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.

OVERVIEW

BioHealth Innovation, Inc. (BHI), is a Montgomery County innovation intermediary which translates market-relevant research into commercial success by bringing together management, funding, and markets. BHI is seeking a life sciences professional with consulting, market research and/or portfolio management experience to join the BHI's team and serve as a Senior Analyst, Ph.D. to manage and support the Analyst team through training and front facing of potential start-up CEOs and Companies.

POSITION DESCRIPTION – Senior Analyst, Ph.D.

The Senior Analyst will manage the analysts and provide project support and guidance to the team as well as to new entrepreneurs on projects including SBIR Grants, corporate and private investments. This will entail market, technology, regulatory and other business intelligence research to support BHI consulting, coaching of companies and the Analyst team profit center. This is a hands-on leadership position. 

Download the Full Job Description.

Athari Biosciences has selected Loudoun County for its new corporate headquarters.

The project includes a wet lab, a tech lab, research and development and office space and is expected to open in early 2022. The project is expected to create 50 jobs with a total investment of $5 million, according to the county’s Department of Economic Development.

The Board of Supervisors will consider a cash incentive of $120,000 to support the completion of the lab space at its Dec. 7 meeting. The incentive has been proposed by the economic development department, which worked with Athari’s leadership team in the search for the firm’s long-term home in the region.

About a decade before becoming NIH Director—a position from which he will step down at year’s end—Francis S. Collins, M.D., Ph.D., was at the center of one of the hottest debates in the nascent days of genomics: How many protein-coding sequences comprise the human genome?

Image: Francis Collins

CoSolve is a biannual, global Open Innovation programme seeking collaborators with innovative solutions to real research challenges. These challenges lie within our R&D research focus areas and require solutions that are immediately translatable. We are looking for collaborators from start-ups and early stage biotechs with expertise in these specialised areas, who can bring innovative ideas that can be rapidly translated into tangible solutions. Working together, your ideas could help shape the development and delivery of new therapies and bring them to patients sooner.

The company said Thursday it’s implementing “a two-pronged variant strategy” for the variant.

Possible Life Sciences and Biotechnology Office Building Coming to Pike & Rose in Location Currently Occupied by Bark Social

We recently learned of plans for a potential new office building that could be constructed at 935 Prose Street in Pike & Rose, the current site of Bark Social. 

The plans, authored by Scheer Partners, state that the new building will be a 10-story trophy-class, state-of-the-art research/lab building that marries iconic design, and superior lab functionality. The architectural plans show lab space, office space, a fitness center, outdoor green terrace, conference facility, and more. 

Image: https://mocoshow.com

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation with a purpose to provide a brighter future for patients, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2022. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The awards list was announced on December 2, 2021, available on Newsweek’s website, recognizes the top 500 most responsible companies in the United States, spanning 14 industries.

In an interview with PharmaShots, Dr. Murat Kalayoglu, MD, Ph.D., President, and Chief Executive Officer at Cartesian Therapeutics shared his insights on the P-I/IIa study of Descartes-08 for the treatment of the chronic autoimmune disorder generalized myasthenia gravis (gMG)

Shots:

• Descartes-08 is an autologous T-cell product that is engineered with RNA to encode for CAR 
• The company focuses to use RNA instead of DNA to engineer the cell target that helps to target antigen without increasing the risk of these cells proliferating out of control and causing the typical CAR-T cell toxicities 
• Cartesian has currently three RNA cell therapies i.e., Descartes-08 & Descartes-11 which are being developed for multiple myeloma, high-risk patients, newly diagnosed multiple myeloma while Descartes-30 is an off-the-shelf, RNA engineered cell therapy. The company is expected to complete the P-II studies in 2022 and registration studies in 2024

A Baltimore startup that uses computer software to develop cancer drugs has raised $1.5 million in new funding, according to a recent filing.

Rasio Therapeutics is part of Early Charm Ventures, a Baltimore company focused on running and growing startups. The $1.5 million investment comes from BlueDot Bio, a relatively new investment company, said Ken Malone, managing director of Early Charm Ventures.

Click here to read more via Bizjournals (subscription required)

Peterborough, 30 November 2021

• Gut health could be boosted without reliance on antibiotics and other medicines
• Bacteriophages are natural and abundant
• Exploration aligns with AB Agri's sustainability agenda for food production

AB Agri has partnered with US biotechnology company Intralytix to explore the use of bacteriophages – the natural viruses of bacteria – in animal feed as an alternative to antibiotics and other drugs.

GAITHERSBURG, Md. (7News) — The Omicron variant is quickly becoming a household name but the hope is that it won’t enter households here in the D.C. area.

After what happened a few months ago with the Delta variant many are growing more concerned with this variant especially because on the surface preliminarily it appears to be more stubborn.

Most scientists believe it’s not a question of if but when it will become an issue here in the United States, so a handful of companies are already working on vaccines to combat it.

In Gaithersburg, Maryland, Novavax says it has already started working on a version of its COVID-19 vaccine to target this new variant detected in South Africa.

Click here to read more via 7News