The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today – NY Stock News

The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today
NY Stock News
The technicals for Puma Biotechnology, Inc. (PBYI) has spoken via its technical chart and the message is loud and clear. Based on that message, this is the relevant information necessary to make sense of that current setup. Often the difference between ...

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The Technical Chart For Puma Biotechnology, Inc. (PBYI) Is Very Revealing Today - NY Stock News

Biotechnology, Panacea To Army Worm Maize Infestation – Leadership Newspapers

By Nkechi Isaac

Maize (also known as corn in some countries) is one of the most common and important food crops across Africa. It is widely eaten in various forms and more than 900 million Africans depend on maize every year because it is often cheaper than rice and wheat, two of the other most consumed cereals.

A report released by the IITA estimates that about 800 million tons of maize is produced worldwide every year.

According to the report, though the United States remains the worlds largest producer with 42 percent of all maize produced globally, Africa contributes significantly in this production with 6.5 percent of this volume which is still insufficient for local consumption.

Nigeria remains Africas largest producer with nearly 8 million tons per annum. It is closely followed by South Africa, Tanzania, Kenya and Uganda.

It was therefore a nightmare when Nigeria like the rest of Africa woke up to the Fall Armyworm (FAW) infestation which was rapidly spreading across the region.

Army worm is very deleterious and like the name suggests it derives its name from its feeding habits, of marching in large numbers from grasslands into crops. They strongly prefer grasses, cereals like maize, and can mercilessly eat the stem of the crop as well as the leaves.

Army worm infestation can be disastrous on the crops. It affects the yield of the crop from the stalk to the stage of maturity and is capable of destroying entire crops in a matter of weeks if it is unchecked.

Like other African countries, Nigeria woke up to a nightmare of recent army worm infestation in the region, leaving farmers worried as the pest, which has grown resistance to chemicals, wreaked havoc on newly cultivated maize farms across the country. This resulted in the severe reduction on the yield recouped by farmers on their maize field.

The Federal Government quickly waded and convened a meeting with commissioners for agriculture from the 36 states in Abuja to find ways of ameliorating the effect of the havoc and contain the infestation.

In his speech, the Minister of Agriculture and Rural Development, Chief Audu Ogbeh, said the achievement of self-sufficiency in maize production would continue to be a mirage with the pest infestation.

He said the spread of the maize disease had negatively affected the poultry industry, which largely depends on maize for the production of feeds.

The minister explained that the aim of the meeting was to brainstorm on ways of finding sustainable solutions to the army worm infestation which had ravaged maize farms in the states.

It is the state government that owns lands; so we need to tackle this problem to boost agricultural production, he said.

Ogbeh told the meeting the federal government required N2.98 billion to curb the army worm infestation of farmlands across the country, adding the United Nations Food and Agriculture Organisation (FAO) had pledged to support the country in its fight against the army worm infestation.

However, scientists are calling on farmers to embrace biotechnology by using genetically modified crops which have been proven safe for man and the environment to permanently tackle such occurrences.

Speaking during an interview with journalists in Abuja, the country coordinator of Open Forum on Agricultural Biotechnology (OFAB), Nigeria Chapter, Dr Rose Gidado, said genetic modification, also known as genetic engineering, is a technologically advanced way to select desirable traits in crops, pointing out that while selective breeding has existed for thousands of years, modern biotechnology is more efficient and effective because seed developers are able to directly modify the genome of the crop.

The OFAB coordinator said adopting genetic modification technology to develop maize variety resistant to pest provided a lasting solution for army worm infestation, adding genetically engineered (GE) plants are selectively bred and enhanced with genes to withstand common problems that confront farmers which include maize that could survive pesticides/infestation.

Gidado, a deputy director, at the National Biotechnology Development Agency (NABDA) revealed that a breakthrough recorded by scientists with the development of a maize variety called Water Efficient Maize for Africa (WEMA) which has proven to resist the attacks from army worm infestations provided a lasting solution to the infestation.

She said: The lasting solution to army worm infestation on maize is the use of genetic modification technology to develop a maize variety that would be resistant to the pest, that gives a permanent solution.

She added, There is already a variety of maize called Water Efficient Maize Variety for Africa that has proven to be resistant to army worm, it has not yet been deployed to Nigeria but we are making plans.

The WEMA project is a public-private partnership to develop royalty-free African drought-tolerant white maize varieties, it also increases yield stability, protects and promotes farmers investment in best management practices.

The project which is water conserving and insect protected conventional and transgenic maize, is expected under moderate drought, to increase yields by 20-35 percent over current varieties; it is also expected to translate into additional 2 million MT of maize during drought to feed 14 to 21 million people.

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Biotechnology, Panacea To Army Worm Maize Infestation - Leadership Newspapers

Why Puma Biotechnology, Applied Optoelectronics, and Ferroglobe Jumped Today – Motley Fool

Monday was a good start to the week for stocks, with major benchmarks climbing around half a percent on the day. Most market participants pointed to a lack of bad news over the weekend and anticipation about expected favorable economic data in the coming days as drivers of the generally positive attitude among investors.

But there are still plenty of factors that are preventing stocks overall from mounting stronger gains, including nervousness about geopolitical issues as well as weaker parts of the global economy. Nevertheless, some stocks posted strong gains, and Puma Biotechnology (NASDAQ:PBYI), Applied Optoelectronics (NASDAQ:AAOI), and Ferroglobe (NASDAQ:GSM) were among the best performers on the day. Below, we'll look more closely at these stocks to tell you why they did so well.

Image source: Getty Images.

Shares of Puma Biotechnology soared 39% as investors anticipated that the biotech company will get approval of its neratinib breast cancer drug from the U.S. Food and Drug Administration. An FDA advisory committee is scheduled to meet later this week, and documents supporting that meeting were released today. In those documents, investors found fewer critical views of neratinib than some had expected, and that led those following the stock to conclude that the drug is likely to get a favorable review from the advisory panel. That by itself won't mean certain approval for neratinib, as the final decision from the FDA doesn't necessarily hinge on the advisory panel. Nevertheless, positive signs have investors excited about Puma, and there's potential for further gains if the FDA does indeed follow through with approval later this year.

Applied Optoelectronics stock climbed 12% after the supplier of fiber-optic components got a favorable review from Wall Street analysts. Needham & Co. began its coverage of Applied Optoelectronics stock with a strong buy rating, arguing that the company has a lot of growth potential stemming from moves among enterprise data center users to upgrade their performance and incorporate faster transfer speeds. Needham set an $85-per-share price target on the stock, which still gives investors nearly 20% upside from current levels. If Applied Optoelectronics can turn the new upgrade cycle into accelerating growth, then investors could see even greater gains in the long run.

Finally, shares of Ferroglobe rose 9%. The producer of silicon metal and various related alloys released its first-quarter financial results, which included flat revenue compared to the fourth quarter of 2016 and a minimal net loss for the quarter. Shipment volumes were down from year-ago levels, but a rise in prices for manganese alloys was sufficient to keep total average selling prices relatively steady. Yet CEO Pedro Larrea was optimistic about the company's performance, noting that "significant margin improvement reflects solid demand across end markets and a continued improvement in the overall pricing environment." Even with the gains, Ferroglobe shares have lost half their value in the past two years, but investors are optimistic that the company can earn back some of those losses over time.

Dan Caplinger has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Why Puma Biotechnology, Applied Optoelectronics, and Ferroglobe Jumped Today - Motley Fool

Reasons to Add Puma Biotechnology (PBYI) to Portfolio Now – Zacks.com

On May 16, 2017, we issued an updated report on Puma Biotechnology, Inc. (PBYI - Free Report) .

