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Monthly Archives: October 2022
Scientists are manipulating the DNA of mosquitoes to fight the spread of malaria – Euronews
Posted: October 4, 2022 at 2:23 am
Scientists say they have managed to genetically modify mosquitoes so that they are unable to spread malaria, a disease that kills well over half a million people each year.
The changes cause mosquitoes to live shorter lives, while the parasites inside them, which cause the fatal infection, develop more slowly.
This slashes the chances of mosquitoes living long enough to carry fully grown parasites and transmit the disease to the humans they bite.
Malaria is spread by the parasite Plasmodium falciparum, which grows and reaches maturation inside the female Anopheles mosquito. The average mosquito survives on average seven to 10 days in the wild.
"Most mosquitoes never have the chance to transmit the parasite. It's only 10 per cent of the mosquitoes out there that live long enough to be able to transmit the parasite," said Professor George Christophides, of Imperial College London.
"By prolonging the developmental time that the parasite needs inside the mosquito to become infectious, this 10 per cent becomes now much smaller".
"At the same time, we managed to cut the mosquito's life a bit short. So the two things combined together now can lead to blocking malaria transmission in the field," he added.
However, the fight against malaria is far from over.
In order for the mosquitoes with modified DNA to survive and propagate widely in nature, they need to defy natural selection.
"These modifications make them weaker because they live shorter. So they will be eliminated naturally by natural selection after a few generations... unless you combine it with what we call the 'gene drive,' which will take this modification and spread it quickly through the populations," Christophides said.
Gene drive is a type of genetic engineering which favours specific hereditary characteristics to increase the likelihood that these are quickly spread through the population and passed on to the next generation, according to the Proceedings of the National Academy of Sciences (PNAS).
The researchers believe that such a "gene drive" will allow all mosquitoes to eventually carry the same modification of their DNA within a few generations.
However, it raises questions about whether massively releasing GM mosquitoes is safe for people, animals, or the environment.
For more on this story, watch the video in the media player above.
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Enzymes Market worth $16.9 billion by 2027 – Exclusive Report by MarketsandMarkets – Yahoo Finance
Posted: October 4, 2022 at 2:23 am
CHICAGO, Sept. 30, 2022 /PRNewswire/ --The Enzymes Market is projected to reach USD 16.9 billion by 2027, growing at a CAGR of 6.8% from 2022 to 2027, according to a new report by MarketsandMarkets.
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The exploitation of new types of enzymes, improvement of enzyme properties, and the production of enzymes are the overall goals of innovations in the enzyme manufacturing industry. The significant progress in genetics and processing technology enables the enzyme industry to offer products with improved properties, often at reduced costs. Genetic engineering opens new paths for enzymes, with improved stability, activity or specificity, and productivity.
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Systematic methods in the field of enzymes and engineering have allowed access to achieve ends, such as screening novel enzymes from natural sources, thus making them safe and secure for manufacturing specialty products, such as pharmaceuticals, as well as for use in biocatalytic processes. According to a study by researchers of University of Notre Dame, USA in January 2022, biocatalytic depolymerization intermediated through enzymes are emerging as a sustainable and efficient alternative for treating plastic treatment recycling it to mitigate the environmental concerns and recapture the components from plastic waste. A new enzyme engineering platform has been developed by researchers from Manchester Institute of Biotechnology (MIB) to enhance the plastic degrading of enzymes through directed evolution. The rapid development in the genetic engineering processes of enzymes and growing research studies on enzyme engineering to use them as sustainable alternatives and safeguard the environment is anticipated to propel the growth of the enzymes market during the forecast period.
Proteases segment is identified to be the fastest growing among the various types of enzymes during the forecast period
Proteases are the enzymes essential for the digestion of protein. They are used to hydrolyze all types of proteins until they become components of the living cells. These enzymes can be obtained from plants, animals, and microorganisms in several conditions, such as high salt concentrations. Proteases have been offered by major key players such as BASF (Germany) and DuPont (US) for industrial applications such as food & beverages, biofuel, textiles & leather, and paper & pulp. The industrial manufacturers are preferring the enzymes over other products as they aid in reducing costs and environmental pollution. For instance, proteases have been used to remove hair from hides, which helps in mitigating the usage of hazardous chemicals. This resulted in mitigating the usage of hazardous chemicals in the leather industry, thereby decreasing the environmental pollution. The usage of enzymes in the pulp & paper industry helps in biofilm removal with less cost involved and lower chemical discharge in the water.
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The manufacturers of cosmetics have also been benefited by the anti-microbial functions of the proteases. In the feed industry proteases are used to decrease the share of amino acids which are indigestible in feed stuffs leading to an increase in the share of digestible amino acids, thereby enhancing the digestibility of the feed in the animals. With the growing demand for meat, the livestock farmers are looking for improved feed products. Therefore, the players in the market are involved in strategic partnerships and research and development to launch new products to increase their market share. For instance, in June 2021, DSM-Novozymes alliance has launched a protease named ProAct 360 for poultry. This product aids in increasing feed efficiency, sustainability, and affordability. Another company, Biocatalysts, in November 2021, has launched a preparation of protease for valorizing the animal protein.
