News

The special protocol assessment (SPA) process allows for FDA evaluation of a clinical trial protocol intended to form the primary basis of an efficacy claim in support of

AeroLEF is being developed as a novel and effective approach to the management of acute pain by delivering a proprietary formulation of inhaled, nebulized, free-and-liposome-encapsulated fentanyl. The free

There are two pivotal studies running in parallel, one in North America and one in Europe. Each is a multicenter, randomized, double-blind, placebo-controlled efficacy study recruiting a total

This was achieved during the final comparative gene selection work carried out by Ark’s scientists in Finland in a second preclinical therapeutic proof-of-principle study. EG011, containing shortform vascular

Stem Cell Sciences (SCS) will incorporate the green fluorescent protein (GFP) technology, which acts as a gene expression marker, into its SC Proven research reagents portfolio as well

This regulatory approval expands the types of patients that can be treated with radiosurgery. As a result of this approval, the CyberKnife system may be used in Japan

This trial is a 14-patient, single-arm, open-label, dose-targeted, non-randomized trial of Reolysin given intravenously in combination with a standard dosage of paclitaxel and carboplatin. Eligible patients include those

Under the terms of this agreement, Hisamitsu will obtain a manufacturing and sales approval for the product, and the two companies will subsequently carry out joint sales activities.

As per the FDA’s special protocol assessment process, the study was powered to detect an 8% reduction in visceral adipose tissue (VAT) versus placebo. The study met its