ROCKVILLE, Md., Nov. 9, 2021 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the closing of its Collaboration and License Agreement with AbbVie to develop and commercialize RGX-314, a potential one-time gene therapy for the treatment of wet age-related macular degeneration (wet AMD), diabetic retinopathy (DR) and other chronic retinal diseases. As previously announced on September 13, 2021, under the terms of the agreement, REGENXBIO will receive an upfront payment from AbbVie of $370 million with the potential for REGENXBIO to receive up to $1.38 billion in additional development, regulatory and commercial milestones.

Under the collaboration, REGENXBIO will be responsible for completion of the ongoing trials of RGX-314. AbbVie and REGENXBIO will collaborate and share costs on additional trials of RGX-314, including the planned second pivotal trial evaluating subretinal delivery for the treatment of wet AMD and future trials. AbbVie will lead the clinical development and commercialization of RGX-314 globally. REGENXBIO will participate in U.S. commercialization efforts as provided under a mutually agreed upon commercialization plan.

VENLO, Netherlands & HILDEN, Germany--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced its commitment to a science-based target of net-zero carbon emissions by 2050 in order to help limit global warming to 1.5˚C. This move supports the goals set out by the Paris Climate Agreement and marks an important milestone in QIAGEN’s sustainability efforts.

“Social and environmental responsibility are vital to our business. In pledging to become carbon neutral by 2050, we are taking these commitments to the next level and embedding environmental sustainability in everything we do.”

Tweet this QIAGEN’s ambition to reach net-zero by 2050 applies to its entire value chain and fulfills the criteria of the Science-Based Targets initiative (SBTi), a partnership between the non-profit disclosure specialist CDP, United Nations Global Compact (UNGC), World Resources Institute (WRI) and World Wide Fund for Nature (WWF).

The efforts to find a functional cure for HIV are speeding up for one Maryland company after the Data Safety and Monitoring Board found no serious, adverse events with the third patient, as was the case for the previous two, American Gene Technologies announced.

"One patient can be lucky. Two can be very lucky. Three is a trend, and so actually the Data Safety and Monitoring Board has decided that they will meet quarterly from now on. We don't need to check in with them between each patient, so that means we can greatly accelerate the clinical trial," said CEO and Founder of American Gene Technologies Jeff Galvin.

Ellington West, CEO & Co-founder of Sonavi Labs, joins BioTalk to discuss their building the startup, their medical device, and raising funds in the BioHealth Capital Region.

Listen via Apple https://apple.co/3H25FPN, Google https://bit.ly/3kfXaXH, Spotify https://spoti.fi/3kgBLxI, and TuneIn https://bit.ly/3H43oU6.

The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC),  announced that it has awarded $1.9 million in grants to three life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 12 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.

“We are excited to continue our mission of supporting collaborations and fostering economic growth in Virginia’s life sciences, enabling the Commonwealth to compete on a national and global scale,” said Mike Grisham, CEO, Virginia Catalyst. “The critical mass achieved by these collaborations provides Virginia with competitive advantages over other states and has resulted in significant outside capital being invested to finance the commercialization of Virginia’s innovations and create significant high-paying jobs for the Commonwealth.”

Richmond, VA, Oct. 13, 2021 (GLOBE NEWSWIRE) — The Center for Innovative Technology (CIT) today announced that CIT GAP Funds, the direct investment program of the Virginia Innovation Partnership Authority (VIPA) has invested in Charlottesville, Va.-based Cerillo. Cerillo designs innovative laboratory technologies that allow scientists to collect data more efficiently and researchers to amplify their impact on the world. Cerillo will use CIT’s funding to expand sales and marketing efforts and to continue expanding its business operations and product development teams, which will position the company for rapid growth.

Germantown, MD (November 4, 2021) – Deka Biosciences is pleased to announce the appointment of six new members to its Scientific Advisory Board: Aurélien Marabelle, MD, PhD (Gustave Roussy), Aung Naing, MD, FACP (MD Anderson Cancer Center), Abhishek Tripathi, MD (OU Health Stephenson Cancer Center), Khusru Asadullah, MD (The Charité – Universitätsmedizin Berlin, Dermatological Practice in Potsdam), Hans-Dieter Volk, MD (The Charité – Universitätsmedizin Berlin), and Florin Selaru, MD (John’s Hopkins University). 