In the enzymes market, microorganism-based enzymes segment is registering the highest growth during the forecast period
Enzymes are biocatalysts that play an important role in metabolic and biochemical reactions. Microorganisms are the primary source of industrial enzymes, as they are cultured in large quantities in a short span of time and genetic manipulations can be done on bacterial cells to enhance enzyme production for usage in various industrial applications such as food & beverages, biofuel, pulp & paper, textiles & leather, and wastewater treatment. The major factor which resulted in manufacturers' preferences for enzymes from microbial sources is their active and stable nature as compared to enzymes from plant and animal. Additionally, microbial enzymes are capable of degrading a wide range of complex substrates, including carbohydrases, into more useful energy sources.
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Asia Pacific region to witness the highest growth rate in the enzymes market during the forecast period
The Asia Pacific region is projected to witness the fastest growth rate of 7.85% during the forecast period. Asia Pacific is the leading region in terms of sugar production and is projected to expand its production share by 2027 (OECD-FAO Agricultural Outlook 20182027). Owing to the large production of sugar, enzymes are often used to hydrolyze starch so as to enhance the sugar production process and improve the overall performance. Furthermore, the use of enzymes in the biofuel industry is expected to grow at a higher rate owing to the increase in bioethanol production and its usage in fueling automobiles and electricity and government support. The enzymes market in China is projected to grow at a higher rate as China has advanced in adapting various new technologies for biotechnology and pharmaceutical-based research & developments. The usage of enzymes in specialty applications has been augmenting in China due to its versatile nature utilized in cell replacements and therapeutic treatments for various medical disorders & diseases. Thus, the expanding production facilities in the region and advancements in adopting technologies for biotech and pharmaceutical industry is boosting the growth of the market in the region.
The key players in this market include Novozymes (Denmark), BASF (Germany), DuPont (US), DSM (Netherlands), Associated British Foods (UK), Merck (Germany), Chr. Hansen (Denmark), Kerry Group (Ireland), Roche Holding (Switzerland), Dyadic International (US), Codexis (US), Sanofi (France), Creative Enzymes (US), Advanced Enzymes Technologies (India), and Biocatalysts (UK).
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Specialty Enzymes Marketby Type (Carbohydrases, Proteases, Lipases, Polymerases & Nucleases, and Other enzymes), Source, Application (pharmaceuticals, Research & Biotechnology, Diagnostics, and Biocatalysts), Form, and Region - Global Forecast to 2025
Agricultural Enzymes Marketby Type (Phosphatases, Dehydrogenases, Sulfatases), Product Type (Fertility Products, Growth Enhancing Products), Crop Type (Cereals & Grains, Oilseeds & Pulses, Turf & Ornamentals), and Region - Global Forecast to 2022
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Smile Coffee Werks upgraded its coffee beans to Fair Trade and USDA Organic – Vending Market Watch
Posted: October 4, 2022 at 2:23 am
Smile Coffee Werksannounced it upgraded its coffee beans toFair TradeandUSDA Organic a compliment to its plant-based, carbon neutral, and USDA-Biobased pods that are certified commercially compostable by both BPI and CMA.
The Fair Trade seal symbolizes to consumers that Smile's coffee was sourced and sold ethically, ensuring adequate working conditions and a fair deal for farmers and workers in developing countries. Fair Trade is a component of the quality of life and social justice aspects of agricultural sustainability.
The USDA Organic certification verifies the quality and production of the product itself. Organic operations must maintain or enhance soil and water quality while also conserving wetlands, woodlands, and wildlife. Synthetic fertilizers, sewage sludge, irradiation, and genetic engineering may not be used. All organic products are protected from prohibited substances and methods from the field to the point of final sale.
"Smile's committed to sustainability and convenience by finally bringing consumers what they want: a guilt-free sustainable coffee pod matched with great sustainable coffee," CEO and co-founderMichael Sands, said in the announcement.
Keurig-compatible pods are available in three flavors: Werkday (Light / Medium Roast), Woke Up (Dark Roast) and Laugh to Decaf. The pods can be bought online at Walmart, Amazon, andwww.smilecoffeewerks.com.
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COVID mRNA Jabs and Testing Kicked Off This Industry of Drug Development: Here’s What You Need to Know – The Epoch Times
Posted: October 4, 2022 at 2:23 am
As we know, there are three major categories of medicines according to their sources, including natural medicines, chemically synthesized drugs, and biological therapeutics.
Among them, biological therapeutics (aka. biologics) are drugs developed and manufactured through biotechnology, such genetic engineering, cell engineering, and protein engineering. Two major categories of biopharmaceuticals have been small molecule- and protein/antibody-based biologics.
Recently, fueled by the global use of mRNA-based COVID-19 vaccines and nucleic acid-based testing for the SARS-CoV-2 virus, the new wave of nucleic acid-based medicine development and production has started taking off (pdf). Furthermore, the increasing number of nucleic acid drugs approved by the U.S. Food and Drug Administration (FDA) demonstrates the potential to treat diseases by targeting the genes responsible for them.
Nucleic acid therapeutics are based on nucleic acids or closely related chemical compounds, and they are completely different from small molecule drugs and antibody drugs.
Instead of targeting protein causes of diseases, they target disease on a genetic level.
Nucleic acid drugs are currently classified into four categories, including medicines based on antisense oligonucleotides (ASOs), small interfering nucleic acids (siRNAs), microRNAs (miRNAs), and nucleic acid aptamers (aptamers).
siRNA and miRNA drugs are called RNA interference (RNAi) medicines.
