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Janssen Biotech

FDA OKs new indications for Janssen’s Simponi Aria

FDA OKs new indications for Janssen’s Simponi Aria

HORSHAM, Pa. — Janssen Biotech Inc. has gained Food and Drug Administration approval for Simponi Aria (golimumab) to treat adults with active psoriatic arthritis or active ankylosing spondylitis. Janssen said Simponi Aria is the only fully-human anti-tumor necrosis factor-alpha therapy administered via a 30-minute infusion. The latest indication follows Simponi Aria’s first FDA approval in

Janssen’s Stelara approved for Crohn’s disease

Janssen’s Stelara approved for Crohn’s disease

HORSHAM, Pa. — Janssen Biotech Inc. has received Food and Drug Administration clearance for Stelara in treating Crohn’s disease in adults. Janssen said Monday that Stelara (ustekinumab), which is also used in the treatement of psoriasis and psoriatic arthritis, represents the first biologic therapy for Crohn’s disease targeting interleukin (IL)-12 and IL-23 cytokines, which play

FDA approves Inflectra, the second U.S. biosimilar

FDA approves Inflectra, the second U.S. biosimilar

WASHINGTON — Just over a year after approving its first biosimilar product, the Food and Drug Administration has approved its second, Celltrion’s Inflectra (biosimilar infliximab). Inflectra is a biosimilar to Janssen Biotech’s Remicade (infliximab), originally licensed in 1998. Inflectra is indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque