FDA will maintain the Emergency Declaration that enabled the EUA program for COVID-19 diagnostics. There can be no assurance that the Company will obtain approved 510K status (or other necessary regulatory approval) for its COVID-19 In Vitro Diagnostics in the event that the Emergency Declaration is lifted. In addition, the Companys iCTC assay is currently limited to RUO (Research Use Only), and there can be no assurance that the Company will obtain the necessary regularly approval for its iCTC assay to expand its use outside of RUO limitations.

About Applied DNA Sciences

Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, and pre-clinical nucleic acid-based therapeutic drug candidates.

Visit adnas.com for more information. Follow us on Twitter and LinkedIn. Join our mailing list.

The Companys common stock is listed on NASDAQ under ticker symbol APDN, and its publicly traded warrants are listed on OTC under ticker symbol APPDW. Applied DNA is a member of the Russell Microcap Index.

Forward-Looking Statements

The statements made by Applied DNA in this press release may be forward-looking in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNAs future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNAs assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNAs diagnostic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications or requests to U.S. FDA, equivalent foreign regulatory agencies or New York State Department of Health, the unknown limited duration of any Emergency Use Authorization (EUA) approval from U.S. FDA, disruptions in the supply of raw materials and supplies, and various other factors detailed from time to time in Applied DNAs SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly reports on Form 10-Q filed on February 6, 2020 and May 14, 2020, and other reports we file with the SEC, which are available at http://www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200709005245/en/

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Applied DNA Forms Clinical Testing Subsidiary to Maximize Utility of FDA EUA-Approved Linea COVID-19 Assay Kit and Expands Utility with Successful EUA...

SEATTLE, July 8, 2020 /PRNewswire/ --Seattle's AVM Biotechnology, an up-and-coming biotech firm whose lead molecule, AVM0703, has received FDA permission to begin clinical trials treating no-option Non-Hodgkin's Lymphoma and is applying to begin trials treating moderate-severely ill COVID-19 patients, announced today the hiring of Janet R. Rea, MSPH, as Chief Operating Officer. As COO, Rea will lead operations and direct regulatory affairs as the company conducts clinical trials and brings AVM0703 to market.

"I am delighted that Janet Rea will join our team at AVM Biotechnology as the Chief Operating Officer. Having worked with Janet during a pivotal time at Protein Sciences while pursuing Flublok FDA approval," said Dr. Manon Cox, AVM Biotechnology's Executive Board Member, "I know that her passion for quality and her tremendousexperience in the transition from development into commercialization is exactly what we need at this crucial time at AVM now that our lead product is moving into the clinic."

Janet R. Rea, MSPH, RAC, brings over 35 years of industry leadership experience in clinical development through commercialization in biologics and small molecules, with focus on oncology, infectious diseases, orphan and rare diseases. She obtained her B.S. in microbiology and M.S. in Public Health from the University of Washington. Her career in the healthcare industry began with then-American Hospital Supply Corporation (now Baxter), followed by Genetic Systems. Ms. Rea was an early employee of Seattle-based Immunex Corporation, where she played a key role in the company's first licensed product, Leukine. She held positions with increasing levels of responsibility with MDS Pharma and Targeted Genetics, as well as executive positions with AVI BioPharma (now Sarepta), Poniard Pharmaceuticals and Protein Sciences Corporation (acquired by Sanofi), and Therapeutic Proteins International. Most recently, she was SVP of Regulatory, Quality and Clinical Affairs at Atossa Therapeutics (Genetics) with focus on breast cancer and COVID-19 therapy development. She has also operated a consulting practice to both small and large organizations and has lectured at the University of Washington for the Biomedical Regulatory Affairs Certificate and Master's Program, where she also served as a parttime Assistant Clinical Professor for two years.Ms. Rea will serve as a non-voting member of AVM's Board of Directors.

