StemCell Therapy

The research report on Genomic Biomarker market, covering the COVID-19 impact, provides a comparative analysis of the historical data with the current market scenario to unveil the growth projections for the industry over the analysis period. As per the study, the market is expected to garner substantial returns and showcase a healthy growth rate throughout the forecast duration.

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A gist of the regional analysis of the Genomic Biomarker market:

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The report follows a comprehensive and rigorous research methodology to provide you accurate estimates and forecasts of a particular market. The report provides estimates, forecast, and analysis primarily based on secondary research, primary interviews, in-house database and other free as well as paid sources. Besides, the research methodology we follow is a systematic approach to estimate and project the market sizing keeping in mind all the ongoing and upcoming trends of the market.

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Genomic Biomarker Market Report, History and Forecast 2015-2025, Breakdown Data by Manufacturers, Key Regions, Types and Application - CueReport

Zinc Market report is to provide accurate and strategic analysis of the Profile Projectors industry. The report closely examines each segment and its sub-segment futures before looking at the 360-degree view of the market mentioned above. Market forecasts will provide deep insight into industry parameters by accessing growth, consumption, upcoming market trends and various price fluctuations.

Zinc Market competition by top manufacturers as follow: , Korea Zinc Group, Nyrstar, Hindustan, Glencore Xstrata, Nexa Resources, Boliden, Shaanxi Nonferrous Metals, Teck, China Minmetals Corp, Noranda Income Fund, Rotometals, Minera Shouxin Peru, Compania Minera Milpo, Zincore Metals, Deutenberg, HATTLER & Sohn GmbH, U.S. Zinc, Ney Metals?Alloys, Chelyabinsk Electrolytic Zinc Plant, EKMEKCIOGULLARI, Accurate Perforating, AirMetals Inc, Clark Perforating, Fairview Architectural, RotoMetals, Umicore Technical Materials, Aldon Corporation, Eljen Technology, All-Chemie, Rheinzink

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This has brought along several changes in This report also covers the impact of COVID-19 on the global market.

Global Zinc Market research reports growth rates and market value based on market dynamics, growth factors. Complete knowledge is based on the latest innovations in the industry, opportunities and trends. In addition to SWOT analysis by key suppliers, the report contains a comprehensive market analysis and major players landscape.The Type Coverage in the Market are: Pure ZincZinc AlloyOthers

Market Segment by Applications, covers:ShipCarBridgeOther

Market segment by Regions/Countries, this report coversNorth AmericaEuropeChinaRest of Asia PacificCentral & South AmericaMiddle East & Africa

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Global Impact of Covid-19 on Zinc Market to Witness Promising Growth Opportunities During 20202026 with Top Leading Players Hindustan, Glencore...

The ' Genomic Biomarker market' study now available with Market Study Report, LLC, delivers a concise outlook of the powerful trends driving market growth. This report also includes valuable information pertaining to market share, market size, revenue forecasts, regional landscape and SWOT analysis of the industry. The report further elucidates the competitive backdrop of key players in the market as well as their product portfolio and business strategies.

The Genomic Biomarker market report offers a thorough evaluation of this industry space and comprises of insights pertaining to the market tendencies including current remuneration, revenue predictions, market size and market valuation during the analysis timeframe.

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This study specially analyses the impact of Covid-19 outbreak on the Genomic Biomarker , covering the supply chain analysis, impact assessment to the Genomic Biomarker market size growth rate in several scenarios, and the measures to be undertaken by Genomic Biomarker companies in response to the COVID-19 epidemic.

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A summary of the Genomic Biomarker market as perthe product type and application scope:

Product landscape:

Product types:

Oncology, Cardiology, Neurology and Nephrology

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Application Spectrum:

Application segmentation:

Hospitals and Diagnostic and research laboratories

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Vendor base of Genomic Biomarker market:

The major players covered in Genomic Biomarker are:, Bio-Rad, Almac, Thermo Fisher Scientific, Beckman Coulter, Epigenomics, Myriad Genetics, Human Longevity, QIAGEN, Roche, Pfizer, Agilent, ValiRx, Illumina, Empire Genomics, Personalis and Eagle Genomics

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Genomic Biomarker Market Size, Share, Application Analysis, Regional Outlook, Growth Trends, Key Players, Competitive Strategies and Forecasts to 2025...

Faculty from the Wayne State University School of Medicine and Wayne State University Law School have teamed to publish a paper this month on legal and ethical issues associated with community detection of COVID-19 through wastewatermonitoring.

Professor of Physiology Jeffrey Ram, Ph.D., and Associate Professor of Law Lance Gable, Ph.D., along with Dr. Rams daughter, University of Maryland Professor of Law Natalie Ram, co-wrote Legal and Ethical Implications of Wastewater SARS-CoV-2 Monitoring for COVID-19 Surveillance, now available in the Journal for Law and Biosciences.

The paper, already a popular download, is listed on the Social Science Research Networks Top Ten download list in several categories.

Dr. Ram also is director of the Wayne State University Belle Isle Aquarium Field Research Laboratory.

Scientists have observed that molecular markers for COVID-19 can be detected in wastewater during an outbreak and, in some cases, before the first case is confirmed, they wrote. The U.S. Centers for Disease Control and Prevention, and other government entities, are considering whether to add community surveillance through wastewater monitoring to assist in tracking disease prevalence and guiding public health responses to the pandemic.

This scientific breakthrough may lead to many useful potential applications for tracking disease, intensifying testing, initiating social distancing or quarantines, and even lifting restrictions once a cessation of infection is detected and confirmed. Yet, new technologies developed in response to a public health crisis may raise difficult legal and ethical questions about how such technologies may impact both the public health and civil liberties of the population, the authors wrote. Even if reliability and efficacy are established, limits on sample and data collection, use and sharing, must also be considered to prevent undermining privacy and autonomy in order to implement these public health strategies consistent with legal and ethical considerations.

The article describes recent scientific evidence regarding COVID-19 detection in wastewater, identifying public health benefits that may result from this breakthrough, and limitations of existing data. It also assesses the legal and ethical implications of implementing policy based on positive sewage signals.

The topic of wastewater epidemiology of COVID-19 is a very new and extremely active one, Dr. Ram said. We (at Wayne State) have assembled a team that includes microbiologists, an epidemiologist, a law professor, medical students, collaborators outside of Wayne State and more.We have support from Healthy Urban Waters.

Healthy Urban Waters is a collaboration of WSU researchers networked with the community to focus on water in an urban setting and future impacts of human culture on community, the ecosystem and economic health.

Dr. Ram and Dr. Gable were invited to present at a new community interaction forum organized with COVID-313 by the WSU Office of theProvosts Social and Behavioral Determinants of Health Steering Committee. They plan additional projects together.

Natalie Ram writes about the legal and ethical uses surrounding various biotechnologies, including the use of DNA by the police. Her decision to pursue the philosophical side of science, including ethics and law, was partly inspired by her Wayne State connections.She was part of a summer science program for girls organized by Wayne State Professor Alvin Saperstein at Wayne State, and while a college student at Princeton she conducted molecular research one summer on pre-implantation genetic diagnosis at WSUs Center for Molecular Medicine and Genetics.

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Wayne Medicine and Wayne Law professors team up to explore legal and ethical issues of wastewater monitoring for COVID-19 - The South End

More than 25,000 people have volunteered so far to be infected with the novel coronavirus through 1DaySooner, an online recruitment organization, as an aid in testing vaccine candidates to prevent Covid-19. These volunteers know that Covid-19 can cause suffering and even death yet they are stepping forward, willing to risk their lives, because some researchers and academics contend that such experiments in humans could accelerate vaccine development.

As a physician and a scientist who has cared for patients and who has been involved in the development of vaccines, I feel the urgency to get a vaccine approved for global use. And I have deep admiration for the courageous volunteers who are willing to put themselves in danger.

In this situation, however, their sacrifice cannot be justified. Volunteers need to be protected from both known and unknown risks. The effort to develop a vaccine should not be jeopardized by this well-intentioned but unnecessary experiment.

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In the context of an ongoing pandemic, the conventional pace of vaccine development frustrates the public, the government, public health experts, vaccine creators, regulators, and others. It is understandable that many are seeking ways to accelerate the demonstration of safety and efficacy of vaccine candidates. The mumps vaccine, considered the fastest vaccine ever developed, took scientists four years to go from collecting viral samples to securing FDA approval in 1967. A decade or longer is more typical. Everyone is hoping that inventing, testing, obtaining approval and producing a Covid-19 vaccine might be on track to set a new record.

The practice of deliberately infecting people with disease, termed human challenge trials, has a long history. It is embedded in the origin of the very first vaccine in 1796, when Edward Jenner, an English physician, purposely infected his gardeners 8-year-old son with cowpox after observing that people previously infected with cowpox, a relatively mild disease, seemed protected from smallpox, one of the deadliest scourges of the time.

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Now, in the midst of the coronavirus pandemic, human challenge studies are being considered again.

