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Found 60 result(s) FROM 1963 pages containing the term 'Humira'.
Wednesday Sep 30, 2009
FDA Finally OKs Stelara for Psoriasis
The FDA has approved Centocor's Stelara (ustekinumab) for moderate to severe psoriasis...
Wednesday Aug 05, 2009
Black Box Added to TNF Inhibitors for Kids, Teens
The FDA has expanded TNF blocker “black box” warnings to include lymphoma and other cancers in children and teens, leukemia in all patients, and new-onset psoriasis...
Wednesday Jul 29, 2009
TNF Inhibitors Have Different TB Risks
The risk of developing tuberculosis is 7 to 17 fold higher among patients receiving anti-TNF monoclonal antibody therapy than for those receiving soluble TNF receptors. How can you protect your patients?...
Thursday Jul 23, 2009
Gene Therapy Cleared in RA Patient Death
The vector used in an RA gene therapy study did not cause the death of a patient who died during the trial...
Monday Jul 06, 2009
IOM's Puts Arthritis Biologics Near Top of List for Comparative Studies
The Institute of Medicine puts biologic anti-inflammatory drugs near the top of its recommended list for comparative effectiveness studies...
Wednesday May 20, 2009
X-ray Stability Lags RA Remission by Months
Radiographic joint damage grinds to a halt only after at least 9 months of sustained disease remission...
Thursday May 07, 2009
Abbott Sues Centocor Over Simponi Rights
Court fights over TNF inhibitors expand with Simponi approval...
Tuesday Feb 17, 2009
Some TNF Inhibitors Raise Shingles Risk in RA. Time to Vaccinate?
Anti-TNF monoclonal antibody drugs (adalimumab, infliximab) significantly increase herpes zoster risk in RA patients, and vaccination should be considered. Etanercept was not associated with increased herpes zoster risk...
Monday Sep 29, 2008
Abbott Reports Continuous Treatment With Humira® Achieves Superior Long-Term Efficacy for Psoriasis Patients in the US and Europe Versus Interrupting Treatment
The findings were from the company's pivotal 52-week REVEAL study and the period of open-label treatment that followed...
Monday Sep 08, 2008
FDA Warns of Histoplasmosis, Invasive Fungal Infections in Patients Taking TNF Inhibitors
The US Food and Drug Administration has issued a “MedWatch” warning about the risk of histoplasmosis and other invasive fungal infections in patients taking TNF blockers...
Wednesday Aug 27, 2008
Pivotal Humira Trial Shows Durable Benefit in Juvenile Rheumatoid Arthritis
The pivotal trial of adalimumab (Humira®) shows durable, safe efficacy for up to 2 years for children with polyarticular JRA and positions the TNF-inhibitor as the reasonable second-line drug to add if methotrexate does not provide sufficient disease control...
Tuesday Jul 29, 2008
CEL-SCI Announces Positive Preclinical Results Using CEL-2000, a Chimeric Peptide with Bi-Functional Properties, as RA Vaccine
CEL-SCI Corp announced the discovery of CEL-2000, a novel peptide vaccine for the treatment of RA. Tests showed that CEL-2000 is equivalent or possibly superior to Enbrel® in slowing disease progression and lessening symptoms in mice...
Monday Jun 09, 2008
FDA Launches Major Investigation of Cancer Risk in Children Taking TNF Blockers
The FDA is investigating a possible link between TNF blockers and cancer in children and young adults...
Monday Apr 21, 2008
Abbott’s Humira® (adalimumab) Approved in Japan for the Treatment of RA
Abbott received approval in Japan for Humira® (adalimumab) to treat RA in patients with inadequate response to conventional therapy...
