ROCKVILLE, Md., Jan. 6, 2022 /PRNewswire/ --

• Potential one-time gene therapy for the treatment of Duchenne includes a novel, optimized microdystrophin transgene and REGENXBIO's proprietary NAV® AAV8 vector 
• Innovative trial design, including comprehensive immunosuppressive regimen, to evaluate safety and optimal dose 
• cGMP process material made at commercial-scale to be used throughout clinical development of RGX-202
• REGENXBIO expects to initiate trial in the first half of 2022

REGENXBIO Inc. (Nasdaq: RGNX) today announced the clearance of its Investigational New Drug (IND) application by the United States Food and Drug Administration (FDA) to evaluate RGX-202, a potential one-time gene therapy for the treatment of Duchenne muscular dystrophy (Duchenne) in a first-in-human clinical trial. RGX-202 is designed to deliver a transgene for a novel microdystrophin that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO's proprietary NAV® AAV8 vector. REGENXBIO plans to initiate the trial in the first half of 2022.

Maryland biotech company Zalgen Labs has moved to Frederick, illustrating the magnetism of the biotech hub for leaders like its own Dr. Luis Branco who want to capitalize on the new sense of collaboration the pandemic has brought about in life sciences companies in the region.

The move to Frederick puts Zalgen closer to the epicenter of what’s known as BioHealth Capital Region (BHCR) that encompasses Maryland, Virginia and DC. Frederick alone is home to over 80 biotech companies, according to the county’s Office of Economic Development.

Imagine you’re working outside and accidentally cut your foot on a protruding stick you didn’t see. No big deal. You go inside and wash the wound, perhaps applying an antibiotic cream, and dress it in a bandage. Days and weeks, even months go by, however, and the wound just doesn’t want to seem to fully heal. Even the simplest of tasks such as walking becomes extremely painful, and just one wrong move reopens the wound.

For millions around the world, this is their daily reality. From diabetic ulcers to bedsores, from burns to cancer complications to infections, chronic wounds are complex and vastly underappreciated as a therapeutic space.

Molecular Biologicals, located in the blossoming biotech hub of Charlottesville, VA, is working to change the game in chronic wound care through its unique and proprietary keratin manufacturing platform.

Click here to read more via BioBuzz.

On this snowy start to 2022, I wanted to share with you two interviews with AHEAD100 Chief Scientist Dr. James Crowe that occurred over the last week on CNBC and Bloomberg TV. Each piece is a powerful continuation of our work to build awareness and support for the work of the Global Pandemic Prevention and Biodefense Center and lead initiative, AHEAD100 — and together, they garnered more than 100 million impressions, representing more than $1 million in advertising value equivalent.

BioHealth Innovation (BHI) is an innovation intermediary that facilitates the commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia). We are seeking a Life Sciences Business Strategist to join our team remotely.

The right candidate will be an energetic and continuous learner who is passionate about accelerating the adoption of new technologies to improve lives. The position is geared toward an early-career scientist (generally in their first 5-7 years after receiving their PhD) who wants to engage with the biohealth industry in new ways.

Download the Full Job Description.

Global health tech companies are queueing up for one of the world’s largest in-person events of the New Year- CES 2022. The global health tech event would showcase innovative ideas from over 2200+ exhibitors between 5 and 8 January in Las Vegas. CES 2022 will go forward as an important innovation for world health and safety, mobility and solving problems will be exhibited. Furthermore, thousands of smaller and medium-sized companies rely on CES for their business.

Image: https://aithority.com

Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against

Omicron (B.1.1.529) and other variants

Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise and a 19.9-fold ACE2 inhibition increase after booster dose

Immune responses in adolescents were 2- to 4-fold higher than adults against broad array of variants of interest and variants of concern Development of Omicron-specific vaccine on track for initiation of GMP manufacturing in early January

Company to host investor conference call today from 4:30 – 5:00 pm ET

GAITHERSBURG, Md., Dec. 22, 2021 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced initial data evaluating the immune response of its COVID-19 vaccine, NVX-CoV2373, against the Omicron variant as well as additional data from its ongoing Phase 2 boost study. New results demonstrate broad cross-reactivity against Omicron and other circulating variants from a primary 2-dose regimen, with responses that increased following a third dose at six months.

The University System of Maryland (USM) retained the Jacob France Institute of the University of Baltimore to prepare this update of the prior 2012 The Economic Impact of the University System of Maryland: A Fiscal Perspective FY2011 report. This analysis uses the Human Capital Approach to assess the system’s economic impact and State of Maryland’s return on its investment by assessing the incremental earnings impacts associated with four cohorts of USM graduates and the current impacts of out-of-state spending attracted to Maryland by the USM. The key findings of this analysis are as follows:

On Thursday, Governor Larry Hogan announced three key appointments in Maryland.

Former Maryland Secretary of Commerce Mike Gill has been named secretary of the Maryland Department of Commerce, succeeding Secretary Kelly Schulz.

