The Move in iShares Nasdaq Biotechnology Index (ETF) (IBB) ETF Is Coming — Get on Board – Investorplace.com

By Nicolas Chahine, InvestorPlace Contributor|May 23, 2017, 1:28 pm EDT

The iShares Nasdaq Biotechnology Index (ETF) (NASDAQ:IBB) is technically tight and a move is coming. While the direction of which is uncertain I am willing to cautiously bet that it will be upwards.

After all, this is an uber-bullish equity market and it will take a really negative headline to cause a selloff, so betting long is easier than shorting. Even when we do sell off, buyers are buying every dip.

Originally I was looking to trade several biotech tickers, but the list got so long that I decided to cast a net over the sector rather than fish with a hook. This will also make managing the risk more streamlined. It came down to a toss-up between IBB and theSPDR S&P Biotech (ETF) (NYSEARCA:XBI).

Click to Enlarge I chose the IBB because it offers me bigger absolute returns with clear levels.

Other names I considered included large components of the ETF so the logic is the same but the vessel has a different ticker. Besides, selling risk on an ETF reduces the chances of a single stock headline which is common among biotech companies.

Fundamentally, the IBB carries a high ticket price but is not currently over-inflated. Four of its top six largest components have shed a lot of froth recently so they shouldnt have far to go without a change in the macro. At almost $300 per share its a tall order to buy outright for most investors but using spreads delivers profits without much risk as this April trade did for me.

The weekly chart shows clear levels where markets avoid, one above $315 and the other below $250.

The Trade: Sell the IBB Dec $245 put and collect $5.50 per contract. Here I have a 90% theoretical chance of keeping my maximum gains. If price falls below $239.50 then I accrue losses there and lower.

Usually I like to balance my trades by selling opposing risk. But since my thesis today revolves around a directional move, I will opt out from selling call risk. Instead, I could even add to the potential profits by adding more positive bias. But I will delay entry for now.

The Juice (Optional): Buy the IBB June 30 $295/$300 debit call spread for $2.30. If price rallies past my spread I stand to double my money.

While adding the optional calls may seem aggressive but its not. I dont even need a rally to profit. As long as IBB stays above my sold puts, any premium I recapture from selling my debit calls spread would be pure profit.

Selling puts is risky business so I only risk what I can afford to lose.

Learn how to generate income from options 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/2017/05/ishares-nasdaq-biotechnology-index-etf-ibb-etf-board/.

2017 InvestorPlace Media, LLC

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The Move in iShares Nasdaq Biotechnology Index (ETF) (IBB) ETF Is Coming -- Get on Board - Investorplace.com

Bosan for establishing Islamic Biotechnology Centre – Pakistan Observer

Staff Reporter

Islamabad

Minister for National Food Security and Research Sikandar Hayat Khan Bosan called for establishing Islamic biotechnology center in order to develop the agriculture and related sectors for the socio-economic prosperity of Muslim countries. Addressing the 3rd International Conference on Agriculture, Food Security and Biotechnology on an other day, he said that government believes that practical collaboration among the Muslim countries in the cutting edge areas of modern biotechnology was the need of time. The event was organized by Pakistan Agricultural Research Council (PARC) in collaboration with COMSATS, Islamic Educational, Scientific and Cultural Organization (ISESCO) and CIMMYT. The aim of the conference was to share the international best practices of using the biotechnology for the development of agriculture sector and food security. The minister termed the exchange of eminent scientist for short term and graduating students among Islamic countries as another good form of cooperation. He called upon the scientists for encouraging and promoting smart agricultural practices to build the resilience in agri-sector. Pakistan was working on the development of infrastructure for using modern and innovative technologies including the biotechnology for uplift of agriculture, health and industrial sectors of the country, he added. Pakistan has improved its crop yield and productivity over the years and it was producing surplus of wheat, maize, potato and sugarcane, he added. He said that scientist and biotechnologist in Pakistan has achieved the diversification in seed development and moved to a higher value added seeds, particularly in the crops sector. The minister said that all the modern techniques should be replicated after tailor-made alterations keeping in view of local settings and environmental factors.

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Bosan for establishing Islamic Biotechnology Centre - Pakistan Observer

OECS highlights outstanding Grenadian making strides in biotechnology – St. Lucia News Online

Dr. Dwayne E. Carter,Post Doctoral Researcher, Tissue Applications.

(PRESS RELEASE) A national of Grenada, Dr. Dwayne E. Carter received his formation in the sciences at the Grenada Boys Secondary School and the T. A. Marryshow Community College in his hometown of Saint Georges.

Dwayne would later migrate to the United States to further pursue his passion for medicine and his curiosity to better understand and cure diseases that plague the human race. After years of study, Dwayne completed his doctoral training in cell biology at the University of Texas Medical Branch where he primarily focused on acute alcohol induced liver injury.

In 2016, he joined ORGANOVO Holdings Inc. as a post-doctoral researcher in liver tissue bioengineering with a focus on modeling progressive liver diseases. Throughout his graduate training, Dwayne received numerous awards for meritorious research from national scientific meetings and has two publications in peer reviewed journals.

When asked about the advice that he would give to young persons in the sub region that may be interested in an investigative science career, Dwayne said: This is a long road but the journey is worth it. A tip is to always make goals for yourself and plan strategic ways to achieve those goals.

Also be prepared to fight for what you want! Very few things are handed to you in this world, so brace yourself for times of adversity because you will inevitably be faced with challenges and the way you deal with them determines your success or failure.

At this stage in my life I consider myself a fighter, I look forward to the challenges because Ive learnt that they bring forward my best, he said.

Dr. Carter will be delivering a presentation on Modeling Human Biology, Drug Response and Progressive Liver Disease Using 3D Bioprinted Human Liver Tissue at the Committee Lecture Hall at TSRI, La Jolla, California at 7:00pm today, August 16, 2017.

ABOUT THE PRESENTATION:

Nonalcoholic fatty liver disease (NAFLD) is a chronic condition that originates as lipid accumulation within hepatocytes (steatosis) and progresses into nonalcoholic steatohepatitis (NASH), characterised by lipid accumulation, inflammation, oxidative stress, and fibrosis. NAFLD is now recognised as the most common cause of chronic liver disease, with a prevalence of 25% worldwide, and is projected to become the leading indication for liver transplant by 2025.

Despite decades of research in rodents and 2D cell cultures, the mechanisms of NAFLD progression, therapeutic approaches and non-invasive diagnostics are still resoundingly absent. Thus, there is a significant need for a more predictive human multicellular 3D in vitro model to study the progression of steatosis into NASH.

Using immune competent ExVive Human Liver Tissue, an in vitro 3D bioprinted liver, Dr. Carter will show preliminary data where the key features of NASH such as steatosis, fibrosis and inflammation will be modeled via nutrient overload followed by inflammatory stimulation using prototypical inducers.

ABOUT THE OECS FEATURE SERIES:

The OECS Feature Series is an initiative that seeks to feature the accomplishments of consummate professionals from OECS Member States making strides within the region and in the Diaspora.

