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Archive for the ‘Biotechnology’ Category

Nerium Biotechnology Issues Shareholder Letter and Commences Selling NeriumAD Advanced in Mexico – Marketwired (press release)

Sunday, June 18th, 2017

SAN ANTONIO, TEXAS--(Marketwired - June 15, 2017) - Nerium Biotechnology, Inc. ("Nerium" or the "Company") today announces that it is mailing a letter to shareholders in advance of the Company's annual meeting on June 29, 2017. The shareholder letter which is reproduced below, provides important information for shareholder consideration regarding the election of directors at the annual meeting. This is an important meeting for shareholders as the decisions made with respect to the election of the Company's board of directors will determine Nerium's future.

Nerium is pleased to confirm the support of its largest shareholders for the re-election of the current board of directors (the "Board"). The shareholder letter, as well as a letter received by Nerium from Crandell Addington, a large shareholder of Nerium and CEO, Chairman and Director of Phoenix Biotechnology, will be mailed to shareholders today. A copy of the shareholder letter and other materials is available on the Company's issuer profile on SEDAR and on the Company's website http://www.nbiinvestors.com.

Your Board needs your support, please vote using only the GREEN proxy FOR Dennis R. Knocke, Gustavo A. Ulloa, Jr., Richard J.G. Boxer, Michael Burke, Kerry Mitchell and Peter A. Leininger, M.D.

Shareholders are encouraged to vote via the internet at http://www.voteproxyonline.com and enter the 12 digit control number located on your GREEN proxy, to ensure your vote is received in advance of the proxy deadline of June 27, 2017 10:00 a.m. (Toronto time). Shareholders may also vote by sending their signed GREEN proxy to TSX Trust Company via fax: 416-595-9593 or email: tmxeproxysupport@tmx.com or by mail in the envelope provided.

The Company also announces that it has commenced selling its over-the-counter product, NeriumAD Advanced, in Mexico. This represents the effective development of a new distribution channel for the Company's products and a source of future revenue that does not depend upon the cooperation of the Company's distributor, Nerium International LLC (the "Distributor").

It has come to the Company's attention that the amount of the Distributor's sales in 2015 and 2016 were incorrect in the Company's June 2, 2017 management information circular (the "Circular"). The Company received multiple versions of the Distributor's 2015 financial statements, each containing different numbers. The Company mistakenly included as the amount of the Distributor's 2015 sales an amount provided in an earlier version of the Distributor's 2015 financial statements and included the amount from a later version of the Distributor's 2015 financial statements as the 2016 sales amount. In fact, the Distributor's 2015 sales were US$496,838,912. The Company has never received a final version of the Distributor's financial statements for 2016, but based on a draft version of the Distributor's 2016 financial statement, the Distributor's 2016 sales were US$336,331,483. Corrected versions of the tables included on pages 19 and 20 of the Circular are provided below. The Company does not believe the updated information changes in any material respect the issues raised by it in the Circular.

Year

In response to the group of dissident shareholders retaining a proxy solicitation agent in connection with the Company's upcoming annual meeting, the Company has retained Shorecrest Group to act as proxy solicitation agent on behalf of the Company for a fee of approximately US$75,000 and reimbursement of its reasonable out-of-pocket expenses. All costs of solicitation by management will be borne by the Company.

YOUR VOTE IS IMPORTANT. To support your current Board, please vote using only your GREEN proxy. Please disregard any other proxy received. If you have already voted using the dissident proxy and wish to vote FOR the current directors, please vote using the GREEN proxy sent to you. This will automatically revoke any previous proxies submitted. If you have any questions or require assistance in voting, please contact the proxy solicitation agent Shorecrest Group toll free at 1-888-637-5789 or direct 647-931-7454.

About Nerium Biotechnology, Inc.

Nerium Biotechnology, Inc. is a biotechnology company involved in the research, product development, manufacture and marketing of Nerium oleander-based products. The Company's shares are not listed on any stock exchange or quotation system.

