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.

Protenus, a Baltimore data security company, has raised $13 million in new equity financing, according to documents filed with the U.S. Securities and Exchange Commission.

By: Brian Darmody, CEO, Association of University Research Parks (AURP)

Across the country and around the world, cities, research universities, government labs and other actors are reformulating the way anchor institutions can help lead technology-based economic development as the geography of innovation shifts. 

Julie Wagner, Bruce Katz, Tom Osha and others have formed the Global Institute on Innovation Districts (GIID) https://www.giid.org/, which is doing research and policy implementation to advance Innovation Districts around the world. These districts, defined by GIID are “geographic areas where leading-edge anchor institutions and companies cluster and connect with start-ups, business incubators, and accelerators. Compact, transit-accessible, and technically-wired, innovation districts foster open collaboration, grow talent, and offer mixed-used housing, office, and retail.”

On April 2, 2019, the U.S. Small Business Administration (SBA) issued a new Policy Directive for the Small Business Innovation Research (SBIR) and the Small Business Technology Transfer (STTR) programs. All provisions in the new Policy Directive apply to both the SBIR and STTR programs unless specifically noted otherwise. The Policy Directive is available here.

The Biotechnology Innovation Organization (BIO) and the National Institutes of Health (NIH) today announced an agreement to feature Small Business Innovation Research (SBIR)-funded early-stage biomedical companies in an Innovation Zone at the 2019 BIO International Convention. The Innovation Zone companies, focused on drug discovery, diagnostics and other therapeutic platform technologies, will have dedicated exhibit space and participate in BIO’s One-on-One Partnering™ system. Select companies will make 15-minute company presentations in the BIO Business Forum.

Dr. Horea Rus is an expert in diagnosing and treating patients with multiple sclerosis, and his research laboratory at the University of Maryland is producing new tools for treating the disease that attacks the central nervous system.

On Tuesday, Rus and former postdoc research fellow Cosmin Tegla were issued U.S. Patent 10,280,465 for developing a biomarker, using Sirtuin 1, RGC-32, FasL, and IL-21 proteins, that indicates if a patient with relapsing-remitting MS is in relapse.

Sirnaomics Inc. has taken in yet another $11 million in investments, closing a Series C funding round that totaled $47 million.

The Gaithersburg biopharmaceutical company kicked off the round last year with $25 million in Series C1 financing — one of the biggest venture deals of the year last year in a generous overall haul for Maryland biotech companies. That was followed by an $11 million raise as part of a Series C2 round in January.

The US FDA approves an extended indication of GSK’s lupus treatment, Benlysta IV, for children five years and older, giving pediatric patients a new therapeutic option. Benlysta (belimumab) from Glaxo-Smith Kline was previously approved in 2011 by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the intravenous administration in adults with systemic lupus erythematosus (SLE) – the recent approval from the FDA extends the indication to children five years and above.

In the past year Sonavex has landed not one, but two FDA 510(k) clearances for their ultrasound-based medical devices. This first of its kind solution is comprised of two components, EchoMark and EchoSure, that use a customized ultrasound technology to perform real-time blood flow monitoring for postoperative patients.

Bahija Jallal, David Berman, Koustubh Ranadel, and now Mohammed Dar lines up as the latest AstraZeneca/MedImmune executive to jump ship into U.K. biotech Immunocore.

What do the technologies that led to the success of Kite Pharma, the creation of the pioneering immune-oncology cancer treatment avelumab (BAVENCIOⓇ) and the founding of miRecule, Inc. all have in common?

For Paragon Bioservices, news came quickly earlier this month. On a Thursday in mid-April, Gov. Larry Hogan and other state and county officials joined biotech community supporters at an Anne Arundel County site near BWI Airport that’s increasing capacity for the company’s work with large firms to manufacture new treatments. Specifically, speakers talked about the company’s expertise in gene therapy, which is an area of medicine that involves introducing DNA to fight a genetic disease.

United Therapeutics and Deka Research and Development have received FDA 510(k) clearance for the co-developed RemUnity system.

The RemUnity system is a subcutaneous delivery system for Remodulin injections. The two companies have co-developed the device that is indicated to treat pulmonary arterial hypertension.

Viela Bio spun out of AstraZeneca last year with six autoimmune and inflammation-aimed programs and $250 million. Now, the biotech is reporting positive pivotal data for its lead drug in a rare, autoimmune disease, teeing it up for an FDA filing later this year. 

Two years after Johns Hopkins Technology Ventures opened new office and lab space for its FastForward 1812 incubator on the Johns Hopkins Hospital campus, two companies have moved on to bigger space. LifeSprout, which had been in the incubator for about a year, moved last month to City Garage, where it will have manufacturing capabilities.