ASO and siRNA drugs have been approved, and both mainly act on cytoplasmic messenger RNAs (mRNA) to achieve regulation of protein expression through base complementary recognition and inhibition of target mRNAs for the purpose of treating unmet medical needs.
According to the central dogma of molecular biology, DNA is transcribed into RNA, which is then translated into proteins. In some specific cases, RNA can be reverse transcribed into DNA. So, we can see that RNA is critical, because it determines what proteins can be expressed.
Therefore, scientists are trying to see if the process of gene expression can be regulated. That is, instead of interfering at the DNA level, scientists try to regulate the RNA, which is produced in the nucleus and then moves to the cytoplasm. The production of proteins is also carried out in the cytoplasm. If drugs can be absorbed by cells, enter the cytoplasm, and influence the process of translating RNA into proteins, then these drugs can also treat related diseases.
Nucleic acid drugs are designed around this rationale to interfere with the synthesis of disease-causing proteins to treat certain diseases.
ASO is a single-stranded oligonucleotide molecule that enters the cell and binds to the target mRNA through sequence complementation. Then, under the action of ribonuclease H1 (RNase H1), this piece of RNA will be degraded and the expression of the disease-causing proteins will be inhibited consequently.
Both siRNA and miRNAtreat diseases through RNA interference, but their molecules have different properties.
siRNAs are encoded by transposons, viruses, and heterochromatin; whereas miRNAs are encoded by their own genes.
miRNAs can regulate different genes, while siRNAs are called the silencing RNAs, as they mediate the silencing of the same or similar genes from which they originate.
miRNAs are single RNAs and have an imperfect stem-loop secondary structure.
siRNA is a class of double-stranded short RNA molecules that bind to specific Dicer enzymes to degrade one strand. Then the other strand will bind to other enzymes including Argonaute Proteins (AGO) to assemble into a RNA-induced silencing complex (RISC).
In the RISC, the single strand RNA will bind to a target mRNA through the principle of base complementary pairing. Subsequently, the target mRNA will be degraded in the RISC complex, thus blocking the expression of the target protein for the purpose of treating a disease.
This mechanism of inhibiting protein expression via siRNA is called RNA interference. The scientists that had discovered RNA interferencegene silencing by double-stranded RNAwere awarded the Nobel Prize in Physiology or Medicine in 2006.
In terms of therapeutic areas, ASO drugs are mostly developed to cure cancers, infections, as well as neurological, musculoskeletal, ocular, and endocrine diseases.
For instance, fomivirsen, manufactured by Ionis/Novartis, was the first FDA-approved ASO drug, and it is currently used as a second-line treatment for cytomegalovirus (CMV) retinitis. Second-line treatment is used after the first-line (initial) treatment for a disease or condition fails or has intolerable side effects.
Several ASO drugs are also used for treatment of certain rare diseases, including Kynamro (phosphorothioate oligonucleotide drug for the treatment of the rare disease of Homozygous familial hypercholesterolaemia [HoFH]), Exondys 51 (for the treatment of a rare disease called Duchenne muscular dystrophy [DMD]), and Spinraza (for the treatment of spinal muscular atrophy [SMA], a rare inherited disease).
Prior to the development of these medicines, these rare diseases didnt have any effective drugs for treatment.
siRNA drugs therapeutic areas include cancers, infections, as well as neurological, ocular, endocrine, gastrointestinal, cardiovascular, dermatologic, and respiratory diseases.
For instance, patisiran, produced by Alnylam/Genzyme, is the first siRNA drug, and it is used for the treatment of polyneuropathy caused by hereditary transthyretin amyloidosis (haTTR). And the worlds second siRNA drug, Givlaari, produced also by Alnylam, was designed and developed for the treatment of acute hepatic porphyria (AHP), which is a family of ultra-rare disease in adults.
The main manufacturer of ASO drugs is the California-based Ionis Pharmaceuticals. The other major ones include ProQR, Sarepta, WAVELife Sciences, Biogen, and Exicure.
The largest manufacturer of siRNA drugs is Alnylam, a Massachusetts-based biopharmaceutical company specializing in the development and manufacturing of RNA interference therapeutics. The other major producers of these medicines include Dicerna, Quark, and Arrowhead.
In terms of the current status of ASO drug development, most of the therapeutics are in the preclinical stage, with their therapeutic areas mainly focused on oncological, neurological, and muscular diseases. The second largest group of ASO drugs are still in their discovery stage, during which medicines are being designed and undergoing preliminary experiments.
The situation with siRNA drugs (pdf) is similar to that of ASO medicines, with the largest group of medicines being in the preclinical stage, and the second largest group in the discovery stage. Currently, five siRNA drugs have been approved, including patisiran, givosiran, inclisiran, lumasiran, and vutrisiran. In addition, around a dozen other drugs are in late stages of phase III clinical trials.
Therefore, in both categories, only a small percentage of drugs have already been launched.
Nucleic acid drugs are considered novel therapeutic modalities, as they have great potential to treat diseases that cannot be treated effectively in the past, such as certain cancers, and some rare diseases for which no small molecule or protein/antibody-based biologics were developed.
In comparison with small molecule drugs and antibody-based biologics, nucleic acid-based therapeutics have high specificity towards RNAs.
Furthermore, they have simple designs and rapid and cost-effective development cycles (which would later translate into lower costs for patients), as their preclinical research and development starts with gene sequence determination and reasonable designs for disease genes, the genes can be targeted and silenced, thus avoiding unnecessary development and greatly saving research and development time.
