Peggy Peck

March 30, 2007

ROCKVILLE, Md. -- The FDA announced today that Novartis has agreed to withdraw Zelnorm (tegaserod), the only approved drug for irritable bowel syndrome (constipation), after a pooled analysis of 29 placebo-controlled, short-term trials found a small but statistically significant increase in ischemic events, including angina and stroke. The analysis identifed 13 such events, including one death, in more than 11,600 patients treated with tegaserod versus one event among a placebo group.

March 30, 2007

ROCKVILLE, Md. -- FDA advisers have recommended that the agency approve a therapeutic personalized vaccine for treatment of metastatic prostate cancer that may increase survival by several months.

March 29, 2007

ROCKVILLE, Md. -- The FDA today withdrew the Parkinson's drug pergolide -- a dopamine agonist sold as Permax and as a generic -- because of an increased risk of valvular heart disease.

March 23, 2007

NEW ORLEANS -- Among the blizzard of clinical trials to be presented at the American College of Cardiology meeting here over the next four days are 11 singled out for special treatment --simultaneous online publication in peer-reviewed journals.

March 22, 2007

ROCKVILLE, Md. -- In an effort to insulate the FDA and members of its advisory panels from suspicion of conflicts of interest, the agency said it will no longer solicit counsel from researchers who have received ,000 or more from a manufacturer with a product under review.

March 20, 2007

NEW YORK -- Minnesota and Vermont require pharmaceutical companies to disclose payments of or more to physicians and other health care providers, but both states have been accused of failing to deliver on that promise of transparency.

March 20, 2007

ROCKVILLE, Md. -- The FDA has issued a safety alert for linezolid (Zyvox) after clinical trial data suggested excess mortality when the drug was used to treat Gram-negative septicemia.

March 19, 2007

ROCKVILLE, Md. -- The FDA has approved eculizumab (Soliris), tbe first of a new class of natural immune system blockers, for paroxysmal nocturnal hemoglobinuria, a rare blood disorder that can lead to disability and death.

March 19, 2007

ROCKVILLE, Md. -- The FDA has approved a rapid test that will allow the diagnosis of viral meningitis within hours of symptoms rather than days.

March 16, 2007

MONTREAL -- White Americans still have longer life expectancies than black Americans, but the gap has narrowed in recent years, researchers here reported.