Johnson & Johnson knew as early as 2001 that its antipsychotic drug Risperdal could cause boys to grow breasts, former FDA chief David Kessler testified in Philadelphia court Wednesday. That's 5 years before the company added a warning about the side effect to the drug's official label.
The Chinese Pharmacopoeia Commission and Waters launched their Joint Open Laboratory on Jan. 28 in Beijing that aims to produce the first official compendium of drugs.
With the sentencing of a second man from Turkey, federal authorities have essentially brought to a close a case stemming from the appearance in the U.S. of counterfeit and unapproved cancer drugs. The drugs were sold to wholesalers and physician practices throughout the U.S., in some cases making patients ill.
Last week opening arguments were made in a case in which Johnson & Johnson is accused of marketing the antipsychotic drug Risperdal for use in young boys and then not sufficiently warning patients that the side effects for some included the possibility they would grow breasts like a woman.
In a no-holds-barred action, the European Medicines Agency has accused India-based CRO GVK Biosciences of systematically faking clinical trials for about 700 generic drugs marketed throughout the world. The products of dozens of generic makers are among the drugs involved, including popular antidepressants.
Merck is financing a $1.85 million study being conducted at Texas Tech University to see if lower dosages of its lucrative but controversial cattle growth drug Zilmax could allow the company to reintroduce the product to U.S. and global markets and kick-start sales.
A federal court has upheld the $350 million-plus in damages that Becton Dickinson owes Retractactable Technologies due to a legal spat over drug-delivering prefilled syringes. But the court stayed a previous order requiring the company to inform end users about its false advertising regarding the syringes.
The saline shortage may have claimed a life. The FDA reported that one person has died and many more have taken ill after receiving simulated intravenous products that are intended for training use only.
"Modified release is a high-risk area, so we're going to put a lot of emphasis on it," said the deputy director of the FDA's new Office of Pharmaceutical Quality, Lawrence Yu, during a press conference describing the new division.
Pet retail chain Petco announced on its new blog Pet Talk Place that it has removed all dog and cat treats made in China from its store shelves, becoming the first national retailer to do so.