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MLL Fusion Proteins Emerge as a Promising Target in AML – OncLive

December 4th, 2020 12:03 am

Novel agents that disrupt protein-protein interactions in the MLL network may be the key to unlocking new therapeutic avenues for patients with acute leukemias, which are characterized by diverse genetic and epigenetic alterations that are challenging to target, according to investigators.1

Early clinical data have demonstrated an antitumor effect of small molecule inhibitors directed at interactions of menin, a tumor suppressor protein, and MLL fusion proteins in acute myeloid leukemia (AML).2 One such agent, KO-539, is being investigated in 2 genetic subsets of AML: patients with rearrangements in KMT2A (also known as MLL1 or MLL) or with NPM1 mutations, which both promote leukemogenesis.

KMT2A(MLL) translocations are found in approximately 5% to 10% of patients with acute leukemias, including lymphoid, myeloid, or biphenotypic subtypes2; the 5-year survival rate for this population is approximately 35%.1 Over 30% of patients with AML have NPM1 mutations that, when they occur along with FLT3-ITD mutations, result in an overall survival rate of less than 50%.1

Investigators believe that menin is involved with a variety of cellular processes including aiding in the structural modification of MLL that stabilizes the bond between MLL and lens epithelium derived growth factor, a transcriptional coactivator believed to play a role in cancer.2 By causing a genetic disruption of the menin-MLL fusion protein interaction, they hypothesize, a novel agent could block the development of acute leukemia (Figure).3

In preclinical research, KO-539 prolonged survival compared with quizartinib, a FLT3 inhibitor, in 2 patient-derived xenograft models of NPM1/DNMT3/FLT3-mutant AML. In a confirmatory study, animals that were NPM1- and FLT3-mutant/DNMT3A wild-type and were treated with quizartinib relapsed by approximately day 35; those treated with KO-539 had no evidence of disease progression after 56 days.4

Although translocations of KMT2A(MLL) occur in approximately 3% of patients with AML, the mutational burden of these patients is far less than that of other cancer types; as a result, the translocations alone may result in the generation of the leukemic phenotype. Further, gene expression profiling has demonstrated overexpression of both HOXA9 and MEIS1, 2 oncoproteins thought to be critical for enhanced self-renewal in AML. Specifically, transcription of the HOXA9 and MEIS1 genes are dependent on KMT2A(MLL)-fusion protein binding to menin.5

The menin-MLL interaction seems to trigger the upregulation of certain leukemogenic or leukemia-promoting proteins, such as HOXA9 and MEIS1, said Amir T. Fathi, MD, in an interview with OncLive. [Developing] drugs that inhibit the leukemogenic signals can, in theory, lead to promotion of differentiation and maturation and response. Fathi is an associate professor of medicine at Harvard Medical School and director of the Leukemia Program at Massachusetts General Hospital, both in Boston.

Although KMT2A(MLL) and NPM1 alterations currently are the frontrunners as targets for in-human studies, Fathi suggested that, in time, investigators may learn more about efficacy in other subpopulations of patients with AML whose disease may be affected by epigenetic dysregulation from the menin-MLL interaction. If so, such findings may emerge as points of interest.

Other mutations that are seen in AML and myeloid malignancies, such as NPM1, DNMT3, EZH2, and others, appear to have their impact upstream from the menin-MLL, interaction, Fathi said. These alterations, too, can theoretically affect the menin-KMT2A interaction and complex and promote epigenetic dysregulation and leukemogenesis.

Because of the potential for broad efficacy, KO-539 is undergoing testing in a varied patient population in the phase 1 portion of the KOMET-001 trial (NCT04067336). We are assessing patients across a wide range of molecular subtypes to further define who may benefit from this class of targeted drug, explained Fathi, one of the leading investigators. We suspect that some patients with an NPM1 mutation or those with MLL rearrangements may be susceptible to response based on what we know from preclinical science, and we should study these populations carefully, but we are also assessing more broadly initially across AML to better characterize the other patient populations that may benefit.

KOMET-001 is the first in-human study of the menin-MLL inhibitor, which is being developed by Kura Oncology. The study will evaluate the safety and tolerability of escalating doses of KO-539 monotherapy for patients with relapsed and/or refractory AML.

Up until now, initial studies have been done extensively in preclinical models, said Eunice S. Wang, MD. If we extrapolate from some of our clinical models, we think that a dose of approximately 600 milligrams once per day would be effective, but because this is a first-in human study, we [followed] the typical phase 1 study design where we increase the dose.

Wang serves as chief of Leukemia Service, medical director of Infusion Services, at Roswell Park Comprehensive Cancer Center, and an associate professor in the Department of Medicine at Jacobs School of Medicine and Biomedical Sciences, State University of New York at Buffalo. She is scheduled to present preliminary data from the study during the 2020 American Society of Hematology Annual Meeting, which is being held in a virtual format December 5 to 8.

In an interview in advance of her presentation, Wang noted that investigators used a novel study design and started the first dose of KO-539 at 50 mg. KO-539 was administered orally once daily to patients in 28-continuous-day cycles and, as of data cutoff of August 10, 2020, 6 patients had proceeded through to the 200-mg dose. Following this, an expansion cohort of 3 patients at a 200 mg dose was initiated to better characterize the pharmacokinetics and exposure of KO-539.6

Early data show that KO-539 demonstrated biologic activity in 3 patients in the first 3 dose cohorts of 50 mg, 100 mg, and 200 mg. Tumor lysis syndrome was reported for 2 patients in the 50- and 200-mg cohorts. The patients had a KMT2A(MLL)-rearrangement and a TP53 mutation with a PICALM-AF10 fusion, respectively. The third patient treated at the 100-mg dose level had SETD2 and RUNX1 comutations and achieved a complete remission with confirmed negative minimal residual disease after 2 cycles of therapy. The patient remains on treatment.6

Although the study sample data are too small to reach conclusions, activity of the agent is promising. The complete remission data was very exciting, for a pill taken once a day for a patient who had multiple relapses, said Fathi. The responding patient did not have an MLL-translocation nor an NPM1-mutation, but there were other alterations that may have ultimate effects on the menin-MLL interaction and whose disease may thus have been susceptible to menin inhibition. It leaves open the door for the possibility to identify other groups of patients across AML who may benefit.

In safety data for 3 evaluable patients, no dose-limiting or dose-interrupting toxicities have been reported.6 Wang plans to present updated safety and efficacy data at the meeting.

Expansion cohorts are planned to further assess the safety and activity of KO-539 in an NPM1-mutant cohort and a KMT2A(MLL)-rearranged cohort. Right now, the expansion cohorts are designed to target subsets of patients with AML that have those specific mutations, said Wang. However, if we see evidence [of efficacy] in the early dose-escalation trials, we may consider trying to expand out [to other mutational subtypes] as well to a pool of patients with leukemia that are what we call mutation agnostic.

Theres still a lot of ground to go and patients to enroll, but there is a lot of opportunity to probe that signal a little bit more, to learn more, and to hopefully help these patients, Fathi said.

Another drug that aims to disrupt menin-MLL interactions is SNDX-5613, an oral inhibitor being developed by Syndax Pharmaceuticals under an FDA orphan drug designation for adults and pediatric patients with AML.7 The phase 1/2 AUGMENT-101 trial (NCT04065399) is testing the agent in patients with relapsed/refractory leukemias.

The study, which seeks to recruit 186 pediatric and adult patients, will evaluate escalating doses of SNDX-5613 monotherapy in phase 1. After the recommended dose is established, patients will be enrolled in 1 of 3 cohorts: acute lymphoblastic leukemia or mixed phenotype acute leukemia; KMT2A(MLL)-rearranged AML; and NPM1-mutant AML.8

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Wielding Powerful Imaging Tools, MSK Researchers Decipher Process of DNA Repair – On Cancer – Memorial Sloan Kettering

December 4th, 2020 12:03 am

Summary

Using cryo-electron microscopy, researchers at the Sloan Kettering Institute have gained an important insight into how cells repair broken DNA, a process fundamental to life that sometimes goes awry in cancer.

