Reports: FDA finds manufacturing problems at Genentech plant
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.
FDA gives new approval to Bristol-Myers Squibb’s, Lilly’s Erbitux
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.
"Erbitux’s ability to extend the lives of patients with head and neck cancers is an important tool for oncologists who often rely on a multitreatment approach for patients," FDA Office of Hematology and Oncology Drug Products director Richard Pazdur said. "Given the aggressive nature of head and neck cancers that cannot be treated with surgery and radiation, it is important for patients to have as many treatment options available as possible."
Report: Sainsbury’s launches ‘The Wells Challenge’
NEW YORK — A supermarket chain in the United Kingdom has launched a new initiative that will enlist 10 families with the same surname, according to published reports.
The Retail Gazette reported that the Sainsbury’s chain had launched "The Wells Challenge," which will assess the effects on the health of 10 families with the surname Wells as the chain’s pharmacists provide them with health-related guidance and support.
The think tank 2020health is monitoring the initiative, which is designed to reduce pressure on Britain’s National Health Service, the country’s state-run healthcare system.