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The Gene Therapy Market is going to produce a Microsoft – American Gene Technology

By News Archive

america-gene-technologies-logo

The most common analogy used to compare the science of DNA to other industries is that of computer software. DNA can be viewed as a series of commands (genes) that are coded in four nucleotides (represented by A, G, C, and T). Those letters are interpreted by the cellular machinery to produce cell products like enzymes, proteins, and various building blocks of the cell itself. This code somewhat parallels the “machine language” of computers. Computer’s lists of commands (coded in zeros and ones) are interpreted to work with numbers or any type of information that is converted to numbers (like audio, video, or sensor data). Resulting numbers generate numerical output for machinery such as screen displays, motors, tools, robots, digital controls, etc.

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2018 In Review with MIMETAS’ CEOs

By News Archive

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2018 was a year in which we saw explosive growth at Mimetas. After such a hectic and promising year, it is important to take a moment to sit down and recap some of the highlights. Today, we sit down with our CEOs, Jos and Paul. In this conversation, you will read their thoughts about the Mimetas culture, corporate dynamics, amazing new products, and the strengths they perceive in each other.

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333rd Edition – December 4, 2018

By BHI Weekly Newsletter Archives




BioHealth Innovation


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December 11, 2018












FOUNDING MEMBER OF



These Five Capital Region Biotechs Are The Fastest Growing in America · BioBuzz

In its 24th year, the Deloitte Technology Fast 500 is the premier technology awards program in North America.  The program celebrates the innovation, entrepreneurship and rapid growth that these cutting-edge companies all embody.  This year’s Fast 500 winners were selected based on percentage fiscal year revenue growth during the period from 2014 to 2017 across a number of sectors, including Biotechnology/Pharmaceutical and Medical Devices. Five of these fast-growing companies call the Biohealth Capital Region home.

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Institute of Human Virology researchers discover that a bacterial protein promotes cancer – EurekAlert! Science News

The Institute of Human Virology (IHV) at the University of Maryland School of Medicine (UMSOM) announced today the discovery that DnaK, a protein of the bacterium mycoplasma, interferes with the mycoplasma-infected cell’s ability to respond to and repair DNA damage, a known origin of cancer.

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GSK Buys Tesaro For $5 Billion In Dramatic Bet On Cancer Genetics

GlaxoSmithKline announced this morning that it will buy Tesaro, the maker of the ovarian cancer drug Zejula, for $5.1 billion in cash in a dramatic bet that the London-based drug giant can see opportunities connected to the genetics of cancer drugs better than the stock market.

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BHI Entrepreneur-in-Residence Feedback Sessions

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

  • 12/12
  • 2/13
  • 3/20
  • 5/22

(30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)

Pre-registration is required; sign up here (“EIR resource”at BHI). For questions/more information, contact BHI.

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Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

Explore Legal Issues for Early Stage Companies

Business formation and governance • Advisory Board vs. Board of Directors Equity incentive plans • NDA’s (w/ potential co-owners/joint ventures/investors and employees) • Worker classifications (exempt vs. non-exempt; W2 or 1099) Employment contracts • Lease and distributor agreements • Customer agreements (for beta testing and beyond) • CRADA’s and technology transfer agreements

Schedule

1 p.m – Networking Lunch

1:30 – Panel Discussion with Q&A 

2:45-4:15 – One-on-one  with Attorneys*

RSVP by noon, December 12 at BHI@BioHealthInnovation.org

No charge to attend • Attend in person or by videoconference

BioHealth Innovation, 1 Church Street, Suite 801, Rockville, MD 20876

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FDA Approves Cutting-Edge Cancer Drug from Inova Schar Cancer Institute Clinical Trial – Inova Newsroom

In groundbreaking news for the medical and cancer research community, the Food and Drug Administration (FDA) approved a new, breakthrough cancer drug, larotrectinib, or Vitrakvi®, that targets specific genetic mutations in adult and pediatric patients. This is only the second tissue-agnostic drug that the FDA has approved.

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Applying Deep Learning to PD-L1 Expression

Perhaps the greatest promise of Artificial Intelligence (AI) is its potential to enhance our ability to predict, diagnose, and treat disease.

That is why our researchers are continuing to look for new ways to leverage AI to aid our discovery and delivery of effective therapies.

