All News
Another Biosimilar Approval - Etanercep-szzs by Novartis
Yesterday the U.S. Food and Drug Administration approved a new biosimilar, Erelzi, (etanercept-szzs), for the same multipile indications as the originator Enbrel, including rheumatoid arthritis, plaque psoriasis, Erelzi, will be generically labelled as etanercept-szzs.
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FDA Approves Updated Denosumab Warnings
In 2015, the Food and Drug Administration (FDA) updated the warnings of all marked bisphosphonates to include the risk of osteonecrosis of the jaw (ONJ) and atypical femoral fractures (AFF).
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RheumNow Week in Review – 26 August 2016
Dr. Jack Cush reviews news and journal reports from the past week on RheumNow.com.
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Prior Cancer Patients May Safely Receive TNF Inhibitors or Rituximab
Current guidelines regarding the use of biologics in patients who have previously had a malignancy are based more on opinion than evidence.
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Remicade Patent Infringements Denied: Opens Door for New Biosimilars
A U.S. court has affirmed its decision that the patent for Johnson & Johnson's drug Remicade is invalid. This new ruling favors the intent of Celltrion and Pfizer, who are seeking to bring their biosimilar versions of infliximab to market in the near future.
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Consensus Recommendations for Juvenile Dermatomyositis
SHARE (Single Hub and Access point for pediatric Rheumatology in Europe) is a group established in 2012 to develop and optimize diagnostic and management regimens in Europe for children and young adults with rheumatic diseases.
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No Added Lymphoma Risk with TNF Inhibitor Use
Warnings of cancer, especially lymphoma, have accompanied the development and promotion of tumor necrosis factor inhbitors (TNFi) in the treatment of RA and other inflammatory disorders.
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EULAR: Guidance for Managing Lupus Pregnancy
The European League Against Rheumatism (EULAR) has published comprehensive recommendations on reproductive health and family planning for women with systemic lupus erythematosus and/or antiphospholipid syndrome – conditions that largely affect women of childbearing age.
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EULAR Updates Gout Guidelines
A EULAR task force of 24 individuals (including 15 rheumatologists) have updated their previous 2006 guidelines for gout. The current update, which includes 11 recommendations, is based on a systematic literature review and a Delphi consensus approach to recommendations.
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RheumNow Week in Review – 5 August 2016
Highlights from this week on RheumNow.com include:
1. Having #RA in addition to solid cancer (breast, lung, prostate, colon) increases mortality rates by 40-50% in elders https://t.co/aitjusmOai
2. The global market for rheumatoid arthritis therapies was $19.9 billion in 2015, expected to reach $21.3B by 2020 https://t.co/d2Sh5C8y9f
3. Half of doctors never heard of MACRA:Medicare Access & CHIP Reauthorization Act. Starts on Jan 1st! https://t.co/eYgWBWCw6y Blog:https://t.co/sRKZSOFyNV
And more!
Biosimilars are Bioequivalent to Original TNF Inhibitors
Chingcuanco and coinvestigators have reported on their comparative analysis of biosimilars and their originator TNF inhibitors in the current issue of Annals of Internal Medicine. (Citation source: http://buff.ly/2arTd1q)
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Long-Term Safety of Adalimumab Reviewed
Burmester and colleagues have published their review of the long-term outcomes and safety issues with the TNF inhibitor, adalimumab (ADA). The analysis included 15,132 patients exposed to adalimumab in global RA clinical trials.
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Will Patent Extensions Delay Biosimilar Arrivals?
In the last 6 months, the FDA Arthritis Advisory Committee has recommended three biosimilars (CT-P13, GP-2015, ABP-501) for approval, with one achieving FDA approval Inflectra/CT-P13) and the other two pending a probable approval in the months to come.
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ORBIT Study Shows Rituximab is Non-Inferior to TNF Inhibitors in Biologic Naive Patients
Porter and colleagues have reported that both rituximab (RTX) and tumour necrosis factor inhibitors (TNFi) are equally and highly effective in early, active, biologic-naive rheumatoid arthritis patients.
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RheumNow Week in Review – 15 July 2016
Dr. Jack Cush reviews highlights from this week's rheumatology news on RheumNow.com.
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Sandoz Etanercept Biosimilar Voted for Approval by FDA Arthritis Advisory Committee
The Food and Drug Administration’s Arthritis Advisory Committee (AAC) yesterday recommended that the Sandoz etanercept (Enbrel) biosimilar (GP-2015) be approved for use in the United States.
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FDA Approves Xiidra (Lifitegrast) for Dry Eyes
MedScape has reported that the US Food and Drug Administration (FDA) has approved lifitegrast ophthalmic solution (Xiidra, Shire) for the treatment of signs and symptoms of dry eye disease.
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FDA Arthritis Advisory Committee Recommends Approval of Adalimumab Biosimilar
The Food and Drug Administration’s Arthritis Advisory Committee yesterday recommended that Amgen biosimilar (ABP 501) to Humira (adalimumab) be approved for use in the United States.
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FDA Says Cryotherapy Lacks Evidence, Poses Risks
Cryotherapy is a non-FDA approved treatment that has been promoted to treat post-athletic injury, osteoarthritis,rheumatoid arthritis, fibromyalgia, alzheimers, migraines, asthma, multiple sclerosis, etc. Cryotherapy may be as simple as ice packs on a localized portion of the body, such as the lower back, or may involve whole body cryotherapy.
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Academic Female Physicians Paid Less than Male Counterparts
Female academic physicians at public medical schools had lower average salaries than their male counterparts, a disparity that was only partly accounted for by age, experience, medical specialty, faculty rank and other factors, according to an article published online by JAMA Internal Medicine.
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