Etanercept News and Research

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Etanercept (Enbrel) is a drug that treats autoimmune diseases by interfering with the TNF receptor (a part of the immune system) by acting as a TNF inhibitor.

Incident malignancy four times higher among children with JIA

New research reports that incident malignancy among children with juvenile idiopathic arthritis (JIA) is four times higher than in those without the disease. Findings now available in Arthritis & Rheumatism, a journal published by Wiley-Blackwell on behalf of the American College of Rheumatology (ACR), suggest JIA treatment, such as tumor necrosis factor (TNF) inhibitors, does not necessarily explain the development of cancer in this pediatric population.

13 Feb 2012

PDUFA goal date of NDA for Protalix's taliglucerase alfa extended

Protalix BioTherapeutics, Inc., announced today that it received notification from the U.S. Food and Drug Administration (FDA) that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date of the New Drug Application (NDA) for taliglucerase alfa to May 1, 2012, a three-month extension from the previous PDUFA date of February 1, 2012.

6 Dec 2011

TNF inhibitors may minimally increase risk of serious infections

Biologic drugs have revolutionized treatment of autoimmune diseases during the past decade despite belief there is an increased risk for serious infections from using them. But new research from the University of Alabama at Birmingham Center for Education and Research on Therapeutics reveals that a class of biologics called tumor necrosis factor antagonists, or TNF inhibitors, may only minimally increase risk compared to more traditional therapies.

17 Nov 2011

Study evaluates JIA disease activity after treatment with etanercept

Among patients with juvenile idiopathic arthritis (JIA) who initiated treatment with the drug etanercept, one-third achieved an excellent response, and this response was associated with low measures of disability at study entry, younger age at the onset of JIA, and fewer disease-modifying antirheumatic drugs used before initiating etanercept, according to a study appearing in JAMA.

7 Nov 2011

Children with polyarticular JIA benefit from early and aggressive therapy

Children with juvenile arthritis who are treated early and aggressively have better outcomes, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Chicago.

7 Nov 2011

Link between use of anti-TNF therapy and malignant melanoma in RA patients

According to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Chicago, people taking anti-tumor necrosis factor therapies to treat rheumatoid arthritis have a higher risk of developing malignant melanoma.

7 Nov 2011

Doctors may stop anti-TNF medications for RA patients before surgery to reduce disease flares

As guidelines recommend, doctors appear to be stopping anti-TNF medications before surgery, but may be doing so far sooner than is necessary, according to a new study by researchers at Hospital for Special Surgery. These medications are used to treat a variety of inflammatory diseases, including rheumatoid arthritis, and better timing of withdrawal prior to surgery might minimize the risk of disease flares.

6 Nov 2011

Psychological stress can trigger flares of vasculitis

In patients with a devastating form of vasculitis who are in remission, stress can be associated with a greater likelihood of the disease flaring, according to a new study by investigators at Hospital for Special Surgery.

6 Nov 2011

FDA accepts Protalix taliglucerase alfa NDA resubmission for review

Protalix BioTherapeutics, Inc., announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.

17 Aug 2011

Amgen reports 8% increase in second quarter total product sales to $3,893 million

Amgen reported total revenue increased 4 percent during the second quarter of 2011 to $3,959 million versus $3,804 million in the second quarter of 2010. Total product sales increased 8 percent in the second quarter of 2011 to $3,893 million versus $3,613 million in the second quarter of 2010. The increase in total revenue in the second quarter of 2011 included a decline in other revenue due to certain milestone payments earned in the second quarter of 2010.

29 Jul 2011

Merck reports worldwide sales of $12.2 billion for second quarter 2011

Merck, known as MSD outside the United States and Canada, today announced financial results for the second quarter of 2011.

29 Jul 2011

Positive results from etanercept pilot study against dermatomyositis

A multicenter pilot study of etanercept for treatment of dermatomyositis found no major safety concerns and many patients treated with the drug were successfully weaned from steroid therapy.

17 Jun 2011

Hanwha, Merck partner to develop and commercialize HD203

Merck, known as MSD outside the United States and Canada, and Hanwha Chemical Corporation today announced that they have entered into an exclusive global agreement to develop and commercialize a candidate biosimilar form of Enbrel.

13 Jun 2011

New clinical practice guidelines developed for juvenile idiopathic arthritis

The American College of Rheumatology has developed new guidelines for starting and monitoring treatments for children with juvenile idiopathic arthritis. These are the first JIA guidelines endorsed by the ACR, with the goal of broad acceptance within the rheumatology community.

30 Mar 2011

Recent rituximab trial with TNF inhibitors reports no new safety risks in patients with RA

A recent trial of rituximab in combination with a tumor necrosis factor inhibitor and methotrexate in patients with active rheumatoid arthritis found the safety profile to be consistent with other RA trials with TNF inhibitors.

8 Mar 2011

Protalix receives FDA CRL for taliglucerase alfa NDA for Gaucher disease

Protalix BioTherapeutics, Inc., announced today that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) regarding the Company's New Drug Application (NDA) for taliglucerase alfa for the treatment of Gaucher disease. Taliglucerase alfa is a plant-cell expressed form of glucocerebrosidase (GCD).

25 Feb 2011

Protalix: New data from taliglucerase alfa, oral GCD trials to be presented at Lysosomal Disease Network Symposium

Protalix BioTherapeutics, Inc., announced today that new clinical data from the switchover trial of taliglucerase alfa in Gaucher disease patients and preclinical data on oral enzyme glucocerebrosidase (oral GCD) will be presented today at the 7th Annual Meeting of the Lysosomal Disease Network: WORLD Symposium 2011 in Las Vegas, Nevada.

19 Feb 2011

Amgen, Pfizer present Enbrel new trial results against psoriasis at 69th AAD meeting in New Orleans, LA

Amgen and Pfizer Inc. today announced results from a new trial that demonstrated Enbrel significantly improved scalp involvement in adult patients with moderate to severe plaque psoriasis, compared with placebo. The data will be presented today at the 69th Annual American Academy of Dermatology meeting in New Orleans, La.

5 Feb 2011

Research identifies potential reversibility of chronic neurologic disability in stroke survivors

A breakthrough in stroke research identifying the potential reversibility of chronic neurologic disability in stroke survivors has published today. In the February 1, 2011 issue of the journal CNS Drugs the first human results of a new method of targeting chronic brain inflammation years after stroke are reported.

2 Feb 2011

Etanercept can restore responsiveness to pain-relieving effects of morphine: Study

A drug called etanercept can restore responsiveness to the pain-relieving effects of morphine in rats that have developed morphine tolerance, reports a study in the February issue of Anesthesia & Analgesia, official journal of the International Anesthesia Research Society.

29 Jan 2011