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ITM’s long-term partner RadioMedix is producing and distributing GeGant® for the U.S. market GARCHING, Germany & MUNICH & HOUSTON--(BUSINESS WIRE)--ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, announced today that ITM has filed a Drug Master File (DMF) with the U.S. Food and Drug Administration (FDA) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, which is manufactured at the RadioMedix Spica Center in Houston, Texas, U.S. and distributed under the brand name GeGant®. The RadioMedix Spica Center is a 21 CFR 211 compliant, and GMP radiopharmaceutical manufacturing facility...

Houston, TX, USA and  Garching, Germany. RadioMedix, and OncoBeta today announced the execution of an exclusive distribution agreement for the next generation of W/Re-188 generators in the U.S. and Canada. The OncoBeta® Tungsten (Wolfram)-188/Rhenium-188 (W/Re-188) Generators can be used for radiolabeling reactions or directly as a high dose liquid radioactive source. Rhenium-188 (Re-188) is a high energy-emitting radioisotope obtained from the W/Re-188 Generator. Re-188 has shown high efficiency and value for a variety of therapeutic applications in nuclear medicine, oncology, and interventional radiology/cardiology areas. Its advantageous physical properties, its potential low cost, and with a long-lived parent, make this generator an...

Houston and St Louis, Jan. 07, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. and its commercial partner Curium announced today that the New Drug Application for copper Cu 64 dotatate injection was filed with the U.S. Food and Drug Administration (FDA). Copper Cu 64 dotatate injection is a PET diagnostic agent intended for somatostatin receptor (SSTR) expressing neuroendocrine tumors (NETs). The FDA previously granted Fast Track designation to copper Cu 64 dotatate injection. “If approved, we expect that copper Cu 64 dotatate injection will be the first FDA approved Cu 64 labeled radiopharmaceutical for PET/CT imaging. In addition, this drug will...

Houston, Jan. 02, 2020 (GLOBE NEWSWIRE) — RadioMedix Inc. is pleased to announce that the company has been selected for the 2019-2020 Commercialization Accelerator Program (CAP) by the National Institute of Health (NIH) SBIR/STTR (Small Business Innovation Research/Small Business Technology Transfer) program office. This award is following our two-years, $2.0 M Phase II SBIR funded in part with Federal funds from the National Cancer Institute, National Institutes of Health and Human Services, under Contract No HHSN261201800048C. The Contract focuses on the clinical development of 212Pb-AlphaMedix™ for the targeted alpha-emitter therapy (TAT) of neuroendocrine tumors. ”Selection for this program highlights the value...

LAUSANNE, Switzerland–(BUSINESS WIRE)–Novigenix SA, a leading Immuno-Transcriptomics company that develops and commercializes solutions for early cancer detection and precision medicine, today announced a collaboration agreement with RadioMedix Inc., a radiopharmaceutical company, to develop a precision diagnostic test based on Novigenix’s technology. The test will measure the response in patients with neuroendocrine tumors (NET) treated with Alpha and Beta Peptide Receptor Radionuclide Therapy (PRRT).   “Precise measurement of the therapy response against NET is extremely important for the management of NET patients.” In order to effectively monitor the response following PRRT, Novigenix will develop an immune-transcriptomic based precision diagnostic test using...