Puma Biotechnology is a development-stage biopharmaceutical company focused on the development and commercialization of innovative treatments that enhance cancer care.

The company posted narrower-than-expected loss in the first quarter of 2017. Reported loss of $1.97 per share was also narrower than year-ago figure of $2.19. With no approved products in its portfolio at the moment, the company does not generate revenues yet. The company reported first-quarter results on May 10, 2017.

So far this year, Pumas shares have outperformed Zacks classified Medical-Biomed/Genetics industry. The companys shares have gained 4.1% while the industry registered an increase of 2.2%.

Puma has made significant progress with its lead candidate, neratinib. The candidate is currently under review in both the U.S. and the EU for HER2+ breast cancer. An approval would be a huge boost for the company given the immense commercial potential in the target market.

We note that several additional studies on neratinib targeting different types of breast cancer patient populations are currently underway. During the quarter, Puma presented encouraging data from several ongoing studies on neratinib at the annual meeting of the American Association for Cancer Research (AACR).

Puma also expects to achieve several milestones in the second quarter of 2017. These include additional data from the phase III study on neratinib in third-line HER2-positive metastatic breast cancer patients and data from a phase II study on neratinib in HER2-positive metastatic breast cancer patients with brain metastases.

However, dependence on the successful development of a single candidate may hurt the companys growth prospects in case of any adverse development or regulatory setback.

Moreover, lack of partnership deals could hamper progress of the candidate as the company has no sales, marketing or distribution capabilities.

Zacks Rank & Key Picks

Puma currently carries a Zacks Rank #2 (Buy). Other stocks in the health care sector that warrant a look include Aeglea BioTherapeutics (AGLE - Free Report) , VIVUS, Inc. (VVUS - Free Report) and MEI Pharma, Inc. (MEIP - Free Report) . While Aeglea carries a Zacks Rank #2, VIVUS and MEI Pharma sport a Zacks Rank #1 (Strong Buy). You can see the complete list of todays Zacks #1 Rank stocks here.

Aegleas loss per share estimates narrowed from $3.64 to $2.48 for 2017, over the last 60 days. The company posted positive earnings surprises in three of the four trailing quarters with an average beat of 20.75%.

VIVUSs loss per share estimates narrowed from 50 cents to 39 cents for 2017, over the last 30 days. The company posted positive earnings surprises in all of the four trailing quarters with an average beat of 233.69%.

MEI Pharmas posted positive earnings surprises in three of the four trailing quarters with an average beat of 66.56%. The companys shares gained 16% so far this year.

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Reasons to Add Puma Biotechnology (PBYI) to Portfolio Now - Zacks.com

Biotechnology sachet solution launched – Cleaning & Maintenance

London-based Cleanology is launching what it claims to be the worlds first biotech wipe for tablets and mobile phones, and pre-portioned cleaning fluids and floor cleaners in sachets.

Biotechnology uses enzymes to eat dirt and bacteria. The tiny molecules access even the hardest to reach areas and carry on working for days after application. Enzyme-based solutions are gaining traction in the industry, but to date no firm has focused on mobile device screens, which are often taken out of the office at night, when cleaning takes place.

Cleanology has created a multi-purpose biotech tech wipe which cleans and sanitises mobile phones, tablets and laptops with a moist tissue impregnated with a biotechnology cleaning solution. It has also addressed portioning, with the development of handy-sized sachets which hold a pre-dosed amount of solution. When added to water, this creates a biotechnology cleaning agent.

CEO Dominic Ponniah said: Biotechnology is a fantastic advance which has rightly been embraced by the industry. However, as with all cleaning products that require dilution, people often use too much product - they think that the more they slosh into a bucket, the more effective they will be. Using too much product - especially biotechnology products which are pH-neutral and completely safe - does not cause any harm, but it is wasting valuable resources. An extra cupful of solution every couple of days might not seem disastrous, but multiply that over a year and across the 450,000 people working in the industry, and the impact becomes significant. The cleaning firm ends up buying larger quantities of product and paying more to transport it, not to mention the environmental impact of extra journeys, waste generation and the unnecessary manufacture of products.

To counteract this excess, Cleanology has introduced its own range of pre-portioned biotechnology solutions and wipes. Each sachet of multi-purpose or floor cleaner is sufficient to fill one bucket or spray can, with a pack of 50 sachets able to last a month. The sachets fit easily into the pocket, so a cleaning operative can carry supplies with them from job to job. The wipes are impregnated with biotechnology solution and pre-diluted with water.

Cleanology was one of the first cleaning firms to embrace biotechnology. It has partnered with InnuScience, a leader in the development and manufacture of biotechnology cleaning products. Ponniah continued: InnuScience are experts in their field, supplying all the major FM companies and retail brands. We are experts in cleaning, while InnuScience provides the cutting-edge technology thats inside our Bioclean sachets.

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Biotechnology sachet solution launched - Cleaning & Maintenance

Puma Biotechnology Stock Slumps as Regulatory VP Departs Before FDA Review – Los Angeles Business Journal

Puma Biotechnology Inc.s stock took a dive last week after its regulatory executive resigned less than three weeks before a U.S. Food and Drug Administration panel is scheduled to review the public companys breast cancer drug Neratinib.

The Westwood companys share price dipped 14 percent to $31.38 at the close of business May 5 from $36.45 the day before, when the company notified the Securities and Exchange Commission that Robert Charnas, senior vice president of regulatory affairs and project management, would step down for health reasons effective May 15.

The stock was trading at $29.15 when the markets closed Monday.

The company, which has a market cap of $1.07 billion, hired 63-year-old Charnas last year with a base salary of more than $330,000, stock options, and a more than $378,000 signing bonus, according to the employment offer letter filed with the SEC.

An independent panel of experts is scheduled to review Neratinib for safety and efficacy May 24 before making a recommendation for its use to the FDA.

Caroline Anderson is a staff reporter covering retail, restaurants, and hospitality. She can be reached at canderson@labusinessjournal.com.

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Puma Biotechnology Stock Slumps as Regulatory VP Departs Before FDA Review - Los Angeles Business Journal

Puma Biotechnology Inc (PBYI) Plunges 5.54% on May 08 – Equities.com

Market Summary Follow

Puma Biotechnology Inc is a A biopharmaceutical company

PBYI - Market Data & News

PBYI - Stock Valuation Report

Puma Biotechnology Inc (PBYI) had a rough trading day for Monday May 08 as shares tumbled 5.54%, or a loss of $-1.7 per share, to close at $29.00. After opening the day at $30.45, shares of Puma Biotechnology Inc traded as high as $31.20 and as low as $28.50. Volume was 1.11 million shares over 8,212 trades, against an average daily volume of 941,762 shares and a total float of 36.97 million.

As a result of the decline, Puma Biotechnology Inc now has a market cap of $1.07 billion. In the last year, shares of Puma Biotechnology Inc have traded between a range of $73.27 and $19.74, and its 50-day SMA is currently $38.11 and 200-day SMA is $43.37.

For a complete fundamental analysis of Puma Biotechnology Inc, check out Equities.coms Stock Valuation Analysis report for PBYI.

Want to invest with the experts? Subscribe to Equities Premium newsletters today! Visit http://www.equitiespremium.com/ to learn more about Guild Investments Market Commentary and Adam Sarhans Find Leading Stocks today.

Puma Biotechnology Inc is a biopharmaceutical company. It is engaged in the acquisition, development and commercialization of products to enhance cancer care.

