Content about Monoclonal antibodies

November 3, 2011

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.

September 26, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.

HORSHAM, Pa. — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating ulcerative colitis in children.

J&J subsidiary Janssen Biotech said Friday that the FDA approved Remicade (infliximab) for moderately to severely active ulcerative colitis in children who have not responded adequately to conventional therapies.

September 19, 2011

The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

THOUSAND OAKS, Calif. — The Food and Drug Administration has approved two new uses for a drug made by Amgen, the drug maker said Monday.

Amgen announced the approval of the biotech drug Prolia (denosumab) for increasing bone mass in men and women who are at risk of fractures due to hormone ablation treatments they are receiving for prostate and breast cancer, respectively.

August 19, 2011

The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new biotech drug for treating two types of lymphoma, the agency said Friday.

August 8, 2011

An investigational treatment made by Roche for asthma increased lung function in patients who could not adequately control their disease with inhaled corticosteroids, according to results of a mid-stage clinical trial.

BASEL, Switzerland — An investigational treatment made by Roche for asthma increased lung function in patients who could not adequately control their disease with inhaled corticosteroids, according to results of a mid-stage clinical trial.

August 1, 2011

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.

July 28, 2011

Biogen Idec has expanded its online resource for patients living with multiple sclerosis to include new resources and support programs.

WESTON, Mass. — Biogen Idec has expanded its online resource for patients living with multiple sclerosis to include new resources and support programs.

MS ActiveSource features have expanded to include additional information and support on a range of issues, including financial assistance and nursing services. Additionally, the website also features a new online patient-to-patient community called ActiveVoices.

July 22, 2011

A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

HORSHAM, Pa. — A panel of experts at the Food and Drug Administration has recommended that the agency approve a drug made by Johnson & Johnson as a treatment for ulcerative colitis in children.

June 20, 2011

A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

June 16, 2011

The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for preventing organ rejection in kidney transplant patients, the agency said Wednesday.

The FDA approved Bristol-Myers Squibb’s Nulojix (belatacept), for preventing acute rejection in adult patients. The drug is approved for use with other immune system-suppressing drugs, specifically Novartis’ Simulect (basiliximab), Genentech’s CellCept (mycophenolate mofetil) and corticosteroids.

June 2, 2011

Bristol-Myers Squibb will collaborate with Roche to investigate the use of a combination of the companies’ drugs in patients with a deadly form of skin cancer.

NEW YORK — Bristol-Myers Squibb will collaborate with Roche to investigate the use of a combination of the companies’ drugs in patients with a deadly form of skin cancer.

The companies will conduct a phase 1/2 trial to test the safety and efficacy of BMS’ Yervoy (ipilimumab) in combination with Roche’s investigational drug vemurafenib in patients with melanoma that has spread to other parts of the body.

May 25, 2011

Biogen Idec is looking to address the advantages and challenges female clinicians experience in treating patients living with multiple sclerosis through a new educational initiative.

WESTON, Mass. — Biogen Idec is looking to address the advantages and challenges female clinicians experience in treating patients living with multiple sclerosis through a new educational initiative.

May 11, 2011

Patients with moderate to severe rheumatoid arthritis who respond to 12 weeks of treatment with a drug made by UCB are more likely to show improvement in their condition in the long run, according to results of a study published in the Journal of Rheumatology.

BRUSSELS — Patients with moderate to severe rheumatoid arthritis who respond to 12 weeks of treatment with a drug made by UCB are more likely to show improvement in their condition in the long run, according to results of a study published in the Journal of Rheumatology.

April 20, 2011

The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Genentech for the treatment of two rare inflammatory disorders, the agency said.

April 18, 2011

The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug made by Genentech for treating a rare and severe form of arthritis that affects children, Genentech said.

The biotech company, the U.S. division of Swiss drug maker Roche, announced the FDA approval of Actemra (tocilizumab) for active systemic juvenile idiopathic arthritis. SJIA has the worst long-term prognosis of all varieties of childhood arthritis.

April 14, 2011

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.

April 8, 2011

Regeneron and Bayer HealthCare have initiated 1-of-2 late-stage clinical trials of their aflibercept ophthalmic solution in the treatment of a complication caused by diabetic retinopathy.

TARRYTOWN, N.Y. and BERLIN — Regeneron and Bayer HealthCare have initiated 1-of-2 late-stage clinical trials of their aflibercept ophthalmic solution in the treatment of a complication caused by diabetic retinopathy.

