Category Archives: Genetic Engineering

Genomics researchers and the agriculture industry have welcomed the publication of a long-awaited report recommending EU legislation on genetically modified organisms be updated to allow the use targeted gene editing in crops.

In the study, the European Commission acknowledges the potential of gene editing and notes most research into commercial applications is taking place outside the EU.

The Commission carried out the study at the request of member states, to assess if gene editing can be used safely for agriculture, industrial and pharmaceutical applications. The report is based on expert opinions from the Commissions in house science and policy advice services, the Joint Research Centre and the Scientific Advise Mechanism, and contributions from member states and stakeholders.

Precision breeding of plants through gene editing is banned in the EU following a 2018 ruling by the European Court of Justice, which found these techniques are subject to the 2001 EU directive banning genetically modified organisms (GMOs).

The GMO directive is not up to date with new technologies. Finally, we are happy to see that the Commission comes to similar conclusions, Petra Jorasch, manager of plant breeding innovation at the industry group Euroseeds told Science|Business.

Oana Dima, science policy manager at EU-SAGE, a group of scientists from 134 European plant science institutes and societies agreed, saying, We are happy that the Commission sees that the current regulatory framework has negative implications for research in Europe.

Researchers and the agriculture industry are calling for an update to the GMO legislation so that crops developed by modern plant breeding techniques that do not involve the introduction of genes from other species are excluded. Gene editing using Crispr-Cas9 and related techniques can improve plant characteristics without introducing foreign DNA.

According to the report, technologies such as Crispr-Cas9 can help the EU make food production more sustainable, with new plants that are more resistant to diseases and harsher environmental conditions and which do not require the use of pesticides and fertilisers.

The EU has a grand plan to make the continent carbon neutral by 2050 and sustainable agriculture is a big part of this. The Commissions farm to fork strategy aims to reduce the use of fertilisers by 30% and turn 25% of agricultural land over to organic farming. The Horizon Europe research programme will fund projects to improve soil health and reduce the use of pesticides and antibiotics in agriculture.

New genomic techniques can promote the sustainability of agricultural production, in line with the objectives of our farm to fork strategy, said Stella Kyriakides, EU commissioner for health and food safety.

The biotech industry has warned before that the current GMO legislation is way behind the times and hitting Europes global competitiveness in food production. Its time for a change that ensures innovation leadership to market, not just in the lab, said Claire Skentelbery, director general of industry group EuropaBio.

Argentina changed its laws to allow genome editing in crops in 2015. Other countries, such as US, Canada, Australia and Japan, soon followed suit. The debate is ongoing in the UK, Russia, China, India and South Africa. The EU remains the only major region in the world where genome edited crops are regulated as GMOs.

Legal proposal

The Commission will present the results to the EU council next week and member states are likely to come up with a position in the coming weeks. They will then consult the European Parliament and should set out a legal proposal later this year. Any kind of legal proposal would need support from parliament and council, said Jorasch.

The EU27 largely agree the current legislation is not fit for purpose but have yet to agree on a common approach to gene editing. Jorasch said the negotiations will be difficult because the decision in member states could fall between agriculture and environment ministries. There is still need for further discussion, she said. Ministers of agriculture are more likely to be supportive, whereas minsters of environment are more critical.

As one case in point, last week Germanys environment minister Svenja Schulze said the current EU law on GMOs should continue to be applied to gene editing, so that products continue to be tested and labelled for risk. However, Germanys agriculture minister Julia Klckner said the Commissions report signals the need for an, overdue modernisation of EU GMO legislation.

In addition to potential hurdles in some member states, organic food producers are opposed to any changes to the GMO legislation, arguing the benefits of gene editing are hypothetical and achievable by other means.

Organic farmers associations say novel genomic techniques should be treated with caution and warn that allowing gene editing in agriculture would undermine the farm to fork strategy. A weakening of the rules on the use of genetic engineering in agriculture and food is worrying news and could leave organic food systems unprotected, said Jan Plagge, president IFOAM Europe, an international association of organic farmers.

The environmental lobby group Friends of the Earth warns food products based on gene editing would not be labelled as GMOs on shelves and new legislation could exempt a new generation of genetically-modified crops from safety checks.

However, Dima said organic farmers and conventional farmers could both thrive under a new legal framework. I think there is some common ground, in view of what we want to achieve, she said. We need to find a way to ensure coexistence.

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Scientists and industry cheer outcome of Commission study on gene editing - Science Business

The world is passing through a calamitous situation with the ongoing pandemic of Covid-19 striking the global population in multiple waves since its onset in December 2019. The pandemic has severely challenged the administrative machineries of the governments and the prevailing healthcare system.We were revelling in the marvels of modern technology with novel inventions of wireless telephony, genetic engineering and digital systems and also latest systems of healthcare, comprising potent chemical drugs and sophisticated surgical procedures. But the onslaught of the pandemic and the death toll of over three million humans that it has taken put big question marks on our technologies and systems. I would like to add that it has cast shadows on our lifestyles and beliefs too.

Pandemics in olden times were regarded as the curses of gods. But even in the present times of professedly high scientific achievements, are we in a position to explain it any better? So many theories were advanced about its origin in scientific terms but there is no satisfactory explanation yet. We seem to be wallowing in confusion and at a total loss to steer our way clearly out of this calamity.That brings us back to the ancient theory of the curse of gods and prompts us to take a holistic, a scientific-spiritualistic look at the phenomenon.