In the June 1 issue of the Journal of Infectious Diseases, Nir Eyal, Marc Lipsitch, and Peter G. Smith argue that this approach could accelerate the development and approval of a Covid-19 vaccine by many months. That may sound tempting, but human challenge studies with live virus are unlikely to save time. Moreover, there are ethical and practical reasons for not undertaking human challenge studies with this virus. These authors, like 1DaySooners volunteers, are well-intentioned but wrong.

Those in favor of human challenge trials propose enrolling as subjects only healthy young adults, since the Covid-19 mortality rate in this group is low. Just 7% of all Covid-19-related deaths in the U.S. have occurred among those aged 25 to 54 years, compared to 80% in those over age 65. Yet the example of fatal infections in health care workers in the prime of life makes clear that even healthy non-elderly adults may succumb to the novel coronavirus.

Human challenge studies are generally contemplated only when rescue with a lifesaving treatment or intervention is available should a vaccine candidate not protect a volunteer from the disease. But there is no cure or treatment against the SARS-CoV-2 virus that can be deployed with confidence, making viral challenge particularly risky and ethically questionable.

Most people, likely including most of the volunteers, tend to think of vaccines as fully effective: They either work or dont. This belief generally stems from the success of vaccines for childhood diseases like measles and mumps. But some vaccines, especially those for adults, are much less effective: There are seasons when the flu vaccine is only 70% to 80% effective, or sometimes even less. Imagine, for a moment, that a vaccine candidate undergoing testing turns out to generate immunity in 80% of those who receive it. Then 20% will become infected with Covid-19.

An equally disturbing scenario is what if one of the first volunteers dies, either due to the play of chance, a problem with the vaccine, or the individuals genetic makeup? This is unlikely to happen but it can, and did, in another setting with consequences that stretched far beyond the single tragic death.

In 1999, Jesse Gelsinger volunteered for one of the first gene therapy trials. The 18-year-old had a rare metabolic genetic disorder, but his condition was managed with medication; he was basically healthy. He volunteered for a safety trial of a virus-based gene-therapy and died as a result. Missteps in the trial, and the subsequent controversy surrounding his death, set the field of gene therapy back by at least two decades. That hiatus deprived a generation of patients with genetic disorders of treatments.

With vaccines already a target of widespread misinformation campaigns, the death of a single volunteer would likely cause even greater damage. From a public health perspective, it would be especially disastrous if it both slowed the race to develop a coronavirus vaccine and fueled the anti-vaccination movement.

There are other ethical considerations. An important principle in human challenge studies is that subjects must give their informed consent in order to take part. That means they should be provided with all the relevant information about the risk they are considering. But that is impossible for such a new disease.

Covid-19 was initially thought to be mainly a respiratory ailment. We now know that it can damage the kidneys, circulatory system, and the heart. It was initially believed that children could not be sickened by SARS-CoV-2, but it now appears that dozens have developed a severe inflammatory syndrome. And we know nothing about potential long-term complications of Covid-19 because the disease has only been in humans for months. Taken together, this means that no volunteer is able to give true informed consent.

Given these risks, there might still be some justification for a human challenge trial if we knew for certain it would accelerate the development of an effective vaccine. But safer trials can get us to a vaccine in the same amount of time without taking on additional risk for volunteers, especially now that some vaccine candidates already have entered Phase 2 clinical trials and several others are close behind.

In a conventional trial, subjects are injected with either the experimental vaccine or placebo. They are then monitored to see if those who got the vaccine are less likely to contract the disease while going about their daily lives. In a human challenge study, things can theoretically happen more quickly, since volunteers are deliberately infected after getting the trial vaccine or placebo.

But human challenge trials take time, too. For Covid-19, subjects would likely have to receive two doses of vaccine (spaced by weeks), wait for potential immunity to develop, then be infected with the live virus and observed for weeks to months. Since the challenge trial would need to start small and be expanded only with great caution because of the risks involved, it would take months to deliver sufficient data. Safety data, in particular, would be lacking, even though this is one of the biggest issues confronting a new vaccine, because the size of the trial would be too small to garner robust safety data and data about adverse effects of the vaccine would be confounded by the administration of the live virus.

There is no short cut for determining safety.

A large-scale, conventional study could likely be conducted just as quickly. In addition, monitoring and interim analyses of conventional trials raise the possibility of some kind of conditional or emergency use approval while the trials continue. If that happened, a vaccine might be available for certain high-risk or vulnerable groups in record time, namely 12 to 18 months from laboratory to clinic.

A final issue is that the results of the proposed human challenge studies come exclusively from the experience of younger adults, and cannot be extrapolated to the elderly, who tend to have weaker immune responses and the highest Covid-19 mortality rate. The volunteers might end up having risked their own health without truly helping those who are in greatest need of vaccine protection.

The world is overwhelmed by the pandemic. It is imperative to expedite development and approval pathways without forgoing safety and effectiveness. Ascertaining the risks intrinsic to the disease versus those of a new vaccine in specific populations health care workers, first responders, the elderly, those with comorbidities, and the like is essential. But acceleration should not mean forsaking ethical concerns, putting well-intentioned volunteers at needless risk, or setting back global vaccine efforts.

Michael Rosenblatt, M.D., is the chief medical officer of Flagship Pioneering, a venture firm that creates life sciences companies. He is the former chief medical officer of Merck and former dean of Tufts University School of Medicine. He serves as an adviser to Moderna, which is developing a Covid-19 vaccine; he is not a Moderna employee or shareholder. The opinions expressed are his own and do not necessarily reflect those of Flagship Pioneering or Moderna.

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Challenge trials aren't the answer to a speedy Covid-19 vaccine - STAT

The same day Oxford Biomedica signed a 5-year deal to make AstraZenecas Covid-19 vaccine, the UK gene therapy company announced they received word Sanofi was sending a couple of decade-old experimental drugs back to them.

In 2009, Sanofi and Biomedica slashed a co-development deal on TroVax, a cancer vaccine that had been one of the centerpieces of the then 14-year-old company. But the pair immediately replaced it with a deal, 8 years before the approval of Spark Therapeutics Luxturna, to develop gene therapies for two eye-related disorders.

Now, with little to show for it but a pair of very early studies, Sanofi is kicking the therapies back to Biomedica. The French drugmaker had already announced last year, amid an internal shakeup, that they were not interested in developing the drugs further, but what would happen to the therapies hung in the air.

In some ways, it still does. Biomedica wouldnt commit to progressing or retiring them. It wasnt even clear when Biomedica would regain the rights.

The timing of return of these programs and operational details are yet to be determined, the biotech said in a statement. However, when the rights to the two programs are returned, the group will undertake its own internal evaluation to determine the potential future for these programs and decide whether to commit further resources to them.

Biomedicas $100 million partnership with Sanofis rare blood disorder subsidiary Bioverativremains intact.

The two gene therapies are SAR422459, for treating a progressive macular disease called Stargardt disease, and SAR421869, for treating Ushers Syndrome, a disorder that can cause both vision and hearing loss. The Stargardt therapy began a Phase I/II study in France in 2011, but the study was ended prematurely last August after Sanofi reprioritized its pipeline. Although the study was designed to measure biological markers of efficacy, Sanofi included no such data when it posted results on clinicaltrials.gov earlier this year.

The therapy for Ushers Syndrome entered its Phase I/II study in 2012. That study was suspended in 2017 while Sanofi reviewed its pipeline and then also terminated last year.

If Biomedica considers the therapies to still have potential, its likely they will try to out-license them again. The company is built around partnerships, licensing out a few in-house candidates and helping manufacture Novartiss CAR-T therapy Kymriah and, as of yesterday, AstraZenecas Covid-19 vaccine. They areexplicitly not a commercial-stage biotech.All of the preclinical candidates on its website are listed as to be spun out, or out-licensed, and they run no clinical trials.

So the best question may be not whether Biomedica sees potential, but if anyone else does.

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Sanofi sends a pair of gene therapies back to Oxford Biomedica. Are they salvageable? - Endpoints News

The Personalized Gene Therapy Treatment Market Research Report 2020 published by Prophecy Market Insights is an all-inclusive business research study on the current state of the industry which analyzes innovative strategies for business growth and describes significant factors such as top developers/manufacturers, production value, key regions, and growth rate. Impact of Covid-19 pandemic on the market will be completely analyzed in this report and it will also quantify the impact of this pandemic on the market.

The research study encompasses an evaluation of the market, including growth rate, current scenario, and volume inflation prospects, based on DROT and Porters Five Forces analyses. The market study pitches light on the various factors that are projected to impact the overall market dynamics of the Personalized Gene Therapy Treatment market over the forecast period (2019-2029).

Regional Overview:

The survey report includes a vast investigation of the geographical scene of the Personalized Gene Therapy Treatment market, which is manifestly arranged into the localities. The report provides an analysis of regional market players operating in the specific market and outcomes related to the target market for more than 20 countries.