Gill is chairman of Columbia-based Evergreen Advisors, which was his role prior to serving as Maryland’s secretary of commerce from 2015 to 2019. He has four decades of experience in business, which includes founding Hoyt Capital, an investment and advisory firm serving startups and growth companies. He served as a member of the University System of Maryland Board of Regents from 2004 to 2009.

Image: Photo of Maryland flag at Annapolis State House (WBFF)

Investment into biotech and health care boomed during the pandemic as thousands of venture capital firms turned their attention to breakthrough artificial intelligence, cancer-detection technology, mental health treatments, digital doctor visits, diagnostics and more. 

But two of those investment firms have emerged as major leaders, not only in the number of biotech funding rounds led, but also in overall dollars invested into the industry. Boston-based RA Capital Management and New York-based OrbiMed ranked first and second, respectively, on the two lists compiled using Crunchbase data. 

Image: https://news.crunchbase.com

Total research and development (R and D) expenditures at American colleges and universities topped $86 billion in Fiscal Year 2020, according to the most recent Higher Education Research and Development (HERD) Survey, released by the National Science Foundation (NSF) on Monday. The total represents an increase of $2.7 billion (3.3%) over FY 2019.

By Holden Wilen - Reporter December 23, 2021, 01:35pm EST Personal Genome Diagnostics has agreed to be acquired by one of the world's largest life sciences companies in a deal that could pay up to $575 million.  

Baltimore-based PGDx has agreed to sell to Laboratory Corp., of America Holdings, better known as Labcorp. The Burlington, North Carolina-based giant is a leader in medical testing and drug development, and has played a particularly important role during the last year and a half with Covid-19 testing. PGDx specializes in developing in vitro diagnostic (IVD) tests that can be used to analyze the DNA of tumors to diagnose cancer.  

Pharmacy Times interviewed Ronald T. Piervincenzi, PhD, the CEO of US Pharmacopeia (USP), on reflections from 2021 and predictions for 2022.

The discussion is the seventh in a video series collaboration between Pharmacy Times and USP that highlights USP’s work to support the pharmacist and discussed USP’s perspective on timely and topical issues in the field.

Personal Genome Diagnostics has agreed to be acquired by one of the world's largest life sciences companies in a deal that could pay up to $575 million.

Baltimore-based PGDx has agreed to sell to Laboratory Corp., of America Holdings, better known as Labcorp. The Burlington, North Carolina-based giant is a leader in medical testing and drug development, and has played a particularly important role during the last year and a half with Covid-19 testing. PGDx specializes in developing in vitro diagnostic (IVD) tests that can be used to analyze the DNA of tumors to diagnose cancer.

Image: Personal Genome Diagnostics, or PGDx, which is based in Canton, is getting bought by life sciences giant Labcorp. Carley Milligan

As the omicron variant became the dominant strain in the U.S. this week, health care providers are left with fewer options to treat positive COVID-19 patients as most of the existing treatments have been found to be less effective in fighting off the new variant.

Up until recently, the U.S. Department of Health and Human Services (HHS) had been distributing three types of COVID-19 antibody treatments, Regeneron monoclonal antibodies, Eli Lilly’s antibody treatments and GlaxoSmithKline’s sotrovimab monoclonal antibody.

Please join us in welcoming our two newest members of the CLS Board of Directors!

• Vasiliki Anest,Ph.D: serves as Chief Innovation Officer for USC Norris Comprehensive Cancer Center

• Kwame Ulmer: is a venture partner at Wavemaker Three-Sixty Health

Their experience and backgrounds will be invaluable in supporting CLS’s goals to empower the life sciences ecosystem.

Image: https://www.linkedin.com/feed/update/urn:li:activity:6877654463474143232/

ROCKVILLE, MD. (PRWEB) DECEMBER 21, 2021 Data from the First Three Patients Shows Critical Efficacy Markers of the HIV Cure Cell Therapy: Engraftment, Persistence, and Maintained HIV-clearing Functionality of Infused Cells

American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached two important milestones for its HIV cure program.  

All three patients achieved engraftment of the genetically modified cell product, AGT103-T, and avoided rejection of the infused cells. In addition, patient samples were challenged to determine if their HIV-specific response remained active. All three products demonstrated an active response. These two studies confirm that the patients retained an appropriate concentration of the product and indicate AGT103-T should be able to create an effective immune response against HIV in the absence of antiretroviral treatment (ART).  

Located in the heart of Maryland’s Shady Grove Life Sciences Center, 9603 Medical Center Drive has efficient access to all points in Montgomery County via Route 355 and I-270 and is minutes to the Intercounty Connector (Route 200), which connects I-270 to I-95.

Click here for more information.

Since the beginning of the global pandemic, capital has flowed into the BioCapital Health Region. Billions of dollars from Operation Warp Speed, as well as private venture firms, have poured in to support startups, as well as companies focused on pandemic responses.

Image: Image / Pixabay  

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.