Company's Third Major Acquisition Expands European Presence in Germany; Adds New Electronic Data Capture Tool to Enhance Real World Evidence Research

ROCKVILLE, Md., Dec. 21, 2021 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that it has acquired Institut Dr. Schauerte, a CRO headquartered in Munich, Germany.  Founded in 1990, Institut Dr. Schauerte is a full-service, technology-oriented CRO that specializes in late-phase, non-interventional, and post-market clinical follow-up studies.  It has conducted more than 400 studies across a range of therapeutic areas. 

Three Johns Hopkins faculty members are among 164 creators or co-developers elected as fellows of the National Academy of Inventors, a distinction that recognizes the people behind the outstanding inventions that have made a difference for society. They join the more than 4,000 current fellows of the academy, which features members of more than 250 institutions worldwide.

Conservationists fear that horseshoe crabs, a 450-million-year-old living fossil, will be pushed to the brink of extinction because of the value of their blood to the pharmaceutical industry. Horseshoe crab blood provides a natural source of limulus amebocyte lysate (LAL) which is used to test vaccines, drugs, and medical devices to ensure that they aren’t contaminated with dangerous bacterial toxins called endotoxins. With hundreds of thousands of horseshoe crabs captured and bled of their milky-blue blood each year, conservation groups are now stepping up their advocacy efforts and taking legal action to help save horseshoe crabs and the other species that rely on them.

Image: Horseshoe crabs are bled at the Charles River Laboratory in South Carolina. Timothy Fadek

Johnson & Johnson Innovation is recruiting a Senior Operations Manager, JLABS @ Washington, DC to be located in Washington, DC.  The goal of Johnson & Johnson Innovation is to advance transformative healthcare solutions that improve the lives of people around the world and, in so doing, to deliver value to Johnson & Johnson (“J&J”).  JJI accomplishes this by catalyzing new science and technology through collaboration and exchange of ideas. This growing team is looking for a colleague inspired to help build and innovate new ways of fostering a productive life-science ecosystem.

The $1 billion Build Back Better Regional Challenge is the marquee of EDA’s American Rescue Plan programs that aims to boost economic recovery from the pandemic and rebuild American communities, including those grappling with decades of disinvestment.

The Challenge provides transformational investments to develop and strengthen regional industry clusters across the country, all while embracing equitable economic growth, creating good-paying jobs, and enhancing U.S. global competitiveness. As part of the $300 million Coal Communities Commitment, EDA will allocate at least $100 million of the Build Back Better Regional Challenge funding to support coal communities.

Last year we had nearly 2,000 votes for our inaugural 2020 awards – this year we not only surpassed that number but smashed it with over 4,500 votes total. The outpouring of support across networks and social media was truly incredible and is a testament to the strength of our community in the Biohealth Capital Region. From all of us at BioBuzz, thank you for being such an important part of our regional community.

The award categories include:

• Community Builder Award
• ‘John Holaday’ BioHealth Leadership Award
• BioBuzz Media Award
• Workforce Champion of the Year Award
• COVID-19 Impact Award
• Breakthrough Company of the Year Award
• Employer of the Year Award

And now, cue the drumroll – here are your 2021 BioBuzz Award winners! Congrats to all of this year’s winners as well as our amazing finalists and nominees.

FREDERICK, Md. and BRISBANE, Australia, Dec. 13, 2021 /PRNewswire/ -- In anticipation of the U.S. Food & Drug Administration's (FDA) granting emergency use authorization to two new antiviral treatments for COVID-19, digital diagnostics company Ellume today announced that its COVID-19 Home Test (ECHT) will soon allow users to connect directly with telemedicine providers, which builds on the test's existing capability to share their result directly to healthcare providers. This direct, digital connection to telemedicine providers, currently in development, will help ensure patients have quick access to the new antiviral treatments, which typically must be taken shortly after infection to be most effective. 

Maryland's Interstate 270 corridor has been a burgeoning life sciences hub for several years, but with the federal government pumping billions into the region during the coronavirus pandemic and more established research tenants beginning to reach maturity, the D.C.-Baltimore region has rocketed to become the third-fastest-growing life sciences market in the country, according to a recent CBRE report.

Image: Bisnow/Jacob Wallace Equilibrium's Jason Rifkin, Scheer Partners' Matthew Brady, the Montgomery County Planning Board's Tina Patterson, GlenLine Investments' Scott Nudelman and JLL Mid-Atlantic's Peter Briskman

D.C.’s Nanochon LLC just got a step closer in its quest to get a 3D-printed implant to market — thanks to $2 million in fresh funding and the potential to raise more.