They can also quickly alter the sequence of the mRNA construct for personalized treatments or to adapt to an evolving pathogen.In addition, they have abundant targets, so they can potentially make a breakthrough for some special targets that were previously undruggable, to treat certain genetic diseases. And the RNA interference technology has already matured in terms of target selection and small RNA segment synthesis.
However, getting the small RNA segment generated is only the initial step of drug development. In order for nucleic acid drugs to be applied clinically, the next important issue is delivering the nucleic acids to target tissues and cells. Since nucleic acids are highly hydrophilic and polyvalent anionic, it is not easy for cell uptake.
The selection of different delivery mechanisms of genes or RNA agents can impact the increase or decrease the expression of proteins in a cell.
The commonly used (pdf) nucleic acid drug delivery systems include drug conjugates (such as antibody-siRNA conjugates and cholesterol-siRNA conjugates), lipid-based nanocarriers (such as stealth liposomes and lipid nanoparticles), polymeric nanocarriers (such as nanoparticles base on degradable or non-degradable polymers and dendrimers), inorganic nanocarriers (such as silica nanoparticles and metal nanoparticles), carbon-based nanoparticles, quantum dots, and natural extracellular vesicles (ECVs).
Just like almost all drugs, nucleic acid therapeutics also have side effects and risks, some of which stem from their delivery methods.
The common adverse drug reactions (ADRs) of FDA-approved ASO drugs include injection site reactions (e.g. swelling), headache, pyrexia, fever, respiratory infection, cough, vomiting, and nausea (pdf). Individual ASO drugs have their own respective side effects. For instance, fomivirsen can potentially increase intraocular pressure and ocular infection. Pegaptanib can cause conjunctival hemorrhage, corneal edema, visual disturbance, and vitreous floaters. The ADRs of mipomersen (Kynamro) resemble flu symptoms. Nusinersen can cause fatigue and thrombocytopenia. And inotersen can also cause contact dermatitis.
Users of ASO drugs should also be aware of hepatotoxicity, kidney toxicity, and hypersensitive reactions (pdf).
Inotersen (Tegsedi) even carries black box warnings, which are required by the FDA for medications that carry serious safety risks, against its severe side effects, including thrombocytopenia, glomerulonephritis, and renal toxicity. Furthermore, users of inotersen are warned against possible reduced serum vitamin A, stroke, and cervicocephalic arterial dissection.
Side effects of siRNA drugs are similar to those of ASO drugs, including nausea, injection site reactions, heart block, vertigo, blurred vision, liver failure, kidney dysfunction, muscle spasms, fatigue, abdominal pain, and the potentially life-threatening anaphylaxis.
Specifically, during clinical trials of givosiran, one siRNA drug, 15 percent of subjects reported alanine aminotransferase (ALT) elevations three times above the normal range, and 15 percent reported elevated serum creatinine levels and reductions in estimated Glomerular Filtration Rate (eGFR), both signs of poor kidney function. Therefore, liver and kidney toxicity was reported during these clinical trials.
The use of siRNA drugs by pregnant mothers may entail risks for their unborn children. So far, although data on using givosiran, patisiran, and lumasiran have not been reported, certain ADRs of these drugs can serve as warning signs for use during pregnancy. For instance, patients using patisiran (Onpattro) will experience a reduction in their vitamin A levels. Vitamin A is essential for the unborn babys developing organs such as eyes and bones, as well asits circulatory, respiratory, and central nervous systems. Also, givosiran is shown to cause unfavorable developmental effects on animals. Furthermore, inclisiran therapy is not recommended for pregnant mothers, as it may harm the fetus.
In order for nucleic acid drugs to be effective, their design and development need to overcome a number of challenges, such as nuclease degradation, short half-life, immune recognition in circulation, accumulation in target tissues, transmembrane transport, and endosomal escape. Although nuclease stability and avoidance of immune recognition can be greatly reduced by combining chemical modifications, other problems remain to be solved.
Since carrier systems can greatly solve the problems that cannot be solved by chemical modifications and enhance the effectiveness and safety of nucleic acid drug therapeutics, these carrier systems are considered by many as the most important for development and overcoming the aforementioned challenges.
Currently, siRNA drug development faces several challenges (pdf), such as efficacy in siRNA delivery, safety, biocompatibility/biodegradability, and issues of their production, standardization, and approval as multi-component systems.
For example, in the case of lipid nanoparticles (LNPs; one type of lipid-based nanocarriers), only 1 to 2 percent of the internalized siRNAs are released into the cytoplasm. Therefore, research should be focusing on making nanoparticles capable of increasing the release of siRNAs.
However, it should also be noted that the safety, biodistribution, biokinetics, clearance or accumulation of LNPs in different tissues and organs are not well characterized for different types of LNPs. Therefore, the side effects or adverse reactions triggered by this delivery system should also be carefully studied.
The unprecedented global usage of mRNA vaccines under the context of pandemic has given a very unusual momentum to drive more RNA-based therapeutic development. However, clear and calm minds are still needed to see the challenges and explore the safety and risks issues comprehensively and longitudinally for any newly designed RNA-based therapeutic drugs.
