On Sept. 22, The Pink Sheet, a medical trade publication, reported the FDA had said that Pfizer received an "approvable letter" from the FDA. Such letters are not approvals but instead a kind of delay, saying that most of the data needed for approval are in but that additional steps need to be taken if the drug is to reach the market.
An FDA panel backed the drug, but then a series of experts wrote letters to the FDA arguing that the data were not adequate for approval.
For the moment, most Wall Streeters believe an approval for the Anchor study data could come in late 2013 or early 2014.
In light of legitimate privacy concerns and the absence of any emergency or extraordinary considerations here, the Court concludes that approval of use of location data for this purpose is best considered deliberately in the legislature, or in the appellate courts.
FORBES: Police Can't Ask Your Mobile Phone Where You Are In Order To Arrest You
Its acne drug Velac seemed a sure thing for federal approval following positive Phase III data.
And the downside to the stock if the FDA does delay approval by asking Dendreon for more data is probably much bigger than any potential gain.
Though some of these medicines work spectacularly, it is worrisome that many biotechs now seem to expect early FDA approval for their drugs despite scanter data.
Because most small-molecule drugs can be manufactured with easily replicable chemical processes that lead to a largely reproducible drug formulation, the clinical trial data that supported approval of the original version can be relied upon for the generic versions.
But instead of acknowledging that all the data is positive, and Avastin still squarely meets the standards for Accelerated Approval, and waiting for the longer, larger OS trial it now says it wants, FDA did what it always does, simply forcing its decision (a bad one) by imposing its power to do so on the sponsor and patients.
FORBES: FDA Did the Right Thing in Pulling Avastin for Breast Cancer
Elizabeth French, the Data Protection commissioner, objected strongly to the idea of relying on in-house approval for their use.
More than 800 companies were awaiting regulatory approval for new listings as of Dec. 20, according to official data.
King notes that Genentech had always said it hoped to receive approval from the U.S. Food and Drug Administration for the colorectal cancer data, not the breast cancer data.
Nissen then walked through a series of slides arguing diabetes drugs are approved with almost no long-term data in patients with heart disease--even though, after approval, heart patients get the drugs for a long time.
Approval for an expanded European bailout fund from Germany and modestly upbeat U.S. economic data set loose a rally on Wall Street Thursday, but with less than two hours left in the session stocks were back in the red.
FORBES: Germany's Green Light For Bigger EFSF Gives Market Short-Lived Tonic
应用推荐