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Archive for the ‘Biotechnology’ Category

Investor Radar: Taking a Closer Look at Puma Biotechnology, Inc. (NASDAQ:PBYI) – Davidson Register

Tuesday, April 18th, 2017

Active investors may be taking a second look at shares of Puma Biotechnology, Inc. (NASDAQ:PBYI). Checking in on some levels, the six month price index is currently at 0.68164. The six month price index is measured by dividing the current share price by the share price six months ago. A ratio above one indicates an increase in the stock price over the six month time frame. A ratio under one signals that the price has lowered over that same time frame.

We can also take a look at some stock volatility data on shares of Puma Biotechnology, Inc. (NASDAQ:PBYI). The 12 month volatility is currently 85.067900. The 6 month volatility is noted at 83.631200, and the 3 month is recorded at 75.587900. When following the volatility of a stock, investors may be challenged with trying to decipher the correct combination of risk-reward to help maximize returns. As with any strategy, it is important to carefully consider risk and other market factors that might be in play when examining stock volatility levels.

Investors may be looking at the Piotroski F-Score when doing value analysis. The F-Score was developed to help find company stocks that have solid fundamentals, and to separate out weaker companies. Piotroskis F-Score uses nine tests based on company financial statements. Puma Biotechnology, Inc. (NASDAQ:PBYI) currently has a Piotroski F-Score of 2. One point is given for piece of criteria that is met. Typically, a stock with a high score of 8 or 9 would be seen as strong, and a stock scoring on the lower end between 0 and 2 would be viewed as weaker.

Shifting gears, Puma Biotechnology, Inc. (NASDAQ:PBYI) has an FCF quality score of -6.273255. The free quality score helps estimate the stability of free cash flow. FCF quality is calculated as the 12 ltm cash flow per share over the average of the cash flow numbers. When reviewing this score, it is generally thought that the lower the ratio, the better. Presently, Puma Biotechnology, Inc. has an FCF score of 0.359983. The FCF score is determined by merging free cash flow stability with free cash flow growth. In general, a higher FCF score value would represent high free cash flow growth. Monitoring FCF information may help provide some excellent insight on the financial health of a specific company.

Investors might want to take a look at shares of Puma Biotechnology, Inc. (NASDAQ:PBYI) from a different angle. Lets take a peek at the current Q.i. (Liquidity) Value. Puma Biotechnology, Inc. (NASDAQ:PBYI) has a Q.i. value of 84.00000. This value ranks stocks using EBITDA yield, FCF yield, earnings yield and liquidity ratios. The Q.i. value may help identify companies that are undervalued. A larger value would indicate low turnover and a higher chance of shares being priced incorrectly. A lower value may show larger traded value meaning more sell-side analysts may track the company leading to a lesser chance that shares are priced improperly.

By DR Staff Writer

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Investor Radar: Taking a Closer Look at Puma Biotechnology, Inc. (NASDAQ:PBYI) - Davidson Register

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M3 Biotechnology Raises $1.4M in Second Funding Round – FinSMEs (blog)

Monday, April 17th, 2017
M3 Biotechnology Raises $1.4M in Second Funding Round
FinSMEs (blog)
M3 Biotechnology, a Seattle, WA-based therapeutics company, raised $1.4m in a second funding round. Backers included Dolby Family Ventures and the Alzheimer's Drug Discovery Foundation (ADDF). The company, which has raised $14M in total financing ...

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Puma Biotechnology Announces FDA Advisory Committee to … – Business Wire (press release)

Monday, April 17th, 2017

LOS ANGELES, Calif.--(BUSINESS WIRE)--Puma Biotechnology, Inc. (Nasdaq: PBYI), a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has scheduled the New Drug Application (NDA) for neratinib for discussion by the Oncologic Drugs Advisory Committee (ODAC) on May 24, 2017. Neratinib is an investigational therapy for the extended adjuvant treatment of early stage HER2-positive breast cancer that has previously been treated with a trastuzumab containing regimen.

ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes appropriate recommendations to the FDA. Although the FDA will consider the recommendation of the panel, the final decision regarding the approval of the product is made by the FDA solely, and the recommendations by the panel are non-binding.

Puma Biotechnology announced on September 20, 2016 that the FDA had accepted for filing the NDA for neratinib. The NDA for neratinib is based on results from both the Phase III ExteNET trial in extended adjuvant early stage HER2-positive breast cancer and the Phase II CONTROL trial in extended adjuvant early stage HER2-positive breast cancer.

About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2. Further information about Puma Biotechnology can be found at http://www.pumabiotechnology.com.

Forward-Looking Statements: This press release contains forward-looking statements, including statements regarding the ODACs scheduled review of the NDA for neratinib. All forward-looking statements included in this press release involve risks and uncertainties that could cause the Company's actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the fact that the Company has no product revenue and no products approved for marketing, the Company's dependence on PB272, which is still under development and may never receive regulatory approval, the challenges associated with conducting and enrolling clinical trials, the risk that the results of clinical trials may not support the Company's drug candidate claims, even if approved, the risk that physicians and patients may not accept or use the Company's products, the Company's reliance on third parties to conduct its clinical trials and to formulate and manufacture its drug candidates, the Company's dependence on licensed intellectual property, and the other risk factors disclosed in the periodic and current reports filed by the Company with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K for the year ended December 31, 2016. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company assumes no obligation to update these forward-looking statements, except as required by law.

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Home Market Research Worldwide Biotechnology Separation Systems Market Projected to reach USD XXXX million at… – Edition Time

Monday, April 17th, 2017

Market.Biz: Research Report on Biotechnology Separation Systems Industry 2016 provides the analytical view of the Biotechnology Separation Systems industry globally, focusing on main regions like North America, Europe, and Asia. Amongst these continental Biotechnology Separation Systems market, the report focuses on Biotechnology Separation Systems market by countries like United States Biotechnology Separation Systems market, Germany Biotechnology Separation Systems market, Japan and China Biotechnology Separation Systems market.

