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.

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.

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. 

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.

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.

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.

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.

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 This email address is being protected from spambots. You need JavaScript enabled to view it.

No charge to attend • Attend in person or by videoconference

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

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.

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

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.

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.

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

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.

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

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.

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.

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.   

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!

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.

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.

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.

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

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.

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.

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

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.

Congratulations to team at #ChildrensNational re groundbreaking for new research & #ChildrensInnovation center on former #WalterReed campus. $150M invested near term creating 300 construction and 110 permanent jobs. Honoring campus' legacy while advancing pediatric treatment, diagostics, and prevention for patients in DC and around the globe. Campus will include not only Children's R&D but also clinical services, schools, retail, affordable housing and more! "Live, work, thrive!"

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.

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).

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.

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.

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.

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.