The Food and Drug Administration has put out a call for volunteer companies to test out the its digital health pre-certification program for software as a medical device (SaMD) technologies.

Coming off the record-breaking venture financing numbers of 2018, the first quarter of 2019 displayed some cooling off, in terms of pre-money valuations across all rounds and amounts raised in Series C and later rounds, although the market remained strong by historical standards. Q1 2019 had slightly fewer up rounds for Series B and later financings than did the last two quarters of 2018. Median pre-money valuations declined moderately across all equity rounds in Q1 2019. Median amounts raised remained strong for Seed, Series A, and Series B rounds, with those medians matching or exceeding those of Q4 2018. But the median amount raised in Series C and later rounds declined significantly, falling from the historic high of $31.1 million reached in Q4 2018 to $15.3 million in Q1 2019.

Maryland Commerce is leading a delegation of 20 biohealth and life sciences companies, educational institutions, federal agencies, and city and county economic development offices to the 2019 BIO International Convention in Philadelphia next month. 

Scott Gottlieb, who resigned as head of the FDA in March, has rejoined NEA as a special partner focused on healthcare investments. Gottlieb was a venture partner with the firm for 10 years before leading the FDA. Founded in 1977, the Maryland-based firm's portfolio includes Opendoor and Desktop Metal.

With expansion, Protenus recently moved to new offices in Fells Point.

The healthcare analytics company moved into a 12,000-square-foot office space that’s roughly triple the size of its previous location, according to People Operations Associate Samantha Barber, who gave us a recent tour.

Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

Navitas Life Sciences, a TAKE Solutions Enterprise today announced the acquisition of US based niche full service CRO and health research company, KAI Research Inc.

KAI Research brings on board top of class offerings in 3 key areas – Clinical Trial Management, Clinical Research Consultation, and Data Management & Standardization. Through this acquisition, Navitas Life Sciences expands Phase II and Phase III capabilities in North America adding to its current capabilities in Europe and APAC. KAI strengthens Navitas' therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology for Pharma and medical devices. The company has differentiated offerings in the areas of patient registries and e-clinical solutions as well as long-standing relationships with clinical sites and trusted network of service providers across the United States and Africa.

QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced that QuantiFERON ® -TB Access, a new solution under development for diagnosis of latent tuberculosis (TB) infection in low-resource regions with a high disease burden of tuberculosis, will be recognized by the Joint United Nations Programme on HIV/AIDS (UNAIDS) at the organization’s Health Innovation Exchange from May 21-23 in Geneva, Switzerland. The event will be held during the World Health Assembly and brings together ministers of health, nonprofits and industry to spotlight innovations with potential to change the world’s health landscape and benefit sustainable development.

NAVAN, Inc. (NAVAN), a privately-held biotechnology company enabling the development of next generation cell and gene therapies through its novel, non-viral NanoStraw platform, announced today the appointment Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti, Inc., and Howard Grimes, Ph.D., Associate Vice President and Associate Vice Provost for Institutional Initiatives at The University of Texas at San Antonio, to its Strategic Advisory Board.

Most Congressional hearings are morality plays designed to reach a predetermined outcome. It wasn’t hard to predict how the second hearing on drug pricing by the House Committee on Oversight and Reform was supposed to go. If the title, “HIV Prevention Drug: Billions in Corporate Profits after Millions in Taxpayer Investments” wasn’t enough of a clue,  when Chairman  Elijah Cummings (D-MD) said it was because of the “phenomenal leadership” of freshman Rep. Alexandria Ocasio-Cortez (D-NY)  that the hearing was being held, any doubts evaporated. In an extraordinary gesture of deference for a new Member of Congress, Rep. Ocasio-Cortez was recognized for an opening statement before senior members of the committee.

Alzheimer’s disease (AD) arises from molecular events that scientists are piecing together to discern an overall story, parts of which are well known, others less so. Some of the lesser-known epigenetic events in the Alzheimer’s story have just been filled in by scientists based at the Van Andel Research Institute (VARI). What’s more, these epigenetic events, which occur early in Alzheimer’s, appear to fit well with what we know about the disease’s progression to its most devastating biological features.

