Category Archives: Biotechnology

WASHINGTON, D.C. In recognition of National Biotechnology Month, the U.S. Department of Agriculture (USDA), the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) recently launched a unified website for biotechnology regulation.

The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part President Donald J. Trumps Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

Agricultural biotechnology has been and will continue to be an essential tool in helping Americas farmers and ranchers feed, fuel and clothe the world, said U.S. Secretary of Agriculture Sonny Perdue.

From producers to consumers, all Americans deserve a government that delivers science-based, common-sense regulations that foster innovation, conserve resources, and protect public healthespecially when it comes to the food supply, said Perdue.

The launch of this unified biotechnology regulation website is proof of President Trumps commitment to provide the American people with sensible regulations in a clear and transparent manner.

EPA is pleased to be working with our partners at USDA, FDA, and across the federal government to implement President Trumps Executive Order and launch this new, coordinated website, said EPA Administrator Wheeler.

This new website will help provide regulatory certainty and clarity to our nations farmers and producers by bringing together information on the full suite of actions the Trump Administration is taking to safely reduce unnecessary regulations and breakdown barriers for these biotechnology products in the marketplace, Wheeler said.

This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace, said FDA Commissioner Stephen Hahn, M.D.

At the FDA, we are committed to fostering flexible, risk-based approaches in this field while upholding our mission of protecting and promoting both human and animal health and animal well-being, Hahn said.

For example, by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Our approach balances our internationally respected, science-based review standards, Hahn said, with our ongoing risk-based regulatory approaches to ensure the safety of our food supply.

Background

The Unified Website for Biotechnology Regulation describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies.

The goals of this website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations.

For more information, visit https://usbiotechnologyregulation.mrp.usda.gov/biotechnologygov/home/.

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Unified website for biotechnology regulation recently launched - Daily Herald

Theres a profound disconnect between what the latest gene-editing methods can do to increase yields and enhance crop disease and stress resistance and the trickle of such improved crops actually getting out into farmers fields.

The first generation of genetically modified (GM) crops has been remarkably successful. The whole world eats food containing ingredients derived from GM crops and feeds them to its myriad agricultural animals and pets. Despite many dire predictions of long-term negative health effects, a quarter century has passed and none have materialized.1 This remarkably clean track record should have assuaged public fears and assured the rapid development and adoption of GM crops of all kinds.

But it hasnt.

Decades after four major commodity biotech crops corn, soybeans, cotton and canola were introduced and rapidly soared to near market saturation in the countries that permitted their cultivation, the number of new GM crops being released to farmers remains tiny.

[Editors note: This article is part one of a four-part series on the progress of agricultural biotechnology. Read part two and part three.]

Yet the need for higher yielding, disease-resistant and stress-tolerant crops grows with each passing year. The pressures of population growth and climate warming are already outpacing the speed with which conventional breeding practices are expanding the global food supply.2 Land and water availability are rapidly becoming limiting, hence the focus is sharply on the intensification of agriculture.3 But the breeding methods that fueled the spectacular advances in agricultural productivity over the 20th century are near exhaustion.

Over the same period, knowledge of plant physiology and genetics has grown at an explosive pace, as has the technology for identifying and modifying genes of agronomic interest. We know vastly more about what genes do and how plant genomes change both naturally and under human intervention than we did even when the first GM crops were introduced in 1996.4

The recent invention and rapid development of gene- or genome-editing technology (aka SSN or sequence-specific nuclease technology) has facilitated a quantum leap in the ease and precision of genetic intervention, positioning researchers to accelerate the increase in crop yields and to make crop plants more resilient to the biotic and abiotic stresses exacerbated by climate warming.5

Yet just a few of the crops that need to be improved are being improved using the latest techniques and of those, only a few reach farmers each year. To understand this deep disconnect between what can be done to improve crops using modern molecular techniques and what is being done requires a look at the tangle of issues around GM technology at the interface between science, business and society.

In this four-part series, I first examine the factors that led to the disconnect between what can be done and what is being done. I then review both the successes and failures of the first generation of GM crops modified using recombinant DNA (rDNA) technology. I next introduce the new gene-editing technologies and what they promise. And finally, I take a look at the regulatory, political and business decisions that actually determine what gets out of research laboratories and into farmers fields. The entire essay is available as a single publication from the author. Please email [emailprotected].