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COVID mRNA Jabs and Testing Kicked Off This Industry of Drug Development: Here's What You Need to Know - The Epoch Times
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22nd Century Group (Nasdaq: XXII) Expands VLN Distributor Network with the Addition of Specialty Distrib – Benzinga
Posted: October 4, 2022 at 2:23 am
BUFFALO, N.Y., Oct. 03, 2022 (GLOBE NEWSWIRE) -- 22nd Century Group, Inc. XXII, a leading agricultural biotechnology company dedicated to improving health with reduced nicotine tobacco, hemp/cannabis, and hops advanced plant technologies, today announced that the Company has added Creager Mercantile as a distribution partner to expand availability and support for its VLN reduced nicotine content cigarette products in the state of Colorado.
Operating since 1958, Creager is a well-known wholesale supplier fora wide array of cigarette retailers including hospital gift shops, gas stations, and tobacco shops across the state. The company supports more than1,000stores across numerous specialty and retail store brands. Combined with 22nd Century's previously announced partnership with Eagle Rock Distributing Company, the Company now has access to thousands of potential retail sites across the state that could be serviced by its VLN distribution partners.
22nd Century Group's proprietary VLN cigarettes smoke, smell, and taste like a cigarette but contain approximately 95% less nicotine than conventional cigarettes, a level shown to be non-addictive. As noted on the packaging, VLN is the only cigarette in the world purposefully designed to "Help You Smoke Less."
"We are excited to work with 22nd Century Group to make VLN available to adult smokers in Colorado who are looking for a new way to cut their ties to nicotine," said Chip Creager, President of Creager Mercantile. "Creager supports a diverse array of specialty stores, often advising retailers on the best new products to add to their shelves. We believe that VLN's uniqueness as the first and only cigarette designed specifically to help smokers smoke less makes it an important and attractive product for adult smokers, and we will be actively working with our retail partners to launch VLN to their stores in the coming months."
"Creager opens up an entire additional channel of specialty retail and tobacco suppliers across the state of Colorado, and its direct role in product recommendations and store support make it an ideal partner for 22nd Century's VLN rollout," said John J. Miller, president of 22nd Century's Tobacco Business. "We look forward to working directly with Creager to place VLN on as many shelves as possible, making our important new product broadly available in as many locations as possible where traditional combustible cigarettes are sold."
More information about Creager can be found online at https://creagermerc.com/.
22nd Century Group's decision to launch in Colorado follows the exceptional pilot results in Chicago and the Company's plans to have distribution and retail partnerships in place to support the expanding availability of VLN to adult smokers across the country. The Chicago pilot demonstrated that in-store outreach was highly effective, and once adult smokers had tried VLN, the vast majority were quick to recommend VLN to other adult smokers. Specialty distribution such as Creager, which supports additional functions such as merchandising and product advice, expands the awareness of VLN's highly differentiated value proposition in key retail channels.
About 22nd Century Group, Inc.22nd Century Group, Inc. (Nasdaq:XXII) is a leading agricultural biotechnology company focused on tobacco harm reduction, reduced nicotine tobacco and improving health and wellness through plant science. With dozens of patents allowing it to control nicotine biosynthesis in the tobacco plant, the Company has developed proprietary reduced nicotine content (RNC) tobacco plants and cigarettes, which have become the cornerstone of theFDA's Comprehensive Planto address the widespread death and disease caused by smoking. The Company received the first and only FDA MRTP authorization of a combustible cigarette in December 2021. In tobacco, hemp/cannabis, and hop plants, 22nd Century uses modern plant breeding technologies, including genetic engineering, gene-editing, and molecular breeding to deliver solutions for the life science and consumer products industries by creating new, proprietary plants with optimized alkaloid and flavonoid profiles as well as improved yields and valuable agronomic traits.
Learn more atxxiicentury.com, on Twitter, onLinkedIn, and on YouTube.
Learn more about VLNattryvln.com.
Cautionary Note Regarding Forward-Looking StatementsExcept 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 Company's Annual Report on Form 10-K filed on March 1, 2022, and in the Company's Quarterly Report filed on August 9, 2022. 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.
Investor Relations & Media ContactMei Kuo22nd Century Group, Inc.Director, Communications & Investor Relationsmkuo@xxiicentury.com
Darrow Associates Investor RelationsMatt KrepsT: 214-597-8200mkreps@darrowir.com
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Researchers are seeking to develop spuds that resist harmful nematodes – FreshPlaza.com
Posted: October 4, 2022 at 2:23 am
University of Idaho researchers are introducing genes from a plant in the nightshade family into potatoes, seeking to develop spuds that resist harmful nematodes. The plant, called litchi tomato, has natural resistance to several species of cyst and root-knot nematodes.
Thats an unusual trait to have such broad resistance, said Allan Caplan, associate professor in U of Is Department of Plant Sciences who is involved in the project.
Nematode cysts can remain viable in fields for more than a decade, and they can be found down to 3 feet deep in soil.U of I researchers led by nematologist and plant pathologist Louise-Marie Dandurand have worked for several years studying a range of possibilities for using litchi tomato as a tool to avert nematode-related yield losses in potatoes. Litchi tomato has been planted as a trap crop in the program to eradicate pale cyst nematode (PCN), which is quarantined in a small area of eastern Idaho. When planted in fields infested with PCN, litchi tomato stimulates cysts to hatch in the absence of a viable host, causing them to starve.
Dandurand also has a post-doctoral researcher seeking to identify chemicals in litchi tomato that harm or kill nematodes. Thechemicals that prove effectivecould be refined and applied directly to fields as a pesticide.
