FDA slams Actelion amid BMS buyout rumors

There's good news and bad news for the Swiss biotech Actelion today. First, the company's stock is up 6.6 percent on news that Bristol-Myers Squibb may announce that it owns more than 3 percent of the company, as Swiss law requires. That, in turn, has fueled speculation that BMS might take over the company completely.

However, the company is in hot water with the FDA for keeping some life-and-death information to itself. In a warning letter, the agency scolds Actelion for failing to report 3,500 deaths in patients using the company's drugs Tracleer and Ventavis, both treatments for pulmonary arterial hypertension.

Now, the FDA does emphasize that the drugs treat a condition that in itself can cause death. And, the agency says, "we are not concluding or implying that the patients' deaths ... would ultimately be determined to have been caused by their use." Nevertheless, the agency says, the company should have handed over that information; otherwise how can FDA "appropriately evaluate the safety of drugs in the postmarket environment"?

- see the FDA letter
- check out the news from Reuters
- get more from Pharmalot