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Emergent BioSolutions Announces FDA Acceptance of Biologics License Application for AV7909 Anthrax Vaccine Candidate

By News Archive

Emergent LogoGAITHERSBURG, Md., June 24, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) accepted for review the Biologics License Application (BLA) for AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted). AV7909 is the company’s new anthrax vaccine candidate evaluated for post-exposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis in persons 18 through 65 years of age when administered in conjunction with recommended antibacterial drugs. The Prescription Drug User Fee Act goal date for a decision by the FDA is in April 2023.

“Over the last 20 years, Emergent has partnered with the U.S. government to lead this program from early- to advanced-stage development,” said Kelly Warfield, senior vice president research and development at Emergent BioSolutions. “As we progress toward licensure of AV7909, which is designed to follow a two-dose immunization schedule and to elicit a faster immune response, we redouble our efforts to support the government’s overall preparedness and response strategy for large-scale emergencies involving anthrax and other threats to public health.”

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NIH seeks industry partners for technology transfer

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Handshake 2021 08 26 18 26 18 utcThe National Institutes of Health (NIH) is the world’s largest public funder of biomedical research, investing more than $30 billion in taxpayer dollars. However, what is little known about the agency is that its technologies are available for licensing and collaboration, according to Michael Salgaller, PhD, supervisor of the technology analysis and marketing unit at the National Cancer Institute’s (NCI) Technology Transfer Center.

 

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The North American Subnational Innovation Competitiveness Index | ITIF

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ITIF LogoThe North American innovation ecosystem is increasingly diverse. In collaboration with Macdonald-Laurier Institute, Fundación IDEA, and the Bay Area Economic Council Institute, ITIF compiled this index to identify economic differences among states and provinces and highlight regions needing more federal attention, identify cross-national innovation performance, and track the continent’s overall competitiveness in the innovation-driven global economy.

 

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Alexandria LaunchLabs at Columbia

Alexandria Real Estate Equities, Inc. Celebrates the Grand Opening of Alexandria LaunchLabs at Columbia to Accelerate the Commercialization of Novel Translational Science to Meet Significant Unmet Medical Needs

By News Archive

Alexandria LaunchLabs at ColumbiaNEW YORK, June 22, 2022 /PRNewswire/ — 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, today celebrates the grand opening of Alexandria LaunchLabs® at Columbia, which was created in a strategic collaboration with Columbia University. As the company’s second LaunchLabs site in New York City, Alexandria LaunchLabs at Columbia builds upon the success of the flagship LaunchLabs site at the Alexandria Center® for Life Science – New York City, which reached its fifth anniversary this month. The grand opening event marks an important milestone for the unique and leading life science startup platform purpose-built to accelerate innovation and growth for promising early-stage companies. With over 10,000 diseases known to humankind and less than 10% currently addressable with therapies, Alexandria LaunchLabs at Columbia is playing an essential role in catalyzing the translation of scientific research emerging from Columbia University and other leading NYC academic and medical research institutions into treatments and cures to help meet humanity’s massive unmet medical need and alleviate patient suffering.

Image: Alexandria LaunchLabs® at Columbia, located on the Columbia University Irving Medical Center campus. Courtesy of Alexandria Real Estate Equities, Inc.

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Vaccitech’s VTP-300 induced sustained reductions of surface antigen in patients with chronic hepatitis B both as a monotherapy – Bloomberg

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Vaccitech Logo 1252348591Vaccitech’s VTP-300 induced sustained reductions of surface antigen in patients with chronic hepatitis B both as a monotherapy and in combination with a single low dose of anti-PD-1

VTP-300 as a monotherapy and in combination with a single administration of
low-dose nivolumab was administered, with no treatment-related serious adverse
events and infrequent transient transaminitis.

Meaningful, durable reductions of Hepatitis B surface antigen (HBsAg) were
seen in some patients who received VTP-300 as either a monotherapy or in
combination with a single low dose of nivolumab at the booster dose. Declines
were most prominent in patients with lower baseline HBsAg.

All patients who received VTP-300 monotherapy or in combination with low-dose
nivolumab and who had a HBsAg decline greater than 0.5 log[10] had durable
reductions of HBsAg until the last measurement (up to eight months after last
dose).

