Romosozumab definition

Romosozumab means the Antibody Product known as romosozumab.

Examples of Romosozumab in a sentence

  • Romosozumab in postmenopausal women with low bone mineral density.

  • Romosozumab or Alendronate for Fracture Prevention in Women with Osteoporosis.

  • Romosozumab or alendronate for fracture prevention in women with osteoporosis.

  • Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis (FRAME).

  • A Double-blind Study to Compare the Safety and Efficacy of Romosozumab (AMG 785) Versus Placebo in Men With Osteoporosis (BRIDGE).

  • Romosozumab is being studied for its potential to reduce the risk of fractures in an extensive global Phase 3 program.

  • Saag KG, Petersen J, Brandi ML, Karaplis AC, Lorentzon M, Thomas T, Maddox J, Fan M, Meisner PD, Grauer A (2017) Romosozumab or alendronate for fracture prevention in women with osteoporosis.

  • Reid, Targeting Sclerostin in Postmenopausal Osteoporosis: Focus on Romosozumab and Blosozumab, BioDrugs 31, 289–297 (2017).

  • Grauer, Romosozumab Treatment in Postmenopausal Women with Osteoporosis, N.

  • Studies have revealed unsatisfactory results for other “orthobiologics” in fracture healing (rhBMP-7 from Olympus Biotech, rhPDGF from Wright Medical Group, PTH from Lilly and Romosozumab from Amgen/UCB), forcing them to withdraw the products from the market or discontinue their clinical development.

Related to Romosozumab

  • Antibody means a molecule or a gene encoding such a molecule comprising or containing one or more immunoglobulin variable domains or parts of such domains or any existing or future fragments, variants, modifications or derivatives thereof.

  • Merck has the meaning set forth in the preamble.

  • Biomarker means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.

  • scientific research means any activity in the field of natural or applied science for the extension of knowledge;

  • Bioassay means the determination of kinds, quantities or concentrations and, in some cases, the locations of radioactive material in the human body, whether by direct measurement, in vivo counting, or by analysis and evaluation of materials excreted or removed from the human body. For purposes of these rules, “radiobioassay” is an equivalent term.

  • Vaccine means a specially prepared antigen which, upon administration to a person, will result in immunity and, specifically for the purposes of this rule, shall mean influenza and pneumococcal vaccines.

  • Licensed Compounds means any EZH2 Compound(s) that is:

  • Halogen means one of the chemical elements chlorine, bromine or iodine.

  • Novartis shall have the meaning set forth in the Preamble.

  • Licensed Compound means [***].

  • Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Opioid antidote means any drug, regardless of dosage amount or method of administration, which has been approved by the United States Food and Drug Administration (FDA) for the treatment of an opioid overdose. “Opioid antidote” includes, but is not limited to, naloxone hydrochloride, in any dosage amount, which is administered through nasal spray or any other FDA-approved means or methods.

  • Diagnostic Product means any test or assay for diagnosing or detecting a disease, disorder, medical condition, or symptom.

  • Opioid antagonist means a drug that binds to opioid

  • BMS means the Company, all related companies, affiliates, subsidiaries, parents, successors, assigns and all organizations acquired by the foregoing.

  • Pre-Licensed Therapist means an individual who has obtained a Master’s Degree in Social Work or Marriage and Family Therapy and is registered with the BBS as an Associate CSW or MFT Intern acquiring hours for licensing. An individual’s registration is subject to regulations adopted by the BBS.

  • HIV means human immunodeficiency virus.

  • Collaboration Know-How means all Know-How conceived, discovered, developed or otherwise made by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing (solely or jointly by or on behalf of a particular Party or any of its Affiliates or permitted subcontractors of any of the foregoing) in the course of [***].

  • Collaboration Technology means the Collaboration Know-How and the Collaboration Patents.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Marihuana-infused product means a topical formulation, tincture, beverage, edible substance, or similar product containing marihuana and other ingredients and that is intended for human consumption.

  • coronavirus means severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2);

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.