The company’s seed round, led by University of Virginia Licensing & Ventures Group’s seed fund, closed at $2 million in September, Nanochon co-founder and CEO Ben Holmes said in an interview. And it’s oversubscribed, now in the process of raising more before a second close.

Quantum computing won’t be an incremental improvement – it will be a step-change in the power of the technology that underpins a huge part of our economy. Exponentially faster computing won’t just help us solve problems more quickly, but it will also allow us to tackle problems that have been impossible to answer and find answers to questions we did not know to ask.

Research Shows Vaccine Has 90 Percent Efficacy at Preventing Infections; Moderate to Severe Disease Occurred Only in Placebo Recipients

An investigational COVID-19 vaccine made by Novavax was found to be 90 percent effective at preventing COVID-19 illness, according to results from a Phase 3 clinical trial published today in the New England Journal of Medicine. The University of Maryland School of Medicine’s (UMSOM) Center for Vaccine Development and Global Health served as one of the trial sites, and Karen Kotloff, MD, Professor of Pediatrics at UMSOM, served as Co-Chair for the trial protocol.

GAITHERSBURG, Md., Dec. 16, 2021 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE: EBS) today announced the first participant dosed in its phase 1 study, EBS-UFV-001, evaluating the safety, tolerability, and immunogenicity of the company’s investigational universal influenza vaccine candidate. This current version of Emergent’s universal influenza vaccine candidate contains multiple components intended to induce broad and supra-seasonal immunity against influenza A viruses.  

“Emergent remains focused on investing in our diverse portfolio of R&D programs targeting infectious disease and other public health threats,” said Kelly Warfield, Ph.D., senior vice president, research and development at Emergent BioSolutions. “Initiating this phase 1 study demonstrates our commitment to advancing our pipeline and our research and development team’s scientific prowess to adopt an innovative technology and investigate a potential vaccine candidate for a disease that affects millions every year.”  

Frederick, MD, December 16, 2021 – One of the leading biotechnology and diagnostics companies in the field of neglected viral diseases with pandemic potential now calls a prime biotechnology and life sciences community its home, as Zalgen Labs LLC today announced its headquarters has relocated to Frederick, Maryland.  

Preparedness is Zalgen’s mantra. Founded on the concept of developing solutions to emerging viral threats in neglected regions of the world, Zalgen is dedicated to making a meaningful difference in developing and deploying medical countermeasures against neglected tropical diseases. The company is currently supplying antibody testing kits to the Coalition for Epidemic Preparedness Innovations (CEPI) for the largest ever Lassa Fever study in West Africa.  

New collaboration with Johnson & Johnson Innovation announced with the aim to accelerate life science sector growth in the New River and Roanoke Valleys by providing access to expert mentors, programming, and commercialization resources for startup companies

Image: https://www.vtcrc.com

BLACKSBURG, Va. (WDBJ) - “Just watch, we’ve got some great things coming,” Virginia Tech Corporate Research Center President and CEO, Brett Malone said as he closed the gathering on Wednesday afternoon.

More than 50 Leaders and residents from the Roanoke Valley and New River Valley gathered as the Virginia Tech Corporate Research Center announced a new “GO Virginia” Grant, that will help advance life science research across the region. The grant is for $599,000 and will cover the majority of the $1.1 million project, with partners helping to cover the rest.

OXFORD, United Kingdom, and BALTIMORE, Dec. 13, 2021 (GLOBE NEWSWIRE) -- Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company engaged in the discovery and development of novel immunotherapies and vaccines, today announced that it has acquired US-based Avidea Technologies, Inc. (“Avidea”).

The consideration to Avidea’s existing shareholders is $40 million (comprised of approximately $12.5 million in cash and $27.5 million in Vaccitech American Depository Shares) in addition to potential future payments that are conditioned upon the achievement of certain development milestones.

Washington D.C., Dec. 10, 2021 (GLOBE NEWSWIRE) — The National Capital Consortium for Pediatric Device Innovation (NCC-PDI) announces five awardees chosen in its prestigious annual “Make Your Medical Device Pitch for Kids!” competition to share $150,000 in grant funding from the U.S. Food and Drug Administration (FDA) to support the advancement of pediatric medical devices. In an unprecedented decision, the competition judges determined that all five finalists were deserving of a grant award and recognition for the potential patient benefit and commercial viability of their innovations. 

Health and Human Services Secretary Xavier Becerra today announced that Lawrence A. Tabak, D.D.S., Ph.D., the principal deputy director of the National Institutes of Health (NIH), will serve as the acting director of NIH effective December 20, 2021.  

Earlier this year, current NIH director Francis S. Collins, M.D., Ph.D., announced his decision to end his tenure as the NIH director by the end of the year, and his last day as director will be December 19, 2021.  Dr. Collins is the longest-serving, presidentially-appointed NIH director, having served three U.S. presidents over more than 12 years.