Puma Biotechnology Inc is based out of Los Angeles, CA and has some 160 employees. Its CEO is Alan H. Auerbach.

Puma Biotechnology Inc is a component of the Russell 2000. The Russell 2000 is one of the leading indices tracking small-cap companies in the United States. It's maintained by Russell Investments, an industry leader in creating and maintaining indices, and consists of the smallest 2000 stocks from the broader Russell 3000 index.

Russell's indices differ from traditional indices like the Dow Jones Industrial Average (DJIA) or S&P 500, whose members are selected by committee, because they base membership entirely on an objective, rules based methodology. The 3,000 largest companies by market cap make up the Russell 3000, with the 2,000 smaller companies making up the Russell 2000. It's a simple approach that gives a broad, unbiased look at the small-cap market as a whole.

To get more information on Puma Biotechnology Inc and to follow the companys latest updates, you can visit the companys profile page here: PBYIs Profile. For more news on the financial markets and emerging growth companies, be sure to visit Equities.coms Newsdesk. Also, dont forget to sign-up for our daily email newsletter to ensure you dont miss out on any of our best stories.

All data provided by QuoteMedia and was accurate as of 4:30PM ET.

DISCLOSURE: The views and opinions expressed in this article are those of the authors, and do not represent the views of equities.com. Readers should not consider statements made by the author as formal recommendations and should consult their financial advisor before making any investment decisions. To read our full disclosure, please go to: http://www.equities.com/disclaimer

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The Technical Facts on Puma Biotechnology, Inc. (PBYI) – The USA Commerce

The Technical Facts on Puma Biotechnology, Inc. (PBYI)
The USA Commerce
We have gathered the technical data on Puma Biotechnology, Inc. (PBYI), and see some interesting trends in the stock's behavior of late. They say the soul of a stock is best known by an examination of its behavior on the tape. With that in mind ...

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The Technical Facts on Puma Biotechnology, Inc. (PBYI) - The USA Commerce

Cellect Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2016 Financial Results – P&T Community

Cellect Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2016 Financial Results
P&T Community
TEL AVIV, Israel, March 23, 2017 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (NASDAQ:APOP) (TASE:APOP), a developer of innovative technology which enables the functional selection of stem cells, today provided a corporate update and ...

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Cellect Biotechnology Provides Corporate Update and Reports Fourth Quarter and Full Year 2016 Financial Results - P&T Community

Biotechnology | FAO | Food and Agriculture Organization of …

Agricultural biotechnologies are being applied to an increasing extent in crops, livestock, forestry, fisheries and aquaculture and agro-industries, to alleviate hunger and poverty, assist in adaptation to climate change and maintain the natural resource base.

They have not sufficiently benefited smallholder farmers and producers and consumers. More research and developmentof agricultural biotechnologies should be focused on the needs of smallholders.

In order to produce food in a sustainable way for an additional 2 billion people by 2050, a business-as-usual approach will not be sufficient.

This is especially true in the face of climate change and other forces threatening natural resources like biodiversity, land and water that are essential for food production and agriculture, including forestry and fisheries.

To meet these challenges, science and the application of biotechnologies as well as conventional technologies will play a key role.

FAO recognizes that when appropriately integrated with other technologies for the production of food, agricultural products and services, biotechnology can be of significant assistance in meeting the needs of an expanding and increasingly urbanized population. Regarding biotechnology, FAO assists its Member countries and their institutions by:

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Biotechnology | FAO | Food and Agriculture Organization of ...

Biotechnology Gets A Shot In the Arm – Barron’s (blog)

Biotechnology Gets A Shot In the Arm
Barron's (blog)
Consider iShares Nasdaq Biotechnology (IBB) and the SPDR S&P Biotech (XBI). IBB has a bigger swath of the sector with 162 constituents in the index that it tracks, while XBI has 87. IBB's top holdings are in large-caps such as Celgene (CELG) and Gilead ...
iShares Nasdaq Biotechnology (IBB) volatility low into Credit Suisse ...StreetInsider.com
iShares NASDAQ Biotechnology Index (IBB) Rating Increased to ...BBNS

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Biotechnology Gets A Shot In the Arm - Barron's (blog)

Frontiers in biotechnology hold vast promise – Cape Cod Times (subscription)

By Thomas Gelsthorpe

Material advantages have been provided mainly by optimists. Wholesome, widely available foods, reliable electricity, and faster, safer transportation are among the most obvious. For nonscientists and nongeniuses (that's most of us), the spiritual and moral advantages of optimism over pessimism are even greater.

Optimists believe a brighter future is likely, with centuries of demonstrable progress to use as a model. Setbacks can be shrugged off as mere bumps in the road. Pessimists, especially doomsday prophets so vocal nowadays, can only win by losing, with slim, sour prospects for gloating: "See? I told you so!" When doomsday predictions flop, and things go well instead, pessimists have to admit another defeat.

Optimists continue to forge breakthroughs that improve conditions for people and wildlife. The State University of New York (SUNY) College of Environmental Science and Forestry (ESF) in Syracuse is near success for a long-sought remedy to the near-extinction of the American chestnut. Career-length teamwork by scientists at SUNY/ESF have added one gene to the 38,000 naturally occurring chestnut genes, and enabled seedlings to resist the blight that wiped out American chestnuts a century ago.

Before the blight, chestnut was the dominant tree in hardwood forests covering much of the eastern United States. Chestnuts formed pure stands in favored areas, and occupied about 25 percent of the hardwood forest overall. To picture chestnuts' former importance, walk into an oak forest and visualize one tree out of every four. Chestnuts are among the fastest-growing, widest, native trees. Only sycamores and tulip trees -- still thriving but never dominant -- reached greater average sizes. Recolonizing mixed forests with blight-proof chestnuts bodes well for forest health, and faster rates of absorbing carbon dioxide. Instead of imported "chestnuts roasting on an open fire," American chestnuts could recapture markets.

Majestic chestnuts were cherished by people, wild and domestic animals who ate the nuts, and they supplied lumber of the highest quality for construction and furniture. Chestnut wood is honey-colored, lightweight, easily worked, durable and holds a finish well. While chestnuts' dominance was still taken for granted, Massachusetts poet Henry Wadsworth Longfellow opens "The Village Blacksmith" like so:

"Under a spreading chestnut tree The village smithy stands, The smith, a mighty man is he, With large and sinewy hands; And the muscles of his brawny arms Are strong as iron bands."

I share a sentimental/poetic streak about chestnuts. My brother lived in a house, built in 1795 as a blacksmith shop, entirely of chestnut: walls, floors, studs, ceilings, the works. Maybe Longfellow saw the place. During long-ago adventures in the antique business, I admired many a chestnut chest, and once came across a stack of chestnut planks stored in a barn. Exquisite wood. I didn't make a dining room table from them, but I should have tried.

Sinclair Lewis, the first American awarded a Nobel Prize in Literature, wrote a novel "Arrowsmith" about a research doctor battling a plague on a Caribbean island -- a foretaste of life-saving biotechnologies still advancing as we speak.

Ongoing developments promise far more than the revival of one cherished species. They point towards preventatives for bugs and diseases that wiped out American elms, and caused the Irish potato famine. Early in my farming years, I planted disease-resistant elms to shade my house and barn. I won't live long enough to know if they succeed, because elm disease waits until trees are mature. Further advances might regenerate for future generations the elm-lined streets of the American towns of my youth.

Gene-splicing is already delivering advances in forestry, agriculture, animal husbandry, and medicine. Don't succumb to pessimism about "Frankenfoods." Doomsday scenarios have notmaterialized, and are becoming lesslikely as techniques become more precise. Nourish biotech's promises. Hope that our brightest and most ambitious minds pursue new breakthroughs.