"I am thrilled and honored to be joining AVM Biotechnology and look forward to working with this distinguished team to make new therapies available," Ms. Rea said. Named one of the "10 Best Biotech & Pharma Companies to Keep an Eye On in 2019" by Mirror Review, AVM Biotechnology was founded in 2008 by Dr. Theresa Deisher, Ph.D. With over 30 years of successful pharmaceutical research experience and holding over 47 patents, Dr. Deisher leads a team of scientists dedicated to changing the meaning of a diagnosis of cancer, autoimmunity, or chronic infectious disease for patients and their loved ones. In April 2020, AVM received FDA permission to begin clinical trials to test its lead molecule AVM0703 for treatment of relapsed/refractory lymphoid malignancies, and is filing for FDA approval to begin clinical trials in treating COVID-19 and influenza induced ARDS. AVM's passion is to deliver drugs that work rapidly and that are safe, effective, and affordable to treat serious worldwide illnesses such as cancer, autoimmunity, and life-altering infectious disease. AVM develops products that improve outcomes without additional suffering because side effects from treatments of cancers or infections should never be worse than the diseases themselves. The addition of Janet Rea to the AVM team, which includes a global group of experienced biotech advisors, makes AVM well positioned to bring AVM0703 to market in treating multiple conditions.

Contact Jena Dalpez Jdalpez@AVMBiotech.com

ALL INFORMATION CONTAINED HEREIN HAS BEEN PROVIDED BY THE COMPANY AND NO OTHER PARTY HAS INDEPENDENTLY VERIFIED ANY OF THE INFORMATION, INCLUDING THE FINANCIAL ESTIMATES AND PROJECTIONS CONTAINED HEREIN. SOME OF THE STATEMENTS IN THE MEMORANDUM ARE "FORWARD-LOOKING STATEMENTS." THESE FORWARD-LOOKING STATEMENTS INCLUDE, BUT ARE NOT LIMITED TO, STATEMENTS ABOUT THE COMPANY'S PLANS, OBJECTIVES, EXPECTATIONS AND INTENTIONS AND OTHER STATEMENTS CONTAINED IN THE MEMORANDUM THAT ARE NOT HISTORICAL FACTS. WHEN USED IN THIS MEMORANDUM, THE WORDS "ASSUMES," "ANTICIPATES," "BELIEVES," "CONTINUE," "COULD," "EXPECTS," "FORECASTS," "INTENDS," "MAY," "PLANS," "SEEKS," "SHOULD," OR "WILL" OR THE NEGATIVE OF THESE TERMS OR SIMILAR EXPRESSIONS ARE GENERALLY INTENDED TO IDENTIFY FORWARD-LOOKING STATEMENTS. BECAUSE THESE FORWARD-LOOKING STATEMENTS INVOLVE RISKS AND UNCERTAINTIES, THERE ARE IMPORTANT FACTORS THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED BY THESE FORWARD-LOOKING STATEMENTS, INCLUDING THE COMPANY'S PLANS, OBJECTIVES, EXPECTATIONS AND INTENTIONS AND OTHER FACTORS DISCUSSED UNDER "RISK FACTORS" SUCH STATEMENTS, ESTIMATES AND PROJECTIONS REFLECT VARIOUS ASSUMPTIONS OF THE COMPANY THAT MAY OR MAY NOT PROVE TO BE CORRECT. AND NO REPRESENTATION IS MADE AND NO ASSURANCE CAN BE GIVEN THAT THE COMPANY CAN OR WILL ATTAIN SUCH RESULTS.

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AVM Biotechnology Expands Executive Team in Preparation for Oncology & COVID-19 Clinical Trials, Appoints Janet R. Rea, MSPH, Chief Operating...

Biotechnologys game-changing role as a catalyst to reboot the economy and build a more sustainable future will be the focus of a summit co-hosted by The University of Manchester.

The panel debate and live Q&A is entitled Biotechnology: The Catalyst for a Sustainable Future and will feature leading experts from the prestigious Manchester Institute of Biotechnology who will be joined by national policy-makers and influencers.

The virtual event will be held on Wednesday, July 15, 3-4pm and the discussion will coincide with a special Spotlight supplement focusing on the UKs world-leading biotechnology capability to be published in the latest edition of the New Statesman. Hosted in partnership with the magazine the expert panel will be made up of:

George Freeman, MP, and former Minister of Life Sciences

Professor Rob Field, Director of the Manchester Institute of Biotechnology

Yvonne Armitage Chair of the External Advisory Board for Future Biomanufacturing Research

Professor Lionel Clarke OBE, Co-Chair of the UK Engineering Biology Leadership Council

Industrial Biotechnology (IB) is the term that describes the application of natures catalysts ie enzymes and other biological systems to sustainably produce chemicals, materials and energy says Professor Rob Field, Director of the Manchester Institute of Biotechnology (MIB).

Using the latest developments in biotechnology, and by collaborating with industry, it will be possible to produce medicines, plastics and fuels that are not are not sourced from carbon-generating fossil fuels.