Part 1: The origins of the disconnect between the science and the farmer

Public resistance to innovation is not unusual, but hardly universal. People line up for the newest Apple iPhone, but have to be persuaded to try a GM apple that doesnt turn brown. Resistance generally subsides as a technology is widely adopted and proves harmless. GM technology in medicine, for example, is now broadly accepted, be it human insulin or any of the many new protein-based therapeutics. But the controversies around GM crops have persisted, and indeed intensified through the deliberate vilification efforts of both individuals and organizations.6,7

According to polls, the public remains largely ignorant of what GM organisms (GMOs) are and of how modern molecular methods fit into the long history of crop improvement.8 Because fear-based disinformation strategies are so effective, what has grown instead is the widespread conviction that GMOs are bad, meaning variously that they are harmful to health, unnatural, or produced by big biotech companies that unfairly exploit farmers.7,9

Part of the problem is that public awareness of genetic modification in agriculture is recent, arguably dating back only to the late 1980s when controversies erupted over field testing of the so-called ice-minus bacterium modified to eliminate a protein that promotes ice formation on the leaves of strawberries.10 Yet in a strictly scientific context, genetic modification denotes the entire spectrum of human interventions in the genetics of other organisms over more than 10 millenia.11

For crop plants, these encompass domestication, breeding, mutation breeding and, most recently, genetic improvement by molecular techniques. All involve genetic changes, aka mutations. Domestication and conventional plant breeding rely on organisms inherent genetic variation.

Direct genetic manipulation of crop plants using chemical and radiation mutagenesis (mutation breeding) dates back to the 1930s.12 But even now, few people other than plant breeders are aware that crops have long been improved through deliberate efforts to induce new mutations using both chemicals and irradiation. So today, it is the general understanding that genetically modified organisms (GMOs) are only those that have been modified by molecular methods. That is, most people think genetic modification is quite new.

And then theres what the regulators built

As if this were not sufficiently problematic, the way in which the regulatory environment evolved reinforced suspicions about GM safety. Early efforts to regulate the commercial introduction of GM crops emphasized the need to regulate new crop traits rather than the particular method by which they were introduced. But thats not what happened.

Starting from the beginning of the regulatory activities in the late 1980s, the U.S. agencies that oversee GM organisms have regulated only organisms modified by molecular methods and theyve regulated all of them, without regard to either nature of the organism or the trait that was added.13 This has been true of the US Department of Agriculture (USDA) and the Environmental Protection Agency (EPA), although the Food and Drug Administration has generally followed its practice of post-market oversight. None of the agencies subjected new crop varieties produced by the older methods of chemical and radiation mutagenesis to regulatory oversight.

Complying with the regulatory requirements proved not only time consuming and prohibitively expensive to developers,14 but also reinforced the altogether unfounded popular conviction that molecular methodology is dangerous. Both negative popular views of GM foods and the high regulatory costs associated with their introduction have shaped the present availability of GMOs in agriculture. Indeed, it is virtually impossible to understand the contemporary paucity of GM crop varieties without considering both regulatory and acceptance issues.

The recent development of gene-editing methods has led to a new round of public and bureaucratic controversy worldwide over what should be classified as a GMO and subject to regulatory oversight. Because gene-editing techniques15 introduce the same kinds of mutations as the older mutagenesis methods, crops modified by gene editing can be indistinguishable at the molecular level from those improved by mutation breeding.

Mutation breeding has been in safe use for a century, hence there is no scientifically defensible rationale for imposing regulations on crops with the same kinds of genetic changes produced by the new, far more precise methods. This is being recognized in some countries by decreasing the regulatory burden on certain types of crop modifications produced by gene-editing techniques.

However, in 2018 the European Court of Justice ruled that gene-edited crops should undergo the same level of regulatory scrutiny as crops modified by older molecular methods.16 As they have over the past 4 decades, the outcome of such regulatory decisions will profoundly influence the kinds of genetic improvements that will be undertaken and actually become available to farmers and consumers.

Thus both public opinion and regulatory practices have made major contributions to the disconnect between the modern science of crop improvement and the farmer.