Forward Looking Statements: Statements made in this press release that relate to future plans, expectations, events or performances, including with respect to the future distribution and sales of the Company's products and possible revenue, are forward looking statements. Forward-looking statements are not based on historic facts, but rather on current expectations regarding future events. They are based on information available to management and/or assumptions management believes are reasonable. Many factors could cause future events and outcomes to differ materially from those discussed in the forward-looking statements. Although the forward-looking statements are based on what management believes are reasonable assumptions, the Company cannot assure shareholders that actual results will be consistent with these forward-looking statements. The forward-looking statements in this press release are made as of the date hereof and, except as required by applicable securities laws, the Company does not assume any obligation to update or revise such forward-looking statements. More information about the Company is available in its disclosure documents, all of which are available on the Company's issuer profile on SEDAR at http://www.sedar.com

To view the shareholder letter and the letter received by Nerium from Crandell Addington please click the following link: http://media3.marketwire.com/docs/NeriumLetter.pdf

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ASA Provides Input to USDA, FDA on Advances in Biotechnology – KTIC

Friday, June 16th, 2017

The American Soybean Association (ASA) submitted comments this week to both the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA) regarding regulations in response to advances in genetic engineering.

ASA included in comments to USDA, that biotechnology is an essential tool in farmers quest to produce enough food to meet the needs of 9.7 billion people by 2050, creating the need for a clear, science-based regulatory system in the U.S. as an example and standard for regulatory systems of biotechnology internationally.

While applauding USDAs efforts to reduce the burden on regulated entities, ASA expressed concern that aspects of the rule as proposed will increase the regulatory burden and stifle research and innovation.

Additionally, ASAs comments to FDA cheered USDAs proposal to exclude certain genome-editing techniques from requiring pre-market approvals because they are low risk and could be found in nature or achieved through traditional breeding methods.

ASA concluded its support saying, Technological advancements such as genome editing offer an additional tool to combat threats while also improving sustainability in production agriculture.

Full comments to USDA and FDA can be found here and here, respectively.

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FBI says Chinese spying, theft of US agricultural biotechnology is ‘a growing threat’ – Genetic Literacy Project

Friday, June 16th, 2017

As a group of visiting scientists prepared to board a plane in Hawaii that would take them back home to China, U.S. customs agents found rice seeds in their luggage. Those seeds are likely to land at least one scientist in federal prison.

Agriculture today is a high-tech business, but as that technology has developed, so has the temptation to take shortcuts and steal trade secrets that could unlock huge profits. The FBI calls agricultural economic espionage a growing threat and some are worried that biotech piracy can spell big trouble for a dynamic and growing U.S. industry.

Had they succeeded in stealing the gene-spliced rice, the scientists may have been able to reverse-engineer it and ultimately undercut [US company] Ventrias market. [Ventria President and CEO Scott] Deeter says it could have driven his company out of business.

Where the commodity in question is grown in open fields, its sometimes difficult, [Jason] Griess [the assistant U.S. attorney for the Southern District of Iowa] says.

Theft of intellectual property costs the U.S. economy hundreds of billions of dollars each year, according to a recent report from the Commission on the Theft of American Intellectual Property, a Washington, D.C.-based ad-hoc panel formed to study intellectual property theft. China, the authors say, is the biggest offender.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:Spies In The Field: As Farming Goes High-Tech, Espionage Threat Grows

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$10M for birthplace of biotechnology – Innovators Magazine

Friday, June 16th, 2017

(CALIFORNIA)

Thebirthplace of biotechnology is to receive$10 million for a pioneering precision medicine programme.

It was announced this week thatthe California Initiative to Advance Precision Medicine (CIAPM) has been awarded the money from the local governments budget, a decision welcomed by theCalifornia Life Sciences Association (CLSA).

Sara Radcliffe, President & CEO, CLSA, said:California Life Sciences Association (CLSA) applauds Governor Jerry Brown, California State Senate and California Assembly leaders for their strong support of life sciences innovation, as demonstrated again in this years 2017-2018 budget deal which allocates a $10 million investment in precision medicine research. California is the birthplace of biotechnology and today the states life sciences sector employs over 287,200 people working to develop innovative new medicines, technologies and therapies needed to treat and cure patients.

The Californian city of San Diego ishostingtheBIO International Conventionalthe global event for biotechnology next week. It will celebrate the industrys many breakthroughs and on going impact on society.It will take place at the San Diego Convention Center between 19 and 22 June.

