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

Jun 7, 2022

Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S. GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

Biotechnology firm United Therapeutics has showcased what it claims to be the “world’s most complex 3D printed object” in partnership with 3D printer manufacturer 3D Systems at the recent LIFE ITSELF conference in San Diego.

The partners have produced a 3D printed human lung scaffold capable of demonstrating gas exchange in animal models, and are now planning to cellularize the scaffold with a patient’s own stem cells to create tolerable, transplantable human lungs.

QIAGEN CEO Thierry Bernard joins Yahoo Finance Live to explain how his company is utilizing technology to track the spread of COVID through wastewater and also discusses how to track the monkeypox outbreak.

Accurately testing wastewater for COVID could help cities and towns prepare for outbreaks, stock up supplies, or put measures in place to prevent further community transmission of COVID-19. And one company recently receiving a nod from the CDC for wastewater testing is German company QIAGEN.

Health and Human Services Secretary Xavier Becerra appointed Adam Russell, Chief Scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS), to serve as acting deputy director of the new Advanced Research Project Agency for Health (ARPA-H).

Proposed by President Joseph R. Biden to improve the U.S. government’s ability to speed biomedical and health research, ARPA-H was established by law on March 15 and will operate as an independent entity within the National Institutes of Health.

image: National Institutes of Health in Bethesda, Md.

Rockville, MD - On June 8th, Korea SMEs and Startups Agency (KOSME), its Korean Business Development Center (KBDC) and BioHealth Innovation, Inc. (BHI) will kick-off their second virtual US Market Entry program for Korean companies expanding to the United States.

Last summer, BHI and KOSME conducted a similar pilot program, which included five medical device and diagnostics companies.

This year’s competitively selected 5-member cohort includes medical diagnostics, medical devices, health AI and software companies. Over 25 Korea-based health-tech companies applied to the program.

The program will guide the cohort to adopt cultural business differences and communication methods, outline a go-to-market strategy, connect with strategic partners & key opinion leaders, and suggest product or prototype modifications. BHI’s Entrepreneurs in Residents (EIRs) mentor the cohort to achieve a successful US biohealth market entry.

image: KOSME President Hakdo Kim and BHI President Rich Bendis

Brian Castleberry, Maryland Department of Commerce Regional Manager - Middle East, Africa and India, Office of International Investment and Trade, and & Robin Wiener, President, Get Real Health, Join Rich Bendis on BioTalk to discuss International Collaborations, Maryland Biotech, and Collaborations.

Listen now via Google https://bit.ly/3xjyLau, Apple https://apple.co/3GU4UIP, Spotify https://spoti.fi/3MrBJ0R, Amazon https://amzn.to/3H0rL5F, and TuneIn https://bit.ly/38Ry0vV

Lung scaffolds developed in partnership with 3D Systems Corporation represent the most complex objects ever printed; reveal took place at the LIFE ITSELF Conference in San Diego

3D-printed lung scaffolds are demonstrating gas exchange in animal models

United Therapeutics expects human clinical trials of 3D-printed, cellularized lungs in the next five years

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & ROCK HILL, S.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that in partnership with 3D Systems Corporation (NYSE: DDD) it has produced the world’s most complex 3D-printed object – a human lung scaffold – and demonstrated it at the LIFE ITSELF Conference that occurred May 31 to June 3, 2022 in San Diego. The event was organized and hosted by Dr. Sanjay Gupta and Marc Hodosh and was sponsored by CNN, United Therapeutics, and other prominent corporate leaders in healthcare.

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.

May 31, 2022

Trial will assess safety and antibody responses of NVX-CoV2515 to the Omicron variant of COVID-19 Two-dose primary regimen of NVX-CoV2373 already demonstrated cross-reactive immune responses against Omicron and other variants

Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine. The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine.

The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation's potential. Learn about the aspects of product development beyond the science of the awards.

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

Optimizing formulation or manufacturing operations Establishing an advisory board  Layering intellectual property protection Preparing for regulatory interactions Gathering evidence to support reimbursement value Engaging with investors or strategic partners Learn more in this video about innovator consultations

GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, the companies said today, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology.

GSK is counting on Affinivax to help it compete better with Pfizer’s blockbuster pneumococcal vaccine franchise, marketed as Prevnar®, and shore up its vaccine offerings as it prepares to spin off its consumer products joint venture with Pfizer.

Image: GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology. (GlaxoSmithKline)

In recent days, prominent venture capital funds have come out with survival tips for their portfolio companies. While asking startup founders to tighten their belt is sound advice, it’s worth wondering when venture capital titans might be urged by their investors to scale back their own pay, too.

Their compensation has been rising fast. Last year, median cash pay for a partner at a venture capital firm, including base salaries and bonuses, rose 10% to $928,000, reported The Information, citing a survey conducted by Holt Private Equity Consultants.