FDAnews Drug Daily Bulletin

Novartis is launching an in-house campaign to underscore employees’ “personal responsibility” for quality as the company’s manufacturing remediation continues.

FDA inspections of Apotheca have revealed possible metal shaving contamination and broken, leaking or damaged bottles for various drugs, resulting in a warning letter.

The FDA has issued Genzyme a refuse-to-file letter on its sBLA for Lemtrada as a treatment for relapsing multiple sclerosis (MS).

Eisai Co. announced Friday that its Australian pharmaceutical sales subsidiary, Eisai Australia Pty. Ltd., has received approval from the Australian Department of Health and Aging to market the anticancer agent Halaven.

Boehringer Ingelheim, the Institute of Molecular Health Science and the Institute of Food, Nutrition and Health of the ETH Zurich will collaborate to achieve new insights into the development of diabetes and obesity.

The U.S. health care system squanders $750 billion a year — roughly 30 cents of every medical dollar — through unneeded care, Byzantine paperwork, fraud and other waste, the influential Institute of Medicine said in a report that ties directly into the presidential campaign.

Drug interactions and drug side effects occur all-too-often in patients’ lives.

The Irish drugmaker Jazz Pharmaceuticals is selling its women’s health business to specialty pharmaceutical company Meda for $95 million in cash so that it can concentrate on its core products.

Starpharma’s cancer drug development platform has attracted the attention of UK pharmaceutical giant AstraZeneca.