Cape Cod Times columnist Thomas Gelsthorpe lives beneath oaks, beeches and hickories in Cataumet. He welcomes comments at thomasgelsthorpe@gmail.com.

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Frontiers in biotechnology hold vast promise - Cape Cod Times (subscription)

Unified Biotechnology Regulation Website Launched – The National Law Review

Thursday, January 16, 2020

In a coordinated effort, the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the Environmental Protection Agency (EPA) launched a Unified Website for Biotechnology Regulation on January 9, 2020. The website serves to streamline information regarding agriculture biotechnology products, which are regulated by FDA, USDA, and EPA. The implementation of the website is in response to the June 2019 Executive Order issued by President Donald Trump on Modernizing the Regulatory Framework for Agricultural Biotechnology Products. The Unified Website for Biotechnology Regulation complements prior joint actions such as the Coordinated Framework for the Regulation of Biotechnology, an Obama administration effort to reform the biotechnology regulatory process by enhancing transparency, predictability, and efficacy. Mintz has previously covered these coordinated efforts here.

Agriculture biotechnology products are products created through genetic engineering of plants, animals, and microbes. Each agency has a role in regulating biotechnology products: USDA has authority to approve all releases of genetically modified organisms (GMOs) to ensure they do not create an environmental hazard; EPA must approve all crops that contain insect-killing genes; and FDA is responsible for evaluating whether GMOs are safe to eat. However, because of the interrelatedness of this area, agency regulatory oversight can be disjointed and unclear. Additionally, the advancement of technology can cause confusion in interpreting the regulatory requirements of each agency. Therefore, a primary goal of the website is to enhance customer service by allowing users to submit questions directly to the three agencies, as well as through providing a Frequently Asked Questions page.

The Unified Website for Biotechnology Regulation does not alter the regulatory process concerning agriculture biotechnology products. Instead, the website acts as an interactive archive containing information about the federal review process, while also enabling users to submit questions to the regulatory agencies with the expectation of a coordinated response. According to the FDA Press Release, "[t]he goals of this website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations.

The website launch follows the October 2018 FDA announcement for its Plant and Animal Biotechnology Action Plan, which provides a risk-based regulatory approach to the oversight of plant and animal-derived products of biotechnology, with a focus on safety and effectiveness. One of the action plan's priorities is to coordinate a new biotechnology approach with EPA and USDA to clarify oversight of genome-edited products. According to FDA Commissioner Stephen Hahn, M.D.: This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace . . . Our approach balances our internationally respected, science-based review standards with our ongoing risk-based regulatory approaches to ensure the safety of our food supply.

While the Unified Website for Biotechnology Regulation is a step towards meeting the goals set in the June 2019 Executive Order, additional efforts are needed to better coordinate biotechnology product regulation as technology continues to advance.

1994-2020 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

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Unified Biotechnology Regulation Website Launched - The National Law Review

Analytical Guide for Puma Biotechnology, Inc. (PBYI), Liberty Property Trust (LPT) Stakeholders – The USA Commerce


The USA Commerce
Analytical Guide for Puma Biotechnology, Inc. (PBYI), Liberty Property Trust (LPT) Stakeholders
The USA Commerce
Presently Puma Biotechnology, Inc. (NASDAQ:PBYI) stock have an ABR of 1.67. This is built on a simplified 1 to 5 scale where 1 represents a Strong Buy and 5 a Strong Sell. Looking ahead to earnings forecasts, for the running fiscal period, Wall Street ...

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Pharmaceutical industry mounts opposition to states effort to curb drug costs – The Boston Globe

As they finalize rules to control the cost of prescription drugs, state officials are meeting new resistance from the pharmaceutical industry.

Legislators and Governor Charlie Baker approved a change in law this summer that allows the administration to curb drug costs in the state Medicaid program, or MassHealth, by negotiating discounts directly with drug companies. If negotiations are unsuccessful, the administration can establish a target value for certain high-cost drugs, hold a public hearing, and refer the matter to the Health Policy Commission, a watchdog agency, for further review.

Then, the commission can demand more information from drug makers, but that information would remain out of public view.

Administration officials and the Health Policy Commission have been drafting detailed regulations to implement the law. But the Massachusetts Biotechnology Council, which represents biopharmaceutical companies, said the proposed regulations go too far.

We have strong concerns, said Zachary Stanley, a spokesman for MassBio. We think they are going beyond what the enabling law allows them to.

Stanley said drug makers are particularly worried that the administration wants to publicly post the target value of drugs. And theyre troubled by the amount and type of information that the Health Policy Commission plans to require from companies that are undergoing a review. For example, companies dont want to disclose the net prices that various insurance companies pay for their drugs or share their research and development costs.

The Pharmaceutical Research and Manufacturers of America, or PhRMA, raised similar issues, telling state officials it is deeply concerned about several aspects of the proposed regulations.

Baker first proposed a plan to tackle drug costs in MassHealth in January and drew immediate fire from pharmaceutical lobbyists. The proposal made for a lengthy debate at the State House. In late July, state lawmakers finally approved a version of Bakers plan but softened some of the language. At the time, MassBio called it a good compromise.

At this point, we want to make sure the law is enacted faithfully to what the Legislature intended, Stanley said.

Drug company lobbyists have argued that controls on prices could stifle innovation, particularly in the biotech hub of Massachusetts, where research labs represent an important piece of the economy.

But as drug costs continue rising for patients and for state governments policy makers have continued to target pharmaceutical companies.

In October, Baker filed a sweeping health care bill that would subject high-cost drugs to further state oversight and penalize companies that raise the price of any drug too sharply.

And in November, the Senate passed a bill that allows state officials to determine fair values for expensive medicines and to cap out-of-pocket costs for insulin.

House leaders are expected to introduce health care legislation in the new year.

Many organizations, including the consumer group Health Care For All, support stronger controls on prescription prices.

A coalition including Health Care For All, AARP Massachusetts, the Greater Boston Interfaith Organization, the Massachusetts Medical Society, and other groups told state officials this month that the proposed MassHealth regulations will save money for the state and taxpayers, while also protecting the 1.8 million residents who rely on the MassHealth program for their health care.

Some of the new MassHealth drug pricing provisions are already in effect. Since the law was enacted this summer, MassHealth officials said they already have negotiated discounts with five drug companies for 11 drugs, saving about $10 million.

Before discounts, the cost of drugs in MassHealth has grown to about $1.9 billion per year.

The administration and the Health Policy Commission plan to finalize their regulations over the next several weeks.

At a recent public hearing, Dr. John Christian Kryder, a board member of the Health Policy Commission, noted the difficult task for state officials.

The tradeoffs here are enormous if we dont get it right and create an environment where drug development does not occur, he said.

Priyanka Dayal McCluskey can be reached at priyanka. mccluskey@globe.com. Follow her on Twitter @priyanka_dayal.

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Pharmaceutical industry mounts opposition to states effort to curb drug costs - The Boston Globe

Biotechnology Careers – Career Path Information | Monster.com

Biotechnology Career Overview

If biology is your bag, you may be interested in biotech careers. Biological technicians often work at universities or in commercial labs assisting with experiments and tests. Biochemists, biophysicists and microbiologists are biotech jobs worked in universities or commercial or private offices and labs studying organisms, microorganisms, biological development and growth.