In the first part, the Biotechnology Separation Systems market report lists the fundamental details of Biotechnology Separation Systems industry elaborating Biotechnology Separation Systems definition, classification, wide range of applications and Biotechnology Separation Systems industry frame structure. The report further includes Biotechnology Separation Systems industry policies and plans, Biotechnology Separation Systems product specification, cost structures and manufacturing process on Biotechnology Separation Systems market scenario. The report then studies the global Biotechnology Separation Systems market in terms of growth rate, Biotechnology Separation Systems consumption volume, Biotechnology Separation Systems production capacity, supply and demand ratio etc.

Do Inquiry Before Purchasing Report Here: https://market.biz/report/global-biotechnology-separation-systems-market-2017-9dimen/70115/#inquiry

1) Report on Biotechnology Separation Systems industry covers growth rate (forecast). 2) Worldwide Biotechnology Separation Systems market 2017 estimated at USD XXXX in 2016. 3) Global Biotechnology Separation Systems industry 2017 projected to reach USD XXXX million at forecast period. 4) Worldwide Biotechnology Separation Systems market projected to grow at CAGR XXXX % During forecast period. 5) Continental Biotechnology Separation Systems Market: (North America, Europe and Asia) Biotechnology Separation Systems market expected to grow at CAGR of XXXX % over the forecast period. 6) 2017 Biotechnology Separation Systems Market Segment by Manufacturers, which covers all details related Biotechnology Separation Systems industry Manufacturers/Companies.

Lastly, 2017 Biotechnology Separation Systems industry report adds the feasibility study related to the futuristic Biotechnology Separation Systems market scenario, SWOT analysis of Biotechnology Separation Systems industry and investment return analysis. The report introduced Biotechnology Separation Systems new project SWOT analysis, investment feasibility analysis, and Biotechnology Separation Systems industry investment return analysis and Biotechnology Separation Systems growth aspects of the industry.

Request For Sample Report Here: https://market.biz/report/global-biotechnology-separation-systems-market-2017-9dimen/70115/#requestforsample

This Biotechnology Separation Systems market study consists of 6 parts, in the 1st part the basic information about Biotechnology Separation Systems , in the 2nd part analysis of the Asia Biotechnology Separation Systems industry; in the 3rd part analysis of North America Biotechnology Separation Systems industry is done; in the 4rth part analysis of the Europe Biotechnology Separation Systems industry is done; 5th part does the analysis of feasibility study and scope of Biotechnology Separation Systems market future investment; in 6th part research conclusions are offered.

Thus, this research report on Biotechnology Separation Systems industry provides the insightful knowledge on current Biotechnology Separation Systems market trends.

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iShares NASDAQ Biotechnology Index (IBB) Upgraded at Vetr Inc. – Markets Daily

Monday, April 17th, 2017
iShares NASDAQ Biotechnology Index (IBB) Upgraded at Vetr Inc.
Markets Daily
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. They currently have $301.57 target price on the stock.

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iShares NASDAQ Biotechnology Index (IBB) Upgraded at Vetr Inc. - Markets Daily

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ProShares Ultra Nasdaq Biotechnology (NASDAQ:BIB) Carving out Recent Gains For the Week – The Herald

Sunday, April 16th, 2017

All three benchmark US indexes closed lower on Friday after fluctuating throughout the session.

ProShares Ultra Nasdaq Biotechnology (NASDAQ:BIB) performed nicely this week, continuing its impressive near-term upward movement. The stock has moved north1.52% over the past week of trading.

Looking further out, over the past twelve months, ProShares Ultra Nasdaq Biotechnologys stock was -0.08% and 7.76% over the last quarter and 12.38% for the past six months.

There are many reasons why a stock might advance so much, so quickly. The total market, including country, continent, or global, might have gone up due to macro reasons. The company might have reported better than expected (consensus) earnings results. A sell-side firm might have issued a buy report on the company. The company might have announced a major change in the business, such as a buyout, M&A, spin-off, R&D results or the acquisition of a new large client. The company might have announced its involvement in a lawsuit. The company might have changed its yearly guidance. The institutional investors might have bought a large chunk of stocks of the company.

Over the past 50 days, ProShares Ultra Nasdaq Biotechnology (NASDAQ:BIB) stock was -8.62% off of the high and 9.22% removed from the low. Their 52-Week High and Low are noted here. -10.28% (High), 39.45%, (Low).

ProShares Ultra Nasdaq Biotechnology (NASDAQ:BIB) may have great momentum, but how has it been performing relative to the market? The stocks price is $47.37 and their relative strength index (RSI) stands at 48.31. RSI is a technical oscillator that shows price strength by comparing upward and downward movements. It indicates oversold and overbought price levels for a stock.

Disclaimer: The views, opinions, and information expressed in this article are those of the authors and do not necessarily reflect the official policy or position of any company stakeholders, financial professionals, or analysts. Examples of analysis performed within this article are only examples. This is not a recommendation to buy or sellProShares Ultra Nasdaq Biotechnology (NASDAQ:BIB).

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ProShares Ultra Nasdaq Biotechnology (NASDAQ:BIB) Carving out Recent Gains For the Week - The Herald

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Funding From Alzheimer’s Drug Discovery Foundation Advances M3 Biotechnology Toward Human Trials – GlobeNewswire (press release)

Sunday, April 16th, 2017

April 13, 2017 20:00 ET | Source: M3 Biotechnology

SEATTLE, April 13, 2017 (GLOBE NEWSWIRE) -- As the first investor in M3 Biotechnology, the Alzheimers Drug Discovery Foundation (ADDF) helped validate the therapeutic potential of M3s drug candidate for Alzheimers disease. With a second investment of $1.4 million, the ADDF is now providing key funds to support the launch of human trials this year.

