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PXVX0200 uses the same attenuated vaccine strain (CVD 103-HgR) previously approved and marketed in several countries under the brand name Orochol. The company plans to submit a Biologics

The trial is designed to evaluate the safety and efficacy of ADXS-PSA as a monotherapy and in combination with Merck’s Keytruda, the first anti-PD-1 (programmed death receptor-1) therapy

The trial is designed to evaluate the safety of talimogene laherparepvec in combination with Merck’s FDA approved, anti-PD-1 therapy Keytruda, as well as the efficacy of this combination

As part of the deal, Merck will pay about $102 per share in cash, which represents a 35% premium to Cubist’s average stock price for the most recent

VAX2012Q incorporates a bacterial flagellin protein designed to improve the adaptive immune response to the vaccine. The trial is designed to evaluate the vaccine’s safety and immunogenicity in

The sNDA for a monotherapy indication is based on data from two double-blind, historical-controlled, multicenter randomized, Phase III trials (093-046 and 093-045) with identical study designs. The trials

The company said that Vimizim was reviewed under the Orphan Drug program and it is the first treatment approved in Australia for Morquio A syndrome, an ultra-rare, severely

Data for the recombinant factor VIII (rFVIII) product NovoEight® were presented at the 56th Annual Meeting of the American Society of Hematology (ASH). The post hoc analysis from

In one long-term study of pediatric patients with acute lymphoblastic leukemia (ALL), results showed that 36 of 39 pediatric patients with relapsed/refractory (r/r) ALL, or 92%, experienced complete