BIO International ConventionalCalifornia Initiative to Advance Precision Medicine

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This Biotechnology Company Wants to Reanimate the Brain-Dead – TrendinTech

Thursday, June 15th, 2017

Ira Pastor, CEO of Bioquark, a Philadelphia-based biotechnology company, believes we will on day be able to reset the brain of patients declared brain-dead using a series of stem cell injections and nerve stimulations.

Until recently, death was medically defined as a loss of heart and lung function but as medical technology has advanced so has the qualifications. Now, since both heartbeat and breathing functions can be performed for a patient by machine, death is almost universally declared when there is a loss of activity in the brain stem. However, Pastor does think that this loss of brain function is as irreversible as weve come expect.

Initially, Bioquark was slated to start trials for the procedure last year in India but, due to strong opposition by the Indian Council of Medical Research, those studies were canceled. Nevertheless, Ira Pastor and his collaborator Himanshu Bansal, an orthopedic surgeon, remain undaunted and have announced a new series of test to happen soon in a nameless South American country.

Although they have not released the details of the revolutionary procedure, we can gather a general idea of their plan to reanimate the brain-dead from the papers regarding their original canceled trial.

Originally, the researchers wanted brain-dead subjects between the ages of 12 and 65. Ideally, the cause of the brain damage would be due to traumatic injury. Scientists would look at MRIs to determine eligibility, then brain cells would be harvested from the patients blood. After the stem cells are injected, the patients would get another injection, this time peptides, directly to the spinal column. The series of injections is followed by two weeks of nerve stimulation, specifically the median nerve, by lasers, which Bioquark thinks is the key to reversing brain death.

Bioquark has not clarified how it intends to obtain consent from technically dead patients but in spite of the controversy, this study is not alone. The work at Bioquark is part of a larger program concerning neuro-reanimation and regeneration called ReAnima.

Pastor, who also serves on the advisory board for the project, told the Daily Mail: The mission of the ReAnima Project is to focus on clinical research in the state of brain death, or irreversible coma, in subjects who have recently met the Uniform Determination of Death Act criteria, but who are still on cardio-pulmonary or trophic support a classification in many countries around the world known as a living cadaver.

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Biotechnology expert proposed for top Chinese University of Hong Kong post – South China Morning Post

Thursday, June 15th, 2017

An internationally renowned biotechnology scientist, Professor Rocky Tuan Sung-chi, has been recommended to succeed Joseph Sung Jao-yiu as Chinese University vice-chancellor.

Born in Hong Kong and educated in the United States, Tuan is currently working at the University of Pittsburgh as director of the institutions cellular and molecular engineering lab, executive vice-chairman of the Department of Orthopaedic Surgery and a professor in the Department of Bioengineering.

He has been serving as a distinguished visiting professor and director of the Institute for Tissue Engineering and Regenerative Medicine at Chinese University.

The institutions council said on Thursday that it would recommend Tuan to be the next vice-chancellor. It will hold a consultation of up to six weeks with staff, students and alumni, but the universitys teachers association vowed to boycott it, saying the council had fooled it by saying it was not sure who the candidate was.

In May 2016, Tuan was one of the 10 Carnegie Science Award winners for his extensive experience in applying adult stem cells for tissue engineering and regenerative medicine.

Hes a good scientist, professionally speaking, with a major interest in bone and tendon regeneration, Professor Chan Wai-yee of the universitys School of Biomedical Sciences said. He used to chair the biology and medicine panel of the Research Grants Council so he should know better than others what improvements can be made to develop Hong Kongs scientific research.

I have high expectations of him. As a successful scholar who has worked for the Research Grants Council for so many years, he could at least reflect our wish for more funding and resources.

However, Professor Chan King-ming, president of the Chinese University Teachers Association, said he was angry about the announcement and that staff and students were being played by the universitys top administration, who two weeks ago told the association they were still not sure about the candidate.

Chan King-ming also said Tuan lacked outstanding academic status and administrative experience. Seldom were his papers published by top journals and he has never served at the level of deputy vice-chancellor or dean in any university, the biochemistry scholar said.