A landmark in cancer research was the discovery, in the early 1990s, of two cancer predisposition genes BRCA1 and BRCA2. When mutated, these genes increase a persons risk of developing several forms of cancer, including breast, ovarian, and prostate cancers. Since then, researchers around the world have been studying these genes and the proteins made from them to learn exactly how they increase the risk of cancer.

Many crucial breakthroughs in scientists understanding of this topic have come from research conducted at Memorial Sloan Kettering. In the late 1990s, Sloan Kettering Institute molecular biologist Maria Jasin showed that the BRCA2 protein was necessary for repairing a type of DNA damage called a double-strand break. When BRCA2 is mutated, it cant repair this damage well, and cancer is often the result.

In 2002, SKI structural biologist Nikola Pavletich determined the structure of the BRCA protein and showed that it binds to DNA. In a follow-up paper published in 2005, Dr. Pavletich showed that BRCA2 is required for DNA repair because it activates another protein, called Rad51, which is the actual machine that repairs double-strand breaks. In 2008, he showed how the bacterial version of Rad51, called RecA, starts the repair process by binding to one strand of the broken DNA.

Now, more than 12 years later, Dr. Pavletich has added yet another piece to the puzzle. In a report published October 14 in the journal Nature, he and his colleagues, including senior research scientist Haijuan Yang, describe the mechanism by which RecA and the broken DNA strand it carries search for the correct segment of a nearby DNA molecule to use as a repair template.

The findings cap a nearly 20-year quest, the pace of which has accelerated in recent years thanks to a new technology called cryo-electron microscopy (cryo-EM).

Because DNA is so fundamental to life, cells have evolved a variety of means to preserve its integrity. When DNA is damaged say by UV light or x-rays there are several ways a cell can attempt to repair it. The most careful, error-free way is called homologous recombination. In this type of repair, a cell finds a segment of DNA on an intact chromosome that matches the broken region of the other and uses that as a template to fill in the gap. (Chromosomes come in pairs, one from mom, one from dad; these chromosomes are said to be homologous.)

From decades of work, it was clear that a single strand of broken DNA finds homologous DNA with the help of a protein called RecA. RecA and single-stranded DNA form a structure called a pre-synaptic filament. The filament binds to double-strand DNA, opens it up to expose its complementary strands, and then searches for homology along one of those strands.

The question we didnt understand was how its searching for homology between the single-stranded DNA that its carrying and the double-stranded DNA that it binds to, Dr. Pavletich says.

To investigate that question, they turned to cryo-EM. This relatively new form of microscopy, whose developers won the 2017 Nobel Prize in Chemistry, allows scientists to visualize the fine-grained structure of biological molecules at unparalleled resolution. MSK acquired a cryo-EM machine in 2017.

Before the advent of cryo-EM, the main way that biologists determined structures of proteins and other molecules was x-ray crystallography, a painstaking and time-consuming effort.

Weve spent a long time with crystallography trying to address these issues and it just did not work out, Dr. Pavletich says. Cryo-EM makes it much easier.

Part of the problem is that to really understand the mechanism, they needed to capture what the RecA protein looks like at various points during the DNA repair process; with x-ray crystallography, they were really only able to look at one point in time.

With cryo-EM, they are able to look at thousands and thousands of RecA proteins bound to DNA at various times points and from these many images piece together the entire sequence.

What we were able to determine is how RecA opens the double-stranded DNA and how one of the DNA strands is sequestered at a second secondary site in the RecA protein, Dr. Pavletich says.

This binding leaves the other DNA strand flipping around and hitting the single-stranded DNA that the filament was carrying, he adds. If there is homology, it stays there. If there are no homology it continues to float around.

Even if the team had had several x-ray crystal structures to work with, they wouldnt have been able to glean what they were able to using a million RecA-DNA particles. Thats the power of cryo-EM, he says. It took us 12 years to solve this, but if we had had cryo-EM in 2008 then it would have been much faster.

Homologous recombination is not only important in fixing mutations that can lead to cancer. Its also how genetic diversity is generated during the formation of sperm and egg: maternal and paternal chromosomes break along their lengths and swap segments before being repaired through homologous recombination. This genetic diversity is why you and your siblings look similar but not identical; you each got a different combination of maternal and paternal chromosomes.

Homologous recombination is also how the genome-editing tool CRISPR works. This technology, whose developers won the 2020 Nobel Prize in Chemistry, relies on the introduction of DNA double-strand breaks at specific locations in the genome and repair through homologous recombination.

Dr. Pavletich says he hopes the new insights into homologous recombination will ultimately help improve cancer care, as past discoveries have done. But he says thats not the primary goal of basic science research.

As scientists, we do what we do because we love the gratification of solving a problem, he says. And homologous recombination is one of those really longstanding and important biological problems to understand. So it feels really good to be able to make this contribution to science.

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Is Sutro Biopharma Inc (STRO) the Top Pick in the Biotechnology Industry? – InvestorsObserver

December 4th, 2020 12:01 am

Sutro Biopharma Inc (STRO) is near the top in its industry group according to InvestorsObserver. STRO gets an overall rating of 65. That means it scores higher than 65 percent of stocks. Sutro Biopharma Inc gets a 81 rank in the Biotechnology industry. Biotechnology is number 35 out of 148 industries.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 65 would rank higher than 65 percent of all stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Sutro Biopharma Inc (STRO) stock is trading at $16.67 as of 12:19 PM on Thursday, Dec 3, a gain of $0.32, or 1.96% from the previous closing price of $16.35. The stock has traded between $16.23 and $17.59 so far today. Volume today is 309,465 compared to average volume of 322,449.

Click Here to get the full Stock Score Report on Sutro Biopharma Inc (STRO) Stock.

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Is Cellectar Biosciences Inc (CLRB) Stock Near the Top of the Biotechnology Industry? – InvestorsObserver

December 4th, 2020 12:01 am

A rating of 80 puts Cellectar Biosciences Inc (CLRB) near the top of the Biotechnology industry according to InvestorsObserver. Cellectar Biosciences Inc's score of 80 means it scores higher than 80% of stocks in the industry. Cellectar Biosciences Inc also received an overall rating of 65, putting it above 65% of all stocks. Biotechnology is ranked 35 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.

This ranking system incorporates numerous factors used by analysts to compare stocks in greater detail. This allows you to find the best stocks available in any industry with relative ease. These percentile-ranked scores using both fundamental and technical analysis give investors an easy way to view the attractiveness of specific stocks. Stocks with the highest scores have the best evaluations by analysts working on Wall Street.

Cellectar Biosciences Inc (CLRB) stock is trading at $2.29 as of 2:18 PM on Thursday, Dec 3, an increase of $0.34, or 17.18% from the previous closing price of $1.95. The stock has traded between $1.95 and $2.40 so far today. Volume today is high. So far 8,826,004 shares have traded compared to average volume of 928,593 shares.

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Reaping the promise of biotechnology – Business Mirror

December 4th, 2020 12:01 am

IT has been nearly two decades since the Philippine government approved the sale and cultivation of genetically modified (GM) corn seeds in local farms. The government issued a permit to commercialize Monsanto Philippiness bacillus thuringiensis (Bt) corn variety dubbed YieldGard on December 5, 2002. With this, the Philippines earned the distinction of being the first in Asia to commercialize Bt corn, a variety that enables corn farmers to save on production cost because they will no longer have to extensively use pesticides to kill the corn borera grain pest, particularly of corn.

Bt corn has been largely instrumental in increasing farmers production in the ensuing years following the issuance of the permit to Monsanto. The increment in output allowed the Philippines to become self-sufficient in corn (See, Yellow corn yield achieved 103 percent self-sufficiency last yearPiol, in the BusinessMirror, March 28, 2018). With the help of the biotech product, farmers were able to earn $642 million from 2003 to 2015, according to the International Service for the Acquisition of Agri-biotech Applications.

