Content about Immunosuppressants

April 30, 2013
FDA approves Genentech arthritis drug for rare disorder in children

The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for a rare form of arthritis in children, the company said Tuesday.

Genentech, a subsidiary of Swiss drug maker Roche, announced the approval of Actemra (tocilizumab) for polyarticular juvenile idiopathic arthritis in children ages 2 years and older, either alone or combined with the generic drug methotrexate.

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.

March 27, 2013
FDA approves new MS drug

The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said Wednesday.

The FDA announced the approval of Tecfidera (dimethyl fumarate) capsules for adults with relapsing forms of MS.

March 11, 2013
Early detection of PML in multiple sclerosis patients treated with immune-suppressing drugs may improve survival

Early detection of a deadly brain infection that sometimes arises due to treatment of autoimmune disorders with immune-suppressing biotech drugs may improve survival, according to a new study.

SAN DIEGO — Early detection of a deadly brain infection that sometimes arises due to treatment of autoimmune disorders with immune-suppressing biotech drugs may improve survival, according to a new study.

The study, released Sunday and scheduled for presentation at the 65th annual meeting of the American Academy of Neurology in San Diego, which starts next Saturday, found that early detection of progressive multifocal leukoencephalopathy, or PML, may improve survival and disability levels.

February 26, 2013
Reports: Elan not responding to acquisition offer from Royalty Pharma

A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan Corp., but hasn't heard back from it, according to published reports.

NEW YORK — A privately owned drug maker in New York is offering $6.5 billion for Irish drug maker Elan, but hasn't heard back from it, according to published reports.

The Associated Press reported that Royalty Pharma's $11-per-share offer for Elan represented a 4% premium over its closing price Friday. Royalty buys royalty interests in drug products that are in late-stage development or have already entered the market, but doesn't develop or market drugs of its own, the AP reported.

February 8, 2013
Elan sells Tysabri rights to Biogen Idec

Elan will sell the rights to its drug for multiple sclerosis to partnering company Biogen Idec for $3.25 billion plus royalties, the Irish drug maker said.

DUBLIN - Elan Corp. will sell the rights to its drug for multiple sclerosis to partnering company Biogen Idec for $3.25 billion plus royalties, the Irish drug maker said.

February 8, 2013
FDA approves multiple myeloma drug

The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Celgene for treating the cancer multiple myeloma, the agency said Friday.

The FDA announced the approval of Pomalyst (pomalidomide) for patients whose disease has progressed after treatment with other cancer drugs.

February 8, 2013
Reports: Amgen plans six biosimilars

Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

NEW YORK — Biotech drug maker Amgen plans to launch six biosimilar drugs starting in 2017, according to published reports.

January 8, 2013
Abbott spins off new drug company

Abbott Labs has spun off its specialty drug division into a new company called AbbVie, which the new company's leaders heralded Wednesday by ringing the first opening bell of 2013 at the New York Stock Exchange.

NEW YORK — Abbott Labs has spun off its specialty drug division into a new company called AbbVie, which the new company's leaders heralded Wednesday by ringing the first opening bell of 2013 at the New York Stock Exchange.

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.

December 10, 2012
FDA grants Astellas NDA for tacrolimus extended-release capsules

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

NORTHBROOK, Ill. — Astellas Pharma US announced the Food and Drug Administration's review of their new drug application for tacrolimus extended-release capsules, a once-daily formulation of the calcineurin-inhibitor immunosuppressant tacrolimus, for the prophylaxis of organ rejection in adult kidney transplant recipients and adult male liver transplant recipients.

December 6, 2012
J&J subsidiary seeks new approval for psoriasis drug

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 13, 2012
Abbott drug shows improvement in young adults with arthritis

Patients with a form of arthritis that affects young people taking a drug made by Abbott experienced improvements in their condition after a year of treatment, according to late-stage clinical trial results.

ABBOTT PARK, Ill. — Patients with a form of arthritis that affects young adults taking a drug made by Abbott experienced improvements in their condition after a year of treatment, according to late-stage clinical trial results.

Abbott announced Monday the first long-term patient-reported health outcomes data for the phase-3 "ABILITY-1" trial of Humira (adalimumab) in patients with nonradiographic axial spondyloarthritis, or nr-axSpA. Results of the trial were presented at the American College of Rheumatology's annual scientific meeting in Washington.

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.

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.

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 26, 2012
Astellas applies for FDA approval of organ transplant drug

The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas is seeking approval from the Food and Drug Administration for a drug to prevent rejection of transplanted organs.

Astellas Pharma US said it applied with the FDA for approval of tacrolimus extended-release capsules to prevent rejection of transplanted kidneys in adults and transplanted livers in men. The drug was approved in Europe in 2007 under the name Advagraf and under the name Graceptor in Japan in 2008; the drug has been approved in 69 countries so far.

September 13, 2012
FDA approves new MS drug

The Food and Drug Administration has approved a new drug for multiple sclerosis.

CAMBRIDGE, Mass. — The Food and Drug Administration has approved a new drug for multiple sclerosis.

Sanofi subsidiary Genzyme announced that the FDA had approved Aubagio (teriflunomide) as a once-daily, oral treatment for patients with relapsing MS.

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 13, 2012
Novartis drug appears effective in liver transplant patients

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

EAST HANOVER, N.J. — An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

A phase-3 study published in the American Journal of Transplantation found that patients taking RAD001 (everolimus) with a reduced dose of Astellas' Prograf (tacrolimus) experienced equal efficacy and superior kidney function to patients taking Prograf alone.

June 14, 2012
Cellceutix gets FDA nod to accelerate development of psoriasis treatment

Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.

BEVERLY, Mass. — Cellceutix on Wednesday reported that the Food and Drug Administration granted a section 505(b) designation for its Prurisol treatment for psoriasis, which would allow the company to forgo early-stage trials and advance Prurisol into latter-stage clinical trials.

March 15, 2012
Abbott to study use of Humira in patients with hidradenitis suppurativa

Abbott is set to enroll patients into two late-stage clinical trials designed to evaluate the safety and efficacy of one of its drugs as a treatment for a difficult-to-treat chronic inflammatory skin disease.

ABBOTT PARK, Ill. — Abbott is set to enroll patients into two late-stage clinical trials designed to evaluate the safety and efficacy of one of its drugs as a treatment for a difficult-to-treat chronic inflammatory skin disease.

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.

November 7, 2011
Abbott announces results of phase-3 trial of Humira

A large number of patients with a serious form of arthritis experienced improvement in their condition after taking a drug made by Abbott Labs for three months, according to results of a late-stage clinical trial announced Monday.

ABBOTT PARK, Ill. — A large number of patients with a serious form of arthritis experienced improvement in their condition after taking a drug made by Abbott Labs for three months, according to results of a late-stage clinical trial announced Monday.