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Aiming to ward off generic competition by an additional six months, Bristol-Myers Squibb (BMS) yesterday filed data with the FDA from two clinical studies involving the pediatric use of its profitable cancer drug Paraplatin (carboplatin).
Although the FDA’s Psychopharmacologic Advisory Committee recently took a stand in favor of stronger warnings regarding the possible increased suicide risk in children using antidepressants, a health advocacy group wants the agency to remove three committee members who have done research, consulting and other work for manufacturers of those drugs.
A House investigation is focusing on allegations that drugmakers have suppressed clinical trial data that shows increased risk of suicide in children who are treated with anti-depressants.
While one group of U.S. researchers recently released a report finding that antidepressants like Prozac, Zoloft and Paxil do not raise the risk of suicide in children, other researchers claimed last week that drug companies’ refusal to release details of negative studies denies physicians and parents critical information needed to assess the safety of such drugs.
Roche is cautioning physicians not to prescribe its popular flu treatment to patients under a year old following recent animal safety trial results, according to a letter released on the FDA’s MedWatch website late Friday.