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

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

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

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

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WSJ's Grant: In biotech, no news is bad news - Seeking Alpha

Somewhat Favorable Press Coverage Somewhat Unlikely to Affect … – The Cerbat Gem

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Somewhat Favorable Press Coverage Somewhat Unlikely to Affect ... - The Cerbat Gem

Zymeworks IPO bears good tidings for Canadian biotechnology – The Globe and Mail

A Toronto Stock Exchange (TSX) logo is seen in Toronto November 9, 2007. (Mark Blinch / Reuters) A Toronto Stock Exchange (TSX) logo is seen in Toronto November 9, 2007. (Mark Blinch / Reuters) Subscribers Only

Sean Silcoff

OTTAWAThe Globe and Mail

Published Sunday, Jun. 04, 2017 3:36PM EDT

Last updated Sunday, Jun. 04, 2017 3:39PM EDT

The Canadian biotechnology business is a picture of good health.

On Friday, management of Vancouver-based cancer therapy developer Zymeworks Inc. rang the bell on the Toronto Stock Exchange, five weeks after its stock debuted in a $59-million (U.S.) initial public offering in Canada and on the New York Stock Exchange. It was by far the largest biotech IPO on a Canadian exchange in a decade and came on the heels of one of the largest stock offerings ever by a Canadian biotech firm, after dual-listed lupus-drug developer Aurinia Pharmaceuticals Inc. raised $150.5-million in March.

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Forge Therapeutics Attracts Biotechnology Leaders To Join Expanded Board Of Directors – PR Newswire (press release)

"Forge is a very exciting, emerging life science company its novel platform and programs, its highly efficient business model, and its creative capitalization all attracted me to join the Board at such a pivotal time in the company's evolution," said John Schmid. "I look forward to providing strategic, operational and financial guidance to the management team in the coming years."

Dr. Worland added, "Multi-drug resistant bacteria 'superbugs' pose a very serious threat to human health and Forge's novel antibiotic program provides a promising solution to this global problem. I am honored to join the Forge Board and excited to work with its talented management team, advisors, and alliance and government partners as the company and technology platforms mature."

About the Forge Board of Directors

Forge's Board of Directors is a well-balanced composition of San Diego biotechnology industry veterans, global drug development experts and corporate finance leaders.

About Forge Therapeutics

Forge Therapeutics is a privately-held biopharmaceutical companydeveloping novel antibiotics to treat multi-drug resistant bacteria, or 'superbugs,' that have ignited a global health epidemic. With its proprietary chemistry approach, Forge develops small molecule inhibitors targeting metalloenzymes. Forge's lead effort is focused on LpxC, a zinc metalloenzyme found only in Gram-negative bacteria and which is essential for bacteria to grow. Forge has discovered novel small molecule inhibitors of LpxC that are potentin vitro, efficaciousin vivo, and effective against drug resistant Gram-negative bacteria 'superbugs.' To complement its innovative approach to drug discovery, Forge hasa capital efficient business model that utilizes a mix of non-dilutive and traditional funding sources to advance itsprograms, including LpxC. Forge has formed a strategic alliance with leading drug discovery alliance and development partnership company Evotec AG and has been awarded multiple government awards to address the global 'superbug' epidemic. In addition, Forge has amassed a rich intellectual property estate on metalloprotein inhibitors to protect its technology and pipeline. For further information, please visit the company's websitewww.ForgeTherapeutics.com and follow us on Twitter @ForgeThera.

Forge Company Contact:Info@ForgeTherapeutics.com

Forge Media Contact:Amy Conrad Juniper Point amy@juniper-point.com 858-366-3243

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/forge-therapeutics-attracts-biotechnology-leaders-to-join-expanded-board-of-directors-300458043.html

SOURCE Forge Therapeutics, Inc.

http://www.forgetherapeutics.com

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Forge Therapeutics Attracts Biotechnology Leaders To Join Expanded Board Of Directors - PR Newswire (press release)

Exploring the cloud laboratory: biotechnology and cloud computing – Information Age

Cloud computing within the biotech sector can take big data analysis to the next level by means of performance, connectivity, on-demand infrastructure and flexible provisioning

The continued drive for innovation puts immense pressure on IT departments to develop new technologies at speed, while also making sure that they do this cost effectively.

Add to this the fact that, more so than other industries, biotech firms are extremely tightly regulated. As a result, IT groups within this industry are often reluctant to introduce more complexity into what is already a very complex environment.

To them, expanding a data centre can often feel a whole lot easier than navigating the regulations of the cloud. Despite this, growth in the demand for cloud computing in life sciences research and development is escalating due to the benefits it brings to the industry benefits like exceeding regulatory requirements, for example.

iland haveworked with many companies in the healthcare, life sciences and biotech industries. Therefore, it knowsfrom experience that the implementation of cloud computing in biotechnology empowers organisations with the control and flexibility needed to lead the way in both the research world as well as the businesses world.

>See also:10 trends that will influence cloud computing in 2017

For example, ilandrecently worked with a US based biotechnology organisation on their backup and disaster recovery (DR) strategy, and were able to drive global data centre consolidation with host-based replication to the cloud. As a result, itsDR testing and auditing processes were greatly simplified and streamlined which drove significant cost savings as well as compliance assurance.

If you still need convincing here are three additional key benefits that cloud brings to biotech organisations.

When the Human Genome Project began it was one of the most extensive research projects in the field to date costing billions of pounds and lasting over a decade.

These days, thanks largely to cloud technology, it can be done in just 26 hours. Things such as drug R&D, clinical research as well as a whole host of other areas have benefited just as much from the rapid growth of computational power. The better your technology is at crunching huge sets of data, the quicker you can innovate.

Cloud computing within the biotech sector can take big data analysis to the next level by means of performance, connectivity, on-demand infrastructure and flexible provisioning.

Labs can also benefit from immense computing power without the cost and complexity of running big onsite server rooms. They can also scale up at will in order to make use of new research and ideas almost instantly.

Concerns have been voiced that so called scientific computing in the cloud may make results less reproducible. One concern is that cloud computing will be a computing black box that obscures details needed to accurately interpret the results of computational analyses.

>See also:How cloud computing can transform the pharmaceutical industry

In actual fact, by leveraging the application program interfaces (APIs) in the iland cloud, biotech customers are able to integrate cloud data back into on-premises IT systems to ensure that data analyses done in the cloud can be easily shared and consumed by other applications.

Essentially, cloud computing services bring more players to the table to solve the giant puzzle. Its a win-win situation from an economic and patient standpoint, and several big name companies are jumping on the biotech cloud bandwagon.

Biotech companies need to maintain strong access and authentication controls, while also being able to collaborate easily. For this reason audit trails and other measures are often required to verify that information has not been improperly altered, and that good experimental and manufacturing procedures have been followed.

At the same time bio-technologists need to be able to access and share data across multiple departments or even multiple companies.

