Content about Genentech

May 15, 2013
FDA approves Genentech drug for lung cancer with genetic mutation

The Food and Drug Administration has approved a drug for a type of lung cancer.

SOUTH SAN FRANCISCO, Calif. — The Food and Drug Administration has approved a drug for a type of lung cancer.

Roche subsidiary Genentech and the U.S. subsidiary of Japan's Astellas Pharma announced the approval of Tarceva (erlotinib) for advanced non-small cell lung cancer whose tumors have mutations that activate the epidermal growth factor receptor. The FDA also approved a test to detect the mutation.

The drug was already approved for advanced NSCLC that did not exhibit the mutation.

 

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.

March 22, 2013
FDA commissioner calls for power to regulate compounding pharmacies

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
Ga. compounding pharmacy recalls all lots of sterile products

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
FDA approves Genentech breast cancer drug

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.

January 25, 2013
New indication approved for Genentech drug

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.

January 22, 2013
FDA addresses Tamiflu shortages

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 17, 2013
Retailers, suppliers make Fortune top-100 workplace list

Fortune magazine has released its list of the 100 best companies to work for this year, and a number of retailers and suppliers made the cut.

NEW YORK — Fortune magazine has released its list of the 100 best companies to work for this year, and a number of retailers and suppliers made the cut.

Among retailers, Wegman's Food Markets came in at fifth place, with 8.3% job growth. Nugget Market, a supermarket chain based in Sacramento, Calif., ranked 37th; Whole Foods ranked 71st; and Publix Super Markets ranked 77th.

Among suppliers, Millennium: The Takeda Oncology Company, ranked 20th; Genentech ranked 36th; and Novo Nordisk ranked 48th. Confectionary manufacturer Mars ranked 95th.

January 14, 2013
U.S., Canadian health authorities report spot shortages of Tamiflu

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

December 21, 2012
FDA approves Tamiflu in children younger than 1 year

The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a common flu drug for use in children as young as 2 weeks old, the agency said Friday.

The FDA announced the new approval for Genentech's Tamiflu (oseltamivir). The agency said that while patients ages 1 year and older can receive the same dosage, those younger than 1 year must be dosed based on their exact weight.

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.

August 13, 2012
FDA approves Genentech's Lucentis for diabetic macular edema

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
FDA panel recommends new approval for Genentech eye drug

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.

June 11, 2012
FDA approves Perjeta

Genentech has received regulatory approval for a drug designed to treat breast cancer.

SOUTH SAN FRANCISCO, Calif. — Genentech has received regulatory approval for a drug designed to treat breast cancer.

April 30, 2012
Reports: Dying woman's plea prompts early release of cancer drug

An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

NEW YORK — An online plea for help from a mother dying of breast cancer prompted the manufacturer of an experimental drug to release it early, according to published reports.

In an article posted on its website, CNN told the story of 46-year-old Darlene Gant, a woman with stage-four breast cancer, as she wrote letters to be given to her 11-year-old son on his upcoming birthday, and at future events, such as his high school and college graduations and marriage.

March 30, 2012
Genentech announces results of cancer drug trial

Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.

SOUTH SAN FRANCISCO, Calif. — Breast cancer patients taking an experimental drug made by Roche subsidiary Genentech lived significantly longer than those taking another drug made by GlaxoSmithKline, according to results of a late-stage clinical trial.

March 21, 2012
FDA approves Watson's generic version of Boniva

The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved Watson's generic version of a drug used to prevent and treat osteoporosis in post-menopausal women, the company said.

Watson announced the FDA's approval of ibandronate tablets in the 150-mg strength, a generic version of Genentech's Boniva. Watson plans to launch its version in second quarter 2012.

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 30, 2012
FDA approves Genentech skin cancer drug

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating the most common type of skin cancer, the agency said Monday.

The FDA announced the approval of Genentech's Erivedge (vismodegib) for adults with basal cell carcinoma who are not surgery or radiation therapy candidates and whose disease is locally advanced or has spread to other parts of the body.

January 27, 2012
FDA approves Pfizer's Inlyta for advanced kidney cancer

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
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 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.

September 12, 2011
Genentech files for approval of skin cancer drug

Genentech has applied for Food and Drug Administration approval of a drug for treating skin cancer, the drug maker said Monday.

SOUTH SAN FRANCISCO, Calif. — Genentech has applied for Food and Drug Administration approval of a drug for treating skin cancer, the drug maker said Monday.

Genentech, the U.S. division of Swiss drug maker Roche, submitted a new drug application to the FDA for vismodegib for the treatment of basal cell carcinoma. BCC generally is curable through surgery, but if it advances, can cause disfigurement and debilitating effects and, in the long term, can be life-threatening.

August 17, 2011
FDA approves drug, diagnostic test for melanoma

The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug and companion diagnostic test for the most dangerous type of skin cancer, the agency said Wednesday.

The FDA announced the approval of Genentech's and Daiichi Sankyo's Zelboraf (vemurafenib), for patients with late-stage melanoma that can't be removed by surgery. Genentech is the U.S. division of Swiss drug maker Roche.

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.