Its advantages and its potential to boost incomes have encouraged more farmers to plant the variety in recent years. The United States Department of Agricultures Foreign Agricultural Service in Manila noted that areas planted with Bt corn in the Philippines expanded by 26 percent to 834,617 hectares this year (See, Gain report: GE corn areas in PHL continue to expand, in the BusinessMirror, November 30, 2020). The availability of more yellow corna raw material used in manufacturing animal feedshas also supported the growing livestock and poultry industry.

These developments illustrate the benefits of biotechnology as well as its potential to enable the Philippines to develop other products that will allow farmers to diversify to other crops as well as cope with the ill effects of climate change. Currently, Bt corn is the only biotech product that is being planted in the Philippines. The GM varieties of other crops, like eggplant, are in various stages of development.

It is also worth noting that the Bt corn variety that was approved for commercialization in 2002 was made in the United States. The Philippines has yet to develop its own GM crop, and we urge Philippine researchers and scientists to make biotech products that are tailor fit to local conditions. Government must support these efforts by putting more money in the research initiatives of our local scientists or introduce policies, such as incentives, that will encourage the private sector to partner with them.

The recent successive typhoons that struck the Philippines should serve as a stark reminder of the increasing difficulties being faced by Filipino farmers and the pressing need for government to look for more sustainable means of ensuring food security. We welcome the Department of Agricultures (DA) pronouncement that it will optimize the use of biotechnology and other science-based solutions to increase farm output from limited farmlands and fishing grounds.

We urge Congress to support the DAs initiatives by passing the proposed Modern Biotechnology Act and by increasing the budget for agricultural research and development. Fully supported, our own scientists can harness the power of modern biotechnology.

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The vaccines of tomorrow: how to invest in biotechnology – Rask Media

December 4th, 2020 12:01 am

Biotechnology has experienced extraordinary growth in recent times and came to popular attention as companies raced to find vaccines and cures for COVID-19. While investing in this area has obvious appeal from a social and moral perspective, it can also be a highly lucrative space as a growth investment in a portfolio.

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

Biotechnology is predicted to be valued at more than US$833.34bn by 2027, compared to US$447.92 billion at the end of 2019, and will continue to grow, driven by the growing global population and the need for affordable, effective treatments and vaccines.Biotechnology will also be a beneficiary of population aging, particularly in Western countries. The reason for this is that an increase in the volume of older citizens is likely to have an accompanying and proportional increase in the volume of age-related diseases such as cardiovascular disease, dementia or arthritis, all requiring treatment.

Gilead is one example of a company with prospects in this space. Gilead is already well-known for its highly effective HIV treatments but is also targeting US and European approvals to market a drug called Filgotinib to treat rheumatoid arthritis.

In a demonstration of the growth in this industry, this year alone, 30-35 biotechnology companies are anticipated to go public, raising approximately US$3.5 billion.

The healthcare sector as a whole is likely to see greater investment as a result of the COVID-19 pandemic. For example, national health spending growth in the US is expected to average 5.4% annually through 2028, reaching US$6 trillion a year. Biotechnology will also be a beneficiary of this increased investment.

Investment and value from biotechnology is expected to grow in the coming years. While the trend already existed due to continuous tech improvements and the needs of a growing population, the COVID-19 pandemic has created a new spotlight on this area which may accelerate its growth.

Australian investors are likely to already be exposed to this growth segment in the concentrated domestic market. However, they may be missing exposure to the US, which dominates the global market for biotechnology.

Biotechnology could be considered part of a sector allocation to healthcare, or investors might view it as a thematic investment. You can find more information about thematic investing and using it in your portfolio in our latest whitepaper.

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-risk approach due to the high failure rates of drug testing and long periods of development (i.e., long periods where there may be no or a limited return on investment). Theres also the element of chance has the investor picked the winner? It could take years to know.

Managed investments, be it actively managed funds or passive options like ETFs, can assist in managing risk by spreading it across a larger number of companies. Investors could choose to invest by taking a sector approach and investing in a fund focusing on broader healthcare, or look at industry-specific options focusing on biotechnology. ETFS S&P Biotech ETF (ASX Code: CURE) is one such example that offers broad exposure to US biotechnology.

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Where Does Agenus Inc (AGEN) Stock Fall in the Biotechnology Field? – InvestorsObserver

December 4th, 2020 12:01 am

The 62 rating InvestorsObserver gives to Agenus Inc (AGEN) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 76 percent of stocks in the Biotechnology industry, AGENs 62 overall rating means the stock scores better than 62 percent of all stocks.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

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.

Agenus Inc (AGEN) stock is down -1.52% while the S&P 500 is higher by 0.15% as of 12:22 PM on Thursday, Dec 3. AGEN is down -$0.06 from the previous closing price of $3.63 on volume of 1,217,123 shares. Over the past year the S&P 500 has risen 18.04% while AGEN is down -9.14%. AGEN lost -$1.09 per share the over the last 12 months.

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Nanoparticles In Biotechnology And Pharmaceuticals Market Detail Analysis Focusing On Application, Types and Regional Outlook – Cheshire Media

December 4th, 2020 12:01 am

Nanoparticles In Biotechnology And Pharmaceuticals Market includes Overview, classification, industry value, price, cost and gross profit. It also covers types, enterprises and applications. To start with, analytical view to complete information of Nanoparticles In Biotechnology And Pharmaceuticals market. It offers market view by regions with countries, development in Nanoparticles In Biotechnology And Pharmaceuticals industry, opportunity with challenges, sales strategies, growth strategies and revenue analysis to include price.

The global Nanoparticles in Biotechnology and Pharmaceuticals market is valued at xx million US$ in 2018 and will reach xx million US$ by the end of 2025, growing at a CAGR of xx% during 2019-2025. The objectives of this study are to define, segment, and project the size of the Nanoparticles in Biotechnology and Pharmaceuticals market based on company, product type, end user and key regions.

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Nanoparticles In Biotechnology And Pharmaceuticals Market report helps to analyses competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the Global Nanoparticles In Biotechnology And Pharmaceuticals Market Sales 2020 Industry Trend and Forecast 2026.

Market Segment by Type, covers

FullerenesLiquid CrystalsLiposomesNanoshellsQuantum dots

Nanoparticles In Biotechnology And Pharmaceuticals Market Segment by Applications, can be divided intoBiotechnologyPharmaceutical

Market Segment by Regions, regional analysis covers North America (United States, Canada and Mexico) Europe (Germany, UK, France, Italy, Russia, Spain and Benelux) Asia Pacific (China, Japan, India, Southeast Asia and Australia) Latin America (Brazil, Argentina and Colombia) Middle East and Africa

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Table of Contents: Nanoparticles In Biotechnology And Pharmaceuticals Market

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Nanoparticles in Biotechnology and Pharmaceuticals Market Size, Comprehensive Analysis, Development Strategy, Future Plans and Industry Growth with…

December 4th, 2020 12:01 am

Global Nanoparticles in Biotechnology and Pharmaceuticals Market

The Global Intelligence Insights added a new report Global Nanoparticles in Biotechnology and Pharmaceuticals Market: Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2016 2024 in its database, which provides an expert and in-depth analysis of key business trends and future market development prospects, key drivers and restraints, profiles of major market players, segmentation and forecasting.

Market Overview:

Nanoparticles in Biotechnology and Pharmaceuticals Market to grow from USD 761.85 billion in 2016 and reach USD 918.74 billion by 2020, growing at a CAGR of 4.8% during the forecast period.

The global Nanoparticles in Biotechnology and Pharmaceuticals Market report offers a complete overview of the Nanoparticles in Biotechnology and Pharmaceuticals Market globally. It presents real data and statistics on the inclinations and improvements in global Nanoparticles in Biotechnology and Pharmaceuticals Markets. It also highlights manufacturing, abilities & technologies, and unstable structure of the market. The global Nanoparticles in Biotechnology and Pharmaceuticals Market report elaborates the crucial data along with all important insights related to the current market status.