Cloud computing in biotechnology makes this all possible it centralises data, ensuring security and data sovereignty while facilitating collaboration.

It supports extensive user and role based access control, two-factor authentication and integrity monitoring to prevent improper access and changes. In addition to data encryption, vulnerability scanning and intrusion detection, these measures facilitate security and compliance, without disrupting the internal workflow.

Complex regulatory requirements and logistics combined with niche markets make efficiency paramount within biotechnology. Even minor mistakes as a result of sloppy process management can easily result in major issues.

Real-time operational reporting dramatically improves efficiency, quality control and decision making, allowing organisations to react instantly to challenges and opportunities, both internal and external.

>See also:Managed cloud: making the most out of public cloud computing

As well as enhanced billing visibility and resource management functions, the release of the vendors secure cloud services means that the itscloud now includes on-demand security and compliance reports.

This advanced cloud management functionality is designed to foster strategic, self-sufficient control of a cloud environment, optimising overall cloud usage and costs to drive business initiatives and growth.

Without a shadow of a doubt, cloud technology can help biotechnology companies build the future. From research and development to marketing, computing affects everything an organisation does.

Sourced by Monica Brink, director of marketing, iland

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Late-Breaking Abstract on LB-100, Lixte Biotechnology’s Protein Phosphatase 2A Inhibitor, in Combination with a PD-1 … – Benzinga

EAST SETAUKET, NY--(Marketwired - Mar 9, 2017) - Lixte Biotechnology Holdings, Inc. (OTCQB: LIXT) announced that a late-breaking abstract entitled "Protein phosphatase 2A inhibition with a novel small molecule inhibitor, LB-100, achieves durable immune-mediated antitumor activity when combined with PD-1 blockade in a preclinical model" has been accepted for presentation as a poster (abstract number LB-193) at the American Association for Cancer Research Annual Meeting 2017 in Washington, DC on April 4th.

Dr. John S. Kovach, Founder and CEO of Lixte, said, "The new preclinical research studies were done by Lixte and scientists at the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), under a Cooperative Research and Development Agreement." Dr. Kovach continued, "LB-100 used alone has recently completed a Phase 1 trial in patients with advanced cancer (Chung 2016)."

About Lixte Biotechnology Holdings, Inc.

Lixte is a drug discovery company that uses biomarker technology to identify enzyme targets associated with serious common diseases and then design novel compounds to attack those targets. Lixte's product pipeline encompasses two major categories of compounds at various stages of pre-clinical and clinical development that the Company believes have broad therapeutic potential not only for cancer but also for other debilitating and life-threatening diseases.

Forward-Looking Statements

This announcement contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, and Section 21E of the Securities Exchange Act of 1934. For example, statements regarding the Company's financial position, business strategy and other plans and objectives for future operations, and assumptions and predictions about future product demand, supply, manufacturing, costs, marketing and pricing factors are all forward-looking statements. These statements are generally accompanied by words such as "intend," anticipate," "believe," "estimate," "potential(ly)," "continue," "forecast," "predict," "plan," "may," "will," "could," "would," "should," "expect" or the negative of such terms or other comparable terminology. The Company believes that the assumptions and expectations reflected in such forward-looking statements are reasonable, based on information available to it on the date hereof, but the Company cannot provide assurances that these assumptions and expectations will prove to have been correct or that the Company will take any action that the Company may presently be planning. However, these forward-looking statements are inherently subject to known and unknown risks and uncertainties. Actual results or experience may differ materially from those expected or anticipated in the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, regulatory policies, available cash, research results, competition from other similar businesses, and market and general economic factors. This discussion should be read in conjunction with the Company's filings with the United States Securities and Exchange Commission at http://www.sec.gov/edgar.shtml.

Additional information on the Company is available at http://www.lixte.com.

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Puma Biotechnology Inc (PBYI) Moves Higher on Volume Spike for March 17 – Equities.com

Market Summary Follow

Puma Biotechnology Inc is a A biopharmaceutical company

PBYI - Market Data & News

PBYI - Stock Valuation Report

Puma Biotechnology Inc (PBYI) traded on unusually high volume on Mar. 17, as the stock gained 0.91% to close at $44.15. On the day, Puma Biotechnology Inc saw 2.2 million shares trade hands on 7,459 trades. Considering that the stock averages only a daily volume of 1.19 million shares a day over the last month, this represents a pretty significant bump in volume over the norm.

Generally speaking, when a stock experiences a sudden spike in trading volume, it may be seen as a bullish signal for investors. An increase in volume means more market awareness for the company, potentially setting up a more meaningful move in stock price. The added volume also provides a level of support and stability for price advances.

The stock has traded between $73.27 and $19.74 over the last 52-weeks, its 50-day SMA is now $35.79, and its 200-day SMA $42.49. Puma Biotechnology Inc has a P/B ratio of 7.77.

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

Headquartered in Los Angeles, CA, Puma Biotechnology Inc has 160 employees and is currently under the leadership of CEO Alan H. Auerbach.

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

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

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

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

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

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Puma Biotechnology to Present at Cowen’s Health Care 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 provide an overview of the Company at 3:20 p.m. EST on Monday, March 6, at the Cowen and Company 37th Annual Health Care Conference. The conference will be held at the Boston Marriott Copley Place.

A live webcast of the presentation will be available on the Companys website at http://www.pumabiotechnology.com. The presentation 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 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.

Forward-Looking Statements:

This press release contains forward-looking statements that 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 risk factors disclosed in the periodic reports filed by the Company with the Securities and Exchange Commission from time to time. 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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Why Puma Biotechnology Inc. Got Hammered Today – Madison.com

What happened

Puma Biotechnology (NASDAQ: PBYI) ended the day down 13.8% after Roche (NASDAQOTH: RHHBY) reported that its rival breast cancer drug, Perjeta, had passed its phase 3 trial, dubbed "Aphinity."

Image source: Getty Images.

In Roche's trial, patients either took Perjeta and Herceptin with chemotherapy or just Herceptin with chemotherapy, and then took Perjeta and Herceptin, or just Herceptin, for an additional year. Roche didn't release the full data from the clinical trial, but it did say the triple combination reduced the risk of recurrence of invasive disease or death compared to Herceptin and chemotherapy alone.

The potential to establish a new standard of care where patients take Herceptin and Perjeta for a year could be problematic for Puma Biotechnology because its drug candidate, neratinib, was tested after just Herceptin use, the current standard of care.

Without any data, doctors will likely wonder whether neratinib helps patients that have received Herceptin and Perjeta. And the relapse rate for patients on the current standard of care is already quite low; if adding Perjeta decreases it further, doctors and their patients may decide taking another drug after that isn't worth it, especially given neratinib's side-effect profile.

Investors will have to wait for the full data from Aphinity -- perhaps at the American Society of Clinical Oncology meeting in June -- to know how much better Herceptin plus Perjeta is than Herceptin alone, and how that might affect neratinib's sales, assuming it's approved later this year.

