Israel's Oramed touted results from a successful Phase IIa trial of its insulin pill, saying the oral Type 2 diabetes treatment is safe and well-tolerated. But since then, some analysts and media outlets have criticized the company for being less than forthcoming about the data.
When the FDA began drafting plans to meet Congress' drug safety legislation, the agency predicted that postmarket surveillance would ultimately become as big a task as premarket review. Since then, the system those plans spawned--named Mini-Sentinel--has given credence to the prediction by growing to cover more than 160 million patients.
The FDA has been monitoring the stroke and heart risks of testosterone-enhancing drugs, which have become popular among baby-boomer men trying to hold onto their middle-aged vitality and sexual performance. Now, in light of two recent studies, the agency has "decided to reassess this safety issue."
Two patients died of sepsis in a Phase II trial of Progenics Pharmaceuticals' in-development prostate cancer treatment, spurring concern that the drug is too toxic to merit further study and sending the biotech's shares down as much as 30%.
The Natural Resources Defense Council, a longtime critic of the FDA's oversight of feed additives, analyzed a slew of FDA documents and found that the FDA's own scientists found 18 farm antibiotics posed a "high risk" of spawning antibiotic-resistant bacteria.
When new drugs roll out, they meet the general population for the first time. Patients are no longer hand-picked as they are in clinical trials. And that often translates into a flurry of side-effect reports to the FDA. Last year's crop of new drugs is no exception.
Evoke Pharma showed in a recent study that its nasal spray for the delivery of a generic gastrointestinal drug performed better than the traditional oral form. The nasal delivery method could help patients take the drug when they are suffering from nausea and have difficulty swallowing a pill.
Pennsylvania's high court put drug design-defect claims on the menu for patients looking to sue for damages. In a closely watched case against Pfizer's Wyeth unit, the state Supreme Court reinstated claims that the company negligently designed and marketed a diet pill, Redux, that's now withdrawn from the market.
The FDA dashed Amag Pharmaceuticals' hopes for its anemia drug Feraheme. The agency rejected Amag's application for broader use of the treatment for iron deficiency, citing a lack of evidence of its safety.
German devicemaker Biotronik launched its Passeo-18 Lux drug-releasing balloon in Europe, backed by stellar results.