Cytori Therapeutics hit the brakes on a pair of clinical trials to find out why three patients in the study suffered from "cerebrovascular" events after they were treated with the biotech's experimental stem cell treatment. The San Diego-based biotech's shares plunged more than 30% in after-hours trading after putting out word of the hold in a late release.
Roche has emerged victorious in its quest to reverse a $2.1 million verdict by a New Jersey jury in favor of a woman who blamed the Swiss pharma's acne med Accutane for her inflammatory bowel disease, Bloomberg reports.
Facing its second scandal in as many months, Novartis' Japanese unit has issued an apology for failing to disclose side effects of its drugs Tasigna and Gleevec, which are used to treat leukemia.
A study carried out the University of Nebraska, Lincoln and the U.S.D.AU Agricultural Research Service found Zilmax had no negative effects on cattle health.
The BMJ has set off a kerfuffle--and a Twitter campaign--over the safety of Boehringer Ingelheim's blockbuster anticoagulant Pradaxa.
An in vitro technique using samples of beating heart tissue may be able to test the effects of drugs on the heart without unnecessary testing on humans or animals, according to new research.
When India-born Altaf Lal was named to run the FDA office in India last year, he pledged to work with Indian drugmakers there to improve quality and their chances of avoiding regulatory actions by the agency. But someone else will have to take on that challenge because Lal has left after just about 9 months on the job.
FedEx has received a special delivery from the U.S. Department of Justice (DoJ), a 15-count indictment accusing it of being the delivery vehicle of choice for a certain kind of drug dealer. If convicted, the agency says FedEx could face penalties of $1.6 billion.
Teva Pharmaceutical Industries, which in April had to recall a children's growth hormone, has now halted production of a parenteral nutrition product as the authorities try to determine why 9 children in Israel developed blood infections after taking it.
GlaxoSmithKline is voluntarily recalling four lots of its Panadol Advance product in 100-count bottles in Puerto Rico because the bottles do not have child-resistant packaging to protect against overdoses.