GAITHERSBURG, 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.”

The 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.

The 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.

NEW 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.

Vaccitech’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).

BETHESDA, 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.

GAITHERSBURG, 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.

Partnership 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.

The 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

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

Treatment of Precursor Lesions Was Found to Significantly Reduce the Risk of Progression to Anal Cancer, with Study Result Highlighted in the New England Journal of Medicine

ROCKVILLE, Md., June 16, 2022 /PRNewswire/ -- Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that a team of its researchers contributed to a successful AIDS Malignancy Consortium (AMC) study. Results of the study, which demonstrated that treating and removing anal cancer precursor lesions reduced the cancer risk for HIV-infected men and women, were published in the New England Journal of Medicine. The Phase 3 trial results included 4,446 participants at 21 clinical sites across the U.S. and Puerto Rico.

The study enrolled people living with HIV aged 35 years and older who had at least one precursor lesion for anal cancer, called high-grade squamous intraepithelial lesions (HSIL). Participants were randomized into two groups: those who received treatment for the lesion(s) and those who were actively monitored but did not receive treatment. Participants were re-evaluated every three to six months. Rates of progression to anal cancer were compared between the two groups. The findings showed that treating HSIL resulted in a nearly 60 percent reduction in anal cancer progression among people living with HIV.

WASHINGTON, D.C. – The Senate Health, Education, Labor and Pensions Committee today passed S. 4348, the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act. The legislation is the Senate's version of user fees reauthorization, including the Medical Device User Fee Amendments agreement (MDUFA V) between the medical technology industry and the FDA. The Senate committee action follows full House of Representatives passage of its version of the legislation last week. Scott Whitaker, president and CEO of AdvaMed, the world's largest trade association representing medical technology companies, made the following comment on the Senate committee work.

"A well-functioning user fee system is essential to help ensure FDA's timely review of innovative medical technology for patients. AdvaMed appreciates the timely work of each chamber of Congress to reauthorize this critical system with improvements to make the process better. MDUFA V has historic firsts, including provisions for greater accountability, predictability, consistency, and communication to increase patient access to safe, effective medical innovations.

Antimicrobial resistance (AMR) is named one of the top 10 global health threats facing humanity by the World Health Organization and was associated with nearly 5 million deaths in 2019. With a challenge of this magnitude, it’s critical to have visibility in the supply chain for antimicrobials—medicines used to prevent and treat infections that include antibiotics (also known as antibacterials), antifungals, antivirals and antiparasitics.

Dr. Michelle McMurry-Heath, BIO 2022 Tuesday Keynote: BIO Unbound, June 14, 2022 SHOW LESS

Synexa Life Sciences (Synexa), a global leader in clinical biomarker and bioanalytics research services, recently secured 5,000 square feet of lab space in Rockville, Maryland. The new lab will be located within Inotiv, Inc.’s (Inotiv) Rockville site and is part of a new partnership between Synexa and Inotiv, a leading contract research organization.

For more than 20 years, Synexa has been delivering expert clinical development insights to life sciences organizations via biomarker and bioanalytics solutions, novel modality analytics, innovative technology platforms and custom assay development and validation. The new Rockville lab adds to the company’s global footprint that, up until very recently, included locations in Leiden, The Netherlands, Dublin, Ireland, Berlin, Germany, London, England and Cape Town, South Africa.

Image: https://biobuzz.io/

What a roller coaster. After stomach-clenching drops in 2020, the Washington, D.C., area market clambered up to new heights in 2021. Multifamily rents rebounded in and outside the District, development flourished in suburban downtowns and along the D.C. waterfront, and a stream of new life sciences tenants populated the I-270 corridor.

Still, while renters and tourists have largely returned, the office population has not, as wave after wave of COVID infections delayed a fuller return to office, leading to what now appears to be a permanent shift. In addition, 2022 brought with it new concerns about inflation, rising costs of capital, and an economic pullback in some areas.