Wed, Jun 12, 2019 at 11:30 AM

The 3rd Annual NCI and FNLCR Technology Showcase will showcase technologies being developed at the National Cancer Institute (NCI) in Bethesda and Frederick, and Frederick National Laboratory for Cancer Research (FNLCR) to encourage startup formation, technology licensing, and collaborations. It will introduce the local scientific community to the regional technology development stakeholders and highlight available resources.

Prospective investors, established companies, interested stakeholders, entrepreneurs and those looking to commercialize technologies are invited and encouraged to attend. The day will feature short technology summaries by NCI and FNLCR innovators, as well as presentations from regional stakeholders involved with technology development and commercialization. An interactive poster session by innovators and technology ambassadors will concurrently occur.

By the end of this year, the biotech expects to have 270 employees in Baltimore's Camden-Carroll neighborhood.

Emergent BioSolutions Inc. (NYSE: EBS) announced today that it has successfully obtained marketing authorization for its oral typhoid vaccine Vivotif® (Typhoid Vaccine Live Oral Ty21a) in five additional European Union Member States, including France, Portugal, Poland, Czech Republic and Slovakia as well as approval of harmonized prescribing information in the EU also known as the Summary of Product Characteristics or SmPC.

BioHealth Innovation has announced the schedule for the next year’s Entrepreneur-in Residence (EIR) feedback sessions.  These 1:1 Sessions with EIRs take place at BioHealth Innovation's office in Rockville OR by videoconference.  There is no charge to participate but entrepreneurs must be working on a biohealth Start-Ups/innovation in the BioHealth Capital Region (MD, DC, VA).  The upcoming dates are:  

2019:  5/22, 7/24, 9/4, 10/9, 11/20

2020:  1/22, 2/26, 3/25, 4/22, 5/27         

Schedule your appointment online here.  For questions or more information, contact This email address is being protected from spambots. You need JavaScript enabled to view it..

The company will use the funding to grow two business lines.

The Maryland Stem Cell Research Commission (Commission) has approved funding to its second round of 2019 recipients for a total of $6,622,673.63. The Commission has also issued its Request for Applications (RFAs) for its first round of funding for fiscal year 2020. 

NextStep Robotics Inc., an early-stage company that has developed a personalized robotic therapy to help treat foot drop in recovering stroke patients, announces the closing of its second funding round. The $600,000 round will allow NextStep to transition from prototyping and development to manufacturing and sales. Led by the Abell Foundation, a new investor, this round includes investments from previous private investors from Vancouver, Canada and new investors the Abell Foundation, University of Maryland (UM) Ventures, and Jeff and Brad Quinn of Engineered Medical Systems, Inc. (EMS), a partner company of the newly-formed LaunchPort™ Accelerator.

AS A CHILD, Susan Hockfield took apart anything she got her hands on to figure out how it worked. One time it was a watch, another time her mother’s iron. Her interest in the anatomy of the physical world grew over time: She pursued a career in neurobiology, and went on to teach at Yale University, where she eventually became provost. In 2005 she became the first female president of the Massachusetts Institute of Technology — and its first biologist-president.

The U.S. government invests a significant amount of money to further research and technology innovation. In 2017, the federal government invested approximately $150 billion in R&D— about one-third at the 17 federal laboratories across the country and two-thirds at universities and private sector R&D institutions, according to government reports. This represents about one-third of all U.S. R&D spending.

The submission to Arlington County ends months of speculation.

The Biomedical Advanced Research and Development Authority (BARDA) will begin procuring Emergent BioSolutions’ anthrax vaccine into the Strategic National Stockpile (SNS) to strengthen U.S. preparedness in the event of a public health threat, the company said on Wednesday.