Our primordial scriptures say that pandemics are the fallout of adharma i.e. violation of the tenets of righteousness by humans. This view is further corroborated by the ancient treatises on medicine authored by Sage Charak who was the greatest exponent of Ayurveda, the science of healthy living.Righteousness is dharmathe 10 principles of human living that promote peace, progress and prosperity in the world. Let us recount these cardinal principles. These arepatience, forgiveness, mind control, regulation of the senses, cleanliness, honesty, application of intellect, true knowledge, abjuring anger and truthfulness.

It is not difficult to see how many of the above tenets of dharma and to what extent are being violated by the present generation of global humans. But the most significant violation in the current context is lack of true knowledge and its application.We are predominantly reductionist in our approach to various things in all walks of life. Modern systems of healthcare regard the human body as a conglomerate of various physical organs carrying out their specific tasks and human physiology as a play of various chemicals in the body internals. We do not take a holistic view of the bodya view that takes into account human mind, intellect, ego self, the soul and the supersoul, God. Our view also fails to consider the interconnectedness of all sentient beings in the infinite spiritual medium which is God. We are working with half knowledge, and half knowledge is dangerous.

We have a largely mechanistic outlook towards dealing with Nature. We think that we are entities outside of the inert Nature and the latter can be milked at will. We have defiled our environmental elementspolluted the air with harmful gaseous effluents, soil with chemical pesticides and fertilisers as also plastic waste, water with hazardous waste of factories and ether by microwave radiation. We have thus polluted the Panchabhut, meaning all the five primal elements of natureair, earth, water, fire and ether. This is the result of using wrong, environment-unfriendly technologies which are not in line with true knowledge. Our medical technologies and systems are also largely misaligned with true knowledge enshrined in Ayurveda.

We are paying a huge price for all this.

The pandemic is a stern reminder to the current crop of humans to revisit and refine its understanding of material nature based on the eternal wisdom of the Vedas. We need to shed our intellectual arrogance and bring about suitable changes in our living paradigms to align them with eternal true knowledge.We need to adopt a holistic approach in dealing with Mother Nature in which all sentient beings are regarded as intimately linked in both material and spiritual terms with their creator God controlling and regulating them real time. We will then be working in line with true knowledge handed down to us by the omniscient creator. Only there lies a lasting solution to the present set of catastrophic problems confronting us.

Atul Sehgal is the author ofGuide to Inner Wellness (Rupa Publications, Jan 2021). Email: atul4956@gmail.com

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Let's handle the pandemic holistically - The New Indian Express

Dyno Therapeutics, a Harvard University spinout working to improve gene therapy, is expanding with $100 million in new funding from tech investor Andreessen Horowitz and several other venture firms.

Since officially launching a year ago, Dyno has struck deals with Novartis, Roche and Sarepta Therapeutics to aid their efforts to develop more efficient delivery of gene therapy. But even after doubling in size to 50 employees, the company hasn't been able to keep up with demand for its services, CEO Eric Kelsic said in an interview.

"Even though it's in the very beginning, we just had so many folks who want to partner with us," said Kelsic. "This is really to meet the demand that we've seen for partnering and to enable us to both expand our [existing] partnerships, as well as to work with new partners."

Over the next two years, Dyno hopes to triple its workforce, adding employees on both the scientific side to work with partners on research as well as on the business side to develop and support those collaborations. The Series A round announced Thursday will help fund that expansion.

Eric Kelsic, CEO of Dyno Therapeutics

Courtesy of Dyno Therapeutics

Dyno emerged last May to take forward technology built by the Harvard Wyss Institute for Biologically Inspired Engineering. It aims to solve some of the limitations of adeno-associated viruses, one of the main delivery vehicles for shuttling genetic material into human cells.

People can have pre-existing immunity to the protein shell, known as a capsid, that surrounds those viruses, for example. Infusion can also trigger immune responses. Other limitations include the efficiency by which genetic material is delivered into cells, the capacity capsids have to carry that material and the types of tissue the capsids can reach.

To get around those challenges, Dyno is leaning on machine learning, combined with data from in vivo research, to optimize AAVs better suited for carrying therapeutic DNA.

Engineering better AAVs is a goal that a number of new startups share, including Affinia Therapeutics and Taysha Gene Therapies. In Dyno's case, however, the company plans to design capsids for its partners rather than developing treatments itself.

All three companies are now flush with new cash, underscoring the growing investor interest. Taysha went public with a $181 million initial public offering in September 2020 and Affinia on Monday announced a $110 million venture funding round.

Manufacturing and quality control is a particular challenge for gene therapy developers and, in the past year, the Food and Drug Administration has appeared to apply closer scrutiny. Both Sarepta and competitor Pfizer, for example, have encountered delays on key research programs for Duchenne muscular dystrophy treatments due to questions on tests they use to measure their product's potency. Others have been set back by FDA requests for more information on their production processes.

Custom-designed capsids can help, Kelsic said. "Scale up is a challenge. In some cases, you need to scale up the dose in order to treat the disease and in other cases it's to scale up to treat other patients who need to benefit."

"Our platform directly helps with that," he added. "By making the delivery more efficient, that means you can actually treat the disease more effectively with a lower dose. With the efficiency being higher you can make more doses per batch and therefore treat more patients."

Deals with Novartis and Sarepta, which were announced when the company launched publicly last May, target muscle and eye diseases, respectively. Together, the two collaborations could earn Dyno up to $2 billion in partnership revenue, depending on how well the projects that emerge from them advance.