Australia, New Zealand, Rest of Asia-Pacific

The facts and data are represented in the Personalized Gene Therapy Treatment report using graphs, pie charts, tables, figures and graphical representations helping analyze worldwide key trends & statistics on the state of the industry and is a valuable source of guidance and direction for companies and individuals interested in the market.

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The research report also focuses on global major leading industry players of Personalized Gene Therapy Treatment market report providing information such as company profiles, product picture and specification, R&D developments, distribution & production capacity, distribution channels, price, cost, revenue and contact information. The research report examines, legal policies, and competitive analysis between the leading and emerging and upcoming market trends.

Personalized Gene Therapy TreatmentMarket Key Companies:

Amgen, Inc., Chengdu Shi Endor Biological Engineering Technology Co., Ltd., SynerGene Therapeutics, Inc., Cold Genesys, Inc., Bellicum Pharmaceuticals, Inc., Takara Bio, Inc.,Ziopharm Oncology, Inc., , Sevion Therapeutics, Inc., OncoSec Medical, Inc., and Burzynski Clinic.

The predictions mentioned in the Personalized Gene Therapy Treatment market report have been derived using proven research techniques, assumptions and methodologies. This market report states the overview, historical data along with size, share, growth, demand, and revenue of the global industry.

Segmentation Overview:

The report provides an in-depth analysis of the Personalized Gene Therapy Treatment market segments and highlights the latest trending segment and major innovations in the market. In addition to this, it states the impact of these segments on the growth of the market. Apart from key players analysis provoking business-related decisions that are usually backed by prevalent market conditions, we also do substantial analysis of market based on COVID-19 impact, detailed analysis on economic, health and financial structure.

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DUBLIN, June 26, 2020 /PRNewswire/ -- The "Non-Viral Transfection Reagents and Systems Market, 2020-2030" report has been added to ResearchAndMarkets.com's offering.

Over the last few years, the exponential growth in the pipeline of nucleic acid based therapies has led to the escalating interest of pharmaceutical industry in this domain. Presently, more than 2,000 trials evaluating different types of gene therapies are underway. Moreover, according to experts at the US FDA, around 40 new gene therapies are likely to be approved by 2022. In this context, it is worth highlighting that viral vectors are a crucial element in gene therapy development and manufacturing. Although, viral vectors have shown significant success in R&D, their applications are limited due to immunogenicity and toxicity related concerns, high development costs and the limitation on amount of genomic material that they can carry. Excessively high price tags associated with viral-based therapies, such as Zolgensma (USD 2.1 million) and Luxtruna (USD 850,000), have led to several reimbursement challenges, thereby decreasing patient access. Owing to the aforementioned concerns related to viral vectors, therapy developers are evaluating a variety of non-viral methods of gene delivery.

In the present scenario, non-viral transfection systems are not yet widely used in therapy development and clinical studies, primarily due to their relatively low efficiency compared to viruses. The applications of these methods are largely restricted to fundamental research, including protein and gene expression, and cell line development. However, there are a number of companies that have developed proprietary technologies and products to facilitate physical (electroporation, gene gun, microinjection and sonoporation), chemical (transfection reagents) and other non-viral methods of transfection (transposon based systems, piggyBac and magnetofection). We believe that, as the demand for advanced therapy medicinal products, which require genetic engineering, the opportunity for non-viral transfection system developers is also likely to grow.

The Non-Viral Transfection Reagents and Systems Market, 2020-2030' report features an extensive study of the various systems and technologies available for non-viral transfection, in addition to the current market landscape and future potential of product developers.

Amongst other elements, the report features:

In order to account for future uncertainties and to add robustness to the model, three forecast scenarios have been provided, portraying the conservative, base and optimistic tracks of the market's evolution. The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in this domain.

In addition, the report features detailed transcripts of interviews held with the following individuals:

A selection of companies mentioned includes:

For more information about this report visit https://www.researchandmarkets.com/r/e2ipme

About ResearchAndMarkets.comResearchAndMarkets.com is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.

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Reblozyl regulates late-stage red blood cell (RBC) maturation to potentially reduce or eliminate the need for regular RBC transfusions

Reblozyl is the first and only erythroid maturation agent to be approved in the European Union, representing a new class of therapy

PRINCETON, NJ & CAMBRIDGE, MA, USA I June 26, 2020 IBristol Myers Squibb (NYSE: BMY) and Acceleron Pharma Inc. (NASDAQ: XLRN) today announced that the European Commission (EC) has approved Reblozyl (luspatercept) for the treatment of:

"Dependence on blood transfusions caused by anemia in hematologic malignancies like MDS can often mean frequent and lengthy hospital visits, which can pose additional health risks and affect patients quality of life, said Uwe Platzbecker, M.D., lead investigator of the MEDALIST study, Head of Clinic and Policlinic for Hematology and Cell Therapy, Leipzig University Hospital. Todays approval of Reblozyl provides healthcare professionals with a new therapy that has been shown to significantly reduce the number of red blood cell transfusions needed by MDS patients and, in some cases, helped them to achieve transfusion independence.

While beta thalassemia remains an orphan disease, the lifelong blood transfusions often needed by patients can have a significant impact on the limited blood supply in their communities, and there are few treatment alternatives, said Maria Domenica Cappellini, M.D., lead investigator of the BELIEVE study, Professor of Medicine, University of Milan, Fondazione IRCCS Ca Granda. The European Commissions approval of Reblozyl provides eligible adult patients with beta thalassemia a new, much needed treatment option for their anemia, and with it, the possibility of becoming less dependent on red blood cell transfusions.

Reblozyl is the first and only erythroid maturation agent approved in the European Union, representing a new class of therapy for eligible patients. This approval is based on data from the pivotal Phase 3 MEDALIST and BELIEVE studies, evaluating the ability of Reblozyl to effectively address anemia associated with MDS and beta thalassemia, respectively.

Across the EU, 25 million blood transfusions occur every year, some of which are needed by patients with anemia due to hematologic diseases like MDS and beta thalassemia, said Diane McDowell, M.D., vice president, Hematology Global Medical Affairs, Bristol Myers Squibb. Reblozyl has the potential to address the ineffective erythropoiesis associated with MDS and beta thalassemia, decrease patients dependence on red blood cell transfusions and impact the underlying consequences of the high burden of anemia for these patients. Alongside our partners at Acceleron, we recognize the continuing need in disease-related anemias and are committed to working collaboratively with European health authorities to make Reblozyl available to these patients as quickly as possible.

About MEDALIST

MEDALIST is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study evaluating the safety and efficacy of Reblozyl plus best supportive care (BSC) versus placebo plus BSC in adults with IPSS-R-defined very low-, low- or intermediate-risk non-del(5q) MDS. All patients were RBC transfusion-dependent and were either refractory or intolerant to prior erythropoiesis stimulating agent (ESA) therapy, or were ESA nave and unlikely to respond due to endogenous serum erythropoietin levels of 200 U/L, and had no prior treatment with disease modifying agents.

The trial showed a statistically significant improvement in RBC transfusion burden with Reblozyl, the studys primary endpoint, with 37.9% of patients treated with Reblozyl achieving independence from RBC transfusions for at least eight weeks during the first 24 weeks of the trial compared to 13.2% of patients on placebo. The trial also met the secondary endpoint of transfusion independence for at least 12 weeks within the first 24 and 48 weeks of the study, which was achieved in a significantly greater proportion of patients receiving Reblozyl versus placebo.

The majority of treatment-emergent adverse events (TEAEs) were Grade 1-2. Grade 3 or 4 TEAEs were reported in 42.5% of patients who received Reblozyl and 44.7% of patients who received placebo. Discontinuation due to an adverse reaction (Grades 1-4) occurred in 4.5% of patients who received Reblozyl. The most common (>10%) all-grade adverse reactions included fatigue, musculoskeletal pain, dizziness, diarrhea, nausea, hypersensitivity reactions, hypertension, headache, upper respiratory tract infection, bronchitis and urinary tract infection.

Results of the MEDALIST trial were first presented during the Plenary Session of the American Society of Hematology (ASH) Annual Meeting in December 2018 (ASH Abstract #001) and were selected for the Best of ASH. The New England Journal of Medicine published the MEDALIST trial results in January 2020.

About MDS

MDS are a group of hematologic malignancies characterized by ineffective production of healthy red blood cells, white blood cells and platelets, which can lead to anemia and frequent or severe infections, and can progress to Acute Myeloid Leukemia (AML). People with MDS who develop anemia often require regular blood transfusions to increase the number of healthy red blood cells in circulation. Frequent transfusions are associated with an increased risk of transfusion reactions, infections and iron overload. There are approximately 50,000 patients with MDS in the EU5 countries (France, Germany, Italy, Spain and the United Kingdom).

About BELIEVE

BELIEVE is a Phase 3, randomized, double-blind, placebo-controlled multi-center study comparing Reblozyl plus BSC versus placebo plus BSC in adults who require regular RBC transfusions (6-20 RBC units per 24 weeks with no transfusion-free period greater than 35 days during that period) due to beta thalassemia.

