The complete response addresses the FDA approvable letter received in March 2008 related to the ceftobiprole new drug application (NDA) for the treatment of complicated skin and skin
Coartem, a fixed-dose combination of two antimalarials, is said to be a highly effective three-day malaria treatment that according to studies achieves cure rates of over 96% even
In the two Phase III clinical trials, patients were randomly assigned to treatment with Botox or placebo injections every 12 weeks. The primary analysis was performed at week
The MDS study is designed as a protocol amendment expanding the ongoing Phase II trial of sapacitabine in elderly patients with acute myeloid leukemia (AML) to include a
The study is a randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, tolerability and efficacy of daily TT-223 treatments for 12 weeks with a six-month follow-up. Approximately
In total, the agreement grants rights to Menarini for Ranexa in 68 countries, including the 27 countries of the EU, the Commonwealth of Independent States, and select countries
Valeant has received approximately $425 million in cash from Meda at closing, which is subject to certain closing adjustments. Goldman, Sachs & Co served as financial advisor to
According to the company, the implantable monitor enables physicians to evaluate heart rhythm signals over a longer period of time than allowed by standard monitoring tests, and is
The patent, which is expected to issue on September 16, 2008, relates to the company’s proprietary processes for manufacturing a broad range of prescription and over-the-counter products with
The multi-center support study evaluated the safety and efficacy of the company’s patch in 170 subjects with pain due to acute, mild-to-moderate ankle sprains. The study achieved statistical
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