While current drugs for Alzheimers disease only provide symptomatic relief, M3s small molecule therapeutics have the potential to be truly disease-modifying. By re-establishing lost connections between brain cells, these therapies may halt the course of the disease. M3 is now in the process of planning a first-in-humans Phase 1a clinical trial for its lead candidate, NDX-1017, to evaluate its safety and determine optimal dosing range.

ADDFs first investment spurred others, including many private investors and Washington state-based venture groups W Fund and WRF Capital. These investments evidenced the faith in our potential, which helped us make it past the valley of death for drug development and raise nearly $14 million in additional funding, said Leen Kawas, M3s CEO.

The most noteworthy new investor in M3 is Dolby Family Ventures, which invests in technology and life sciences. The fund makes early stage investments in the most promising Alzheimer's-specific therapeutics which require funding for the critical phase of translating successful animal therapies to human clinical trials. The fund honors the late inventor, Ray Dolby, who died in 2013 and who lived with Alzheimer's disease.

The relationship with the ADDF has been vital to our progress as they have fostered a dynamic, collaborative biotech ecosystem, Kawas said. By providing early funding and connecting us with potential partners and investors, the ADDF has helped us reach the clinic.

Howard Fillit, MD, Founding Executive Director and Chief Science Officer of the ADDF, says, We are excited by the promising therapeutic approach of Dr. Kawas and her team at M3 Biotechnology. By helping neurons survive, NDX-1017 may restore cognitive function for Alzheimers patients. The ADDF looks forward to the results from this first human trial.

Alzheimers Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, ADDF is dedicated to accelerating the discovery of drugs to prevent, treat and cure Alzheimers disease. The ADDF is a public charity solely focused on funding the development of drugs for Alzheimers, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, ADDF has awarded over $100 million to fund more than 500 Alzheimers programs in 18 countries.

M3 Biotechnology, Inc. M3 Biotechnology is a therapeutics company with a novel platform of disease-modifying regenerative small molecules, particularly relevant to neurodegenerative diseases like Alzheimers. M3s lead asset is being advanced as a first-in-class, disease-modifying treatment with the potential to restore lost connections between brain cells, turning degeneration into regeneration. Total financing of $14M to-date is used to prepare for and conduct Phase I clinical trials.

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Funding From Alzheimer's Drug Discovery Foundation Advances M3 Biotechnology Toward Human Trials - GlobeNewswire (press release)

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Biotechnology: navigating a minefield – Cordis News

Friday, April 14th, 2017

When it comes to getting biotechnology innovations to market, with commercial protection, it can be tough. Around three quarters of patent applications normally fail to cut it. Although biotechnology is recognised as being important for the economy and society, it can also be highly controversial attracting public protests

The European Patent Office (EPO) has faced opposition in the past, for instance, over patents relating to processes for re-engineering genes, for use in medical research into cancer treatment. These processes could apply to various animals, including great apes and that became a magnet for criticism from animal rights campaigners.

The number of patent filings for biotechnology increased by 0.3 percent in 2016, to 5,744 making it the tenth largest sector in its field.

Youris.com spoke to Benoit Battistelli, President of the EPO, about the role of patent protection and how it can aid biotechnology innovation and the wider bioeconomy despite the obstacles faced by some.

How much of a focus is the bioeconomy for patents and what are some of the key developments?

Biosciences play an important role in patent applications at the EPO, given the growing convergence of technologies, which is widely responsible for technical progress in a wide number of sectors. Such inventions are mainly found in industrial biotechnology, for instance, in the development of novel products such as new detergents, functional food or even new eco-friendly material in construction, such as pollution-eating concrete and self-healing concrete.

The area of clean energy production is also very important. For example, when it comes to using biomass as an energy source [editors note: In 2011, a Danish inventor won a European Inventor Award organised by the EPO for developing a system which increases the types of biomass fuels that can be used. Typically, biomass materials have to be dried before they can be used as fuel, but Jens Dall Bentzens furnace design can also burn materials with a moisture content of up to 60 percent. Hes since reported to have attracted interest from Europe and the US, selling the furnace to an American manufacturer, as well as building two others for use in Denmark].

Is the bioeconomy an increasing sector?

Biotech is among our top ten technical fields and it has increased. At the end of the patent granting process, its about 50 percent on average that become a patent. Its only 26 or 27 percent in the case of biotech. Why? Because it is a very sensitive issue and we are applying the patentability criteria very rigorously. There are huge European capacities in biotech and we have seen that we must find a good balance between the regulatory constraints and the economic capacities that this sector represents.

The position of the EPO is very clear and simple. There is an EU directive concerning biotech, which we respect and which we have integrated in our own legal framework, the European Patent Convention. Then you have the interpretations of the Directive by the European Court of Justice and we adapt our practice to these judgements.

Overall, how complicated is it to obtain a patent, and is it expensive?

I would not say that it is complicated, but it is a difficult process, because we always start from the basis that a patent is an exception to the principle of free trade, free industry, free competition. Globally, for around 20 to 25,000 euros, you can obtain a patent as the EPO. For this amount, 5,000 euros are the EPO fees and the rest is the fees of those who helped to draft a patent and then discuss it with the patent office.

So, with a patent, you are giving the holder the exclusive right of commercially exploiting his invention, for a certain period of time, a maximum 20 years.

By Damon Embling

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Trump Administration should unshackle further innovation in ag biotechnology by rolling back undue regulations – Fence Post

Friday, April 14th, 2017

WASHINGTON Overly cautious regulations that contravene decades of academic research and ignore the lessons from massive real-world experience are stifling innovation in plant and animal improvement, said the Information Technology and Innovation Foundation.

The Trump administration should roll back overly precautionary regulations to encourage much-needed innovations that produce safer and more sustainable crops and livestock while still preventing unreasonable risks to public and environmental welfare, argues the science- and tech-policy think tank in a recently released report.