The project highlights one outstanding OECS national per month and aims to inspire the regions youth to think big and open their minds to extraordinary possibilities through the success stories of their OECS peers.

Criteria for nominations include: being a national of an OECS Member State; possessing an academic distinction of the highest order; scientific invention; high political accomplishment (regionally and in the Diaspora); and extraordinary community or national service achieved (regionally and in the Diaspora).

This article was posted in its entirety as received by stlucianewsonline.com.This media house does not correct any spelling or grammatical error within press releases and commentaries.The views expressed therein are not necessarily those of stlucianewsonline.com, its sponsors or advertisers.

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OECS highlights outstanding Grenadian making strides in biotechnology - St. Lucia News Online

iShares NASDAQ Biotechnology Index (IBB) Upgraded to Buy at Vetr Inc. – The Cerbat Gem

iShares NASDAQ Biotechnology Index (IBB) Upgraded to Buy at 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 issued to investors on Wednesday. They currently have $301.57 price target on ...
iShares NASDAQ Biotechnology Index (IBB) Stake Raised by Mycio Wealth Partners LLCSports Perspectives
iShares NASDAQ Biotechnology Index (IBB) Position Lowered by Bartlett & Co. LLCBBNS
The Crestwood Advisors Group LLC Acquires 5651 Shares of iShares NASDAQ Biotechnology Index (IBB)Petro Global News 24

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iShares NASDAQ Biotechnology Index (IBB) Upgraded to Buy at Vetr Inc. - The Cerbat Gem

3SBio: Is this Chinese Biotechnology Stock a Buy? – Barron’s


Barron's
3SBio: Is this Chinese Biotechnology Stock a Buy?
Barron's
Shenyang-based 3SBio (1530.HK) is a biopharmaceutical pioneer that offers a unique play on China's rising demand for healthcare. The company is best known for its rheumatoid arthritis drug YSP, which accounts for 33% of revenues, and TPIAO, ...

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3SBio: Is this Chinese Biotechnology Stock a Buy? - Barron's

Improving Joint Health with Putative Therapeutics at Matis, Iceland’s Food & Biotechnology Research Institute – SelectScience

Use of cell imaging technology enables cutting-edge research into the assessment of bioactive compounds in cell lines

Matis is a leading food and biotechnology research institute in Iceland. Matis vision is to increase the value of food processing and food production, and to ensure the safety and quality of food and food products. SelectScience spoke to Dr. Eva Kuttner, to learn more about the technology the company is using in its research.

SS: Could you briefly introduce yourself and your place of work?

EK: My name is Dr. Eva Kuttner, Im a Project Leader in the Analysis and Structure division at Matis (mat=food + is=Iceland). Matis is a government owned, non-profit, independent research company in Iceland. The main focus of Matis is research and development, aligned to the food and biotechnology industries, as well as providing Iceland's leading food analytical testing service for public and private authorities.

I personally am German, and I hold a Diploma (equal to an MSc) in Botany, from the Universitt Braunschweig in Germany. I received my PhD in Integrative Biology (2007-2012) from the University of Guelph (Ontario, Canada).

SS: Could you describe your job role and work at Matis?

EK: My job title is Regional Manager, which means I am responsible for the 2 locations of Matis in the North of Iceland, Saurkrkur and Akureyri. My main work is that of a project leader (bioactives) in the Analysis and Structure Division and I am specialized in screening for bioactive secondary metabolites using in vitro chemical and cell-based assays.

Our laboratory focus is on identifying and describing compounds regarding antioxidant activity for healthcare (anti-diabetes, anti-inflammatory) and skin care. We now have a fully equipped cell laboratory (currently working with two cell lines), and we routinely run chemical and cell-based assays to identify and describe the bioactivity properties of extracted and fractionated compounds.

Testing putative therapeutics

SS: Please tell us about your marine compounds project that you are working on, and the main challenges involved?

EK: We are currently looking into how marine compounds influence the mineralization in a murine chondrocyte cell line (ATDC5). The aim of the project is to test putative therapeutics, to improve joint health. Specifically, we are interested in seeing how they affect differentiation of these cells.

SS: Which methods do you use to investigate this project and how does the BioTek Cytation 5 play a part in this?

EK: We are exposing the cells to different concentrations of fractionated marine compounds in a 96-well microplate format. After 24 days of incubation we stain the cells both with calcein and Alizarin Red to quantify calcium deposition. This is when the Cytation 5 from BioTek comes in: we have a workflow set up that images (magnification 4x) each well in phase contrast and fluorescence (we are using a GFP filter cube for this assay), and also carries out a read of the fluorescence signal. We then perform the Alizarin Red staining, take more pictures and extract the bound color after several washing steps. A further reading step quantifies the Alizarin Red using an absorbance read.

The figure below shows an example read of the calcein stain: first picture, phase contrast, second picture, fluorescence channel (GFP filter cube) and the third picture, overlay of both:

Image courtesy of Dr. Eva Kuttner

SS: What are your main research findings so far?

EK: We have identified several possible inhibitors of mineralization, but we are still in the process of improving the assay protocol to make the quantification of the mineralization more reproducible. The Alizarin Red stain has proven to represent more accurate calcium deposition into the cells, when testing the assay protocol using standard inhibitors like levamisole, so we are using the calcein stain to visualize mineralization, and Alizarin Red to quantify.

SS: What is the future of your research?

EK: We are looking into setting up assays investigating blood pressure. Our project partner developed a product line based on fish protein hydrolysate using trimmings from cod (Gadus morhua). The proteins are extracted and broken down to smaller peptides that have been shown to inhibit a key enzyme involved in increasing blood pressure (ACE). For this research we will develop and perform cell-based assays.

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Improving Joint Health with Putative Therapeutics at Matis, Iceland's Food & Biotechnology Research Institute - SelectScience

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

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

Why Silicon Valley Keeps Getting Biotechnology Wrong – New York Magazine

Photo: Jamie McCarthy/Getty Images for Glamour

Two years after the $9 billion start-up unicorn Theranos crumbled, Silicon Valley still appears to be struggling to learn its lesson when it comes to health and medical start-ups. Improbable-sounding companies continue to turn up with tens of millions of dollars in funding, no published research to back them up, and nothing but criticism from scientists. Last week, BuzzFeed News examined a new set of start-ups promising to detect cancer early via a simple blood test Freenome, Grail, and Guardant and found them on paths dangerously similar to the one Theranos was on just a few years ago. A year ago, Freenome promised to publish about its product in a scientific journal very soon to Fast Company, and still hasnt. Cancer researchers told BuzzFeed very plainly that such a simple test would be miraculous but seemed improbably advanced beyond our current technology, which was also the case with Theranoss miniature blood tests and Freenome made its lofty promises only months after Theranos started to fall apart. Like a Kickstarter project well over its anticipated delivery date, one begins to wonder if it was all fake.

