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Vical Incorporated and Astellas Pharma Inc. announced topline results from a randomized, double-blind, placebo-controlled phase 2 study evaluating the safety and efficacy of cytomegalovirus (CMV) vaccine, ASP0113, versus placebo in kidney transplant patients receiving an organ from a CMV-seropositive donor. Results from the study demonstrated that the trial did not meet its primary endpoint, which was the proportion of patients having CMV viremia defined as a plasma viral load of = 1000 IU/ml by central laboratory assay through one year after first injection of study drug. Additionally, the secondary endpoints of CMV-associated disease and CMV-specific antiviral therapy, which were evaluated by an independent, blinded Adjudication Committee, were similar in both treatment groups.
Lannett Company, Inc., a company manufactures and distributes high quality affordable generic medications, announced that the US Food and Drug Administration (FDA) recently completed a cGMP inspection of the company's manufacturing facility in Philadelphia, as well as inspections of two facilities located in Armenia: Darmantest Laboratory, the company's pharmacokinetic subsidiary, and Firmplace, a stability laboratory with which the company has a strategic relationship. The inspections concluded with two minor 483 observations at the company's facility in Philadelphia and zero observations at the laboratories in Armenia.
Lannett Company, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, the therapeutic equivalent to the reference listed drug, Suboxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg. According to IMS, total U.S. sales in 2015 of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg and 8 mg/2 mg, at Average Wholesale Price (AWP) were approximately $270 million.
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