Roche, which bought the gene therapy pioneer Spark Therapeutics in 2019, came along in October with a partnership aiming at neurological and liver diseases. That deal could be worth up to $1.8 billion in milestone payments.

And if Dyno's expansion plans pay off, more announcements could be coming still.

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Dyno, in demand for its gene therapy work, raises $100M for fast expansion - BioPharma Dive

Waiving vaccine producer patents,vaccinatingthe world more quickly against COVID-19 those are the popular demands that have already been made by 100 nations of the World Trade Organization (WTO) since October 2020. It is not entirely clear why US President Joe Biden has recently adopted this much too simple concept as well. Biden has not given reasons for his change of tack, least of all officially vis--vis European partners in the EU. It might be a simple case of populism.

Regrettably, the problem of vaccine shortage is more complex than claims made by many governments and aid organizations suggest, according to which the allegedly profit-seeking pharmaceutical industry must simply be deprived of its knowledge. Firstly, there is no single patent for a single vaccine. If anything, companies have been safeguarding techniques.

Production of every single COVID vaccine is based on several patents to which different companies claim ownership or for which they've made an application. Secondly, it's not the formula that's crucial, it's the detailed knowledge of how the vaccine is actually produced. To this end, vaccine manufacturers must issue licenses, equip production facilities and train staff. Of course, the World Trade Organization is entitled to discuss those details in Geneva.

Licensing and cooperation between vaccine developers and manufacturers have been in place for quite some time. According to the EU, pharmaceutical companies have by now sealed 200 applicable technology transfer agreements worldwide. The problem is not protection of intellectual property but a lack of sufficiently large production facilities, which are currently being set up in many places. In the short term, handing over a vaccine blueprint to a generic drugs manufacturer in India or South Africa will, in the short term, be justpointless. At least this will not alleviate acute vaccine shortage in India, for example.

DW's Europe Correspondent Bernd Riegert

A vaccine based on genetic engineering such as the BioNTech/Pfizer vaccine is made up of more than 300 components which are manufactured as preliminary products in 20 different countries. Those vaccines are just like the viral vector vaccines offered by AstraZeneca or Johnson & Johnson complex biological products which cannot simply be reproduced as a generic drug, unlike a painkiller consisting of chemicals.

The European Commission is prepared to discuss patents and licenses; thus far, however, there is no proof that protection of intellectual property slows down vaccine production at least according to the findings of the World Trade Organization (WTO). The manufacturers themselves also claim that patents are not the problem and that waivers would not mean changes in production at this point.

The German Government, therefore, does the right thing by not just chimingin with Washington's simplistic, sweeping demand. For a lack of protection of their own achievements could lead to a situation in which companies become reluctant to take part in the elaborate development of new vaccines. However, BioNTech, Moderna, AstraZeneca et al. are urgently needed, because as early as autumn it might be necessary to put booster shots against coronavirus mutations on the market.

The EU has, by the way, stipulated in its contracts on funding pharmaceutical company research that knowledge gained through public financing must be openly published for the benefit of all which means there is no patent which would have to be abolished.

The establishment of production facilities is already in progress. The aim is to produce some nine billion COVID shots this year. 11.5 billion shots are needed, however. The EU, the US, India and some other countries with large pharmaceutical companies should therefore make an effort to establish production facilities more quickly, facilitate investments and support manufacturers instead of cracking down on them.

The US, Britain and India, for instance, could help if they refrained from stockpiling preliminary products for vaccine production, or by imposing an export ban on those products. Currently, supply chains across all continents are a huge problem. The EU tries to plead innocent, referring to its altruistic actions: Thus far, 200 million COVID shots have been exported from the EU to Asia and Africa. If US President Biden wished to offer short-term help as well, he could, at long last, give the green light to exporting COVID vaccines from the US.

If we want to achieve that developing countries receive more vaccines quickly, we must simply share the scarce vaccines at our disposal today. It is rather doubtful that governments in Germany, Europe or the US can push through such a policy vis--vis their respective populations. Simple concepts and a demand for waiving patents of little relevance are a much more practicable approach.

Regrettably, that approach will also be ineffective.

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Opinion: COVID vaccine patents are not the issue - DW (English)

Industry Growth Insights published a new data on CRISPR Genome Editing Market. The research report is titled CRISPR Genome Editing Market research by Types (Genetic Engineering, Gene Library, Human Stem Cells, Others), By Applications (Biotechnology Companies, Pharmaceutical Companies, Others), By Players/Companies Editas Medicine, CRISPR Therapeutics, Horizon Discovery, Sigma-Aldrich, Genscript, Sangamo Biosciences, Lonza Group, Integrated DNA Technologies, New England Biolabs, Origene Technologies, Transposagen Biopharmaceuticals, Thermo Fisher Scientific, Caribou Biosciences, Precision Biosciences, Cellectis, Intellia Therapeutics. As per the latest research CRISPR Genome Editing market is expected to expand at a CAGR of xx% in the forecast period.