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Maastricht, the Netherlands, Selected to Host European Congress on Biotechnology 2020 – Exhibitor Online

2/16/2017 The Executive Board of the European Federation of Biotechnology has selected Maastricht as the host city for their flagship congress from 28 June 1 July, 2020. The European Congress on Biotechnology is the longest established congress in biotechnology and attracts 1,000+ delegates from academia and industry. The scientific programme covers the spectrum of biotechnologies, reflecting the EFBs mission to promote the safe, sustainable and ethical use of biological systems for the benefit of mankind.

Jeff Cole, Vice President, EFB and Chair of the Congress Organising Committee, announced the win for Maastricht, saying Following a competitive process, we are delighted to confirm Maastricht as our host destination for ECB 2020. We were particularly impressed with the Local Organising Committee members from the Dutch Biotechnology Society who have committed their time and connections to ensure we have an outstanding scientific programme and the essential support of industry. The strength of Maastricht as a biotechnology hub will undoubtedly be an attraction for our delegates.

Caroline Windsor, TFI Group - professional conference organiser for the EFB added Maastricht is a superb location for ECB 2020. The MECC lends itself to our congress requirements including integrated space for exhibition, posters and catering as well as multiple auditoria for concurrent sessions. The city is compact with a good choice of hotels and social programme venues for networking out of conference hours.

The bid was led by Jurgen Moors, Managing Director, Maastricht Convention Bureau and Jordy Rijksen, Business Development Manager, Maastricht MECC. They reacted to the news by saying On behalf of the city of Maastricht and the Maastricht Convention Bureau we can state we are pleased to hear that Maastricht has officially been selected as destination for the 2020 edition of the ECB. This underlines that everything our city has to offer, the proactive local congress community and the fact that the Maastricht Region is internally recognised as a main European hub in the field of biotechnology were main decisive criteria for the Executive Board of the European Federation of Biotechnology.

The scientific ambassadors for the bid, Prof. Aldrik Velders, Chair of the BioNanoTechnology Group at Wageningen University, and Dr Emile van de Sandt, Director Research & Development of DSM Sinochem Pharmaceuticals, added The Dutch Society of Biotechnology is very pleased to host the ECB2020. With our strong academic and industrial network we are looking forward to organising an inspiring conference that will bring together scientists from all over Europe that are active in the more established as well as emerging fields of Biotechnology.

The biennial European Congress on Biotechnology circulates to cities that are centres of excellence in biotechnology. The ECB2018 congress will be in Geneva from 1 4 July 2018: for more information, see http://www.ecb2018.com.

The Maastricht Convention Bureau is the intermediary to promote convention and meeting visits to Maastricht and surroundings. Our goal is to make a structural contribution to the economic development of Maastricht and surroundings. The Maastricht Convention Bureau office is situated in building where the offices of MECC Maastricht are located as well. The complete address details are: Maastricht Convention Bureau | Duboisdomein 5b | 6229 GT MAASTRICHT | THE NETHERLANDS

Contact: info@maastrichtconventionbureau.com

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Maastricht, the Netherlands, Selected to Host European Congress on Biotechnology 2020 - Exhibitor Online

When Celebrity And Science Collide: Hollywood And The Anti … – Genetic Literacy Project

Julie Kelly, cooking instructor, food writer, blogger and a Mom who lives in the Chicago area. In 2015, she got passionate about GMOs. Kelly is a contributing writer to the Wall Street Journal, National Review, Huffington Post, The Hill and other media outlets.| March 2, 2017

HIGHLIGHTS:

Hollywood is in our homes daily,often spreading misconceptions about science, and GE crops in particular Gary Hirshberg, founder of Stonyfield Organic and Just Label It, is the key celebrity organizer Gwyneth Paltrow has emerged as the face of celebrity moms who question the safety of GE foods Mark Ruffalo questions GE foods but also rejects biotechnological solutions beyond food, such as the gene-edited mosquito that could curtail the Zika virus Celebrity misinformation campaigns have filled a void created by the agricultural and food industries, which have been reticent to defend the science of biotechnology While the Internet and social media are valuable tools for disseminating information about complicated subjects like science and agriculture, it has also given rise to a modern-day monster: the expert celebrity From movie stars to television chefs, a cadre of self-promoting yet often ill-informed celebrities are influencing the public discussion about topics way beyond their expertise, particularly consequential issueslike vaccines and biotechnology

The explosive growth of cable television and more recently of the Internet has led to a celebrication of everyday lifeHollywood has invaded our homes in an oddly intimate way. Celebrities have long weighed in on public issues, which is okay if the issue is what clothes to wear next season, but science is different: it actually can impact peoples lives.

If Big Bang star Mayim Bialik talks about Zikas impact on the brain, we might be interested because she has a PhD in neurosurgeryshe has genuine credentials. But science-educated stars are few and far between. For example, campaigns led by Robert Kennedy, Jr., reality TV star Jenny McCarthy and her former husband Jim Carrey and flip comments by Bill Maher have convinced a lot of credulous fans to forgo getting their kids vaccinated the lowest vaccination rates in the country are in the swanky Hollywood suburban playgrounds. And thats just one of many misguided celebrity-driven campaigns.

Celebrities may have any number of motives for injecting themselves into the middle of debates over controversial, scientific issues. Ego, for example. Its a way to get publicity for themselves (McCarthy is more known now for her anti-vaccine activism than for her acting.) And as we know, stars are eager to follow the cause du jour. It is science-as-fashion.

While some people wisely ignore celebrity advice, their ill-informed and selectively ignorant comments can sway public opinion in destructive ways. Thats whats happening in the ongoing debate over our food and farming systems. In the last few years, movies such as Consumed and GMO OMG have fueled misperceptions about genetic engineering. And celebrity chefs such as Tom Colicchio have joined the fray, partnering with other anti-GMO chefs in a Facebook page, Chefs Against GMOs, and making appeals in Washington and on TV shows. But Hollywood is where anti-GMO groups draw their most visible campaigners.

A slew of Hollywood celebrities, have lent their names to one anti-GMO or pro-labeling campaign or another, among them a fading generation of actors and musicians: Morgan Freeman, Paul McCartney, Dave Mathews, Danny DeVito, Woody Harrelson and Neil Young, to name just a few. But there are some younger faces who have lobbied hard against modern agriculture, mostly B-list actresses, with Gwyneth Paltrow the most prominent. They rail against GMOs in an effort to persuade consumers our food system is hopelessly broken, and that crop biotechnology is scary, unnatural and part of a corporate conspiracy to control the worlds food supply. Its easily dismissible nonsense to those who know the consensus science, but their distortions have consequences outside of clickbait headlines.