“It is my honor to welcome such a highly esteemed group of world leaders and experts in regulation of the immune system to the company’s Scientific Advisory Board” said Dr. John Mumm, CEO, Deka Biosciences. “Each member will be invaluable to Deka as we continue to develop our Diakines into the next generation targeted cytokine platform that drive cures in both cancer and in patients suffering from autoinflammatory disease.”

The U.S. Department of Health and Human Services declared a Public Health Emergency (PHE) in response to the COVID-19 pandemic on January 31, 2020.

The Centers for Medicare & Medicaid Services followed by issuing waivers covering certain requirements that directly impact nurse aide training.  Legislators and regulators reacted by approving individual state waivers aligned with CMS’ guidance that aimed to ease the challenges of increasing the number of certified nurse aide caregivers. Some of the most significant challenges include the closure of or limited access to nurse aide testing facilities, a shortage of qualified nurse instructors and mandated quarantine protocols.   

November 2, 2021, Baltimore, MD – In a move to accommodate its continued fast growth, Early Charm – a company that creates, owns and operates ventures that convert science to revenue – announced today it is more than doubling its production and lab space at Baltimore's 1100 Wicomico building.

This significant expansion will occur adjacent to Early Charm's 3,200 square feet of current production and development space, bringing total production and development space to just under 7,000 square feet.

Image: https://www.earlycharm.com/

By Giacomo Bologna

November 03, 2021, Maryland is on track to top $2 billion worth of venture capital deals in 2021, its highest ever total.

The state had 34 deals totaling almost $400 million in the third quarter of the year, according to the most recent PitchBook-NVCA Venture Monitor report, which is released quarterly with support from Silicon Valley Bank and Affinity.

Through three quarters of 2021, Maryland has had 134 deals worth about $1.6 billion, the report said. This surpasses the entire amount of venture capital raised in 2020, when companies in Maryland raised about $1.26 billion.

PitchBook-NVCA Venture Monitor revised some figures it released earlier this year, but Greater Baltimore still appears headed for a record-breaking year. The area had 13 deals totaling $72 million in Q3, pushing its year-to-date total past $500 million. That's just shy of 2020's $524 million VC total for the entire year.

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Among the world’s largest nations, the U.S. has by far the highest rate of startup investment relative to population. Over the past year, venture investors put nearly $270 billion to work—averaging out to around $800 for every person in the country. 

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But among all countries, the U.S. ranks fourth in per capita startup investment. The No. 1 and No. 2 slots go to Singapore and Israel, two smaller countries that punch well above their weight class for tech-driven entrepreneurship.

Image: https://news.crunchbase.com

Rockville, Md. — Thus far in 2021, a record pace for initial public offerings (IPO), private investment and venture capital deals has been set in Montgomery County. Over $18 billion of investment across 76 companies and 87 separate transactions have been made in the first three quarters of the year from January 1 through September 30. The companies receiving funding span major industries from life sciences and health tech to quantum and media.

Image: https://thinkmoco.com

Since the start of the COVID-19 pandemic, the response from public health agencies, regulators, researchers, and industry has been dominated by the development of vaccines. As of October 14, McGill University’s McGill COVID19 Vaccine Tracker listed 153 vaccines in clinical development, of which 23 had been approved or authorized for emergency use in at least one country.

In the United States, the FDA has approved one COVID-19 vaccine (Pfizer/BioNTech’s Comirnaty) and authorized for emergency use two others (Moderna’s Moderna COVID-19 Vaccine and Johnson & Johnson’s Janssen COVID-19 Vaccine). Beyond the United States, most approvals and authorizations have been granted to those vaccines and others developed by AstraZeneca/University of Oxford (122 countries), Sinopharm (65), Sinovac Biotech (40), Russia’s Gamaleya Research Institute (16), and CanSino Biologics (9).

GAITHERSBURG, MD, November 2, 2021 – Adaptive Phage Therapeutics, Inc. (APT), a clinical-stage biotechnology company dedicated to providing therapies to treat infectious diseases, today announced that it has entered into an agreement with the Antibacterial Resistance Leadership Group (ARLG) to support a multi-center Phase 1b/2, randomized, double-blind, placebo-controlled trial assessing the safety and microbiological activity of a single dose of bacteriophage therapy in cystic fibrosis subjects colonized with Pseudomonas aeruginosa. 