"From reducing the need for pesticides to increasing crop yields, genetically modified crops have already made farming more safe and environmentally friendly," said L. Val Giddings, a senior fellow at ITIF and the report's author. "Researchers are discovering ever more precise, predictable, and easy-to-use techniques derived directly from nature. But despite decades of evidence on the safety of genetically improved crops, unfounded fears and politically driven opposition have led to regulations that chill innovation. It's time to rethink these policies and allow and enable a new generation of discoveries that can feed the world even more safely and sustainably."

Giddings explains that in the 1980s, the U.S. government decided to regulate biotech-improved crops using the same principles and methods it would for any other crops, because expert bodies repeatedly found no unique or novel hazards that made these crops and livestock any different than those derived from the classical plant and animal breeding that has occurred for millennia. But since then, Giddings says the disparity between the minimal risk associated with these innovations and the major regulatory hurdles they must clear has widened from a gap to a chasm.

This discordance between the degree of regulatory oversight and the actual hazards is posing economic and environmental costs, as innovative new products are delayed from reaching the market, Giddings said. To overcome these barriers and unleash a new generation of innovation in agricultural biotechnology, the report recommends that:

The Trump administration should enforce the mandate from the Office of Science and Technology Policy that agencies update their regulations and policies for innovative agricultural-biotechnology products, and that the revised regulations should be effective in preventing unreasonable risks while still encouraging and enabling innovation;

The Animal and Plant Health Inspection Service should set aside its proposal for process-based revisions to existing regulations;

The Food and Drug Administration should enforce the federal law prohibiting misleading food labels;

The FDA should revise its current proposal for regulating gene-edited animals, withdraw its proposal for gene-edited plants, and develop new proposals to exercise its discretion in preventing unreasonable risks;

The Environmental Protection Agency should not prematurely obstruct gene-silencing technologies;

The Fish and Wildlife Service should immediately withdraw the prohibition on planting biotech-improved seeds on national refuge lands; and

The Trump administration should pursue efforts through the World Trade Organization to hold China and the European Union accountable for continuing to discriminate against crops improved through biotechnology, despite being obligated otherwise.

"Biotechnology innovations have improved the lives of farmers around the world, enhanced their stewardship of the land, and benefitted consumers and the environment," Giddings said. "The principle obstacle to even greater and more widespread benefits is regulatory hurdles that aren't grounded in the facts. Setting these barriers aside will unshackle innovators to solve challenges impeding our ability to meet the food, feed and fiber needs of a growing population while reducing undesirable environmental impacts."

Read the full report at http://www2.itif.org/2017-unshackle-agricultural-innovation.pdf?_ga=1.155989245.717142650.1491235245.

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Trump Administration should unshackle further innovation in ag biotechnology by rolling back undue regulations - Fence Post

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Separation Systems for Commercial Biotechnology Market 2017: Key Players are Thermo Fisher Scientific, Agilent … – Business Wire (press release)

Friday, April 14th, 2017

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Separation Systems for Commercial Biotechnology" report to their offering.

The market for bioseparation systems is growing rapidly across all regions. Bioseparation purifies biological products on a large-scale. The report focuses on the global market of bioseparation systems and provides an updated review, including basic design and its applications, in various arenas of biomedical and life science research.

The bioseparation techniques that are covered in this report are chromatography, centrifugation, electrophoresis, membrane filtration, flow cytometry, microarray, lab-on-a-chip, biochip, and magnetic separation. Among chromatography techniques, liquid chromatography is the most active market.

Also included in the report are relevant patent analysis and comprehensive profiles of companies that lead the bioseparation systems market. Key players include Thermo Fisher Scientific, Agilent Technologies Inc., Bio-Rad Laboratories, Danaher Corp., Qiagen N.V., Merck KGaA GmbH, and Waters Corp. among others.

Key Topics Covered:

1: Introduction

2: Summary and highlights

3: Overview

- History of biotechnology

- Classification of biomolecular separation systems in biotechnology

- New methods of biomolecular separations

- Molecular classes of biomolecular separation

- End users of biotechnology separation systems

4: New Developments

- Mergers and acquisitions

5: Market Analysis

- Market by type

- Market by region

6: Industry Structure

- Chromatography

- Centrifugation

- Electrophoresis

- Membrane filtration

- Flow cytometry

- Magnetic separation

- Microarrays

- Biochip

- Lab-on-a-chip

7: Patent Analysis

- Patents by year

- Patents by type

- Patents by company

- Patents by country

- Patents by assignee

8: Current Situation

- Factors affecting bioseparation system market

- Market opportunities

9: Company Profiles

- 3M Company

- Abaxis Inc.

- Abtech Scientific Inc.

- Agilent Technologies Inc.

- Alfa Laval Group

- Alfa Wassermann Separation Technologies

- Arrayit Corp.

- BD BioSciences (Becton, Dickinson and Company)

- Biocept Inc.

- Biodot Inc.

- BioMerieux SA

- Bio-Rad Laboratories Inc.

- Boston Microfluidics

- Customarray Inc.

- Danaher Corp.

- DNAmicroarray Inc.

- Falcon Genomics Inc.

- Flottweg Separation Technology

- GE Healthcare Life Sciences

- Hitachi Koki Co. Ltd.

- Illumina Inc.

- Luminex Corp.

- Merck KGaA

- Microarray Inc.

- Nanostring Technologies Inc.

- Novasep Inc.

- PerkinElmer

- Qiagen Gmbh

- Randox Laboratories Ltd.

- Sartorius Corp.

- Shimadzu Scientific Instruments

- Spectrum Chemical Manufacturing Corp.

- Sysmex Partec Gmbh

- Thermo Fisher Scientific

- W. R. Grace & Company

For more information about this report visit http://www.researchandmarkets.com/research/npn5zk/separation

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Separation Systems for Commercial Biotechnology Market 2017: Key Players are Thermo Fisher Scientific, Agilent ... - Business Wire (press release)

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Funding From Alzheimer’s Drug Discovery Foundation Advances M3 Biotechnology Toward Human Trials – Yahoo Finance

Thursday, April 13th, 2017

SEATTLE, April 13, 2017 (GLOBE NEWSWIRE) -- As the first investor in M3 Biotechnology, the Alzheimers Drug Discovery Foundation (ADDF) helped validate the therapeutic potential of M3s drug candidate for Alzheimers disease. With a second investment of $1.4 million, the ADDF is now providing key funds to support the launch of human trials this year.