Novavax Inc. (NASDAQ: NVAX) just earned a critical approval to expand its Gaithersburg campus, paving the way for the homegrown biotech to exponentially grow its local footprint and stand up facilities to support research, development and manufacturing for years to come.

The Gaithersburg city council unanimously approved Novavax’s development plan on Monday, marking the end of the approval process and giving the company the green light to advance the project — which could extend up to 605,000 square feet.

“Novavax is pleased with this next step in our continued progress, and we appreciate the support from Mayor [Jud] Ashman and the City Council as we expand our important work in the Maryland biotech ecosystem,” Silvia Taylor, Novavax’s senior vice president of global corporate affairs and investor relations, said in an email Tuesday.

The project stands to swell the company’s Montgomery County footprint, which today comprises 79,000 square feet. It’s slated to include two seven-story buildings, a parking garage and green space in the center of the campus. The 180,000-square-foot facility would include laboratory, office and manufacturing space. It may also include up to 5,000 square feet of retail space.

Click here to read more via the WBJ

The United States Agency for International Development has awarded a $204 million extension to the Johns Hopkins Center for Communication Programs to continue Breakthrough ACTION, its flagship global social and behavior change project, through July 2025.

Started as a five-year, $300 million project in July 2017, Breakthrough ACTION has now worked in 42 countries in Africa, Asia, and Latin America to forge, test, and scale up new and hybrid approaches to social and behavior change. The project uses state-of-the-art, evidence-based tools and collaborations to encourage people to adopt healthy behaviors such as using modern contraceptive methods, sleeping under bed nets, or being tested for HIV. Breakthrough ACTION harnesses the power of communication to inspire long-lasting change and incorporates behavioral science approaches such as behavioral economics and human-centered design to improve programs.

Image: CENTER FOR COMMUNICATION PROGRAMS

A global center focusing on pandemic prevention and biodefense work will be in Rockville, county officials and partners in the project said Wednesday.

Connected DMV, a nonprofit that focuses on initiatives with government, private industry academia and community partners, will launch the center.

Monoclonal antibodies have become one of humanity’s most powerful, multi-use tools in biology and medicine. Once the field of immunology established that they could be produced to bind very specifically to almost any suitable substance, science has had a means of detecting and/or purifying those substances or, in the case of viruses, identifying the antibodies that will serve as effective treatments. And in these times of pandemic, tools to detect viruses such as SARS-CoV-2 at the point of care and produce novel vaccines are more important than ever. 

Image: Dr. James Crowe, Vanderbilt University Medical Center, Nashville, Tennessee

AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.

The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.

ROCKVILLE, Md., Dec. 08, 2021 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (NASDAQ: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, today announced it has resubmitted its New Drug Application (NDA) for its apomorphine infusion device (SPN-830) for the continuous treatment of motor fluctuations (OFF episodes) in Parkinson’s Disease (PD).

Following the original submission of the NDA for SPN-830, the U.S. Food and Drug Administration (FDA) issued a Refusal to File (RTF) letter in November 2020 indicating that the NDA was not sufficiently complete to permit a substantive review. The FDA provided additional clarity related to the contents of the November 2020 RTF letter and the requirements for resubmission during a Type A meeting with Supernus in March 2021

Rockville, Md. — Montgomery County is home to the new Global Pandemic Prevention and Biodefense Center launched by Connected DMV. The Center will be co-located in Rockville at the US Pharmacopeia offices at 12601 Twinbrook Pkwy, Rockville, MD 20852. 

Connected DMV, a leading Greater Washington organization that seeks to help solve complex regional challenges, spearheaded efforts to establish the Global Pandemic Prevention and Biodefense Center in response to the COVID-19 pandemic. The Center’s goal is to help prevent future outbreaks from becoming pandemics by developing a stockpile of human monoclonal antibodies in advance for emerging infectious diseases and by integrating antibody distribution and delivery across the global health and pandemic prevention ecosystem. Montgomery County is uniquely positioned to be the host location for the Center, which aims to harness the rich talent and critical health research, biotech, defense, and government assets required to deliver a full-scale response.

Our internal 24-hour circadian clock regulates many aspects of physiology, including the response to infectious disease and vaccination. A new study published in the Journal of Biological Rhythms demonstrates that antibody levels are higher when people receive the SARS-CoV-2 vaccine in the afternoon versus the morning.