Silicon Valley has a kind of blind spot when it comes to biotechnology, health-related start-ups, and other medical pursuits. The Theranos hype train was only stopped when The Wall Street Journal surfaced evidence that Theranos had misrepresented how far along it was in its research process to its investors, passing off mediocre test results as much more conclusive than they were. Venture-capital firms insist that the standard that needs to be met for investment is much higher for medical start-ups, which must prove that their technology works with data, not just a pitch. And yet somehow, when these start-ups finally surface to public consciousness, they dont appear to pass even the most basic smell test with literally any experienced researcher in the field.

There are some confounding factors to take into account: venture capitalists invest in ambitious businesses and expect a high failure rate; health start-up failures are highly visible in part because biotechnology businesses are more unusual, and because they tend to be involved with actual life-or-death human experiences. No one really cares about another Uber-alike (just as no one really cared about Uber until it had established itself) but almost everyone has a personal relationship with cancer, and everyone wants a solution to it as soon as possible.

But the fact that we all have bodies, and all need doctors may also be why Silicon Valley seems unable to avoid dabbling in medical technology. The intersection of future tech and health has become crowded with some of the countrys richest hobbyists. They love biohacking (theres even a subscription box). They believe, almost to a man, that the singularity is a question of not if, but when. Elon Musk is very seriously investing in arming biological humans against computers; Peter Thiel takes human growth hormone, a popular practice among transhumanists, and has expressed interested in getting blood transfusions from young people as a way of reversing aging (to his credit, there is some published scientific evidence this might actually work, however fundamentally sinister it sounds). Larry Page, Sergey Brin, Mark Zuckerberg, Sean Parker, and Martine Rothblatt have all sincerely expressed interests in similar pursuits. They often seem less concerned with protecting humanity than their own consciousnesses, designing brain-machine interfaces that will both preserve their own copious knowledge reserves and merge them with the larger internet, turning each tech CEO, investor, and founder into an army of IBM Watsons, but smarter.

There is a pervasive sense in Silicon Valley, bolstered by ten years of world-conquering success, that any sufficiently intelligent, sufficiently driven person can will what they want. The only thing slowing the unrelenting forward march of medical tech is funding. Solutions are an inevitability, and the realities of the human body are simply a set of inefficiencies that can, with enough time and attention, be brought to heel. The culture of Silicon Valley meritocracy affords its practitioners cynicism when confronted with realities other than their own: If you were dumb enough to trust new tech, or too poor to have more options, you deserve what you had coming.

Health tech is certainly valuable and ripe for profit. Machines and medical tests used in hospitals for treatment and diagnosis are wildly expensive, but their cost is determined both by demand (high; no one wants to die, and enough people have insurance) and research (expensive, very costly to get right and get through all the hoops of being brought to market). For further evidence, look at the pharmaceutical industry. Investors who sense a rich potential for profit if only they can insert themselves at the right place in the process are not wrong, in that sense.

But the move fast and break things mantra that has helped Silicon Valley disrupt countless industries over the last two decades is more dangerous when applied to medical science. The roadblocks that health tech companies run into are not qualitatively different from the ones that all tech companies run into. But when Uber or Airbnb run afoul of their respective laws, the result is abstracted lost money out of someones pocket the government, independent contractors, independent businesses, other segments of the market. When Airbnb keeps viable apartments off the market so they can be rented short-term to its users, the money can theoretically be remanded if someone determines that Airbnb is doing something wrong. The things being broken by the current generation of unicorns are regulatory regimes. (Valuable, useful regulatory regimes, to be sure.) The things being broken by health start-ups are laws of science and ironclad guidelines for research. When a health start-up moves fast and breaks things, it can directly result in the death, dismemberment, and injury of real people. You cant un-kill someone who died thanks to a bad diagnosis (at least, theres no start-up hawking that yet).

Theres always room to be wrong in business. But theres less of that room when it comes to medical treatment. That it appears all the same to even the highest-profile venture capitalists actually turns out to make a lot of sense.

The Snapchat 101: The Best, Coolest, Smartest, Weirdest Accounts on the Hottest Social Network on Your Phone

F**k.

We give it three months before Facebook rips off the idea.

Move fast and break things doesnt work when those things are research procedures, laws of science, and human bodies.

A day in the life of YouTubes reigning teen queen.

Cabana lets you watch videos with your friends in real time.

You may be able to give a five-star review, and tip a dollar or two, at the end of an Uber ride in the near future.

Cant keep a good content farm down.

F**k.

How Robert Taylor, who passed away Thursday at the age of 85, essentially created the internet as we know it.

It is kind of contagious, the optimism. I guess it just becomes a part of you.

Add a little pinch of electoral participation.

As YouTube becomes big business for families willing to film everything, are the kids adequately protected?

This is bad news for a lot of PC owners.

Some assembly required.

Everything you need to make the best slime at home.

Lemme up there to hang out with these good boys.

True art takes courage.

When product placement goes wrong.

Au revoir.

Instagrams Stories are now more popular than the app it ripped off.

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Why Silicon Valley Keeps Getting Biotechnology Wrong - New York Magazine

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

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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Puma Biotechnology Announces FDA Advisory Committee to ... - Business Wire (press release)

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

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

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

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

Worldwide Biotechnology Separation Systems Market Projected to … – Edition Time

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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Worldwide Biotechnology Separation Systems Market Projected to ... - Edition Time

Puma Biotechnology, Inc. (NASDAQ:PBYI) held by 19 SEC 13F Filers – Post Analyst


Post Analyst
Puma Biotechnology, Inc. (NASDAQ:PBYI) held by 19 SEC 13F Filers
Post Analyst
Puma Biotechnology, Inc. (NASDAQ:PBYI) reached 80.6% versus a 1-year low price of $19.74. The stock was last seen -0.14% lower, reaching at $35.65 on Apr. 13, 2017. At recent session, the prices were hovering between $35.4 and $36.75. This company ...

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Puma Biotechnology, Inc. (NASDAQ:PBYI) held by 19 SEC 13F Filers - Post Analyst

This is The Biggest Threat To Catalyst Pharmaceuticals, Inc. (CPRX), Vir Biotechnology, Inc. (VIR) – The RVC News

The shares of Catalyst Pharmaceuticals, Inc. (NASDAQ:CPRX) are trading at $3.41 after going up by $0.48. This increase in stock price represents a 52.91% rise from its 52-week low price of $2.23 which was attained back on May 09, earlier this year. But the price still lags -124.93% behind the highest price mark of $7.67 attained on 2019-09-11. CPRX hasnt been performing well over the past few days, with its price dropping by -13.67% during that time frame. The same cant be said for its performance over the past 90 days as it dropped by roughly -20.7% while its overall gain so far this year stands at 14.05%. Looking further than that, its shares have gone down by just -9.07% this year to date. Over the next one year, Catalyst Pharmaceuticals, Inc. shares are expected to reach $9.17, which means that it is expected to rise by 168.91% from its current position.

Out of 6 Wall Street analysts, 6 (100%) of them have rated CPRX as a Buy. The remaining 0 brokerage firms which represent 0% that recommend investors to Hold while it wasnt rated as a Sell by any analyst. Catalyst Pharmaceuticals, Inc. shares held by institutional investors have dropped by 62.8% over the past three months. During that same time, 30 institutions invested in the stock, while 77 added the shares to their existing portfolios. 51 institutional investors reduced their shares in the compnay with only 17 selling their total positions.

