News

WASHINGTON (Dec. 4, 2024) — In a significant collaboration to help advance pediatric health, Children’s National Hospital and the U.S. Food and Drug Administration’s (FDA) Office of Science and Engineering Laboratories (OSEL) in the Center for Devices and Radiological Health (CDRH) have signed a five-year research collaboration agreement to develop regulatory science tools (RSTs) intended to assist in the technical evaluation of pediatric and perinatal medical devices. 

This partnership aims to address long-standing challenges in testing novel medical devices for children and for perinatal care. By sharing de-identified clinical data and leveraging advanced technologies such as multimodal imaging and machine learning, the collaboration will generate data that may help inform the design and development of new pediatric and perinatal device-centered RSTs.

The National Cancer Institute (NCI) Technology Transfer Center is hosting a webinar on an exciting new technology that could revolutionize MRI metabolic imaging. Scheduled for Wednesday, December 18, 2024, at 11:00 AM ET, this free webinar will introduce a novel Signal Amplification By Reversible Exchange (SABRE) catalyst technology, co-developed by the National Heart, Lung, and Blood Institute (NHLBI) and NCI. This innovation promises to enhance MRI imaging capabilities, enabling groundbreaking advancements in the detection and monitoring of cancer, cardiovascular disease, stroke, and traumatic brain injury.

FREDERICK, Md., Dec. 03, 2024 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced updated efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis (MG) and provided details on the design of its planned Phase 3 AURORA trial. The updated data will be presented today at the 2^nd Annual Cell Therapy for Autoimmune Disease Summit being held in Philadelphia.

GAITHERSBURG, Md., Nov. 26, 2024 (GLOBE NEWSWIRE) — Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) (“Shuttle Pharma”), a discovery and development stage specialty pharmaceutical company focused on improving outcomes for cancer patients treated with radiation therapy (RT), announced today first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma. UVA is one of six cancer centers conducting the clinical trials. Shuttle Pharma previously announced the dosing of patients at Miami Cancer Institute, part of Baptist Health South Florida.

Uncovering bias in AI models used in medical diagnosis. Identifying patients with potentially life-threatening antibiotic-resistant infections. Predicting the spread of disease with advanced computing.

These are just a few of the advances in medical care in the works at the University of Maryland Institute for Health Computing (UM-IHC), which uses high-performance computing and artificial intelligence to benefit public health in ways unimaginable just a few years ago.

Washington, D.C. – November 25, 2024 – Arlington Capital Partners (“Arlington”), a Washington, D.C.-area private investment firm specializing in government regulated industries, today announced it has acquired TEAM Technologies, Inc (“TEAM Tech”), a leading global manufacturer of essential healthcare products, from Clearlake Capital Group (“Clearlake”).

TEAM Technologies is a leading provider of specialized manufacturing and strategic supply chain solutions to blue-chip healthcare customers. The Company provides a broad array of end-to-end outsourced design and manufacturing services to medical device and pharmaceutical OEMs, with a growing specialty in advanced medical devices that are critical to the healthcare system. Through its comprehensive suite of vertically integrated processes, TEAM Tech enables customers to streamline their supply chains and reduce lead times in delivering critical products. TEAM Tech has approximately 1,000,000 square feet of manufacturing space across nine campuses in the U.S., Mexico, and Singapore.

Michelle Tarver, the new leader of the Food and Drug Administration’s medical device center, faces significant challenges ahead. 

Tarver is taking over as director of the Center for Devices and Radiological Health as the regulator grapples with questions around artificial intelligence in medical devices, racial bias in pulse oximeters, concerns about the recall process after Philips pulled millions of respiratory machines, and scrutiny of its former leader’s potential conflicts of interest. 

In this episode of BioTalk with Rich Bendis, Dr. Eric Edwards, Co-Founder and CEO of MedPhlow, shares how his innovative company is reshaping emergency medicine through cutting-edge drug delivery systems. Dr. Edwards discusses his journey from co-founding Kaléo, where he helped develop life-saving products like AUVI-Q, to leading MedPhlow, a subsidiary of Phlow Corp. Based in Richmond, VA, MedPhlow is dedicated to addressing critical challenges in essential medicine delivery, with its first product focused on improving outcomes during sudden cardiac arrest.

Dr. Edwards explains the groundbreaking technology behind MedPhlow’s platform and how it is poised to transform emergency care. He also highlights the impact of investor partnerships, such as those with Virginia Venture Partners, and discusses MedPhlow’s next milestones in its mission to make emergency medicine more efficient and accessible.

As a part of the BioHealth Capital Region, Dr. Edwards reflects on the advantages of being based in this vibrant hub of innovation and his contributions as a BioHealth Innovation (BHI) board member. Tune in to learn about the future of MedPhlow and the inspiring work being done to advance life-saving solutions in healthcare.

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The Biomedical Advanced Research and Development Authority (BARDA) has announced the launch of the SPARK Hub Prize Challenge, offering up to $50,000 in funding to innovators working on medical countermeasures (MCMs) designed specifically for children. The challenge supports technologies and products that enhance health security for pediatric populations and is open for submissions until December 16, 2024. https://www.mcm4kids.org/funding/

About BARDA and the Challenge
BARDA plays a pivotal role in safeguarding public health by advancing the development of MCMs for various health security threats, including chemical, biological, radiological, and nuclear (CBRN) hazards, pandemic influenza, and emerging infectious diseases. The SPARK Hub Prize Challenge is an extension of this mission, focusing on solutions tailored to pediatric needs. BARDA’s aim is to ensure that medical countermeasures are accessible to all segments of the population, including children, who have unique requirements during public health emergencies.

CHARLOTTESVILLE, Va., Nov. 21, 2024 (GLOBE NEWSWIRE) — TearSolutions, Inc., a privately held biotech company developing potentially disruptive therapies for the treatment of ocular surface related diseases, today announced the successful closure of a $3M Series B round designed to accelerate its development programs for rare corneal diseases at both pre-clinical and clinical stages.