ARLG consists of more than 100 leading experts, working together to combat the ongoing antibacterial resistance crisis and improve patient care. Created in 2013, ARLG is funded by a grant from the National Institute of Allergy and Infectious Diseases (NIAID) part of the National Institutes of Health (NIH) under Award Number UM1AI104681. It is facilitated by the Duke Clinical Research Institute and works under the leadership of an executive committee, four component centers, and two Principal Investigators: Vance Fowler, MD, of Duke University, and Henry "Chip" Chambers, MD, of University of California, San Francisco. The NIAID is the Sponsor of this study.

Are you a biohealth start-up in Maryland, DC or Virginia seeking feedback on your biohealth business idea, pitch deck, or commercialization plan? Schedule your feedback session with BHI EIRs on one of the following dates. Pre-registration is required; Sign up here tinyurl.com/EIRfeedback

For questions/more information, contact BHI.

BALTIMORE, MD, OCT. 29, 2021 – The University of Maryland BioPark (UM BioPark) today announced that JuneBrain Inc., a telehealth device company that empowers ophthalmology and neurology communities, joined the UM BioPark as its newest tenant. JuneBrain, a Maryland-based company, is located in the BioPark’s innovation space in the Lion Brothers Building on Hollins Street.

“We are delighted to welcome JuneBrain to our tenant community,” said Jane Shaab, executive director of the UM BioPark. “The BioPark is an ideal fit for emerging technology companies seeking pre-built space to grow. By fostering unique opportunities and connections, we provide a supportive environment that helps companies thrive at any stage in their development.”

Amritha Jaishankar, PhD, Executive Director, Maryland Stem Cell Research Fund (MSCRF), joins BioTalk to discuss her career, investing in Maryland, and accelerating cures.

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Nkarta to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its oncology cell-therapy candidates

SOUTH SAN FRANCISCO and GAITHERSBURG, Md., Oct. 28, 2021 (GLOBE NEWSWIRE) -- MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Nkarta, Inc., a biopharmaceutical company developing engineered natural killer (NK) cell therapies to treat cancer.

Organizations and governments around the world are pouring billions of dollars into quantum research and development, with the likes of Google, Microsoft and Intel racing to reach quantum supremacy. 

The stakes are high, and with so many major players, the arrival of full-scale quantum computers could be around the corner. 

In order to prepare, it’s vital that we as technology leaders educate ourselves on the reality of these machines, and the impacts they could have around the world. Unfortunately, it’s not all positive. 

BALTIMORE, MD (October 26, 2021) — The Maryland Department of Commerce has launched the Maryland Innovation Investment Tax Credit, which will help foster the growth of the state’s technology sectors by incentivizing investment in early-stage companies. The program, which has $2 million in funding for FY 2022, will also help increase overall investments in current and emerging tech sectors, and boost the number of individual investors in Maryland tech companies.

Applications from potential qualified Maryland technology companies are now being accepted. To submit an application, click here. To be eligible, a company must have 50 employees or less; an aggregate capitalization of at least $100,000; and be in a qualifying tech sector, which includes advanced manufacturing, aerospace, agriculture, artificial intelligence, blue technology, cybersecurity, education, energy and sustainability, financial, life sciences, quantum, and sensors and robotics. 

SOMERSET, N.J. – October 26, 2021 — Catalent, the global leader in enabling biopharma, cell, gene and consumer health partners to optimize development, launch, and supply of better patient treatments across multiple modalities, today announced a $230 million expansion project to add three further commercial-scale viral vector manufacturing suites and associated support facilities and services at its gene therapy campus in Harmans, Maryland, to meet growing customer demand.

The Harmans campus, located close to Baltimore Washington International Airport (BWI), includes a now fully operational, state-of-the-art U.S. FDA- and EMA-approved facility comprising 10 commercial-scale manufacturing suites. A second facility is under construction following an initial $130 million investment by Catalent in 2020, which will add five new manufacturing suites that are expected to be operational mid-2022. This latest investment will include the construction of three additional multi-room commercial suites, as well as expanding the site’s storage capabilities for just-in-time inventory space, ultra-low temperature freezers, and its water-for-injection infrastructure. When complete at the end of 2022, the campus will house a total of 18 CGMP viral vector manufacturing suites, each designed to accommodate multiple bioreactors up to 2,000-liter scale and enable the execution of commercial manufacturing from cell bank to purified drug substance.