The trading volume of CPRX, when compared with its 50-day average volume of 2,058,700, has gone up by 94.57% after additional 4,005,597 shares were sold. The price of the stock is -21.91% below its 20-day SMA, which means that it is currently in a bearish trend. In addition to that, it is also -20.63% below its 50-day SMA, and -27% below its 200-day SMA. At the moment, Catalyst Pharmaceuticals, Inc.s ROE stands around 15.5% and market experts are of the view that the companys earnings per share growth will stand at roughly 0% annually till 2023. If that happens, then it would be off by just -4.4% when compared to the previous five years.

The stock is expected to encounter its first resistance point at $3.78, which is just 9.79% above its current position while the next resistance stands at $4.16, 18.03% from its current price. If CPRX fails to break the immediate resistance, then it is in danger of seeing its price drop to $2.18. The stocks 14-day MACD is -0.69, which means that it is currently in a downward trading trend. Its two weeks RSI meanwhile stands at 39.52, indicating that the stock has been neutral while its 20-day historical volatility reads 127.81%, which is higher than its 50-day equivalent (94.1%).

Vir Biotechnology, Inc. has seen its stock (NASDAQ:VIR) climbed by 16.12% over the past few days and is now trading around at $43.66 on the Wall Street in the intra-day deal. During that period, roughly 1.1 Million VIR shares were traded on NASDAQ. The 90-days average daily trading volume of the stock has been around 821. Thousand but 293.5 Thousand extra shares were traded on that day. VIR has gone up by 274.76% from its 52-week low of $11.65.

Over the past one month, the stock has performed well as it surged by 129.91% during that period. This led to its price increase to stand at 247.2% since the start of the year. The situation still not remains the same when its performance over the past few days was reviewed as it lost -4.46% of its value in the past week. This recent development has seen its 12-month potential target price placed at $26.33, which means that it is expected to decrease by -39.69% from its current price. Of the 5 Wall Street analysts that rated the stock, 60% (3 analysts) have rated VIR as a Buy while the remaining 20% (1 analysts) rated it as a Hold, with 20% (1 analysts) rated the stock as a Sell.

The company has been making use of ROE that stands around 0%, with market experts of the view that their EPS over the next five years will likely fall by 0% annually. This will be a drop from the 0% growth achieved over the past five years. At the moment, VIR is on a bullish trend, up 35.33% from its SMA20, 86.35% above its SMA50, and 140.13% above its SMA200. VIR shares held by institutional investors have jumped by 63.4% over the past three months. A total of 37 institutional investors entered new positions while 37 added to their existing portfolio. 0 hedge funds lowered their positions in the stock with only 0 selling their shares entirely.

VIRs 9-day MACD currently stands at -1.58, which means that the price is on a downward trend. The stocks 9-day RSI score reads 59.6, signaling that the stock is neutral. Its 20-day historical volatility currently stands at 358.49% and is on the upside when compared with its 50-day historical volatility which is 221.75%. A look at VIRs daily chart reveals that its first resistance point stands at $47.18, a 7.46% rise from its current position, while the second resistance point is 13.89% ($50.7) ahead of its current position. If the share fails to break the immediate resistances, it could drop down to $29.58.

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This is The Biggest Threat To Catalyst Pharmaceuticals, Inc. (CPRX), Vir Biotechnology, Inc. (VIR) - The RVC News

Biotechnology Media, Sera and Reagents Market Business Opportunities,Chain Structure Analysis and Industry Development Overview by 2025 – Press…

The current report provides detailed exposure of media, sera and reagents used in cell culture. This report highlights the current and future market potential of culture media, sera and reagents used in cell culture along with a detailed analysis of the competitive environment, regulatory scenario, and technological advancement, and patent analysis, drivers, restraints, opportunities and trends in market growth. The report also covers market projections to 2025 and market shares for key market players.

This press release was orginally distributed by SBWire

New York, NY -- (SBWIRE) -- 03/04/2020 -- The global biotechnology media, sera and reagents market was valued at $18,794 million in 2017 and is estimated to reach at $32,974 million by 2025, registering a CAGR of 7.3% from 2018 to 2025.

Biotechnology is the branch of science that uses living organisms to make technological advancements and adapt those technologies to various different fields including agriculture, genetic engineering, novel drug developments, and several others. Media and sera find their application in animal tissue culture and plant tissue culture, while reagents are used in various biotechnology applications such as diagnosis, laboratory research, drug development, and others.

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Global Biotechnology Media, Sera, and Reagents Market: OverviewThe branch of science dealing with the study of living organisms and their usage to make technological innovations is termed as biotechnology. Media is referred to as a nutrient growth substance that is provided in laboratory as well as research settings for the purpose of growth, proliferation, maintenance, and storage of microorganisms as well as other cell types such as stem cells, mammalian, and other cell lines. A large number of culture media are present in the market for the survival and growth of various cell cultures in their incubation environment. They include classical media, lysogeny broth, serum free media, and chemically defined media. Additionally, sera are utilized as additional growth supplement factors due to the presence of hormones required for cell growth, proliferation, as well as cell differentiation. Moreover, a reagent is a substance that is utilized to stir a chemical reaction and often used to specify the presence of another substance.Considerable rise in the biotechnological R&D pertaining to the development of biopharmaceuticals has led to an increase in demand for culture media, sera, and reagents market. Moreover, increase in investments and funding for research interventions in both developed and developing countries further boost the market growth. However, ethical & scientific concerns associated with the potential of misuse of biotechnology research practices and dearth of skilled personnel restrict the market growth. On the contrary, untapped potential of the emerging economies is anticipated to provide lucrative opportunities to the key players involved in the biotechnology media, sera and reagents market in the near future.

Global Biotechnology Media, Sera, and Reagents Market: Key TrendsThe biotechnology media, sera, and reagents market is expected to expand at a rapid pace in the coming years. Factors propelling the growth of the biotechnology media, sera, and reagents market include less competition from generic or biosimilar drugs and technological advancements resulting in improvement in market growth. However, the demand for media, sera, and reagents is likely to slow down, owing to the requirement for precision-driven cell culture processes and difficulty in keeping a check on parameters such as aeration, humidity, temperature, and nutrients.

Global Biotechnology Media, Sera, and Reagents Market: SegmentationThe global biotechnology media, sera, and reagents market can be segmented based on type, end-user, and region. Based on type, the biotechnology media, sera, and reagents market can be segmented into media, sera, and reagents. The reagent segment is anticipated to account for a key market share during the forecast period, owing to the wide applications of reagents in most biotechnological research such as cell culture, biopharmaceutical research, and others. In terms of end-user, the global biotechnology media, sera, and reagents market can be divided into research laboratories, academic laboratories, biotechnology and pharmaceutical company, and others. The biotechnology and pharmaceutical company segment is anticipated to account for a significant market share during the forecast period, owing to a substantial rise in R&D for the development of biopharmaceutical drugs and cancer research.