1EC (2010). A decade of EUfunded GMO research (20012010). European Commission https://ec.europa.eu/research/biosociety/pdf/a_decade_of_eu-funded_gmo_research.pdf; NASEM (2016). Genetically Engineered Crops: Experiences and Prospects. National Academies of Sciences, Engineering, and Medicine 978-0-309-43735-6 http://www.nap.edu/catalog/23395/genetically-engineered-crops-experiences-and-prospects

2Ray DK et al. (2013). Yield trends are insufficient to double global crop production by 2050. PloS One 8:e66428.

3Tilman D et al. (2011). Global food demand and the sustainable intensification of agriculture. Proc Natl Acad Sci USA 108:20260-4.

4Richroch AE (2013). Assessment of GE food safety using -omics techniques and long-term animal feeding studies. New Biotechnol 30:351-54; Fedoroff NV (2013). Plant transposons and genome dynamics in evolution. (Wiley-Blackwell, Oxford, UK), p.212; Anderson JE et al. (2016). Genomic variation and DNA repair associated with soybean transgenesis: a comparison to cultivars and mutagenized plants. BMC Biotechnol 16:41.

5Podevin N et al. (2013). Site-directed nucleases: a paradigm shift in predictable, knowledge-based plant breeding. Trends Biotechnol 31:375-83; Zhang D et al. (2016). Targeted gene manipulation in plants using the CRISPR/Cas technology. J Genet Genomics 43:251-62; Zhang Y et al. (2019). The emerging and uncultivated potential of CRISPR technology in plant science. Nature Plants 5:778-94.

6Apel A (2010). The costly benefits of opposing agricultural biotechnology. New Biotechnol 27:635-40.

7Ryan CD et al. (2019). Monetizing disinformation in the attention economy: The case of genetically modified organisms (GMOs). European Management J 38:7-18.

8Funk C et al. (2015). Public and scientists views on science and society. Pew Research Center http://www.pewinternet.org/2015/01/29/public-and-scientists-views-on-science-and-society/

9Funk C and Kennedy B (2016). Public opinion about genetically modified foods and trust in scientists connected with these foods. Pew Research Center http://www.pewinternet.org/2016/12/01/public-opinion-about-genetically-modified-foods-and-trust-in-scientists-connected-with-these-foods/

10Palca J (1986). Ice-minus bacteria: Further snag and further delay. Nature 320:2.

11Fedoroff NV (2015). Food in a future of 10 billion. Agricult Food Security 4:11.

12Ahloowalia B et al. (2004). Global impact of mutation-derived varieties. Euphytica 135:187-204.

13Fedoroff NV (2013). Will common sense prevail? Trends Genet 29:188-9; Wolt JD et al. (2016). The regulatory status of genomeedited crops. Plant Biotechnol J 14:510-8; Van Eenennaam A and Fedoroff N. How the federal government can get biotech regulation right. Des Moines Register, 1 March 2018

14McDougall P (2011). The cost and time involved in the discovery, development and authorisation of a new plant biotechnology derived trait. Crop Life International https://croplife.org/plant-biotechnology/regulatory-2/cost-of-bringing-a-biotech-crop-to-market/

15Kleter GA et al. (2019). Gene-edited crops: towards a harmonized safety assessment. Trends Biotechnol 37:443-7.

16Kupferschmidt K (2018). EU verdict on CRISPR crops dismays scientists. Science 361:435.

Nina V. Fedoroff is an Emeritus Evan Pugh Professor atPenn State University

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Viewpoint: How consumer fear and misguided regulation limit the progress of crop biotechnology - Genetic Literacy Project

The 72 rating InvestorsObserver gives to Iovance Biotherapeutics Inc (IOVA) stock puts it near the top of the Biotechnology industry. In addition to scoring higher than 84 percent of stocks in the Biotechnology industry, IOVAs 72 overall rating means the stock scores better than 72 percent of all stocks.

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 72 means the stock is more attractive than 72 percent of stocks.

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.

Iovance Biotherapeutics Inc (IOVA) stock has risen 13.99% while the S&P 500 is unchanged 0% as of 9:50 AM on Tuesday, Apr 14. IOVA is higher by $4.23 from the previous closing price of $30.23 on volume of 285,317 shares. Over the past year the S&P 500 is down -4.95% while IOVA is higher by 209.06%. IOVA lost -$1.59 per share the over the last 12 months.