The trial showed a statistically significant improvement in RBC transfusion burden during weeks 13 to 24 compared to the baseline 12-week interval prior to randomization (21.4% Reblozyl versus 4.5% placebo), meeting the studys primary endpoint. The trial also met the secondary endpoint of transfusion burden reduction of at least 33% (with a reduction of at least two units) during weeks 37 to 48, which was achieved in a significantly greater proportion of patients receiving Reblozyl versus placebo. The trial also met an exploratory endpoint, with 70.5% of patients treated with Reblozyl achieving at least a 33% reduction in RBC transfusion burden of at least two units for any 12 consecutive weeks compared to the 12-week interval prior to treatment, compared to 29.5% of patients on placebo.

The majority of TEAEs were Grade 1-2. Discontinuation due to an adverse reaction (Grades 1-4) occurred in 5.4% of patients who received Reblozyl. The most common adverse reactions (>10%) were headache, bone pain, arthralgia, fatigue, cough, abdominal pain, diarrhea and dizziness.

Results of the BELIEVE trial were first presented at the ASH Annual Meeting in December 2018 and selected for the Best of ASH. The New England Journal of Medicine published the BELIEVE trial results in March 2020.

About Beta Thalassemia

Beta thalassemia is an inherited blood disorder caused by a genetic defect in hemoglobin. The disease is associated with ineffective erythropoiesis, which results in the production of fewer and less healthy RBCs, often leading to severe anemiaa condition that can be debilitating and can lead to other complications for patientsas well as other serious health issues. Treatment options for anemia associated with beta thalassemia are limited, consisting mainly of frequent RBC transfusions that have the potential to contribute to iron overload, which can cause serious complications such as organ damage. Across the United States, Germany, France, Italy, Spain and the United Kingdom, there are approximately 17,000 patients with beta thalassemia.

About Reblozyl

Reblozyl (luspatercept-aamt), a first-in-class erythroid maturation agent, promotes late-stage red blood cell maturation in animal models. Bristol Myers Squibb and Acceleron are jointly developing Reblozyl as part of a global collaboration. Reblozyl is currently approved in the U.S. for the treatment of:

Reblozyl is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.

Bristol Myers Squibb: Advancing Cancer Research

At Bristol Myers Squibb, patients are at the center of everything we do. The goal of our cancer research is to increase patients quality of life, long-term survival and make cure a possibility. We harness our deep scientific experience, cutting-edge technologies and discovery platforms to discover, develop and deliver novel treatments for patients.

Building upon our transformative work and legacy in hematology and Immuno-Oncology that has changed survival expectations for many cancers, our researchers are advancing a deep and diverse pipeline across multiple modalities. In the field of immune cell therapy, this includes registrational chimeric antigen receptor (CAR) T-cell agents for numerous diseases, and a growing early-stage pipeline that expands cell and gene therapy targets, and technologies. We are developing cancer treatments directed at key biological pathways using our protein homeostasis platform, a research capability that has been the basis of our approved therapies for multiple myeloma and several promising compounds in early to mid-stage development. Our scientists are targeting different immune system pathways to address interactions between tumors, the microenvironment and the immune system to further expand upon the progress we have made and help more patients respond to treatment. Combining these approaches is key to delivering potential new options for the treatment of cancer and addressing the growing issue of resistance to immunotherapy. We source innovation internally, and in collaboration with academia, government, advocacy groups and biotechnology companies, to help make the promise of transformational medicines a reality for patients.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

About Acceleron

Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron's leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair.

Acceleron focuses its commercialization, research, and development efforts in hematologic and pulmonary diseases. In hematology, Acceleron and its global collaboration partner, Bristol Myers Squibb, are co-promoting REBLOZYL (luspatercept-aamt), the first and only approved erythroid maturation agent, in the United States for the treatment of anemia in certain blood disorders. The Companies are also developing luspatercept for the treatment of chronic anemia in patient populations of MDS, beta-thalassemia, and myelofibrosis. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension, having recently reported positive topline results of the Phase 2 PULSAR trial.

For more information, please visit http://www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.

SOURCE: Bristol-Myers Squibb

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European Commission Approves Reblozyl (luspatercept) for the Treatment of Transfusion-Dependent Anemia in Adult Patients with Myelodysplastic...

In the race to produce a coronavirus vaccine, some companies are experimenting with a novel approach using gene therapy. The faster, cheaper method could trigger peoples bodies to produce their own antibodies against the virus more quickly than a traditional vaccine would.

The new techniquestill in the early stages of researchinvolves taking antibodies from the blood of someone who has survived COVID-19 and isolating their genetic material. Doctors would then inject the DNA into the arm or leg of a patient, where it would provide instructions for the muscle to produce more antibodies to fight the virus. The gene therapy technique could provide immunity or lessen the severity of the disease in those already infected.

Doctors could enhance the treatment with a gene gun. The device delivers an electric shock that causes the muscle cells to pop open for an instant, increasing absorption of the injected DNA. The procedure could, within just hours, turn the muscle into an antibody-producing factory, according to SmartPharm, one of the companies working on the treatment.

You can make DNA very readily, its dirt cheap, and you let the muscle make the antibody, Sorrento Therapeutics CEO Henry Ji, who is working with SmartPharm, told MIT Technology Review.

Traditional vaccines depend on the recipients immune system to mount a protective response against the virus. But it takes several weeks for a body to generate an immune response strong enough to provide protection. Some peoples bodies cant do it at all, particularly the elderly and others at high risk for COVID-19. With the new treatment, the muscles could produce protective levels of the antibody within a day or two. The antibody production could last weeks, or even months, regardless of the strength of the patients immune system.

Vaccines usually only work if given before someone contracts the disease. But the gene therapy can neutralize the virus even in an active infection.

Scientists have not yet tested this method of preventing and treating COVID-19 in humans. But David Weiner, director of the vaccine and immunotherapy center at the Wistar Institute in Philadelphia, told MIT Technology Review his center has tested anti-COVID-19 gene injections on animals. Last year, researchers at AbCellera in Vancouver, Canada, developed a gene shot that allowed mice to survive a dose of avian influenza 20 times the lethal amount.

DNA injections might also prove useful as an inexpensive way to treat cancer and arthritis, Weiner said. Even if scientists cannot develop the technique in time to prevent or treat COVID-19, the research could enable a quick solution to the next pandemic.

In the future, we will have gone through the drill, Ji said. Youll just snap your gene in.

Link:
A different kind of shot in the arm against COVID-19 - WORLD News Group

Ultrasound abnormalities are widespread in patients with rheumatoid arthritis (RA) who are in clinical remission, with no significant association with clinical parameters in remission, according to study results published in Therapeutic Advances in Musculoskeletal Disease.

The study cohort included patients with an established diagnosis of RA who were enrolled in the Biomarkers of Remission in Rheumatoid Arthritis study, which evaluated disease-modifying antirheumatic drug (DMARD) cessation. Patients included this analysis were in clinical remission (Disease Activity Score 28 C-reactive protein [DAS28-CRP], <2.4) and receiving synthetic DMARDs at time of study entry. Patients from the Newcastle Early Arthritis Clinic who were DMARD-naive and undergoing clinical and ultrasonographic evaluation at first presentation with early active RA (DAS28-CRP >2.4) were included in the positive control group and those with seronegative noninflammatory arthralgia (NIA) were included in the negative control group.

Investigators examined the association between clinical parameters and total ultrasound scores with individual dependent variables, which included synovial power Doppler and greyscale, tenosynovial greyscale, and erosions.

Of 294 patients included in the study, 66 with RA were in clinical remission, 146 with early active RA were in the positive control group, and 82 were in the NIA negative control group. Synovial greyscale was common in patients in RA remission and occurred both in patients who did and did not meet the clinical remission criteria irrespective of whether it was the DAS28-CRP <2.4 (n=66) or the American College of Rheumatology/European League Against Rheumatism Boolean criteria (n=40). Other ultrasound abnormalities that occurred frequently included tenosynovial greyscale, erosions, and synovial power Doppler.

There was a significant association between swollen joint count and higher total synovial greyscale score (odds ratio [OR], 1.17; 95% CI, 1.08-1.26; P <.001) in the active RA group. In addition, the investigators observed a significant association between swollen joint count and higher total synovial power Doppler score (OR, 1.20; 95% CI, 1.12-1.30; P <.001). In the NIA group, there were no significant associations between swollen joint count and total synovial greyscale score or synovial power Doppler score. In the RA remission group, there were 6 significant variable-score associations (P <.05) in an adjusted model, but these associations were not significant in the adjusted analysis. In addition, there were no significant associations between the total synovial power Doppler score and clinical parameters in this group.

Study limitations included the reliance on a 7-point scan protocol, the small sample size, and the inclusion of only patients with established disease in the remission group.

Researchers concluded that ultrasound and clinical examination findings do not overlap in RA remission, challenging the proposition of ultrasound-driven management strategies in this setting.

