News Archive

FDA IDE approval of Sonavex’s randomized trial comes months after meeting the endpoint of its first clinical study

BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ — Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).

The U.S. National Science Foundation today announced the first-ever Accelerating Research Translation (ART) investment — more than $100 million to 18 teams at academic institutions across the nation. NSF’s investment will enable academic institutions to accelerate the pace and scale of translational research that will grow the nation’s economy.

“NSF endeavors to empower academic institutions to build the pathways and structures needed to speed and scale their research into products and services that benefit the nation,” said NSF Director Sethuraman Panchanathan. “The Accelerating Research Translation program in NSF’s new Technology, Innovation and Partnerships (TIP) Directorate identifies, and champions institutions positioned to expand their research translation capacity by investing in activities essential to move results to practice.”

• The year “gaslighting” of women with hard-to-diagnose maladies was finally given the kabosh?
• The year we found the hormone causing acute morning sickness?
• Impressive and large funding rounds despite a bleak funding environment?
• “Birth control for men” makes it to the clinical trial stage?

By Anna Zornosa – In the shadow of one very bad, no-good horrible development setting women’s health back decades (the overturning of Roe V. Wade), I spent the year taking note of some amazing advances happening in the pursuit of health solutions for women. Curious if others were also seeing bright spots, I asked some of the smartest women I know if they’d also seen events signaling notable progress.

My timing was bad: with the holidays upon us I knew some could not answer. But to my delight I got observations Barbara Levy, MD, FACOG, FACS : from CEO/Founders Somer Baburek, MBA (Hera Biotech), Melody Roberts (Liv Labs), and Melissa Bowley (Flourish Care); from author Susan Salenger; medtech designer and diversity driver Nada (Osman) Hanafi ; investors Jessica Karr and Susan Solinsky; and Ayse McCracken, Founder of the Ignite Accelerator for women leading life science companies.

What did we miss? A lot, certainly. Please add your own “brightspots of note” to comments. This will create something we can all turn to if (when) bad developments happen in 2024.

• CEPI to invest funding of up to $34.8 million to Barinthus Bio in addition to funds previously committed to the University of Oxford to develop and stockpile a ready reserve of emergency MERS vaccine candidate, VTP-500.
• VTP-500 project with Barinthus Bio and University of Oxford uses tested ChAdOx1 platform.
• If successful in Phase II trials, this will progress VTP-500 significantly towards regulatory approval and doses could be rapidly deployed in a clinical trial setting in response to a substantial outbreak.

OXFORD, United Kingdom, Dec. 21, 2023 (GLOBE NEWSWIRE) — Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc, today announced a project with the Coalition for Epidemic Preparedness Innovations (CEPI) and the University of Oxford, aiming to fast-track the development of a vaccine candidate known as VTP-500 for the prevention of Middle East Respiratory Syndrome (MERS), the often fatal disease caused by the MERS coronavirus. Barinthus Bio is a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity, and cancer.

GERMANTOWN, Md., Dec. 19, 2023 /PRNewswire/ — Deka Biosciences (“Deka”) today announced the appointments of Stanley Frankel, M.D., FACP, as senior clinical advisor, interim chief medical officer and scientific advisory board member, and Stuart Chaffee, Ph.D. as an independent director and chairman of the Board. Deka is a privately held biotech company developing next-generation cytokine therapies to treat cancer and inflammatory diseases based on a patient’s individual immune response. Deka’s lead asset, DK2¹⁰ (EGFR), is currently being evaluated for the treatment of multiple solid tumors in a Phase 1 clinical trial.

In a landmark study led by the University of Maryland School of Medicine, researchers discovered for the first time that a certain kind of protein similar to hemoglobin, called cytoglobin, plays an important role in the development of the heart. Specifically, it affects the correct left-right pattern of the heart and other asymmetric organs. The findings, published today in the journal Nature Communications, could eventually lead to the development of new therapeutic interventions to alter the processes that lead to these defects.

The team, led by senior author Paola Corti, PhD, along with along with University of Maryland School of Medicine Dean Mark T. Gladwin, MD, as senior co-author, used CRISPR gene editing technologies to knock out the cytoglobin gene in zebrafish. The lack of cytoglobin caused the development of embryos with a mirrored heart, meaning the heart had a reversed left-right pattern. In humans, cytoglobin is involved in processes involving nitric oxide, a compound that helps regulate healthy blood flow to organs.

On December 8, 2023, the National Institute of Standards and Technology (NIST) published a draft guidance document regarding the government’s exercise of “march-in” rights under the Bayh-Dole Act. The following Q&A, in connection with our previously published Client Alert, illuminates the details of the Proposed Framework.

Q: If my company takes SBIR/STTR funding from a federal agency, does the Bayh-Dole Act apply?

A: Yes. A company that receives Small Business Innovation Research (SBIR) or Small Business Technology Transfer (STTR) funding is considered a “contractor” under the Bayh-Dole Act. As such, inventions conceived of or first actually reduced to practice using SBIR or STTR funds will be subject to the Bayh-Dole Act. This applies even if the funds are used only to develop confirmatory data for an invention conceived of without the use of SBIR or STTR funds.

by Ellen D. Harpel | Dec 17, 2023

As Smart Incentives marks its 10th year, we have been revealing the top ten ways that incentives have changed since 2013. We are pleased to share the full list of incentive trends here in our last blog article of 2023. 

1. Big incentive deals are getting bigger. Top projects receive significantly higher offers than in the past. The most prominent incentive packages are for new electric vehicle and semiconductor facilities. However, looking past these high profile projects, the average incentive offer has been surprisingly stable over the past decade.

2. The rise of remote work. Remote and hybrid work continue to reshuffle our living and working patterns. Incentives to attract remote workers have become part of the landscape. Many traditional business incentive programs are adjusting how they count workers to account for remote or hybrid work.

3. Better project compliance and reporting. State and local governments have improved their ability to track incentivized projects, monitor performance, and share results with internal and external stakeholders.