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Biotechnology expert proposed for top Chinese University of Hong Kong post - South China Morning Post

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Vontobel Swiss Wealth Advisors AG Acquires 4956 Shares of iShares Nasdaq Biotechnology Index Fund (IBB) – The Cerbat Gem

Thursday, June 15th, 2017
Vontobel Swiss Wealth Advisors AG Acquires 4956 Shares of iShares Nasdaq Biotechnology Index Fund (IBB)
The Cerbat Gem
iShares Nasdaq Biotechnology Index Fund logo Vontobel Swiss Wealth Advisors AG increased its position in shares of iShares Nasdaq Biotechnology Index Fund (NASDAQ:IBB) by 36.0% during the first quarter, according to its most recent 13F filing with the ...
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Biotechnology company opens mosquito factory in Lexington … – Lexington Herald Leader

Thursday, June 15th, 2017

Lexington Herald Leader
Biotechnology company opens mosquito factory in Lexington ...
Lexington Herald Leader
A Lexington biotechnology company aimed at fighting mosquito-borne diseases such as the Zika virus opened a mosquito factory Friday on Malabu Drive.

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Puma Biotechnology Inc (PBYI) Expected to Post Earnings of -$2.13 Per Share – The Cerbat Gem

Thursday, June 15th, 2017

NormanObserver.com
Puma Biotechnology Inc (PBYI) Expected to Post Earnings of -$2.13 Per Share
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Biotechnology FAQs | USDA

Wednesday, June 14th, 2017

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.

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Biotechnology FAQs | USDA

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iShares Nasdaq Biotechnology Index Fund (IBB) Stock Rating Upgraded by Vetr Inc. – The Cerbat Gem

Wednesday, June 14th, 2017
iShares Nasdaq Biotechnology Index Fund (IBB) Stock Rating Upgraded by Vetr Inc.
The Cerbat Gem
iShares Nasdaq Biotechnology Index Fund logo Vetr upgraded shares of iShares Nasdaq Biotechnology Index Fund (NASDAQ:IBB) from a hold rating to a buy rating in a report issued on Wednesday, May 17th. They currently have $303.00 target price on the ...
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New Master’s Program Prepares Leaders in Biotechnology – Azusa Pacific University

Monday, June 12th, 2017

Preparing competent, competitive, and ethical leaders, Azusa Pacifics new Master of Science in Biotechnology equips graduates to make significant contributions to and profoundly influence this emerging science field. Set to launch in fall 2017 with a cohort of 24, the advanced degree distinguishes itself from counterparts at other institutions by approaching the discipline from a distinctly Christian worldview and instilling in students the ability to synthesize human need, potential, and responsibility.

Graduates with this level of training find a wide-open marketplace eager to hire. Jobs in the biomedical industry show an upward trend throughout the country, and particularly in California, home to more than 50 percent of these companies. According to a 2014 report from Genetic Engineering and Biotechnology News, the industry expects significant job growth over the next decade in the areas of epidemiology, bioinformatics and genetic counseling, microbiology, biomedical engineering, and biomedical research. Nestled in the heart of the countrys second-largest cluster of bioscience businesses, APU offers students a distinct advantage that surpasses traditional internships and networking. A collaborative enterprise, this program partners APU with local bioscience companies, including Grifols Biologicals, Gilead Sciences, Johnson & Johnson, Allergan, and others. In addition to technical proficiency, APUs program also provides industry-critical skills, such as project and program management, communication skills, teamwork, business ethics, and leadership, which produces graduates who are productive employees on the first day of hire in a corporate setting.

Open to students and professionals with bachelors degrees in molecular or cellular biology, biochemistry, applied mathematics, statistics, engineering, or computer science, the M.S. in Biotechnology offers a unique approach to the field through the lens of Christian faith and imparts a clear understanding of how believers can participate in and provide guidance to the industry in a way that advances science and glorifies God.

Posted: June 12, 2017

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Genetic engineering boosts immunity against crop disease – Daily Nation

Monday, June 12th, 2017

= By ANGELA OKETCH More by this Author 3 hoursago

The chemicals that farmers spray on their crops in form of pesticides to kill pests and prevent diseases have always been a bone of contention, with researchers trying to find safer alternatives. A new variety of rice that fights multiple pathogens with no effect on the yield of the crop, is thus a welcome relief for both farmers and scientists.

The discovery is based on a study of the plants immune system. Plants use receptors on the outside of their cells to identify molecules that signal a microbial invasion, and respond by releasing antimicrobial compounds. Therefore, identifying genes that kickstart this immune response yields disease-resistant plants.