The biotechnology media, sera and reagents media market is segmented based on type, application, end user, and region. Based on type, the market is divided into media, sera and reagents. The media segment is further bifurcated into lysogeny broth, classical media, serum free media, chemically defined media, specialty media, stem cell media and others. The sera segment is further classified into fetal bovine sera, new born calf sera, and others. Likewise, the reagents segment is further segmented into antibiotics, DNA/RNS isolation reagents, PCR reagents, buffers and others. Based on application, the market is categorized into cancer research, biopharmaceuticals, clinical diagnostics, regenerative medicine & tissue engineering, and others. Based on end user, it is classified into biotechnology & pharmaceutical industry, academic institute, research laboratory, and others. Based on region, the market is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

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Global Biotechnology Media, Sera, and Reagents Market: Regional AnalysisBased on region, the biotechnology media, sera, and reagents market can be segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. The market in North America is expected to constitute a prominent market share, owing to a signficant rise in health care investments by manufacturers and high R&D expenditure incurred by companies for the development of biotechnology media, sera and reagent. Additionally, a rise in the prevalence of food allergies is fuelling the biotechnology media, sera, and reagents market.

By TypeMediaLysogeny BrothClassical MediaSerum Free MediaChemically Defined MediaSpecialty MediaStem Cell MediaOthersSeraFetal Bovine SeraNew Born Calf SeraOthersReagentsAntibioticsDNA/RNS Isolation ReagentsPCR ReagentsBuffersOthers

By ApplicationCancer ResearchBiopharmaceuticalsRegenerative Medicine & Tissue EngineeringOthers

By End UserBiotechnology & Pharmaceutical CompaniesAcademic InstituteResearch LaboratoryOthers

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Few TOC points :

CHAPTER 5: BIOTECHNOLOGY MEDIA, SERA AND REAGENTS MARKET BY APPLICATION

5.1. Overview5.1.1. Market size and forecast5.2. Cancer research5.2.1. Market size and forecast, by region5.2.2. Market analysis, by country5.3. Biopharmaceuticals5.3.1. Market size and forecast, by region5.3.2. Market analysis, by country5.4. Regenerative medicine & tissue engineering5.4.1. Market size and forecast, by region5.4.2. Market analysis, by country5.5. Other Applications5.5.1. Market size and forecast, by region5.5.2. Market analysis, by country

CHAPTER 6: BIOTECHNOLOGY MEDIA, SERA AND REAGENTS MARKET, BY END USER6.1. Overview6.1.1. Market size and forecast6.2. Biotechnology & pharmaceutical industry6.2.1. Market size and forecast, by region6.2.2. Market analysis, by country6.3. Academic institute6.3.1. Market size and forecast, by region6.3.2. Market analysis, by country6.4. Research laboratory6.4.1. Market size and forecast, by region6.4.2. Market analysis, by countryContinue.

Biotechnology is the branch of science that uses living organisms to make technological advancements and adapt those technologies to various different fields including agriculture, genetic engineering, novel drug developments, and several others. Media and sera find their application in animal tissue culture and plant tissue culture, while reagents are used in various biotechnology applications such as diagnosis, laboratory research, drug development, and others.

Considerable rise in the biotechnological R&D pertaining to the development of biopharmaceuticals has led to an increase in demand for culture media, sera, and reagents market. Moreover, increase in investments and funding for research interventions in both developed and developing countries further boost the market growth. However, ethical & scientific concerns associated with the potential of misuse of biotechnology research practices and dearth of skilled personnel restrict the market growth. On the contrary, untapped potential of the emerging economies is anticipated to provide lucrative opportunities to the key players involved in the biotechnology media, sera and reagents market in the near future.

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Biotechnology Media, Sera and Reagents Market Business Opportunities,Chain Structure Analysis and Industry Development Overview by 2025 - Press...

Generex Biotechnology Appoints Independent Director Carol Nacy, PhD to the NuGenerex Immuno-Oncology Board of DirectorsBiotechnology industry veteran…

MIRAMAR, Fla., Feb. 05, 2020 (GLOBE NEWSWIRE) -- Generex Biotechnology Corporation(www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is proud to announce the appointment of Dr. Carol Nacy, PhD to the NuGenerex Immuno-Oncology (NGIO) Board of Directors. Dr. Nacy is a founder and the Chief Executive Officer of Sequella, Inc., a privately held pharmaceutical company that discovers and develops new and more effective treatments for life threatening infectious diseases. Previously, Dr. Nacy was Executive Vice President and Chief Scientific Officer at EntreMed,Inc. from 1993 through its successful public offering in June 1996. Prior to her career in biotechnology, Dr. Nacy worked for 17 years at the Walter Reed Army Institute of Research in Washington, DC, where she studied tropical infectious diseases. She has published over 165 scientific papers to date.

Dr. Nacy has a long and successful career in infectious disease research and has been widely recognized for her achievements in the biotechnology industry. She was singled out as a Top 50 Innovator in the U.S. by Inc. Magazine in 2002, named Entrepreneur of the Year by Women in BIO in 2004, the state of Maryland named her in its Top 100 Business Women in 2005, and the Washington Business Journal named her as a top 25 female executive in the Washington DC metropolitan area in 2005. In 2006, she received a National Leadership Award in Healthcare from the National Urban Technology Center in New York City, and in 2007 she was honored with a Special Outstanding Achievement Award for Clinical Trials by Women in BIO. In 2009 she was awarded the Humanitarian Award, Hope is a Vaccine, by the Global Alliance for Immunization against Aids (GAIA) for her work to create new drugs for TB. She is an Editor for the American Academy of Microbiology journal, mBio, and an adjunct faculty member of the Department of Tropical Diseases at the George Washington University, Washington, DC. She earned her A.B., M.S., and Ph.D. degrees from the Catholic University of America in Washington, DC, which awarded Dr. Nacy with a Lifetime Achievement Award in Science.

Dr. Nacy commented on her appointment to the NGIO Board, The field of cancer immunotherapy has finally come into its own, and I am thrilled to be part of NuGenerex Immuno-Oncology. I am looking forward to working with the company to bring important new therapies to patients in need.

We are proud to welcome Dr. Nacy to our Board of Directors for NGIO, said Joseph Moscato, President & CEO of Generex Biotechnology. She is an innovator and a leader in the field of infectious disease and vaccine development, bringing together science, business, and policy to make a positive impact on global health. Her knowledge and experience will be highly valuable as we build NuGenerex Immuno-Oncology.

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with end-to-end solutions for patient centric care from rapid diagnosis through delivery of personalized therapies. Generex is building a new kind of healthcare company that extends beyond traditional models providing support to physicians in an MSO network, and ongoing relationships with patients to improve the patient experience and access to optimal care.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.

Generex Contact:

Generex Biotechnology Corporation

Joseph Moscato646-599-6222

Todd Falls1-800-391-6755 Extension 222investor@generex.com

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Generex Biotechnology Appoints Independent Director Carol Nacy, PhD to the NuGenerex Immuno-Oncology Board of DirectorsBiotechnology industry veteran...