Image: https://commercialobserver.com

SAN DIEGO — (June 14, 2022) — The licensing of university and nonprofit research has made a significant contribution to US gross domestic product (GDP), industrial gross output, and jobs over the last 25 years and underscores the importance of basic and applied research to the US economy, as well as the demand for public-private partnerships. The findings are based on an independent study released today and commissioned by the Biotechnology Innovation Organization (BIO) and AUTM, a global nonprofit that works to advance ideas from research institutions into the marketplace.

Emergent BioSolutions, already flush with products against public health threats like anthrax attacks and opioid overdoses, is expanding its arsenal of medical countermeasures by scooping up global rights to smallpox newcomer Tembexa.

Emergent will furnish developer Chimerix with $225 million in upfront cash plus upward of $100 million in milestone payments for worldwide rights to the med, also known as brincidofovir. The drug last summer snagged FDA approval as the first antiviral cleared to treat smallpox regardless of a patient's age.

The Seoul National University Bundang Hospital (SNUBH) set up a "K-Bio Health Regional Center" in a ceremony Tuesday in line with a government project supporting the commercialization of biohealth technology.

SNUBH President and CEO Paik Nam-jong, Seongnam Mayor Eun Soo-mi, Ryu Hae-pil, director of Seongnam Industry Promotion Agency, Lee Cheon-haeng, head of the Health Industry Promotion Corps at Korea Health Industry Development Institute (KHIDI), and CEOs of companies in the center attended the opening ceremony.

Image: SNUBH President Paik Nam-jong (third from right) and Seongnam Mayor Eun Soo-mi (fourth from right) were among the dignitaries who cut the tape to open the K-Biohealth Reginal Center on Tuesday. 출처 : KBR(http://www.koreabiomed.com)

Children’s National Hospital in Washington, D.C., was ranked #5 nationally in the U.S. News & World Report (USNWR) Best Children’s Hospitals annual rankings. It’s the sixth straight year has been in the top 10. Also for the 6th straight year, Children’s National’s neonatology program was ranked No. 1 among all children’s hospitals in the nation. Children’s National’s neurology and neurosurgery program is ranked the best in the Mid-Atlantic for a second year in a row.

Image: https://www.washingtonian.com

The biopharma bear market has ended the financing boom of recent years and led the valuations of companies to plunge after years of soaring—conditions that may compel smaller biotechs to pursue merger-and-acquisition (M&A) deals with pharma giants, according to a recently released report.

The challenges to valuations and access to capital come as the industry and the rest of the world move beyond the COVID-19 pandemic, EY, the professional services firm formerly known as Ernst & Young, observed in the 32nd annual edition of its “Beyond Borders” report.

Avidea Technologies, a Baltimore-born developer of immunotherapies, had been acquired in December in a splashy $40 million deal by high-profile UK biopharma firm Vaccitech. The 14-employee startup, since folded in as Vaccitech’s North American subsidiary, would be doubling in size and needed a true home base after the five years it spent growing in Johns Hopkins Tech Ventures’s (JHTV) FastForward 1812 incubator in East Baltimore.

Image: A rendering of a planned building with wet lab space and other facliities for the University of Maryland BioPark in West Baltimore. (Image via Wexford Science + Technology, ZGF and the City of Baltimore's Urban Design & Architecture Advisory Panel)

A delegation of Maryland companies and organizations is heading to San Diego June 13-16 for the BIO International Convention. At BIO, the life sciences industry’s leading trade show, Maryland will showcase the unparalleled life science assets within the state.

The Maryland Department of Commerce, in collaboration with the Maryland Tech Council, will exhibit at Booth #5013. The Maryland Department of Commerce, Maryland Tech Council and various sponsors are supporting a delegation of 15 Maryland life sciences companies’ attendance at the show. Companies in the Maryland delegation receive premium access to BIO, including its exhibit hall, educational program, and one-on-one partnering to meet with potential partners and investors. Companies in the Maryland delegation include:

ROCKVILLE, MARYLAND, June xx, 2022 – BioHealth Innovation Inc. (BHI) announces the additions of Anna Zornosa, MA, as an Entrepreneur-in-Residence (EIR) with the NIH Office of Extramural Research, and Aliye Hashemi, B.Sc., a BHI Analyst. The Entrepreneur-in-Residence Program at BHI ensures that disruptive technologies receive all the resources required to transform the technology from a discovery into a commercially relevant product and eventually have a measurable impact on human health. The program was created to support scientists, early-stage startups, and licensed technologies to provide them with access to these resources.