The report additionally provides a pest analysis of all five along with the SWOT analysis for all companies profiled in the report. The report also consists of various company profiles and their key players; it also includes the competitive scenario, opportunities, and market of geographic regions. The regional outlook on the Nanoparticles in Biotechnology and Pharmaceuticals market covers areas such as Europe, Asia, China, India, North America, and the rest of the globe.

Note In order to provide more accurate market forecast, all our reports will be updated before delivery by considering the impact of COVID-19.

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Top Key Players: Roche, GE Healthcare, Merck, Novartis, AMAG Pharmaceuticals, Amgen, Bausch & Lomb, Biogen, Celgene, Gilead, Ipsen, Leadiant Biosciences, nanoComposix, Pacira Pharmaceuticals, Pfizer, and Shire

The main goal for the dissemination of this information is to give a descriptive analysis of how the trends could potentially affect the upcoming future of Nanoparticles in Biotechnology and Pharmaceuticals market during the forecast period. This markets competitive manufactures and the upcoming manufactures are studied with their detailed research. Revenue, production, price, market share of these players is mentioned with precise information.

Market Dynamics:

The report analyzes the factors impacting the growth and the current market trends influencing the global Nanoparticles in Biotechnology and Pharmaceuticals market. Detailed pricing information with ex-factory prices of various products by key manufacturers form a crucial part of the report. Competition analysis, along with regional government policies affecting the Nanoparticles in Biotechnology and Pharmaceuticals market provides a detailed overview of the current status and prospects of the market. The impact of the ever-growing global population, coupled with technological advancements affecting the global Nanoparticles in Biotechnology and Pharmaceuticals market is also covered in the report.

Drivers & Constraints:

The report provides extensive information about the factors driving the global Nanoparticles in Biotechnology and Pharmaceuticals market. Factors influencing the growth of the Nanoparticles in Biotechnology and Pharmaceuticals market, along with technological advancements, are discussed extensively in the report. The current restraints of the market, limiting the growth and their future impact are also analyzed in the report. The report also discusses the impact of rising consumer demand, along with global economic growth on the Nanoparticles in Biotechnology and Pharmaceuticals market.

Regional Segment Analysis:

This report provides pinpoint analysis for changing competitive dynamics. It offers a forward-looking perspective on different factors driving or limiting market growth. It provides a five-year forecast assessed on the basis of how they Nanoparticles in Biotechnology and Pharmaceuticals Market is predicted to grow. It helps in understanding the key product segments and their future and helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments.

Key questions answered in the report include:

What will the market size and the growth rate be in 2026?

What are the key factors driving the Global Nanoparticles in Biotechnology and Pharmaceuticals Market?

What are the key market trends impacting the growth of the Global Nanoparticles in Biotechnology and Pharmaceuticals Market?

What are the challenges to market growth?

Who are the key vendors in the Global Nanoparticles in Biotechnology and Pharmaceuticals Market?

What are the market opportunities and threats faced by the vendors in the Global Nanoparticles in Biotechnology and Pharmaceuticals Market?

Trending factors influencing the market shares of the Americas, APAC, Europe, and MEA.

The report includes six parts, dealing with:

1.) Basic information;

2.) The Asia Nanoparticles in Biotechnology and Pharmaceuticals Market;

3.) The North American Nanoparticles in Biotechnology and Pharmaceuticals Market;

4.) The European Nanoparticles in Biotechnology and Pharmaceuticals Market;

5.) Market entry and investment feasibility;

6.) The report conclusion.

Reasons for Buying this Report:

This report provides pin-point analysis for changing competitive dynamics

It provides a forward looking perspective on different factors driving or restraining market growth

It provides a six-year forecast assessed on the basis of how the market is predicted to grow

It helps in understanding the key product segments and their future

It provides pin point analysis of changing competition dynamics and keeps you ahead of competitors

It helps in making informed business decisions by having complete insights of market and by making in-depth analysis of market segments

TABLE OF CONTENT:

1 Report Overview

2 Global Growth Trends

3 Market Share by Key Players

4 Breakdown Data by Type and Application

5 United States

6 Europe

7 China

8 Japan

9 Southeast Asia

10 India

11 Central & South America

12 International Players Profiles

13 Market Forecasts 2019-2025

14 Analysts Viewpoints/Conclusions

15 Appendixes

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Nanoparticles in Biotechnology and Pharmaceuticals Market Size, Comprehensive Analysis, Development Strategy, Future Plans and Industry Growth with...

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Is Crispr Therapeutics AG (CRSP) The Right Choice in Biotechnology? – InvestorsObserver

December 4th, 2020 12:01 am

Crispr Therapeutics AG (CRSP) is around the top of the Biotechnology industry according to InvestorsObserver. CRSP received an overall rating of 56, which means that it scores higher than 56 percent of all stocks. Crispr Therapeutics AG also achieved a score of 69 in the Biotechnology industry, putting it above 69 percent of Biotechnology stocks. Biotechnology is ranked 35 out of the 148 industries.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Crispr Therapeutics AG (CRSP) stock is trading at $141.80 as of 3:01 PM on Thursday, Dec 3, a rise of $10.26, or 7.8% from the previous closing price of $131.54. The stock has traded between $130.35 and $147.82 so far today. Volume today is more active than usual. So far 1,323,678 shares have traded compared to average volume of 1,022,719 shares.

Click Here to get the full Stock Score Report on Crispr Therapeutics AG (CRSP) Stock.

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Is Crispr Therapeutics AG (CRSP) The Right Choice in Biotechnology? - InvestorsObserver

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Is Evogene Ltd (EVGN) Stock Near the Top of the Biotechnology Industry? – InvestorsObserver

December 4th, 2020 12:01 am

The 57 rating InvestorsObserver gives to Evogene Ltd (EVGN) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 70 percent of stocks in the Biotechnology industry, EVGNs 57 overall rating means the stock scores better than 57 percent of all stocks.

Trying to find the best stocks can be a daunting task. There are a wide variety of ways to analyze stocks in order to determine which ones are performing the strongest. Investors Observer makes the entire process easier by using percentile rankings that allows you to easily find the stocks who have the strongest evaluations by analysts.

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.

Evogene Ltd (EVGN) stock is trading at $3.29 as of 10:31 AM on Wednesday, Dec 2, a decline of -$0.19, or -5.45% from the previous closing price of $3.48. The stock has traded between $3.15 and $3.68 so far today. Volume today is less active than usual. So far 388,651 shares have traded compared to average volume of 867,936 shares.

Click Here to get the full Stock Score Report on Evogene Ltd (EVGN) Stock.

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Is Evogene Ltd (EVGN) Stock Near the Top of the Biotechnology Industry? - InvestorsObserver

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Where Does Tauriga Sciences Inc (TAUG) Stock Fall in the Biotechnology Field? – InvestorsObserver

December 4th, 2020 12:01 am

The 5 rating InvestorsObserver gives to Tauriga Sciences Inc (TAUG) stock puts it near the bottom of the Biotechnology industry. In addition to scoring higher than 4 percent of stocks in the Biotechnology industry, TAUGs 5 overall rating means the stock scores better than 5 percent of all stocks.

Searching for the best stocks to invest in can be difficult. There are thousands of options and it can be confusing on what actually constitutes a great value. Investors Observer allows you to choose from eight unique metrics to view the top industries and the best performing stocks in that industry. A score of 5 would rank higher than 5 percent of all stocks.

These rankings allows you to easily compare stocks and view what the strengths and weaknesses are of a given company. This lets you find the stocks with the best short and long term growth prospects in a matter of seconds. The combined score incorporates technical and fundamental analysis in order to give a comprehensive overview of a stocks performance. Investors who then want to focus on analysts rankings or valuations are able to see the separate scores for each section.

Tauriga Sciences Inc (TAUG) stock is unmoved -5% while the S&P 500 is down -0.21% as of 11:20 AM on Wednesday, Dec 2. TAUG is unmoved $0.00 from the previous closing price of $0.03 on volume of 482,338 shares. Over the past year the S&P 500 is higher by 18.16% while TAUG is unmoved 0.00%. TAUG lost -$0.04 per share the over the last 12 months.