Novavax Inc. (NASDAQ: NVAX) has filed for regulatory approval of its Covid-19 vaccine candidate in the U.K. — a major step toward seeking approval in more countries, including the U.S.

The Gaithersburg biotech said Wednesday it has completed all of the requirements for its submission to the U.K.’s regulatory agency, after kicking off a rolling review process earlier this year. It’s a big step for the company, which has faced numerous manufacturing challenges that have prolonged its ability to get its protein-based vaccine across the finish line in multiple markets.

Congrats to Dr Sean Parsons and the Ellume team for taking out the Accenture Australia Award for Product Innovation at the Lord Mayor’s Business Awards.

Ten Johns Hopkins University faculty members have been elected to the National Academy of Medicine, an independent organization of leading professionals from diverse fields, including health, medicine, and the natural, social, and behavioral sciences. It serves alongside the National Academy of Sciences and the National Academy of Engineering as adviser for the nation and the international community.

Through its domestic and global initiatives, the academy works to address critical issues in health, medicine and related policy. Membership is considered one of the highest honors in health and medicine.

Image: https://hub.jhu.edu

As creators, we are frequently told to find our passion and begin building our portfolio and network as early as possible. After all, the more time we can dedicate to something, the better the outcome will be. Inherently, entrepreneurs are creative which can lead to being multi-passionate, meaning a lot of different ideas excite us at once. Radmila Lolly, a musician and fashion designer, says being an artist isn’t a one-size-fits-all endeavor. In fact, finding success as an artist is all about not having limits.

In today's world, successful entrepreneurs know that effective leadership requires development through diligent, intentional practice; and the best leaders among us invest in building their skill sets to improve their performance over time. 

Many of us still focus on strengthening the traditional skills associated with leadership, such as effective decision-making, strategic thinking and managing others. But one of the most vital skill sets a leader can have is often the least understood: emotional intelligence.

October 2021, A 2020 survey conducted by BIO found that in the 100 biotech companies surveyed, women made up nearly half of total employees, but accounted for only 31% of executives and 23% of CEOs. Women’s representation suffers a steep decline in leadership positions across the life sciences, and the gap only widens for women of color.

When Lynn Johnson Langer and Debra Bowes, started their careers in the life sciences they both knew that gender diversity was rare, and even scarcer as women entrepreneurs. “Networking events I attended were mainly comprised of men. There were no opportunities to talk with women about their experiences and career opportunities,” said Johnson Langer.

We thought 2021 would bring a stronger path forward for Greater Washington — and the world — after a debilitating, unpredictable, unprecedented 2020.

And yet, we remain steeped in uncertainty and adversity after a Delta variant of the Covid-19 virus deepened the death toll and put thousands more at risk on a daily basis, physically and mentally, while businesses and employers continue to navigate through reopening delays and staff departures. 

OCT 06, 2025 08:30 EST

PediaMetrix received 510(k) clearance from the US Food and Drug Administration (FDA) for SoftSpot^TM, a cross platform software solution for infant cranial evaluation at the point of care. The FDA clearance demonstrates SoftSpot’s safety and efficacy for infant cranial measurements using a smartphone.

“This is an important milestone for PediaMetrix and we see great potential in now bringing this innovative technology to pediatricians in the US and around the world”, said Fereshteh Aalamifar, PhD, President & CEO of PediaMetrix. Currently, pediatricians are not equipped with any tool for quantitative measurement of cranial shape and only perform visual assessment. They refer parents of children at risk to specialists for quantitative measurements, which can cause delays in the early detection and intervention. SoftSpot brings the power of a specialist to a pediatric office using a smartphone.

Andrea Alms, Co-Fund Manager & Partner, BioHealth Capital Fund, recently joined a panel on “Impact Firms Take the Lead: Private Equity & Private Credit” with Emerge Capital Management on October 11th. Emerge’s EMPWR Program has a talented roster of sub-advisors that features a special focus on women private fund leaders. During this special webinar panel, we will be focusing on EMPWR’s private equity and private debt sleeve. We will have three private fund managers join us and present how their private, impact funds can improve the quality of life around the world.

