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GAITHERSBURG, Md., Dec. 10, 2024 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the first participants have been dosed in its COVID-19-Influenza Combination (CIC) and stand-alone seasonal influenza Phase 3 trial. The trial will evaluate the immunogenicity and safety of the CIC and stand-alone seasonal influenza vaccine candidates compared to Novavax’s updated 2024-2025 COVID-19 vaccine (NVX-CoV2705) and a licensed seasonal influenza vaccine comparator in adults aged 65 and older.

FREDERICK, Md., Dec. 10, 2024 /PRNewswire/ — Theradaptive, a privately held, clinical stage biologics company developing protein therapeutics for spine, orthopedics, soft tissue repair, and targeted immuno-oncology, announced today that the US Food and Drug Administration (FDA) has approved an expansion to its Phase I/II clinical program, broadening it to include three spinal fusion indications and tripling the number of investigational sites in the US.

The OASIS trial was approved by the FDA earlier this year to assess the safety and efficacy of OsteoAdapt™ SP, Theradaptive’s implant with targeted biologics to treat degenerative disc disease, in a transforaminal interbody fusion (TLIF) approach. The recent approval encompasses two other common spinal fusion approaches: anterior lumbar interbody fusion (ALIF) and lateral lumbar interbody fusion (LLIF). The company anticipates enrollment of its first ALIF and LLIF study subjects in early 2025.

On December 4th, TEDCO hosted its 10th Entrepreneur Expo in Baltimore, bringing together over 1,000 entrepreneurs, investors, and industry leaders for a day of connection, learning, and celebration. As a premier event in Maryland, the Expo showcased the state’s vibrant entrepreneurial ecosystem through workshops, roundtable discussions, and exhibitions, featuring 95 speakers and 84 companies, including 34 startups. The BioHealth Innovation, Inc. (BHI) team was proud to participate in this dynamic gathering, further strengthening its commitment to fostering growth and commercialization in the BioHealth Capital Region.

BELTSVILLE, Md., Dec. 10, 2024 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class, and best-in-class therapies to treat cancer, today announced that the U.S. Food and Drug Administration (FDA) accepted an Investigational New Drug (IND) application for initiation of a Phase 1 clinical trial to evaluate LNCB74, a B7-H4-targeting antibody-drug conjugate (ADC) as a therapeutic for treating multiple cancers.

ANNAPOLIS, Md., Dec. 10, 2024 /PRNewswire/ —  Alphyn, a clinical-stage dermatology company developing first-in-class Multi-Target Therapeutics^®, announced today that the U.S. Patent and Trademark Office (USPTO) has granted the company a patent covering compositions and methods of use for the drug formulation of Zabalafin Hydrogel (AB-101a) for atopic dermatitis (AD). The patent covers Zabalafin Hydrogel through 2042 and is eligible for listing in the U.S. Food and Drug Administration’s (FDA) Orange Book, which provides additional protective benefits once Zabalafin Hydrogel receives FDA approval.

The Maryland Business Innovation Association (MBIA), with support from TEDCO, has announced the launch of the FY25 MBIA Commercialization Innovation Grant (MCIG). Designed to provide strategic funding to Maryland-based innovative companies, the program opens its application window on Tuesday, December 10, at 12pm noon ET. The MCIG offers eligible companies the opportunity to secure funding that supports entrepreneurial advancement and commercialization efforts, driving growth in Maryland’s innovation ecosystem and economy.

Baltimore, MD—The Baltimore Development Corporation (BDC) and the Maryland Department of Commerce are pleased to announce the Baltimore City Board of Estimates’ approval of a $200,000 conditional loan to support the establishment of 4MLK Connect Labs, a state-of-the-art flex lab space in the University of Maryland BioPark in Baltimore, Maryland. This joint funding effort marks a significant step toward strengthening Maryland’s position as a national leader in the life sciences industry.

The $200,000 convertible loan from Baltimore City, combined with the state’s $2 million conditional loan, awarded through Advantage Maryland (formally known as MEDAAF), will fund specialized scientific lab equipment for approximately 35,000 square feet of flex lab space. The space will be operated by 4MLK Connect Labs JV LLC, a joint venture formed by affiliates of Wexford Science & Technology, LLC, and Ventas, Inc. It is projected to create at least 100 full-time permanent jobs in Baltimore by 2028.

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.