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Holding place for old articles.

CarrTech

The Frederick News-Post: CarrTech seeks FDA approval for product to prevent glass contamination in medication

By News Archive

CarrTechSue Carr clearly remembers the moment that pushed her to become a full-time entrepreneur.

In 2018, Carr was working at a hospital in Montgomery County and responding to a critical situation in the emergency room. She had to administer life-saving medication that was packaged in a glass ampoule — a small glass vial with a bottle head — to a patient.

To open the ampoule, the bottle head must be broken off, which Carr said results in glass shards getting in medication.

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WomensHealth

BHI/NIH EIR Anna Zornosa: “Was 2023 Actually a GOOD Year in Women’s Health?”

By News Archive
  • WomensHealthThe 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.

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Barinthus

Barinthus Bio New partnership aims to advance vaccine against MERS coronavirus

By News Archive
  • BarinthusCEPI 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.

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Deka250

Deka Biosciences Adds Industry Veterans to its Executive Leadership Team and Board of Directors

By News Archive

Deka250GERMANTOWN, 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.

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umsom logo

University of Maryland School of Medicine Researchers Discover First Ever Link Between Hemoglobin-Like Protein and Normal Cardiac Development

By News Archive

umsom logoIn 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.

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Aurinia

Aurinia Submits IND Application to US Food & Drug Administration for AUR 200

By News Archive
  • AuriniaAUR200, a potent recombinant fusion protein, has a clinically validated MOA with a high affinity for targeting both BAFF (B-cell Activating Factor) and APRIL (A Proliferation-Inducing Ligand)
  • Upon FDA clearance of the IND, AUR 200 will be studied in a Phase 1 first-in-human trial in healthy volunteers, marking a significant advancement for Aurinia’s emerging autoimmune pipeline

ROCKVILLE, Md. & EDMONTON, Alberta–()–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) – Aurinia announced today the submission of its Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for AUR200, a potential next generation therapy for B-cell mediated autoimmune diseases. Upon receiving FDA clearance to proceed with proposed research, Aurinia plans to initiate a Phase 1 study in the first half of 2024 to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic properties of AUR200 in healthy volunteers.

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JD Supra

JD SUPRA: Federal Government Releases Proposed Guidance for Exercising “March-In” Rights Under the Bayh-Dole Act: Q & A

By News Archive

JD SupraOn 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.

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Top10

Smart Incentives: Our top incentive trends

By News Archive

Top10by  | 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. 

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Juregen and Rich 250

Navigating the AI Wave: Dr. Juergen Klenk Explores AI’s Reality in the BioHealth Industry on BioTalk

By News Archive

Juregen and Rich 250Have you ever wondered about the true impact of Artificial Intelligence (AI) in the BioHealth industry? In this episode of BioTalk with Rich Bendis, we have the privilege of hosting Dr. Juergen Klenk, a Principal at Deloitte and a Board Member at BioHealth Innovation. Dr. Klenk brings a wealth of expertise and experience with a unique background combining formal scientific training and entrepreneurial ventures.

Join us as we embark on an insightful discussion about the current state of AI in the BioHealth industry, diving deep into the realities and challenges of this cutting-edge technology. Dr. Klenk shares his interest in AI and the reasons behind its increasing prominence in the field. We explore the historical origins of the AI hype cycle and how we’ve reached the stage we’re in today.

Listen now via your favorite podcast platform:

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irazu oncology

citybiz: Irazu Oncology Secures $2.6M Debt to Advance UMB’s Vaccine Technology

By News Archive

irazu oncologyIrazu Oncology, which is using a platform built by researchers at University of Maryland, Baltimore to develop cancer vaccines, has secured $2.6 million in debt from an undisclosed source, according to a recent listing on Crunchbase.

Founded by Marco A. Chacón, an industry veteran who founded and ran Paragon Bioservices for over two decades, Irazu Oncology is commercializing UMB’s novel immunotherapeutic vaccine technology. It operates out of the University of Maryland BioPark. The company is a winner of TEDCO’s Maryland Innovation Initiative Company Formation Awards.

Novel Approach

Irazu Oncology has a licensing deal with UMB to commercialize a membrane vesicle vaccine development platform built at the university by a research team led by James Galen, Ph. D. The platform uses the outer membrane of vesicles — a structure within or outside a cell — as cancer vaccines that can stimulate an immune response. Irazu Oncology’s proprietary, attenuated bacteria are engineered to produce OMVs bearing tumor antigens on their surface. These antigens are delivered to various sites in the body, stimulating a natural immune system that can destroy cancerous cells.

 

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