“BHI is proud to welcome Anna and Aliye to the team,” said Richard Bendis, BHI President and CEO. “Anna brings a wealth of experience, and Aliye is ready to continue her impressive development with us.”

The University System of Maryland may soon have a new pilot program to fund early stage startups.

The measure, which was approved by both the USM Board of Regents Committee on Economic Development and Technology Commercialization and the Committee on Finance on Thursday, would allocate $200,000 per year to the Early Capital Pilot fund over three years.

Image: The University System of Maryland may establish a new fund to help early stage entrepreneurs. Jessica Iannetta/BBJ

The life sciences revolution remains robust.

A variety of megatrends (demographic, economic, technological, etc.) coupled with rapid advances in technology have boosted life sciences growth over the last decade. More recently, the COVID-19 pandemic catapulted the life sciences industry to a new level of prominence with cutting-edge innovations.

Fierce competition for talent—exacerbated by demographic changes, pandemic-induced burnout and shifting family responsibilities—presents challenges as the industry seeks to meet growing demand for its products and services.

Tackling health inequities. Pinpointing the sources of pain. Helping the immune system target cancer. These are just some of the ambitious goals of the companies residing at Johnson & Johnson's newest incubator, JLABS @ Washington, DC. Meet three healthcare innovators leading the way.

Image: https://www.jnj.com/

Ear infections, or the inflammation of the middle ear typically caused by bacteria, are a notorious nuisance in early childhood. The high incidence, recurrent nature, and non-specific presentation of ear infections in children have made it a feared diagnosis among parents. According to the National Institute on Deafness and Other Communication Disorders, ear infections are the most common reason for a trip to the pediatrician, with five out of six children experiencing at least one ear infection by age three, and 25% of children having repeated ear infections. Researchers at the University of Maryland (UMD), in collaboration with Johns Hopkins University (JHU), have developed an innovative technology that could save a trip to the doctor’s office by enabling virtually anyone to record and triage a child’s symptoms and status confidently and competently.

Image: Inventor John Rzasa Photo by Sage Levy

The Deka Biosciences team is now 17 strong –  and growing!

Image: https://www.linkedin.com

ABU DHABI, UAE , June 9, 2022 /PRNewswire/ -- The Department of Health – Abu Dhabi (DoH), the regulator of the healthcare sector in the Emirate of Abu Dhabi, signed a Declaration of Collaboration with the Children's National Hospital, home to the Sheikh Zayed Institute for Pediatric Surgical Innovation, as part of the Abu Dhabi Life Science Mission to the USA.

The signing cements the long-standing partnership between Abu Dhabi and Children's National Hospital in Washington DC and facilitates both entities collaborating on three key areas including genomics and oncology research and other innovations to address pediatrics, diseases and patients' management. The agreement also explores establishing Abu Dhabi as a regional pediatric hub.

BHI was pleased to join our partners at today's BLUE KNIGHT Symposium 2022 hosted at JLABS @ Washington, DC. Thanks to BARDA, Johnson & Johnson and all of the entrepreneurs and innovative minds who are strategizing  today for tomorrow's public health challenges.

The Gaithersburg biotech has had no product to market in its 35-year history.

The fourth annual HERstory Gala took place on Thursday, April 21, 2022 at the VisArt Studio in Rockville Town Square. This gala is the chapter’s premier event honoring outstanding women in biotech in the Washington DC metro region. Attendees included 85 members and supporters from diverse professional backgrounds, including science, marketing, legal, and entrepreneurship.

Image: https://www.womeninbio.org