Just like sick humans who are unproductive at work, plants grow poorly and produce unfavourable yields when their immune systems are overloaded. For a long time, scientists have focused on the NPR1 gene from a small, woody plant called Arabidopsis thaliana, to boost the immune systems of rice, wheat, tomatoes and apples.

However, NPR1 is not very useful for agriculture because it has negative effects on plants. To make it useful, researchers needed a better gene that would activate the immune response only when the plant is under attack. Rice with the gene was able to combat rice blast which often causes an estimated 30 per cent loss of rice crop worldwide, every year.

A segment of DNA called the TBF1 cassette acted as a control switch for the plants immune response. When the TBF1 cassette from the Arabidopsis genome was copied and pasted alongside and in front of the NPR1 gene in rice plants, it resulted in a strain of rice that could fend off offending pathogens without causing stunted growth seen in previously engineered crops.

The researchers tested the superiority of engineered rice over regular rice by inoculating crop leaves with the bacterial pathogens that cause rice blight and leaf streak, as well as the fungus responsible for blast disease. Whereas the infections spread on the leaves of wild rice plants, the engineered plants confined the invaders to a small area.

The researchers say this innovation could come in handy in the developing world where farmers with no access to fungicide often lose their entire crop to disease. The study was published in Nature.

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iShares NASDAQ Biotechnology Index (IBB) Stock Rating Upgraded by Vetr Inc. – The Cerbat Gem

Sunday, June 11th, 2017

Chaffey Breeze
iShares NASDAQ Biotechnology Index (IBB) Stock Rating Upgraded by Vetr Inc.
The Cerbat Gem
iShares NASDAQ Biotechnology Index logo Vetr upgraded shares of iShares NASDAQ Biotechnology Index (NASDAQ:IBB) from a hold rating to a buy rating in a research note released on Wednesday, May 17th. They currently have $303.00 target price on ...
iShares NASDAQ Biotechnology Index (IBB) Shares Bought by Neville Rodie & Shaw Inc.Sports Perspectives
Shoker Investment Counsel Inc. Reduces Position in iShares NASDAQ Biotechnology Index (IBB)Chaffey Breeze
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Transcript Daily -BangaloreWeekly -Stock Observer
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Puma Biotechnology Inc (PBYI) Releases Quarterly Earnings Results, Beats Expectations By $0.09 EPS – The Cerbat Gem

Saturday, June 10th, 2017

Normangee Star
Puma Biotechnology Inc (PBYI) Releases Quarterly Earnings Results, Beats Expectations By $0.09 EPS
The Cerbat Gem
Puma Biotechnology logo Puma Biotechnology Inc (NYSE:PBYI) issued its earnings results on Wednesday, May 10th. The biopharmaceutical company reported ($1.97) earnings per share (EPS) for the quarter, beating the Thomson Reuters' consensus ...
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Royal Bank of Canada Analysts Give Puma Biotechnology Inc (PBYI) a $40.00 Price TargetTranscript Daily
Puma Biotechnology's (PBYI) Buy Rating Reaffirmed at Stifel NicolausNormangee Star

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North Forsyth grad plans to study biotechnology – Winston-Salem Journal

Friday, June 9th, 2017

As if the stress of senior year isnt enough of a headache, Michael Vega began his final chapter of high school with a serious concussion.

A soccer injury in May 2016 had mandated three months recovery time, stealing a summer of soccer training from the North Forsyth graduate.

It hit me hard that I couldnt play, coming in with a big concussion, said Vega, a two-time all-conference award recipient. I had to jump right back into it.

Vega, 17, was cleared to play in the final round of the Forsyth Cup last year, helping his team secure a victory in the championship round for the second year in a row, making school history.

Vega, who spent three years on the varsity team, said one of his favorite high school moments was scoring the conference-winning goal against Asheboro High School as a sophomore.

It was a great experience; theres nothing like it, said Vega, who plays goalie and center back. I knew half the guys from growing up, so its hard to say good-bye.

While Vega said he will not play soccer in college, he will continue playing with the Hispanic League.

Graduation is bittersweet, but Vega said he is glad to have AP Biology and AP Chemistry behind him and is applying to Forsyth Tech to study biotechnology.

Ive learned to surround myself with the right people and never give up, Vega said. Im excited for graduation.

