Content about Bevacizumab

September 30, 2013

The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

September 16, 2013

The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

The FDA announced the approval of Teva Pharmaceutical Industries' capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they've spread to other parts of the body.

The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.

 

March 22, 2013

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 21, 2013

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

February 22, 2013

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

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

The FDA announced the approval of Genentech's Kadcyla (ado-trastuzumab emtansine) for HER2-positive breast cancer that has spread to other parts of the body. HER2 is a protein involved in the growth of normal cells but found in increased amounts in some kinds of cancer cells, which contributes to cancer cell growth and survival. Genentech is the U.S. subsidiary of Swiss drug maker Roche.

February 8, 2013

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 25, 2013

The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

The FDA announced the approval of Avastin (bevacizumab) combined with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy for treating colorectal cancer that has spread to other parts of the body, also known as metastatic colorectal cancer, or mCRC.

The drug is also approved for treating lung cancer, kidney cancer and brain cancer.

August 13, 2012

Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

SILVER SPRING, Md. — Regulators have approved a biotech drug made by Genentech for treating a complication related to diabetes.

The Food and Drug Administration approved Lucentis (ranibizumab) for diabetic macular edema, a cause of vision loss in people with diabetes. The drug already was approved for age-related macular degeneration.

July 27, 2012

A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.

SILVER SPRING, Md. — A panel of Food and Drug Administration experts is recommending the approval of a drug made by Genentech for diabetic macular edema, the company said.

February 15, 2012

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 27, 2012

The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Pfizer for treating advanced kidney cancer, the agency said Friday.

The FDA announced the approval of Inlyta (axitinib) for patients with advanced kidney cancer, also known as renal cell carcinoma, who have not responded to another drug for the disease. The drug, a twice-daily pill, works by blocking certain proteins called kinases that are involved with tumor growth and disease progression.

November 18, 2011

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 7, 2011

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.

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 9, 2011

Women with ovarian cancer who received a drug made by Genentech lived longer without their disease becoming worse, according to a late-stage clinical trial.

SOUTH SAN FRANCISCO, Calif. — Women with ovarian cancer who received a drug made by Genentech lived longer without their disease becoming worse, according to a late-stage clinical trial.

Genentech, part of Swiss drug maker Roche, announced results from its phase-3 “OCEANS” study, in which women with recurring ovarian cancer received Avastin (bevacizumab) with gemcitabine and carboplatin, both chemotherapy drugs, followed by use of Avastin alone.

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.

December 16, 2010

Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

SILVER SPRING, Md. — Just a few months after a Food and Drug Administration advisory committee recommended limiting the use of a Genentech drug designed to treat breast cancer, the regulatory agency is looking to revoke the approval altogether.

September 19, 2010

Biotech company Genentech has amended its application to the Food and Drug Administration seeking an...

SOUTH SAN FRANCISCO, Calif. Biotech company Genentech has amended its application to the Food and Drug Administration seeking an additional approval for one of its drugs, which the FDA has deemed a “major amendment,” Genentech said Monday.

 

August 31, 2010

The Food and Drug Administration has granted priority review for a diabetic macular edema treatment....

ATLANTA The Food and Drug Administration has granted priority review for a diabetic macular edema treatment.

July 20, 2010

A Food and Drug Administration advisory committee has voted to recommend limiting use of a...

June 22, 2010

The Food and Drug Administration has approved a drug made by Genentech for treating a...

June 15, 2010

Drug maker OXiGENE has finished enrolling patients for a mid-stage clinical trial of a lung...

May 2, 2010

A combination of a biotech drug and laser treatment may improve vision in patients with...

March 17, 2010

Roche leaders appear confident about their company’s research and development position, with several investigational drugs...

March 11, 2010

A late-stage clinical trial of a Genentech drug for men with late-stage prostate cancer has...