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Report Attributes

Report Details

Report Title

CRISPR Genome Editing Market Research Report

By Type

Genetic Engineering, Gene Library, Human Stem Cells, Others

By Application

Biotechnology Companies, Pharmaceutical Companies, Others

By Companies

Editas Medicine, CRISPR Therapeutics, Horizon Discovery, Sigma-Aldrich, Genscript, Sangamo Biosciences, Lonza Group, Integrated DNA Technologies, New England Biolabs, Origene Technologies, Transposagen Biopharmaceuticals, Thermo Fisher Scientific, Caribou Biosciences, Precision Biosciences, Cellectis, Intellia Therapeutics

Regions Covered

North America, Europe, APAC, Latin America, MEA

Base Year

2020

Historical Year

2018 to 2019 (Data from 2010 can be provided as per availability)

Forecast Year

2028

Number of Pages

245

Number of Tables & Figures

172

Customization Available

Yes, the report can be customized as per your need.

The global CRISPR Genome Editing market is segmented on the basis of:

Types

Genetic Engineering, Gene Library, Human Stem Cells, Others

The product segment provides information about the market share of each product and the respective CAGR during the forecast period. It lays out information about the product pricing parameters, trends, and profits that provides in-depth insights of the market. Furthermore, it discusses latest product developments & innovation in the market.

Applications

Biotechnology Companies, Pharmaceutical Companies, Others

The application segment fragments various applications of the product and provides information on the market share and growth rate of each application segment. It discusses the potential future applications of the products and driving and restraining factors of each application segment.

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Some of the companies that are profiled in this report are:

We have studied the CRISPR Genome Editing Market in 360 degrees via. both primary & secondary research methodologies. This helped us in building an understanding of the current market dynamics, supply-demand gap, pricing trends, product preferences, consumer patterns & so on. The findings were further validated through primary research with industry experts & opinion leaders across countries. The data is further compiled & validated through various market estimation & data validation methodologies. Further, we also have our in-house data forecasting model to predict market growth up to 2028.

Regional Analysis

Note: A country of choice can be added in the report at no extra cost. If more than one country needs to be added, the research quote will vary accordingly.

The geographical analysis part of the report provides information about the product sales in terms of volume and revenue in regions. It lays out potential opportunities for the new entrants, emerging players, and major players in the region. The regional analysis is done after considering the socio-economic factors and government regulations of the countries in the regions.

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How you may use our products:

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Global CRISPR Genome Editing Market by Type (Genetic Engineering, Gene Library, Human Stem Cells, Others), By Application (Biotechnology Companies,...

Like almost all science journalists, the idea that Covid would appear at the Wuhan Institute of Virology (IVW), the city of origin of the pandemic, has been dismissed as a conspiracy theory. Not after reading a report by veteran Nicholas Wade on the Medium website at the suggestion of another animal, lvaro Pereira Jnior.

Not that Donald Trump or Jair Bolsonaro rightly spread the news that the Sars-CoV-2 virus was made by Chinese to bring the world to its knees, far from it. But no one has proven that they were completely wrong; It cannot be ruled out that the corona accidentally escaped from the IVW.

Wade thoroughly reconstructed the pros and cons of the two competing explanations for the virus appearance. The most widely accepted indicates that bats are a natural repository of the pathogen that would have jumped onto humans from an unidentified host (pangolins have been mentioned, but there is no evidence of this).

The other theory is that Sars-CoV-2 infected people from the laboratory of virologist Shi Zengli at the IVW, possibly his staff. Neither hypothesis can be ruled out, but Wade a journalist who has studied genetic engineering since its inception in the 1970s argues that the evidence supports the latter.

First, some reasons he had queued against declaring a natural origin for the zoonosis. No population of bats has been found with this particular variety of coronavirus, which incidentally have difficulty infecting them, nor with the intermediate animal.

Caves, where there are many suspicious chiropters, are 1,500 km from Wuhan, and the beetles do not fly more than 50 km. There is no biological or molecular evidence that Sars-CoV-2 has undergone changes characteristic of the adaptations expected in a long inter-species transfer process.

There is no medical record of atypical pneumonia nearby where bat and human populations are in close contact (this is not the case with Wuhan). Previous cases of Covid have been discovered that had nothing to do with the market, which was originally cited as a base in the city.

Articles by critics of conspiracy theory claim that the new coronavirus does not bear the scars typical of laboratory-built viruses. Wade counters that there are other techniques to modify their genomes that would not leave the traces skeptics seek.

Shi specialized in collecting bats and beta coronaviruses in caves and in the genetic manipulation of the pathogen. The experiments involved gain in function: modification of proteins such as S (Spike) to increase infectivity in human cells under the pretext of acquiring knowledge in order to identify wild varieties with pandemic potential.

In the fall, before the Covid outbreak was detected in Wuhan, IVW officials fell ill with symptoms compatible with Covid and were hospitalized. The Chinese government sealed all the institutes records and documents and controlled the steps taken by the WHO commission investigating the origin of Sars-CoV-2, which is far from conclusive.

The report lists intricate technical details that indicate a laboratory leak. Things like sequences of genetic letters (bases), which are typical of humans, which are used in experiments to obtain function, also by Shi ironically with funds from the US National Institutes of Health (NIH).

Reading Wades investigation becomes mandatory. Especially for those who, like me, very much rejected an artificial origin for the new coronavirus because Trump and Bolsonaro could only have a lie.

PRESENT LINK: Did you like this column? The subscriber can release five free hits of each link per day. Just click the blue F below.

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Nobody has proven that Trump and Bolsonaro were wrong in the origin of Sars-CoV-2 08/05/2021 Marcelo Leite KSU | The Sentinel Newspaper - KSU | The...

Key Business and Financial Highlights

Note: All financials referenced in this release are in conformity with U.S. Generally Accepted Accounting Principles (GAAP) and comparisons in this release are to the same period in the prior year unless otherwise noted.