If you're looking at biotechnology careers, be prepared to get an education. Technicians and microbiologists need at least a bachelor's degree in biology, microbiology or a related field. Biochemists and biophysicists need a doctoral degree to find employment doing independent research and even development. Occasionally, you may find an entry-level biotech job that only requires a bachelor's or master's degree, but you'll want to go on to complete your Ph.D. if you aspire to move up the biotechnology ladder.

Overall, biotech careers are expected to increase in demand over the next 10 years. The Bureau of Labor Statistics (BLS) projects a 10 percent growth for biological techs, biochemists and biophysicists between 2012 and 2022, and a seven percent increase in microbiologists' jobs. Increased demand for research in the biotechnology field and the aging baby boomer population are the key issues that the BLS names for the positive job market outlook in these fields. That's good news for biochemists, biophysicists and microbiologists, as they held roughly only 49,300 jobs in 2012. The biotech techs, however, were almost double the other three biotech careers combined, expected to be around 88,300 by 2022, up from 80,200 jobs in 2012.

As with any job that requires a degree, biotech positions command higher salaries. Techs are the low men on the totem pole with an average annual salary of $38,750. If you put the time and effort into earning a master's degree or a Ph.D. for one of the other biotech jobs, however, the pay increases. Microbiologists earn an annual median wage of $66,260 and biochemists and biophysicists bring in even more with average annual pay at $81,480.

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B.R.A.I.N. Biotechnology Research And Information Network AG: BRAIN Group expands production capacit – PharmiWeb.com

DGAP-News: B.R.A.I.N. Biotechnology Research And Information Network AG / Key word(s): Miscellaneous17.12.2019 / 08:52 The issuer is solely responsible for the content of this announcement.

BRAIN Group expands production capacities as demand increases

Zwingenberg, Germany Ascheberg, Germany and Cardiff, UK17 December 2019

The BRAIN Group announces an expansion of its production capacities. The installation of new production facilities in both Bttelborn, near Darmstadt, Germany, by WeissBioTech GmbH (WBT) and in Cardiff, Wales, by Biocatalysts Ltd. lays the foundation for future growth.

The companies of the BRAIN Group form a closely knit network in the fields of R&D and production or as suppliers in specific markets. Drawing on the particular competencies of its subsidiaries, BRAIN brings its own innovative research results to market launch and commercializes existing products. By expanding its production capacities, BRAIN reinforces the strategic focus on its product business.

WeissBioTech sets up new production facility in Bttelborn

WeissBioTech GmbH (WBT) has been a part of BRAIN Group since 2014 and is a leading supplier in the field of enzymes, yeast starter cultures, natural preservation systems, and other fermentative products for the food industry and other market segments.

In order to open up capacities for further growth and to increase logistics efficiency, WBT has set up a new production facility at Bttelborn. The Bttelborn labs, where components such as enzymes, yeasts, and process adjuvants for the production of fruit and vegetable juices, wine, beer, and bioethanol are developed and manufactured, are specifically geared towards application-oriented work. The labs benefit from the local proximity to BRAIN AG and other key partners because, because for the most part the group's research and development activities still take place at BRAIN AG's Zwingenberg head office. The new production facility was designed in accordance with the latest ISO and food safety standards such as ISO 22000 and the FSSC system. Its size of 4,500sq. m. means a significant expansion of WBT's storage, production and research facilities.

The new facility was opened on December 11th, 2019 and is intended to be brought into service in early 2020. WeissBioTech will retain its head office and administrative headquarters in Ascheberg near Mnster, Germany. However, the company will give up its plant in Chanteloup-en-Brie near Paris, France.

Matthias Enste, who assumed the position of Managing Director at WeissBioTech on November 1st, 2019, says: "The new building constitutes our basis for further growth. It allows us to guarantee a more efficient execution of our logistics processes since we now have our own warehouse space. The local proximity to BRAIN AG will make our cooperation even more efficacious."

Biocatalysts expands and optimizes its production capacities

Biocatalysts Ltd., a member of the BRAIN Group since 2018, is one of Europe's leading suppliers of specialty enzymes. The company's portfolio includes the development of enzymes and their small- and large-scale production, ranging from kilograms to tons, as well as global distribution operations for various industries such as the food and fine chemicals sectors.

In 2019, the company made significant progress on the construction of a new production plant in Cardiff. The facility will contain leading edge technology delivering LEAN manufacturing methodology. This sixteen fold increase in Biocatalysts fermentation capacity will give seamless scale up capability from bench top to full commercial manufacturing. The facility will safeguard customer supply and enable delivery of the company growth strategy. Commissioning, site hand-over, celebratory opening events and ultimately routine manufacturing are scheduled for the near future.

Rod Sears-Black, Managing Director of Biocatalysts, says: "The new facility is key to delivery of our corporate vision of being the worlds leading speciality enzyme company and confirms Biocatalyst's position as the complete supplier to the biotech industry."

Ludger Roedder, Chief Business Officer at BRAIN, adds: "We draw on the specific competencies of our subsidiaries to bring our own innovative research results to market launch and to commercialize existing products. The expansion of our production capacities is a logical step on the path to commercializing our product base."

More Information

The BRAIN Group: https://www.brain-biotech.com/brain-group

Biocatalysts Plant Extension - Progress Update, June 27th, 2019: http://www.biocatalysts.com/2019/06/biocatalysts-plant-extension/

Download the photos at:https://www.brain-biotech.com/press

About BRAIN

B.R.A.I.N. Biotechnology Research and Information Network AG (BRAIN AG; ISIN DE0005203947 / WKN 520394) is one of Europe's leading technology companies in the field of industrial biotechnology, the core discipline of Bioeconomy. As such, BRAIN identifies previously untapped, efficient enzymes, microbial producer organisms or natural substances from complex biological systems that can be put to industrial use. The innovative solutions and products developed by help of this "Toolbox of Nature" are successfully applied in the chemistry, the cosmetics and the food industries. BRAIN's business model is based on two pillars. The BioScience segment comprises mainly of the research and development business with industrial partners (the "Tailor-Made Solutions" cooperation business), and the company's own research and development. The BioIndustrial segment consists mainly of the industrially scalable products business. Further information is available at http://www.brain-biotech.com.

About WeissBioTechWeissBioTech GmbH, headquartered in Ascheberg near Mnster, Germany, is a leading supplier in the field of enzymes, yeast starter cultures, natural preservation systems and other fermentative products for the food industry and other market sectors. It supplies both large multinationals and medium-sized manufacturers of fruit juices, beer and wine. The customer base also includes industries that process starch and bioethanol. WeissBioTech was founded in 2002 and has been a member of the BRAIN Group since 2014.www.weissbiotech.com.

About BiocatalystsBiocatalysts Ltd. is one of Europe's leading companies in specialty enzyme production. Their strategy is to be able to satisfy any customer's enzyme requirement either through standard, customized or novel enzyme products. Their focus is on using new technology to drive down the cost of novel enzyme production to make it more widely available across multiple sectors. The development of their own metagenomic library, MetXtra gives access to over 300 million unique sequences offering customers a huge choice of potential enzymatic solutions. Biocatalysts enjoys strategic relationships with many of the world's top blue-chip companies. More information can be found at http://www.biocatalysts.com.