Paltrow has emerged as the face of the anti-GMO movement over the last few years. Its unclear exactly how or why she decided to take up this cause except that she has worked closely with one of the most powerful figures in the organic movement, Gary Hirshberg, founder of Stonyfield Organic, who also started Just Label It, which has campaigned for mandatory labels. Just Label it and the organic industry in general have spent hundreds of millions of dollars in recent years to demonize conventional agriculture and mislead consumers into thinking organic food is healthier, safer and more nutritious than conventional food.

Although state-of-the-art meta studies conclude there are no meaningful differences, and some research shows organic farming is more stressful on the environment than farming using advanced technology including genetically engineered crops, organic companies peddle that narrative in hopes of driving consumers toward their pricier products. As the self-appointed priestess of all that is healthy and good in the world, Paltrow promotes organic food, which is by definition non-GMO.

Hirshberg has fueled and funded anti-GMO advocacy under the guise of promoting mandatory GMO labels. He has organized several anti-GMO groups, and has used celebrities like Paltrow to push his agenda. At his invitation, Paltrow was featured at a press conference on Capitol Hill in August 2015 to voice her support for mandatory GMO labeling. A bill the organic industry opposed had just passed in the House, and Paltrow wanted to use her powers of persuasion to stop the bill from advancing in the Senate:

Im not here as an expert, Im here as a mom who honestly believes I have the right to know whats in the food I feed my family. And we dont even know, the science is still inconclusive about GMOs, there are arguments they could possibly be harmful and there are arguments that they could be incredibly beneficial. But at this point, we just dont know.

The presser echoed widely on social media, but most disturbingly, her comments were reported uncritically by major media sites, giving her credibility on an issue she did not deserve.

Here is where Paltrow is wrong. We do know that GMOs are safe. They hold tremendous potential and promise to alleviate global hunger now and into the future as food demands are expected to nearly double by 2050.Nearly every major independent scientific organization and governmental agency in the world, including most recently the National Academies of Sciences, Engineering and Medicine (NAS), have affirmed that genetically engineered crops and food are just as healthy and environmentally safe as other conventionally grown foods, including organic. American farmers have been using genetically modified seeds for 20 years and most of the corn, soy, cotton and sugarbeets grown are from those seeds. This has cut down on the use of pesticides (since some of those crops have been developed to include natural pesticides already used by organic farmers), which has reduced crop losses and increased yield, a huge boon to both farmers and consumers.

In its analysis of the GMO controversy, the NAS also noted several problems with mandatory labeling, such as higher costs to consumers and the probability that companies might eliminate genetically engineered ingredients in order to avoid labels. The report also outlined several crops that can only be achieved through genetic engineering that boost nutrients, withstand climate challenges and resist crop diseases. Promising new crops in the pipeline include nutritionally enhanced rice and bananas and disease-resistant cassava, a plant that hundreds of millions depend on every day. So, its galling for an ultra-rich celebrity to spread falsehoods about a technology that can feed and fortify the diets of hundreds of millions of poor people around the world.

That wasnt the last we heard from Paltrow. In April 2016, she made a brief cameo in a video sponsored by Just Label It (with Hirshberg taking a star turn) entitled GMO Transparency in the Real World. A harried mother attempts to use her smart phone to scan a QR code on a can of soup to see if the soup contains GMOs (QR codes are anathema to the pro-GMO labeling crowd). As she stumbles to use her smart phone, and her kids smash a watermelon in the aisle, a fresh-faced Paltrow appears from the dairy aisle, asking the distraught mom if she has a scanner on her smart phone that she could use.

Paltrow isnt the only actress to play the Im not an activist, Im a mom card. Around Mothers Day 2015, several B-list mom-actresses appeared in a Moms Against GMOs video produced by another Hirshberg group to talk about GMOs, including Sarah Michelle Gellar, The Talks Sarah Gilbert, UnREALs Constance Zimmer, Once Upon a Times Ginnifer Goodwin, Furious 7s Jordana Brewster, The Biggest Losers Jillian Michaels, Mariel Hemingway and Sharon Osbourne. They pledged to protect their little ones from the dangers of GMOs: This Mothers Day, give moms the right to know whats in the food we feed our kids. Tell the FDA to require GMO labeling.

These actresses are now part of a coordinated, calculated attack on American agriculture and an attempt to stop millions of farmers from using technological tools necessary for their livelihood and Americas food security. They are part of a destructive campaign to hurt American farmers and our overall agricultural and food system.

Since a bill requiring mandatory GMO labels passed Congress and was signed into law by President Obama in August 2016, the GMO labeling groups have been more forthcoming about their true motives. Anti-GMO activist and Institute for Responsible Technology founder Jeffrey Smith, who makes regular appearances on Dr. Oz and other celebrity-type shows, acknowledged their real agenda:

Labeling GMOs was never the end goal for us. It was a tactic. Labels make it easier for shoppers to make healthier non-GMO choices. When enough people avoid GMOs, food companies rush to eliminate them. Labeling can speed up that tipping pointbut only if consumers are motivated to use labels to avoid GMOs.

Some celebrities brazenly profit by spreading misinformation about biotechnology. Jessica Alba parlayed her fame into selling organic, non-GMO products as part owner of The Honest Company. She boasts about the naturality of her products, from organic baby formulameticulously blended using non-GMO, naturally derived, organicto organic tampons to non-GMO lip balm. Many items brandish a non-GMO label. Alba explains her healthy eating habits as trying to have the least amount of GMOs and pesticides you have energy, arent starving and dont have to count calories.

Actor and progressive environmental activist Mark Ruffalo, who does not have a college education, has embraced any number of controversial causes, from fracking to GMOs, where the science is contested. He became a rock star in the anti-GMO community, even confronting Monsanto CEO Hugh Grant in a CBS green room rant before a joint TV appearance and later bragging about it.

You are wrong, he lectured Grant. You are engaged in monopolizing food. You are poisoning people. You are killing small farms. You are killing bees. What you are doing is dead wrong. Its the horrible stuff you guys do that makes you and your company horrible. People like you and your company are horrible because you are horrible.

He has more than 2 million followers on Twitterthats scary. His obsession to demonize genetic engineering took a bizarre turn earlier this year when he started tweeting that the Zika virus was caused by a chemical manufactured by an obscure Japanese company that has a research pact with Monsanto, the bete noire of anti-GMO activists. By doing so, he deflects attention from what experts now say is the only feasible solution to containing Zikathe release of genetically engineered sterile mosquitoes to drive out the poison-carrying ones.

Chef Attack

Many celebrity chefs have taken up the anti-GMO crusade, apparently believing their ability to run a restaurant or cook on television gives them special insight into how food is grown on a farm. Tom Colicchio, the star of Bravos Top Chef program, gathered signatures of more than 4,000 chefs on a petition he delivered to Capitol Hill in March 2016 demanding mandatory GMO labels and rejecting a Senate bill that would have made the labels voluntary.