BUFFALO, N.Y., May 06, 2021 (GLOBE NEWSWIRE) -- 22nd Century Group,Inc. (NYSE American: XXII), a leading plant-based, biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco, and hemp/cannabis research, announced today that the Company filed its 2021 First Quarter Report on Form 10-Q with the U.S. Securities and Exchange Commission. The Company will provide a business update for investors on a live audio webcast to be held today at 10:00 a.m. ET.

James A. Mish, chief executive officer of 22nd Century Group, together with Michael Zercher, president and chief operating officer, and John Franzino, chief financial officer, will host the webcast. Interested parties are invited to participate by visiting the Events section on the Companys Investor Relations website at http://www.xxiicentury.com/investors/events. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from industry analysts. Investors, shareholders, and members of the media will also have the opportunity to submit their questions through the interactive webcast.

Our 2021 is off to an exciting start as we anticipate achieving multiple key milestones that will dramatically expand our commercial opportunities in both our tobacco and hemp/cannabis franchises, said James A. Mish, chief executive officer of 22nd Century Group. I remain highly confident in our MRTP authorization. We continue to steadily increase our advocacy activities at both the federal and state levels to achieve MRTP authorization, in support of this critical public health issue. In addition to our primary VLN launch strategy to go to market within 90 days of authorization, we remain willing to license our technology to every cigarette manufacturer to help them join us in our efforts to reduce the harm caused by smoking and to protect future generations from ever becoming addicted to cigarettes. Our technology and capabilities make the FDAs reduced nicotine mandate feasible. According to the Centers for Disease Control and Prevention (CDC), 80% of U.S. adult cigarette smokers favor requiring cigarette makers to reduce nicotine levels in cigarettes, so they are less addictive.

The first quarter also saw a continued strong cadence of moves by both state and federal government bodies advancing marijuana legalization, including positive changes in policy on both the medical and recreational use cases, Mish continued. 22nd Century has established a strong position in the upstream hemp/cannabis market through our focus on plant genetics and IP critical to the successful commercialization of consumer products at the scale the market will ultimately demand. In doing so, we have positioned ourselves to provide valuable, tailored plant lines similar to a boutique Monsanto focused on high-value markets, including tobacco, hemp/cannabis, and our third franchise.

Tobacco Franchise Highlights and Recent Key Events

Hemp/Cannabis Franchise Highlights and Recent Key Events

2021 Priorities and Areas of Focus

2021 First Quarter Financial Results

Balance Sheet and Liquidity

First Quarter Earnings Conference Call

22nd Century will host a live audio webcast today at 10:00 a.m.ET to discuss its first quarter 2021 financial results and business highlights. Following prepared remarks, the Company will host a Q&A session during which management will accept questions from interested analysts. Investors, shareholders, and members of the media will also have the opportunity to pose questions to management by submitting questions through the interactive webcast during the event.

James A. Mish, chief executive officer of 22nd Century Group, together with Michael Zercher, chief operating officer, and John Franzino, chief financial officer, will host the webcast. Interested parties are invited to participate by visiting the Events section on the Companys Investor Relations website at http://www.xxiicentury.com/investors/events. An archived replay of the webcast and the event transcript will also be available shortly after the live event has concluded.

About 22nd Century Group,Inc.

22nd Century Group, Inc. (NYSE American: XXII) is a leading plant biotechnology company focused on technologies that alter the level of nicotine in tobacco plants and the level of cannabinoids in hemp/cannabis plants through genetic engineering, gene-editing, and modern plant breeding. 22nd Centurys primary mission in tobacco is to reduce the harm caused by smoking through the Companys proprietary reduced nicotine content tobacco cigarettes containing 95% less nicotine than conventional cigarettes. The Companys primary mission in hemp/cannabis is to develop and commercialize proprietary hemp/cannabis plants with valuable cannabinoid profiles and desirable agronomic traits.

Learn more atxxiicentury.com, on Twitter@_xxiicentury,and onLinkedIn.

Cautionary Note Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations, and assumptions contained in this press release are forward-looking statements. Forward-looking statements typically contain terms such as anticipate, believe, consider, continue, could, estimate, expect, explore, foresee, goal, guidance, intend, likely, may, plan, potential, predict, preliminary, probable, project, promising, seek, should, will, would, and similar expressions. Actual results might differ materially from those explicit or implicit in forward-looking statements. Important factors that could cause actual results to differ materially are set forth in Risk Factors in the Companys Form 10-K filed on March 11, 2021. All information provided in this release is as of the date hereof, and the Company assumes no obligation to and does not intend to update these forward-looking statements, except as required by law.

Below is a table containing information relating to the Companys Adjusted EBITDA for the three months ended March 31, 2021 and 2020, including a reconciliation of net (loss) income to Adjusted EBITDA for such periods.

1Fav = Favorable variance, which increases Adjusted EBITDA; Unfav = unfavorable variance, which reduces Adjusted EBITDA

Adjusted EBITDA, which the Company defines as earnings before interest, taxes, depreciation and amortization, as adjusted by the Company for certain non-cash and non-operating expenses, as well as certain one-time expenses, is a financial measure not prepared in accordance with generally accepted accounting principles (GAAP). In order to calculate Adjusted EBITDA, the Company adjusts the net (loss) income for certain non-cash and non-operating income and expense items listed in the table above in order to measure the Companys operating performance. The Company believes that Adjusted EBITDA is an important measure that supplements discussions and analysis of its operations and enhances an understanding of its operating performance. While management considers Adjusted EBITDA to be important, it should be considered in addition to, but not as a substitute for or superior to, other measures of financial performance prepared in accordance with GAAP, such as operating loss, net (loss) income and cash flows from operations. Adjusted EBITDA is susceptible to varying calculations and the Companys measurement of Adjusted EBITDA may not be comparable to those of other companies.