BRAINBiotechnology ResearchAnd Information Network AGDarmstdter Str. 34-3664673 ZwingenbergGermanywww.brain-biotech.com

+49 (0) 6251 9331 0E-Mail IR: ir@brain-biotech.comE-Mail Media:pr@brain-biotech.com

Biocatalysts LimitedUnit 1, Cefn Coed,Parc Nantgarw, CardiffCF15 7QQWales, UK+44 (0) 1443 843712enquiries@biocats.comwww.biocatalysts.com

WeissBioTech GmbHAn der Hansalinie 48-5059387 AschebergGermany+49 (0) 2593 919 386info@weissbiotech.comwww.weissbiotech.com

Disclaimer

This press release contains forward-looking statements. These statements reflect the current views, expectations, and assumptions of the management of BRAIN AG and are based on information currently available to the management. Forward-looking statements are not guarantees of future performance and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. There are numerous factors which could influence the future performance by and future developments at BRAIN AG and the BRAIN group of companies. Such factors include, but are not limited to, changes in the general economic and competitive environment, risks associated with capital markets, currency exchange rate fluctuations, changes in international and national laws and regulations, in particular with respect to tax laws and regulations, and other factors. BRAIN AG does not undertake any obligation to update or revise any forward-looking statements.

17.12.2019 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.The issuer is solely responsible for the content of this announcement.

The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at http://www.dgap.de

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B.R.A.I.N. Biotechnology Research And Information Network AG: BRAIN Group expands production capacit - PharmiWeb.com

Biotechnology Degree, Online Biotechnology Degree

Biotechnology is a branch of biology. It deals with modifying some traits of living things so that they are of better use to human beings. The field of biotechnology has informally been around for more than a thousand years, in fact ever since agriculture and domestication of animals was started by humans. Selective breeding to produce high yielding crops and to breed the fittest horses are some of the earlier examples of the field whereas development of bacteria that can treat oil spills and genetic engineering of crops are some of the newer examples.

Degrees Offered in BiotechnologyAs in other disciplines, biotechnology may be taken through five degree levels which include Certificate, Associate, Bachelor, Master and Doctorate programs. Certificate courses may be taken mid-career in biotechnology to develop a certain skill that is desired in a job or they may be taken to earn credits towards completing a college degree.

The most common degree most people take in Biotechnology is a Bachelor degree. This program is a comprehensive path to Biotechnology. It also incorporates principles of biology and other related fields that may come in useful for a Biotechnologist. A Masters degree gives a jump to your career and usually involves two years of independent study along with a research dissertation.

People may also choose to take dual degrees, like Biotechnology along with Business Administration. This equips the students to take up a challenging job in a related field with administrative responsibilities. This is obviously a much more prestigious degree and people with it can look forward to a more progressive career in the companies they may choose to work in.

All programs aim to develop critical and analytical thinking in the students and make them proficient in the laboratory procedures that they will invariably be required to use in their career.

Online Degrees in BiotechnologyBiotechnology degrees are also offered online now by accredited colleges. These are flexible and you may take them at the convenience of your time and place. Some degrees are completely online while some can be taken partly online with a few hours of lab work put in on college premises.

careers that a Degree Leads to in BiotechnologyLike all other fields, biotechnology is further divided into many sub-areas. After obtaining a degree in biotechnology, a student may choose to work in either of the following branches of biotechnology, if they fulfill the basic requirements for the area.

BioinformaticsAlso known as computational biology, this branch of biotechnology serves to solve biological problems by using computerized models and techniques.

Blue BiotechnologyBlue biotechnology refers to applications of biotechnology to marine resources. This field needs to be developed a lot as yet.

Green BiotechnologyThis field refers to the use of biotechnology in agriculture and is probably the most common field chosen by biotechnologists.

White BiotechnologyWhite Biotechnology refers to applications of biotechnology for industrial uses such as production of useful chemicals and enzymes.

Red BiotechnologyRed Biotechnology refers to the medical applications of biotechnology and typically involve production or modification of bacteria and other micro biota to develop medicines and vaccines.

Frequently Asked Question(s)

Q:What careers can I pursue with a Biotechnology degree?

A:Students can pursue a number of careers with a Biotechnology degree. Some of the careers are as Biotechnology Laboratory Technician, Quality Control Analyst, Senior Research Analyst, Biomedical Engineer, Validation Technician, Crime Lab Technician, Biotechnology Research Associate and Clinical Research Associate. With the health care industry expanding all over the United States, there is huge potential for students interested in this qualification.

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Biotechnology Degree, Online Biotechnology Degree

Biotechnology FAQs | USDA

1. What is Agricultural Biotechnology?

Agricultural biotechnology is a range of tools, including traditional breeding techniques, that alter living organisms, or parts of organisms, to make or modify products; improve plants or animals; or develop microorganisms for specific agricultural uses. Modern biotechnology today includes the tools of genetic engineering.

2. How is Agricultural Biotechnology being used?

Biotechnology provides farmers with tools that can make production cheaper and more manageable. For example, some biotechnology crops can be engineered to tolerate specific herbicides, which make weed control simpler and more efficient. Other crops have been engineered to be resistant to specific plant diseases and insect pests, which can make pest control more reliable and effective, and/or can decrease the use of synthetic pesticides. These crop production options can help countries keep pace with demands for food while reducing production costs. A number of biotechnology-derived crops that have been deregulated by the USDA and reviewed for food safety by the Food and Drug Administration (FDA) and/or the Environmental Protection Agency (EPA) have been adopted by growers.

Many other types of crops are now in the research and development stages. While it is not possible to know exactly which will come to fruition, certainly biotechnology will have highly varied uses for agriculture in the future. Advances in biotechnology may provide consumers with foods that are nutritionally-enriched or longer-lasting, or that contain lower levels of certain naturally occurring toxicants present in some food plants. Developers are using biotechnology to try to reduce saturated fats in cooking oils, reduce allergens in foods, and increase disease-fighting nutrients in foods. They are also researching ways to use genetically engineered crops in the production of new medicines, which may lead to a new plant-made pharmaceutical industry that could reduce the costs of production using a sustainable resource.

Genetically engineered plants are also being developed for a purpose known as phytoremediation in which the plants detoxify pollutants in the soil or absorb and accumulate polluting substances out of the soil so that the plants may be harvested and disposed of safely. In either case the result is improved soil quality at a polluted site. Biotechnology may also be used to conserve natural resources, enable animals to more effectively use nutrients present in feed, decrease nutrient runoff into rivers and bays, and help meet the increasing world food and land demands. Researchers are at work to produce hardier crops that will flourish in even the harshest environments and that will require less fuel, labor, fertilizer, and water, helping to decrease the pressures on land and wildlife habitats.

In addition to genetically engineered crops, biotechnology has helped make other improvements in agriculture not involving plants. Examples of such advances include making antibiotic production more efficient through microbial fermentation and producing new animal vaccines through genetic engineering for diseases such as foot and mouth disease and rabies.

3. What are the benefits of Agricultural Biotechnology?

The application of biotechnology in agriculture has resulted in benefits to farmers, producers, and consumers. Biotechnology has helped to make both insect pest control and weed management safer and easier while safeguarding crops against disease.

For example, genetically engineered insect-resistant cotton has allowed for a significant reduction in the use of persistent, synthetic pesticides that may contaminate groundwater and the environment.

In terms of improved weed control, herbicide-tolerant soybeans, cotton, and corn enable the use of reduced-risk herbicides that break down more quickly in soil and are non-toxic to wildlife and humans. Herbicide-tolerant crops are particularly compatible with no-till or reduced tillage agriculture systems that help preserve topsoil from erosion.

Agricultural biotechnology has been used to protect crops from devastating diseases. The papaya ringspot virus threatened to derail the Hawaiian papaya industry until papayas resistant to the disease were developed through genetic engineering. This saved the U.S. papaya industry. Research on potatoes, squash, tomatoes, and other crops continues in a similar manner to provide resistance to viral diseases that otherwise are very difficult to control.