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Creatv MicroTech Receives Japanese Patent for Cancer Screening

Creatv MicroTech, Inc. (Creatv) has received notice from the Japanese Patent Office that its patent covering numerous clinical applications for the detection of cancer associated macrophage-like cells (CAMLs) in cancer patient blood samples has been issued. Clinical applications of the CAML biomarker include cancer screening, various cancer diagnostics, and early detection of disease recurrence. Approved claims cover all solid tumors. Similar patents have been issued in Europe and Australia.

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QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer | Business Wire

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

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Commerce’s NIST Announces Actions to Stimulate Commercialization of Federally Funded R&D | NIST

The United States spends more than any other nation on research and development (R&D) each year, investing over $150 billion in federally funded R&D alone. In line with President Donald J. Trump’s Management Agenda, the U.S. Department of Commerce’s National Institute of Standards and Technology (NIST) today released a draft green paper detailing steps to modernize the U.S. system of technology transfer and innovation for the 21st century. The actions outlined in the green paper would help maximize returns on the taxpayer investment in R&D.

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Greater Washington Board of Trade releases 2019-2021 Strategic Plan

The Board of Trade has served Greater Washington and its business community for 130 years. Today, it released a new three-year strategy for driving inclusive economic growth and improving livability, critical factors for the region’s long-term success.

The strategy includes nine goals related to the Board of Trade’s operations, offerings for members, and regional development initiatives.

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CELLINK and Prellis Biologics announce powerful, $1.2M Holograph-X Bioprinter – 3D Printing Media Network

Swedish bioprinting company CELLINK has entered into a partnership with organ and tissue engineering company Prellis Biologics, Inc. with the goal of commercializing high-resolution holographic bioprinting technology for micro-scale printing. By combining their IP and respective expertise, the companies will introduce what they call the “first system enabling ultra-high resolution bioprinting of microstructures” for producing vascular networks.

Read More




Why do digital health startups keep failing?

A decade ago, a wave of companies promised to transform people’s health by allowing them to track data about their eating, sleep, exercise, and other habits. One hot startup of that moment, Zeo, raised more than $30 million from investors to develop a headband that tracked users’ sleep patterns and an accompanying app to serve as their personal “sleep coach.” Despite devoted users and buzz about its product in publications like Wired and Popular Science, Zeo quietly went out of business a few years later.

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Cancer researchers in Australia develop universal blood test

Australian scientists have developed a simple blood test that they claim can diagnose cancer in mere minutes by identifying a unique DNA signature present in all types of the disease.

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Copyright © BioHealth Innovation 2017
All Rights Reserved.



332nd Edition – December 4, 2018

By BHI Weekly Newsletter Archives




BioHealth Innovation


If you are having trouble viewing this email, please click here


December 4, 2018












FOUNDING MEMBER OF



Children’s National Breaks Ground on One-of-a-Kind Pediatric Research and Innovation Hub – Benzinga

On Wednesday, Nov. 28, 2018, Children’s National Health System marked the official start of construction on its pediatric research and innovation campus with a groundbreaking event. It will be distinct nationally as a freestanding research and innovation complex focused on pediatric medicine.

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A Year of Historic Action to Combat the Opioid Crisis, Emergent BioSolutions Recognized – The White House

One year ago this week, President Donald J. Trump declared the opioid crisis a public health emergency. Ever since, the Trump Administration has applied an all-of-Government approach to the epidemic, allowing each agency and department to do their part to help the cause

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Six Things to Consider When Choosing a Location for Your Bio Business – Maryland Business News

Driven by breakthrough research and innovation, biohealth and life science are high-risk, high-expense fields. The right location is critical to your success, but that doesn’t mean you need to pay Boston’s and San Francisco’s high rents for lab and office space. Maryland, a booming bio hub itself, is not only cost-efficient, but offers many advantages you may not find elsewhere. Before narrowing your shortlist for your new biotech business or expansion of existing biotech business, consider these six factors that contribute to Maryland’s innovation ecosystem.

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REGENXBIO and Rocket Pharmaceuticals Announce New License Agreement for the Treatment of Danon Disease Using NAV AAV9 Vector

REGENXBIO Inc. (Nasdaq: RGNX), a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, and Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT), a leading U.S.-based multi-platform gene therapy company, today announced an exclusive, worldwide license agreement for Rocket to develop and commercialize gene therapy treatments for Danon disease using REGENXBIO’s NAV AAV9 vector, as well as exclusive options for two additional NAV AAV vectors for the treatment of Danon disease.

