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.
Baxter International has initiated a worldwide recall of three lots of sodium chloride as well as one of highly concentrated potassium chloride, the company announced today. The recall of the saline comes even as hospitals for months have been facing a shortage of the essential product.
The Wall Street Journal said that the drugmaker plans to test Zilmax in about 250,000 cattle in a randomized, controlled study. But sources say beef producers like Cargill and JBS SA have pushed back against the move. While Merck planned to have the feed additive on the market by this summer, the study has been delayed.
Merck wants to get its cattle feed additive Zilmax back to multimillion-dollar sales. But with lingering reservations from beef producers and sellers, that may be easier said than done--and competition is ramping up in the meantime.
Questcor is disclosing that its immune-system drug Acthar may pose more risks than it had let on. An SEC filing from Thursday reported that 14% of prescriptions written for the drug in 2013 resulted in adverse side effects, up from 9.1% in 2011.
In February and again in May, Merck sent a cease-and-desist order to Alberto Donzelli, head of education, appropriateness, and evidence-based medicine at Milan's public health authority. Donzelli had openly criticized Merck's cholesterol-lowering drug Ezetrol (ezetimibe), which is sold in the U.S. as Zetia. Now the company is doing an about-face.