While current drugs for Alzheimers disease only provide symptomatic relief, M3s small molecule therapeutics have the potential to be truly disease-modifying. By re-establishing lost connections between brain cells, these therapies may halt the course of the disease. M3 is now in the process of planning a first-in-humans Phase 1a clinical trial for its lead candidate, NDX-1017, to evaluate its safety and determine optimal dosing range.

ADDFs first investment spurred others, including many private investors and Washington state-based venture groups W Fund and WRF Capital. These investments evidenced the faith in our potential, which helped us make it past the valley of death for drug development and raise nearly $14 million in additional funding, said Leen Kawas, M3s CEO.

The most noteworthy new investor in M3 is Dolby Family Ventures, which invests in technology and life sciences. The fund makes early stage investments in the most promising Alzheimer's-specific therapeutics which require funding for the critical phase of translating successful animal therapies to human clinical trials. The fund honors the late inventor, Ray Dolby, who died in 2013 and who lived with Alzheimer's disease.

The relationship with the ADDF has been vital to our progress as they have fostered a dynamic, collaborative biotech ecosystem, Kawas said. By providing early funding and connecting us with potential partners and investors, the ADDF has helped us reach the clinic.

Howard Fillit, MD, Founding Executive Director and Chief Science Officer of the ADDF, says, We are excited by the promising therapeutic approach of Dr. Kawas and her team at M3 Biotechnology. By helping neurons survive, NDX-1017 may restore cognitive function for Alzheimers patients. The ADDF looks forward to the results from this first human trial.

Alzheimers Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, ADDF is dedicated to accelerating the discovery of drugs to prevent, treat and cure Alzheimers disease. The ADDF is a public charity solely focused on funding the development of drugs for Alzheimers, employing a venture philanthropy model to support research in academia and the biotech industry. Through the generosity of its donors, ADDF has awarded over $100 million to fund more than 500 Alzheimers programs in 18 countries.

M3 Biotechnology, Inc. M3 Biotechnology is a therapeutics company with a novel platform of disease-modifying regenerative small molecules, particularly relevant to neurodegenerative diseases like Alzheimers. M3s lead asset is being advanced as a first-in-class, disease-modifying treatment with the potential to restore lost connections between brain cells, turning degeneration into regeneration. Total financing of $14M to-date is used to prepare for and conduct Phase I clinical trials.

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Funding From Alzheimer's Drug Discovery Foundation Advances M3 Biotechnology Toward Human Trials - Yahoo Finance

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Expert: Biotechnology will aid sustainable agricultural production – P.M. News

Thursday, April 13th, 2017

Biotech

Prof. Benjamin Ubi, the President, (BSN), says the adoption of biotechnology will facilitate sustainable agricultural production in the country.

Ubi made the declaration in an interview with News Agency of Nigeria (NAN) in Abuja on Thursday

He said that the adoption of biotechnology applications was the panacea to the current food challenges facing the country.

Biotechnology, including genetic engineering and production of Genetically Modified Organisms (GMOs), provides powerful tools for the sustainable development of agriculture, fishery and forestry, as well as meeting the food needs of the population.

GMOs currently account for about 16 per cent of the worlds crops, particularly crops like soybean, maize, cotton and canola, and there are indications that the growing trend will continue.

So, we must eat what we grow and grow what we eat. This means we ought to produce more and agricultural biotechnology is a tool for achieving this, he said.

Ubi also pledged the support of the BSN for the efforts of National Biosafety Management Agency (NBMA) to harness the potential of modern biotechnology.

READ: Kwara International Vocational Centre gets equipment

BSN, as a stakeholder in biosafety, will continue to support NBMA; we should all be rest assured that no biotechnology product will be imposed on anyone.

Hunger and peace work hand-in-hand, so lack of hunger consequently promotes peace; therefore, biotechnology and its derivatives should be adopted for the benefit of Nigerians, while maintaining regulatory standards.

Biotechnology and biosafety stakeholders must, therefore, work in tandem with global bodies because Nigeria is not a pariah nation; we are a responsible and respected member of the global community, he said.

Ubi urged anti-GMO campaigners not to play politics with issues that could engender food security and alleviate poverty, saying that tangible efforts should be made to enhance the availability and affordability of high-quality foods via biotechnology applications.

I assure all that modern biotechnology had been found to be safe by global certification bodies.

All the same, informed criticism is good for checks and balances but it should not be allowed to be a clog the wheel of progress, he added.

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Expert: Biotechnology will aid sustainable agricultural production - P.M. News

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Go Long the iShares Nasdaq Biotechnology Index (ETF) (IBB) ETF With Confidence – Investorplace.com

Thursday, April 13th, 2017

By Nicolas Chahine, InvestorPlace Contributor|Apr 13, 2017, 12:59 pm EDT

The iShares Nasdaq Biotechnology Index (ETF) (NASDAQ:IBB) has been under technical pressure. For the past few weeks, IBB shares have been building a bearish head-and-shoulders pattern. To catch that breakdown I shared a trade that will do it for free, and its working already.

In the short term, the IBB ETF is tight, suggesting that a sizable move should be coming. But with no major changes in the thesis, the breakout from the current squeeze is more likely up than down. So for that reason, I want to book my small profits in the bearish setup and reset a long IBB trade for the next year.

The Bet: Sell the IBB Jan 2018 $240/$235 credit put spread. This is a bullish trade for which I collect 90 cents per contract to open.

I have a 90% theoretical chance of having it expire for maximum gains. If IBB shares close above $240, this trade would yield 20% on money risked.

By taking this risk, I accept the fact that IBB shares could fall $20 or more in the next few weeks. But with a 20% price buffer and the amount of time until expiration I am confident that I will be able to manage the short term price challenges.