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Biotechnology Industry: Does Iovance Biotherapeutics Inc (IOVA) Stock Beat its Rivals? - InvestorsObserver

Scientists at the University of California-San Diego say they have moved one step closer to the ability to make heparin in cultured cells. Heparin is a potent anti-coagulant and the most prescribed drug in hospitals, yet cell-culture-based production of heparin is currently not possible, according to the researchers who published their study, ZNF263 is a transcriptional regulator of heparin and heparan sulfate biosynthesis in PNAS.

In particular, the researchers found a critical gene in heparin biosynthesis: ZNF263 (zinc-finger protein 263). The team believes this gene regulator is a key discovery on the way to industrial heparin production. The idea would be to control this regulator in industrial cell lines using genetic engineering, paving the way for safe industrial production of heparin in well-controlled cell culture.

Heparin is the most widely prescribed biopharmaceutical in production globally. Its potent anticoagulant activity and safety makes it the drug of choice for preventing deep vein thrombosis and pulmonary embolism. In 2008, adulterated material was introduced into the heparin supply chain, resulting in several hundred deaths and demonstrating the need for alternate sources of heparin. Heparin is a fractionated form of heparan sulfate derived from animal sources, predominantly from connective tissue mast cells in pig mucosa. While the enzymes involved in heparin biosynthesis are identical to those for heparan sulfate, the factors regulating these enzymes are not understood, write the investigators.

Examination of the promoter regions of all genes involved in heparin/heparan sulfate assembly uncovered a transcription factor-binding motif for ZNF263, a C2H2 zinc finger protein. CRISPR-mediated targeting and siRNA knockdown of ZNF263 in mammalian cell lines and human primary cells led to dramatically increased expression levels of HS3ST1, a key enzyme involved in imparting anticoagulant activity to heparin, and HS3ST3A1, another glucosaminyl 3-O-sulfotransferase expressed in cells. Enhanced 3-O-sulfation increased binding to antithrombin, which enhanced Factor Xa inhibition, and binding of neuropilin-1. Analysis of transcriptomics data showed distinctively low expression of ZNF263 in mast cells compared with other (nonheparin-producing) immune cells. These findings demonstrate a novel regulatory factor in heparan sulfate modification that could further advance the possibility of bioengineering anticoagulant heparin in cultured cells.

The UC San Diego scientists reasoned that heparin synthesis must be under the control of transcription factors, whose tissue-specific occurrence might give mast cells the unique ability to produce heparin. Since regulators for heparin were not known, a research team led by UC San Diego professors Jeffrey Esko, PhD, and Nathan Lewis, PhD, used bioinformatic software to scan the genes encoding enzymes involved in heparin production and specifically look for sequence elements that could represent binding sites for transcription factors. The existence of such a binding site could indicate that the respective gene is regulated by a corresponding gene regulator protein, i.e. a transcription factor.

One DNA sequence that stood out the most is preferred by a transcription factor called ZNF263 (zinc-finger protein 263), explains Lewis, who holds appointments in the UC San Diego School of Medicines Department of Pediatrics and in the UC San Diego Jacobs School of Engineerings Department of Bioengineering.

Using CRISPR/Cas9, the researchers mutated ZNF263 in a human cell line that normally does not produce heparin. They found that the heparan sulfate that this cell line would normally produce was now chemically altered and showed a reactivity that was closer to heparin. Experiments further showed that ZNF263 represses key genes involved in heparin production. Analysis of gene expression data from human white blood cells showed suppression of ZNF263 in mast cells (which produce heparin in vivo) and basophils, which are related to mast cells. The researchers report that ZNF263 appears to be an active repressor of heparin biosynthesis throughout most cell types, and mast cells are enabled to produce heparin because ZNF263 is suppressed in these cells.

This finding could have important relevance in biotechnology. Cell lines used in industry (such as CHO cells that normally are unable to produce heparin) could be genetically modified to inactivate ZNF263 which could enable them to produce heparin, like mast cells do.

Philipp Spahn, PhD, a project scientist in the Lewis lab, described further directions the team is pursuing: Our bioinformatic analysis revealed several additional potential gene regulators which can also contribute to heparin production and are now exciting objects of further study.