He claims he only supports the right to know. But his twitter feed is filled with anti-GMO propaganda and like most activists in the GMO labeling movement, he is also broadly against the technology. In a December 2015 op-ed in the New York Times entitled, Are you eating Frankenfish? Colicchio warned readers that the newly approved GE fast-growing salmon could escape enclosed tanks and endanger native speciesclaims multiple US and Canadian regulators have reviewed and rejected as untrue. Colicchio has also come out in opposition to insect-resistant eggplant, grown with government developed seeds distributed free to farmers in Bangladesh, which has reduced the spraying of dangerous chemicals by 85 percent.

Why are celebrities getting so much traction in their campaign against GMOs? They are filling an information void left by the scientific and agricultural communities. Scientists are reluctant to engage the public, either out of trepidation or arrogance, convinced that science will win the day. Infighting has plagued the science communications effort as leaders dispute the best way to fight misinformation from people like Paltrow and Ruffalo.

Some want to take a submissive approach and others want to fight fire with fire. The agricultural community and companies that benefit from genetic engineering arent standing up to defend the technology, either.

While science and farming communicators struggle with how to best educate consumers and the media, organic executives and celebrities are defining the narrative on GMOs. This is not without serious ramifications if we turn away from genetically modified crops. Food prices will rise and farmers will be forced to use more insecticide and more toxic herbicides. Its wonderful to celebrate the performances of TV, movie and music celebrities, but their opinions on science issues are no more relevantnow than they were when they were waiting tables in Hollywood and Nashville looking for a break. Hit the mute button when they start opining on serious policy issues that have considerable consequences for vulnerable people around the world.

Julie Kelly is a cooking instructor, food writer, blogger and mother of two who lives in the Chicago area. In 2015, she got passionate about GMOs. Kelly is a contributing writer to the Wall Street Journal, National Review, Huffington Post and other media outlets.

The Genetic Literacy Project is a 501(c)(3) non profit dedicated to helping the public, journalists, policy makers and scientists better communicate the advances and ethical and technological challenges ushered in by the biotechnology and genetics revolution, addressing both human genetics and food and farming. We are one of two websites overseen by the Science Literacy Project; our sister site, the Epigenetics Literacy Project, addresses the challenges surrounding emerging data-rich technologies.

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When Celebrity And Science Collide: Hollywood And The Anti ... - Genetic Literacy Project

The biotechnology trial of the century over CRISPR patent settled in US court – NEWS.com.au

CRISPR is a life-changing genetic modification technology that could potentially cure cancer and eradicate genetic conditions before a child is born. But there is a dark side to the potential of this technology.

The patent dispute over CRISPR technology has been settled.

AN INFLUENTIAL US science advisory committee this week said genetic modification of human embryos should be allowed in the future to eliminate diseases, sparking new debate on a controversial topic.

The report by the National Academy of Sciences (NAS) caused concern among some researchers who fear that genetic tools could be used to boost certain peoples intelligence or create people with particular physical traits.

Clinical trials for genome editing of the human germ line adding, removing or replacing DNA base pairs in gametes or early embryos could be permitted in the future, said the report, released Wednesday (AEST).

But only, it added, for serious conditions under stringent oversight.

The emergence of inexpensive and accurate gene-editing technology, known as CRISPR/Cas9, has fuelled an explosion of new research opportunities and potential clinical applications, both heritable and non-heritable, to address a wide range of human health issues, the report said.

The committee of international experts was convened to examine scientific, ethical and governance issues surrounding human genome editing.

The experts noted that clinical trials on gene editing for certain non-hereditary traits are already under way.

These therapies affect only the patient, not any offspring, and should continue for treatment and prevention of disease and disability, using the existing ethical norms and regulatory framework for development of gene therapy, it said.

There is plenty of concern about the designer human floodgates opening.Source:YouTube

The warning come as a major patent battle over the technology was settled in the US in recent days.

What many described as the biotechnology trial of the century, the Broad Institute won the patent to the popular gene-editing process known as CRISPR/Cas-9.

The legal battle over who really invented the technology pitted Feng Zhang of the Broad Institute a research facility affiliated with Harvard University and the Massachusetts Institute of Technology against French microbiologist Emmanuelle Charpentier of the Max Planck Institute in Berlin and biochemist Jennifer Doudna of the University of California, Berkeley.

Both sides claimed to have developed CRISPR-Cas9, which allows scientists to edit stretches of the genome by removing, adding or changing pieces of the DNA sequence.

Jennifer Doudna of UC Berkeley ultimately lost out in the dispute.Source:Getty Images

Scientists say the technology has the potential to cure diseases but also raises ethical questions, particularly when it comes to the prospect of forever altering the human race.

Charpentier and Doudna have won multiple prizes in the past four years and were widely considered to have discovered this gene-editing technique. Their work was first published in the journal Science in June 2012.

This important decision affirms the inventiveness of the Broads work in translating the biology of the natural world into fundamental building blocks to create unprecedented medicines, said a statement by Katrine Bosley, president and chief executive officer of Editas Medicine, which has an exclusive licence on the Broad Institutes patent for human-therapy applications.

The Atlantic magazine described Editas Medicine as the biggest winner.

Assuming the patent decision does not change, Editas will be the major player in human CRISPR therapies in the foreseeable future, it said.

Follow three people who hope the mapping of the human genome will transform their lives. Will the Human Genome Project change our relationship with ourselves forever?

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The biotechnology trial of the century over CRISPR patent settled in US court - NEWS.com.au

Biotech 2020 and the decade of the bioeconomy – SynBioBeta

I spend my time focused on leveraging biotechnology for the public good, and Im ecstatic about what well see in the coming years. Biotechnology is advancing at an unprecedented rate, and engineered biology, commonly referred to as synthetic biology (SynBio), is taking the world by storm. The past 12 months have seen a major focus on the bioeconomy, the economy based on biology and biotechnology. It promises to be integral to the next decade of growth and opportunity. Its hard to imagine that artificial intelligence has only been in resurgence since 2012 less than ten years. But as AI impacts the digital world, biotechnology impacts the physical world, and over the next decade, well see innovations that rival, or even outpace, AI.

If youre not well versed in biotechnology, it helps to understand the context were in. For thousands of years, weve had physical solutions to our problems. I have a heavy rock that needs to get from point A to point B, so I push it, pull it, or roll it. Then, during the industrial revolution, we developed industrial synthetic chemistry.For the last 100 to 150 years, we have combined physical and chemical technologies to accelerate the economy and the quality of life for people around the world.

Biotechnology adds an entirely new dimension of technology development in the bioeconomy

Now were in a new industrial revolution, bringing the bioeconomy to the forefront of technology and economic growth where were combining biotechnology with chemical and physical technologies to revolutionize the world.

Were combining biotechnology with chemical and physical technologies to revolutionize the world.