Reference

Baker KF, Thompson B, Lendrem DW, Scadeng A, Pratt AG, Isaacs JD. Lack of association between clinical and ultrasound measures of disease activity in rheumatoid arthritis remission [published online May 11, 2020]. Ther Adv Musculoskelet Dis. doi:10.1177/1759720X20915322

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No Association Between Clinical and Ultrasound Measures of Disease Activity in RA Remission - Rheumatology Advisor

In the early part of the 2014 season, Jason Day missed six weeks with a thumb injury, which he aggravated at that years Masters tournament.

Getty Images

Arnold Palmer is famous for, among other things, his iconic thumbs up to adoring galleries. (Sorry, Phil.) I was lucky enough to call Arnold a good friend; in 2006, we launched the Arnold Palmer Sports Health Center. He had an abiding interest in keeping people healthy and participating in the game he loved.

The thumb is remarkable, and we ask much of it. Gripping a golf club throughout the swing means positioning the thumb at multiple points in space, and that demands great flexibility. This flexibility is provided by two hinge joints and the very agile basilar joint where the thumb plugs into your wrist plus great strength and stability.

This balancing act can create a problem that manifests as friction at the basilar jointaka arthritis. Almost all golfers will eventually get a little degenerative wear and tear arthritis at the thumb joint. Ive operated on several PGA Tour Champions players, but most of us will have milder cases treatable by conservative measures.

Symptoms: Pain and modest swelling at the thumbs base is common; more advanced cases may lead to a decrease in motion. Your hand may feel weakened as discomfort can lead to protecting the thumb from tasks (e.g., opening jars) in which grip power is necessary and potentially painful.

Self-Care: There is a wide range of nonsurgical managementsice, heat, splints and judicious use of over-the-counter anti-inflammatories. Any splint used should include the thumb to help support the basilar joint.

Doctor Visit: A diagnosis will likely entail the doctor loading the thumbs basilar joint and briefly grinding it you may feel the discomfort and mechanical symptoms that accompany joint irregularity. An X-ray can help establish matters definitively. As for treatment beyond splinting and activity modification, a steroid shot can bring temporary relief. As a last resort, a reliable surgery can be performed that allows you to participate in most activities without restriction including golf. Thumbs up to that!

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Heres how to deal with one of the most dreaded injuries in golf - Golf.com

Dual-energy computed tomography (DECT) appears to have limited utility for differentiating between gout and calcium pyrophosphate deposition disease (CPPD), according to a German prospective cohort study. Findings were reported at the annual European Congress of Rheumatology, held online this year because of COVID-19.

Dr Valentin S. Schfer

"Differentiation of gout and pseudogout, or CPPD, is sometimes difficult," said presenting investigator Valentin S. Schfer, MD, associate professor of internal medicine and head of the department of rheumatology and clinical immunology at University Hospital Bonn (Germany).

"Arthrocentesis and subsequent polarization microscopy remains the gold standard," he noted. "Novel diagnostic approaches, such as DECT, have recently been validated for gout, but limited data [are] available on the use of DECT in patients with CPPD."

The investigators studied 30 patients: 22 with suspected gout and 8 with suspected CPPD. All underwent arthrocentesis with subsequent polarization microscopy for definitive diagnosis, plus clinical examination, ultrasound examination, conventional radiography, DECT, and assessment of 12 laboratory parameters.

For diagnosis of gout, DECT had a sensitivity and specificity of 59.1% and 100%, respectively, Dr. Schfer reported, noting that this sensitivity falls considerably short of the 90% previously reported for gout (Figure 1).

Figure 1: Gout tophus formation (curved arrow) shown on 80-kV DECT with color-coded overlay showing monosodium urate crystals in green and calcium in blue, as well as articular and juxta-articular osseous erosions (straight arrow).

Corresponding sensitivity and specificity were 90.9% and 75% for ultrasound, 58.8% and 100% for conventional radiography, and 81.8% and 87.5% for the rheumatologists' suspected clinical diagnosis.

For diagnosis of CPPD, DECT had sensitivity of 37.5% and specificity of 81.8%. Corresponding values were 87.5% and 91% for ultrasound, 0% and 94.1% for conventional radiography, and 75.0% and 100% for suspected clinical diagnosis (Figure 2).

None of the 12 laboratory parameters studied uric acid, C-reactive protein, organic phosphate, and leukocytes, among others significantly differentiated between conditions.

Figure 2: DECT image with color-coded overlay shows typical findings of CPPD along the medial and lateral menisci (arrow) and calcium in tissues where it's not usually found (e.g., hyaline cartilage).

"Both ultrasound and suspected clinical diagnosis had higher sensitivities than DECT for gout and CPPD," Dr. Schfer concluded. "Further studies with larger patient cohorts and perhaps modified scan protocols are needed in order to determine the diagnostic utility of DECT in CPPD."

"Noninvasive, accurate methods for distinguishing between gout and CPPD will improve clinical care," Sara K. Tedeschi, MD, MPH, predicted in an interview.

"Arthrocentesis is painful in an acutely inflamed joint, can be difficult to perform on small joints, and is underutilized in clinical practice," she elaborated. And ultrasound is operator dependent and does not quantify crystal volume in and around the joint.

The question addressed by the study is therefore clinically relevant, according to Dr. Tedeschi, a rheumatologist at Brigham and Women's Hospital and assistant professor of medicine at Harvard Medical School, Boston.

However, among the patients with CPPD, the study did not report specific phenotypes (acute inflammatory arthritis, chronic inflammatory arthritis, and osteoarthritis with calcium pyrophosphate deposits), she noted. "It is difficult to draw conclusions about the sensitivity or specificity of DECT for CPPD without this information, especially among just 8 CPPD patients."

In addition, among the patients with gout, the proportion having new-onset disease with flare duration less than 6 weeks and the proportion with tophi were unknown, both of which affected DECT sensitivity in the previous study that reported 90% sensitivity. "Based on the 95% confidence interval in the present study, it is possible that with a larger sample size, DECT sensitivity for gout would have been higher," she pointed out. "We also do not know the DECT software settings, which impact DECT interpretation as positive or negative for the crystal of interest."

Finally, "it would be relevant to know what joints were aspirated and imaged in each group," Dr. Tedeschi said. "For example, if the first metatarsophalangeal (MTP) joint was aspirated and imaged for half of the gout patients but for none of the CPPD patients, that may affect the study interpretation."

The study did not receive any specific funding. Dr. Schfer disclosed a variety of financial relationships with multiple pharmaceutical companies. Dr. Tedeschi disclosed receiving grant support from the National Institutes of Health to study imaging modalities for CPPD, and being first author on a study comparing the sensitivity of DECT, ultrasound, and x-ray for acute CPP crystal arthritis.

Ann Rheum Dis. 2020;79:196. Abstract

This article originally appeared on MDedge.

For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.

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DECT Has Mixed Performance in Differentiating Gout vs CPPD - Medscape

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At first no one believed the mom from Lyme. Polly Murray moved with her family to the Connecticut River town in the late 1950s and within a few years began experiencing mysterious symptoms. There were rashes, migraines, recurring fevers, and severe joint pain including a swollen knee. Over the years her children and even the family dog had similar ailments. Doctors believed it was all in her head, and she agreed to a psychiatrists suggestion to obtain three weeks of inpatient treatment.

By 1975 her two sons were diagnosed with juvenile rheumatoid arthritis, but neighbors had children with similar ailments, and Murray, who died last year, didnt believe the occurrences of this rare condition in children were a coincidence. Murray and another mother reached out to the state Health Department and the Yale School of Medicine.

A few months earlier, a 33-year-old doctor named Allen Steere had started a fellowship in rheumatology at Yale School of Medicine. Steere had spent the previous two years investigating disease outbreaks as an epidemic intelligence officer with the Centers for Disease Control in Atlanta. State officials thought he would be the ideal person to investigate these cases. Steere asked Dr. Stephen Malawista, who headed the rheumatology program at the Yale School of Medicine, for permission to start.

He said, Fine, why dont you take six months and see what you can do? Its now 45 years later, and I and lots of other people are still working on this, Steere says.

Steere, now a professor of medicine at Harvard Medical School and director of translational research in rheumatology at Massachusetts General Hospital, began contacting parents who had children with joint pain, particularly knee pain. Consulting with school nurses in Lyme and surrounding communities, Steere identified 39 children and 12 adults with this unexplained rheumatoid arthritis in Lyme,as well as neighboring Old Lyme and East Haddam. It was clear that they had inflammatory arthritis, he says, but the condition was occurring far too frequently in the area, particularly in children. If you had one child in that Lyme, Connecticut, area that had inflammatory arthritis, maybe thats what youd expect, but not 39. Moreover, there was clustering within certain areas. There were a couple of roads where 1 in 10 children had this type of inflammatory arthritis.

It was apparent that this was something different than had been seen before and described in the medical literature, and we began to call it Lyme arthritis, Steere adds.

Through contact tracing, Steere learned that most cases had occurred in the summer and early fall, and there was no evidence of person-to-person spread. Twenty-five percent of the patients remembered having a strange skin lesion shortly before they developed symptoms. Around the same time, Steere learned from a Danish dermatology resident at Yale that a similar skin lesion called erythema migrans had been known in Europe for years and was caused by a tick bite.