Monday Apr 07, 2008
Analysis Finds Etanercept, Adalimumab More Cost-Effective Than Infliximab for Medicare Use
A model comparing costs and effectiveness of the biologics currently covered for treating RA in US Medicare beneficiaries has shown that etanercept (ETN) and adalimumab (ADA) are both more cost-effective than infliximab (INF)…
Tuesday Feb 26, 2008
Abbott Receives FDA Approval for Humira® (Adalimumab) for Polyarticular Juvenile Idiopathic Arthritis; EOW Dosing
Abbott Laboratories announced it has received US FDA approval to market Humira® (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis...
Friday Feb 08, 2008
TNF Inhibitors, Efalizumab, Alefacept Herald New Era in Psoriasis Treatment
New treatment strategies that include TNF-α inhibitors, efalizumab, and alefacept offer better psoriasis control with less toxicity, but still need to be compared with traditional agents in clinical trials...
Tuesday Jan 29, 2008
Newer Rheumatoid Arthritis Drugs Lower Production of B Cells
New findings suggest that drugs such as Enbrel®, Humira®, and Remicade® reduce activity of abnormal B-cells, benefiting the patient's immune system...
Wednesday Jan 23, 2008
Abbott's Humira® Approved in US for Treatment of Moderate-to-Severe Chronic Plaque Psoriasis
Abbott Laboratories announced it has received US FDA approval to market Humira® (adalimumab) for adults with moderate-to-severe chronic plaque psoriasis...
Tuesday Jan 15, 2008
Three More Cases of Significant Neutropenia Lead to Recommendation for Routine CBC Monitoring
Three more cases of significant neutropenia in rheumatoid arthritis (RA) and psoriatic arthritis patients treated with etanercept lead to a recommendation for regular monitoring of complete blood counts (CBC)...
Monday Jan 07, 2008
Abbott's Humira® Approved in the EU for Treatment of Moderate-to-Severe Plaque Psoriasis
Abbott announced it has received marketing authorization from the European Commission for the use of the TNF antagonist Humira® (adalimumab) as a treatment for moderate-to-severe plaque psoriasis. Humira is the first fully human, self-injectable biologic for the treatment of psoriasis...
Tuesday Nov 20, 2007
Abbott's Humira® Receives Positive Opinion From EMEA for Treatment of Moderate-to-Severe Plaque Psoriasis
Abbott Laboratories announced that the Committee for Medicinal Products for Human Use (CHMP), granted Abbott a positive opinion recommending approval of Humira® (adalimumab) for the treatment of moderate-to-severe plaque psoriasis...
Thursday Aug 23, 2007
NICE Issues Positive Appraisal of Abbott's Humira® (adalimumab) for the Treatment of Psoriatic Arthritis in UK Patient Population
The National Institute for Health and Clinical Excellence has published final guidance on the use of Humira® (adalimumab, Abbott Laboratories), a recombinant human monoclonal antibody that binds specifically to TNF-a, for the treatment of psoriatic arthritis (PsA)...
Monday Jun 11, 2007
Abbott's HUMIRA® (Adalimumab) Approved in the European Union for the Treatment of Crohn's Disease
Abbott Laboratories announced that it has received marketing authorization from the European Commission for the use of Humira® (adalimumab) as a treatment for severe Crohn's disease (CD)...
Tuesday Jun 05, 2007
Peptech's Anti-TNF Domain Antibody (PN0621) Enters Phase I Clinical Trial
Peptech Limited, is a clinical-stage biopharmaceutical company dedicated to developing and providing antibody- and peptide-based human therapeutic products for the treatment of inflammatory diseases and cancer...
Friday May 25, 2007
Accumulating Evidence Supports Adalimumab for Severe Psoriatic Arthritis
Adalimumab (Humira®) is safe and effective for patients with active psoriatic arthritis (PsA) who showed an inadequate response to disease-modifying antirheumatic drugs (DMARDs)...
