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news.FDA accepts Addrenex’s new drug application for CloniBID
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 19, 2008. Upon FDA approval, Sciele expects to launch this product in early 2009.
The FDA has assigned a Prescription Drug User Fee Act (PDUFA) date of December 19, 2008. Upon FDA approval, Sciele expects to launch this product in early 2009.
Using current methods, detection can only be done by taking regular bone marrow aspirates, which are typically very painful to extract for the patient. The program is planned
The primary objectives of the Phase Ia trial were to examine the safety, tolerability and pharmacokinetics of RVX-208. This study successfully met those objectives. In addition to the
The consideration for the acquisition of Advanced Medical Partners (AMPI) included both cash and stock that was paid at closing, as well as a potential earn out. The
The patents cover design and methods for creating integrated fluidic microchip devices. Microchip Biotechnologies (MBI) will use the technology licensed from GE Healthcare to develop and commercialize easy
The product will be marketed by Taro’s US affiliate, Taro Pharmaceuticals USA. Taro’s cetirizine oral solution is bioequivalent to McNeil Consumer Healthcare’s Zyrtec oral solution. Cetirizine oral solution
The total value of the transaction, including payment of Restore Medical debt will be approximately $29 million. The transaction, which is anticipated to close within 90 days, is
The primary endpoint of the study was the change in International Prostate Symptom Score (IPSS), the standard method of assessing benign prostatic hypertrophy (BPH) symptoms. Secondary endpoints included
The approval of Cimzia was based on safety and efficacy data from clinical trials in more than 1500 patients with Crohn’s disease. Each pivotal study demonstrated that a
Under the agreement, a subsidiary of GlaxoSmithKline (GSK) will commence a cash tender offer to purchase all of the outstanding shares of Sirtris, at $22.50 per share followed