Caplan and Fangming Xiao, professor in the Department of Plant Sciences, have been working to identify the genes in litchi tomato that are specifically expressed when nematodes attack the plant.
We found at least 277 genes that got turned on, Caplan said. We think not all of them are necessary. We have to make educated guesses of which to try first, and its really a matter of trial and error. Were pretty certain some of these are going to have a big effect but we cant say with certainty which ones theyre going to be.
They turned over some of the genes they suspect may be directly involved in killing nematodes to Joseph Kuhl, associate professor in the Department of Plant Sciences, who used biotechnology to introduce them into a red-skinned potato variety, Desiree, last summer. Desiree was chosen because its relatively easy to transform through genetic modification.
If we see resistance in Desiree then well make the effort to put it in russets, Caplan said.
Xiao created some biotech potatoes using litchi tomato genes last fall, and Caplan is set to introduce additional litchi tomato genes into potatoes this summer. All their growing, infecting and analysis is taking place in closed growth chambers.
Byfirst using genetic engineering to find the pathway through which litchi tomato protects itself, Caplan believes researchers may later be able to change gene expression to protect potatoes from nematodes through laboratory methods that arent considered to be genetic modifications.
For more information:Louise-Marie DandurandUniversity of Idaho Tel.: +1 208-885-6080lmd@uidaho.edu
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Cleveland Clinic
Posted: October 4, 2022 at 2:21 am
Youve probably heard of diabetes. And obesity. But what the heck is diabesity? Its a new medical term for a condition thats becoming a worldwide epidemic. And if you have it, losing weight could cure the condition. Endocrinologist Jay Waddadar, MD, explains.
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Diabesity isnt an official diagnosis. It means you have both obesity and Type 2 diabetes. Together, these closely related conditions greatly increase your risk of heart disease the leading cause of death in the country.
Diabesity is a disease with enormous potential to cause ill effects on the body in the long run, says Dr. Waddadar. Some people dont understand the importance of taking the steps to manage it because theyre feeling well at the time of diagnosis. But thats a big mistake. Diabesity is a silent disease that damages your body if its not controlled, even while you feel fine.
The good news: You can prevent, control and even reverse it. Dr. Waddadar shares more about how obesity causes and worsens diabetes. And why losing weight holds the key to possibly making it all go away.
Having obesity makes you more likely to develop diabetes, the condition of having too much glucose (sugar) circulating in your bloodstream. Obesity also causes diabetes to worsen faster.
Heres what happens: Managing the level of glucose in your blood is the job of the pancreas. The pancreas creates insulin, which is a hormone that moves glucose out of your blood. Normally, insulin transports glucose to your muscles to use right away for energy or to the liver, where its stored for later.
But when you have diabesity, your cells resist letting insulin move glucose into them. To make matters worse, the area of your liver where excess glucose is usually stored is filled with fat. Its like trying to put furniture in a room thats already packed. Theres no space for anything else, Dr. Waddadar explains.
With nowhere to be stored, the glucose remains in the bloodstream. So your pancreas creates even more insulin trying to accomplish the job of moving glucose out of the blood, says Dr. Waddadar. Its trying to push against the resistance created by the fat. Your pancreas becomes overworked, and as a result, it wears out. It starts producing less insulin. Diabetes develops and then quickly worsens if the fat resistance remains.
If you have obesity, youre about six times more likely to develop Type 2 diabetes than those at a healthy weight. But not everyone with obesity automatically gets diabetes. Other factors are likely at play, too, including:
It may be that some people with obesity can produce more insulin without overtaxing the pancreas, says Dr. Waddadar. Others might be limited in insulin production, making it more likely that obesity will lead to diabesity.
Since excess fat worsens diabetes, losing weight can greatly improve the condition. When you have diabesity, you may start with one medication to get the pancreas to produce enough insulin. But very soon and much earlier, you need two or more medicines for diabetes. But if you lose weight, you may do fine with just one medication or even go off medication entirely, explains Dr. Waddadar.
Losing as little as 5% to 10% of your overall body weight can greatly improve Type 2 diabetes. For example, if you weigh 200 pounds, 5% of that is 10 pounds. So bringing your weight down to 190 pounds can significantly help your health. The first treatment goal for diabesity is to get to and maintain a healthy weight along with eating a low-carb diet, Dr. Waddadar says.
Changing your diet and increasing exercise to lose weight can be challenging. But the hard work is worth it to avoid serious complications of uncontrolled diabetes like heart disease, kidney failure and nerve damage.
Ready to take the first step toward better health? Ask your doctor for resources and guidance to help you beat diabetes.
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Cleveland Clinic
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Living with diabetes: Nutrition, exercise, routines, and more – Medical News Today
Posted: October 4, 2022 at 2:21 am
A diabetes diagnosis will require a person to make numerous changes to their lifestyle and routines. However, devising and sticking to a good treatment plan can help someone maintain a sense of agency around their condition and high quality of life.
Living with diabetes requires a person to eat a healthy diet, remain active, manage their symptoms, and know the signs of diabetic health issues.
Diabetes is a chronic illness that affects the bodys ability to convert glucose from food into energy, and it has three prominent types. Type 2 diabetes usually presents in adulthood and is the most common form, accounting for about 90% of all diabetes diagnoses. It causes insulin resistance, which means that the bodys insulin is not as effective at turning glucose into energy as it should be.