The bioeconomy is not a new concept. The U.S. has a robust bioeconomy in healthcare and agriculture and is a global leader in emerging biotechnologies. Its these emerging applications in engineered biology, however, that will drive the next wave of growth in the bioeconomy over the next decade. Just in 2019, weve seen scientists and engineers createnew therapies to incurable infectionsandways to make plants grow in soil that should be too salty. In recent years, the private sector and the government have partnered toadvance regenerative manufacturingandbiopharmaceutical development.

MIT scientists have figured out how to make plants grow in soil that should be too salty Fast Company

Innovations like these in the bioeconomy will increasingly be driven by our ability toleverage synthetic biology and other forms of engineered biology to change the paradigmof how we think about the life sciences.

While biotechnology and bioeconomy have enjoyed major growth over the past decade, in the last 12 months, the bioeconomy has become a central topic in academia, industry, and government. Recognizing the strategic advantage that leadership in biotechnology represents, 2019 saw the launch of theU.S. Promote and Protect the Bioeconomy initiativeas well as theDepartment of Defense establishing biotechnology as an enterprise modernization priority(BIO).

Biotech experts gather at the White House for Summit on Americas Bioeconomy GeekWire

Just in the past month, weve seen theEngineering Biology Research and Development Act of 2019 passed in the House and moved into the Senate for consideration.The DoD released a notice of intent to stand up a synthetic biology manufacturing innovation institute, commonly referred to as SynBio MII. The SynBio MII, like the two partner institutes already running, ARMI and NIIMBL, will accelerate the U.S. biomanufacturing industry in support of the bioeconomy.

Its the combination of a strong private sector, and federal government funding for research and development in this sector, that will drive the next decade of bioeconomy growth.

As exciting as new technology is, these advances rarely come without ethical and societal implications to misuse. In the last year, weve seen the overstep of biotechnology use with the Chinese and Russian application of human genome editing despite an international call for a moratorium on human genome editing. In addition, in the past year, the New York Times has reported extensively on Chinas misuse of genetic information and artificial intelligence to target minority populations. And at the end of the decade, the Department of Defense in December 2019 warned its service members against using at-home DNA kits.

As we stand on the edge of the next decade, two things have become clear. First, just as graphical processing units revolutionized our ability to do AI at-scale, the next decade will see unprecedented advances in biomanufacturing and our ability to produce new products at-scale in a global market. We will advance in our ability to manufacture and process large quantities of new products in faster and faster development cycles.

The second is that we need the U.S. to go all-in on biotechnology. There is no doubt our competitors see biotechnology as the future of global leadership. Chinas Made in China 2025 has put biotechnology at the heart of the initiative. If we are to have a globally leading bioeconomy, then we need everyone on board.

We need policymakers to pass legislation to bolster the bioeconomy and incentivize the growth of companies in the industry. This means we need new policies in economics, education, and workforce development. We need industry leaders to recognize this is no longer a technology just for watching, and the future of your company depends on your ability to adapt and capitalize on the future bioeconomy. We need scientists and engineers to bring hard technical skills to the field and finish the job of making biology a true engineering discipline. We need influencers, celebrities, and those in the spotlight to voice your support in revolutionizing the world. But most importantly, we need the consumer, thats you and me, to vote with our dollars and show that biotechnology is not just an interesting advance in technology, but mandatory to our future and our vitality.

The views expressed here are of Alexanders own and do not represent the official views of the Department of Defense or the U.S. government.

Originally published on https://alexandertitus.com/2019/12/30/biotechnology-2020-and-the-decade-of-the-bioeconomy/

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Biotech 2020 and the decade of the bioeconomy - SynBioBeta

Health News – 2016 Science and Medicine Articles

Published in Health December 19, 2016

December 19, 2016 | article

f you're In the hospital, the gender of your doctor may matter.

Published in Health December 19, 2016

December 19, 2016 | article

Nearly 50 people died recently in a Siberian city after they drank bath oil as a substitute for alcohol. But why was the substance so deadly?

Published in Health December 19, 2016

December 19, 2016 | article

Marijuana use among pregnant women in the U.S. increased by 62 percent from 2002 to 2014, a new study finds.

Published in Health December 17, 2016

December 17, 2016 | video

The body breaks fat down after it runs out of another energy source, sugar.

Published in Health December 16, 2016

December 16, 2016 | article

Six people in Colorado recently became infected with a "nightmare" superbug that until now, has mostly been limited to people in hospitals.

Published in Health December 16, 2016

December 16, 2016 | article

At your next doctor's exam, one thing will be certain: Your physician won't be using powdered medical gloves.

Published in Health December 15, 2016

December 15, 2016 | article

There may be a way to tap into people's brain activity to boost their confidence, a new study suggests.

Published in Health December 15, 2016

December 15, 2016 | article

Abortions don't harm women's mental health, but being denied access to one might, a new study finds.

Published in Health December 15, 2016

December 15, 2016 | article

Scientists have found a way to turn back the clock on cells, and mice given the treatment looked younger and had a longer lifespan.

Published in Health December 15, 2016

December 15, 2016 | article

Someday, a mother-to-be may be able to put on a virtual reality headset and get a clear, 360-degree look at her own fetus in the womb.

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Health News - 2016 Science and Medicine Articles

PDS Biotechnology to Present at the 12th Annual LD Micro Main Event – BioSpace

PRINCETON, N.J., Dec. 03, 2019 (GLOBE NEWSWIRE) -- PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical stage immuno-oncology company with a broad pipeline of novel products based on the companys proprietary Versamune T-cell activating technology, today announced that Dr. Frank Bedu-Addo, President and Chief Executive Officer, is scheduled to present the company's upcoming clinical trials and recent clinical data demonstrating the potential of the Versamune-based products to overcome key limitations of current cancer immunotherapy at the 12th Annual LD Micro Main Event being held on December 10-12, 2019 at the Luxe Sunset Boulevard Hotel in Los Angeles, CA.

Event: 12th Annual LD Micro Main EventFormat: Presentation & 1x1 MeetingsDate: Wednesday, December 11, 2019Time: 1:40pm PTLocation: Luxe Sunset Boulevard Hotel, Los Angeles, CA: Track 3

About PDS Biotechnology

PDS Biotechnology is a clinical-stage immuno-oncology company with a broad pipeline of novel products based on the companys proprietary Versamune T-cell activating technology. The Versamune platform effectively delivers tumor-specific antigens for in-vivo uptake and processing, while also activating a critical immunological pathway, the type 1 interferon pathway, thus resulting in the production of potent tumor-specific killer T-cells. Using Versamune, PDS Biotechnology is engineering therapies designed to better recognize cancer cells and break down their defense systems to effectively attack and destroy tumors. PDS Biotechnologys pipeline combines the Versamune technology with tumor-specific antigens across several cancer types. To learn more, please visit http://www.pdsbiotech.com or follow us on Twitter @pdsbiotech.