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RoosterBio Submits U.S. FDA Master Files for CliniControl™ Line of Human Mesenchymal Stem/Stromal Cell Products

RoosterBio Inc, a leading supplier of human Mesenchymal Stem/Stromal Cell (hMSC) working cell banks and hMSC-specific bioprocess systems, announces today it has submitted a U.S. Food and Drug Administration (FDA) Type II Master File (MF) for its CliniControl™ line of cGMP hMSC working cell banks. This MF complements the MF for the CliniControl RoosterNourish™-MSC-CC bioprocess media that was filed in 2017. The MFs contain confidential information on the products including their chemistry, manufacture, and controls. This enables RoosterBio to protect proprietary product information yet allows the FDA to review the information in support of an investigator’s submission. Upon request, RoosterBio will grant a customer authorization to cross reference the stated MF(s) to support their own regulatory filing, such as an Investigational New Drug (IND) application to the FDA. INDs are filed with the FDA prior to beginning clinical evaluation of new therapeutic products in human subjects.

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Job Opportunity: NIH Associate Entrepreneur-In-Residence

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking an early stage life sciences professional with market research or portfolio management experience to join the BHI EIR team and serve as an associate Entrepreneur-in-Residence (EIR) at the National Institutes of Health (NIH). This position will report to and work closely with our lead at the NIH Office of the Director, Office of Extramural Research (OER) at the Bethesda, MD campus. The Associate will provide analyst and project support to the EIR team on product, corporate and private investment strategy advisory for companies which have SBIR/STTR awards. This will entail market, technology, regulatory and other business intelligence research to support EIR consulting and coaching of companies. The Associate will also undertake the alliance management responsibilities with collaborating organizations such as the Angel Capital Association or others with which the OER establishes relationships.

The NIH is the world’s largest early stage biomedical investor providing nondilutive funding for US companies in the form of grants and contracts through the SBIR/STTR program. In FY19 the Congressional funds set aside for company funding exceeds $1B USD. The EIR program supports NIH interests in commercial success of its SBIR/STTR portfolio companies.

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BHI Entrepreneur-in-Residence Feedback Sessions

Are you a start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? business/commercialization plan, pitch deck, or idea?

Schedule your feedback session with BHI EIRs on one of the following dates: 

  • 12/12
  • 2/13
  • 3/20
  • 5/22

(30 minute blocks of time beginning at 9:00 in the morning. If the morning slots are filled, more time will be allotted beginning at 1 p.m.)

Pre-registration is required; sign up here (“EIR resource”at BHI). For questions/more information, contact BHI.

Read More




Join us December 13, 2018 for PATHFINDER INNOVATION PROGRAM

Explore Legal Issues for Early Stage Companies

Business formation and governance • Advisory Board vs. Board of Directors Equity incentive plans • NDA’s (w/ potential co-owners/joint ventures/investors and employees) • Worker classifications (exempt vs. non-exempt; W2 or 1099) Employment contracts • Lease and distributor agreements • Customer agreements (for beta testing and beyond) • CRADA’s and technology transfer agreements

Schedule

1 p.m – Networking Lunch

1:30 – Panel Discussion with Q&A 

2:45-4:15 – One-on-one  with Attorneys*

RSVP by noon, December 12 at BHI@BioHealthInnovation.org

No charge to attend • Attend in person or by videoconference

BioHealth Innovation, 1 Church Street, Suite 801, Rockville, MD 20876

Read More




How a Chinese immigrant used WeChat to win a seat in the Maryland House of Delegates – The Washington Post

As a first-generation Asian American running for a seat in the Maryland state legislature, Democrat Lily Qi felt disconnected from the party establishment.

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FDA chooses 8 medtech companies for opioid crisis challenge – MassDevice

The FDA has selected eight medtech companies to develop devices to help reduce the country’s opioid abuse crisis.

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Rooster Bio and Paragon Biosolutions Recognized as Champions of Manufacturing

On November 29, 2018 at Martin’s West, RMI’s 2018 Champions of Maryland Manufacturing Awards ceremony drew over 600 stakeholders from around the State. The evening awards program touched on the themes of togetherness and family as we celebrated a variety of different leaders from young students to business executives.

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NEA completes secondary sale of 26 portfolio companies for about $1 bln – PE Hub

New Enterprise Associates has completed a roughly $1 billion secondary sale of 26 portfolio companies in a deal designed to bring early liquidity to limited partners in four of its funds. T

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University System of Maryland: Maryland’s Most Powerful Economic Engine – USM

The University System of Maryland (USM) is Maryland’s public higher education system, consisting of 11 degree-granting universities, two regional higher education centers and one environmental research institution. With approximately 170,000 students and 38,000 graduates each year, USM is the most significant producer of talented workers and educated citizens in Maryland. USM institutions, faculty, students and graduates attract billions of federal and privately funded research dollars to the state that support thousands of jobs. They also create hundreds of new companies. Combined, these activities enable USM to support one of America’s most vibrant economies.

