The U.S. Food and Drug Administration sent a warning letter to Pfizer about overdosing of at least 13 children in a clinical trial of its antipsychotic drug Geodon, Reuters reported. The FDA told Pfizer that it failed to ensure proper monitoring of the trial in which several children given overdoses experienced tremors, restless legs and other complications. The company is seeking to market the drug to children with bipolar disorder. While the study in question ended in 2007, the FDA is concerned Pfizer has not done enough to ensure the problem does not happen again. In its letter, the FDA said the company did not properly monitor the study and "as a result of inadequate monitoring, widespread overdosing of study subjects at multiple study sites was neither detected nor corrected in a timely manner.” Pfizer said it is committed to addressing the concerns. It says that many items cited in the letter occurred as long as four years ago. Pfizer has instituted several new measures designed to improve monitoring and execution of clinical trials, it said.

Phenomix said Forest Laboratories, which was collaborating with the San Diego-based biopharmaceutical in the development of the experimental diabetes drug dutogliptin, said it was ending its development and commercialization agreement because of “business reasons.” The decision by Forest comes in the wake of positive top-line results from a six-month late-stage trial comparing dutogliptin 400mg and 200mg once daily as monotherapy versus placebo for the treatment of patients with type 2 diabetes mellitus. The deal announced in October 2008 included an upfront payment to Phenomix of $75 million and milestone payments that could have pushed the total to $340 million.

Genzyme said the U.S. Food and Drug Administration sent it a draft consent decree that calls for the disgorgement of past profits totaling $175 million because of contamination problems at its Allston manufacturing plant. Genzyme booked this expense in the first quarter because it will likely have to pay this. In addition, the consent decree says if the Allston fill/finish facility is still operating after deadlines for domestic and exported products, the draft provides for disgorgement of 18.5 percent of revenues from sales of products manufactured and distributed from Allston after those deadlines [see story].

Bayer HealthCare is facing at least 1,100 lawsuits over alleged health risks from its Yasmin and Yaz birth control pills, the Los Angeles Times reported. The suits have alleged that Yasmin and Yaz caused blood clots, strokes, heart attacks, and gallbladder disease. Yaz is the top selling birth control pill and is supposed to have less side effects than older versions of the Pill, but studies have been inconclusive. The Bayer drugs contain drospirenone, a synthetic form of progesterone. The newspaper notes some studies have found drospirenone poses no greater health risk than other birth control pills, but other studies suggest there’s a six-fold greater risk of getting blood clots in women who use the drug.

Gilead Sciences says it's stopping its ongoing mid-stage clinical trial of GS 9450, an investigational caspase inhibitor, in patients with chronic hepatitis C. The company says the decision follows reports of significant laboratory abnormalities and adverse events in a number of clinical study participants. Gilead plans to conduct a review of all available data to assess future clinical development of the compound.

Acura Pharmaceuticals and King Pharmaceuticals said a U.S. Food and Drug Administration advisory panel voted that the companies did not have adequate evidence to support approval of Acurox, their experimental drug for the treatment of moderate to severe pain. Acurox is oxycodone HC1 and niacin. The addition of niacin is intended to minimize the potential for abuse of the drug by snorting or intravenous use. The agency is not bound by the recommendation.

Pfizer said it has discontinued a late-stage trial of Sutent (sunitinib malate) in patients with advanced liver cancer. The decision follows a review by the Independent Data Monitoring Committee. The study was discontinued based on a higher incidence of serious adverse events because sunitinib did not meet the criteria to demonstrate that it was either superior or non-inferior to sorafenib in the survival of patients with advanced liver cancer. No new or unexpected types of serious adverse events were observed in the SUN 1170 trial.