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news.FDA delays approval of Prestwick drug
The approvable letter specifies conditions that the company must meet prior to obtaining approval to market Xenazine (tetrabenazine) in the US. In this letter, the FDA also indicated
The approvable letter specifies conditions that the company must meet prior to obtaining approval to market Xenazine (tetrabenazine) in the US. In this letter, the FDA also indicated
The acquisition follows similar, recent strategic moves by Ranbaxy in Romania and Italy, and will allow Ranbaxy to anticipate local market dynamics and capitalize on the changing business
Specifically, the companies are seeking approval for the use of the drug as a treatment of previously-untreated patients with low-grade or follicular, CD20-positive, B-cell non-Hodgkin’s lymphoma (NHL). The
A study of Vical’s influenza DNA vaccine, formulated with the company’s patented Vaxfectin adjuvant, protected mice against lethal challenges with two different strains of human influenza virus. The
The company said that it anticipates having initial results from this study available by mid-2007 and anticipates at least one long-term safety study and one additional pivotal study
The potential indication is for the treatment of metastatic colorectal cancer in patients who have failed prior chemotherapy, including oxaliplatin and/or irinotecan containing regimens. The rolling biologic license
The first trial, which has recruited 400 healthy adult volunteers in Germany, is testing a pandemic flu vaccine using a classic alum adjuvant to improve individuals’ immune response
The study has been designed as two-stage trial for third- and fourth-line treatment of colorectal cancer patients. In this investigation, patients with colon cancer, which has spread despite
The primary objective of this open-label study is to demonstrate an improvement in overall survival. Secondary objectives are evaluation of safety, overall response rate, time to progression, and
The drug candidate, called PTC124, was granted orphan drug designation for the treatment of Duchenne muscular dystrophy (DMD) in December 2004. PTC124 is currently in phase II clinical