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news.Roche’s oral cancer drug effective over intravenous chemotherapy
This treatment also results in fewer days spent in hospital to manage adverse events when compared to intravenous therapy. The report is published in Annals of Oncology, which
This treatment also results in fewer days spent in hospital to manage adverse events when compared to intravenous therapy. The report is published in Annals of Oncology, which
The updated clinical data from the pivotal international Phase III trial reported median time-to-disease progression (TTP) in patients receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus
The transaction represents Haemonetics’s third blood management-related acquisition in 2007. Chris Lindop, CFO of Haemonetics, said: “The TEG business acquisition is strategic and strengthens our vision of being
Avexa will move forward with two pivotal clinical trials which have been reviewed and will form the basis for future approval. The end point of the trials will
The company will be able to use these newly patented components to manufacture an optimized vaccine against beta-amyloid, the peptide responsible for the onset of Alzheimer’s disease. The
Focalin XR is manufactured by Elan Holdings for Novartis Pharmaceuticals. Barr filed its abbreviated new drug application (ANDA) containing a paragraph IV certification for a generic Focalin XR
The acceptance for review is an indication that the FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes
The decision was based on preliminary safety data, in which a clinical safety finding of QTc prolongation was observed in one patient. The drug, MK-0457, is being investigated
This supplemental new drug application (sNDA) approval is based on results from two six-week, double-blind, randomized, placebo-controlled, multicenter studies. The results demonstrated significant improvement in depressive symptoms in
This decision follows Delcath’s meeting with representatives of the FDA, along with the principal investigator at the National Cancer Institute (NCI). Resumption of study accrual follows a voluntary