Qiagen received FDA approval on June 24 under a full PMA for an assay that monitors the viral load of cytomegalovirus (CMV), a common virus that can be fatal to weakened immune systems, in organ transplant patients.
The FDA has sent a scathing warning letter to GlaxoSmithKline's influenza vaccine plant in Quebec City, Canada, saying it is not doing near enough to avoid contamination of products there. It said GSK has had ongoing problems with bacteria at the facility and had to reject a fifth of its production just this year.
The Center for Devices and Radiological Health, an affiliated FDA center, is proactively working to reduce the gender information gap plauging some clinical trials.
The Food and Drug Administration opted to use its enforcement discretion by not regulating mobile health app Abriiz from Ideomed. This case provides an early glimpse at how the agency will enforce its mobile medical app guidelines that were finalized just last fall.
The FDA has dealt a blow to the $1.6 billion testosterone supplement market, which includes the top-selling AndroGel, made by AbbVie. The drug labels must now include a general warning about the risk of blood clots in veins.
The FDA continued to build its patchwork quilt of social media guidance this week with the publication of two new draft documents, one of which is the long-awaited discussion on how to use Twitter. And while the guidance places significant constraints on how biopharma can use the platform, some think the clarity it brings will prompt companies to become more active tweeters.
Ranbaxy Laboratories, operating under the yoke of four FDA plant bans, has been unable to find a strategy that will allow it to launch three blockbuster for which it has exclusives. AstraZeneca's Nexium went off patent several weeks ago and Ranbaxy should have a generic on the market. That is because the plant where it makes the active pharmaceutical ingredient is banned from shipping product to the U.S. as is the plant where Ranbaxy was expected to make the formulated version.
Investors made an infusion of $64 million into Benvenue Medical on the heels of an FDA approval and U.S. launch of a new device earlier this year. In January, FDA approved its Kiva VCF Treatment System, an implant to treat vertebral compression fractures and the company launched the product in March.
The FDA has unveiled two more pieces of its social media guidance.
If approved, EnteroMedics' vagal nerve blocker would be the first new device to treat obesity in the U.S. in over a decade. But the FDA Gastroenterology and Urology Device panel narrowly voted against its Maestro System on the crucial issue of efficacy in a 4-to-5 vote on June 17.