Wednesday May 09, 2007
Abbott's ABT-874 Shows Positive Results in Phase II Psoriasis Study
Abbott Laboratories announced positive results from a 12-week, double-blind, placebo-controlled phase II study in which its investigational treatment, ABT-874, a fully human monoclonal antibody designed to target and neutralize interleukin-12 and interleukin-23, significantly reduced psoriasis symptoms in the majority of patients treated...
Monday Apr 16, 2007
Abbott Seeks US and EU Regulatory Approval for HUMIRA® (Adalimumab) in Psoriasis; Receives US FDA Approval in Crohn's Disease
Abbott Laboratories announced that it has simultaneously submitted a supplemental Biologics License Application (sBLA) with the US FDA and a Type II Variation to the European Medicines Agency (EMEA) seeking approval to market HUMIRA® (adalimumab) as a treatment for moderate-to-severe chronic plaque psoriasis, the fifth autoimmune disease targeted for HUMIRA therapy in both the US and Europe...
Thursday Apr 05, 2007
More Evidence Points Toward Safety of Anti-TNF Drugs During Pregnancy
Three recent case reports add to an accumulating body of evidence that the TNF-blockers are safe during pregnancy, but one new report is far from the final word on the issue...
Thursday Mar 22, 2007
6000-Patient Open-Label ReAct Study Shows Adalimumab Safe, Effective Alone or With DMARDs in Hard-to-Treat RA
The largest prospective study to date of the use of a TNF-inhibitor in RA shows that adalimumab (Humira®) is safe and effective alone or in combination with standard disease-modifying antirheumatic drugs (DMARDs)...
Thursday Mar 22, 2007
New Studies Urge Closer Monitoring for JIA-Related Uveitis, TNF-Inhibitors Effective For Difficult Cases
New studies report that uveitis occurs in up to 20% of JIA patients, that TNF-inhibitors may be effective in hard-to-treat cases, and that close monitoring for uveitis should continue even during arthritis remissions...
Wednesday Feb 28, 2007
Abbott's HumiraR (Adalimumab) Receives FDA Approval for Self-Administered Treatment of Moderate-to-Severe Crohn's Disease; Represents 4th FDA Approval in Immune-Mediated Diseases for Humira
Abbott announced it has received US FDA approval to market Humira® (adalimumab, a fully human anti-TNF-α monoclonal antibody) as a treatment for reducing the signs and symptoms and inducing and maintaining clinical remission of moderately-to-severely active Crohn's disease (CD) in adults who have had an inadequate response to conventional therapy...
Monday Dec 11, 2006
Steroids, Cytotoxics Cause More Heart Damage than Biologics in Treating RA
Biologic immunosuppressive agents used to treat rheumatoid arthritis (RA) carry cardiovascular risks similar to that of methotrexate (MTX), but oral glucocorticoids and other cytotoxic RA drugs are more damaging to the heart...
Tuesday Dec 05, 2006
Humira Receives Expanded Indication for Preventing Joint Destruction in PsA
Thursday Nov 16, 2006
Abbott's HUMIRA (adalimumab) Approved in Canada for Treatment of Ankylosing Spondylitis
Abbott announced that it has received approval from Health Canada to market HumiraR (adalimumab) as a treatment for active ankylosing spondylitis (AS) in Canada.
Monday Nov 06, 2006
Array BioPharma Reports Success in Two Approaches to Inflammatory Disease: MEK Inhibitor Achieves Phase I Clinical Objectives; p38 MAP Kinase Inhibitor Advances into Clinical Development
Array BioPharma Inc. (BOULDER, Colorado), a biopharmaceutical company focused on the discovery, development, and commercialization of orally active, small molecule drugs for the treatment of inflammatory diseases and cancer, announced preliminary results from a phase I clinical trial evaluating its first-in-class MEK (MAPK kinase) inhibitor for the treatment of inflammatory diseases.
Monday Sep 25, 2006
Rituximab Quickly Reduces Disease Activity in Treatment-Resistant RA
Rituximab added to methotrexate significantly reduces disease activity in patients whose RA is resistant to TNF inhibitors... Cohen SB, et al. Arthritis Rheum. 2006;54:2793-2806.