Blue Biotechnology Market Global Analysis, Opportunities and Forecast To 2027 With New England Biolabs, Nurture Aqua Technology Pvt. Ltd., PML…

Blue biotechnology refers to the use of marine bio-resources as the source of biological applications. Blue biotechnology is used in various applications such as preservation of marine species, restoration of the aquatic wildlife in its original habitat. This field is also used to develop new medicines as well as conduct genetic study of plants. The increase in commercial applications of blue biotechnology has witnessed growth during the recent years, due to the adaptive nature of marine resources.

The blue biotechnology market is anticipated to grow in the forecast, owing to rising awareness regarding the use of synthetic medicines and growing use of algae to produce drugs. In addition, the increasing in R&D investments made by government bodies as well as private entities for drug discovery is expected to offer significant growth opportunities in the market during the forecast period.

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The Global Blue Biotechnology Market Analysis to 2027 is a specialized and in-depth study of the biotechnology industry with a special focus on the global market trend analysis. The report aims to provide an overview of blue biotechnology market with detailed market segmentation by product, application, end user, and geography. The global blue biotechnology market is expected to witness high growth during the forecast period. The report provides key statistics on the market status of the leading blue biotechnology market players and offers key trends and opportunities in the market.

MARKET PLAYERS:-

Below mentioned is the list of few companies engaged in the blue biotechnology market.

Key developments in the blue biotechnology market as organic and inorganic growth strategies. Various companies are focusing on organic growth strategies such as product launches, product approvals and others such as patents and events. Inorganic growth strategies activities witnessed in the market were acquisitions, and partnership & collaborations. These activities have paved way for expansion of business and customer base of market players. The market payers from blue biotechnology market are anticipated to lucrative growth opportunities in the future with the rising demand for blue biotechnology market in the global market.

MARKET SEGMENTATION:-

The global blue biotechnology market is segmented on the basis product, application and end user. Based on product, the market is segmented as, biopolymers, bulk chemicals, enzymes, pharma products, and other products. The blue biotechnology market is categorized based on application such as, bio-engineering, drug discovery, genomics, vaccine development, and other applications. Similarly, based on end user, the market is categorized such as, biotechnology companies, pharmaceutical companies, hospitals, research institutes & laboratories, and other end users.

REGIONAL FRAMEWORK:-

The report provides a detailed overview of the industry including both qualitative and quantitative information. It provides overview and forecast of the global blue biotechnology market based on various segments. It also provides market size and forecast estimates from year 2017 to 2027 with respect to five major regions, namely; North America, Europe, Asia-Pacific (APAC), Middle East and Africa (MEA) and South & Central America. The blue biotechnology market by each region is later sub-segmented by respective countries and segments. The report covers analysis and forecast of 18 countries globally along with current trend and opportunities prevailing in the region.

The report analyzes factors affecting blue biotechnology market from both demand and supply side and further evaluates market dynamics effecting the market during the forecast period i.e., drivers, restraints, opportunities, and future trend. The report also provides exhaustive PEST analysis for all five regions namely; North America, Europe, APAC, MEA and South & Central America after evaluating political, economic, social and technological factors effecting the blue biotechnology market in these regions.

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Blue Biotechnology Market Global Analysis, Opportunities and Forecast To 2027 With New England Biolabs, Nurture Aqua Technology Pvt. Ltd., PML...

FDA on mission to explain its animal biotech approval process – Agri-Pulse

The Food and Drug Administration, facing increased criticism of its regulatory process for gene-edited animals, is mounting a new effort to defend its policies to farmers, researchers and developers, but the industry is backing the Agriculture Department's push to take over some of FDA's oversight role.

FDA regulates as animal drugs any intentional genomic alterations in animals, achieved through gene editing or older genetic engineering technologies,a position roundly criticized by the animal ag and biotechnology industries. The subject has gained more attention recently with statements from FDA defending its oversight role as necessary both for the safety of animals and humans.

We havent announced most of them yet, but were going to have a series of meetings, said Laura Epstein, senior policy adviser in FDAs Center for Veterinary Medicine. FDAs presentations will include case studies examining hypothetical products.

One of the primary goals of the presentations will be to explain the process and FDAs regulatory intentions to farmers, an audience FDA acknowledges it has not communicated with very much, Epstein said.

As a result, theres a lot of confusion and misinformation out there about what we plan on doing, she said. We got word back that farmers seemed to think were going to require them to register them as drug manufacturers. We want to assure them thats absolutely not the case.

One meeting FDA will definitely be attending is the Large Animal Genetic Engineering Summit in Utah in June, said Heather Lombardi, director of FDAs Division of Animal Bioengineering and Cellular Therapies.

FDAs effort follows publication of a commentary in Nature Biotechnology by Steven Solomon, director of FDAs Center for Veterinary Medicine, asserting the importance of regulatory oversight of intentional genomic alterations in animals, even when the intended modification seeks to replicate a naturally occurring mutation.

Solomons piece accompanied an FDA analysis on how the agency was able to detect unintended alterations in genome-edited bulls, Solomon said in a statement on FDAs website.

The biotech and conventional animal ag industries have been pushing for years to get FDA to loosen its regulatory reins, arguing that FDAs development of disease-resistant animals, for example, has been unduly delayed.

Agriculture Secretary Sonny Perdue made that point at USDAs Agricultural Outlook Forum last week, stating at a press conference that USDA is "in the process of working with FDA currently to help divide up the responsibilities, hopefully with an agreeable type of consensual memorandum of understanding with the agency over new breeding techniques. Perdue said FDA could handle oversight of food animal breeding, with FDA handling any other animals.

He pointed to the example of the nearly year-old agreement between USDA and FDA on cell-cultured technology, used to create meat that has been described as clean by supporters and fake by its opponents.

Under that agreement, the agencies said FDA would handle cell collection, cell banks, and cell growth and differentiation, with the Food Safety and Inspection Service overseeing the production and labeling of human food products derived from the cells of livestock and poultry.

Ag Secretary Sonny Perdue and FDA Commissioner Stephen Hahn meet in Perdue's USDA's office.

Without an easier path to commercialization, new breeding techniques are going to go to Argentina, Brazil, Canada, China, or other countries, Perdue said, making the U.S. a follower rather than a leader in the new technologies.

Representatives of both USDA and FDA were reluctant to discuss the interagency communications. A USDA spokesperson said only, We are always in discussion with various FDA officials on a number of issues dealing with American agriculture. FDAsaid the agency "continues to engagewith our federal partners in the regulation of agriculture biotechnology products.

Referring to USDA and EPA, its other participants in the governments effort to modernize biotech regulations, FDA said each agency has a role to play within its existing statutory structure.

Interested in morecoverage and insights? Receive a free month of Agri-Pulse or Agri-Pulse West by clickinghere.

USDAs Flickr account shows Perdue did meet with new FDA Commissioner Stephen Hahn only nine days before his appearance at Ag Outlook, along with Anna Abram, FDAs deputy commissioner for policy, legislation and international affairs, and Frank Yiannas, FDAs deputy commissioner for food policy and response.

The description on the Flickr site doesnt say what they talked about, but one longtime observer and participant in the animal biotech space said, I would be shocked if they had not discussed the issue. The meeting came two days after publication of Solomons commentary and the release of a statement from Hahn touting the potential of gene-editing technology for animals.