Investor Relations & Media Contact:Mei KuoDirector, Communications & Investor Relations22nd Century Group, Inc.(716) 300-1221mkuo@xxiicentury.com

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22nd Century Group Reports Business Highlights and Financial Results for the First Quarter 2021 - GlobeNewswire

SEATTLE--(BUSINESS WIRE)--According to Coherent Market Insights, the global CRISPR and CAS gene market is estimated to be valued at US$ 830.7 million in 2020 and is expected to exhibit a CAGR of 22.8% during the forecast period (2020-2027).

Key Trends and Analysis of the Global CRISPR and CAS Gene Market:

Key trends in the market include increasing research and development activities, product launches, inorganic activities such as collaborations, and others.

Key players are focusing on increasing research and development for new treatments for genetic disorders, which is expected to drive the growth of the global CRISPR and CAS gene market over the forecast period. For instance, in June 2019, GlaxoSmithKline Plc partnered with gene-editing pioneers based at the University of California (UC) to establish a new laboratory that aims to speed up discovery of new treatments by exploring how gene mutations cause disease, and developing new CRISPR-based technologies.

Market players are indulged in launching new kits, which is expected to drive growth of the market over the forecast period. For instance, in June 2019, Synthego, a global genome engineering solutions company, announced the launch of the Gene Knockout Kit v2. This is the only product that leverages a novel bioinformatics- powered multi-guide strategy to guarantee a gene knockout. The kit will accelerate research by saving scientists from multiple trial-and-error cycles in optimizing their CRISPR experiment.

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Various biotechnology and pharmaceutical companies are focusing on collaborations to conduct research and development for treatment of diseases such as cancer, AIDS, genetic diseases, and others, which is expected to drive growth of the market. For instance, in October 2019, CRISPR Therapeutics and Bayer announced plans for a joint venture between CRISPR Therapeutics and Bayer and Casebia Therapeutics would operate under the direct management of CRISPR Therapeutics. Casebia Therapeutics would focus on the development of its lead programs in hemophilia, ophthalmology, and autoimmune diseases.

Key Market Takeaways:

Increasing prevalence of genetic disorders such as Downs syndrome, Sickle cell anemia, and Huntingtons disease worldwide is expected to drive the growth of the global CRISPR and CAS gene market over the forecast period. For instance, according to National Health Service (NHS) U.K., 2018 report, the highest rate of Huntingtons disease in the U.K. is 12 per 100,000 people.

Among all the regions, North America is expected to hold a dominant position in the global CRISPR and CAS gene market over the forecast period, owing to the increasing number of research studies regarding the CRISPR and CAS gene technology in the region. For instance, in 2017, Editas partnered with Juno Therapeutics for cancer-related research using CRISPR. Under the terms of the agreement, Juno had to pay Editas an initial payment of US$ 25 million, in which up to US$ 22 million will be used in research support for three programs over five years.

Competitive Landscape:

Key players operating in the global CRISPR and CAS gene market include Thermo Fisher Scientific Inc., Merck KGaA (Sigma-Aldrich), OriGene Technologies, Inc., New England Biolabs, Cellecta, Inc., Agilent Technologies, Inc., Applied StemCell, Inc., Synthego, Genscript, Mirus Bio LLC, Integrated DNA Technologies, Inc., and Mammoth Biosciences, Inc.

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A biologist releases genetically modified mosquitoes in February 2016 in Piracicaba, Brazil. Technicians from the Oxitec laboratory released genetically modified mosquitoes Aedes Egypti to combat Zika virus. (Photo by Victor Moriyama/Getty Images)

Editors note: This story was originally published by UNDARK.It appears here as part of theClimate Deskcollaboration.

This spring, the biotechnology companyOxitecplans to release genetically modified (GM) mosquitoes in the Florida Keys. Oxitec says its technology will combat dengue fever, a potentially life-threatening disease, and other mosquito-borne viruses such as Zika mainly transmitted by theAedes aegyptimosquito.

While there have been more than7,300 dengue casesreported in the United States between 2010 and 2020, a majority are contracted in Asia and the Caribbean,accordingto the U.S. Centers for Disease Control and Prevention. In Florida, however, there were 41 travel-relatedcases in 2020, compared with 71 cases that were transmitted locally.

Native mosquitoes in Florida are increasingly resistant to the most common form of control insecticide and scientists say they need new and better techniques to control the insects and the diseases they carry. There arent any other tools that we have. Mosquito nets dont work. Vaccines are under development but need to be fully efficacious, saysMichael Bonsall, a mathematical biologist at the University of Oxford, who is not affiliated with Oxitec but has collaborated with the company in the past, and who worked with the World Health Organization to produce a GM mosquito-testing framework.

Bonsall and other scientists think a combination of approaches is essential to reducing the burden of diseases and that, maybe, newer ideas like GM mosquitoes should be added to the mix. Oxitecs mosquitoes, for instance, are genetically altered to pass what the company calls self-limiting genes to their offspring; when released GM males breed with wild female mosquitoes, the resulting generation does not survive into adulthood, reducing the overall population.