Residents told Steere that as recently as the 1960s there were no ticks, but that the area had been inundated with them by the 1970s. This was due to massive swaths of farmland being converted back to forests, which supported tick and wildlife habitats. By 1976 Steere and his fellow researchers put forth the belief that ticks were responsible for spreading the infection. In 1981 a researcher at the Rocky Mountain Biological Laboratory named Willy Burgdorfer identified the bacteria that causes Lyme. Meanwhile, Steere helped to research early antibiotic treatments for the disease.

Though Lyme emerged from the wilds in Connecticut in and around the 1970s, it was not a new disease, Steere says. There are descriptions of what sounds like Lyme disease in writings from the 1600s and confirmed cases of the disease found in preserved specimens in New England and Europe from the 1800s. The 2010 autopsy of tzi the Iceman, a 5,300-year-old frozen mummy found in the Eastern Alps in the 1990s, revealed he had Lyme disease.

Despite this historical evidence of the condition, conspiracy theories as to its origins are rampant. The most prominent holds that it was a biological warfare agent developed at Plum Island Animal Disease Center, a federal island research facility dedicated to the study of animal diseases 8 miles off the Connecticut coast. Between 1952 and 1954, the island also served as the headquarters for the Army Chemical Corps. The corps hoped to study biological weapons, but according to credible accounts, never truly pursued its work on the island. In addition, Lyme-like conditions were never studied at the island, and there would be records if they were, as the work that takes place on the island is not classified. In addition, tick specimens from 1945 from the South Fork of Long Island were also found to contain the disease, several years before the island facility opened in the 1950s.

Back in the 1970s, Steere says, I knew nothing about Plum Island and nobody thought that Plum Island had anything to do with this. He adds that it wasnt until many years later that he first started hearing conspiracy theories linking Lyme disease to Plum Island.

Jane Marsh, a lifelong Old Lyme resident, recalls her father being one of the first adults to get the disease. Marsh later got the disease, as did everyone in her family. We did not suspect that anything came floating across from there to Old Lyme, she says. She got wind of the conspiracy theory later and, though she never bought into it, Marsh says she knows people in the area who believe it.

The theory has also stretched beyond Connecticut. Last year New Jersey Rep. Chris Smith called for an investigation into whether the Department of Defense experimented with ticks and other insects to deliver biological weapons between 1950 and 1970.

Plum Island isnt the only controversy associated with Lyme disease. Chronic Lyme is a condition many patients believe they have but which the Centers for Disease Control does not recognize, and which Steere has said is overdiagnosed.

Lyme disease is a complex infection, there are no two ways about it, Steere says. Its an illness that without treatment can occur in stages with different manifestations at each stage. People can have neurologic involvement, they can have cardiac involvement, they can have arthritis. But it does not cause everything. There are advocacy groups that have grown up that attribute a much wider spectrum of illness to Lyme disease than is the case in mainstream medicine.

Read more here:
Lyme disease emerged in Connecticut in the 1970s ... then the conspiracy theories started - Connecticut Magazine

COVID-19 remains a mystery in many ways, but as it continues to rampage through the worlds population, some things are becoming more clear. One of them is that cytokine storms a deranged immune response to the virus, in which the body literally attacks its own cells instead of the invading coronavirus appear to be one reason some patients end up extremely ill.

A drug developed in St. Louis aims to combat those cytokine storms. Called ATI-450, it was originally developed by Confluence Discovery Technologies in 2013 with the idea of helping people suffering from autoimmune diseases, particularly rheumatoid arthritis.

But as scientists began to understand the way COVID-19 affects the body, the company realized it could potentially help with the new coronavirus as well.

Were actually in a Phase 2 rheumatoid arthritis study, explained Joe Monahan, Confluence Discovery Technologies executive vice president of research and development, on St. Louis on the Air. That started earlier in the year. But when we saw what was happening with COVID back in January or February, and we started to think about the possibility of both COVID being driven by the cytokine storm in the lung, and [rheumatoid arthritis] being driven by a similar storm of cytokines regulated in the joint, we thought maybe we could do some quick studies in the laboratory to validate that ATI-450 may have an impact on these cytokines in the lung, and in particular things driven by the SARS CoV-2.

Added Monahan, It was the right place at the right time.

And so even as most businesses around St. Louis closed their offices and moved to remote work this spring, Confluence doubled down. With staggered shifts and seven-day workweeks, researchers in its headquarters at Cortexs BioSTL building were able to show strong enough results in the lab to receive FDA approval to begin human trials.

Those are to begin in two weeks at the University of Kansas Medical Center, Monahan said. Thirty-six patients will be given the drug in a double-blind, placebo-controlled study.

The company hopes to show that, by blocking the pathways used to make cytokines, ATI-450 stops the cytokine storms that can be so damaging. Explained Monahan, In so doing, we believe that we would reduce the [acute respiratory distress syndrome] observed in these patients, and reduce the need for mechanical ventilation, decrease the hospital stay, and reduce the mortality.

Listen:

Normally, good results in such a study would mean another three to six years before bringing a drug to market. But Monahan has hopes for a speedier process for ATI-450 when it comes to COVID-19.

If this works really well [against] the disease, and we expand it to more people and it continues to work, I think theres an ability to really shorten those timelines, he said.

Confluence was acquired by Pennsylvania-based Aclaris Therapeutics in 2017, but its researchers remain based in St. Louis. Monahan helped to co-found the company as part of BioSTL after spending 28 years at Pfizer and its legacy companies. The pharmaceutical giant was moving a unit to the Boston area, and rather than relocate, Monahan and some colleagues decided to stay in St. Louis and go out on their own.

We had maybe some different ideas on how to do drug discoveries that we had not been able to do at Pfizer, he said.

St. Louis on the Air brings you the stories of St. Louis and the people who live, work and create in our region. The show is hosted by Sarah Fenske and produced by Alex Heuer, Emily Woodbury, Evie Hemphill, and Lara Hamdan. The audio engineer is Aaron Doerr.

Send questions and comments about this story to feedback@stlpublicradio.org.

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COVID-19 Treatment Developed In St. Louis To Begin Human Trials - St. Louis Public Radio

Technology may typically be thought of in termsof computers and communications but its use inthe sphere of biotechnology is saving lives andchanging how we treat diseases. While investingin this area has obvious appeal from a social andmoral perspective, it can also be a highly lucrativespace as a growth investment in a portfolio.

Biotechnology is a sub-industry of the healthcaresector, which is typically divided into two spheres:

Biotechnology specifically refers to technologiesthat use biological processes, capturing companies that focus on research, development, manufacturing and/or marketing of products based onbiological and genetic information. The differenttypes of biotechnology include biological drugs,vaccines, immunotherapy, gene therapy, orphandrugs and genetic engineering.

While it may sound like a newer industry, biotechnology has a long rich history the creation ofpenicillin is in fact a form of biotechnology. Thecontinued improvements in technology over timehave also benefitted the biotechnology industry,enhancing the ability to access and use biologicalprocesses which we may not have even beenaware existed in the past. For example, DNAsequencing has revolutionised our ability to diagnose certain health concerns in individuals.Genome editing is a newer technology which maytransform how we treat or cure genetic diseases.

Demand is only likely to continue, not just on thebasis of the permanent need for treatments andvaccines for existing and yet to be identifieddiseases, but also because of the ability toimprove the way in which we treat. Imagine aworld where any illness you have can be treatedwith a drug specifically designed to work withyour genes and therefore minimise negativeside-effects and reduce recovery time? This is afuture that biotechnology is working towards.

It is no secret that biotechnology has experiencedextraordinary growth in recent times. Even in Australia, the fact that CSL Limited toppled Commonwealth Bank and BHP this year to become thelargest company by market capitalisation is anindication of the growing importance and value ofbiotechnology (1).

Biotechnology is predicted to be valued at morethan US$729bn by 2025, compared to US$295bntoday (2), and will continue to grow, driven by thegrowing global population and the need for affordable, effective treatments and vaccines to supporttreatment in the population.

Biotechnology will also be a beneficiary of population ageing, particularly in Western countries. Thereason for this is that an increase in the volume ofolder citizens is likely to have an accompanyingand proportional increase in the volume of age-related diseases such as cardiovascular disease,dementia or arthritis, all needing treatment (3).

Gilead is one example of a company with prospects in this space. Gilead is already well-knownfor its highly effective HIV treatments but is alsotargeting US and European approvals to market a drug called Filgotinib to treat rheumatoidarthritis (4).

In a demonstration of the growth in this industry,this year alone, 30-35 biotechnology companiesare anticipated to go public, raising approximatelyUS$3.5bn (5)

The COVID-19 pandemic may assist in accelerating the growth in biotechnology. Biotechnologycompanies have been at the forefront in seekingvaccines and cures for COVID-19. There arecurrently 11 potential COVID-19 vaccines in clinical evaluation (that is, undergoing testing) and afurther 128 in pre-clinical evaluation (6). Moderna isan example of a major biotechnology companyrunning clinical testing currently. It was the firstcompany to start human trials and anticipatesentering phase 3 trials with 30,000 participants byJuly (7).

