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news.FDA accepts Sciele’s reformulated heart drug for review
Sular is a calcium channel blocking agent for the treatment of high blood pressure. The new Sular formulation utilizes SkyePharma’s patented Geomatrix technology, which is designed to provide
Sular is a calcium channel blocking agent for the treatment of high blood pressure. The new Sular formulation utilizes SkyePharma’s patented Geomatrix technology, which is designed to provide
The FDA has also granted GTC permission to submit the associated biologics license application, or BLA, for ATryn on a rolling basis. Fast Track status speeds up the
Biovail Pharmaceuticals Canada (BPC), Biovail’s Canadian sales and marketing division, will introduce the features and benefits of Ralivia to health-care professionals throughout Canada. BPC anticipates launching Ralivia shortly.
The randomized, double-blind, placebo-controlled study of 410 adult patients with major depressive disorder achieved the primary endpoint of mean change from baseline in the Montgomery-Asberg Depression Rating Scale
The Phase I component enrolled patients at three centers in Canada and is evaluating the safety and feasibility of administrating nimotuzumab, a humanized monoclonal antibody that targets the
During the next several months the company plans to seek FDA approval to manufacture additional solid dosage products at the facility. By early 2008, the Goa facility is
The UK company said that only Daytrana packages with an expiration date of March 31, 2009 or earlier and Daytrana packages with lot numbers 2563511, 2563611, and 2570411
Abbott acquired the license agreement between Jerini US and Kos Life Sciences as part of the company's takeover of Kos Pharmaceuticals. After an in-depth review following the Kos
The submission is supported in part by data from a study that demonstrated the efficacy of Erbitux as a first-line treatment in metastatic colorectal cancer (mCRC) patients. The
The technical board of appeal of the European patent office (EPO) has affirmed the decision to revoke the claims of European patent 1093381 as granted to Pharmexa in