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Johnson & Johnson Innovation – Quick Pitch – JNJ Innovation

At Johnson & Johnson, we believe a good idea can come from anywhere. Our aim is to identify, empower and enable the best ideas to get to patients and consumers around the globe. In an effort to unearth the unseen and brightest innovations in healthcare, Johnson & Johnson Innovation is launching a Quick Pitch event where innovators can apply to present to Johnson & Johnson Innovation’s leadership during the week of the 37th Annual JP Morgan Healthcare Conference in San Francisco, CA. If you are selected, you will have an opportunity to present for 5 minutes followed by a 5 minute Q&A session with Johnson & Johnson Innovation’s leadership.

If you have a novel idea that has yet to be introduced to Johnson & Johnson and fits our areas of interest, we would like to hear from you. Apply for an open spot at the Johnson & Johnson Innovation Quick Pitch event to be held on Wednesday, January 9th from 9-11am. Limited spots available.

Applications must be submitted by December 7th.

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Georgetown Entrepreneurship dishes out $100K at second annual pitch competition – Technical.ly DC

Georgetown Entrepreneurship hosted its second annual Leonsis Family Entrepreneurship Prize “Bark Tank” pitch competition on Nov. 28, where eight university students and alumni pitched their business ventures for a chance to win a share of the $100, 000 in cash prize.

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Global biotech rankings – Measuring biotech innovation in 50+ countries

Why measure global biotechnology? The scope of biotechnology is broad and impacts economies, policies, and people globally.

Applications range from advanced medicines to and improvements in agriculture to feedstocks and biofuels, and further to exotic industrial materials and processes.

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Time is running out to register for SoPE National Chapter: Telemedicine: Leveraging Technology to Change the Face of Healthcare…Are you In or Out?

The use of tele-medicine is no longer a far off, futuristic concept. It is presently being used in many medical disciplines and in institutions from academic medical centers to privately owned Assisted Living facilities. So what have we learned from utilizing this technology? Have outcomes improved and costs been curtailed? What are the current legislative hurdles regarding licensure and insurance for practitioners? Can the data be easily integrated and accessible to your EHR? Can new entrants into the tele-medicine field differentiate themselves and be fundable to investors? Can we trust the data from wearables and is there enough cybersecurity embedded in these technologies?

Come to the SoPE National Capital Chapter event on December 5th and learn from the experts!

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Useful Stats: Higher Ed R&D by state, 2008-2017 – SSTI

Higher education R&D expenditures (HERD) grew by 38.9 percent from 2008 to 2017, an increase of more than $21 billion, according to an SSTI analysis of recently released data from the National Science Foundation’s National Center for Science and Engineering Statistics. From 2016 to 2017, HERD grew by $3.8 billion, the largest year-over-year increase since 2010-2011. Higher education R&D expenditures grew the fastest in Connecticut (66.2 percent), Massachusetts (63.9 percent), and Wyoming (63.0 percent) over the 10-year period, while New York ($2.3 billion increase), California ($2.0 billion), and Massachusetts ($1.6 billion) saw the largest absolute gains during this time.

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NCSES Higher Education Research and Development short form: Fiscal Year 2017 – US National Science Foundation (NSF)

Higher education R&D expenditures, ranked by FY 2017 R&D expenditures: FYs 2008–17

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Ten with Hopkins ties named to ‘Forbes’ 30 Under 30 list | Hub

Ten trailblazers with ties to Johns Hopkins University who have become leaders in their fields have been named to the Forbes “30 Under 30” list for 2019.

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Small Business Innovation Research Program Phase I – NSF – National Science Foundation

The National Science Foundation’s Small Business Innovation Research (SBIR) program- also known as America’s Seed Fund powered by NSF – provides small businesses with equity-free funding to conduct research and development (R&D) work that will lead to the commercialization of innovative new products and services. The NSF SBIR program seeks innovative proposals that show promise of commercial and societal impact. We invite the submission of proposals in almost any area of science and technology (more information on our technical topics is available here).

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The Real Threat Of Identity Theft Is In Your Medical Records, Not Credit Cards

The 2017 holiday season has been complicated by data breaches that have plagued consumers all year long, such as the massive Equifax hack. As a result, consumers must worry about fraud and the misuse of our financial information during a time of increased financial transactions, tight budgets and heightened stresses.