Themes that will be put under the spotlight at the live streamed debate will include the potential capability of biotechnology to meet the global grand challenges and how might the COVID-19 crisis act as a catalyst to accelerate the adoption of biotechnology by society.

Sustainable development is one of the biggest challenges facing society and industry today as we look to meet todays energy, food and manufacturing needs without exhausting the Earths resources, explained Professor Field.

Biotechnology could provide the catalyst for revolutionary change and help us build a better more sustainable future.

COVID-19 has shown science at its best agile yet focused, collaborative while competitive. We can learn from the experience to develop a more resilient and sustainable world. Biotechnology has a large part to play in supporting a clean growth recovery.

Our panel discussion and the special edition of the New Statesmans Spotlight which supports this talk will reveal just of how biotechnology could help support a sustainable re-booting of the economy.

Register to tune in to this online event at 3pm on Wednesday, July 15, and receive joining information closer to the date. Spaces are available on a first come, first serve basis. Registration details here: https://www.newstatesman.com/2020/06/new-statesman-and-mib-webinar-biotechnology-catalyst-sustainable-future

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Could biotechnology be the vital catalyst to deliver a green economic recovery? (Study) - Tdnews

NEWPORT BEACH, Calif.--(BUSINESS WIRE)--ROTH Capital Partners (ROTH), http://www.roth.com, a full service investment bank focused on serving emerging growth companies and their investors, today announced that Dr. Elemer Piros has rejoined the firms healthcare research team, as Managing Director, Senior Research Analyst covering biotechnology. His research coverage is expected to include SMID cap Biotechnology companies across the therapeutic space, with an initial focus on companies developing novel drugs for CNS, hematology, ophthalmology and liver indications.

Prior to joining ROTH, Dr. Piros was a senior biotechnology analyst at Cantor Fitzgerald and ROTH between 2015 and 2019. Previously, Dr. Piros was the interim CEO of eMMUNITY, Inc, an immunotherapy startup company. Prior to the position at eMMUNITY, he was a publishing senior biotechnology analyst at Rodman & Renshaw and Burrill Securities, covering 80 total companies at various points of time, including companies developing products for CNS disorders, inflammation and the diagnosis and treatment of cancer.

Dr. Piros was a buyside biotechnology analyst at Spear, Leeds & Kellogg, a wholly owned subsidiary of Goldman Sachs. From 1990 to 2000, he conducted academic research in the field of neuroscience, focusing on understanding the molecular mechanism of communication in the nervous system.

Dr. Piros was ranked as the #1 Biotechnology analyst by the Wall Street Journal in 2006 and by the Financial Times in 2010, both based on stock portfolio performance.

Jeff Martin, CFA - Director of Research, commented, ROTH continues to invest in biotechnology research talent to enhance the strength of our Healthcare platform. Im pleased to welcome back Elemer to our thought-leading biotechnology research team. His strong academic background combined with his biotechnology industry experience will undoubtedly serve our clients well.

Dr. Piros commented, I am delighted to rejoin ROTH, a highly regarded investment bank with a strong track record in healthcare. I am very impressed by the quality and depth of the ROTH research portfolio. My goal is to provide a significant contribution by analyzing companies with cutting-edge medical research and translating science and clinical findings to actionable investment recommendations.

We are excited to have Elemer back on our healthcare research team, said Byron Roth, CEO of ROTH. His addition further demonstrates our unwavering commitment to the life sciences sector. Im confident that Elemers expertise in biotechnology will enhance our ability to continue to build upon our over 10-year track record of success in assisting both companies and investors in the healthcare sector.

About Roth Capital Partners, LLC:

ROTH Capital Partners, LLC (ROTH), is a relationship-driven investment bank focused on serving emerging growth companies and their investors. As a full-service investment bank, ROTH provides capital raising, M&A advisory, analytical research, trading, market-making services and corporate access.

Headquartered in Newport Beach, Calif., ROTH is privately-held and owned by its employees, and maintains offices throughout the U.S. For more information on ROTH, please visit http://www.roth.com.