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Global $92.9 Billion Biotechnology/Pharmaceutical Services Outsourcing Market Analysis, By Service And Segment … – PR Newswire (press release)

Thursday, June 8th, 2017

The global biotechnology services outsourcing market is expected to reach USD 92.9 billion by 2025

Pharmaceutical industry has been adaptive of the function of outsourcing certain clinical and corporate functions as early as 2002. Among the services outsourced, clinical trial management and contract manufacturing were the forerunners. For instance, Johnson & Johnson was the first pharmaceutical company to outsource its applications development and maintenance (ADM).

In 2015, over USD 50.0 billion was spent on pharmaceutical R&D activities majorly on oncology, diabetes, and autoimmune therapy classes, which is expected to propel the biotechnology services outsourcing market growth over the forecast period.

Shrinking profit margins coupled with rising competition in the market space, and augmenting regulatory burden are other vital impact rendering factors. The pharmaceutical services outsourcing market is expected to register growth at a CAGR of 8.7% during the forecast period. On the other hand, pending immigration legislations in the U.S. may hinder business economics and outsourcing risks.

Pharmaceutical and biotechnology industries in Europe are significantly investing in R&D in the recent year owing to rising demand for advanced medicines. This may be attributed to increasing aging population, incidence of chronic diseases, and communicable diseases.

Further key findings from the study suggest:

Key Topics Covered:

1 Research Methodology

2 Executive Summary

3 Pharmaceutical/Biotechnology Services Outsourcing Market Variables, Trends, & Scope 3.8 Service pricing analysis

4 Pharmaceutical/Biotechnology Services Outsourcing Market: Service Estimates & Trend Analysis 4.1 Pharmaceutical/biotechnology services outsourcing market: Service movement analysis 4.2 Consulting services 4.2.2 Regulatory compliance 4.2.3 Remediation 4.2.4 Quality management 4.2.5 Other 4.3 Auditing & assessment 4.4 Regulatory affairs services 4.4.2 Clinical trial applications & product registration 4.4.3 Regulatory writing & publishing 4.4.4 Legal representation 4.4.5 Other 4.5 Product maintenance services 4.6 Product design & development 4.7 Product testing & validation 4.8 Training & education 4.9 Other services

5 Pharmaceutical/Biotechnology Services Outsourcing Market: Regional Estimates & Trend Analysis

6 Competitive Landscape

For more information about this report visit http://www.researchandmarkets.com/research/5b9f3q/biotechnologyphar

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-929-billion-biotechnologypharmaceutical-services-outsourcing-market-analysis-by-service-and-segment-forecasts-2014---2025---research-and-markets-300470992.html

SOURCE Research and Markets

http://www.researchandmarkets.com

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Stephens Inc. AR Acquires 1166 Shares of iShares NASDAQ Biotechnology Index (IBB) – The Cerbat Gem

Thursday, June 8th, 2017
Stephens Inc. AR Acquires 1166 Shares of iShares NASDAQ Biotechnology Index (IBB)
The Cerbat Gem
iShares NASDAQ Biotechnology Index logo Stephens Inc. AR raised its stake in shares of iShares NASDAQ Biotechnology Index (NASDAQ:IBB) by 74.6% during the first quarter, according to its most recent filing with the Securities and Exchange Commission ...
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Puma Biotechnology’s Neratinib Set To Target Extended Adjuvant Opportunity – Seeking Alpha

Thursday, June 8th, 2017

Puma Biotechnology (NYSE:PBYI) is inching closer to its transformation from a research and development (or R&D) biopharmaceutical company to a full-fledged commercial organization. This company which has in-licensed development and commercialization rights for oral and intravenous formulations of irreversible tyrosine kinase inhibitor or TKI, neratinib, and also another irreversible TKI, PB357, achieved the first major milestone for 2017 on May 24, 2017. On this day, FDA's Oncologic Drugs Advisory Committee or ODAC recommended approval for Nerlynx (neratinib) as extended adjuvant therapy for patients suffering with early stage, human epidermal growth factor receptor type 2 - positive or HER2-positive breast cancer after being previously treated with surgery and adjuvant treatment with Roche Holdings' (OTCQX:RHHBY) Herceptin (trastuzumab).

Besides this indication, Puma Biotechnology expects neratinib to demonstrate efficacy in other cancers such a non small cell lung cancer and tumors related to expression or over-mutation in HER2 such as HER2-positive cancer, HER-2 cancer that has metastasized to brain, HER2-positive neoadjuvant breast cancer.