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Researchers Move Closer to Industrial Production of Heparin in Cell Culture - Genetic Engineering & Biotechnology News

Vir Biotechnology, Inc. (VIR) is priced at $29.50 after the most recent trading session. At the very opening of the session, the stock price was $29.75 and reached a high price of $29.9, prior to closing the session it reached the value of $29.90. The stock touched a low price of $29.15.

Price records that include history of low and high prices in the period of 52 weeks can tell a lot about the stocks existing status and the future performance. Presently, Vir Biotechnology, Inc. shares are logging -60.67% during the 52-week period from high price, and 153.21% higher than the lowest price point for the same timeframe. The stocks price range for the 52-week period managed to maintain the performance between $11.65 and $75.00.

The companys shares, operating in the sector of healthcare managed to top a trading volume set approximately around 1.32 million for the day, which was evidently higher, when compared to the average daily volumes of the shares.

When it comes to the year-to-date metrics, the Vir Biotechnology, Inc. (VIR) recorded performance in the market was 134.59%, having the revenues showcasing 123.15% on a quarterly basis in comparison with the same period year before. At the time of this writing, the total market value of the company is set at 3.20B, as it employees total of 229 workers.

During the last month, 3 analysts gave the Vir Biotechnology, Inc. a BUY rating, 0 of the polled analysts branded the stock as an OVERWEIGHT, 1 analysts were recommending to HOLD this stock, 1 of them gave the stock UNDERWEIGHT rating, and 0 of the polled analysts provided SELL rating.

According to the data provided on Barchart.com, the moving average of the company in the 100-day period was set at 23.08, with a change in the price was noted +16.65. In a similar fashion, Vir Biotechnology, Inc. posted a movement of +129.57% for the period of last 100 days, recording 687,913 in trading volumes.

Total Debt to Equity Ratio (D/E) can also provide valuable insight into the companys financial health and market status. The debt to equity ratio can be calculated by dividing the present total liabilities of a company by shareholders equity. Debt to Equity thus makes a valuable metrics that describes the debt, company is using in order to support assets, correlating with the value of shareholders equity. The total Debt to Equity ratio for VIR is recording 0.00 at the time of this writing. In addition, long term Debt to Equity ratio is set at 0.00.

Raw Stochastic average of Vir Biotechnology, Inc. in the period of last 50 days is set at 22.76%. The result represents improvement in oppose to Raw Stochastic average for the period of the last 20 days, recording 8.85%. In the last 20 days, the companys Stochastic %K was 9.35% and its Stochastic %D was recorded 9.02%.

Bearing in mind the latest performance of Vir Biotechnology, Inc., several moving trends are noted. Year-to-date Price performance of the companys stock appears to be pessimistic, given the fact the metric is recording 134.59%. The shares increased approximately by 1.57% in the 7-day charts and went up by -19.62% in the period of the last 30 days. Common stock shares were driven by 123.15% during last recorded quarter.

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Reasons Why Long-term Faith on Vir Biotechnology, Inc. (VIR) Could Pay Off Investors - The InvestChronicle

Inovio Pharmaceuticals Inc (INO) is near the top in its industry group according to InvestorsObserver. INO gets an overall rating of 72. That means it scores higher than 72 percent of stocks. Inovio Pharmaceuticals Inc gets a 83 rank in the Biotechnology industry. Biotechnology is number 6 out of 148 industries.

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

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

Inovio Pharmaceuticals Inc (INO) stock has risen 8.82% while the S&P 500 is lower by -0.22% as of 10:32 AM on Thursday, Apr 16. INO is up $0.63 from the previous closing price of $7.14 on volume of 5,210,923 shares. Over the past year the S&P 500 is down -4.25% while INO is up 108.87%. INO lost -$1.21 per share the over the last 12 months.

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Is Inovio Pharmaceuticals Inc (INO) Stock Near the Top of the Biotechnology Industry? - InvestorsObserver

Carl Harald Janson of the International Biotechnology Trust

After a torrid three weeks, financial markets stabilised in recent days in response to the stimulus packages announced both by central banks and governments.

This steadying of performance will enable investors to take a more rational and considered approach.

The impact of quarantines required to bring Covid-19 under control will have profound economic ramifications and while certain sectors will bear the brunt of this hardship, others will play a significant role in helping society to navigate this pandemic.

