novavax

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).

 

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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.

 

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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.

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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.”

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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.

 

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Noble Life Sciences is delighted to welcome Rigoberto Sanchez, Associate Director, Quality Assurance (QA).

Dr. Sanchez will be responsible for Quality Assurance and regulatory compliance with Title 21 of the US Code of Federal Regulations (CFR), Part 58, for studies conducted in accordance with Good Laboratory Practices; animal welfare regulations provided by the Guide for the Care and Use of Laboratory Animals and the Office of Laboratory Animal Welfare (OLAW); the Institutional Animal Care and Use Committee (IACUC); standards provided by the Association for Assessment and Accreditation for Laboratory Animal Care (AAALAC) and additional local, state, federal and international regulations.

Image: https://content.noblelifesci.com

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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. 

 

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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. 

 

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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.

 

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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.

 

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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

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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.

 

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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.