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ROTH Capital Partners Announces the Addition of Elemer Piros, Ph.D. to its Healthcare Research Team - Business Wire

New Jersey, United States,- Verified Market Research sheds light on the market scope, potential, and performance perspective of the Nanoparticles in Biotechnology and Pharmaceuticals Market by carrying out an extensive market analysis. Pivotal market aspects like market trends, the shift in customer preferences, fluctuating consumption, cost volatility, the product range available in the market, growth rate, drivers and constraints, financial standing, and challenges existing in the market are comprehensively evaluated to deduce their impact on the growth of the market in the coming years. The report also gives an industry-wide competitive analysis, highlighting the different market segments, individual market share of leading players, and the contemporary market scenario and the most vital elements to study while assessing the Nanoparticles in Biotechnology and Pharmaceuticals market.

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Leading Nanoparticles in Biotechnology and Pharmaceuticals manufacturers/companies operating at both regional and global levels:

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The Nanoparticles in Biotechnology and Pharmaceuticals market report is extensively categorized into different product types and applications. The study has a separate section for explaining the cost of raw material and the revenue returns that are gained by the players of the market.

The segmentation included in the report is beneficial for readers to capitalize on the selection of appropriate segments for the Nanoparticles in Biotechnology and Pharmaceuticals sector and can help companies in deciphering the optimum business move to reach their desired business goals.

In Market Segmentation by Types of Nanoparticles in Biotechnology and Pharmaceuticals, the report covers-

Bytype1

In Market Segmentation by Applications of the Nanoparticles in Biotechnology and Pharmaceuticals, the report covers the following uses-

Byapplication1

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The Nanoparticles in Biotechnology and Pharmaceuticals market report provides successfully marked contemplated policy changes, favorable circumstances, industry news, developments, and trends. This information can help readers fortify their market position. It packs various parts of information gathered from secondary sources, including press releases, web, magazines, and journals as numbers, tables, pie-charts, and graphs. The information is verified and validated through primary interviews and questionnaires. The data on growth and trends focuses on new technologies, market capacities, raw materials, CAPEX cycle, and the dynamic structure of the Nanoparticles in Biotechnology and Pharmaceuticals market.

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Sales Forecast:

The report contains historical revenue and volume that backing information about the market capacity, and it helps to evaluate conjecture numbers for key areas in the Nanoparticles in Biotechnology and Pharmaceuticals market. Additionally, it includes a share of each segment of the Nanoparticles in Biotechnology and Pharmaceuticals market, giving methodical information about types and applications of the market.

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In the end, the Nanoparticles in Biotechnology and Pharmaceuticals market is analyzed for revenue, sales, price, and gross margin. These points are examined for companies, types, applications, and regions.

To summarize, the Nanoparticles in Biotechnology and Pharmaceuticals market report studies the contemporary market to forecast the growth prospects, challenges, opportunities, risks, threats, and the trends observed in the market that can either propel or curtail the growth rate of the industry. The market factors impacting the global sector also include provincial trade policies, international trade disputes, entry barriers, and other regulatory restrictions.

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Nanoparticles in Biotechnology and Pharmaceuticals Market Growth By Manufacturers, Countries, Types And Application, End Users And Forecast To 2026 -...

Akero Therapeutics Inc (AKRO) is around the top of the Biotechnology industry according to InvestorsObserver. AKRO received an overall rating of 69, which means that it scores higher than 69 percent of all stocks. Akero Therapeutics Inc also achieved a score of 78 in the Biotechnology industry, putting it above 78 percent of Biotechnology stocks. Biotechnology is ranked 11 out of the 148 industries.

Finding the best stocks can be tricky. It isnt easy to compare companies across industries. Even companies that have relatively similar businesses can be tricky to compare sometimes. InvestorsObservers tools allow a top-down approach that lets you pick a metric, find the top sector and industry and then find the top stocks in that sector.

These scores are not only easy to understand, but it is easy to compare stocks to each other. You can find the best stock in an industry, or look for the sector that has the highest average score. The overall score is a combination of technical and fundamental factors that serves as a good starting point when analyzing a stock. Traders and investors with different goals may have different goals and will want to consider other factors than just the headline number before making any investment decisions.

Akero Therapeutics Inc (AKRO) stock is trading at $37.79 as of 10:20 AM on Wednesday, Jul 8, a rise of $0.73, or 1.97% from the previous closing price of $37.06. The stock has traded between $37.61 and $41.00 so far today. Volume today is above average. So far 607,617 shares have traded compared to average volume of 380,338 shares.

To screen for more stocks like AKRO click here.

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Is Akero Therapeutics Inc (AKRO) Stock Near the Top of the Biotechnology Industry? - InvestorsObserver