The race for a vaccine: The investment trust managers combating coronavirus

The biotechnology sector will be integral in developing both treatments and vaccines to control the disease. Some healthcare companies will contribute to the responses to this virus or maintain their existing drug sales while others will see their business models under threat.

One company that should help to control the pandemic is the US biotechnology giant Gilead. It specialises in anti-viral therapies and it has a number of drugs used to treat HIV and a blockbuster therapy for Hepatitis C.

Gilead's experimental drug, remdesivir, is currently undergoing multiple late-stage clinical trials as a potential treatment of Covid-19.

This anti-viral drug was previously tested in humans with ebola and has shown promise in trials of other diseases caused by coronaviruses.

If the drug is shown to be safe and effective for the treatment of Covid-19, it is likely to receive accelerated regulatory approval.

In addition, the company has considerable cash reserves which will help weather any adverse impacts if either remdesivir proves not to be effective or sales of its other drugs falter.

Concept stocks: An opportunity for short sellers

It is not only companies involved directly in the battle against Covid-19 which are likely to continue positively contributing to society.

Genmab has a drug used to treat multiple myeloma. As there is unmet medical need for this condition, patients will continue with this therapy, irrespective of a global downturn.

In addition, the company is profitable and cash generative making it a safe haven for investors.

Another such company is Vertex, which has an oral treatment for patients suffering from cystic fibrosis, enabling them to avoid visiting a hospital at this dangerous time.

This chronic condition will need continuous treatment, which protects the sales of this drug.

Contract research organisations will, however, struggle in the current environment as many clinical trials will be halted as the people operating these medical explorations go into lockdown.

Those companies with limited cash reserves will also be hit hard as they will quickly run out of funds and will find it difficult to raise additional money given the current uncertainty.

Companies providing drugs which are mainly used by the elderly but are not essential, such as treatments for glaucoma and osteoporosis, may see sales falter as this vulnerable patient population avoids doctors' surgeries.

In light of the current situation, the relationship between the healthcare industry and President Donald Trump's administration might change. His re-election chances are dependent on how the pandemic and the economic downturn is handled.

If re-elected, Trump is less likely to clamp down heavily on future drug pricing if the biotech sector has enabled him to control the crisis and get the economy back on track.

Nor is it likely that Joe Biden would, if elected, erode healthcare profit margins as the sector will have helped the US to win the war against Covid-19.

Carl Harald Janson is lead investment manager of the International Biotechnology Trust

A stabilisation in financial markets will help investors act more rationally and select those sectors making a positive contribution.

Biotechnology companies that can develop either treatments or vaccines should perform well, so should those companies whose drug sales will continue despite most healthcare systems being overwhelmed by the treatment of this virus

Bear points

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What impact will Covid-19 have on the biotech sector? - Investment Week

Lets start up with the current stock price of PDS Biotechnology Corporation (PDSB), which is $1.22 to be very precise. The Stock rose vividly during the last session to $1.62 after opening rate of $1.01 while the lowest price it went was recorded $1.01 before closing at $0.83.

PDS Biotechnology Corporation had a pretty Dodgy run when it comes to the market performance. The 1-year high price for the companys stock is recorded $9.45 on 05/15/19, with the lowest value was $0.62 for the same time period, recorded on 04/02/20.

Price records that include history of low and high prices in the period of 52 weeks can tell a lot about the stocks existing status and the future performance. Presently, PDS Biotechnology Corporation shares are logging -87.08% during the 52-week period from high price, and 98.39% higher than the lowest price point for the same timeframe. The stocks price range for the 52-week period managed to maintain the performance between $0.62 and $9.45.

The companys shares, operating in the sector of healthcare managed to top a trading volume set approximately around 16.77 million for the day, which was evidently higher, when compared to the average daily volumes of the shares.

When it comes to the year-to-date metrics, the PDS Biotechnology Corporation (PDSB) recorded performance in the market was -68.68%, having the revenues showcasing -68.08% on a quarterly basis in comparison with the same period year before. At the time of this writing, the total market value of the company is set at 12.68M, as it employees total of 15 workers.

