Emergent BioSolutions Inc. (NYSE:EBS) today announced that Health Canada has approved the company’s New Drug Submission (NDS) for its anthrax vaccine, BioThrax® (Anthrax Vaccine Adsorbed). BioThrax is indicated for active immunization for the prevention of disease caused by Bacillus anthracis, in individuals 18 through 65 years of age, whose occupation or other activities place them at risk of exposure, regardless of the route of exposure. BioThrax is administered in a three-dose primary schedule (0, 1 and 6 months) with boosters at three-year intervals recommended thereafter. BioThrax was approved under the Extraordinary Use New Drug Regulations, which provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible.

A large chunk of the school's research spending — about $1.5 billion — can be attributed to Hopkins' Applied Physics Laboratory, based in Laurel.

Senseonics Holdings, Inc. (NYSE American: SENS) a medical technology company focused on the development and commercialization of a long-term, implantable continuous glucose monitoring (CGM) system for people with diabetes, today has announced that the Eversense® Continuous Glucose Monitoring (CGM) System has been awarded one of Popular Science’s 2018 “Best of What’s New” Awards in the Health category.

The Maryland Stem Cell Research Fund provides a variety of grant programs for human stem cell research in the state of Maryland. Each RFA has its own timeline and review process; please read carefully the RFA when applying.

University of Maryland (UM) Ventures and Educational & Scientific, LLC (ESL) announced today that the University of Maryland, Baltimore (UMB) has again granted ESL an exclusive license for a novel cancer treatment. This agreement focuses on the development of Galeterone, a molecule with the potential to inhibit prostate cancer growth in patients with castration-resistant prostate cancer (CRPC). Galeterone is a steroidal antiandrogen that acts by disrupting the androgen receptor signaling pathway, which is the primary pathway that drives prostate cancer growth.

BullFrog AI, Inc, a precision pharmaceutical company built around a powerful artificial intelligence (AI) platform, proudly announces the addition of executive Everett Lee as its Chief Technology Officer.  Mr. Lee brings nearly 3 decades of technical expertise and continuous advancement in technology management, strategic business planning and IT organizational leadership at major pharmaceutical/biotech and drug development companies such as AstraZeneca, Roche/Genentech, Eli Lilly & Co., Pfizer and Covance.

Intelligent nanobots offer the promise of smart drug delivery systems for a variety of therapeutic applications. A promise that experts in the field believe will become a reality within the next 30-40 years.

But at MedImmune, we don’t think patients should have to wait.

The idea of using patients’ own immune cells to fight cancer is over a hundred years old. In the late 19th century, an American doctor called William Coley attempted to treat cancer by stimulating the immune system with dangerous bacteria, arguably the first example of what is now known as immunotherapy. His procedure appeared to shrink some patients’ tumours, but was criticised as unsafe and largely forgotten about. Chemotherapy and radiotherapy became the focus of cancer research and the standard tumour treatment for the rest of the 20th century.

The former Belly Wine Bar and The Blue Room in Cambridge’s Kendall Square has been transformed into a biotech incubator.

The last time GEN compiled a list of CEOs, investors, and others with the biggest stakes in biopharma companies—what GEN calls “molecular millionaires”—was last year, based on 2016 data. Only one new person who had not been listed in previous editions made the cut back then.

This eighth, biennial report focuses on the economic progress and footprint of the industry geographically including the performance, positioning and latest trends in the bioscience industry for the nation, states and metropolitan areas. For the first time, it includes a national assessment of the full economic impact of the bioscience industry not only in terms of employment, but also with respect to economic output and fiscal impacts. In addition, the report details the nation’s academic research activities and trends in federal funding, access to critical angel and venture capital and the innovation outputs context via patent activities.

The Global Health Innovative Technology (GHIT) Fund has awarded VLP Therapeutics a $3.9 million grant to further develop a novel tetravalent dengue virus-like particle vaccine.

In a world where it seems like startups are created every other day and market economics remain largely unpredictable, securing funding for your biotech startup can prove to be an arduous task. Venture capitalists prefer tested and proven biotech enterprises, government- and NGO-backed funding remain ever so slightly out of reach, and every other funding outlet seemingly comes with its own set of hard-to-match requirements and specifications. What is the fate of the budding startup without experience in the harsh economic climate of today’s biotech ecosphere? As it turns out, it's not quite as bad as one would expect. It’s all down to knowing the ropes and peculiarities of the market.

After months of anticipation, the just released draft paper Return on Investment Initiative to Advance the President’s Management Agenda: Unleashing American Innovation signals that the Administration is serious about addressing a wide range of long neglected issues undermining effective technology commercialization. The paper, generated under the leadership of Commerce Under Secretary Walter Copan, who heads the National Institute of Standards and Technology (NIST), is “a discussion document”  based on feedback from a series of public meetings and written comments for improving the return on investment from $150 B spent annually on government-supported R&D.

Early-stage pharmaceutical company Spiral Therapeutics received $3.7 million in new investment as it looks to advance treatments for hearing loss and other inner ear disorders.

The Frederick National Laboratory for Cancer Research and the Frederick Innovative Technology Center Inc. signed a memorandum of understanding with partners Monday to start an accelerator program for biotechnical companies.

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.

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.

When it comes to drug discovery and development, nowadays a lot of the work is done by small- or medium-sized healthcare companies. The biopharma industry heavily relies on their results, so SMEs carry an immense load on their shoulders. But without outside help, their mission is nearly impossible.

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.

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.

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.

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.

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.