Image: https://news.harvard.edu/

COLLEGE PARK, Md., December 07, 2021--(BUSINESS WIRE)--IonQ, Inc. ("IonQ") (NYSE: IONQ), a leader in trapped-ion quantum computing, today announced its participation at the fifth Q2B Practical Quantum Computing Conference (Q2B 2021). On the heels of multiple recent milestones, the IonQ team will discuss strategies and tactics for a successful enterprise partnership approach, as well as practical machine learning applications as the team paves the way for quantum computing commercialization.

The transition from Angel to institutional funding is a key step (but not quite an absolute requirement) in the evolution of a start-up bringing a new device to market. Broadening investments accompany deepening organizational sophistication, as start-ups more and more take on the business and regulatory trappings of larger device companies. However, even the best medical devices proposed by the best founding teams must cross the most critical governing threshold before reaching the market.

Image: https://medium.com

We work alongside our entrepreneurs as partners to drive the next wave of startups. We leverage our diverse operating and investing experience to uncover opportunities to add value throughout the life cycle of our portfolio companies. Our goal is to meaningfully contribute to the greatest shared outcomes.

Innoforce (“INF”), a biopharmaceutical manufacturing & development company, announced today the completion of a 1 billion CNY ($156.6M) Series A financing, with the closing of an additional 375M CNY ($58.7M) following the first tranche of 625M CNY ($96M) completed in March 2021.

The Series A financing round was co-led by Yanchuang Capital and South China Venture Capital (SCVC) with additional investment from existing investor Quan Capital Management. In the most recent tranche, Yanchuang Capital increased its investment and additional investors joined, including Advantech Capital, Triwise Capital, CICC Capital, Highrun Capital, Euland Venture, S&G CAPITAL and others.

The critical shortage of “wet lab” space in Baltimore is an indictment of a city economic development strategy more concerned with real estate development than with job development (”Baltimore officials hoping to address shortage of ‘wet lab’ space to retain more innovators,” Nov. 15). Colin Tarbert, head of the Baltimore Development Corporation, warned that the shortage jeopardizes the city’s ability to retain existing life science companies, let alone attract new ones.

Image: https://www.baltimoresun.com/opinion/readers-respond/bs-ed-rr-wet-labs-letter-20211206-dgtyymlxqrbgnijb4xg277gpje-story.html

BD has settled on a new name for its new company, the independent spinout that will house its billion-dollar diabetes care business. 

Embecta is set to launch as its own, publicly traded brand in the second quarter of 2022 after almost a century of supplying a portfolio of insulin pens and syringes under the BD banner. The diabetes division contributed about 6% of the company’s revenues in the 2020 fiscal year, or nearly $1.1 billion, by serving about 30 million users worldwide.

Image: Carrying over the “bect” in its logo as a nod to Becton, Dickinson and Company, embecta will maintain international manufacturing sites that previously produced around 8 billion injection devices annually. (BD)

SAN JOSE, Calif. & BETHESDA, Md.--(BUSINESS WIRE)--Accellix Inc., which provides quick and accurate flow cytometry results in a compact and easy-to-use platform designed for use by cell therapy companies on the manufacturing floor and at the point-of-need, today announced that it has raised $10 million from BroadOak Capital Partners.

BroadOak is known for its flexible growth capital and M&A advice for life sciences tools and services companies. The investment is part of BroadOak’s fifth fund and marks the firm’s third investment in the last six months in the rapidly growing market of tools and services for cell and gene therapy development and manufacturing. BroadOak previously invested in Accellix as part of a prior fund.

The Maryland Stem Cell Research Fund (MSCRF) offers six grant programs to accelerate human stem cell-based research, commercialization, and cures. The six programs are designed to support scientists at universities/research institutes or companies based in MD as well as any US-based company with a clinical trial site in MD.  

All programs are now accepting applications. Learn more and apply by January 13, 2022: https://www.mscrf.org/funding-opportunities

Research funded by the MSCRF has led to breakthroughs in stem cell technologies. Discover how MSCRF is accelerating cures - https://www.mscrf.org/our-impact

• Initial Phase 1/2 data presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition 
• Phase 1/2 study of NEXI-002 as a monotherapy in patients with relapsed/refractory multiple myeloma patients who have failed ≥3 prior lines of therapy is ongoing

GAITHERSBURG, Md., Dec. 12, 2021 (GLOBE NEWSWIRE) -- NexImmune, Inc. (Nasdaq: NEXI), a clinical-stage biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells, today announced preliminary Phase 1/2 results from an ongoing study of NEXI-002, a patient-derived multi-antigen-specific CD8+ T cell treatment for patients with relapsed/refractory multiple myeloma who have failed ≥3 prior lines of therapy. The data on low doses of NEXI-002, presented at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition, showed a promising safety and tolerability profile and evidence of immunologic and clinical activity.