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Where Does Tauriga Sciences Inc (TAUG) Stock Fall in the Biotechnology Field? - InvestorsObserver

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AVM Biotechnology President Selected to Speak at ESWI Conference in Novel and Outstanding Discoveries Track – PRNewswire

December 4th, 2020 12:01 am

I'm honored to be able to present our data, which speaks to the broad and significant potential of AVM0703, Dr. Deisher

Dr. Deisher's presentation entitled "Acute Suprapharmacologic Dexamethasone Mobilizes Natural Killer T and Cytotoxic T cells for Influenza A/B-induced or COVID-19-induced Acute Respiratory Distress Syndrome (ARDS)" will be streamed live during the conference on December 9th.

"I'm honored to be able to present our data, which speaks to the importance of the work being done at the company as well as the broad and significant potential of AVM0703," Dr. Deisher said.

Acute suprapharmacologic dexamethasone sodium phosphate as AVM0703 mobilizes very active Natural Killer T-cells (NKT) and cytotoxic T-cells. Low doses of generic dexamethasone are currently the standard of care in COVID-19 disease and mitigate cytokine release that can trigger ARDS. The high dose of dexamethasone provided by AVM0703 is expected to provide an added benefit to these patients because NKT cells are programmed to eliminate abnormal cells, whether cancer or virus-infected, or autoreactive cells. Rapid elimination of infected monocytes in COVID-19 patients could reduce ICU stays and decrease long-term lung damage as well as provide long term immunity. Since this treatment is microbial strain independent, it could provide an immediate therapy for future pandemics. AVM Biotechnology is currently enrolling patients with Relapsed Refractory Non-Hodgkin's Lymphoma at several US sites, and has received FDA approval to treat moderate to severe ARDS due to COVID-19 or Influenza, enrolling Q1 2021.

AVM0703 is a patent pending, innovative formulation of dexamethasone. This proprietary formulation does not contain excipients such as benzyl alcohol and parabens used in generic formulations which preclude the safe use of generic versions at the acute doses required to mobilize the AVM0703 novel immune cells. AVM0703 is expected to have therapeutic effects in a variety of blood cancers, solid tumors, Type 1 Diabetes, and infectious diseases. Despite the availability of vaccines and anti-virals, influenza continues to lead to ARDS in a substantial number of patients each year. COVID-19 induced ARDS is also likely to continue to be problematic, even after vaccines are available.

AVM Biotechnology is led by Dr. Theresa Deisher, a biotech veteran with a productive history including 47 patents and four discoveries in clinical trials. AVM's COO, Janet R. Rea, has a proven track record working with federal regulators and successfully bringing drugs to market. The Executive Board is comprised of world leaders in the areas of respiratory illness, regulatory affairs, and vaccine development, and AVM is guided by a global Advisory Board that includes well-respected leaders in the areas of cancer and immunology. The company has received two federal SBIR grants and holds eight worldwide patent families protecting its intellectual property. AVM is committed to transforming the future of immunotherapy while reducing the potential for undesirable treatment side effects.

Contact Jena Dalpez Director of Communications and Public Relations [emailprotected]

This contains certain statements that constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not relate strictly to historical or current facts and they may be accompanied by words such as "could," "would," "may," "potentially," "suggest," "believes," "expects," "should," and similar words or expressions. These forward-looking statements reflect our current views as of the date this is published, and are subject to risks, uncertainties, assumptions, changes in circumstances, and other factors; drug development and commercialization are highly risky and early clinical results in animals or humans may not reflect the full results from later stage or larger scale clinical trials. These forward-looking statements are subject to risks and uncertainties that could cause our actual results, performance, and expectations to differ materially from those expressed or implied by these statements, including statements about: future and ongoing drug development and timing; the applications of drugs to specific diseases; the potential for ongoing preclinical or clinical trial results; FDA or other regulatory findings and approvals; potential market opportunities; and the occurrence of future events or circumstances. There are risks and uncertainties involving and not limited to our ability to progress in our research and development efforts, complete clinical testing, achieve our expected results, commercialize our products, avoid infringement of patients, trademarks and other proprietary rights of third parties, protect products from competition, navigate the political environment, maintain sufficient capital and funding, avoid problems with our manufacturing processes, maintain our operations, and obtain regulatory approval to sell and market the drugs in the United States and elsewhere. The reader should not place any undue reliance on such forward-looking statements. We have no obligation to release publicly the results of any revisions to any of our forward-looking statements to reflect events or circumstances after the date these statements are made or to reflect the occurrence of unanticipated events, except as may be required by law.

SOURCE AVM Biotechnology, LLC

http://www.avmbiotech.com

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AVM Biotechnology President Selected to Speak at ESWI Conference in Novel and Outstanding Discoveries Track - PRNewswire

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Agricultural Biotechnology Market Research Report: Overview With Geographical Segmentation By Revenue With Forecast 2026 – The Haitian-Caribbean News…

December 4th, 2020 12:01 am

The researchoffers a comprehensive analysis of the Agricultural BiotechnologyMarket. Bringing out the complete key insights of the industry, the report aims to provide an insight into the latest trends, current market scenario, and technologies related to the market. In addition, it helps the venture capitalists to understand the revenue opportunities across different segments to make better decisions. Global Agricultural Biotechnology market provides a detailed report which covers market analyses before COVID19 & opportunities after this pandemic. With COVID-19 pandemic, many industries are transforming rapidly. The Global Agricultural Biotechnology Market is one of the major industries undergoing changes. This year many industries have vanished entirely from the market and many industries have risen.

Moreover, the government-backed schemes throughout the globe are offering many advantages to businesses. As the governing bodies are supporting the industries, it be a strong pillar to support the market growth of Agricultural Biotechnology in the upcoming decade (2020-2026). Organizations planning to move into new market segments can take the help of market indicators to draw a business plan. With the technological boom, new markets are blossoming across the globe, making it a breeding ground for new businesses.

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Global Agricultural Biotechnology Market 2020: Covering both the industrial and the commercial aspects of the Global Agricultural Biotechnology Market, the report encircles several crucial chapters that give the report an extra edge. The Global Agricultural Biotechnology Market report deep dives into several parts of the report that plays a crucial role in getting the holistic view of the report. The list of such crucial aspects of the report includes company profile, industry analysis, competitive dashboard, comparative analysis of the key players, regional analysis with further analysis country wise.

Global Agricultural Biotechnology Market Analysis by Key Players:

Moreover, one of the uniqueness in the report is that it also covers the country-level analysis of the regulatory scenario, technology penetration, predictive trends, and prescriptive trends. This not only gives the readers of the report the actual real-time insights but also gives country-wise analysis, that plays a vital role in decision making. The inclusion of the report is not limited to the above mention key pointers. The report also emphasizes on the market opportunities, porters five forces, and analysis of the different types of products and application of the Global Agricultural Biotechnology Market.

The report splits by major applications:

Then report analyzed by types:

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Global Agricultural Biotechnology Market Report is a professional and in-depth research report on the worlds major regional market conditions of the Agricultural Biotechnology industry, focusing on the main regions and the main countries as Follows:

COVID-19 Impact on Agricultural Biotechnology Market:

The outbreak of COVID-19 has brought along a global recession, which has impacted several industries. Along with this impact COVID Pandemic has also generated few new business opportunities for Agricultural Biotechnology Market. Overall competitive landscape and market dynamics of Agricultural Biotechnology has been disrupted due to this pandemic. All these disruptions and impacts has been analysed quantifiably in this report, which is backed by market trends, events and revenue shift analysis. COVID impact analysis also covers strategic adjustments for Tier 1, 2 and 3 players of Agricultural Biotechnology Market.

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Table of Contents Includes Major Pointes as follows:

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Agricultural Biotechnology Market Research Report: Overview With Geographical Segmentation By Revenue With Forecast 2026 - The Haitian-Caribbean News...

