FDA
– Imaging study confirms the biodistribution of TTX-MC138 in models of metastatic cancer, supporting TransCode’s TTX platform for delivery of RNA targeted therapy to metastatic solid tumors – — eIND submission for TTX-MC138 anticipated in 1Q 2022 to support Phase 0 study in metastatic solid tumors, designed to establish proof of concept for TTX delivery platform — BOSTON–(BUSINESS…
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PHILADELPHIA, Sept. 22, 2021 /PRNewswire/ — CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CT-0508, a human epidermal growth factor receptor 2 (HER2) targeted chimeric antigen receptor macrophage (CAR-M) for the treatment of patients…
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Excerpt from the Press Release: BOSTON, Sept. 16, 2021 (GLOBE NEWSWIRE) — SHEPHERD Therapeutics, a company dedicated to catalyzing lifesaving treatments for cancer patients, is pleased to present an e-poster of results from a computational approach to optimizing therapeutic selection for cancer patients using the Company’s proprietary precision-oncology DELVE platform, at the European Society for…
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Excerpt from the Press Release: NTLA-5001 is Intellia’s first ex vivo candidate using its proprietary cell engineering process for the treatment of cancer to enter clinical study NTLA-5001 targets Wilms’ Tumor 1 (WT1), an overexpressed intracellular antigen on many hematologic malignancies and solid tumors Initiation of patient screening in Phase 1/2a study of NTLA-5001 expected…
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Excerpt from the Press Release: WATERTOWN, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company pioneering a new class of small-molecule medicines that selectively destroy disease-causing proteins through degradation, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to CFT7455…
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Excerpt from the Press Release: Moderna Inc. plans to double enrollment in a trial of its Covid vaccine in children under age 12, following a request from U.S. regulators to collect additional safety data. Moderna’s study will enroll an estimated 13,275 participants ages 6 months up to 12 years old, according to a listing on the clinicaltrials.gov website. In a…
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Excerpt from the Press Release: TOLEDO, Ohio & PHILADELPHIA–(BUSINESS WIRE)–NAMSA, the world’s only 100% medical device-focused Contract Research Organization (CRO) providing full continuum development solutions, announced today its acquisition of Clinlogix, a leading, Philadelphia-based global clinical research organization. Third in an advancing series, this acquisition follows NAMSA’s purchase announcements of Syntactx and American Preclinical Services (APS) in early…
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Excerpt from the Press Release: RADNOR, Pa.–(BUSINESS WIRE)–Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company dedicated to the development of innovative therapeutics to treat seizure disorders, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the use of its lead product candidate ganaxolone, to treat seizures…
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Excerpt from the Press Release: Vaxart (NSDQ:VXRT) announced today that the FDA cleared the investigational new drug (IND) application for its oral COVID-19 vaccine. Upon news of the IND application approval for the S-only protein construct-based vaccine candidate, shares of VXRT were up 16.1% at $8.35 in early-morning trading today. Click the button below to read…
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Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 2, 2021 /PRNewswire/ — Vaxart, Inc., (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines administered by tablet, announced today that the U.S. Food and Drug Administration has cleared Vaxart’s Investigational New Drug application for an S-only oral tablet SARS-CoV-2 vaccine candidate. “This is great news because it allows us to move forward…
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