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Infliximab News

FDA Approves Ixifi (infliximab-qbtx), a Biosimilar to Remicade

Posted 14 Dec 2017 by Drugs.com

December 13, 2017 – Pfizer Inc. (NYSE:PFE) announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade® (infliximab)* for all eligible indications of the reference product.1 The FDA has approved Ixifi as a ...

FDA Approves Renflexis (infliximab-abda), a Biosimilar to Remicade

Posted 27 Apr 2017 by Drugs.com

INCHEON, Korea – April 24, 2017 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Renflexis (infliximab-abda), a biosimilar referencing Remicade®i (infliximab), across all eligible indications. In the US, Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheu ...

Early Treatment Equals Better Results for Rheumatoid Arthritis

Posted 25 Apr 2017 by Drugs.com

TUESDAY, April 25, 2017 – Treating rheumatoid arthritis early may make for better outcomes, a new study suggests. Patients who were treated within six months of developing the first signs of the autoimmune disease did better in the long run and were less likely to suffer early death, British researchers found. The findings stem from an analysis of more than 600 patients who were initially ...

New Meds Make Inroads Against Crohn's Disease

Posted 13 Apr 2017 by Drugs.com

THURSDAY, April 13, 2017 – Fewer Americans with Crohn's disease are ending up in the hospital than in the past, according to a new federal study. Crohn's is a chronic inflammatory bowel disorder that often leads to surgery for most with the disease. Hospitalization rates for Crohn's disease remained stable in the United States between 2003 and 2013. That's a change from a study done from 1998 to ...

Could a Germ Link Gum Disease, Rheumatoid Arthritis?

Posted 15 Dec 2016 by Drugs.com

THURSDAY, Dec. 15, 2016 – A specific germ may help explain the long-noticed connection between gum disease and rheumatoid arthritis, a new study suggests. The discovery might also point to the potential origins of the painful joint illness. "If we're right, this will totally change the view of rheumatoid arthritis and treatment of patients," said study co-author Dr. Felipe Andrade. But, Andrade, ...

Inflectra Approved as 'Biosimilar' to Remicade

Posted 7 Apr 2016 by Drugs.com

WEDNESDAY, April 6, 2016 – The U.S. Food and Drug Administration has approved its second-ever "biosimilar" drug, Inflectra, for adults with Crohn's disease, rheumatoid arthritis or chronic plaque psoriasis, among other prescribed uses. In a media release, the agency said Inflectra was biosimilar to Janssen Biotech's Remicade (infliximab), first licensed in 1998. A biosimilar drug is sanctioned ...

FDA Approves Inflectra (infliximab-dyyb) a Biosimilar to Remicade

Posted 7 Apr 2016 by Drugs.com

April 5, 2016 – The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by a health c ...

Gene Discoveries Could Help Rheumatoid Arthritis Treatment

Posted 28 Apr 2015 by Drugs.com

TUESDAY, April 28, 2015 – Genetic variations may hold clues to rheumatoid arthritis – suggesting not only who will develop the painful condition, but also predicting its severity and even who might die from it, a new study says. "Genetic factors predisposing to disease, to disease severity, and response to treatment will allow tailoring treatment to individual patients' needs," said lead ...

Some Arthritis Meds Cost Seniors Thousands Annually

Posted 21 Apr 2015 by Drugs.com

TUESDAY, April 21, 2015 – Arthritis medications known as biologic disease-modifying drugs can cost Medicare patients more than $2,700 in co-payments a year, a new report finds. Researchers say the tab is an immense burden on patients with disabling conditions such as rheumatoid arthritis, a chronic disorder that affects an estimated 1.3 million Americans. Biologic anti-rheumatic medications – ...

Smokers May Get Less Benefit From Drugs for Arthritic Back Pain

Posted 10 Feb 2015 by Drugs.com

TUESDAY, Feb. 10, 2015 – Smoking may hamper the effects of certain drugs used to treat inflammatory arthritis in the lower back, a new study from Switzerland says. Researchers from University Hospital Zurich looked at how 700 people with this type of arthritis responded to treatment with a class of drugs called tumor necrosis factor (TNF) inhibitors. About two-thirds of the patients were ...

Certain Autoimmune Drugs in Pregnancy May Up Newborn Infection Risk: Study

Posted 3 Oct 2014 by Drugs.com

FRIDAY, Oct. 3, 2014 – When given to pregnant women, a common treatment for ulcerative colitis may inadvertently lower their baby's ability to fight off infections at birth, new French research suggests. The treatment, called anti-TNF therapy, is an injected, artificial antibody. This type of medication is widely seen as a safe and effective way to tackle a wide range of autoimmune disorders, ...

Popular Crohn's, Colitis Drugs Not Linked to Short-Term Cancer Risk: Study

Posted 18 Jun 2014 by Drugs.com

WEDNESDAY, June 18, 2014 – A popular class of drugs used to treat inflammatory bowel disease isn't linked to an increase in the short-term risk of cancer, Danish researchers report. Researchers found that people with Crohn's disease or colitis who received the drugs – tumor necrosis factor alpha (TNF-a) antagonists – had about the same risk of cancer as other people with these inflammatory ...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

Posted 6 Nov 2011 by Drugs.com

  [UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include: patient characteristics (age, gender, no patient identifiers) risk factors for malignancy exposure to other immune suppressing products or products with risk of malignancy indication for TNF blocker t ...

FDA Approves Remicade to Treat Ulcerative Colitis in Children Older than 6 Years

Posted 26 Sep 2011 by Drugs.com

The U.S. Food and Drug Administration today approved Remicade (infliximab) to treat moderately to severely active ulcerative colitis (UC) in children older than 6 years who have had inadequate response to conventional therapy. Remicade reduces signs and symptoms of UC and induces and maintains clinical remission in these patients. UC is a type of inflammatory bowel disease (IBD) that affects the ...

FDA Medwatch Alert: Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria

Posted 8 Sep 2011 by Drugs.com

including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) ISSUE: FDA notified healthcare professionals that the Boxed Warning for the entire class of Tumor Necrosis Factor-alpha (TNFα) blockers has been updated to include the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the Boxed Warning ...

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Crohn's Disease, Ankylosing Spondylitis, Crohn's Disease - Maintenance, Crohn's Disease - Acute, Celiac Disease, Bullous Pemphigoid, Behcet's Disease, Sjogren's Syndrome, Rheumatoid Arthritis, view more... SAPHO Syndrome, Sarcoidosis, Toxic Epidermal Necrolysis, Spondyloarthritis, Subcorneal Pustular Dermatosis, Pulmonary Fibrosis, Ulcerative Colitis, Ulcerative Colitis - Maintenance, Pyoderma Gangrenosum, Plaque Psoriasis, Psoriatic Arthritis, Psoriasis, Polychondritis, Pemphigus, Pemphigoid, Neurosarcoidosis, Kawasaki Disease, Juvenile Idiopathic Arthritis, Inflammatory Bowel Disease, Giant Cell Arteritis, Cogan's Syndrome, Uveitis

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Remicade, Ixifi, Renflexis, Inflectra

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