The drug makers said that it would evaluate the efficacy of VEGF Trap-Eye (aflibercept ophthalmic solution) in the treatment of diabetic macular edema, a prevalent cause of vision loss among diabetes patients, after promising results from its previous clinical trial.

March 25, 2011

The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for late-stage skin cancer, the agency said Friday.

The FDA approved Bristol-Myers Squibb’s Yervoy (ipilimumab) for patients with melanoma that has spread to other parts of the body, also known as metastasis. More than 68,000 new cases of melanoma were diagnosed in the United States in 2010, and about 8,700 died from it, according to the National Cancer Institute, part of the National Institutes of Health.

March 24, 2011

Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

PRINCETON, N.J. — Bristol-Myers Squibb said its late-stage clinical trial for a cancer treatment, which currently is under review by the Food and Drug Administration, achieved its primary endpoint.

The company said its phase-3 trial for investigational compound ipilimumab, designed for previously untreated patients that were diagnosed with metastatic melanoma, improved overall survival. The study compared the combination of ipilimumab 10 mg/kg and chemotherapy (dacarbazine) with chemotherapy alone.

March 11, 2011

While failing to improve overall survival, an investigational treatment for non-small cell lung cancer made by Sanofi-Aventis and Regeneron Pharmaceuticals did keep the disease from worsening and, overall, caused patients to respond to treatment, according to results of a late-stage clinical trial.

TARRYTOWN, N.Y. — While failing to improve overall survival, an investigational treatment for non-small cell lung cancer made by Sanofi-Aventis and Regeneron Pharmaceuticals did keep the disease from worsening and, overall, caused patients to respond to treatment, according to results of a late-stage clinical trial.

Sanofi and Regeneron announced Thursday results of the phase-3 “VITAL” trial of aflibercept. Patients were administered either the drug or placebo in addition to docetaxel chemotherapy.

March 7, 2011

The board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer, Genzyme said Monday.

CAMBRIDGE, Mass. — The board of directors of Genzyme unanimously recommended that shareholders accept French drug maker Sanofi-Aventis’ $74-per-share buyout offer, Genzyme said Monday.

Genzyme recently accepted Sanofi’s $20.1 billion offer for the Cambridge, Mass.-based biotech company. Sanofi had sought to buy the company since last July, when it offered $18.5 billion, or $69 per share.

February 11, 2011

Genentech, a subsidiary of Roche, reported that its eye drug helped improve vision in patients suffering from a complication caused by diabetes.

SOUTH SAN FRANCISCO, Calif. — Genentech, a subsidiary of Roche, reported that its eye drug helped improve vision in patients suffering from a complication caused by diabetes.

In its phase-3 RISE study, Genentech said diabetic macular edema patients that received monthly Lucentis (ranibizumab injection) achieved an improvement in vision at 24 months, compared with placebo.

February 4, 2011

A drug used to treat inflammatory diseases improved the conditions of patients with psoriasis that affected the scalp compared with placebo, according to results of a new study.

THOUSAND OAKS, Calif. — A drug used to treat inflammatory diseases improved the conditions of patients with psoriasis that affected the scalp compared with placebo, according to results of a new study.

Amgen and Pfizer on Friday announced the results of the phase-4 study of Enbrel (etanercept), in patients with moderate to severe plaque psoriasis with scaling on the scalp, also known as scalp involvement. Data from the trial will be presented Friday at the 69th annual meeting of the American Academy of Dermatology in New Orleans.

January 19, 2011

Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

NEW YORK — Drug maker Genentech is hoping to keep a breast cancer treatment on the market as the Food and Drug Administration considers whether to revoke its approval for the disease, according to published reports.

The San Francisco Business Times reported Tuesday that Genentech, part of Swiss drug maker Roche, is appealing the FDA’s plan to revoke approval for the drug Avastin (bevacizumab) as a first-line treatment for advanced HER2-negative breast cancer in combination with paclitaxel chemotherapy.

January 18, 2011

Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

HOLZKIRCHEN, Switzerland — Generic drug maker Sandoz has started a mid-stage clinical trial of a monoclonal antibody used to treat cancer and autoimmune disease, the company said.

Sandoz (pronounced “SAN-doh”), the generics arm of Swiss drug maker Novartis, announced the start of a phase-2 trial of rituximab, a biosimilar of Genentech’s Rituxan, used to treat such conditions as non-Hodgkin’s lymphoma and rheumatoid arthritis.