Forward Looking StatementsThis communication contains forward-looking statements (including within the meaning of Section 21E of the United States Securities Exchange Act of 1934, as amended, and Section 27A of the United States Securities Act of 1933, as amended) concerning PDS Biotechnology Corporation (the Company) and other matters. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the Companys management, as well as assumptions made by, and information currently available to, management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as may, will, should, would, expect, anticipate, plan, likely,believe,estimate,project,intend,and other similar expressions among others. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability of the Company to integrate Edge and PDS Biotechnology following the merger; the Companys ability to protect its intellectual property rights; competitive responses to the completion of the merger; potential adverse reactions or changes to business relationships resulting from the completion of the merger;the Companys anticipated capital requirements, including the Companys anticipated cash runway and the Companys current expectations regarding its plans for future equity financings; the timing for the Company or its partners to initiate the planned clinical trials for its lead assets, PDS0101 and PDS0102; the Companys interpretation of the results of its Phase 1 trial for PDS0101 and whether such results are sufficient to support additional trials or the future success of such trials;the successful implementation of the Companys research and development programs and collaborations, including any collaboration studies concerning PDS0101 and the Companys interpretation of the results and findings of such programs and collaborations and whether such results are sufficient to support the future success of the Companys product candidates; the acceptance by the market of the Companys product candidates, if approved;the timing of and the Companys ability to obtain and maintainU.S. Food and Drug Administrationor other regulatory authority approval of, or other action with respect to, the Companys product candidates;and other factors, including legislative, regulatory, political and economic developmentsnot within the Companys control. The foregoing review of important factors that could cause actual events to differ from expectations should not be construed as exhaustive and should be read in conjunction with statements that are included herein and elsewhere, including the risk factors included in the Companys annual and periodic reports filed with the SEC. The forward-looking statements are made only as of the date of this press release and, except as required by applicable law, the Company undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

Media & Investor Relations Contacts:

Tram Bui / Alexander LoboThe Ruth GroupPhone: +1-646-536-7035 / +1-646-536-7037Email: tbui@theruthgroup.com / alobo@theruthgroup.com

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PDS Biotechnology to Present at the 12th Annual LD Micro Main Event - BioSpace

ASU, Mexico partnership takes on biotechnology challenges – Arizona State University

June 6, 2017

Never in the history of human existence has the opportunity to genetically modify or protect life been as great and accessible to anyone interested in the topic as it is today.

Cures for human hereditary diseases. Designer babies. Glow-in-the-dark fish. Bioterrorism. Mosquitoes programmed to perish. The opportunities and risks are here now, but lagging are policies, ethical considerations and safety precautions needed to proceed prudently on an international scale.

Arizona State University experts will delve into the issues presented by biotechnology during the annual International Biosafety and Biosecurity Symposium (SIBB) held this year in Morelia, Mexico, and organized by the Asociacin Mexicana de Bioseguridad (AMEXBIO), June 710.

Were enhancing biosafety and biosecurity across international borders, said Irene Mendoza, associate biosafety officer with ASUs Office of Environmental Health and Safety, who will be one of the featured speakers at the symposium. Anything that affects Mexico, like the release of a pathogenic agent, can travel north and affect us.

Although infectious diseases willbe addressed at the symposium, the ASU delegation will lead a technical discussion on gene editing and gene drive technologies, said David Gillum, ASU Environmental Health and Safety associate director and institutional biosafety officer. In simplest terms, its about the ability to modify plants or mammals by manipulating their genome i.e., the chromosomes in each cell of an organism.

These technologies can drive a change in an entire species from just one modification, Gillum said. It can be propagated in all future generations.

David Gillum, ASU Environmental Health and Safety associate director and institutional biosafety officer, said that with the increased use of CRISPR Cas9 gene editing technology in Mexico comes great opportunities for ASU to form a more strategic partnership with AMEXBIO by conducting training sessions, lab site visits, joint research and other symposia.Photo by Charlie Leight/ASU Now

The gene drive of mosquitoes, for example, can be modified so the specific types that carry malaria and Zika will not reproduce and eventually die off. But once their genome is changed and released into the environment, there is no easy way to predict any unintended consequences.

Thats what is scary about it, Gillum said. Theres no easy undo button.

The leading gene editing method capable of making such changes is called CRISPR Cas9. This technological process takes advantage of the immune systems of bacteria to delete nucleic acids in living cells and replace them with the desired nucleic acid to change the genome.

When youre doing this genome editing, youre looking for very specific nucleic acids to change, Gillum said. Lets consider that you have sickle cell anemia and you have one gene that is wrong, and you just want to target that one gene. But the genome is huge; there are billions of base pairs. So how do you make sure that you target the one that youre looking for and not similar sequences somewhere else in your body?

Unlike past costly and complex genome editing technologies, CRISPR Cas9 is simpler, relatively inexpensive and thus more accessible to people who may not be working in a modern laboratory with established biosafety policies and procedures.

There are a lot of citizen labs all over the place where science enthusiasts are getting together in their garages and experimenting, Mendoza said. The risk is that although they may just be trying to do something fun, what they create may have unintended consequences.

Irene Mendoza, associate biosafety officer with ASUs Office of Environmental Health and Safety, will be one of the featured speakers during the annual International Biosafety and Biosecurity Symposium held this week in Morelia, Mexico, and organized by the Asociacin Mexicana de Bioseguridad.

The use of CRISPR Cas9 has increased in Mexico in the past few years, Gillum said. Experts there recognize the challenge, and that drives such events as the SIBB, which includes participation from other Latin American countries.

What we want to achieve in SIBB is to continue the academic efforts of diffusing specific knowledge on biosafety and biosecurity, as well as raise awareness among those involved in manipulating biological agents, said Luis Alberto Ochoa Carrera, AMEXBIO president and founder. The importance of the work of AMEXBIO is based on the need to create a biosafety culture and appropriate communication within institutions to mitigate risks associated with experimenting with biological agents.

ASU contacts AMEXBIO remotely throughout the year, but opportunities exist to engage in person and at a higher level by way of training sessions, site visits, joint research and other symposia to address the wide array of biosafety and biosecurity aspects.

There is a huge opportunity here for ASU and AMEXBIO in Mexico to partner on these projects, Gillum said. Theyre very interested in biodefense. Were looking into philanthropy to help with funding that will allow us to form a more strategic partnership.

With funding, ASU biosafety experts like Gillum and his team can work with AMEXBIO to visit labs in Mexico to observe operations and offer suggestions on improving safety and security.

The interesting aspect of biosafety is that in general its based on best management practices, Gillum said. Except for very highly pathogenic agents and toxins, everything else is done with a best management practices point of view. Theres not always a black-and-white way to do certain things.

Forming strategic links between biosafety and biosecurity experts across the border enables mutual collaboration and training in the region, Ochoa Carrera said.

