Durect suffered a regulatory setback with the FDA rejection of its Posidur treatment for postoperative pain.
Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's Janssen unit complete response letters regarding use of the anticoagulant in ACS patients.
Pradaxa has become a bigger legal headache for Boehringer Ingelheim. The German drugmaker says it's facing more than 2,000 lawsuits in the U.S., filed by patients claiming the anticoagulant drug caused severe or fatal bleeding.
The FDA has rejected Durect's pain therapy Posidur, telling the biotech that investigators didn't provide sufficient data to prove that it could be safely administered. And regulators sent Durect back to the drawing board, instructing the company to do additional safety studies if it still wants to seek an approval for the drug, intended to ease postsurgical pain.
Five days after the FDA announced it would investigate the heart and stroke dangers of testosterone-enhancing drugs, 5 lawsuits were filed against Abbott Laboratories and its spinoff AbbVie by men who claimed they suffered heart attacks or strokes after using one of those products, AndroGel.
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.