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Where Does Chanticleer Holdings Common Stock (SONN) Stock Fall in the Biotechnology Field? – InvestorsObserver

December 4th, 2020 12:01 am

A rating of 44 puts Chanticleer Holdings Common Stock (SONN) near the middle of the Biotechnology industry according to InvestorsObserver. Chanticleer Holdings Common Stock's score of 44 means it scores higher than 44% of stocks in the industry. Chanticleer Holdings Common Stock also received an overall rating of 42, putting it above 42% of all stocks. Biotechnology is ranked 35 out of the 148 industries.

Analyzing stocks can be hard. There are tons of numbers and ratios, and it can be hard to remember what they all mean and what counts as good for a given value. InvestorsObserver ranks stocks on eight different metrics. We percentile rank most of our scores to make it easy for investors to understand. A score of 42 means the stock is more attractive than 42 percent of stocks.

Our proprietary scoring system captures technical factors, fundamental analysis and the opinions of analysts on Wall Street. This makes InvestorsObservers overall rating a great way to get started, regardless of your investing style. Percentile-ranked scores are also easy to understand. A score of 100 is the top and a 0 is the bottom. Theres no need to try to remember what is good for a bunch of complicated ratios, just pay attention to which numbers are the highest.

Chanticleer Holdings Common Stock (SONN) stock has fallen -3.79% while the S&P 500 has risen 0.15% as of 12:21 PM on Thursday, Dec 3. SONN is lower by -$0.10 from the previous closing price of $2.61 on volume of 250,062 shares. Over the past year the S&P 500 has gained 18.04% while SONN is lower by -84.46%. SONN lost -$37.00 per share the over the last 12 months.

Click Here to get the full Stock Score Report on Chanticleer Holdings Common Stock (SONN) Stock.

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Where Does Chanticleer Holdings Common Stock (SONN) Stock Fall in the Biotechnology Field? - InvestorsObserver

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Eluminex Biosciences, an Ophthalmology-Focused Biotechnology Company, Announces Closing of $50 Million Series A Financing – PRNewswire

December 4th, 2020 12:01 am

SHANGHAI, Nov. 27, 2020 /PRNewswire/ -- Eluminex Biosciences Limited (Eluminex), an ophthalmic biotechnology company committed to the discovery and development of first-in-class and/or best-in-class therapies, today announced the completion of a $50 million (USD) Series A Financing co-led by Lilly Asia Ventures, GL Ventures (venture capital arm of Hillhouse Capital), and Quan Capital. The Eluminex headquarters and research and development center are located in Suzhou Industrial Park; the business center is based in Shanghai, and future plans include establishing a global clinical and registration center in the San Francisco Bay Area.

"We greatly appreciate the profound level of support and trust from three global investors,"said Jinzhong Zhang, PhD, Co-Founder, Chairman, and Chief Executive Officer. "With these proceeds, our goal is to build an innovative pipeline addressing critical unmet medical needs in vision-threatening diseases for patients worldwide. Additionally, we are pleased to have three world-renowned professors of ophthalmology as members of our Scientific Advisory Board: Quan Dong Nguyen, MD, MSc (Stanford University), Zuguo Liu, MD, PhD (Xiamen University), and Xiaodong Sun, MD, PhD (Shanghai Jiao Tong University). We are grateful for their significant contributions in helping us develop our pipeline programs."

The company also announced that Charles Semba, MD, has joined Eluminex as Chief Medical Officer (CMO). Dr. Semba is an internationally recognized leader in ophthalmic drug development. He has served as CMO in three prior ophthalmic companies: SARcode Bioscience (acquired by Shire/Takeda), ForSight VISION5 (acquired by Allergan), and Graybug Vision (NASDAQ: GRAY). He has held senior leadership roles as Vice President Ophthalmic Medicine at Shire/Takeda and Ophthalmology Group Head at Genentech. Dr. Semba led the clinical development of ranibizumab (LUCENTIS), the first global blockbuster anti-VEGF agent to reverse blindness in wet age-related macular degeneration and lifitegrast (XIIDRA), the first novel agent for the treatment of both signs and symptoms of dry eye disease; XIIDRA was acquired by Novartis for over $5 billion (USD).

Regarding the success of this financing, all parties have expressed their confidence and expectations for the new company. "Closing Series A financing is indeed a major milestone. The leadership at Eluminex should be congratulated for this impressive achievement amidst current global events," commented Dr. Nguyen, Professor of Ophthalmology at the Byers Eye Institute, Stanford University. "Such financial success and security demonstrate the trusts that the company has earned from the investment community in Eluminex's research and development therapeutic plans to preserve and enhance vision for patients with devastating ocular diseases worldwide."

"Driven by an aging population and overuse of eyes in various ages, the ophthalmic market is seeing huge unmet needs for new products. The team's solid track record and rich experience in ophthalmic drug development enables the company to develop innovative therapies not only for China but also for the global market. We are thrilled and honored to join hands with this seasoned team and partner with the reputable investors from the very beginning," said Stephen Lin, Partner at Lilly Asia Ventures.

"The founding team of Eluminex Biosciences has rich experience in drug development and innovation with great potential in the future. Hillhouse will help Eluminex continue to innovate, research and develop leading ophthalmic disease treatment drugs, meeting the needs of a large number of patients, and continue to create social well-being," said Michael Yi, Partner and Co-Chief Investment Officer of Hillhouse Capital Group.

"Quan Capital is committed to foster innovation and bring new solutions to patients with great unmet needs. We are pleased to co-lead the Series A round of Eluminex and are truly impressed by the stellar management team," said Marietta Wu, Managing Director of Quan Capital. "We believe this team of seasoned industry veterans both globally and in China will build a leader in ophthalmology with accelerated development of novel therapeutics. Quan looks forward to working closely with the team and contributing our local resources and global networks."

About Eluminex Biosciences

Eluminex was established in February 2020 with the commitment to leading the development of novel therapeutics for the benefit of patients with vision-threatening eye diseases worldwide. Co-Founders, Dr. Jinzhong Zhang and Dr. Zhenze John Hu, have assembled a top tier management team with significant ophthalmic drug development experience, aiming to build a robust and sustainable innovative ophthalmic pipeline to tackle the unmet clinical needs. For detailed information contact Zhenze John Hu at [emailprotected]

About Lilly Ventures Asia

Lilly Asia Ventures (LAV) is a leading biomedical venture capital firm founded in 2008, with offices in Shanghai, Hong Kong, and Menlo Park. LAV's vision is to become the trusted partner for exceptional entrepreneurs seeking smart capital and to build great companies developing breakthrough products that can treat diseases and improve human health.For more information, visit http://www.lillyasiaventures.com.

About GL Ventures

GL Ventures focuses on early-stage innovative companies in healthcare, software services, consumer Internet, emerging consumer brands and services. The GL Ventures team is passionate about partnering with visionary entrepreneurs to create industry leaders that stand the test of time. GL Ventures is the early stage affiliate of Hillhouse Capital, and we have been investing with innovators across the world since 2005. We were one of the earliest investors into some of the largest global companies today, including BeiGene, Zoom, Meituan, JD, Woowa Brothers and many more.

About Quan Capital

Quan Capital (Quan) is a life sciences venture capital firm with strong China expertise and global capabilities. Quan discovers, incubates, and grows next-generation life science companies in early and growth stage, worldwide. Their portfolio companies pioneer differentiated therapies and enabling technologies to address major human diseases with high unmet medical needs. With offices in Shanghai, Palo Alto and Boston, Quan's investment professionals combine their strong expertise in both science and business with their diverse experiences in global drug development and healthcare investments, and leverage their broad network worldwide to help maximize the company's value across geographies and development stages.For more information, visit http://www.quancapital.com.

SOURCE Eluminex Biosciences

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Eluminex Biosciences, an Ophthalmology-Focused Biotechnology Company, Announces Closing of $50 Million Series A Financing - PRNewswire

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Utah District Court Dismisses Putative Securities Class Action Against Biotechnology Firm For Failure To Allege Falsity And Loss Causation – JD Supra

December 4th, 2020 12:01 am

On November 22, 2020, Judge Howard C. Nielson, Jr. of the United States District Court for the District of Utah dismissed with prejudice a putative class action asserting claims under the Securities Exchange Act of 1934 against a biotechnology company and certain of its executives. In re PolarityTE, Inc. Sec. Litig., No. 2:18-cv-00510, 2020 WL 6873798 (D. Utah Nov. 22, 2020). Plaintiffs alleged that the company made material misstatements in the course of a reverse merger and in subsequent SEC filings. The Court held that plaintiffs failed to adequately allege falsity with respect to certain challenged statements and failed to establish loss causation for the remainder.

