Incyclinide demonstrated an excellent side effect profile similar to placebo. A clear dose-response relationship was also observed. While the study was not powered for statistical significance, incyclinide showed
The trial will specifically examine people with progressive hormone-refractory prostate cancer who have failed docetaxel-based regimens. The primary objective of the study is to determine if there is
The submission is based primarily on an improvement in overall survival observed in a phase III study. Prostate cancer is the most common non-skin cancer in the US
The inspection of the site began in late January 2007 and is related to an FDA Warning Letter received in May 2006 that raised several specific concerns about
Authors of the study have notified Bristol-Myers Squibb, which makes and sells entecavir under the brand name Baraclude. They have also informed the FDA so that prescribing physicians
Maraviroc is part of a class of drugs known as CCR5 inhibitors and works in a new way to existing therapies. The drug blocks the virus’ entry to
Thirty-eight patients with malignant melanoma were included in the US study and 53 patients with resected stage II/III melanoma were included in the European study. Sanofi-Aventis has worldwide
This decision was made after a meeting with the FDA, where the agency requested that Avanir supplement the new drug application for Zenvia with additional clinical data to
Under the terms of the agreement, Salix will also make up to $6 million in potential sales-based milestone payments to Merck. Pepcid is a prescription product indicated for
As many as 800 jobs could go including sales team employees Hiromitsu Iwasaki, the unit's president, told reporters. The reductions come as Pfizer has six drugs that are
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