The letter follows a routine FDA inspection of GlaxoSmithKline’s (GSK’s) reporting processes conducted last year. The observations from the inspection primarily relate to omissions from periodic reports to
The Halo Research Platform is for basic research scientists in academia and other research institutions. The Halo Stem and Progenitor Cell, Quality Control (SPC-QC) and Halo-96 PQR (Potency,
The trial in healthy volunteers is being conducted in the UK to evaluate aerosol delivery by assessing lung distribution, pharmacokinetics and safety of inhaled treprostinil delivered by the
The Raven technology platform has generated well-characterized, high-affinity monoclonal antibodies to proteins on the cell surface that can be used to quickly identify and validate targets. The platform
The study will evaluate the efficacy and tolerability of APD125 in patients with primary insomnia characterized by difficulty maintaining sleep. The trial, which is expected to enroll a
Under the terms of the agreement, Achillion will pay to FOB a $500,000 upfront license payment, and FOB could also earn additional license and milestone payments of up
The activities associated with patient screening have commenced and the company expects to enroll the first patient during the second quarter of 2008. The goal of this Phase
Under the terms of the agreement, Iverson Genetics will use ParagonDx’s products to test patients to determine if they possess genetic traits shown to increase or decrease sensitivity
This new indication for Orencia provides significant evidence of its durable efficacy and long-term safety in pediatric patients, including those initiating biologic therapy for the first time. The
The allowed claims cover the use of antibodies reactive with CD74, the major histocompatibility complex (MHC) class-II invariant chain, Ii, of immune cells to deliver cancer and infectious
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