The healthcare sector as a whole is likely to seegreater investment as a result of the COVID-19pandemic. For example, national health spendinggrowth in the US is expected to average 5.4%annually through 2028, reaching US$6tr a year (8).Biotechnology will also be a beneficiary of thisincreased investment.

Australian investors tend to have a concentrateddomestic exposure to biotechnology given thedominance of players such as CSL, Cochlear orResMed but may be missing the growth and diversification offered overseas. The US in particular ispositioned as the global centre of biotechnology.

The US biotechnology industry is valued at113.3bn (9), approximately 14x the size of the Australian biotechnology industry (10).

The reason for the US dominance in this field isdue in part to the world-renowned US Food & DrugAdministration (FDA) approval process and alsoto the size of its customer base.

Any companies seeking access to distribute theirproducts in the US market need to submit to FDAevaluation and in turn, many companies havesought to base themselves there for easieraccess to the process and for easier distributionand marketing to US consumers.

Australian investors can consider the US biotechnology industry as a diversification measure,along with exposure to a high growth segmentinternationally.

Biotechnology can be a high-risk industry, withhigh costs for drug development and high chances of failure. The rewards for successful trials canalso be immense.

To put this in perspective, in any given year, 54% ofclinical phase 3 trials typically fail for a range ofreasons (11), with average costs for developing adrug estimated at more than US2.1bn (12). The trialsand approval process can take years, often 10years or more, with less than 12% reachingapproved status with the FDA (13).

Biotech and healthcare companies then deriverevenue from approved products using patents,which last approximately 20 years from the dateof application (but also require maintenance feesand in some cases, can be extended) (14). Thismeans generic, cheaper versions from competitors cannot be sold in this period, allowing a company an effective monopoly over a particular formof treatment in that time. Of course, once thispatent expires, competitors can enter, so companies will continue research, development and testing on a permanent basis in the hope of findingthe next major treatment they can generaterevenue from.

Another source of return for this industry is from ahigh rate of merger and acquisition activity. Smaller and mid-size biotechnology companies areoften targets for larger firms, wanting to expandwith complementary capabilities they might notpreviously have had. Its a mutually beneficial relationship, providing smaller and mid-size companies with the capital they need to finance development and testing.

Mergers and acquisitions for biotechnology wasvalued at US$23bn in 2019 (15). Pre-COVID-19,activity was tipped to step up in activity for 2020,with oncology, cardiovascular/metabolic disease, immunology, infectious disease and centralnervous system disorders anticipated to benefit (16).

Investment and value from biotechnology isexpected to grow in coming years. While the trendalready existed due to continuous tech improvements and the needs of a growing population, theCOVID-19 pandemic has created a new spotlighton this area which may accelerate its growth.

While Australian investors are likely to already beexposed to this growth segment in the concentrated domestic market, they may be missingexposure to the US, which dominates the globalmarket for biotechnology.

There are a range of ways to access the biotechnology industry.Investors could consider direct shares in biotechnology companies or alternatively consider managed funds. Direct shares can be a high-riskapproach due to the high failure rates of drug testing and long periods of development (i.e., longperiods where there may be no or a limited returnon investment). Theres also the element ofchance has the investor picked the winner? Itcould take years to know.

Managed investments, be it an actively managedfund or passive options like ETFs, can assist inmanaging the risks by spreading it across a largernumber of companies. Investors could choose toinvest by taking a sector approach and investingin a fund focusing on broader healthcare, or lookat industry-specific options focusing on biotechnology. ETFS S&P Biotech ETF (ASX:CURE)is one such example that offers broad exposure toUS biotechnology.

ETFS S&P Biotech ETF (ASX:CURE),offers investors exposure to US biotechnology companies engaged in research, development, manufacturing and/or marketing of products based on genetic analysis and genetic engineering.

For more information on investing in biotechnology please hit the 'CONTACT' button below.

Footnotes

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Investing in the vaccines of tomorrow: the case for biotechnology - Livewire Markets

What happened

The stocks of several biotechs focused on developing treatments and vaccines for COVID-19 jumped on Wednesday. Shares of Dynavax Technologies (NASDAQ:DVAX) were up 4% as of 3:13 p.m. EDT today after rising as much as 10.1% earlier in the day. Novavax (NASDAQ:NVAX) was up 13.4%, and shares of Vir Biotechnology (NASDAQ:VIR) were soaring 16.8% higher.

None of these companies reported news today. But the overall stock market fell on concerns about the increased number of COVID-19 cases in the U.S. This bad news translated to good news for Dynavax, Novavax, and Vir as investors scooped up shares of the key players in the fight against the coronavirus.

Image source: Getty Images.

Buying coronavirus-focused biotech stocks just because the pandemic appears to be worsening isn't a great idea without assessing the overall prospects for each individual stock. The dynamics are quite different for Dynavax, Novavax, and Vir.

Dynavax is the only one of the three to already have an approved product of any kind on the market. Its hepatitis B vaccine Heplisav-B generated $10.5 million in sales in the first quarter. The CpG 1018 adjuvant used in Heplisav-B is also being used in four COVID-19 vaccines, including ones developed by Chinese drugmakers Clover Biopharmaceuticals and Sinovac Biotech.

Novavax appears to be on track to win its first Food and Drug Administration approval, though. The company reported positive results in March from a late-stage study of flu vaccine NanoFlu. The vaccine could potentially generate peak sales in the ballpark of $1.7 billion if approved, according to one analyst's estimate. Novavax also has a promising COVID-19 vaccine in development that's in a phase 1/2 clinical trial.

Meanwhile, Vir Biotechnology has three clinical programs. The company thinks that its lead candidate, VIR-2218, which is being developed in collaboration with Alnylam Pharmaceuticals, holds the potential to be a functional cure for hepatitis B in combination with other therapies. Vir is also evaluating three COVID-19 therapies in pre-clinical testing.

Higher numbers of COVID-19 cases don't necessarily translate to greater prospects for any of these companies. But headlines about the pandemic definitely drive higher interest in their stocks.

The main thing to watch with each of these biotechs is their pipeline progress. For Dynavax, investors will also want to keep their eyes on sales of Heplisav-B in the coming quarters. Novavax expects to report initial results from its COVID-19 vaccine study in July. Vir plans to advance its VIR-7831 and VIR-7832 antibody therapies for COVID-19 directly into phase 2 testing this summer pending FDA review.

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Why Dynavax, Novavax, and Vir Biotechnology Stocks Jumped Today - The Motley Fool

NEW DELHI: Keeping in view the Covid-19 situation, Regional Centre for Biotechnology (RCB), Faridabad has postponed the Graduate Aptitude Test 2020 which was scheduled for June 30.

The Department of Biotechnology, Ministry of Science and Technology has also postponed the Biotechnology Eligibility Test 2020 which was also scheduled on June 30.

The new dates of the GAT-B 2020 and BET-2020 exam will be announced soon. The admit card of GAT-B 2020 was released on June 25. However, the admit card link has been removed now. The admit card of GAT-B 2020 will be released again.

The All India level entrance examination of GAT-B 2020 is conducted for admission to DBT- supported postgraduate programmes in all the participating institutions.

Biotechnology Eligibility Test is conducted to award the DBT-Junior Research Fellowship for pursuing research in biotechnology and life sciences.

Write to us at news@careers360.com

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GAT-B 2020 and BET 2020 postponed, new dates to be announced soon - Careers360

Expanding number of life science and research-based associations worldwide has accounted high number of innovative work exercises, this has added to the developing interest for catalysts and reagents. Increasing utilization of these proteins and reagents in biotechnology and pharmaceutical organizations and scholarly foundations have brought about an expansion sought after for better than ever items, which will additionally add to this current markets development. Additionally, government activities in biotechnology industry will support the request from this market, subsequently this will add to the development sought after for atomic science catalysts, units and reagents. Some of the real driving variables for the development of this market incorporate expanding innovative work exercises in biotechnology research and medication disclosure, rising number of uses for these proteins and reagents and expanding interest for as good as ever chemicals and reagents.

The Molecular Biology Enzymes and Kits & Reagents Market is expected to exceed more than US$ 17.0 Billion by 2024 at a CAGR of 17% in given forecast period.

Browse Full Report: https://www.marketresearchengine.com/molecular-biology-enzymes-and-kits-and-reagents-market

The report covers detailed competitive outlook including the market share and company profiles of the key participants operating in the global market. Key players profiled in the report include Inc. (U.S.), Merck KGaA (Germany), New England Bio labs, Thermo Fisher Scientific, Inc. (U.S.), Promega Corporation (U.S.), Becton, Dickinson and Company (U.S.), Agilent Technologies, Inc. (U.S.), Illumina, Inc. (U.S.), QIAGEN N.V. (Netherlands), F. Hoffmann-La Roche Ltd. (Switzerland), and Takara Bio, Inc. (Japan).Company profile includes assign such as company summary, financial summary, business strategy and planning, SWOT analysis and current developments.