People with diabetes must develop strategies for managing their blood glucose, maintaining a moderate weight, and preventing complications like circulatory health problems and infections. Lifestyle changes, diabetes education, and medication can help a person living with diabetes achieve their best possible health outcomes and quality of life.
Read on to learn more about living with diabetes.
All forms of diabetes affect the bodys ability to convert glucose to energy using insulin. The three main types of diabetes include:
Because diabetes affects the bodys ability to metabolize glucose, high glycemic index foods are more likely to increase a persons blood glucose and cause diabetes complications. This means they should reduce sweetened, processed foods and simple carbohydrates, such as white bread and white pasta, from their diet.
Instead, a person should focus on eating nutrient-dense foods. Some other strategies for a healthier diet include:
People with type 2 diabetes often carry excess weight or have obesity. This can increase their risk of diabetes complications, such as heart disease. Exercise may help a person achieve or maintain moderate body weight.
Exercise can also increase the bodys sensitivity to insulin, which can improve a persons diabetes symptoms and support healthy blood glucose levels. Unless a doctor has specifically told a person not to exercise, almost everyone can benefit from exercise. More exercise generally offers more benefits.
The Centers for Disease Control and Prevention (CDC) recommends a minimum of 150 minutes of moderate-intensity physical activity per week. Some strategies for increasing a persons activity levels include:
Because people with type 1 diabetes do not produce enough insulin, they need insulin treatment. A person may need to give themselves insulin injections or use an insulin pump.
People with type 2 diabetes and gestational diabetes may need insulin if they cannot control their blood glucose with lifestyle changes alone.
Several other medications may also help a persons diabetes symptoms when insulin alone does not work. Some drug classes a doctor may recommend include:
A person might also need medication for diabetes-related complications. Some common drugs include:
It can take time to make the healthy changes that diabetes requires. A person should focus on making incremental changes that steadily improve their health. A routine may make these changes easier. Some strategies for building a healthy routine include:
Major life changes can affect a persons routine, making it more difficult to maintain a healthy lifestyle. For example, when a person is sick, they may be less able to exercise or make healthy meals.
When life changes disrupt a persons routine, consider slowly reincorporating healthy habits one by one. Small changes matter and add up. Also, finding alternative ways to maintain a healthy lifestyle can be helpful.
For example, a person working long hours, who cannot exercise, can still eat healthy meals. They might also take frequent breaks to walk or stretch during audio calls.
Various physiological changes throughout of a persons life may also affect their diabetes symptoms and management.
For instance, stress can influence a persons blood glucose levels. Menopause may affect the bodys insulin secretion ability and sensitivity, too. However, hormone replacement therapy has positive effects on a persons blood sugar levels. It is important to talk with a doctor about how major life changes may affect a persons diabetes and ways to best reduce any negative effects.
A person with diabetes will need support to make necessary lifestyle changes. Moreover, insulin injections and regular medical appointments may feel stressful or overwhelming. Some strategies for finding the right support include:
Diabetes is a chronic illness that often gets worse with time, especially without effective treatment or healthy lifestyle changes.
Both genetic and environmental factors play a role in the development and progression of diabetes. Therefore, even with a healthy lifestyle, a person may require medication and ongoing medical support.
People with diabetes should find a doctor they like and trust to help them develop a comprehensive plan for living with diabetes.
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Once-weekly insulin icodec demonstrates superior reduction in HbA1c in combination with a dosing guide app versus once-daily basal insulin in people…
Posted: October 4, 2022 at 2:21 am
Bagsvrd, Denmark, 3 October 2022 Novo Nordisk today announced headline results from the ONWARDS 5 phase 3a trial with once-weekly insulin icodec in people with type 2 diabetes.
The ONWARDS 5 trial was a 52-week, open-label efficacy and safety treat-to-target trial investigating once-weekly insulin versus once-daily basal insulin (insulin degludec or insulin glargine U100/U300) in 1,085 insulin-nave people with type 2 diabetes in a clinical practice setting including fewer trial visits compared to the other ONWARDS phase 3a trials. Once-weekly insulin icodec was used in combination with a dosing guide app to guide titration.
The trial achieved its primary endpoint of demonstrating non-inferiority in reducing HbA1c at week 52 with insulin icodec compared with once-daily basal insulin analogues. From an overall baseline HbA1c of 8.9%, once-weekly insulin icodec achieved a superior reduction in estimated HbA1c of 1.68%-points compared with 1.31%-points for the once-daily basal insulins (estimated treatment difference: 0.38%-points).
In the trial, there was no statistically significant difference in estimated rates of severe or clinically significant hypoglycaemia (blood glucose below 3 mmol/L) with 0.19 events per patient-year exposed to once-weekly insulin icodec and 0.14 events per patient-year exposed to the once-daily basal insulins. In the trial, once-weekly insulin icodec appeared to have a safe and well-tolerated profile.
We are very pleased to share the positive results from the ONWARDS 5 trial. These results include real-world elements and a dosing guide app, which help us better understand how insulin icodec can make a difference for patients in a clinical practice setting, said Martin Holst Lange, executive vice president for Development at Novo Nordisk. Todays results confirm the results from the previous reported ONWARDS trials and highlight that insulin icodec has the potential to be an ideal insulin for people with type 2 diabetes. We now look forward to sharing the results with regulatory authorities.
Novo Nordisk expects to file for regulatory approval of once-weekly insulin icodec in the US, the EU and China in the first half of 2023.