The angel investor market in 2018 experienced an increase in market participation in more companies, albeit at smaller amounts, according to the Center for Venture Research at the University of New Hampshire. Total angel investments in 2018 were $23.1 billion, a negligible decrease of 3.4% over 2017. A total of 66,110 entrepreneurial ventures received angel funding in 2018, an increase of 7.4% over 2017 investments. The number of active investors in 2018 rose to 334,565 as compared to 288,380 in 2017, a robust increase of 16%. The change in total dollars and the number of investments resulted in a deal size for 2018 that was smaller than in 2017, reflecting lower valuations. The increase in number of investments likely offsets a decline in activity by institutional investors in seed and start-up deals and the smaller deal size may have partially contributed to the increase in angel investors.

Venture capital firms are starting to launch and raise funds to invest in companies located in designated Opportunity Zones, where investors can get ..

The Food and Drug Administration (FDA) has approved Qternmet XR (AstraZeneca) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes (T2D).

If 2017 was a banner year for biotech venture capital, 2018 blew it out of the water. Last year, private biotech companies reeled in a grand total of $16.8 billion, eclipsing 2017’s then-record $12.1 billion by 39%. And it wasn’t just the total spent that smashed records: The average per financing round increased too, and so did the proportion of enormous megarounds. 

The net proceeds from the IPO, along with NextCure's cash on hand, will largely be used to drive its lead product, NC318, through clinical trials and testing.

Alexis Borisy, Third Rock Ventures partner, discusses the fund's biotech investment strategy on "Bloomberg Technology

Vaccine development has slowed over the past five years, but changes to investment strategies and a shift in focus to more technical and complex vaccines could renew the innovation engine.

Viela Bio today announced results from a pivotal study of its anti-CD19 monoclonal antibody, inebilizumab, in patients with neuromyelitis optica spectrum disorder (NMOSD) — a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Results were presented today during the Clinical Trials Plenary Session at the 2019 American Academy of Neurology (AAN 2019) Annual Meeting held in Philadelphia from May 4-10.

It's not often a piece of property with existing research facilities in a perfect location comes on the market.

So when a 12-acre portion of the former Walter Reed Army Medical Center campus in Washington, D.C., became available a few years ago, it was too good an opportunity for Children's National Health System to pass up. The pediatric research hospital is now in the midst of building a new $190 million pediatric research and innovation campus on the site that is expected to open in 2020.

The Bio Lab Pilot is a reimbursement grant program created by the Montgomery County Economic Development Corporation (MCEDC) with funding support from the Maryland Department of Commerce.

MCEDC recognizes the financial challenges small BioHealth companies face when securing small wet lab space in the region. Because young BioHealth companies are not always well-suited for conventional financing mechanisms for lab and office fit-out, MCEDC’s year-long pilot project will award grants to small-scale biotech companies that are struggling to fund lab fit-out costs.

The Bio Lab Pilot will focus on growth-stage BioHealth companies that want to lease small wet lab space in Montgomery County that is less than 5,000sf. This project will not fund shared lab space or incubators.

Four biotechnology companies were looking to raise a combined $303.9 million starting on Thursday as they announced Wednesday the pricings of their initial public offerings.

The companies – NextCure, Milestone Pharmaceuticals, Cortexyme and Axcella Health – all said Wednesday that they would begin trading on the Nasdaq Thursday, with their offerings expected to close Monday. BioPharmCatalyst, a biotech and healthcare investor website, had listed the companies as expected to begin trading Wednesday.

MJ Biotech, Inc. (f/k/a Michael James Enterprises, Inc.) (OTC: MJTV) announces that the Company has executed a Letter of Intent to explore a strategic relationship with VideoKall, Inc., a new player in telehealth, pioneering the first unmanned micro-clinics for indoor, mobile, and outdoor locations. Once the relationship is formalized, MJ Biotech will raise funds to pursue areas of common interests with market penetration in underserved locations across the US.

Virginia Bio, the premier statewide non-profit trade association representing the life sciences industry in the Commonwealth of Virginia, announced on May 2, 2019, during its innovative, bioscience conference, THRiVE 2019, that three new award winners are getting inducted into the prestigious Outstanding Contribution to Bioscience in Virginia Award Ceremony.