Hence, there is high probability that Neratinib can prove to be a blockbuster drug for Puma Biotechnology. I believe this is a solid reason for considering the company as a favorable investment opportunity in 2017. In this article, I will explain the key drivers that make Puma Biotechnology a compelling investment opportunity in 2017.

Extended adjuvant setting is a larger underserved market segment

Currently, the target breast cancer market in extended adjuvant setting comprises around 36,000 patients in USA and 34,000 in EU. In 2015, Herceptin's sales in adjuvant indication were around $4.5 billion to $5.0 billion. All these patients form a target market for neratinib in the following year. Currently, letrozole is the only FDA approved therapy in extended adjuvant setting.

Puma Biotechnology expects to launch Neratinib as extended adjuvant breast cancer therapy in 2017

In July 2016, Puma Biotechnology filed new drug application or NDA with FDA, seeking approval for neratinib in extended adjuvant setting for early stage HER2-overexpressed/amplified breast cancer. The regulatory agency accepted the application in September 2016.

Further, the European Medicines Agency or EMA also validated Puma's application for neratinib in extended adjuvant setting in August 2016. On advice of EMA, in March 2017, the company revised its label to only include those early stage HER2+ breast cancer patients who had been previously treated for up to 1 year with adjuvant herceptin. Puma Biotechnology initiated a managed access program for neratinib in this indication in Q4 2016 and an expanded access program in Q1 2017.

While all these have been major milestones for the company in the past, the upcoming milestone will be FDA approval for orally administered neratinib in extended adjuvant setting, anticipated in 3Q 2017.

This approval is expected to be mainly based on results obtained from phase 3 trial, ExteNET, in which neratinib managed to hit its primary endpoints. In the intent-to-treat or ITT population, the 2-year disease free survival or DFS in neratinib arm was seen to be 93.9% while that in the placebo arm was 91.6%, which implies absolute improvement of 2.4%. In ITT population, there has been a 2.5% absolute improvement in 5-year DFS for neratinib arm as compared to placebo arm.

In case of patients confirmed with HER+ breast cancer, neratinib demonstrated 2-year DFS of 94.7%, while it was only 90.6% for the placebo arm. While this is an absolute improvement of 4.1%, the 5-year DFS with neratinib in HER+ patients is slightly higher at 4.4%.

Data from ExteNET trial has also shown 33% reduction in risk of disease recurrence for patients in neratinib arm as compared to those in placebo arm in ITT population. Further, for confirmed HER+ early stage breast cancer patients, the reduction in risk of disease recurrence for those on neratinib therapy in extended adjuvant setting is as high as 49%.

All these statistics are in line with those seen for the already approved extended adjuvant breast cancer drug, letrozole, as well as data obtained from development trials for hormone receptor positive or HR+ adjuvant breast cancer therapies, Pfizer's (NYSE:PFE) Aromasin and AstraZeneca's (NYSE:AZN) Arimidex. This implies that there are high chances for neratinib to secure FDA approval in extended adjuvant setting.

Neratinib has demonstrated higher benefit as adjuvant therapy in HR+ breast cancer patients

For HR+ breast cancer patients in ExteNET trial, the adjuvant therapy of neratinib demonstrated DFS rate of 95.4%, while the placebo arm showed DFS of 91.2%. This implied an absolute benefit of 4.2% after 2 years.

For 5-year period, the DFS with neratinib in HR+ patients was 91.7% while that in placebo arm was 86.9%, implying 4.8% absolute benefit.

Neratinib has demonstrated superior results in HR+ patients mainly on account of dual suppression of the crosstalk between estrogen receptor-positive or ER+ and HER+. Since ER+ breast cancer patients in the ExteNET trial were already on background endocrine therapy, it helped suppress the ER while neratinib suppressed both EGFR and HER2. This dual suppression has been seen only in neratinib and not in trials of other breast cancer drugs such Roche Holdings Herceptin and Novartis' (NYSE:NVS) Tykerb.

In case of HR- patients, however, ExteNET trial demonstrated improvement with neratinib between months 0 to 12 as compared to placebo. This was essentially when the patients were being administered the drug. However, the benefit in DFS in the neratinib arm over placebo arm seemed to become statistically insignificant over 5 year horizon.