Click to Enlarge The fundamentals of the components of the IBB are, for the most part, solid after all.

I also have to acknowledge the political threat that still looms from President Donald Trump. He has vowed to address the pricing models of biotech and healthcare sectors. If not for these threats I would have sold the bet as naked Jan 2018 $220 puts for $5 per contract instead. But given that we are near all-time highs in addition to the aforementioned threats, I will start the trade as a spread then decide if I want to turn it into a naked put position.

Learn options as easy as 1-2-3 here. Nicolas Chahine is the managing director of SellSpreads.com. As of this writing, he did not hold a position in any of the aforementioned securities. You can follow him on Twitter at @racernicand stocktwits at@racernic.

Article printed from InvestorPlace Media, http://investorplace.com/2017/04/ishares-nasdaq-biotechnology-index-etf-ibb-etf-confidence/.

2017 InvestorPlace Media, LLC

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Go Long the iShares Nasdaq Biotechnology Index (ETF) (IBB) ETF With Confidence - Investorplace.com

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Biotechnology Education vs Industry Requirements: Where – BSI bureau (press release)

Thursday, April 13th, 2017

Dr Vinay Rale shares his thoughts with BioSpectrum on current biotech education and the academia-industry gap

Dr Vinay Rale, Director, Symbiosis School of Biomedical Sciences (SSBS)

Brief recapitulation of genesis of Biotechnology in India A quick recapitulation of the genesis of Biotechnology in India will not be out of place to apprise the lay public. We essentially (and blindly) followed the USA in 1985 in initiating Biotechnology programs at Master's level at six select universities across India. In the 1970s, the ability to modify DNA molecules and the realization of the power of genetic engineering led prominent universities in the US to convince their Government to allocate huge funds to start

Biotechnology' - a term newly coined by them. The Indian model, first at Masters level, to cater to the need for trained manpower for the anticipated boom in the Biotechnology industry was supported by the Department of Biotechnology (DBT). Very soon a large number of institutions both in private and public sector followed suit to attract students. The wildfire spread to undergraduate programs equally rapidly. However, this led to two major disadvantages - the relegation of basic courses in Life Sciences such as Microbiology, Biochemistry, Zoology and Botany and severely inadequate infrastructure and untrained faculty. As a matter of fact, the first Masters programs supported by DBT at six prominent institutions in the country were turned to the advantage of the then faculty expertise, e.g., developmental biology turning a blind eye to the basic essentials that the students have to be proficient in.

A rough estimate of the students enrolled in Biotechnology at undergraduate and postgraduate levels suggests a number exceeding 100,000 at any given time. Also, some institutions offer a bouquet of 8 to 9 allied courses in Biotechnology. Naturally the demand-supply ratio is skewed. The curricula in Biotechnology tries to accommodate' as many subsets as possible with little attention to the fundamentals - especially at the undergraduate levels. Moreover, to overcome the infrastructure deficiency, a good number of students (especially at postgraduate level) are encouraged to bank upon either research institutes or industries to undertake dissertations.

Unfortunately, both categories of organizations take little interest in the welfare of such dissertation research; more so due to the unavailability of mentors from either side. Therefore-, little research done at such levels goes unnoticed. As a consequence-, it is estimated that well over 70 percent of Biotechnology students are considered as unemployable by industries. This is the net result of a large number of factors contributing to the creation of unfit student mass. Reliable sources indicate that industries now prefer to hire students trained in conventional Life Sciences like Microbiology and Biochemistry (also Chemistry) to meet their stringent requirements. The general complaint is that the Biotechnology students lack fundamentals. This is also the observation of this author over the decades.

Considering the seriousness of the Government to increase funding for the DBT and the intiative of the Biotechnology Industry Research Assistance Council (BIRAC) coupled with those of SIDBI and MSME to strengthen research in academia and foster strategic alliances between academia and industry, one can only expect better things to happen. However, like Biotechnology, Microbiology and Biochemistry programs too need nourishment.

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Biotechnology Education vs Industry Requirements: Where - BSI bureau (press release)

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Nature Biotechnology Features ReadCoor as a 2016 Leading Spinout – PR Newswire (press release)

Thursday, April 13th, 2017

CAMBRIDGE, Mass., April 12, 2017 /PRNewswire/ --ReadCoor, Inc. today announced that an article appearing in the April 2017 issue of Nature Biotechnology named the company among the 10 leading academic spinouts for 2016. Each year the journal identifies and features companies originating from academic institutions who have generated significant initial funding and who in the editors' assessment have demonstrated novel, potentially disruptive technology. In the words of the journal, "We believe these [ventures] represent some of the best science coming out of academia in 2016."

"It is a tremendous honor to be included in this group of amazing technologies and companies," said Shawn Marcell, ReadCoor co-founder and CEO. "The team at ReadCoor is excited to deliver on the promise this revolutionary platform holds."

The ReadCoor platform, called FISSEQ Fluorescent In-Situ Sequencing is the first application of in-situ spatial sequencing. ReadCoor was founded in 2014 by Richard Terry and George Church at the Harvard Wyss Institute, to bring Fluorescent In-Situ Sequencing into mainstream research use. Several key applications are being advanced including pathogen detection under a grant provided by the Bill & Melinda Gates Foundation, brain mapping or neural connectomics funded by IARPA, and drug development in areas such as central nervous system, neurodegenerative diseases, oncology, immunotherapy and gene therapy. Unlike traditional sequencing technologies, ReadCoor provides a method to pinpoint the precise locations of specific RNA molecules in intact tissue.

About ReadCoor

ReadCoor is leading the next generation of "omics" by delivering the first panomic spatial sequencing platform to researchers, clinicians, pharma and diagnostics companies, and ultimately patients. It is spearheading the charge with Fluorescent In-Situ Sequencing, a fundamental innovative technology that simultaneously integrates high throughput next generation sequencing, morphometric tissue analysis and three-dimensional spatial imaging. This uniquely powerful tool is the first and only implementation of "In-situ Sequencing" and will revolutionize the next phase in understanding the transcriptome, introducing vast new opportunities for important and meaningful clinical insights.

