MIRAMAR, Fla., Jan. 23, 2024 /PRNewswire/ -- On September 26, 2023, Kimera® Labs Inc., a privately held clinical stage biotechnology company, responded to a Warning Letter (WL) received from the Food and Drug Administration (FDA) on September 5, 2023. That same WL was listed on the FDA website on January 4, 2024. The WL was in response to an inspection conducted in its Miramar, FL facility between July 11, 2022, and July 21, 2022. During that inspection, FDA took the position that three cellular exosome products produced at that facility for research use, XoGlo®, XoGlo Pro®, and Amino2X®, were pharmaceutical drugs required to comply with the most stringent current good manufacturing practices (cGMPs) applicable to commercial manufacturers of pharmaceutical products.
MIRAMAR, Fla., May 16, 2023 /PRNewswire/ -- Kimera® Labs Inc., the first and leading worldwide MSC exosome research lab and producer, is pleased to announce the FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial. The trial will assess the safety and efficacy of a single intravenous dose of a isolated, proprietary placental cell line derived, mesenchymal stem extracellular vesicles for the treatment of COVID-19 symptoms in adults with mild to moderate illness.
Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, today announced the appointments of Karen Weisbach, as Vice President, People and Culture, and Jolly Bhatia as Vice President, Quality.