Puma Biotechnology has also introduced loperamide prophylaxis therapy to prevent diarrhea resulting from neratinib.

Prior to Puma Biotechnology in-licensing Neratinib, it was being tested on 3,000 patients in various trials. It was seen that these patients suffered from grade 3 or grade 4 diarrhea in the first 28 days after initiating therapy. However, this could be treated with antidiarrheal drug, loperamide.

Puma Biotechnology is instead focusing on preventing this side-effect of neratinib using loperamide prophylaxis. Data from multiple studies has shown that the rate of grade 3 diarrhea reduced from the range of 30% to 53% in case of no loperamide prophylaxis to the range of 0% to 17% with loperamide prophylaxis. The total duration of diarrhea also dropped from 14 days to 2 days with loperamide prophylaxis.

Since ExteNET trial did not involve any anti-diarrheal prophylaxis therapy, Puma Biotechnology separately studied the impact of loperamide prophylaxis alone and in combination with other anti-inflammatory agents in extended adjuvant setting in early stage HER2+ breast cancer patients in another phase 2 trial, CONTROL. Data from this trial showed that while rate of grade 3 diarrhea in ExteNET trial was 39.8%, loperamide prophylaxis reduced the rate to 30.7%, loperamide and budesonide prophylaxis to 23.4%, and loperamide and colestipol to 11.5%.

Further, while the duration of diarrhea in ExteNET trial was 59 days, the various prophylaxis regimens in the CONTROL trial have brought the down to the range of 8 to 12 days. Episodes of diarrhea were also brought down from 8 in ExteNET trial to the range of 2 to 4 in CONTROL trial.

The CONTROL trial has also shown improvement in tolerability for the drug, which was being mainly affected due to diarrhea.

All this shows that the major side-effect of Neratinib, diarrhea, is easily manageable with effective prophylaxis therapy. Further, it is only seen that grade 3 diarrhea was witnessed by patients only in first cycle or first 28 days of neratinib therapy.

The company's cash reserves can sustain its operations through mid-2018

At the end of Q1 2017, Puma Biotechnology had $194 million worth cash reserves on its balance sheet. The company's cash burn rate in Q1 2017 was $36.0 million. This can be considered representative for all the quarters in 2017, as Puma has been highly involved in preparing for regulatory approval and commercial launch of neratinib. Based on these assumptions, the company can sustain its business operations upto the first half of 2018, without depending on external funding.

Further, with a solid oncology drug in the pipeline, Puma Biotechnology will also not find it difficult to raise capital from the public, either as equity or debt. Hence, the company seems to be at a comfortable position.

Investors should not ignore certain company-specific risks

Today, Puma Biotechnology is equivalent to neratinib. In absence of any commercial product or advanced stage research product, Puma Biotechnology is excessively dependent on the successful commercial launch of Neratinib. Since the product has not yet received FDA approval for even a single indication, this may prove to be too risky investment for investors with average risk appetite.

Further, the company also does not have proven marketing and distribution capabilities. In absence of a strong commercial partner, Puma Biotechnology may land up being commercially unsuccessful, despite securing FDA approval for neratinib.

Investors should consider these major risk factors while considering Puma Biotechnology as an opportunity in 2017.

Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.

I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.

Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.

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WSJ’s Grant: In biotech, no news is bad news – Seeking Alpha

Thursday, June 8th, 2017

The American Society of Clinical Oncology annual meeting passed without much of a stir, writes Charley Grant in the WSJ. Naturally, there were exceptions with individual companies, but the biotech sector as a whole barely budged throughout the major conference.

So what? The S&P Biotechnology Select Industry Index isup 19%in 2017, and there are treatment categories outside of oncology. But, says Grant, the majority of stocks in that index aren't profitable, and are thus dependent on things like ASCO to rev up sentiment. In the bull market of 2013-15, ASCO was enough to send the sector sharply higher.

With that catalyst not working this year, all biotech may have to look forward to are blockbuster drug launches, and there's not much going on there - just three drugs are set to come to market this year that are expected to top $2B in annual sales by 2022.

ETFs: IBB, XBI, LABU, BBH, FBT, HQL, PBE, LABD, BBC, BBP, UBIO, ZBIO, LABS

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