Content about Autoimmune diseases

June 25, 2013

Takeda Pharmaceutical Co. is seeking Food and Drug Administration approval for an experimental treatment for inflammatory bowel disease, the drug maker said.

DEERFIELD, Ill. — Takeda Pharmaceutical Co. is seeking Food and Drug Administration approval for an experimental treatment for inflammatory bowel disease, the drug maker said.

Takeda announced that it had submitted a biologics license application to the FDA for vedolizumab in patients with severe Crohn's disease and ulcerative colitis. IBD is estimated to affect more than 4 million people worldwide, and ulcerative colitis and Crohn's disease affect as many as 700,000 Americans each, according to Takeda.

May 15, 2013

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

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.

April 5, 2013

GlaxoSmithKline has started a late-stage clinical trial of a drug in patients with an inflammatory disease that affects the blood vessels.

LONDON — GlaxoSmithKline has started a late-stage clinical trial of a drug in patients with an inflammatory disease that affects the blood vessels.

The drug maker announced the start of a phase-3 trial of Benlysta (belimumab) in patients with vasculitis, a condition in which the body's immune system attacks blood vessels, leading to inflammation, disruption of blood flow and possible damage to the organs. The drug is being tested in patients with a common form of the disease known as anti-neutrophil cytoplasmic antibodies-positive vasculitis.

April 2, 2013

A population-based study in Olmsted County, Minn., has shown an increase in the incidence of celiac disease, a digestive condition triggered by eating protein gluten.

ROCHESTER, Minn. — A population-based study in Olmsted County, Minn., has shown an increase in the incidence of celiac disease, a digestive condition triggered by eating protein gluten.

March 22, 2013

Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

CAMBRIDGE, Mass. — Disease relapse rates and worsening of disability were low among patients taking a drug made by Genzyme for multiple sclerosis, the company said.

Genzyme, a division of French drug maker Sanofi, announced results of an extension study of the drug Lemtrada (alemtuzumab). The study was a follow-up to two other late-stage clinical studies of the drug, finding that relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug.

February 8, 2013

The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

DUBLIN — The Food and Drug Administration has approved a new drug from Warner Chilcott for treating ulcerative colitis, the drug maker said.

Warner Chilcott announced the approval of mesalamine in the 400-mg strength.

The company plans to market the drug under the brand name Delzicol and launch it in March.

January 16, 2013

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.

January 8, 2013

An organization focused on inflammatory bowel disease has enlisted a star of "NYPD Blue," "Judging Amy" and "Private Practice" to raise awareness of the condition.

NEW YORK — An organization focused on inflammatory bowel disease has enlisted a star of "NYPD Blue," "Judging Amy" and "Private Practice" to raise awareness of the condition.

The Crohn's and Colitis Foundation of America hired actress Amy Brenneman, who has ulcerative colitis, one of two diseases that collectively make up IBD; the other is Crohn's disease. Both conditions are autoimmune diseases that cause discomfort and inflammation of the intestines and require frequent trips to the bathroom.

December 6, 2012

Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.

HORSHAM, Pa. — Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.

J&J subsidiary Janssen Biotech submitted an application to the FDA for Stelara (ustekinumab) for adult patients with the disease, which affects more than 2 million people in the United States, according to the National Psoriasis Foundation. Another subsidiary is seeking approval for Stelara for the same usage in Europe.

November 28, 2012

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

ALLEGAN, Mich. — The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

Perrigo said that Cobrek, with which it is partnering, had received approval for betamethasone validate foam in the 0.12% strength. The drug is a generic version of Luxiq foam, made by GlaxoSmithKline subsidiary Stiefel Labs, and is used to treat corticosteroid-responsive skin conditions of the scalp, also known as scalp psoriasis.

The branded version of the drug has annual sales of about $40 million, according to Perrigo.

October 22, 2012

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 17, 2012

Vitamin D supplementation could be considered an immunomodulatory agent for systemic lupus erythematosus, an autoimmune disease characterized not only by skin, joint, neurological and renal symptoms, but also by inflammation of tissue linings in the body, according to a new clinical study published Tuesday in BioMedCentral's open access journal Arthritis Research and Therapy.

LONDON — Vitamin D supplementation could be considered an immunomodulatory agent for systemic lupus erythematosus, an autoimmune disease characterized not only by skin, joint, neurological and renal symptoms, but also by inflammation of tissue linings in the body, according to a new clinical study published Tuesday in BioMedCentral's open access journal Arthritis Research and Therapy

An immunomodulatory agent has an effect on the immune system. 

October 9, 2012

Ranbaxy Labs has launched an authorized generic drug for treating dry mouth associated with an autoimmune disorder, the company said Tuesday.

PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic drug for treating dry mouth associated with an autoimmune disorder, the company said Tuesday.

The India-based generic drug maker announced the launch of cevimeline hydrochloride in the 30-mg strength under an agreement with parent company Daiichi Sankyo. The drug is used in patients with Sjogren's syndrome, which affects the moisture-producing glands.

October 9, 2012

Diabetes is one of the country’s most serious public health crises, and it will likely remain so for some time. According to the American Diabetes Association, 25.8 million Americans now have the disease, with another 79 million at risk, and most of those with the disease have Type 2 diabetes — the kind that results from lifestyle choices.


Diabetes is one of the country’s most serious public health crises, and it will likely remain so for some time. According to the American Diabetes Association, 25.8 million Americans now have the disease, with another 79 million at risk, and most of those with the disease have Type 2 diabetes — the kind that results from lifestyle choices.


But half of “public health” is “public,” and recent efforts by retailers and suppliers have sought to combat the disease at the community level.


September 28, 2012

The Food and Drug Administration has approved a drug made by Abbott for treating ulcerative colitis.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Abbott for treating ulcerative colitis.

The agency announced Friday the approval of Humira (adalimumab) for moderate to severe UC. The drug was already approved for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis and juvenile idiopathic arthritis.

UC is a chronic disease that affects about 620,000 Americans, according to the National Institutes of Health.

September 28, 2012

The Food and Drug Administration has approved a treatment for psoriasis of the scalp made by a subsidiary of British drug maker GlaxoSmithKline.

 RESEARCH TRIANGLE PARK, N.C. — The Food and Drug Administration has approved a treatment for psoriasis of the scalp made by a subsidiary of British drug maker GlaxoSmithKline.

Stiefel announced Friday the approval of Sorilux (calcipotriene) foam for psoriasis of the scalp in adults. The drug was already approved for psoriasis of other parts of the body in October 2010.

September 19, 2012

The Undy 5000 5K Run/Walk, presented by Dulcolax, returned to Philadelphia for the fifth consecutive year to help raise funds for colon cancer research.

PHILADELPHIA — The Undy 5000 5K Run/Walk, presented by Dulcolax, returned here for the fifth consecutive year to help raise funds for colon cancer research. Almost 1,000 participants ran in their underwear as a tongue-in-cheek reference to the area affected by colon cancer, raising $120,000 for Colon Cancer community programs.

The Philadelphia Undy 5000 featured the Colon Cancer Alliance’s Inflatable Colon; a giant, walk-through colon that shows the various stages of colon cancer, including descriptions about Crohn’s disease and Colitis. 

September 19, 2012

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.

August 29, 2012

A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

WASHINGTON — A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

According to published reports, the panel voted 15-2 that the benefits of Humira outweighed the risks in treating ulcerative colitis. However, the panel asked Abbott to conduct more studies upon Humira's approval.

July 27, 2012

Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.

DEERFIELD, Ill. — Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.

The drug maker said Rayos (prednisone) delayed-release tablets — in the 1-mg, 2-mg and 5-mg stregnths — were approved for the treatment of rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma and chronic obstructive pulmonary disease.

July 17, 2012

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.

June 26, 2012

An organization focused on Crohn's disease and ulcerative colitis has revamped its website, the group said Tuesday.

NEW YORK — An organization focused on Crohn's disease and ulcerative colitis has revamped its website, the group said Tuesday.

The Crohn's and Colitis Foundation of America said it worked with Pittsburgh-based digital marketing agency BarkleyREI to redesign the website. The new site includes a section for people newly diagnosed with the diseases; a library that includes webcasts, brochures, fact sheets and videos; social media integration; pages listing local chapters and support groups; and other resources.

June 12, 2012

A Sanofi company is seeking regulatory approval from the Food and Drug Administration for a drug designed to treat relapsing multiple sclerosis.

CAMBRIDGE, Mass. — A Sanofi company is seeking regulatory approval from the Food and Drug Administration for a drug designed to treat relapsing multiple sclerosis.

June 1, 2012

An experimental drug for multiple sclerosis produced a noticeable reduction in symptoms of the disease in a late-stage clinical trial, the drug's developer said Friday.

CAMBRIDGE, Mass. — An experimental drug for multiple sclerosis produced a noticeable reduction in symptoms of the disease in a late-stage clinical trial, the drug's developer said Friday.

Genzyme, a unit of French drug maker Sanofi, announced results from a phase-3 study of Aubagio (teriflunomide) in patients with relapsing forms of MS. According to the study, patients taking the drug in the 14-mg strength experienced a 36.3% reduction in annualized relapse rates and 31.5% reduction in the risk of sustained accumulation of disability over a 12-week period.