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Garching/Munich, Germany, and Houston, Texas, U.S., December 08, 2020: ITM Isotopen Technologien München AG (ITM), a biotechnology and radiopharmaceutical group of companies, and RadioMedix Inc., a clinical stage biotechnology company, today announced that the U.S. Food and Drug Administration (FDA) has issued the Drug Master File (DMF no. 34938) for ITM’s next generation Germanium-68/Gallium-68 (68Ge/68Ga) Generator, distributed under the brand name GeGant®.The DMF will allow parties interested in developing new drugs for the U.S. market to refer to the DMF and use GeGant® in clinical tests for radiopharmaceuticals and in other settings. The GeGant® Generators will be manufactured at the...

ST. LOUIS, Dec. 09, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that the Centers for Medicare & Medicaid Services (CMS) has granted Detectnet Transitional Pass-Through Status (code C9068) effective January 1, 2021. The descriptor for Detectnet will be: Copper Cu-64, dotatate, diagnostic, 1 millicurie. C9068 will be used to bill Detectnet for Medicare patients seen in the hospital outpatient department. “The response to Detectnet in the neuroendocrine community has been tremendous,” said Curium CEO, North America, Dan Brague. “Once in effect, this code will simplify the billing and reimbursement of Detectnet for our customers....

Houston, TX, Oct. 13, 2020 (GLOBE NEWSWIRE) -- Radiomedix a clinical-stage biotechnology company focused on innovative targeted radiopharmaceuticals for diagnosis, monitoring, and therapy of cancer, announced the appointment of Dr. Ferey Faridian as a member of its Board of Directors. “It is an honor to join the world-class team at Radiomedix to guide in the areas of strategy and finance at a time when the company is at the brink of creating new treatment modalities in neuroendocrine cancers, said Faridian.” Faridian is a partner at Newport LLC, a nationwide business advisory firm of experienced CEOs and executives helping middle-market companies...

Houston, TX and St. Louis, MO, Sept. 07, 2020 (GLOBE NEWSWIRE) -- RadioMedix Inc. and its commercial partner Curium announced today that DetectnetTM (copper Cu 64 dotatate injection) was approved by the U.S. Food and Drug Administration (FDA).  Detectnet is a positron emission tomography (PET) agent indicated for the localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.  Curium expects to launch Detectnet immediately with doses available through various nuclear pharmacies or directly from Curium.    “Detectnet brings an exciting advancement in the diagnosis of neuroendocrine tumors for healthcare providers, patients, and their caregivers,” said Ebrahim Delpassand, MD, CEO...

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...