Biotech crops can make farming more profitable by increasing crop quality and may in some cases increase yields. The use of some of these crops can simplify work and improve safety for farmers. This allows farmers to spend less of their time managing their crops and more time on other profitable activities.

Biotech crops may provide enhanced quality traits such as increased levels of beta-carotene in rice to aid in reducing vitamin A deficiencies and improved oil compositions in canola, soybean, and corn. Crops with the ability to grow in salty soils or better withstand drought conditions are also in the works and the first such products are just entering the marketplace. Such innovations may be increasingly important in adapting to or in some cases helping to mitigate the effects of climate change.

The tools of agricultural biotechnology have been invaluable for researchers in helping to understand the basic biology of living organisms. For example, scientists have identified the complete genetic structure of several strains of Listeria and Campylobacter, the bacteria often responsible for major outbreaks of food-borne illness in people. This genetic information is providing a wealth of opportunities that help researchers improve the safety of our food supply. The tools of biotechnology have "unlocked doors" and are also helping in the development of improved animal and plant varieties, both those produced by conventional means as well as those produced through genetic engineering.

4. What are the safety considerations with Agricultural Biotechnology?

Breeders have been evaluating new products developed through agricultural biotechnology for centuries. In addition to these efforts, the United States Department of Agriculture (USDA), the Environmental Protection Agency (EPA), and the Food and Drug Administration (FDA) work to ensure that crops produced through genetic engineering for commercial use are properly tested and studied to make sure they pose no significant risk to consumers or the environment.

Crops produced through genetic engineering are the only ones formally reviewed to assess the potential for transfer of novel traits to wild relatives. When new traits are genetically engineered into a crop, the new plants are evaluated to ensure that they do not have characteristics of weeds. Where biotech crops are grown in proximity to related plants, the potential for the two plants to exchange traits via pollen must be evaluated before release. Crop plants of all kinds can exchange traits with their close wild relatives (which may be weeds or wildflowers) when they are in proximity. In the case of biotech-derived crops, the EPA and USDA perform risk assessments to evaluate this possibility and minimize potential harmful consequences, if any.

Other potential risks considered in the assessment of genetically engineered organisms include any environmental effects on birds, mammals, insects, worms, and other organisms, especially in the case of insect or disease resistance traits. This is why the USDA's Animal and Plant Health Inspection Service (APHIS) and the EPA review any environmental impacts of such pest-resistant biotechnology derived crops prior to approval of field-testing and commercial release. Testing on many types of organisms such as honeybees, other beneficial insects, earthworms, and fish is performed to ensure that there are no unintended consequences associated with these crops.

With respect to food safety, when new traits introduced to biotech-derived plants are examined by the EPA and the FDA, the proteins produced by these traits are studied for their potential toxicity and potential to cause an allergic response. Tests designed to examine the heat and digestive stability of these proteins, as well as their similarity to known allergenic proteins, are completed prior to entry into the food or feed supply. To put these considerations in perspective, it is useful to note that while the particular biotech traits being used are often new to crops in that they often do not come from plants (many are from bacteria and viruses), the same basic types of traits often can be found naturally in most plants. These basic traits, like insect and disease resistance, have allowed plants to survive and evolve over time.

5. How widely used are biotechnology crops?

According to the USDA's National Agricultural Statistics Service (NASS), biotechnology plantings as a percentage of total crop plantings in the United States in 2012 were about 88 percent for corn, 94 percent for cotton, and 93 percent for soybeans. NASS conducts an agricultural survey in all states in June of each year. The report issued from the survey contains a section specific to the major biotechnology derived field crops and provides additional detail on biotechnology plantings. The most recent report may be viewed at the following website: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

For a summary of these data, see the USDA Economic Research Service data feature at: https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx

The USDA does not maintain data on international usage of genetically engineered crops. The independent International Service for the Acquisition of Agri-biotech Applications (ISAAA), a not-for-profit organization, estimates that the global area of biotech crops for 2012 was 170.3 million hectares, grown by 17.3 million farmers in 28 countries, with an average annual growth in area cultivated of around 6 percent. More than 90 percent of farmers growing biotech crops are resource-poor farmers in developing countries. ISAAA reports various statistics on the global adoption and plantings of biotechnology derived crops. The ISAAA website is https://www.isaaa.org

6. What are the roles of government in agricultural biotechnology?

Please note: These descriptions are not a complete or thorough review of all the activities of these agencies with respect to agricultural biotechnology and are intended as general introductory materials only. For additional information please see the relevant agency websites.

Regulatory

The Federal Government developed a Coordinated Framework for the Regulation of Biotechnology in 1986 to provide for the regulatory oversight of organisms derived through genetic engineering. The three principal agencies that have provided primary guidance to the experimental testing, approval, and eventual commercial release of these organisms to date are the USDA's Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Department of Health and Human Services' Food and Drug Administration (FDA). The approach taken in the Coordinated Framework is grounded in the judgment of the National Academy of Sciences that the potential risks associated with these organisms fall into the same general categories as those created by traditionally bred organisms.

Products are regulated according to their intended use, with some products being regulated under more than one agency. All government regulatory agencies have a responsibility to ensure that the implementation of regulatory decisions, including approval of field tests and eventual deregulation of approved biotech crops, does not adversely impact human health or the environment.

The Animal and Plant Health Inspection Service (APHIS) is responsible for protecting U.S. agriculture from pests and diseases. APHIS regulations provide procedures for obtaining a permit or for providing notification prior to "introducing" (the act of introducing includes any movement into or through the U.S., or release into the environment outside an area of physical confinement) a regulated article in the U.S. Regulated articles are organisms and products altered or produced through genetic engineering that are plant pests or for which there is reason to believe are plant pests.

The regulations also provide for a petition process for the determination of non-regulated status. Once a determination of non-regulated status has been made, the organism (and its offspring) no longer requires APHIS review for movement or release in the U.S.

For more information on the regulatory responsibilities of the FDA, the EPA and APHIS please see:

https://www.fda.gov

https://www.epa.gov

APHIS Biotechnology Regulations

Market Facilitation

The USDA also helps industry respond to consumer demands in the United States and overseas by supporting the marketing of a wide range of agricultural products produced through conventional, organic, and genetically engineered means.

The Agricultural Marketing Service (AMS) and the Grain Inspection, Packers, and Stockyards Administration (GIPSA) have developed a number of services to facilitate the strategic marketing of conventional and genetically engineered foods, fibers, grains, and oilseeds in both domestic and international markets. GIPSA provides these services for the bulk grain and oilseed markets while AMS provides the services for food commodities such as fruits and vegetables, as well as for fiber commodities.

These services include:

1. Evaluation of Test Kits: AMS and GIPSA evaluate commercially available test kits designed to detect the presence of specific proteins in genetically engineered agricultural commodities. The agencies confirm whether the tests operate in accordance with manufacturers' claims and, if the kits operate as stated, the results are made available to the public on their respective websites.

GIPSA Link: https://www.gipsa.usda.gov/fgis/rapidtestkit.aspx

GIPSA evaluates the performance of laboratories conducting DNA-based tests to detect genetically engineered grains and oilseeds, provides participants with their individual results, and posts a summary report on the GIPSA website. AMS is developing a similar program that can evaluate and verify the capabilities of independent laboratories to screen other products for the presence of genetically engineered material.

2. Identity Preservation/Process Verification Services: AMS and GIPSA offer auditing services to certify the use of written quality practices and/or production processes by producers who differentiate their commodities using identity preservation, testing, and product branding.