BrainScope announced today the publication of a study conducted by physicians at Washington University Barnes Jewish Medical Center in St. Louis in the peer-reviewed journal The American Journal of Emergency Medicine entitled “Reduction in unnecessary CT scans head-injury in the emergency department using an FDA cleared device.” The study demonstrated that the FDA-cleared BrainScope One medical device reduced the use of unnecessary head CT scans by nearly one-third in a hospital emergency room setting when compared to the use of standard clinical practice.

Project Onramp today announced they have placed more than 50 students in well-paid internships with top companies for summer 2019 through its first-in-the-nation Project Onramp program. The program will give the students – many of them the first in their families to attend college – hands-on experience and a valuable start towards a career in biotechnology.

“Project Onramp has created a new model for extending opportunities in the thriving biotech industry for high-achieving students who don’t have the personal or family connections that often play a big part in awarding internships,” said David Lucchino, chairman of MassBio and CEO and co-founder of Frequency Therapeutics. “The enthusiastic response from leading life sciences companies in Massachusetts has been overwhelming.”

Are you an experienced biohealth industry executive seeking full time or part time employment as a consultant or start-up C suite executive? BioHealth Innovation is establishing a database of experienced industry executives who may be able to share their expertise with early stage/growing companies.  To be considered by companies or technology transfer organizations seeking leaders for their spin-out companies and/or advisors to support their business growth, please complete the following form.

The University of Maryland has opened a 215,600-square-foot computer science facility on its College Park campus.

The university says the Brendan Iribe Center for Computer Science and Engineering will support team-based, interdisciplinary research in virtual and augmented reality, artificial intelligence, robotics, computer vision, algorithms, programming languages and systems.

Venture capital dollars are flooding into biotech, totaling $8.5 billion in 2017 alone. But there’s no one way to fund a startup.

Kilpatrick Townsend & Stockton and GreyB Services released today their findings from The First Annual Kilpatrick Townsend & GreyB Services Patenting Trends Study (Study). The Study provides clear and actionable information that assists decision makers in envisioning the technological future of their respective industries and setting their companies’ strategies over the coming years and decades in an increasingly globalized economy. 

The privacy and security of patient data continues to be increasingly important as access to this data increases and threats to this sensitive information continue to grow. At the same time, several new federal health information policies will make electronic health information about individuals more widely available to individuals and their caregivers and health care professionals. Lucia Savage, Former Chief Privacy Officer of HHS Office of the National Coordinator, will provide the opening keynote for the Privacy and Analytics (PANDAS) conference, focusing on innovation that equips privacy teams to effectively navigate the shift that occurs when organizations begin to more frequently utilize consumer tools to deliver healthcare.

The 3rd hour of TODAY looks at the Virginia-based biotech company Aperiomics, which says it has technology that could shake up health care and find answers for the millions of people living with chronic and undetected illnesses.

Car crashes, battle wounds, and surgeries can leave people with gaping holes in soft tissue that are often too large for their bodies to repair. Now, researchers have developed a nanofiber-reinforced injectable gel that can rebuild missing muscle and connective tissues by serving as a scaffold and recruiting the body’s wound-healing cells. So far, the team has tested the material only in rats and rabbits. But if it performs as well in humans, it could give reconstructive surgeons a fast and easy way to help patients regenerate lost tissues without scarring or deformity.

The newly published document, “2018: Evidence and Opportunity: Impact of Life Sciences in North Carolina,” is a fascinating story of transformation for a state that once held the unfortunate reputation as the second-poorest in the nation.

It marks the 10th anniversary of the North Carolina Biotechnology Center’s contract with TEConomy Partners to track and evaluate the state’s life science landscape.

The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announced five winners of its "Make Your Medical Device Pitch for Kids!" competition who will each receive $50,000 in grant funding and access to the consortium's first-of-its-kind "Pediatric Device Innovator Accelerator Program" led by MedTech Innovator. A panel of expert judges from business, healthcare, regulatory and legal sectors selected the winners based on the clinical significance and commercial feasibility of their medical devices for children. The competition focused solely on advancing care in pediatric orthopedics and spine, a sector that the FDA identified as an emerging underserved specialty which lacks innovation.

The University of Vermont Health Network Ventures and legal firm Wilson Sonsini Goodrich & Rosati recently invested in BioFactura’s $6M Series B Financing Round.

“With the commitment from the UVM fund and WSGR, BioFactura is now securing value-added institutional investors who bring significant financial and business resources to bear as we advance our biopharmaceutical products to the clinic,” said Darryl Sampey, BioFactura’s President and CEO.

In February 2019, the French immuno-oncology diagnostics company HalioDx opened its first laboratory in North America. The five-year-old company, a Qiagen spin-off, selected Richmond, VA, as the location of the lab, in part, because the state’s capital city is only a two-hour drive from the FDA’s headquarters in Maryland.