Methotrexate is an antimetabolite and antifolate agent with antineoplastic and immunosuppressant activities. Methotrexate binds to and inhibits the enzyme dihydrofolate reductase, resulting in inhibition of purine nucleotide and thymidylate synthesis and, subsequently, inhibition of DNA and RNA syntheses. Methotrexate also exhibits potent immunosuppressant activity although the mechanism(s) of actions is unclear.
Methotrexate is approved by the Food and Drug Administration (FDA) to be used by itself to treat the following types of gestational trophoblastic tumors, Chorioadenoma destruens, Choriocarcinoma, Hydatidiform mole. Methotrexate is also approved to be used alone or with other drugs to treat acute lymphoblastic leukemia (ALL) that has spread to the central nervous system (CNS) or to keep it from spreading there, and to treat the following, breast cancer, certain types of head and neck cancer, lung cancer, advanced non-Hodgkin lymphoma (NHL), advanced mycosis fungoides (a type of cutaneous T-cell lymphoma), osteosarcoma that has not spread to other parts of the body, following surgery to remove the primary tumor. Methotrexate is also approved to treat the following non-cancer conditions, rheumatoid arthritis, severe psoriasis.
Chelsea Therapeutics International, Ltd. announced that preliminary analyses of its Phase III NORTHERA™ Study 301 met its primary endpoint. Treatment with Northera provided clinically meaningful and statistically significant improvement.
Chelsea Therapeutics International, Ltd. announced confirmation by the U.S. Food and Drug Administration (FDA) that its proposed Phase II protocol for CH-4051 in rheumatoid arthritis has been approved by the agency.
Protalex, Inc., a clinical stage biopharmaceutical company engaged in developing a class of biopharmaceutical drugs for treating autoimmune and inflammatory diseases, today announced the dosing of the first patient in a multicenter Phase 1b clinical study of PRTX-100 in adult patients with active Rheumatoid Arthritis (RA). The study is being conducted in South Africa.
Chelsea Therapeutics International, Ltd. announced that a new investigator-led phase II clinical study of Droxidopa, an oral synthetic precursor of norepinephrine, has been initiated in chronic fatigue syndrome (CFS).
For people living with rheumatoid arthritis (RA), the level of disease activity measured using the standard DAS 28 score is the factor most strongly affecting the level of RA-related disability, according to a study in Journal of Clinical Rheumatology.
Merck is pleased to announce that New Brunswick, Nova Scotia and Alberta are the first provinces in Canada to reimburse SIMPONI(golimumab) for the treatment of three different rheumatic conditions. SIMPONI, a subcutaneous anti-tumor necrosis factor therapy, is now reimbursed by the drug formularies of these three provinces for people living with moderately to severely active rheumatoid arthritis, moderately to severely active psoriatic arthritis and active ankylosing spondylitis.
Antares Pharma, Inc. today reported financial and operating results for the second quarter ended June 30, 2010.
The Canadian Agency for Drugs and Technologies in Health's (CADTH) Therapeutic Review Panel released last week their recommendations for Biologic Response Modifier Agents for Adults with Rheumatoid Arthritis (RA).
The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor (TNF) blockers, raising concerns of an associated risk and prompting an investigation. Researchers from the FDA set out to identify all reports of malignancy in children using infliximab, etanercept, and adalimumab and their report is published in the August issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology.
The Food and Drug Administration (FDA) received reports of malignancies in children using tumor necrosis factor a (TNF) blockers, raising concerns of an associated risk and prompting an investigation.
Bristol-Myers Squibb Company today reported results for the second quarter of 2010 which featured data on key marketed and investigational compounds in its oncology, diabetes and cardiovascular franchises, and growth in sales and EPS. The company also confirmed guidance for 2010 and minimum guidance for non-GAAP EPS in 2013.
Bristol-Myers Squibb Company has today announced that on 1 July 2010 the European Commission approved a new indication for ORENCIA® (abatacept), in combination with methotrexate (MTX), for the treatment of moderate to severe active rheumatoid arthritis (RA) in adult patients who have responded inadequately to previous therapy with one or more disease-modifying anti-rheumatic drugs (DMARDs) including MTX or a TNF-alpha inhibitor.
Chelsea Therapeutics International, Ltd. announced the completion and favorable outcome of an independent Data Monitoring Committee (DMC) review of the safety and efficacy data from approximately half the target enrollment in Chelsea's Phase II trial of droxidopa in fibromyalgia.
Chelsea Therapeutics International, Ltd. has successfully reached its target enrollment of 150 patients in its Northera™ (Droxidopa) pivotal Phase III Study 301 for the treatment of symptomatic, neurogenic orthostatic hypotension (NOH). Results from the trial are expected in September 2010 and the full registration program is on track to initiate a new drug application (NDA) in the first half of 2011.
Chelsea Therapeutics International, Ltd. announced the initiation of Study 306, a pivotal Phase III trial evaluating the efficacy of NORTHERA™, an oral synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH) associated with Parkinson's disease.
The Multiple Sclerosis Research Center of New York (MSRCNY), together with the International Multiple Sclerosis Management Practice (IMSMP), today announced that results from its Intrathecal Methotrexate Treatment in Multiple Sclerosis study have been published in this month's issue of Journal of Neurology. This study reports on the feasibility of using intrathecal methotrexate (ITMTX) in treatment unresponsive multiple sclerosis (MS) patients with progressive forms of the disease.
Disease-modifying antirheumatic drugs should be used early and aggressively at the first sign of rheumatoid arthritis. The results of an 11-year trial, published in BioMed Central's open access journal Arthritis Research & Therapy, demonstrate that active treatment from the very beginning pays off, even in the long run.
Chelsea Therapeutics International, Ltd. announced that data from its pivotal studies of Northera™ (droxidopa) in symptomatic neurogenic orthostatic hypotension was presented during a poster session and featured in a symposium highlighting the role of norepinephrine (NE) deficiency in Parkinson's disease at the 14th International Congress on Parkinson's Disease and Movement Disorders in Buenos Aires, Argentina.
Bristol-Myers Squibb Company and Alder Biopharmaceuticals today announced that new data from a dose-ranging Phase 2a trial support further development of BMS-945429/ALD518, an investigational monoclonal antibody directed against interleukin-6 (IL-6), as a potential treatment for rheumatoid arthritis (RA). The Phase 2a data will be presented in a scientific session on June 18, 2010, at the Annual Congress of the European League against Rheumatism (EULAR).
Trubion Pharmaceuticals, Inc. today announced Pfizer's decision to discontinue development of TRU-015 (PF-05212374), an investigational drug in Phase 2 evaluation for the treatment of rheumatoid arthritis (RA) developed under the companies' CD20 collaboration. However, Pfizer has confirmed that it will continue to develop SBI-087 (PF-05230895), Trubion's next-generation, humanized, subcutaneous CD20 RA product candidate also in Phase 2 clinical evaluation.
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