It is paramount, however, that as we move forward, we maintain standards of safety and effectiveness, Hahn said.

The Center for Food Safety agrees. The FDA has scientists that better understand genetic engineering of animals given that it has been working for more than 20 years on both GE animals for research purposes and drug testing, and now GE animals for food, CFS Policy Director Jaydee Hanson said.

USDA, he said, has refused to develop regulations for its review of GE animals and insects, despite having agreed to do so in 2011 after a review by its own inspector general.

Perdues suggestion of an MOU was welcome news to the biotech community. Dana OBrien, the Biotechnology Innovation Organizations executive vice president of food and agriculture, called Perdues words encouraging. In an opinion piece posted on Agri-Pulses site Feb. 12, OBrien said BIO had shown the White House how the President could move animal biotechnology oversight to USDA an approach championed by key livestock and scientific stakeholders.

Im all for it, Acceligen CEO Tad Sonstegard saidof Perdues remarks supporting a division of responsibilities. Acceligen is a subsidiary of Recombinetics, which uses gene editing to develop animals for the agriculture and biomedical markets.

I agree with what BIO said, Sonstegard said. We need to get FDA to come to the table.

Jack Bobo, a food industry consultant who is a former vice president at biotech company Intrexon, said Perdues statement may lead to things moving a little more quickly on the animal biotech front. However, he added, Its not clear to me that this is a detailed proposal.

Intrexon owns Aquabounty, developer of genetically engineered salmon that was approved by FDA in 2015 after a 20-year process the only GE animal to be approved thus far. Sold in Canada since 2017, the fish will be available commercially in the U.S. later this, year according to Aquabounty.

Their record stands for itself one approval, Sonstegard said.

But FDA wants to improve its process. It is touting its Veterinary Innovation Program, which Hahn said encourages development and research and supporting an efficient and predictable pathway to approval.

The latest developments on the animal biotech front were triggered by FDAs publication of a paper detailing its discovery of unintended alterations in the progeny of a gene-edited, hornless bull. That paper was published in Nature Biotechnology the same day as the commentary by FDAs Solomon.

The bull was developed by Recombinetics and its calves were monitored by Alison Van Eenennaam, who runs the Animal Genomics and Biotechnology Laboratory at UC-Davis.

Alison Van Eenennaam, UC-Davis

Van Eenennaam responded to the FDA paper and commentary by saying she was "disappointed that the FDA failed to mention that the genome-edited bulls and their offspring were followed for years by researchers at UC Davis and were hornless (polled) and healthy.

The unintended alteration, a plasmid, was not transmitted to half of the offspring, so in one generation there were animals with just the targeted edit, she said, then wondered why her explanation of the project, also published in Nature Biotechnologyback in October, was not referred to in FDAs analysis.

Alexis Norris, a bioinformatician in FDAs Division of Animal Bioengineering and Cellular Therapies, said there was no deliberate attempt to ignore Van Eenennaams paper. FDA submitted its paper to Nature Biotechnology before hers was released, she said. Hers was in revision when ours was submitted to Bio. It was just a timing issue.

Van Eenennaam has been critical of FDAs process. There is nothing fundamentally hazardous about genetic variation in food, and suggesting intentional alterations are equivalent to drugs will frighten consumers who might logically infer the presence of drugs in their food, she wrote on the Nature Research Bioengineering Community blog in a piece entitled Responsible Science Takes Time.

"It's just DNA, man," said Sonstegard.We eat it in every food except vegetable oil.

For more news, go to http://www.Agri-Pulse.com

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FDA on mission to explain its animal biotech approval process - Agri-Pulse

Puma Biotechnology to Participate in Panel Discussion at Citi’s Biotech Conference – Business Wire (press release)

LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder of Puma, will participate in a panel discussion on breast cancer at 9:00 a.m. EDT on Wednesday, September 6, at Citis 12th Annual Biotech Conference in Boston.

A live webcast of the panel discussion will be available on the Companys website at http://www.pumabiotechnology.com. The discussion will be archived on the website and available for 30 days.

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 candidates PB272 (neratinib (oral)), PB272 (neratinib (intravenous)) and PB357. NERLYNX (neratinib) is approved for commercial use by prescription in the United States as extended adjuvant therapy for early stage HER2-positive breast cancer following adjuvant trastuzumab-based therapy and is marketed as NERLYNX. 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 commercialization of NERLYNX and the continued development of its other advanced drug candidates directed at the treatment of HER2-positive breast cancer. The Company believes that NERLYNX has clinical application in the potential treatment of several other cancers that over-express or have a mutation in HER2.

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

Forward-Looking Statements

This press release and the webcast of the panel discussion contain forward-looking statements, including statements regarding the benefits of NERLYNX and neratinib, the Companys clinical trials and the announcement of data relative to those trials. All forward-looking statements involve risks and uncertainties that could cause the Companys 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 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 Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2017. 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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Puma Biotechnology to Participate in Panel Discussion at Citi's Biotech Conference - Business Wire (press release)

Plant Biology Conference | Plant Biotechnology Conference …

Past Conference Information

GlobalConference onPlant ScienceandMolecular Biology2017Report:

Magnus Grouptakes a great pride in declaring the GlobalConference on Plant Science and Molecular Biology (GPMB 2017) which was held in Valencia, Spain, during September 11-13, 2017.

Plant Science Conference 2017witnessed an amalgamation of outstanding speakers who enlightened the crowd with their knowledge and confabulated on various new-fangled topics related to the field of Plant Science and Molecular Biology. The extremely well-known conference hosted by Magnus Group was marked with the attendance of young and brilliant researchers, business delegates and talented student communities representing diverse countries around the world.

For GPMB 2017 Final Program:Click Here

The theme of the conference is Accentuate Innovations and Emerging Novel Research in Plant Sciences. The meeting captivated a vicinity of utilitarian discussions on novel subjects like Plant Physiology and Biochemistry, Plant Biotechnology, Plant Pathology: Mechanisms Of Disease, Applications In Plant Sciences And Plant Research, to mention a few. The three days event implanted a firm relation of upcoming strategies in the field of Plant Science and Molecular Biology with the scientific community. The conceptual and pertinent knowledge shared, will correspondingly foster organizational collaborations to nurture scientific accelerations.

For GPMB 2017 Gallery:Click Here

GPMB 2017Organizing Committee

Prof. Ammann Klaus, University of Bern, Switzerland

Prof. Leif Sundheim, Norwegian Institute of Bioeconomy Research, Norway

Prof. Cornelia Butler Flora, Kansas State University, USA

Dr. Monica Ruffini Castiglione, University of Pisa, Italy

Dr. Samir C. Debnath, St. Johns Research and Development Centre, Canada

The Organizing Committee would like to thank the moderatorsDr. Victoria A Piunova, IBM Almaden Research Center, United States, Dr. Selcuk Aslan, Max Planck Institute of Molecular Plant Physiology, Germany and Dr. Susan Yvonne Jaconis, CSIRO Agriculture, Australia for their contributions which ensued in smooth functioning of the conference.