Plaintiffs alleged that the company made misstatements concerning: (1) the companys registration of a product with the FDA under a particular provision of the Public Health Service Act, which the company ultimately abandoned and refiled under a different provision after the FDA disagreed with the companys original approach, id. at *3-4; (2) the quality of the companys manufacturing facilities, in light of violations reported by the FDA, id. at *4; (3) the companys patents, including with respect to an application for which the company had received a non-final rejection a week before the merger closed and subsequently received a final rejection, id. at *2; and (4) the non-existence of any pending or contemplated government proceedings against the company, in light of the company having received a document request from the SEC after reporting to the SEC suspicious trading of its stock. Id. at *5.

The Court first assessed the companys statements regarding its products registration with the FDA and concluded that plaintiffs likely failed to allege a material misstatement, id. at *8, because the challenged statements were either true (to the extent they preceded the companys announcement that it intended to proceed under a different regulatory scheme) or constituted statements of opinion as to whether it was appropriate to pursue registration under the framework originally chosen by the company. Id. at *8. The Court further stated that plaintiffs likely fail[ed] to allege that the company lacked any factual basis for its opinions, thus rendering the opinions nonactionable. Id.

The Court did not, however, definitively determine whether a material misrepresentation had been alleged with regard to the registration issues, relying instead on its conclusion that plaintiffs failed to allege loss causation because the purported corrective disclosures (articles published regarding the company) relied on information previously disclosed to the market. Id. at *9. While noting that the Tenth Circuit had not squarely addressed the issue, the Court observed that other Circuits have held that, to qualify as a corrective disclosure, the disclosure must reveal non-public information. Id. at *6. Here, however, the articles plaintiffs relied upon did not actually reveal any then-undisclosed facts; instead, all the materials the articles referenced were publicly available. Id. at *9. Furthermore, the Court explained that, although some courts have ruled that expert analysis of publicly available information could constitute a corrective disclosure, there was no indication that the authors of the articles relied upon by plaintiffs had any expertise beyond that of careful investors. Id.

The Court next assessed plaintiffs allegations that the companys statements concerning the quality of its manufacturing facilities were materially misleading because the FDA had reported violations in July 2018. Id. at *10. The Court concluded that the challenged statements were either puffery or, in any event, plaintiffs failed to allege how the statements were rendered false by the FDAs findings. Id. While noting that the company had received the FDAs report before the challenged statements were made, the Court emphasized that the FDA had not made a final determination at the time, and that ultimately the FDA closed the inspection indicating that the allegedly objectionable conditions [did] not meet the threshold of regulatory significance. Id. Furthermore, the Court noted that two months passed between the FDAs inspection and the statements in question, during which time it appear[ed] that [the company] had made at least some improvements to its processes in response to the FDAs concerns. Id. at *11. In light of those circumstances, the Court concluded that the FDAs report does not support a reasonable inference that the individual who made the statements did not believe the puffing statements of corporate optimism. Id. at *11.

Turning to statements concerning the companys patents, the Court first noted that statements by the company that its products were subject to pending patent applications were true. Id. To the extent the company erroneously described certain technology as patented, the Court reasoned that those statements were immaterial because other company statements made clear that the technology at issue was not presently protected by existing patents but was rather the subject of pending patent applications. Id. The Court reasoned that, to the extent these statements were conflicting, that would have given a reasonable investor sufficient pause to warrant independent verification. Id. at *12. While the Court thus concluded that plaintiffs likely failed to adequately allege a material misstatement, id. at *11, it held that, regardless, plaintiffs again failed to adequately allege loss causation because the articles relied on as corrective disclosures were based on previously available information. Id. at *12.

Finally, the Court rejected plaintiffs argument that the companys statements about not being subject to any pending or contemplated governmental proceedings were false because the company had received a document request from the SEC. Id. at *13. The Court concluded that an isolated document request is not an investigation, and, in context, it was not reasonable to believe the company should have expected the SEC to conduct an investigation based on the request received. Id. The Court also observed that, even if an investigation had been contemplated, the companys statement was not false because [a]n investigation on its own is not a pending legal proceeding, and the SEC had not informed the company that it was contemplating further action. Id.

Because plaintiffs had not filed a motion seeking leave to amend, the Court dismissed the action with prejudice. Id.

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Utah District Court Dismisses Putative Securities Class Action Against Biotechnology Firm For Failure To Allege Falsity And Loss Causation - JD Supra

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Global Biotechnology/ Pharmaceutical Services Outsourcing Market Expected to reach highest CAGR in forecast period :Quantic Group, QuintilesIMS,…

December 4th, 2020 12:01 am

Global Biotechnology/ Pharmaceutical Services Outsourcing market is anticipated to embark on a nail-biting growth trajectory identified with several core factors and elements such as dominant trends and technological developments, along with prominent growth drivers and retardants that collectively influence overall growth scenario in global Biotechnology/ Pharmaceutical Services Outsourcing market. Further in the report readers are offered details on competition mapping that includes details on complete overview of major players. This section of the report categorically focuses on the versatility of manufacturer segment, highlighting prominent players. Each vendor profile has been assessed on the basis of stringent analytical parameters and research practices such as SWOT analysis.

As per high end research initiatives carried out by expert researchers and analysts, global Biotechnology/ Pharmaceutical Services Outsourcing market is likely to experience rampant growth upsurge, highlighting a favorable CAGR percentage throughout the growth span. Based on in-depth micro and macro-economic growth factors, global Biotechnology/ Pharmaceutical Services Outsourcing market is anticipated to demonstrate high potential growth and is anticipated to echo past growth trends even in the coming years.

The study encompasses profiles of major companies operating in the Biotechnology/ Pharmaceutical Services Outsourcing Market. Key players profiled in the report includes:

Quantic GroupQuintilesIMSParexel International CorporationLachman AssociatesGMP PharmaceuticalsManagement ForumQuality ContextInspired PharmaConcept Heidelberg GmbHRSSL_LIST

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Detailed Indicator Analysis: Global Biotechnology/ Pharmaceutical Services Outsourcing Market

This segment assessment clearly focuses on the array of novel changes and new investments made by market forerunners towards improving product qualities to align with end-use needs.The segmentation section of the market is diversified primarily it product and service based segmentation followed by application. Emphasis on other associated segment analysis have also been roped in the report.

The report also gauges into market performance and profitability ratio across a vast array of geographical domains to understand most dominant trends, manufacturer investments and end-user preferences across five different regions, besides also including prominent development leads across several countries.

By the product type, the market is primarily split into

ConsultingAuditing & AssessmentRegulatory AffairsProduct MaintenanceProduct Design & DevelopmentProduct Testing & ValidationTraining & EducationOthers_LIST

By the end-users/application, this report covers the following segments

Regenerative MedicineBiobankingDrug Discovery_LIST

Global Biotechnology/ Pharmaceutical Services Outsourcing Market Segment Analysis The report includes actionable insights and relevant data on diverse product offerings inclusive of product specifications, their revenue generation potential as well as manufacturer investments in product improvisation and consumer response in the area. Based on application segments, this versatile research report on global Biotechnology/ Pharmaceutical Services Outsourcing market elaborates end-user and application specific milestones for best reader experience and guidance. Various market sub-segments are also highlighted in the report besides moving forward with CAGR performance in the forecast tenure.

