Content about Rheumatoid arthritis

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 8, 2013
Patients taking AstraZeneca RA drug show partial improvement

An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients' conditions, according to results of a late-stage clinical trial.

NEW YORK — An experimental drug developed by AstraZeneca for rheumatoid arthritis produced mixed results in measurements of patients' conditions, according to results of a late-stage clinical trial.

AstraZeneca announced initial results of the phase-3 "OSKIRA-1" trial of fostamatinib, which it calls the first oral spleen tyrosine kinase inhibitor in development for RA.

April 2, 2013
Study finds specialty drug costs increase 15% annually

Specialty drugs are expected to account for 50% of all drug costs by 2018, according to two new studies.

SAN DIEGO — Specialty drugs are expected to account for 50% of all drug costs by 2018, according to two new studies.

By contrast, specialty drugs accounted for 20% of all drug costs in 2009, but increased to 28.7% by 2012. Pharmacy benefit manager Prime Therapeutics and Blue Cross and Blue Shield of Minnesota conducted the studies, and Prime is presenting them Tuesday at the Academy of Managed Care Pharmacy's 25th annual meeting and expo in San Diego.

March 25, 2013
Drug makers ramp up treatments for chronic conditions in the elderly, PhRMA report finds

More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

WASHINGTON — More than 400 drugs are under development for the 10 most common chronic health conditions affecting elderly people, according to a new report by a drug industry trade group.

December 18, 2012
Most prescribers would pick biosimilar RA drugs

A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.

BURLINGTON, Mass. — A majority of prescribers would prescribe biosimilar versions of two treatments for rheumatoid arthritis within a year of their approval, according to a new study.

November 6, 2012
FDA approves Pfizer rheumatoid arthritis drug

The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for rheumatoid arthritis ahead of the day the agency was scheduled to decide whether or not to approve it, the agency said Tuesday.

November 5, 2012
ReportersNotebook — Chain Pharmacy, 11/5/12

Pharmacy automation manufacturer Kirby Lester has launched a version of one of its tablet counters with streamlined verification software.

SUPPLIER NEWS — Pharmacy automation manufacturer Kirby Lester has launched a version of one of its tablet counters with streamlined verification software. The company announced the launch of KL1Plus, which it said combines the KL1 tablet counter with the updated software.


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 12, 2012
FDA approves new use for Genentech arthritis drug

The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a new use for a drug made by Roche division Genentech.

The drug maker said Friday that the FDA had approved Actemra (tocilizumab) for adults with moderately to severely active rheumatoid arthritis who have not responded adequately to one or more disease-modifying antirheumatic drugs. The drug was already approved for systemic juvenile idiopathic 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 28, 2012
FDA approves Abbott's Humira for ulcerative colitis

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 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.

August 29, 2012
Abbott's Humira gets support for expanded use

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.

August 23, 2012
J&J, GSK start phase-3 trial program for rheumatoid arthritis drug

A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.

SPRING HOUSE, Pa. — A division of Johnson & Johnson has started a late-stage clinical trial program for a drug for rheumatoid arthritis under a partnership with British drug maker GlaxoSmithKline.

August 22, 2012
FDA postpones decision on Pfizer RA drug, citing time needed to review new data

The Food and Drug Administration has postponed its decision whether or not to approve an experimental arthritis drug made by Pfizer, the drug maker said.

NEW YORK — The Food and Drug Administration has postponed its decision whether or not to approve an experimental arthritis drug made by Pfizer, the drug maker said.

Pfizer said the FDA had extended its action date for the drug tofacitinib by three months, to Nov. 21, because additional analyses of data that the company submitted constituted a "major amendment" to Pfizer's regulatory application and will require additional time to review.

July 27, 2012
FDA approves Rayos

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
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.

July 12, 2012
FDA approves Watson arthritis drug

The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic drug for arthritis made by Watson Pharmaceuticals, the company said.

Watson announced that the FDA approved a subsidiary's application for diclofenac sodium and misoprostol delayed-release tablets. The drug is a generic version of G.D. Searle's Arthrotec, used to treat osteoarthritis and rheumatoid arthritis in patients who have high risk of developing ulcers related to the use of non-steroidal anti-inflammatory drugs, or NSAIDs, a class that includes the painkiller ibuprofen.

May 10, 2012
FDA panel recommends approval for Pfizer RA drug

A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

NEW YORK — A Food and Drug Administration expert panel has recommended approval for a drug made by Pfizer for treating rheumatoid arthritis.

December 20, 2011
Pfizer submits regulatory application for rheumatoid arthritis drug to FDA

Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

NEW YORK — Pfizer is seeking approval from the Food and Drug Administration for its investigational treatment of moderately to severely active rheumatoid arthritis.

The company said the FDA accepted a new drug application for tofacitinib for review. The agency also has provided an anticipated Prescription Drug User Fee Act action date of August 2012. Tofacitinib, which is a novel, oral JAK inhibitor, currently is under review by the European Medicines Agency.

November 17, 2011
Need for more convenient therapies, competition from generics, biosimilars spurs RA drug development

The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

MOUNTAIN VIEW, Calif. — The increase in the number of people with rheumatoid arthritis, and the challenges posed to drug makers by generics, is encouraging the development of new drugs for the disease, according to a new report by Frost & Sullivan.

November 3, 2011
BMS to present abstracts from Orencia studies at American College of Rheumatology meeting

Drug maker Bristol-Myers Squibb will present 20 study abstracts at the American College of Rheumatology Annual Scientific Meeting in Chicago, the company said Thursday.

NEW YORK — Drug maker Bristol-Myers Squibb will present 20 study abstracts at the American College of Rheumatology Annual Scientific Meeting in Chicago, the company said Thursday.

Bristol said that of those, 18 contain new data from studies of Orencia (abatacept) in patients with rheumatoid arthritis or lupus nephritis.

November 2, 2011
CareFirst BlueCross BlueShield, Cardinal Health develop clinical pathways program for RA

CareFirst BlueCross BlueShield and Cardinal Health Specialty Solutions on Tuesday launched the nation's first clinical pathways program for rheumatoid arthritis, a chronic disease that leads to inflammation of the joints and surrounding tissue and affects nearly 2.1 million Americans each year.

BALTIMORE — CareFirst BlueCross BlueShield and Cardinal Health Specialty Solutions on Tuesday launched the nation's first clinical pathways program for rheumatoid arthritis, a chronic disease that leads to inflammation of the joints and surrounding tissue and affects nearly 2.1 million Americans each year.

August 1, 2011
FDA approves subcutaneous formulation of Orencia

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

PRINCETON, N.J. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for injection under the skin to treat rheumatoid arthritis, Bristol said Friday.

The New York-based drug maker said the approval of Orencia (abatacept) for subcutaneous injection in patients with moderate to severe RA made it the first biotech drug for RA available in self-injectable and intravenous infusion formulations.

June 17, 2011
Watson's nabumetone tablets get FDA OK

The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for arthritis made by Watson Pharmaceuticals, Watson said Friday.

The drug maker announced the approval of nabumetone tablets in the 500-mg and 750-mg strength. The drug is used to treat signs and symptoms of rheumatoid arthritis and osteoarthritis.

Nabumetone had sales of $58 million during the 12-month period ended in April, according to IMS Health.