Publicly disgraced after cardiologist Steven Nissen and his colleagues unveiled data on its cardiovascular risks in 2007, Avandia was withdrawn in Europe and put under tight rein in the U.S. Now, the FDA is revisiting the issue, and Nissen himself has issues with that.
The agency has given the coveted status to the Lexington, MA-based biotech company's experimental treatment for use against early onset lysosomal acid lipase deficiency, an inherited disorder that typically kills infants within the first 6 month of life, according to the company.
FDA staffers found clear evidence to prove that Merck's blockbuster drug candidate suvorexant is quite effective in promoting sleep, but the internal review cites multiple safety issues for the high doses studied in clinical trials.
The pivotal study for SAR302503 nailed the primary endpoint for the proportion of patients with a greater than 35% reduction in the volume of their spleens, which become enlarged as a result of abnormal blood cell production.
The FDA cast a wider net this year as it sent inspectors into what it called 30 "high risk" compounding pharmacies, those that made sterile drugs that can easily be contaminated. The attack has had a pronounced effect on the number of recalls the agency has ordered.
Hospira is back in the FDA's spotlight as the agency issued another warning letter over problems in the company's infusion pump manufacturing, this time targeting the device Hospira hopes to carry it back to revenue growth.
The approval comes just three months after the FDA granted priority review status for Alpharadin, a radiopharmaceutical from Bayer and Norway's Algeta that will now enter an increasingly competitive--and growing--market.
Just a few months after Leona Brenner-Gati was named Acting Deputy Commissioner for Medical Products and Tobacco to replace the outgoing Steven Spielberg, who served only a brief stint at the post, Brenner-Gati is gone as well.
A revolving door inside the FDA has captured the attention of a group of Republican lawmakers in Congress. Just a few months after Leona Brenner-Gati was named Acting Deputy Commissioner for Medical Products and Tobacco to replace the outgoing Steven Spielberg, who served only a brief stint at the post, Brenner-Gati is gone as well.
The India-based generics maker pleaded guilty to U.S. drug safety violations and agreed to pay $500 million in penalties, in the largest-ever federal settlement with a maker of copycat drugs.