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HHS selects 15 tech leaders to discuss healthcare innovation, investment – Health Data Management

The Department of Health and Human Services has picked 15 technology leaders from the private sector with which to initiate a year-long dialogue on how to accelerate healthcare innovation and investment.

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BIO CEO Greenwood talks drug pricing politics after the midterms – STAT

BIO CEO Jim Greenwood won’t admit last month’s midterm elections spell trouble for the drug industry.

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The Untold CRISPR Story

The recent shocking reports about a human genome editing experiment have led to increased murmurings about the potential pitfalls of improved access to molecular technologies. Sharing speeds science. That’s been the driving concept behind Addgene since its founding. Nowhere has this proved more prescient than in the acceleration of basic research using CRISPR-Cas9 genome editing tools. It would be a tremendous loss of efficiency and funding if this rogue experiment resulted in a reduction in repository deposits and the sharing of research materials.

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Despite CRISPR baby controversy, Harvard University will begin gene-editing sperm – MIT Technology Review

In the wild uproar around an experiment in China that claimed to have created twin girls whose genes were altered to protect them from HIV, there’s something worth knowing—research to improve the next generation of humans is happening in the US, too.

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Biotech giant Moderna Therapeutics bumps IPO goal to staggering $600M – Boston Business Journal

The biggest proposed IPO in biotech history just got even bigger.

Cambridge-based Moderna Therapeutics disclosed Wednesday that it’s hoping to raise up to $600 million in an initial public offering, an increase from the $500 million maximum it proposed earlier this month. Either sum would shatter the previous record for a life sciences IPO, both in biotech-rich Massachusetts and nationwide.

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Roche buys U.S. biotech Jecure in race for liver disease drugs

Swiss drugmaker Roche is buying U.S.-based Jecure Therapeutics, joining Pfizer, Gilead Sciences and Novartis in pursuit of new drugs to treat fatty liver disease.

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Top 10 Pharma Companies of 2018 – GEN

Unlike their biotech counterparts, pharmaceutical companies have largely surpassed analyst expectations on earnings per share during the third quarter. Yet, pharma stocks have not been immune to the stock market swoon of recent weeks.

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Rise of the Global Startup City

America’s long-held singular dominance of startup and venture capital activity is being challenged by the rapid ascent of cities in Asia, Europe, and elsewhere. While the United States remains the clear global leader, the rest of the world is gaining ground at an accelerating rate.

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Year-End Planning – The Private Bank – Wells Fargo

Recent tax-law changes may bring opportunities for you and your family, so it’s good to know what to look for and when to take action. Download our 2018 Year-End Planning Guide now to find out about potential impacts to your estate, charitable giving strategy, business, and more. Then, contact The Private Bank to discuss how our responsive, team approach to wealth planning may benefit you now and year-round.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright © BioHealth Innovation 2017
All Rights Reserved.



graph-decrease-pixa

Why do digital health startups keep failing?

By News Archive

graph-decrease-pixa

A decade ago, a wave of companies promised to transform people’s health by allowing them to track data about their eating, sleep, exercise, and other habits. One hot startup of that moment, Zeo, raised more than $30 million from investors to develop a headband that tracked users’ sleep patterns and an accompanying app to serve as their personal “sleep coach.” Despite devoted users and buzz about its product in publications like Wired and Popular Science, Zeo quietly went out of business a few years later.

Read More
NewImage

CELLINK and Prellis Biologics announce powerful, $1.2M Holograph-X Bioprinter – 3D Printing Media Network

By News Archive

NewImage

Swedish bioprinting company CELLINK has entered into a partnership with organ and tissue engineering company Prellis Biologics, Inc. with the goal of commercializing high-resolution holographic bioprinting technology for micro-scale printing. By combining their IP and respective expertise, the companies will introduce what they call the “first system enabling ultra-high resolution bioprinting of microstructures” for producing vascular networks.

Read More
qiagen logo

QIAGEN announces new collaboration to develop companion diagnostic to guide treatment for patients with PIK3CA-mutated advanced breast cancer | Business Wire

By News Archive

qiagen-logo

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that a clinical development program is underway with Novartis to bring to market a molecular test as a companion diagnostic to guide the use of the investigational compound BYL719 (alpelisib) in combination with fulvestrant for men and postmenopausal women living with PIK3CA mutated hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

Read More

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