 

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Aledade Raises $123 Million Series E to Accelerate Growth

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BPhysician led Accountable Care Organization ACO AledadeETHESDA, Md., June 06, 2022 (GLOBE NEWSWIRE) — Today, Aledade announced it has closed a $123 million Series E funding round to support investments in value-based care for more seniors covered by Medicare Advantage (MA) and innovation that improves patient care and increases medical cost savings, including expanded offerings through its new health services subsidiary, Aledade Care Solutions (ACS). Returning investor OMERS Growth Equity led the round, which also included Fidelity Management & Research Company and other current investors.

 

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BioHealth Innovation is seeking a Senior Life Sciences Business Strategist (2)

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NewImage

BioHealth Innovation, Inc., (BHI) is a regional non-profit innovation intermediary, which facilitates the development of growth-stage biohealth companies by connecting commercially relevant research assets to appropriate funding, management and markets.

JOB TITLE – Senior Life Sciences Business Strategist

Reporting to the Vice President of Economic Development, the Senior Life Sciences Business Strategist evaluates the commercial potential of emerging technologies and provides recommendations on go-to- market strategies. This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals.

The Senior Life Sciences Business Strategist also supervises junior Life Sciences Business Strategists and manages consultants and interns, as needed.

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Emergent BioSolutions Announces Publication of CHIKV VLP

By News Archive

Emergent LogoGAITHERSBURG, Md., June 21, 2022 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that two-year persistence data from its phase 2 clinical study evaluating the safety and immunogenicity of the company’s investigational chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate were published in The Lancet Infectious Diseases. The article, Safety and immunogenicity of PXVX0317, an aluminum hydroxide-adjuvanted chikungunya virus-like particle vaccine: a randomised, double-blind, parallel-group, phase 2 trial, is available online.

“Emergent is pleased that results from our CHIKV VLP phase 2 study have been published and shared with the scientific community in The Lancet Infectious Diseases, a highly esteemed peer-reviewed journal,” said Chris Cabell, M.D., chief medical officer and SVP clinical development at Emergent BioSolutions. “Publication of this body of work highlights the importance of developing ways to address Chikungunya disease, a public health threat for which no vaccine or treatment exists.”

Summary of published results
This randomized, double-blind, parallel-group, phase 2 study was conducted at three U.S. sites with 415 participants. Eligible participants were healthy CHIKV-naïve adults aged 18–45 years. The primary endpoint was the geometric mean titer of anti-CHIKV neutralizing antibody on day 57 (28 days after the last vaccination). Safety was also assessed.

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New Mountain Capital Announces Growth Partnership with Emmes

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Emmes-LogoPartnership to Support Emmes’ Next Phase of Tech-Enabled Growth NEW YORK and ROCKVILLE, Md., June 21, 2022 /PRNewswire/ — New Mountain Capital, a leading growth-oriented investment firm with more than $37 billion in assets under management and Emmes, a global, tech-enabled full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that they have formed a partnership to support and accelerate Emmes’ next phase of growth. Affiliates of New Mountain will acquire the ownership interest of Behrman Capital, the majority investor in Emmes since March 2019, and the ownership interests of Emmes’ other investors. The transaction is expected to close in early July and terms were not disclosed. 

Emmes is a leading CRO that provides its clients with expertise in biostatistics, technologies and dedicated service required to manage clinical research studies with the highest standards of quality. The company sits at the intersection of the public and private healthcare sectors with clients including biopharmaceutical companies, government agencies, foundations, academic institutions and other non-profit organizations. Emmes is proud to support the research efforts of agencies such as the National Institutes of Health (NIH), Food and Drug Administration (FDA), Department of Defense (DOD), Department of Health and Human Services (HHS) and the Biomedical Advanced Research and Development Authority (BARDA). Emmes’ five acquisitions since December 2020 have complemented the company’s core operations in the greater Washington, D.C. area, Canada and India, while expanding its international presence throughout Europe.

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Maryland Inno – USM creates new pilot program to invest $600,000 in early stage startups

By News Archive

The University System of Maryland (USM) approved a new pilot program investing $200,000 a year in early stage startups.
Jessica Iannetta/BBJThe University System of Maryland this week approved a new pilot program to fund early-stage startups.

The measure, which was approved by the USM Board of Regents on Friday, will allocate $200,000 per year to the Early Capital Pilot fund over three years.

The program will be funded with money currently allocated for the Maryland Momentum Fund, a USM-run venture capital fund that began with $25 million in 2016. The Board of Regents recently authorized an additional $6 million over three years for the program.

Image: The University System of Maryland (USM) approved a new pilot program investing $200,000 a year in early stage startups.
Jessica Iannetta/BBJ

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