AMEXBIO recognizes ASUs efforts and transcendence in Mexico and within the international biosafety community, Ochoa Carrera said. The ASU and AMEXBIO alliance enables the dissemination of knowledge in this field, and its also an area of opportunity between Mexico and the United States.

Top photo: DNA sequence, courtesy freeimages.com.

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ASU, Mexico partnership takes on biotechnology challenges - Arizona State University

Global $92.9 Billion Biotechnology/Pharmaceutical Services … – PR Newswire (press release)

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

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

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

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

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

Further key findings from the study suggest:

Key Topics Covered:

1 Research Methodology

2 Executive Summary

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

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

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

6 Competitive Landscape

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

Media Contact:

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

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

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

SOURCE Research and Markets

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Global $92.9 Billion Biotechnology/Pharmaceutical Services ... - PR Newswire (press release)

Form 8-K PUMA BIOTECHNOLOGY, INC. For: May 24 – StreetInsider.com

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May30, 2017 (May 24, 2017)

PUMA BIOTECHNOLOGY, INC.

(Exact Name of Registrant as Specified in its Charter)

10880 Wilshire Boulevard, Suite 2150

Los Angeles, California 90024

(Address of principal executive offices) (Zip Code)

(424) 248-6500

(Registrants telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (240.12b-2 of this chapter).

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

On May24, 2017, Puma Biotechnology, Inc. (the Company) announced that the U.S. Food and Drug Administrations (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to 4 to recommend approval of PB272 (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer based on finding that the risk-benefit profile of neratinib is favorable. 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.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

/s/ Alan H. Auerbach

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Form 8-K PUMA BIOTECHNOLOGY, INC. For: May 24 - StreetInsider.com

BBP: A Diversified Biotech ETF – Seeking Alpha

While 2017 has been a pretty good year overall for biotechs - the two largest ETFs in the space, the iShares Nasdaq Biotechnology ETF (NASDAQ:IBB) and the SPDR S&P Biotech ETF (NYSEARCA:XBI), are up 10% and 17%, respectively - it's tough to forget that both of these funds are still about 25% off of their 2015 highs. IBB, which is heavily influenced by the largest biotech names, has been impacted by 50% drops in Gilead (NASDAQ:GILD) and Biogen (NASDAQ:BIIB). XBI has a much more diversified all-cap mix but has experienced similar results.

But not all news coming out of the sector is bad. In fact, one biotech ETF has been downright ripping it since its launch at the end of 2014. The BioShares Biotechnology Products ETF (NASDAQ:BBP), which invests in companies that have at least one primary product that's received FDA approval, is up roughly 42% since its inception at the end of 2014 compared to a loss of 4% for IBB during the same time frame.

IBB Total Return Price data by YCharts

As fund advisor Virtus says on its website, companies that the fund invests in are "typically more established companies with much clinical trial failure risk behind them. They have already successfully completed multiple human clinical trials and have received FDA approval to sell and market a drug." That sounds a lot like IBB so what's the big differentiator between the two funds? It's BBP's focus on small- and micro-cap biotechs. Nearly 60% of fund assets are dedicated to this space whereas IBB has nearly 40% of the portfolio alone invested in the big five of Regeneron (NASDAQ:REGN), Biogen , Celgene (NASDAQ:CELG), Amgen (NASDAQ:AMGN) and Gilead .

So what did BBP have going for it that IBB didn't over the past year or so? I think it's a combination of portfolio construction and M&A.

BBP has a portfolio that has performed almost as well as can be expected, especially in 2017. Take a look at this chart with the year-to-date performance of the fund's biggest components.

That's exactly what you want to see out of your ETFs - the largest holdings performing the best. Part of that is due to the fact that the fund is equal-weighted and rebalanced semiannually (the last rebalance was done on December 15th). Still, that's a lot of companies whose stocks have risen by 20% or more.

Among the top 10 holdings, all have posted double-digit gains with seven components delivering 25%+ gains.

The other advantage the fund has is that a number of its holdings are in the sweet spot of being developed enough to generate meaningful revenue from their approved product line yet being small enough that they can be potential takeover targets. We've seen that within the fund multiple times recently. Relypsa (RYLP) has a top holding when it got bought out by Galenica (OTC:GNHAY). Not an M&A deal, but the fund's stake in Progenics (NASDAQ:PGNX) spiked when its partnership with Valeant (NYSE:VRX) was announced. Current holdings such as Exelixis (NASDAQ:EXEL) and Acadia (NASDAQ:ACAD) have been rumored as potential takeover targets for a while so further action could be in store for the fund in the near future as well.

Conclusion

Equal weighting the mature biotech players has been a strategy that's paid off for investors in the last year. The relatively limited exposure to the likes of Celgene and Gilead, which are still nearly 50% off of recent highs, has made the fund more attractive than its more well-known counterpart.

This fund will underperform when the mega-cap biotech names begin to rally again, but over the long-term this ETF should hold up well to IBB given its more diversified portfolio.

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

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

Link:
BBP: A Diversified Biotech ETF - Seeking Alpha

Global Biotechnology Congress 2017 – Corporate Registration … – Business Wire (press release)

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Global Biotechnology Congress 2017 - (5th in the Series) Corporate" conference to their offering.

The 'Global Biotechnology Congress 2017' would provide eminent scientists the opportunity to present their cutting edge researches in the field of biotechnology and its applications in medicine. A number of Nobel Laureates and leading researchers are expected to participate in this important conference.

This unique international conference provides a platform for researchers and decision makers in biotechnology to present their latest findings and learn about all the important developments in biotechnology. Many Nobel Laureates and world's renowned experts will participate in the conference.

The conference will cover the translational nature of biotechnological research, with emphasis on both the basic science as well as its applications in industry and academia. Presentations will include major research advances in biotechnology, business development, strategic alliances, partnering trends, product opportunities, growth business models and strategies, licensing and pharmaceutical biotechnology (e.g. vaccines, CNS, cancer, antibodies), medical biotechnology, industrial biotechnology, bioprocess engineering, protein engineering, plant and environmental technologies, transgenic plant and crops, bioremediation, and microbial diversity research.

Throughout the course of the four day conference, you will have the opportunity to both network and hear leaders from the international academic and corporate biotechnology communities.

Benefits of Attending

- Exchange ideas and network with leading biotechnologists and decision makers.

- Bring together top international biotechnology professionals presenting cutting-edge discoveries, research and opportunities for new biotech business practices and partnerships.

- Participants can gain direct access to a core audience of biotechnology professionals and decision makers, and have increased visibility through branding and networking at the conference.

- Obtain a global roundup of Pharmaceutical research capabilities and opportunities.

- The conference will feature a commercial exhibition and poster sessions.

For more information about this conference visit http://www.researchandmarkets.com/research/k2mmsx/global

More here:
Global Biotechnology Congress 2017 - Corporate Registration ... - Business Wire (press release)