Content about Monoclonal antibodies

March 20, 2012

Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

EAST HANOVER, N.J. — Novartis has launched a new treatment for chronic obstructive pulmonary disease, the drug maker said Monday.

Novartis Pharmaceuticals, the U.S. division of the Swiss drug manufacturer, announced the launch of Arcapta Neohaler (indacaterol inhalation powder) in the 75-mcg strength. The Food and Drug Administration approved the drug last July.

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.

February 29, 2012

FDA approves Biogen Idec's Avonex Pen, dose titration regimen

The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.

WESTON, Mass. — The Food and Drug Administration has approved two separate dosing innovations for multiple sclerosis patients that are being treated with a Biogen Idec drug.

Biogen Idec said the FDA approved Avonex pen, the first single-use, once-weekly intramuscular autoinjector approved for MS, and a dose titration regimen, which gradually escalates the dose of Avonex at treatment initiation. The drug maker said the new offerings are designed to improve the treatment experience.

February 15, 2012

Biogen Idec to acquire Stromedix

Drug maker Biogen Idec plans to spend up to more than $560 million to buy a company developing treatments for organ failure.

CAMBRIDGE, Mass. — Drug maker Biogen Idec plans to spend up to more than $560 million to buy a company developing treatments for organ failure.

Biogen Idec announced that it would pay $75 million upfront, plus up to $487.5 million in milestone payments to acquire privately-owned biotech company Stromedix. Stromedix's lead drug candidate is STX-100, a monoclonal antibody entering phase-2 trials as a potential treatment for idiopathic pulmonary fibrosis, a disease that causes difficulty breathing due to scarring of the lungs and is almost always fatal.

February 15, 2012

Counterfeit Avastin circulating in U.S., FDA warns

Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

SILVER SPRING, Md. — Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

The FDA advised healthcare professionals and patients that a counterfeit version of Genentech's Avastin (bevacizumab) had been distributed in the United States. The agency said the counterfeit versions carried Roche's logo instead of Genentech's and displayed batch numbers starting with B6010, B6011 or B86017.

January 26, 2012

Amgen acquiring Micromet for $1.16 billion

Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

THOUSAND OAKS, Calif. — Drug maker Amgen is acquiring a Rockville, Md.-based company developing therapies for cancer, the companies said Thursday.

Amgen announced plans to buy Micromet for $1.16 billion, or $11 per share. Micromet, originally founded in Germany, is developing blinatumomab, currently in phase-2 trials as a treatment for acute lymphoblastic leukemia and non-Hodgkin's lymphoma. The acquisition also will include the company's research and development center in Munich.

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 18, 2011

FDA revokes breast cancer approval for Avastin

A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

SILVER SPRING, Md. — A drug widely used to treat breast cancer is not safe or effective, the Food and Drug Administration said Friday.

November 14, 2011

Genzyme announces phase-3 results of Lemtrada in patients with relapsing MS

A late-stage clinical trial of a drug under development as a treatment for multiple sclerosis has shown "successful" results.

CAMBRIDGE, Mass. — A late-stage clinical trial of a drug under development as a treatment for multiple sclerosis has shown "successful" results.

Genzyme, acquired earlier this year by French drug maker Sanofi, announced results of the phase-3 "CARE-MS II" trial of Lemtrada (alemtuzumab), saying the drug "significantly reduced" worsening of disability and relapse in patients with MS, compared with Rebif (interferon beta-1a), made by Pfizer and German drug maker Merck KGaA, a separate company from U.S.-based Merck.

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.

November 7, 2011

FDA gives new approval to Bristol-Myers Squibb's, Lilly's Erbitux

The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb for treating head and neck cancer, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Bristol-Myers Squibb and Eli Lilly & Co. for treating head and neck cancer, the agency said Monday.

The FDA announced the approval of Erbitux (cetuximab) for use with chemotherapy in treating head and neck cancer that had spread to other parts of the body. The drug originally was approved in 2004 for treating certain cases of late-stage colon cancer in patients who had stopped responding to chemotherapy.

November 7, 2011

Reports: FDA finds manufacturing problems at Genentech plant

A new report from the Food and Drug Administration indicated that Roche division Genentech may not have followed proper procedures to prevent the contamination of certain drugs, according to published reports.

NEW YORK — A new report from the Food and Drug Administration indicated that Roche division Genentech may not have followed proper procedures to prevent the contamination of certain drugs, according to published reports.

Dow Jones Newswires reported that an FDA report from September regarding an inspection of a plant in South San Francisco, Calif., found problems related to gaskets and caps used to cover vials of the cancer drug Avastin (bevacizumab).

The caps are made by a contract manufacturer, according to the reports.

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.

September 26, 2011

FDA approves Remicade for ulcerative colitis in children

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

FDA approves two new indications for Amgen's Prolia

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

FDA approves first new Hodgkin's lymphoma treatment in 34 years

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

Roche drug improves lung function in patients with uncontrolled asthma, study finds

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

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.

July 28, 2011

Biogen Idec expands MS ActiveSource

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

FDA panel recommends approval of Remicade for UC in children

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

FDA panel unanimously recommends approval of Eylea

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

FDA approves Nulojix

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

BMS, Roche to study skin cancer drugs

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 introduces Women in MS educational initiative

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

UCB’s Cimzia improves rheumatoid arthritis condition among patients in study

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.