Contact Sam Inverso ReadCoor, Inc. Readcoor.com (617) 453-2660

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/nature-biotechnology-features-readcoor-as-a-2016-leading-spinout-300438536.html

SOURCE ReadCoor, Inc.

http://www.readcoor.com

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Nature Biotechnology Features ReadCoor as a 2016 Leading Spinout - PR Newswire (press release)

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Pennsylvania Biotechnology Center begins long-awaited expansion … – Bucks County Courier Times

Thursday, April 13th, 2017

The Pennsylvania Biotechnology Center on Wednesday broke ground on a long-awaited expansion that will add laboratories, office space and at least 100 new jobs to its campus in Buckingham.

"This has become a real state resource," said biotechnology center President Timothy Block. "We can't exist in these two buildings anymore. We need to grow."

Created more than 10 years ago through a partnership between the Hepatitis B Foundation and Delaware Valley University, the Biotechnology Center has grown to become an economic powerhouse in the region, contributing an estimated $1.8 billion to the local economy and supporting more than 700 jobs, half of those within the center itself.

Because of the center's success, it's been a draw for scientists and entrepreneurs throughout the region. Lab space is at a premium, and there's a waiting list for tenants. The new wing is already 40 percent leased, Block said.

The first tenant, contract research organization FlowMetric Inc., credits the center with its growth. The company now has three dozen employees.

"I could have set up my company in New Jersey. But there was no place that was quite like this, and that has continued for us," said CEO Ren Capocasale.

"This center is why I do what I do."

While construction likely won't begin until the summer, biotech center officials chose Wednesday for the ceremonial groundbreaking in part because it also happened to be the 96th birthday of Joshua Feldstein, a longtime supporter for whom a wing of the center is named.

Feldstein was on hand for Wednesday's event, seated among a variety of state and local dignitaries that included state Rep. Marguerite Quinn, R-143, Doylestown, and state Sen. Chuck McIlhinney, R-10, Doylestown both longtime supporters of the center and Congressman Brian Fitzpatrick, R-8, Middletown.

"This is not a Republican or Democrat thing," said Quinn. "We've had support from both sides of the aisle, recognizing what you do here: jobs, cures and research. Well-paying jobs and phenomenal research."

First proposed in 2015, the expansion project stalled during a dispute between the Hepatitis B Foundation and Delaware Valley University. Unhappy with how the foundation was running the center's day-to-day operations, the university refused to sign off on the expansion plans.

The dispute ended in October, when the Hepatitis B Foundation agreed to pay $2 million to buy DelVal's interests in the center.

The final project will cost between $12 million and $13 million, center officials said. That will be offset by a $4.6 million grant from the federal government and a $2 million state grant. The rest will be financed with a conventional loan awarded by Univest Bank.

Officials on Wednesday, however, weren't just celebrating the expansion. They were thinking about the future.

"We need to be thinking about what the next thing we're going to put the shovel in the ground (for) here with what's happening here," said Bucks County Commissioner Rob Loughery.

Block envisions a biotechnology hub within Bucks County one that equals the well-known Kendall Square area of Boston.

"There is a resource in Bucks County as vital and powerful, with as much potential, as the shale under the earth here," Block said. "That's what we're going to tap into."

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Pennsylvania Biotechnology Center begins long-awaited expansion ... - Bucks County Courier Times

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Caligor to Support Puma Biotechnology’s Expanded Access … – Yahoo Finance

Thursday, April 13th, 2017

SECAUCUS, N.J.--(BUSINESS WIRE)--

Caligor Opco LLC, which specializes in early access to medicines and drug life-cycle management, today announced that it will provide regulatory and logistical management for Puma Biotechnologys (PBYI) expanded access program (EAP) for its investigational breast cancer therapy, PB272 (neratinib), in the United States.

The U.S. Food and Drug Administration (FDA) permits expanded access to investigational drugs for treatment use for patients with serious or immediately life-threatening diseases or conditions who do not otherwise qualify for participation in a clinical trial and lack satisfactory therapeutic alternatives.

The EAP will provide access to neratinib for the treatment of early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. Patients must not be able to participate in any ongoing neratinib clinical trial to qualify for the EAP. Caligor also is providing regulatory, logistical, and supply chain support for Pumas Managed Access Program for neratinib outside the United States.

We are gratified by the trust and confidence Puma has placed in us, said Tammy Bishop, Caligors Chief Commercial Officer. Within the past year, the FDA has introduced a streamlined application process and new guidance designed to improve its expanded access programs, and those initiatives have been extremely positive. We look forward to working with regulators and physicians to facilitate access to neratinib for patients who may benefit from this therapy.

About the Neratinib Expanded Access Program

The neratinib EAP is a program for U.S. patients with early stage HER2-positive breast cancer (extended adjuvant setting), HER2-positive metastatic breast cancer and HER2-mutated solid tumors. This EAP is being administered on behalf of Puma by Caligor Opco. U.S. healthcare professionals seeking more information about the neratinib EAP can email neratinibUSA@caligorrx.com for additional information. Patients who are interested in enrolling in the neratinib EAP should speak with their physician to determine if neratinib is an appropriate option. Neratinib is an investigational agent and, as such, has not been approved by the FDA or any other regulatory agencies in any markets.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. The Company in-licenses the global development and commercialization rights to three drug candidatesPB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. Neratinib is a potent irreversible tyrosine kinase inhibitor that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4. Currently, the Company is primarily focused on the development of the oral version of neratinib, and its most advanced drug candidates are directed at the treatment of HER2-positive breast cancer. The Company believes that neratinib has clinical application in the treatment of several other cancers as well, including non-small cell lung cancer and other tumor types that over-express or have a mutation in HER2.