The highlights of the conference were the keynote forum by prominent scientists,Prof. Klaus Ammann, University of Bern, Switzerland; Prof. Cornelia Butler Flora, Kansas State University, USA; Dr. Monica Ruffini Castiglione, University of Pisa, Italy; Prof. Leif Sundheim, Norwegian Institute of Bioeconomy Research, Norway; Dr. Samir C. Debnath, St. Johns Research and Development Centre, Canada; Dr. Goutam Gupta, Los Alamos National Laboratory, USA; Dr. Elena Rakosy-Tican, Babes-Bolyai University, Romania; Dr. Ivica Djalovic, Institute of Field and Vegetable Crops, Serbia; gave their fruitful contributions in the form of very informative presentations and made the conference a top notch one.

Magnus Groupis privileged to thank the Organizing Committee Members, Keynote speakers, Session chairs on transcribing the sessions, in a varied and variegate manner to make this conference a desirable artifact.

Speakers of GPMB 2017

Day 1: Speakers

Antonova Galina Feodosievna, VN Sukachev Institute of Forest Siberian Branch of Russian Academy of Sciences, Russian Federation

Cezary Piotr Sempruch, Siedlce University of Natural Sciences and Humanities, Poland

Ivan Paponov, Norwegian Institute of Bioeconomy Research, Norway

Malgorzata Adamiec, Adam Mickiewicz University, Institute of Experimental Biology, Poland

Michael Handford, Universidad de Chile, Chile

Natalia Repkina, Institute of Biology Karelian Research Centre of the Russian Academy of Sciences, Russia

Elide Formentin, University of Padova, Italy

Magdalena Opalinska, University of Wroclaw, Poland

Moses Kwame Aidoo, Ben-Gurion University of the Negev, Israel

Yuke He, Shanghai Institutes for Biological Sciences, China

Sameera Omar Bafeel, King Abdulaziz University, Science college, Saudi Arabia

Joerg Fettke, University of Potsdam, Germany

Siti Nor Akmar Abdullah, Universiti Putra Malaysia, Malaysia

Alberto Guillen Bas, University of Valencia, Spain

Carmen Quinonero Lopez, University of Copenhagen, Denmark

Laura Fattorini, Sapienza University of Rome, Italy

Meltem Bayraktar, Ahi Evran University, Turkey

Victoria Cristea, Babes-Bolyai University Cluj-Napoca, Romania

Selcuk Aslan, Max Planck Institute of Molecular Plant Physiology, Germany

Sofia Kourmpetli, Cranfield Soil and AgriFoodInstitute, UK

Seanna Hewitt, Washington State University, USA

Javier Terol Alcayde, Centro de Genomica, IVIA , Spain

Susan Yvonne Jaconis, CSIRO Agriculture, Australia

Magdalena Szechynska-Hebda, Institute of Plant Physiology, Polish Academy of Sciences, Australia

Acga Cheng, University of Malaya, Malaysia

Henrik Toft Simonsen, Technical University of Denmark, Denmark

Yeyun Xin, China National Hybrid Rice Research and Development Center, China

Sandhya Mehrotra, Birla Institute of Technology and Science Pilani, India

Gustavo Souza, Federal University of Pernambuco Bioscience Center, Brazil

Rachel Swee-Suak Ko, Academia Sinica, ABRC/BCST, Taiwan, Province of China

Yougasphree Naidoo, School of Life Sciences, South africa

Julian Witjaksono, The Assessment Institute for Agricultural Technology of Souhteast Sulawesi, Indonesia

Day-1 Posters

Lingling Shang, The Faculty of Agriculture and Food Sciences, Laval University, Canada

Nahaa Miqad Alotaibi, Swansea University, United Kingdom

Layla Al Hijab, West of England Universtiy, United Kingdom

Tomasz Goral, Plant Breeding and Acclimatization Institute NRI, Poland

Mikhail Oliveira Leastro, Instituto Biologico de Sao Paulo, Brazil

Michael Handford, Universidad de Chile, Chile

Polzella Antonella, University of Molise, Italy

Wisniewska Halina, Institute of Plant Genetics Polish Academy of Sciences, Poland

Costel Sarbu, Babes-Bolyai University Cluj-Napoca, Romania

Benjamin Dubois, Walloon Agricultural Research Center (CRA-W), Belgium

Sandra Cichorz, Plant Breeding and Acclimatization Institute - NRI, Poland

Elzbieta Kochanska-Czembor, Plant Breeding and Acclimatization Institute, Poland

Woo Taek Kim, Yonsei University, Republic of Korea

Prashanth Tamizhselvan, Masaryk University, CEITEC MU, Czech Republic

Yun Hee Kim, Gyeongsang National University, Republic of Korea

Nada Bezic, University of Split, Croatia

Havrlentova Michaela, Research Institute for Plant Productio, Slovakia

Seok Keun Cho, Yonsei University, Republic of Korea

Prasanna Angel Deva, Ben Gurion University of the Negev, Israel

Kebede Mesfin Haile, Kangwon National University, Korea

Lidia Kowalska, Plant Breeding and Acclimatization Institute, Poland

Motyleva Svetlana Mikhailivna, FSBSI ARHIBAN, Russian Federation

Paulina Drozdz, Forest Research Institute, Poland

Chul Han An, Korea Research Institute of Bioscience and Biotechnology, Republic of Korea

Jurga Jankauskiene, Nature Research Centre, Lithuania

Day 2: Speakers

Victoria A Piunova, IBM Almaden Research Center, United States

Miroslava Cuperlovic-Culf, National Research Council Canada, Canada

Paola Leonetti, IPSP-CNR, Italy

Giulia Chitarrini, Fondazione Edmund Mach, Italy

Antonio Domenech-Carbo, University of Valencia, Spain

Nurshafika Mohd Sakeh, Universiti Putra Malaysia, Malaysia

Adel Saleh Hussein Al-Abed, National Center for Agricultural Research and Extension, Jordan

Manju Sharma, Amity Institute of Biotechnology, India

Sergio Molinari, IPSP-CNR, Italy

Jaroslava Ovesna, Crop Research institute, czech Rpublic

John B. Carrigan, RebelBio SOSV, Ireland

Bardouki Haido, VIORYL S.A., Greece

Natalia Tomas Marques, Universidade do Algarve, Portugal

Azza M. Salama, Cairo University, Egypt

Chang-Yoon JI, University of Science & Technology, Korea

Kgabo Martha Pofu, Agricultural Research Council, South Africa

Siegfried Zerche, Leibniz-Institute of Vegetable- & Ornamental Crops, Germany

Piergiorgio Stevanato, University of Padova, Italy

Seong Wook Yang, Yonsei University, Republic of Korea

Alexander Hahn, Max Planck Institute for Biophysic, Germany

Klaus Harter, University of Tuebingen, Center for Plant Molecular Biology, Germany

Laigeng Li, Institute of Plant Physiology and Ecology, China

Thomas C Mueller, University of Tennessee, United States

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Plant Biology Conference | Plant Biotechnology Conference ...