But Oxitec has been proposing to experimentally release GM mosquitos in the Keys since 2011, and the plan has long been met with suspicion among locals and debate among scientists. Some locals say they fear beingguinea pigs. Critics say they are concerned about the possible effects GM mosquitoes could have on human health and the environment. In 2012, the Key West City Commissionobjected to Oxitecs plan; in a non-binding referendum four years later, residents of Key Haven where the mosquitoes would have been released rejected it, while residents in the surrounding county voted in support of the release. With the decision left up to the Florida Keys Mosquito Control District, officialsapproved the trialto be conducted elsewhere in the Keys.

According to Oxitec, the releasewas delayeddue to a transfer of jurisdiction over the project from the U.S. Food and Drug Administration to the Environmental Protection Agency.

The company reapplied for approval to release a new version of the mosquitoes, called OX5034,in the Keys. In May, the EPAgranteda two-year experimental use permit, which the agency can cancel at any time.Stateandlocal sign-off soon followed finally giving the project the greenlight.

Oxitecs OX5034 mosquitoes are the first GM mosquitoesapprovedfor release in the U.S. The company has alreadyconducted a trialwith the OX5034 mosquitoes in Brazil and released more than a billion of a previous version, called OX513A, there and in other locations over the years including the Cayman Islands. The company says it is confident in the effectiveness and safety of the technology.

But some scientists want to hit pause on Oxitecs Florida trial, to find what they say is a fairer process in deciding to release the mosquitoes. Others want to see clearer proof that this technology is even necessary, claiming that the company has only released its most positive data with the public and has kept other key data, including whether the mosquitoes curb disease transmission, private. And if the release actually launches as planned, some Keys residents say they aim to interfere.

Critics also say that Oxitec failed to engage with local communities in Florida and get their consent to release the mosquitoes. Whats the most upsetting is that the very people that are going to be most impacted, both by the benefits or the risks of such a decision, have like the smallest voice in how these choices are made. I think thats a really big issue, says Natalie Kofler, a molecular biologist and bioethicist who founded Editing Nature, a platformthat advocatesfor inclusive decision-making processes to steer the use of genetic technology. If Oxitec doesnt do this right, she adds, we could have huge impact on delaying the use of other beneficial technologies like that in the future.

OXITECS OX5034 MOSQUITOESare programmed to combat the transmission of mosquito-borne illnesses by suppressing localAedes aegyptipopulations. Oxitec which is U.S.-owned and based in the United Kingdom describes their mosquitoes asfriendly because they will only release males, which, unlike females, do not bite humans or transmit disease.

At Oxitecs laboratory in the U.K., the company genetically engineers the mosquitoes, giving the insects the self-limitinggenethat makes the females dependent on the antibiotic tetracycline. Without the drug, they will die. Eggs from these genetically-altered mosquitoes which will hatch both male and female insects will be shipped to the Keys. Mosquitoes require water to mature from an egg to an adult; when Oxitecs team adds water to the boxes the mosquitoes will be deployed in, both GM males and GM females will hatch. With no tetracycline present in the box, the GM females are expected to die in early larval stages.

The male mosquitoes will survive and carry the gene. When they leave the boxes, the insects will, hypothetically, fly away to mate with wild females to pass the gene to the next wild generation, according to Nathan Rose, head of regulatory affairs at Oxitec. Kevin Gorman, the companys chief development officer, says the local female mosquito population will be increasingly reduced which will also reduce the number of wild male mosquitoes in the treatment areas.

Gorman emphasized to Undark that the EPA and other regulators found no risk in using tetracycline in breeding their genetically-altered mosquitoes. But some scientists think the presence of this antibiotic in the environment does pose a risk. According to Jennifer Kuzma, co-founder and co-director of the Genetic Engineering and Society Center at North Carolina State University, tetracyline is commonly used in Florida to prevent bacterial diseases in agriculture particularly incitrus groves and to treat bacteria insewage plants. The use of the antibiotic for these purposes may mean that it will remain in the environment, especially in water where the mosquitoes breed, which could allow Oxitecs female mosquitoes to survive. While the company does not plan to release the mosquitos near areas where the antibiotic is used, Kuzma says the EPAsrisk assessment did not include testing of any standing water for tetracycline something, she adds, would have been easy enough to do for good due diligence.

Skeptics of Oxitecs GM mosquitoes include local residents,physicians, scientists, and environmental activists. Many of these opponents say they arent anti-GMO, but disagree with how the approval process has been handled. One group has even kept arunning listof what it sees as Oxitecs wrongdoings since it first began experimental releases. The list includes Oxitecs lack of disease monitoring in the countries where it has released mosquitoes; the unknown price of its technology; andcomplaintsthat the company hasoverstatedthe success of some of it its trials.

I cannot trust this company. I cannot trust this technology, says Mara Daly, a resident of Key Largo who says shes been following Oxitecs plans for nine years.

This is not a traditional pesticide, she adds. This is not a chemical that you can trace. This is something completely different, new emerging technology and we need better regulation.

Phil Goodman, chairman of the Florida Keys Mosquito Control District (FKMCD), an independently-elected commission carrying out mosquito control within Monroe County, says that many of those who discredit Oxitecs evidence do not understand the technology. Theyre fearmongering, he says.

They have very little credibility here in the Florida Keys as far as Im concerned, he adds.

