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news.DeCode and FDA agree on phase III cardio trial design
The special protocol assessment (SPA) enables DeCode to proceed with the recruitment of participants for the phase III trial. The SPA is an agreement between the FDA and
The special protocol assessment (SPA) enables DeCode to proceed with the recruitment of participants for the phase III trial. The SPA is an agreement between the FDA and
The investigators concluded that OGX-011 in combination with the chemotherapeutic agents was well tolerated at the doses studied and most toxicities were typical for gemcitabine/cisplatin. The one-year survival
The melanoma (skin cancer) trial is designed to evaluate the safety and efficacy of Nexavar when co-administered with chemotherapy, and has progression-free survival as its primary endpoint. Approximately
Biogen Idec is to acquire all shares of Conforma for $150 million, payable at closing, and up to an additional $100 million upon the achievement of certain development
In it approvable letter regarding the new drug application for the drug, the FDA requested that the company, prior to receiving approval, provide additional clinical data and some
The initial trials are designed to establish the safety of Neumune in this population, and to help identify the optimal patient subsets for further study in phase II
Now that the FDA has given its approval for the drug, MGI Pharma will waste no time in making it available to patients with a commercial launch expected
Although Biovail will begin promotimg the 3.6mg dosage of the drug, AstraZeneca will continue to manufacture and supply all quantities of Zoladex. Endometriosis is a painful, chronic disease
The test will examine the safety and pharmacokinetics of Siga-246 at different dosages in healthy volunteers. The company said that it expects to collect all of the data
The US Centers for Disease Control (CDC) is studying Bausch’s ReNu MoistureLoc solution, which was voluntarily removed from the market earlier this year, as part of its investigation