Further information about Puma Biotechnology may be found at http://www.pumabiotechnology.com.

About Caligor

Caligor Opco LLC, a portfolio company of Diversis Capital, LLC, is a global company that manages the regulatory, logistics and supply chain needs for global access programs as well as the sourcing, storing and distribution of comparator drugs for clinical trials. Caligors global access programs help to meet the medical needs of patients worldwide by providing access to medicines in situations where the drug has not yet been approved, or is otherwise commercially unavailable. In addition, through its proprietary TrialAssist program, Caligor optimizes its services by providing for labeling, QP certification, storage, distribution and destruction of clinical trial and unlicensed medicines managed in the access programs. The company serves pharmaceutical and biotechnology companies from facilities in Secaucus, New Jersey and Dartford, UK, as well as strategically situated depot locations worldwide. More information is available at http://caligorrx.com.

View source version on businesswire.com: http://www.businesswire.com/news/home/20170412005708/en/

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Caligor to Support Puma Biotechnology's Expanded Access ... - Yahoo Finance

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Biotechnology: navigating a minefield – Youris.com

Wednesday, April 12th, 2017

In our fast-moving world, biotech is at the forefront of developments but, by its very nature, it can provoke ethical and moral concerns.

The European Patent Office (EPO) has faced opposition in the past, for instance, over patents relating to processes for re-engineering genes, for use in medical research into cancer treatment. These processes could apply to various animals, including great apes and that became a magnet for criticism from animal rights campaigners.

The number of patent filings for biotechnology increased by 0.3 percent in 2016, to 5,744 making it the tenth largest sector in its field.

Youris.com spoke to Benoit Battistelli, President of the EPO, about the role of patent protection and how it can aid biotechnology innovation and the wider bioeconomy despite the obstacles faced by some.

Benoit Battistelli -Courtesy of EPO

How much of a focus is the bioeconomy for patents and what are some of the key developments? Biosciences play an important role in patent applications at the EPO, given the growing convergence of technologies, which is widely responsible for technical progress in a wide number of sectors. Such inventions are mainly found in industrial biotechnology, for instance, in the development of novel products such as new detergents, functional food or even new eco-friendly material in construction, such as pollution-eating concrete and self-healing concrete.

The area of clean energy production is also very important. For example, when it comes to using biomass as an energy source [editors note: In 2011, a Danish inventor won a European Inventor Award organised by the EPO for developing a system which increases the types of biomass fuels that can be used. Typically, biomass materials have to be dried before they can be used as fuel, but Jens Dall Bentzens furnace design can also burn materials with a moisture content of up to 60 percent. Hes since reported to have attracted interest from Europe and the US, selling the furnace to an American manufacturer, as well as building two others for use in Denmark].

Is the bioeconomy an increasing sector? Biotech is among our top ten technical fields and it has increased. At the end of the patent granting process, its about 50 percent on average that become a patent. Its only 26 or 27 percent in the case of biotech. Why? Because it is a very sensitive issue and we are applying the patentability criteria very rigorously. There are huge European capacities in biotech and we have seen that we must find a good balance between the regulatory constraints and the economic capacities that this sector represents.

The position of the EPO is very clear and simple. There is an EU directive concerning biotech, which we respect and which we have integrated in our own legal framework, the European Patent Convention. Then you have the interpretations of the Directive by the European Court of Justice and we adapt our practice to these judgements.

Overall, how complicated is it to obtain a patent, and is it expensive? I would not say that it is complicated, but it is a difficult process, because we always start from the basis thata patent is an exception to the principle of free trade, free industry, free competition. Globally, for around20 to 25,000 euros, you can obtain a patent as the EPO. For this amount, 5,000 euros are the EPO fees and the rest is the fees of those who helped to draft a patent and then discuss it with the patent office.

So, with a patent, you are giving the holderthe exclusive right of commercially exploiting his invention, for a certain period of time, amaximum 20 years.

This article is part of the communication of theProBIO project, a support action for KBBE projects which identifies research results to facilitate their uptake into the relevant sector.

youris.com provides its content to all media free of charge. We would appreciate if you could acknowledge youris.com as the source of the content.

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Earnings Preview: Biotechnology Looks Healthy – Barron’s

Monday, April 10th, 2017

Barron's
Earnings Preview: Biotechnology Looks Healthy
Barron's
The iShares Nasdaq Biotechnology (IBB) has climbed 0.34%. Meanwhile the SPDR S&P Biotech ETF (XBI) has declined 0.21%. IBB could be benefiting from having a wider swath of companies, in addition to the fact that the average market cap of its index ...

and more »

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Earnings Preview: Biotechnology Looks Healthy - Barron's

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President of Senegal bucks anti-biotechnology pressure: ‘I am for the use of GMOs’ – Genetic Literacy Project

Monday, April 10th, 2017

President Macky Sall of Senegal has thrown his weight behind the adoption of agricultural biotechnology in the country.

.

President Sall made it clear that he supported the implementation of biotechnology in Senegal provided necessary measures to minimise risks were taken.

Macky Sall

I must say very clearly that I am for the use of GMOs based on the precautions taken and based on a dynamic regulation, otherwise we would be against progress. We must decide and step forward. We need to move forward because we have food security imperatives.

It is undeniable that GMOs can help meet current challenges, such as food insecurity, public health issues, natural resource conservation and climate change, he stressed.

We need serious thought to develop a strategy to maximise the use of GMOs, while mitigating the risks associated with them. That is why it is necessary to strengthen the National Biosafety Authority and to have an appropriate legal system combined with an efficient information system based on objective scientific values to assess the cost/benefit/risks ratio, he further stressed.

The GLP aggregated and excerpted this blog/article to reflect the diversity of news, opinion, and analysis. Read full, original post:GMOs: Senegal supports adoption of agric biotech

For more background on the Genetic Literacy Project, read GLP on Wikipedia

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President of Senegal bucks anti-biotechnology pressure: 'I am for the use of GMOs' - Genetic Literacy Project

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