Click here to watch the recording.

PASADENA, Calif., Oct. 18, 2021 /PRNewswire/ -- Alexandria Venture Investments, the strategic venture capital platform of Alexandria Real Estate Equities, Inc. (NYSE:ARE), an urban office REIT and the first, longest-tenured and pioneering owner, operator and developer uniquely focused on collaborative life science, agtech and technology campuses in AAA innovation cluster locations, was recognized by Silicon Valley Bank in its Healthcare Investments and Exits: Mid-Year 2021 Report as the #1 most active biopharma corporate investor by new deal volume from 2020 to 1H21 for the fourth consecutive year and the #1 most active new Series A investor in biopharma by new deal volume from 2020 to 1H21. These most recent leadership rankings are a testament to Alexandria's position at the vanguard and heart of the life science ecosystem. In addition to its leadership in early-stage life science venture capital investing, Alexandria Venture Investments was listed as one of the five most active U.S. investors in agrifoodtech in the 2021 AgFunder AgriFoodTech Investment Report earlier this year. Alexandria Venture Investments has for more than 25 years strategically invested in some of the most disruptive life science, agrifoodtech and technology companies advancing transformative new modalities and platforms to meaningfully improve human health. Fully integrated into Alexandria's differentiated and multifaceted business, the highly successful mission-critical Alexandria Venture Investments platform provides the company with strategic insight into these industries, strengthens relationships with key entrepreneurs and investors and enables the curation of the highest-quality tenant base.

October 19, 2021 07:00 AM Eastern Daylight Time

GYEONGGI-DO, Korea & GAITHERSBURG, Md.--(BUSINESS WIRE)--D&D Pharmatech Inc., a clinical-stage biotechnology company focused on development and commercialization of revolutionary medicines, and parent company of U.S.-based Neuraly Inc., Precision Molecular, Inc., Theraly Fibrosis Inc., P4Microbiome and Valted Seq, today announced that it has completed a $51 million Series C round of financing led by Praxis Capital Partners, a private equity firm that focuses on growth acquisitions and investments in Asia; other investors included DS Asset Management, Kudos Ventures and Korea Investment & Securities. The new round of financing builds upon the $137.1 million the company secured in Series B financing in August 2019. The company is planning an initial public offering in Korea in 2022.

BETHESDA, Md., Oct. 19, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced the appointment of Matthias Alder as Chief Operating Officer to advance the Company’s strategic and operational objectives, including the establishment of additional industry partnerships and the transition of the Company’s lead program in Gaucher and Parkinson’s Disease into clinical trials, which is expected to occur in 2022.

“I am delighted to welcome Matthias to Gain’s growing team as we methodically scale our platform and build our internal clinical trial capabilities and operations,” said Eric Richman, Chief Executive Officer of Gain. “He brings extensive experience in the pharma and biotech industries and is a seasoned executive who will complement our current executive team at a pivotal time for Gain as we grow the organization and prepare to advance our lead program into clinical trials.”

Home to an array of renowned universities, federal labs, and government resources, it’s no surprise that the globally renowned Milken Institute found that Maryland “has one of the nation’s strongest life sciences industries,” according to its recent report.

It’s clear that Maryland’s efforts to grow its recognition as a life sciences/biotech hub have paid off. However, there is still more work to be done in order for Maryland’s R&D growth trajectory to keep up with other leading hubs such as Massachusetts and North Carolina.

Image: https://biobuzz.io

Scientists temporarily attached a pig’s kidney to a human body and watched it begin to work, a small step in the decades-long quest to one day use animal organs for life-saving transplants.

Pigs have been the most recent research focus to address the organ shortage, but among the hurdles: A sugar in pig cells, foreign to the human body, causes immediate organ rejection. The kidney for this experiment came from a gene-edited animal, engineered to eliminate that sugar and avoid an immune system attack.

Image: Photo: Joe Carrotta/NYU Langone Health via AP. In this September 2021 photo provided by NYU Langone Health, a surgical team at the hospital in New York examines a pig kidney attached to the body of a deceased recipient for any signs of rejection. From left are Drs. Zoe A. Stewart-Lewis, Robert A. Montgomery, Bonnie E. Lonze and Jeffrey Stern. The test was a step in the decades-long quest to one day use animal organs for life-saving transplants.