Two studies are fueling concerns about the cardiovascular risks of using GlaxoSmithKline’s diabetes drug Avandia. An FDA expert panel is set mid-month to consider whether Avandia should be pulled from the market. The first study, published in the New England Journal of Medicine, analyzed 42 trials involving Avandia. The research found a significant increase in the risk of myocardial infarction with an increase in the risk of death from cardiovascular causes that had borderline significance. A separate study published online in the Journal of the American Medical Association looked at data on 227,571 Medicare beneficiaries aged 65 years or older (mean age, 74.4 years) who initiated treatment with Avandia or Takeda pharmaceutical’s competing drug Actos. Both are members of the thiazolidinedione class of drugs.

Specialty pharmaceutical company Santarus said with the anticipated launch of a competitor’s generic version of its prescription drug Zegerid it is implementing a corporate restructuring that includes a 37 percent or 120-person reduction in its workforce. Zegerid is an immediate-release proton pump inhibitor approved as a prescription product in the United States for the treatment of certain upper gastrointestinal diseases and disorders. Santarus expects that selling and marketing expenses will be reduced by approximately $40 million annually beginning in the 2010 fourth quarter as a result of the corporate restructuring and workforce reduction. Excluding non-cash charges associated with the modification of stock options, the company expects to record restructuring-related charges in the third quarter totaling approximately $7.4 million to $8.5 million.

Forest Laboratories and Gedeon Richter said that top-line results from a mid-stage trial of its experimental drug radiprodil for the treatment of neuropathic pain associated in diabetes patients failed to show statistically significant or clinically meaningful reductions in mean daily pain scores, the primary endpoint, compared to placebo for any of the dosages studied. The companies said they will review the complete study database over the coming weeks to determine the appropriate next steps regarding the development of radiprodil.

The U.S. Food and Drug Administration sent a warning letter to Australia-based CSL over problems at its flu vaccine plant and told the company it wants to meet with senior management to discuss its findings from an inspection. The letter from the FDA said investigators documented deviations from current good manufacturing practice requirements. Among the agency’s concerns was observed failures to investigate “unexplained discrepancies of a batch or any of its components to meet any of its specifications.”

Bristol-Myers Squibb has recalled samples of its blood thinner Coumadin because of inconsistency in the stabilizer used in the drug, Reuters reported. The company said that eight lots, or nearly 1.5 million tablets, have been recalled. The affected lots were only distributed as samples. BMS sent a letter to doctors June 25 announcing the recall of 1 mg tablets of blister-packed samples of Coumadin. Coumadin, also known as warfarin, is used to prevent blood clots.

The U.S. Food and Drug Administration warned Baxter Healthcare in a letter that an inspection of its renal division in McGaw Park, Illinois determined it failed to report adverse events of patients using its dialysis products in a timely manner. The agency also notified the company it failed to provide for internal systems that assure timely and effective identification, communication, and evaluation of events under medical device reporting requirements. The company has 15 days to inform the agency of corrective action it has taken.

AutoImmune said it filed a certificate of dissolution with the Delaware Secretary of State in line with its previously announced plan to liquidate the company. The biopharmaceutical company said as a result of such filing, the company has closed its stock transfer books and will discontinue recording transfers of its common stock.