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. reported findings from Study 305, a study evaluating the effect of Northera™ (Droxidopa), an investigational agent being studied for the treatment of neurogenic orthostatic hypotension (NOH), on patients' 24-hour blood pressure (BP) profile.
Pathway Genomics Inc., a U.S. based genetic testing company, announced the immediate availability of its personal Genetic Health Report. This customized and innovative personal genetic health report contains information on more than 70 health conditions, including pharmacogenetics (prescription medication response), propensity for complex disease, and carrier status (pre-pregnancy health).
Genentech, Inc., a wholly-owned member of the Roche Group, today announced that the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for ACTEMRA® (tocilizumab) for the prevention of structural joint damage (as assessed by radiograph) and improvement in physical function in adults with moderately to severely active rheumatoid arthritis (RA).
Chelsea Therapeutics International, Ltd. reported financial results for the fourth quarter and full year 2009 and will host a conference call this afternoon at 4:30 PM ET to discuss these results and provide a quarterly update on the Company's development progress.
Data evaluating the efficacy and safety of STELARA™ (ustekinumab) and REMICADE® (infliximab) in patients with plaque psoriasis who had an inadequate response to Enbrel® (etanercept) will be presented at the 68th Annual Meeting of the American Academy of Dermatology (AAD) in Miami, Fla., from March 5-9, 2010.
Genentech, Inc., a wholly owned member of the Roche Group, and Biogen Idec announced today the U.S. Food and Drug Administration (FDA) approved Rituxan® (rituximab) in combination with fludarabine and cyclophosphamide (FC) for people with previously untreated and previously treated CD20-positive chronic lymphocytic leukemia (CLL).
AstraZeneca and Rigel Pharmaceuticals today announced an exclusive worldwide license agreement for the global development and commercialization of fostamatinib disodium (R788), Rigel's late-stage investigational product for rheumatoid arthritis (RA) and additional indications.
Biogen Idec Inc., a global biotechnology leader in the discovery, development, manufacturing, and commercialization of innovative therapies, today announced its full year and fourth quarter 2009 results.
Spectrum Pharmaceuticals, a commercial-stage biotechnology company with a primary focus in oncology, today announced that it has met with the FDA regarding it’s supplemental New Drug Application (sNDA) for FUSILEV® (levoleucovorin) for injection for the treatment of patients with advanced metastatic colorectal cancer. In October 2009, the FDA issued a Complete Response letter regarding its sNDA for FUSILEV.
Findings from a cost model suggest that expenses for systemic psoriasis therapy appear to be increasing at a faster rate than inflation, and newer biologically derived treatments are more expensive than traditional systemic therapies, according to a report in the January issue of Archives of Dermatology, one of the JAMA/Archives journals.
Clinical trials to test the effectiveness of two prescription drugs for the debilitating skin condition psoriasis have revealed significant differences that should help inform physicians treating patients with the condition.
Trubion Pharmaceuticals, Inc. today announced that its collaboration partner, Pfizer, has initiated a Phase 2 clinical trial of SBI-087 (PF-05230895) for the treatment of rheumatoid arthritis (RA). SBI-087 is a next-generation, humanized Small Modular ImmunoPharmaceutical (SMIP(TM)) protein therapeutic directed against the CD20 antigen. SBI-087 is also being evaluated in Phase 1 clinical trials for RA and systemic lupus erythematosus (SLE).
Genentech, Inc., a wholly owned member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) approved ACTEMRA® (tocilizumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
Researchers from Johns Hopkins University determined that immune responses to the tetanus vaccine were not changed when rituximab in combination with methotrexate (MTX) was compared with MTX alone in patients with rheumatoid arthritis (RA).
Rheumatoid arthritis (RA) patients are partially protected by the influenza vaccine 6-10 months after treatment with rituximab. Researchers determined that while the flu vaccine is safe, it is ineffective for RA patients in the first 6 months following rituximab treatment.
Eli Lilly and Company and Incyte Corporation announced today that they have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Incyte's oral JAK1/JAK2 inhibitor, INCB28050, and certain follow on compounds, for inflammatory and autoimmune diseases. The lead compound, INCB28050, is currently being studied in a six-month dose-ranging Phase II trial for rheumatoid arthritis.
ChemoCentryx, Inc. today announced that it has begun enrolling patients in a Phase 2 clinical trial of CCX354, an orally-bioavailable, novel, small molecule drug designed to specifically target the CCR1 chemokine receptor for the treatment of rheumatoid arthritis (RA).
Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec announced today a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks.
Roche announced today at the 51st Meeting of the American Society of Hematology (ASH) in New Orleans, LA (USA) that the pivotal Phase III study CLL8 showed that patients with previously-untreated chronic lymphocytic leukemia (CLL) survived their disease longer when treated with Rituxan (rituximab) compared to chemotherapy alone.
Genentech, Inc., a wholly owned member of the Roche Group, and Biogen Idec today announced that three-year follow up of the pivotal Phase III CLL8 trial showed Rituxan plus fludarabine and cyclophosphamide (FC) chemotherapy helped patients in the trial with previously untreated chronic lymphocytic leukemia (CLL) live longer than FC alone.
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