The global molecular biology enzymes and kits & reagents market is segmented on the basis of key regions, namely, North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa. Furthermore, each region is segmented to provide market revenue for select countries such as the U.S., Canada, the U.K., Germany, China, Japan, India, Brazil, and GCC countries. The report includes a detailed study of the global and regional molecular biology enzymes and kits & reagents market and analyzes the variations in the growth of the industry in certain regions.

The scope of the report includes a detailed study of global and regional markets onMolecular Biology Enzymes and Kits & Reagents Marketwith the reasons given for variations in the growth of the industry in certain regions.

The restraining factors of Molecular Biology Enzymes and Kits & Reagents Market are as follows:

The major driving factors of Molecular Biology Enzymes and Kits & Reagents Market are as follows:

The Molecular Biology Enzymes and Kits & Reagents Market has been segmented as below: (Accordingly)

The Molecular Biology Enzymes and Kits & Reagents Market is Segmented on the lines of Application Analysis, Product Analysis, End User Analysis and Regional Analysis. By Application Analysis this market is segmented on the basis of PCR, Sequencing, Cloning, Epigenetics, Restriction Digestion, Synthetic Biology and Other Applications. By Product Analysis this market is segmented on the basis of Kits & Reagents and Enzymes its covers Polymerases, Ligases, Restriction Endo nucleases, Reverse Transcriptases, Phosphatases, Proteases and Proteinases & Other Enzymes.

By End User Analysis this market is segmented on the basis of Academic & Research Institutes sector, Hospitals & Diagnostic Centers sector, Pharmaceutical & Biotechnology companies sector and Other End Users sector. By Regional Analysis this market is segmented on the basis of North America, Europe, Asia-Pacific and Rest of the World.

This report provides:

1) An overview of the global market for Molecular Biology Enzymes and Kits & Reagents Market and related technologies.2) Analyses of global market trends, with data from 2015, estimates for 2016 and 2017, and projections of compound annual growth rates (CAGRs) through 2024.3) Identifications of new market opportunities and targeted promotional plans for Molecular Biology Enzymes and Kits & Reagents Market.4) Discussion of research and development, and the demand for new products and new applications.5) Comprehensive company profiles of major players in the industry.

Request Sample Report: https://www.marketresearchengine.com/molecular-biology-enzymes-and-kits-and-reagents-market

Table of Contents

1 INTRODUCTION

2 Molecular Biology Kits Market: Research Methodology

3 Molecular Biology Kits Market: Executive Summary

3.1 Introduction3.2 Current Scenario3.3 Future Outlook3.4 Conclusion

4 Premium Insights

5 Molecular Biology Kits Market: Market Overview

6 Industry Insights

7 Global Molecular Biology Enzymes and Kits & Reagents Market, By Product

8 Global Molecular Biology Enzymes and Kits & Reagents Market, By Application

9 Molecular Biology Enzymes and Kits & Reagents Market, By End User

10 Molecular Biology Enzymes and Kits & Reagents Market, By Region

11 Competitive Landscape

12 Company Profiles

12.1 Introduction

12.2 Thermo Fisher Scientific, Inc.

12.3 Merck KGAA

12.4 Promega Corporation

12.5 New England Bio labs, Inc.

12.6 Illumina, Inc.

12.7 Takara Bio Inc.

12.8 Qiagen N.V.

12.9 Agilent Technologies, Inc.

12.10 F. Hoffmann-La Roche Ltd

12.11 Becton, Dickinson and Company

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Molecular Biology Enzymes and Kits & Reagents Market 2019 | How The Industry Will Witness Substantial Growth In The Upcoming Years | Exclusive...

Current Trend 2020: Latest Analysis on Cell Sorter Market

Toronto, Canada: The report involves insightful data on the main sectors of theGlobal Cell Sorter Market. The report has segmented market, by its types and applications. Each segment has analyzed completely on the basis of its production, consumption as well as revenue. Further, it is classified on the basis of geographical areas which include: North America, Europe, Asia Pacific, Latin America, Middle East and Africa.

SDMR Research has recently published a report, titled COVID-19 Impact on Global Cell Sorter Market Insights, Forecast to 2025. The market research report is a brilliant, complete, and much-needed resource for Cell Sorter . The research report speak about the potential development openings that exist in the worldwide market. The report is broken down on the basis of research procedures procured from historical and forecast information. The global Cell Sorter market is relied upon to develop generously and flourish as far as volume and incentive during the gauge time frame. The report will give a knowledge about the development openings and controls that will build the market. Pursuers can increase important perception about the eventual fate of the market.

Key companies that are operating in the global Cell Sorter market are: Beckman CoulterBio-Rad LaboratoriesSony BiotechnologyMiltenyi BiotecAffymetrixSysmex PartecOn-Chip BiotechnologiesCytonomeBecton DickinsonUnion Biometrica

Get Free PDF Sample Copy of this Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart)

The study is a source of reliable data on:

NOTE: Our team is studying Covid-19 impact analysis on various industry verticals and Country Level impact for a better analysis of markets and industries. The 2020 latest edition of this report is entitled to provide additional commentary on latest scenario, economic slowdown and COVID-19 impact on overall industry. Further it will also provide qualitative information about when industry could come back on track and what possible measures industry players are taking to deal with current situation.

Segmental Analysis:

The report incorporates significant sections, for example, type and end user and a variety of segments that decide the prospects of the market. Each type provide data with respect to the business esteem during the conjecture time frame. The application area likewise gives information by volume and consumption during the estimate time frame. The comprehension of this segment direct the readers in perceiving the significance of variables that shape the market development.

Global Cell Sorter Market Segment By Type:

Cell SortersCell Sorting Reagents & ConsumablesCell Sorting Services

Global Cell Sorter Market Segment By Application:Research ApplicationClinical Applications

Competitive Landscape:

The report incorporates various key players and producers working in the local and worldwide market. This segment shows the procedures received by players in the market to remain ahead in the challenge. New patterns and its reception by players assist readers with understanding the elements of the business and how it very well may be utilized to their own benefit. The readers can likewise recognize the strides of players to comprehend the global market better.

Key questions answered in the report:

What is the growth potential of the Cell Sorter market?

Which product segment will grab a lions share?

Which regional market will emerge as a frontrunner in the coming years?

Which application segment will grow at a robust rate?

What are the growth opportunities that may emerge in the Cell Sorter industry in the years to come?

What are the key challenges that the global Cell Sorter market may face in the future?

Which are the leading companies in the global Cell Sorter market?

Which are the key trends positively impacting the market growth?

Which are the growth strategies considered by the players to sustain hold in the global Cell Sorter market?

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TOC:

Report Overview: It includes major players of the global Cell Sorter market covered in the research study, research scope, market segments by type, market segments by application, years considered for the research study, and objectives of the report.

Global Growth Trends: This section focuses on industry trends where market drivers and top market trends are shed light upon. It also provides growth rates of key producers operating in the global Cell Sorter market. Furthermore, it offers production and capacity analysis where marketing pricing trends, capacity, production, and production value of the global Cell Sorter market are discussed.

Market Share by Manufacturers/Keyplayers : Here, the report provides details about revenue by manufacturers, production and capacity by manufacturers, price by manufacturers, expansion plans, mergers and acquisitions, and products, market entry dates, distribution, and market areas of key manufacturers.

Market Size by Type: This section concentrates on product type segments where production value market share, price, and production market share by product type are discussed.

Market Size by Application: Besides an overview of the global Cell Sorter market by application, it gives a study on the consumption in the global Cell Sorter market by application.

Production by Region: Here, the production value growth rate, production growth rate, import and export, and key players of each regional market are provided.

Consumption by Region: This section provides information on the consumption in each regional market studied in the report. The consumption is discussed on the basis of country, application, and product type.

Company Profiles: Almost all leading players of the global Cell Sorter market are profiled in this section. The analysts have provided information about their recent developments in the global Cell Sorter market, products, revenue, production, business, and company.

Market Forecast by Production: The production and production value forecasts included in this section are for the global Cell Sorter market as well as for key regional markets.

Market Forecast by Consumption: The consumption and consumption value forecasts included in this section are for the global Cell Sorter market as well as for key regional markets.

Value Chain and Sales Analysis: It deeply analyzes customers, distributors, sales channels, and value chain of the global Cell Sorter market.

Key Findings: This section gives a quick look at the important findings of the research study.

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For More Information Kindly Contact: We have a strong network of high powered and experienced global consultants who have about 10+ years of experience in the specific industry to deliver quality research and analysis. Having such an experienced network, our services not only cater to the client who wants the basic reference of market numbers and related high growth areas in the demand side, but also we provide detailed and granular information using which the client can definitely plan the strategies with respect to both supply and demand side.

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Cell Sorter Market 2020 Report Forecasts the Impact of COVID-19 Pandemic on Business and future opportunity | Beckman Coulter, Bio-Rad Laboratories,...