More than 13, 000 patients have been enrolled in one study to test the drug's safety and efficacy for an application with the Food and Drug Administration.
Merck today withdrew its application with the Food and Drug Administration for Arcoxia, its next-generation painkiller.
Pfizer then withdrew that use from its application after a Food and Drug Administration audit found dozens of discrepancies in its trial records.
Dendreon said today that it is planning to file an application with the Food and Drug Administration to have its cancer vaccine, Provenge, approved.
Dendreon (nasdaq: DNDN - news - people ) said today that it is planning to file an application with the Food and Drug Administration to have its cancer vaccine, Provenge, approved.
The updates are designed to address shortcomings and inconsistent application of the current rules through increased simplification and cutting administration costs.
But the actual hosting of the application, the actual requirements for that application to exist in a cloud environment, to connect to the virtualized resources and whatever administration tools the cloud providers may give you to configure and maintain the application, will be, for the most part, controlled by the cloud provider.
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The next day ImClone announced that the U.S. Food and Drug Administration had rejected its application for the approval of its Erbitux cancer drug, the one product in its pipeline, causing a steep decline in the share price.
Genentech has finished filing its application with the U.S. Food and Drug Administration to sell Avastin as a treatment for colorectal cancer.
Optimer, a San Diego-based company with no marketed products, completed a marketing application to the U.S. Food and Drug Administration on Nov. 30.
Last week, Merck withdrew an application with the U.S. Food and Drug Administration for a new drug that many hoped would revive its sagging arthritis franchise.
Merck will submit an application to the U.S. Food and Drug Administration by the end of the year, and if all goes well, the drug could be approved six months later.
This morning, Roche announced that the Food and Drug Administration refused to consider the application for the TDM-1 breast cancer drug based on technology that it licensed from Immunogen, a Waltham, Mass. biotechnology company.
Those numbers mirror the results ImClone boasted of in 2001, before the U.S. Food and Drug Administration rejected a new drug application on the grounds that the data were not sufficient to prove that Erbitux worked.
Northfield is currently in the data analysis stage with PolyHeme and expects to report top-line trial data in the fourth quarter of this year, followed by filing its biologic license application with the U.S. Food and Drug Administration in the first half of 2007.
In fact, a supergeneric will sometimes need a completely new drug application in order to gain approval from the Food and Drug Administration (FDA).
Pfizer also said this morning that the Food and Drug Administration refused to accept a new drug application for an experimental medicine the company got from its acquisition of FoldRx.
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The new application is similar to the previous one that the Food and Drug Administration refused to consider, insiders say--but with the crucial addition of positive new trial results from Germany's Merck KGaA .
An application should be filed with the U.S. Food and Drug Administration by the first half of next year.
Mark Karvosky, a biotechnology analyst at Piper Jaffray, wrote in a note to investors that he expects the application to be filed with the U.S. Food and Drug Administration in June or July.
"'We the People' is just part of the administration's commitment to open government and the code powering the application has been made available to anyone, including other countries, who wish to set up a similar system, " White House spokesman Matt Lehrich said.
On the horizon, Novartis just submitted a new drug application for an arthritis drug, Prexige, to the U.S. Food and Drug Administration.
Geron has submitted a 22, 000 page submission to the Food and Drug Administration - the body which approves clinical trials in the US - the largest application on record.
In December, the Food and Drug Administration rejected ImClone's (nasdaq: IMCL - news - people ) application to sell Erbitux.
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