But people like Daly and Barry Wray, executive director of theFlorida Keys Environmental Coalition, disagree. We want to know its safe, says Wray, who notes that his group more generally supports GM technology. We dont have another Florida Keys ecosystem. We dont have another Florida Keys community. We have this one.

Daly, Wray, and others point to what they perceive as the FKMCDs disrespect for public opinion. They argue that the community wasnt given a chance to consent before the EPA approval. There was a 30-daypublic forumin September 2019 about Oxitecs technology application, with 31,174 comments opposing release and 56 in support. A statement emailed to Undark by Melissa Sullivan, an EPA spokesperson, noted that the agencyconsideredthese comments during the review, but critics think it happened too quickly to be of real use.

Oxitec has already released more than a billion of a previous version of GM mosquitoes, OX513A, in Brazil and other locations. Visual: Victor Moriyama / Getty Images

In June, Kofler and Kuzma wrote anopinion piecein The Boston Globe about the EPA approval, critiquing the agencys regulatory system and calling for a better process for evaluating new biotechnologies. The researchers expressed concern that the EPA did not convene an independent, external scientific advisory panel to review Oxitecs claims about its mosquito strategy and that the agency only publicly released its risk assessment after approving the technology. The American public, Kofler and Kuzma wrote, needs to be assured that these decisions are made free of conflicts of interest. The statement from the EPAs Sullivan noted that the agency conducted anextensive risk assessmentbased on the best available science.

Some critics also wanted there to be more public engagement. Kofler and Kuzma say they offered to provide their expertise, along with other outside experts, to the mosquito control district to allow more discussion about the GM mosquitoes with the Keys community. But Kofler says the district wasnt responsive. Oxitec itself launchedwebinarsabout their new product, but not until after the EPA approval. Here we are, like in the final hour, having these conversations that needed to be happening a year ago, says Kofler.

Without public trust and enthusiasm, it doesnt matter whether Oxitecs mosquito technique works, says Guy Reeves, a genetic researcher at the Max Planck Institute for Evolutionary Biology in Germany, who stresses that he doesnt think the companys approach is unsafe. If the population in Florida Keys becomes so sensitized to this issue that they can no longer cooperate with each other thats good for the mosquitoes, not good for the people, he adds.

Based on their first generation mosquito OX513A, Oxitec says it has shown that the approach reduces a targeted mosquito population in trials in bothBraziland theCayman Islands. But theres no evidence that this new OX5034 mosquito release will actually be worth it for mosquito suppression, says Reeves. Oxitec also hasnt explained how their new mosquito will directlycurbhuman diseases, such as dengue. Reducing disease transmission and burden should be measures of efficacy for this technology, says Kofler.

According to Gorman, independent disease suppression data has only been collected by municipalities in Brazil because thats where most of the companys trials have been released in larger scales. These municipalities have shown that Oxitec mosquitoes have reduced dengue cases in areas of release, Gorman says. In order for Oxitec to collect additional data, he adds, the company needs to release and test large areas over sustained periods of time. Gorman maintains that the company is not required to report formal health impact studies.

Reeves adds that Oxitec also hasnt explained what resources are needed to sustain this product, how long it could take to be effective, or the cost. When asked about the cost of the Florida Keys project, Oxitec responded to Undark by email: Oxitec is a pre-commercial, pre-profit company. We will not profit from this pilot project in Florida.We are paying for it ourselves.

OXITEC HAS RELEASEDmore than a billion of their OX513A mosquitoes over the past 10 years. According to independent scientists, some of those experiments did not go well.

For example, researchers at Yale University and collaborators from Brazil analyzed Oxitecs 2015 release of OX513A in Brazil. The scientists confirmed that some offspring of the genetically modified mosquitoes which were supposed to die and not pass new genes to the wild population survived to adulthood and mated with their native counterparts. Between 10 and 60 percent of the native mosquitoes contained genes from Oxitec, according to the Yale study, which published in Nature in2019. The papers authors concluded they do not know what impacts these mixed mosquitoes have on disease control or transmission, but added that their findings underscore the importance of monitoring the genetics of the insects.

Oxitec disagreed with the findings andrespondedon the journals website. Oxitec toldGizmodothat Yales study includes numerous false, speculative, and unsubstantiated claims and statements about Oxitecs mosquito technology. And when Kofler and three other scientistswrote about Oxitecs Brazil trial in The Conversation, Oxitec pushed to have the article retracted, says Kofler.

For this coming release, some Key Largo locals are willing to act on their anger. Daly, for instance, says that if the mosquitoes are deployed in her neighborhood, shell try to put insecticide in any box she finds or send it to an expert to test even if it means getting in trouble with the federal authorities. I already have my arresting officer and she said shes gonna clean her handcuffs for me, she says. I dont care.

Ideally, Daly says, it wont have to come to that. She and other locals hope to stop Oxitec before the latest mosquitos are delivered. Daly says she has been busy organizing protests like one thathappened recentlyin Key Largo and giving out yard signs to residents who dont want their property used in the trial. Locals are pissed off. So I have been busy getting the press to cover the local opposition, Daly wrote in an email to Undark.

The first flying insect or animal that can actually use our human blood for a friggin trial for a product to come to market without my consent, Daly says.

Thats my blood, she adds. Thats my sons blood. Thats my dogs blood.

See the original post here:
Paradise altered: EPA approves first release of genetically modified mosquitoes in Florida Keys - Bulletin of the Atomic Scientists

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