Archives for September 22, 2009

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Teva further streamlines ops with Czech plant closure

By Gareth Macdonald

Israeli generics giant Teva Pharmaceutical Industries will close one of its manufacturing plants in the Czech Republic by the end of the year, resulting in the loss of around 400 jobs.

Florida Biologix wins ASC-101 contract

By Gareth Macdonald

US CMO Florida Biologix (FB) says its new contract with America Stem Cell (ASC) shows that demand for trial-phase biologics manufacturing is starting to recover.

FDA EOP2A guidance aims to boost trial success

By Nick Taylor

The FDA is hoping to increase the likelihood of a clinical trial being successful by making best use of science and alternative study designs and has issued end-of-Phase IIa (EOP2A) meeting guidance to explain the process.

CROs alter IRB selection policies after GAO sting; VP

By Nick Taylor

The GAO sting operation and subsequent increased scrutiny will “definitely change how pharma and CROs choose IRBs”, according to the VP of NEIRB who spoke to Outsourcing-Pharma after successfully completing a FDA audit.