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Lantheus Holdings announces submission of Drug Master File for NM-01 in the U.S.

Press releases may be edited for formatting or style | January 13, 2021 Molecular Imaging

“We are very encouraged by the results of the Phase I study, which validated our innovative nanobody platform and demonstrated strong correlation with tissue-based biomarker,” said Dr. H.H. Ting, Chief Executive Officer of NanoMab. “We are pleased that leading cancer research centers are progressing with the use of NM-01 in I/O clinical trials.”


About a Drug Master File (DMF)
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A Drug Master File (DMF) is a submission to the Food and Drug Administration that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.


About NanoMab Technology Limited
NanoMab Technology Limited is a privately held biopharmaceutical company focusing on cancer precision therapies via the development of radiopharmaceuticals. The company’s goal is to develop a pipeline of theranostics with its proprietary camelid antibody platform to address the unmet medical need for cancer patients across the world. An IMPD on NM-01 was filed with UK Medical Healthcare products Regulatory Agency (MHRA) last year. NanoMab is also developing its radio-labelled NM-02 for clinical trials in both imaging and treatment of breast and gastric cancers. NanoMab’s third program, NM-03, a single domain antibody targeting a pan-cancer marker, is in preclinical development as a theranostic.


About Lantheus Holdings, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; AZEDRA® for the treatment of certain rare neuroendocrine tumors; and RELISTOR® for the treatment of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden.

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