Content about Golimumab

May 15, 2013
FDA approves J&J's Simponi for ulcerative colitis

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis, the agency said Wednesday.

April 16, 2013
J&J sales rise in first quarter 2013

Johnson & Johnson's sales increased by 8.5% to $17.5 billion in first quarter 2013, the healthcare products company said Tuesday.

NEW BRUNSWICK, N.J. — Johnson & Johnson's sales increased by 8.5% to $17.5 billion in first quarter 2013, the healthcare products company said Tuesday.

The increase included a domestic sales increase of 11.2%. Profits for the quarter were $3.5 billion.

October 22, 2012
J&J drug appears more effective in ulcerative colitis patients than placebo, according to study

More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.

LAS VEGAS — More patients with an inflammatory disease of the bowels responded to a drug used for autoimmune disorders than those taking a placebo, according to results of a late-stage clinical trial announced Monday.

Johnson & Johnson said phase-3 trial findings showed that "significantly" more patients with severely active ulcerative colitis responded to Simponi (golimumab), maintaining their responsiveness to the drug through the 54th week. The drug is already approved by the Food and Drug Administration for treating conditions like rheumatoid arthritis.

October 9, 2012
ReportersNotebook — Chain Pharmacy, 10/15/12

The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said. The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients ages 6 years and older. The drug maker plans to launch the drug in early 2013.

September 19, 2012
J&J seeks FDA approval for intravenous Simponi

A subsidiary of Johnson & Johnson is hoping to gain Food and Drug Administration approval for a new formulation of one of its drugs.

HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to gain Food and Drug Administration approval for a new formulation of one of its drugs.

Janssen Biotech announced that it had filed an application with the FDA seeking approval for an intravenous formulation of Simponi (golimumab) in adults with moderately to severely active rheumatoid arthritis, which affects an estimated 1.5 million Americans.

July 17, 2012
J&J seeks approval for Simponi in ulcerative colitis

A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.

HORSHAM, Pa. — A subsidiary of Johnson & Johnson is hoping to win an additional approval for one of its drugs.

Janssen Biotech and Janssen Biologics B.V. announced the submission of a supplemental regulatory application to the Food and Drug Administration for Simponi (golimumab) for treatment of moderately to severely active ulcerative colitis, an inflammatory bowel disease that affects about 700,000 people in the United States. The drug already is approved for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.

May 24, 2012
Patients with ulcerative colitis respond to Simponi, study finds

Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.

Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.

December 20, 2011
Ulcerative colitis market to hit $3 billion by 2020

The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

BURLINGTON, Mass. — The market for drugs to treat ulcerative colitis will increase from 2010's $1.7 billion to $3 billion in 2020, according to a new report by market research firm Decision Resources.

April 14, 2011
FDA: Certain TNF blockers could be linked to rare cancer

The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has received reports of a rare and usually deadly cancer in patients using a class of biotech drugs to treat autoimmune and inflammatory diseases, the agency said Thursday.

September 29, 2010
Centocor Ortho Biotech seeks expanded approval for Simponi

The biotech division of Johnson & Johnson is hoping to expand the use of a...

HORSHAM, Pa. The biotech division of Johnson & Johnson is hoping to expand the use of a treatment for autoimmune disorders.

 

Centocor Ortho Biotech said it had filed an application with the Food and Drug Administration to get approval for Simponi (golimumab) to stop the progression of structural damage, induce major clinical response, maintain reductions in signs and symptoms, and improve physical function in the treatment of rheumatoid arthritis.

 

 

January 3, 2010
Decision Resources projects same U.S., Europe patient share of ulcerative colitis biologic

A new report by Decision Resources revealed that a biological therapy with a mechanism of...