Tuesday Sep 19, 2006
TNF Inhibitors Do Not Increase Cancer Risk More Than MTX in RA Patients
A study of 1152 RA patients who used biologics and 7306 treated with methotrexate concludes that the risk of cancer is about the same in both groups, once RA disease severity is considered. Setoguchi S, et al. Arthritis Rheum. 2006;54:2757-2764.
Monday Sep 11, 2006
Abbott Seeks US and EU Approvals for HUMIRA (Adalimumab) for Crohn's Disease
Abbott announced it has simultaneously submitted a supplemental Biologics License Application with the US FDA and a Type II Variation to the European Medicines Agency seeking approval to market HUMIRAR (adalimumab) as a treatment for moderate-to-severe Crohn's disease...
Tuesday Aug 01, 2006
Schering-Plough's REMICADE Receives EU Approval as Monotherapy for Treatment of Psoriatic Arthritis; Abbott's HUMIRA Receives FDA Approval for Treatment of Ankylosing Spondylitis
Schering-Plough Corporation announced that the European Commission approved the use of REMICADE® (infliximab) as monotherapy in the treatment of active and progressive psoriatic arthritis (PsA) in patients who show intolerance to methotrexate (MTX) or for whom MTX is contraindicated.
Tuesday Jun 27, 2006
Abbott Receives FDA Approval for New HUMIRA® Injection Device
Abbott Laboratories announced that the US FDA approved the HUMIRA® Pen, a new single-use, disposable, pen-like device for administering HUMIRA, a treatment approved in the US for moderate-to-severe rheumatoid arthritis and for active psoriatic arthritis....
Thursday Jun 22, 2006
JRA Patients Do Better With Adalimumab, With or Without MTX
Phase III data show that adalimumab quickly and durably reduces disease flares and improves response rates in children with juvenile rheumatoid arthritis... Ruperto N; 2006 EULAR Meeting. Ann Rheum Dis. 2006;65(suppl):OP0007.
Monday Jun 12, 2006
Abbott's Humira® Approved in European Union for Severe Ankylosing Spondylitis
Abbott Laboratories announced that Humira® (adalimumab) was approved by the European Commission for marketing in Europe as a treatment for severe, active ankylosing spondylitis...
Monday May 01, 2006
Abbott's HumiraR (Adalimumab) Receives Positive Opinion From EMEA for Ankylosing Spondylitis
Abbott Laboratories, of Abbott Park, Illinois, announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMEA), issued a positive opinion recommending approval of Humira® (adalimumab)...
Monday Jan 30, 2006
Sales of Abbott's Humira® Exceed $1B in 2005
Abbott Laboratories reported that worldwide sales for Humira® (adalimumab) reached $1.4 billion...
Tuesday Jan 10, 2006
ARMADA Trial Supports Long-Term Safety and Efficacy of Adalimumab and Background Methotrexate for RA
Adalimumab plus background methotrexate is a safe and well-tolerated combination that has demonstrated a sustained clinical response and remission in patients with active rheumatoid arthritis (RA) for up to 4 years... Weinblatt ME, et al. Ann Rheum Dis. Published online Dec. 16, 2005; doi:10.1136/ard.2005.044404.
Wednesday Jan 04, 2006
Eisai and Abbott Submit NDA in Japan for RA Drug Adalimumab
Eisai Co, Ltd, and Abbott Japan Co, Ltd, have announced the submission of a new drug application (NDA) to the Minister of Health, Labor and Welfare in Japan for the rheumatoid arthritis (RA) drug adalimumab...
Monday Nov 21, 2005
Genentech, Biogen IDEC's Rituxan® Benefits RA Patients Unresponsive to Methotrexate and Anti-TNF Therapies
Genentech, Inc, and Biogen IDEC, who filed in October for US Food and Drug Administration approval to market rituximab (Rituxan®)...
Wednesday Nov 16, 2005
TNF-α Antagonist Adalimumab Shows Promise in AS
Encouraging results from the ATLAS trial suggest that adalimumab and other TNF-α inhibitors may be effective in reducing the signs and symptoms of ankylosing spondylitis... Presented at: Annual Meeting of the American College of Rheumatology; November 12–17, 2005; San Diego, Calif.
Monday Nov 07, 2005
Abbott's Humira® Demonstrates Maintenance of Clinical Remission in Phase III Extension
Results from a phase III extension study (CLASSIC II) presented at the 70th Annual Scientific Meeting and Postgraduate Course of the American College of Gastroenterology in Honolulu, Hawaii...
Tuesday Nov 01, 2005
CAT and Abbott Resolve Royalty Dispute Regarding Humira®
Cambridge Antibody Technology Group PLC (CAT), a British biotechnology company headquartered in Cambridge, England, and Illinois-based Abbott Laboratories have reached an agreement...
Thursday Oct 06, 2005
Abbott's HumiraR (Adalimumab) Approved in Europe for Psoriatic Arthritis and Severe Rheumatoid Arthritis
Abbott Laboratories announced that it has received US Food and Drug Administration (FDA) approval to market HumiraR (adalimumab)...
Monday Aug 15, 2005
Abbott's Humira Approved in Europe for Psoriatic Arthritis and Early RA
Abbott Laboratories has received approval from the European Commission to market HumiraR...
Wednesday Jun 29, 2005
EMEA Recommends HumiraR as First Line for Moderate-to-Severe RA
Abbott Laboratories announced that the European Medicines Agency (EMEA) has recommended approval of HumiraR (adalimumab) for first-line treatment of moderate-to-severe early rheumatoid arthritis (RA).
Wednesday Apr 06, 2005
Study Links TNF Inhibitors to Dermatologic Problems in Rheumatoid Arthritis Patients
Although a causative relationship has yet to be established, the new data put physicians on alert for a "less than major complication" Flendrie M, et al. Arthritis Res Ther. 2005;7:666-676.
Thursday Feb 03, 2005
Crohn's Disease Patients With Attenuated Response to Infliximab May Respond to Adalimumab
Mimicking the paradigm seen with TNF-blockade in rheumatoid arthritis, preliminary data suggest that switching infliximab nonresponders to adalimumab may improve the clinical response and reduce disease activity...Papadakis KA. Am J Gastroenterol. 2005;100:75-79.
Thursday Oct 21, 2004
Treating Early and in Combination May Lessen Damage in Rheumatoid Arthritis
An emerging body of clinical evidence supports the concept that combination therapy with an antitumor necrosis factor-α agent and methotrexate brings symptomatic relief and reduces radiographic progression... Breedveld FC, et al. Presented at: Annual Meeting of the American College of Rheumatology; October 20, 2004; San Antonio, Tex.
Tuesday Oct 19, 2004
Emerging Data Underscore Long-Term Efficacy of Adalimumab in Combination With Methotrexate for RA
Several clinical trials presented at the ACR annual meeting demonstrated that the combination of adalimumab and MTX achieved clinical remission and inhibition of structural damage for up to 4 years... Schiff MH et al. Presented at: Annual Meeting of the American College of Rheumatology; October 19, 2004; San Antonio, Tex.
Wednesday Sep 15, 2004
Advances in anti-TNF Therapy for RA
Two studies give insight regarding the time after RA onset to introduce anti-TNF therapy, and which doses to use to get an optimal response. (Baumgartner SW, et al. J Rheumatol. 2004;31:1532-1537; Stern R, Wolfe F. J Rheumatol. 2004;31:1538-1545.)
Thursday Jun 10, 2004
Early Results of the ReAct Trial Confirm the Efficacy and Safety of Adalimumab (HUMIRA)
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