According to the data provided on Barchart.com, the moving average of the company in the 100-day period was set at 1.8275, with a change in the price was noted -0.9400. In a similar fashion, PDS Biotechnology Corporation posted a movement of -42.34% for the period of last 100 days, recording 277,945 in trading volumes.

Total Debt to Equity Ratio (D/E) can also provide valuable insight into the companys financial health and market status. The debt to equity ratio can be calculated by dividing the present total liabilities of a company by shareholders equity. Debt to Equity thus makes a valuable metrics that describes the debt, company is using in order to support assets, correlating with the value of shareholders equity. The total Debt to Equity ratio for PDSB is recording 0.00 at the time of this writing. In addition, long term Debt to Equity ratio is set at 0.00.

Raw Stochastic average of PDS Biotechnology Corporation in the period of last 50 days is set at 31.88%. The result represents downgrade in oppose to Raw Stochastic average for the period of the last 20 days, recording 66.16%. In the last 20 days, the companys Stochastic %K was 67.22% and its Stochastic %D was recorded 54.64%.

Lets take a glance in the erstwhile performances of PDS Biotechnology Corporation, multiple moving trends are noted. Year-to-date Price performance of the companys stock appears to be encouraging, given the fact the metric is recording -68.68%. Additionally, trading for the stock in the period of the last six months notably deteriorated by -74.77%, alongside a downfall of -86.93% for the period of the last 12 months. The shares increased approximately by 0.46% in the 7-day charts and went up by 13.82% in the period of the last 30 days. Common stock shares were lifted by -68.08% during last recorded quarter.

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Here is why PDS Biotechnology Corporation (PDSB) stock volatility recorded over the last month was 17.46% - The InvestChronicle

Orgenesis plans to combine ranpirnase with its Bioxome technology for enhanced payload delivery directly to cells

Inc () has entered into an agreement to acquire the assets of Tamir Biotechnology Inc including its broad-spectrum anti-viral platform ranpirnase.

The acquisition will be completed for total stock and cash consideration valued at about $19 million based on the value of the stock at closing, according to a statement.

Orgenesis said it plans to combine ranpirnase with its co-developed Bioxome technology for enhanced payload delivery directly to cells.

TamirBio is a clinical stage anti-viral therapeutics company engaged in the discovery and development of a new class of prophylactic and therapeutic drugs for the treatment of viruses and other pathological conditions.

TamirBios ranpirnase, its lead asset, is a ribonuclease (RNase),a member of the superfamily of enzymes that catalyze the degradation of RNA, and mediate several essential biological activities, including the regulation of cell proliferation, maturation, differentiation, and cell death.

Orgenesis said it is a potential candidate for the development of therapeutics for life-threatening diseases, including viral and autoimmune diseases, that require anti-proliferative and apoptotic properties.

TamirBios first target is the human papilloma virus (HPV), the worldwide leading cause of genital warts. The companys lead asset, topical ranpirnase, was evaluated in a Phase I/II clinical trial targeting genital warts. The Phase I/II study demonstrated the clear clinical effect of ranpirnase. Additional clinical trials are currently being planned.

Orgenesis and TamirBio plan to combine ranpirnase with Bioxomes, which have demonstrated the ability to fuse with cell membranes and deliver an intracellular cargo, in a similar manner to natural exosomes.

Bioxomes can carry selected therapeutic cargo inside the target cells when loaded with predesignated genetic material, proteins, signaling molecules and drugs, as these mimic the natural membrane fusion capacity of exosomes. Orgenesis and TamirBio believe the combination of the two platforms will result in enhanced efficacy and anti-viral results.

READ:Orgenesis and ExcellaBio develop a breakthrough manufacturing process for bioxomes

Combining TamirBios broad antiviral platform, ranpirnase, with Bioxomes could result in an enhanced payload delivery into cells, said Orgenesis CEO Vered Caplan.

In independent third-party testing, ranpirnase has shown anti-viral activity in multiple viruses. Additionally, over 1,000 patients have been dosed with ranpirnase in previous cancer/mesothelioma clinical trials. Ranpirnase demonstrated a strong safety and tolerability profile that should help accelerate the approval pathway.

Caplan added: We believe combining ranpirnase with the Bioxome platform has the potential to become a potent and powerful combination given the natural intracellular trafficking abilities of Bioxomes. We look forward to testing a variety of additional anti-viral therapies in the near future.

