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Shire filed a Biologics License Application (BLA) for Replagal in December 2009. The FDA requested additional human pharmacokinetic data to confirm comparability between product that was manufactured in

The initiative involves two interrelated scientific disciplines: translational science, the shaping of basic scientific discoveries into treatments; and regulatory science, the development and use of new tools, standards

WuXi produces solid oral dosage forms-tablets and capsules-for use in clinical trials in its Shanghai c-GMP manufacturing facility. In its analytical testing facility, WuXi develops and validates methods

Reportedly, Arena has submitted Lorcaserin NDA on December 22, 2009, and expects to learn the Prescription Drug User Fee Act (PDUFA) date in the next few weeks. The

Revovir is a Nucleoside Reverse Transcriptase Inhibitor (NRTI). It exerts anti-hepatitis B virus (HBV) effects by inhibiting DNA polymerase, the enzyme that is necessary for the virus to

Brenntag said that the new warehouse in Thailand enables it to separate storage of pharmaceutical as well as food products. Reportedly, the Brenntag team composed of 15 employees

In BD FACSAria III Cell Sorting System the gel coupled cuvette in the flow cell ensures that the system’s lasers are focused precisely on the sample stream and

Under the collaboration, FivePrime identified multiple potential therapeutic targets through screening its comprehensive proprietary protein library in cell-based assays that were focused on therapeutic pathways underlying specific immune

The randomised, controlled, open-label Phase 3 trial, conducted under a Special Protocol Assessment (SPA) and Fast Track designation, had enrolled 903 patients with Stage IIIb/IV NSCLC, which includes