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More clinical trial data addressing the exacerbation benefit is expected to be reported later in 2013.
The Food and Drug Administration told Bristol-Myers Squibb yesthatay that it must conduct at least one more clinical trial before the agency will consider approving its hypertension drug Vanlev.
A brief hiccup in the discussions occurred recently when Amgen demanded to see more clinical trial data on Kyprolis, people briefed on the discussions have said.
However, more clinical trial data with adequately-powered, well-designed and advanced methodology will be mandatory to conclude whether ALC as a monotherapy or augmentation agent may be efficacious and clinically beneficial for depression.
The company is arguing that even if the F.D.A. reaffirms that data do not support Avastin's effectiveness, the approval should be retained while Genentech does one more clinical trial.
Drug companies have been under pressure to release more clinical trial data since revelations that they kept information from antidepressant and other drug trials secret.
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It has more clinical trials than any other country.
It said the Food and Drug Administration was requiring more clinical trials before any approval of two painkiller medicines.
The top five American hospitals together conduct more clinical trials than any entire European country.
Approval from the US Food and Drug Administration will be sought for nanosuturing in dermatology with more clinical trials planned.
What's more, clinical trials still rely on sometimes outdated metrics.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com