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news.Osiris wins Canadian approval for Prochymal expanded access program
Under the expanded access program, children two months to 17 years in age inclusive with Grades B-D acute graft versus host disease (GVHD) not responsive to steroids are
Under the expanded access program, children two months to 17 years in age inclusive with Grades B-D acute graft versus host disease (GVHD) not responsive to steroids are
The company has reported results from two identically designed, randomized, double blind, placebo-controlled global studies. Patients with an established diagnosis of uncontrolled partial onset seizures (POS) for one
The study, initiated in September 2008, was a blinded, placebo-controlled study in 32 healthy volunteers which studied multiple ascending doses up through the highest planned dose of 1800mg.
The application for the marketing authorization for nimotuzumab was submitted to the European Medicines Agency on October 4, 2007. At the time of the withdrawal it was under
The preliminary analysis of the safety data showed that the combination of four drugs was generally well tolerated in patients who had received no prior therapies and response
According to the company, patients receiving Promacta were eight times more likely than those on placebo to maintain platelet counts between 50,000 to 400,000/microliters during a six-month treatment
No new safety signals were observed in either of these studies and the safety profile was consistent with previous experience with Rituxan, the company said. In CLL8, patients
The reported data are from a Phase I trial of XL019 in patients with advanced primary myelofibrosis, or with advanced myelofibrosis occurring post-polycythemia vera or post-essential thrombocythemia. This
The objective of the multinational study was to assess the safety of four dose regimens of DU-176b in patients with non-valvular atrial fibrillation (AF), as compared to warfarin.
The Phase III global study will compare DU-176b with warfarin in preventing stroke and systemic embolic events in patients with atrial fibrillation. The primary safety assessment will be