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Data from the rheumatology portfolio of both injection and infusion biologic treatment options will include efficacy and safety data from Phase 3 studies for STELARAA (ustekinumab), Phase 3 health-related quality of life data for SIMPONI ARIAA (golimumab for infusion), long-term outcomes data for SIMPONIA (golimumab), an ethnographic study investigating shared decision-making between rheumatologists and rheumatoid arthritis (RA) patients, and a patient-reported outcomes assessment of intravenous (IV) treatment for RA patients, which includes REMICADEA (infliximab).
In the European Union, SIMPONI is contraindicated in patients with active tuberculosis, severe infections such as sepsis, opportunistic infections, in patients with moderate or severe heart failure (NYHA Class III/IV), as well as in patients who are hypersensitive to SIMPONI or any of its excipients.
In respect to Johnson & Johnson's pharmaceutical division, new drugs such as Xarelto, Simponi, Invokana and Zytiga should continue to lead the growth in pharmaceuticals for the company, according to a Standard & Poor research note.
The TNF blockers that will receive the warnings include Remicade (infliximab), Enbrel (etanercept), Humira (adali-mumab), Cimzia (certolizumab pegol), and Simponi (golimumab), according to the FDA announcement.
for SIMPONI Supplemental Biologic License Application(C)2011 ENPublishing - http://www.
At issue is whether Merck's $41 billion acquisition of Schering-Plough last year constituted a "change of control" at Schering that would cede the lucrative overseas Remicade and Simponi rights back to J&J, which owns the drugs and sells them in the United States.
Golimumab, marketed under the brand name Simponi, inhibits an immune protein called TNF-alpha that contributes to this runaway inflammation.
Abbott contends that Centocor's new drug, to be sold under the brand name Simponi, would infringe a patent it owns that was issued in 2007.
According to the latest release ofRealTime Dynamix: Psoriatic Arthritis , an increasing number of rheumatologists view Otezla as a first line treatment option before the ever-popular TNFs (AbbVie's Humira, Pfizer/Amgen's Enbrel, Janssen's Remicade and Simponi, and UCB's Cimzia).
03 billion in the fourth quarter of 2008, bolstered by Schering-Plough products such as allergy medicine Nasonex and rheumatoid arthritis drugs Remicade and Simponi, plus higher sales for Merck vaccines and some of its top-selling drugs.
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