Jamie Sulley, president of TamirBio, pointed out that ranpirnase has already demonstrated preclinical antiviral activity in such viral diseases as HPV, HIV, Ebola, and SARS.

Not only do we believe Orgenesis will help advance ranpirnase through the clinic using their global development platform, but by combining ranpirnase with the Bioxome technology, we believe we can deliver ranpirnase through a more effective delivery mechanism, Sulley said.

Germantown, Maryland-based Orgenesis is a vertically integrated biopharmaceutical company with expertise in developing advanced cell therapies and manufacturing.

Contact the author: [emailprotected]

Follow him on Twitter @PatrickMGraham

See the rest here:
Orgenesis to acquire assets of Tamir Biotechnology and its anti-viral platform ranpirnase for $19M - Proactive Investors USA & Canada

The "Agricultural Biotechnology: Emerging Technologies and Global Markets" report has been added to ResearchAndMarkets.com's offering.

The study scope includes key agricultural biotechnology tools (i.e., next-generation DNA sequencing, biochips, RNA interference, synthetic biology tools, and gene editing tools); synthetic biology-enabled chemicals and biofuels; biotech seeds; and biologicals.

The report analyzes these technologies and products to determine present and future market sizes, and to forecast growth from 2019 through 2024. The report also discusses industry strategic alliances, industry structures, competitive dynamics, patent status and market driving forces.

The research provides in-depth coverage of the agricultural biotechnology industry structure, including genomics technology providers (e.g., genome editing, NGS and microarray companies); major seed companies; biotech trait companies; synthetic biology tools companies; companies developing plant feedstocks; and agricultural biologicals companies. It provides an in-depth analysis of major industry acquisitions and alliances during 2018 and 2019.

96 agricultural and biotechnology companies are profiled in this report.

The report includes:

Market Insights

Global megatrends are driving the need for higher agricultural yields, creating strong tailwinds for innovative seed traits and biological pesticides and stimulants.

World population growth, coupled with rising incomes, lead to consumption of higher-quality foods, including meat. This, in turn, creates higher consumption of feed crops, including maize, soy, and wheat. At the same time, the total acreage of arable land available for producing crops is under pressure from a range of forces, including growing populations, urbanization, and global warming.

These global forces are creating leverage in the industry to increase productivity and crop yields. Biotechnology provides strategic tools for the agricultural industry to meet these market demands. This report examines the role of these technologies in agriculture and quantifies their market impact.

Reasons for Doing the Study

Agriculture is a fundamental and strategic component of a country. As a result, agricultural technologies provide competitive geographic advantage and are highly desirable. Biotechnologies address the pressing industry need for higher crop yields and other desirable traits. Agricultural biotechnology is a key and growing component of the global agriculture industry and is thus of interest to a wide audience.

This report seeks to provide a qualitative and quantitative description of the agricultural biotechnology industry so that emerging market opportunities can be identified and exploited by the reader. The report does this by examining the main product applications and markets, thereby helping companies to prioritize product opportunities and strategic opportunities. The report highlights key market and industry trends, as well as quantifying the main market segments, in order to help the reader better understand industry structure and changes occurring in the industry.

Rapid changes in technology-intensive fields such as DNA sequencing, gene editing, and synthetic biology are driving new products and applications in agriculture. These developments create unique market opportunities. This report analyzes these trends and their impact on future markets for agricultural products.

Based on these market and technology dynamics, it is especially timely to examine the agricultural biotechnology industry.

Key Topics Covered

Chapter 1 Introduction

Chapter 2 Summary and Highlights

Chapter 3 Overview

Chapter 4 Technology Background

Chapter 5 Agricultural Biotechnology Applications

Chapter 6 DNA Read, Write and Edit Industries

Chapter 7 Acquisitions and Strategic Alliances

Chapter 8 Agricultural Biotechnology Markets

Chapter 9 Patents

Chapter 10 Company Profiles

For more information about this report visit https://www.researchandmarkets.com/r/fwyt4b

View source version on businesswire.com: https://www.businesswire.com/news/home/20200327005159/en/

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The Agricultural Biotechnology Industry 2020: Emerging Technologies and Global Markets - ResearchAndMarkets.com - Yahoo Finance