GIPSA Link: https://www.gipsa.usda.gov/fgis/inspectionweighing.aspx

AMS Link: https://www.ams.usda.gov/fv/ipbv.htm

Additional AMS Services: AMS provides fee-based DNA and protein testing services for food and fiber products, and its Plant Variety Protection Office offers intellectual property rights protection for new genetically engineered seed varieties through the issuance of Certificates of Protection.

Additional GIPSA Services: GIPSA provides marketing documents pertaining to whether there are genetically engineered varieties of certain bulk commodities in commercial production in the United States. USDA also works to improve and expand market access for U.S. agricultural products, including those produced through genetic engineering.

The Foreign Agricultural Service (FAS) supports or administers numerous education, outreach, and exchange programs designed to improve the understanding and acceptance of genetically engineered agricultural products worldwide

1. Market Access Program and Foreign Market Development Program: Supports U.S. farm producer groups (called "Cooperators") to market agricultural products overseas, including those produced using genetic engineering.

2. Emerging Markets Program: Supports technical assistance activities to promote exports of U.S. agricultural commodities and products to emerging markets, including those produced using genetic engineering. Activities to support science-based decision-making are also undertaken. Such activities have included food safety training in Mexico, a biotechnology course for emerging market participants at Michigan State University, farmer-to-farmer workshops in the Philippines and Honduras, high-level policy discussions within the Asia-Pacific Economic Cooperation group, as well as numerous study tours and workshops involving journalists, regulators, and policy-makers.

3. Cochran Fellowship Program: Supports short-term training in biotechnology and genetic engineering. Since the program was created in 1984, the Cochran Fellowship Program has provided education and training to 325 international participants, primarily regulators, policy makers, and scientists.

4. Borlaug Fellowship Program: Supports collaborative research in new technologies, including biotechnology and genetic engineering. Since the program was established in 2004, the Borlaug Fellowship Program has funded 193 fellowships in this research area.

5. Technical Assistance for Specialty Crops (TASC): Supports technical assistance activities that address sanitary, phytosanitary, and technical barriers that prohibit or threaten the export of U.S. specialty crops. This program has supported activities on biotech papaya.

Research

USDA researchers seek to solve major agricultural problems and to better understand the basic biology of agriculture. Researchers may use biotechnology to conduct research more efficiently and to discover things that may not be possible by more conventional means. This includes introducing new or improved traits in plants, animals, and microorganisms and creating new biotechnology-based products such as more effective diagnostic tests, improved vaccines, and better antibiotics. Any USDA research involving the development of new biotechnology products includes biosafety analysis.

USDA scientists are also improving biotechnology tools for ever safer, more effective use of biotechnology by all researchers. For example, better models are being developed to evaluate genetically engineered organisms and to reduce allergens in foods.

USDA researchers monitor for potential environmental problems such as insect pests becoming resistant to Bt, a substance that certain crops, such as corn and cotton, have been genetically engineered to produce to protect against insect damage. In addition, in partnership with the Agricultural Research Service (ARS) and the Forest Service, the Cooperative States Research, the National Institute of Food and Agriculture (NIFA) administers the Biotechnology Risk Assessment Research Grants Program (BRAG) which develops science-based information regarding the safety of introducing genetically engineered plants, animals, and microorganisms. Lists of biotechnology research projects can be found at https://www.ars.usda.gov/research/projects.htm for ARS and at https://www.nifa.usda.gov/funding-opportunity/biotechnology-risk-assessment-research-grants-program-brag for NIFA.

USDA also develops and supports centralized websites that provide access to genetic resources and genomic information about agricultural species. Making these databases easily accessible is crucial for researchers around the world.

USDA's National Institute of Food and Agriculture (NIFA) provides funding and program leadership for extramural research, higher education, and extension activities in food and agricultural biotechnology. NIFA administers and manages funds for biotechnology through a variety of competitive and cooperative grants programs. The National Research Initiative (NRI) Competitive Grants Program, the largest NIFA competitive program, supports basic and applied research projects and integrated research, education, and/or extension projects, many of which use or develop biotechnology tools, approaches, and products. The Small Business Innovation Research Program (SBIR) funds competitive grants to support research by qualified small businesses on advanced concepts related to scientific problems and opportunities in agriculture, including development of biotechnology-derived products. NIFA also supports research involving biotechnology and biotechnology-derived products through cooperative funding programs in conjunction with state agricultural experiment stations at land-grant universities. NIFA partners with other federal agencies through interagency competitive grant programs to fund agricultural and food research that uses or develops biotechnology and biotechnology tools such as metabolic engineering, microbial genome sequencing, and maize genome sequencing.

USDA's Economic Research Service (ERS) conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. ERS also addresses economic issues related to the marketing, labeling, and trading of biotechnology-derived products.

Link:
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HudsonAlpha Institute for Biotechnology

President and Scientific Director, Ontario Institute for Cancer Research and Director, P3G (Public Population Project in Genomics)President and Scientific Director, Ontario Institute for Cancer Research Scientific Director, P3GDr. Thomas J. Hudson is president and scientific director of the Ontario Institute for Cancer Research. He is implementing the institutes strategic plan, working with cancer research institutions across Ontario to leverage existing strengths. The plan focuses on prevention, early diagnosis, cancer targets and new therapeutics. Its innovation platforms include imaging and interventions, bio-repositories and pathology, genomics and high-throughput screening, and informatics and biocomputing. Dr. Hudson is recruiting more than 50 internationally recognized principal investigators.Dr. Hudson was the founder and Director of the McGill University and Genome Quebec Innovation Centre and Assistant-Director of the Whitehead/MIT Center for Genome Research. Dr. Hudson is internationally renowned for his work in genomics. At the Whitehead Institute, Dr. Hudson led the effort to generate dense physical and gene maps of the human and mouse genomes. He is a leader in the development and applications of robotic systems and DNA-chip based methodologies for genome research. In June 1996, he founded the Montreal Genome Centre based at the McGill University Health Centre Research Institute. In 2003, this group expanded to become the McGill University and Genome Quebec Innovation Centre. Dr. Hudson and his team were founding members of the International Haplotype Map Consortium. Dr. Hudsons interests in human genetic diseases focus on the dissection of complex genetic diseases. Disease projects in Dr. Hudsons laboratory included the search for genes predisposing to lupus, inflammatory bowel disease, coronary artery disease, asthma, diabetes and colon cancer. The laboratory also used the DNA-chip technology to characterize breast and ovarian cancer.

In 2007, Dr. Hudson was appointed to the rank of professor (status-only) in the Department of Molecular Genetics at the University of Toronto. He taught in the departments of Human Genetics and Medicine at McGill University and practiced medicine at the McGill University Health Centre Montreal General Hospital.

Dr. Hudson is a fellow of the Royal Society of Canada. He was one of the co-founding members of P3G and is currently serving as its scientific director. He is editor-in-chief of the journal Human Genetics.

The recipient of numerous awards, Dr. Hudson has received the 2005 Achievement of the Year in Healthcare from Macleans magazine, the 2005 Award for Research in Immunology by the Canadian Society for Allergy and Clinical Immunology, the Andr-Dupont 2002 Young Investigator Award given by Quebecs Clinical Research Club, an Investigator Award from the Canadian Institutes of Health Research, a Burroughs-Wellcome Clinician-Scientist Award, The 2002 Prix de la Sant from the Armand-Frappier Foundation, the 2001 Young Scientist Award by the Genetics Society of Canada, the 2000 Scientist of the Year by Radio-Canada, and the 1999 Canadas Top 40 Under 40.

http://oicr.on.ca/person/oicr-investigator/tom-hudson

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HudsonAlpha Institute for Biotechnology