About the ONWARDS clinical development programme The ONWARDS programme for once-weekly insulin icodec currently comprises six phase 3a global clinical trials, including a trial with real-world elements, involving more than 4,000 adults with type 1 or type 2 diabetes.
ONWARDS 1 is a 78-week trial comparing the efficacy and safety of once-weekly insulin icodec with once-daily insulin glargine U100 both in combination with non-insulin anti-diabetic treatment in 984 insulin-nave people with type 2 diabetes. Following the completion of the main phase of the trial, a 26-week extension phase is ongoing. The results of the main phase were reported on 3 June 2022.
ONWARDS 2 was a phase 3a, 26-week efficacy and safety treat-to-target trial investigating once-weekly insulin icodec vs insulin degludec in 526 people with type 2 diabetes switching from a once-daily insulin. Results were reported on 28 April 2022.
ONWARDS 3 was a 26-week trial comparing once-weekly insulin icodec with once-daily insulin degludec. The objective of the trial was to assess the efficacy and safety of insulin icodec in 588 insulin-nave people with type 2 diabetes. Results were reported on 29 July 2022.
ONWARDS 4 was a 26-week trial comparing once-weekly insulin icodec with once-daily insulin glargine, both in combination with mealtime insulin. The objective of the trial was to assess the efficacy and safety of insulin icodec in 582 people with type 2 diabetes treated with basal and bolus insulin. Results were reported on 29 July 2022.
ONWARDS 5 was a 52-week trial comparing once-weekly insulin icodec with once-daily basal insulin (insulin degludec and insulin glargine U100 and U300) The objective of the trial was to assess the effectiveness and safety of insulin icodec, with an app providing dosing recommendation, in 1,085 insulin-nave people with type 2 diabetes in a clinical practice setting including no upper limit at HbA1c at time of inclusion, no limitations on use of oral antidiabetic treatments and fewer planned site visits compared to the other ONWARDS phase 3a trials (every third month in accordance with recommended clinical practice)
ONWARDS 6 is a 52-week trial comparing once-weekly insulin icodec with once-daily insulin degludec, both in combination with mealtime insulin. The objective of the trial is to assess the efficacy and safety of insulin icodec in 583 people with type 1 diabetes. Following the completion of the main phase of the trial, a 26-week extension phase is ongoing. The results of the main phase were reported on 3 June 2022.
About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 50,800 people in 80 countries and markets its products in around 170 countries. Novo Nordisks B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com, Facebook, Twitter, LinkedIn and YouTube.
Further information
Company announcement No 73 / 2022
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THE DIABETES LINK LAUNCHES TO HELP YOUNG ADULTS THRIVE WHILE LIVING WITH THE DISEASE – PR Newswire
Posted: October 4, 2022 at 2:21 am
After 12 years of serving more than 11,500 college students on over 300 campuses nationwide, the College Diabetes Network is expanding and rebranding to The Diabetes Link in effort to serve more young adults
BOSTON, Oct. 3, 2022 /PRNewswire/ -- Currently, there are 3 million young adults (ages 17-30) living with diabetes in the U.S. and that number continues to increase every day. The Diabetes Link is the only national organization that focuses specifically on people in their teens and twenties, in recognition that this time of their lives is full of enough change and challenges without a chronic disease added to the mix.
Formerly known as the College Diabetes Network (CDN), this new name reflects a commitment to expand support to the larger young adult diabetes community, whatever the type of diabetes they live with and whether they're in school or in the workforce.
Currently, there are 3 million young adults (ages 17-30) living with diabetes in the U.S.
The Diabetes Link offers peer support, leadership development, and expert, age-relevant resources tailored specifically to the dynamics of emerging adulthood. In addition to growing their flagship campus network, The Diabetes Link is launching a new online resource hub that will offer 24/7 access to first-hand peer experiences and perspectives, as well as information reviewed and endorsed by clinical experts.
Christina Roth, CEO & Founder, states, "We will stay true to our roots in type 1 diabetes, but the insights we've gained over these last 12 years will also benefit those with Type 2 and other types of diabetes. These young people make over 180 life-altering decisions a day, and they deserve access to support that will help them manage their diabetes AND enjoy the exhilaration of young adulthood. We are here to guide them."
"As the father of a son with type 1 diabetes who just started college, I joined the board of directors to ensure that my son and all teens and young adults like him have the support and information they need to safely and successfully navigate this stage of life" says Brad Stadler, Chair of The Diabetes Link Board of Directors. "It is my privilege to continue advancing this goal while ensuring that all young adults, regardless of where they are in life or in the country, have access to the invaluable resources we have built."
About the Diabetes Link:
The Diabetes Linkis a national 501c3 non-profit organization dedicated to empowering young adults with diabetes by providing access to the peer support, connections, and expert resources they need to thrive. Over the years The Diabetes Link (formerly CDN) has been recognized as the preeminent organization serving young adults with diabetes, establishing national partnerships with organizations such as ADA, JDRF, and the Association for Diabetes Care and Education Specialists (ADCES); also, as the leading provider of young adult patient education by healthcare providers and certification boards such as The Certification Board for Diabetes Care and Education (CBDCE).
For more information, please contact:Alyssa Sullivan 617-899-8631 [emailprotected]
SOURCE The Diabetes Link
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THE DIABETES LINK LAUNCHES TO HELP YOUNG ADULTS THRIVE WHILE LIVING WITH THE DISEASE - PR Newswire
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