Browse Full Report with Facts and Figures of Biotechnology/ Pharmaceutical Services Outsourcing Market Report at @ https://www.orbismarketreports.com/global-biotechnology-pharmaceutical-services-outsourcing-market-analysis-by-growth-and-forecast-2025?utm_source=PujaM

Detail Trend Analysis The report progresses further with minute detailing of dominant as well as contributing trends that largely influence growth prognosis. A thorough reference of technological innovations, product and service-based developments as well as policy alterations, funding schemes and the like are monitored aggressively to make appropriate deductions.

Geographical Segmentation and Competition Analysis North America (U.S., Canada, Mexico) Europe (U.K., France, Germany, Spain, Italy, Central & Eastern Europe, CIS) Asia Pacific (China, Japan, South Korea, ASEAN, India, Rest of Asia Pacific) Latin America (Brazil, Rest of L.A.) Middle East and Africa (Turkey, GCC, Rest of Middle East)

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Report Highlights: A dedicated interpretation of innovative technological developments align with value and volume based assessment of the global Biotechnology/ Pharmaceutical Services Outsourcing market has been orchestrated The report is in place to invoke tremendous revenue generation initiatives by carrying out thorough assessment of market dimensions in a bid to deduce market progression in terms of value and volume based market developments The performance of each of the prominent segments, along with elaborate assessment of opportunity mapping, SWOT and PESTEL analysis along with data triangulation methodologies have been meticulously pinned in the report These minute report details allow market participants and stakeholders to optimally understand the growth potential of the market, thus encouraging future ready investment decisions The illustrative market research report is a brainchild creation to identify prevalent market threats, evaluate barrier limitations besides roping in details on growth stimuli that foster growth.

At the end of the report, readers are expected to understand the following market scenarios:

About Us : With unfailing market gauging skills, has been excelling in curating tailored business intelligence data across industry verticals. Constantly thriving to expand our skill development, our strength lies in dedicated intellectuals with dynamic problem solving intent, ever willing to mold boundaries to scale heights in market interpretation.

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Global Biotechnology/ Pharmaceutical Services Outsourcing Market Expected to reach highest CAGR in forecast period :Quantic Group, QuintilesIMS,...

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Pandemic Impact Outlook on Pharmaceutical and Biotechnology Market and Latest Developments during the forecasted period – Khabar South Asia

December 4th, 2020 12:01 am

The Pharmaceutical and Biotechnology Market research report recently presentedby Prophecy Market Insights which provides reliable and sincere insights related to the various segments and sub-segments of the market. The market study throws light on the various factors that are projected to impact the overall dynamics of the Pharmaceutical and Biotechnology market over the forecast period (2019-2029).

Influences of the market report:

An executive summary provides the markets definition, application, overview, classifications, product specifications, manufacturing processes; raw materials, and cost structures.

Market Dynamics offers drivers, restraints, challenges, trends, and opportunities of the Pharmaceutical and Biotechnology market

Segment Level Analysis in terms of types, product, geography, demography, etc. along with market size forecast

Get Sample Copy of This Report @ https://www.prophecymarketinsights.com/market_insight/Insight/request-sample/881

Regional and Country- level Analysis different geographical areas are studied deeply and an economical scenario has been offered to support new entrants, leading market players, and investors to regulate emerging economies. The top producers and consumers focus on production, product capacity, value, consumption, growth opportunity, and market share in these key regions, covering

Australia, New Zealand, Rest of Asia-Pacific

Stakeholders Benefit:

Segmentation Overview:

By Product Type(Vaccines (Recombinant Vaccines, Conventional Vaccines, Recombinant Enzymes, Cell and Gene Therapies and Other Product Types) and Synthetic Immuno-modulators (Cytokines, Interferones, Interleukins and Tumor Necrosis Factor))

By Therapeutic Application (Oncology, Inflammatory and Infectious Diseases, Autoimmune Disorders, Metabolic Disorders, Hormonal Disorders, Disease Prevention, Cardiovascular Diseases, Neurological Diseases and Other Diseases)

By Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa)

The Pharmaceutical and Biotechnology research study comprises 100+ market data Tables, Graphs & Figures, Pie Chat to understand detailed analysis of the market. The predictions estimated in the market report have been resulted in using proven research techniques, methodologies, and assumptions. This Pharmaceutical and Biotechnology market report states the market overview, historical data along with size, growth, share, demand, and revenue of the global industry.

Download PDF Brochure for report overview @ https://www.prophecymarketinsights.com/market_insight/Insight/request-pdf/881

Competitive landscape Analysis provides mergers and acquisitions, collaborations along with new product launches, heat map analysis, and market presence and specificity analysis.

Highlights of the Report

Complete access to COVID-19 Impact on the Pharmaceutical and Biotechnology market dynamics, key regions, market size, growth rate and forecast to 2029

The report on the Pharmaceutical and Biotechnology market includes an assessment of the market, trends, segments, and regional markets. Overview and dynamics have been included in the report.

Get In-depth TOC @ https://www.prophecymarketinsights.com/market_insight/Global-Pharmaceutical-and-Biotechnology-Market-881

Some important Questions Answered in Pharmaceutical and Biotechnology Market Report are:

Pharmaceutical and Biotechnology Market by Top Manufacturers:

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About us:

Prophecy Market Insights is specialized market research, analytics, marketing/business strategy, and solutions that offers strategic and tactical support to clients for making well-informed business decisions and to identify and achieve high-value opportunities in the target business area. We also help our clients to address business challenges and provide the best possible solutions to overcome them and transform their business.

Contact Us:

Mr. Alex (Sales Manager)

Prophecy Market Insights

Phone: +1 860 531 2701

Email: [emailprotected]

Excerpt from:
Pandemic Impact Outlook on Pharmaceutical and Biotechnology Market and Latest Developments during the forecasted period - Khabar South Asia

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Impact of Covid-19 on Biotechnology Separation Systems Market 2020 | Top Business Growing Strategies, Technological Innovation and Emerging Trends of…

December 4th, 2020 12:01 am

Up-To-Date research on Biotechnology Separation Systems Market 2020-2026 :

The Reputed Garner Insights website offers vast reports on different market.They cover all industry and these reports are very precise and reliable. It also offers Biotechnology Separation Systems Market Report 2020 in its research report store. It is the most comprehensive report available on this market. The report study provides information on market trends and development, drivers, capacities, technologies, and on the changing investment structure of the Global Biotechnology Separation Systems Market.

The market is segmented into different sections such as: by product type, by application, by end-users, by deployment mode, and by key geography. The report then employs market breakdown and data triangulation procedures to complete the overall market engineering process and arrive at the exact statistics for all segments and sub-segments. The report on the Global Biotechnology Separation Systems Markethas been curated by analyzing the top players functioning in the market. In order to get an in-depth analysis of the market, the report carried out SWOT analysis, Porters five forces analysis, and Pestel analysis.

Request Sample Report of Global Biotechnology Separation Systems Market https://garnerinsights.com/Biotechnology-Separation-Systems-Market-Status-and-Trend-Analysis-2017-2026-COVID-19-Version#request-sample

Some of the major geographies included in the market are given below:North America (U.S., Canada)Europe (U.K., Germany, France, Italy)Asia Pacific (China, India, Japan, Singapore, Malaysia)Latin America (Brazil, Mexico)Middle East & Africa

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Components of the Biotechnology Separation Systems Market report:-A detailed assessment of all opportunities and risk in this Market.-Recent innovations and major events-A comprehensive study of business strategies for the growth of the Biotechnology Separation Systems leading market players.-Conclusive study about the growth plot of Biotechnology Separation Systems Market for the upcoming years.-Understanding of Biotechnology Separation Systems Industry-particular drivers, constraints and major micro markets in detail.-An evident impression of vital technological and latest market trends striking theMarket.

The objectives of the study are as follows:

View Full Report @ https://garnerinsights.com/Biotechnology-Separation-Systems-Market-Status-and-Trend-Analysis-2017-2026-COVID-19-Version

Contact UsKevin ThomasEmail: sales@garnerinsights.comContact No:+1 513 549 5911 (US) | +44 203 318 2846 (UK)

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Impact of Covid-19 on Biotechnology Separation Systems Market 2020 | Top Business Growing Strategies, Technological Innovation and Emerging Trends of...

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