EMA posts draft guidelines on transgenic animal production
The EMA has published draft guidelines on ensuring drug quality when producing APIs in transgenic animals.
Archives for June 3, 2012
Table in mix up was only use of relative data by vendor; Vertex
The table that caused shares in Vertex to plunge last week was the only use of relative data in the third-party analysis, the biotech’s CEO said.
WuXi calls theft of two client compounds an “isolated case”
WuXi PharmaTech has called the theft of two compounds by an employee an “isolated case” and said it is upping oversight.
Catalent sells US packaging biz, focuses on formulation
Catalent has sold its US commercial packaging business to Frazier Healthcare as part of plans to focus on “innovative pipelines”.
EXCLUSIVE
GDUFA means a level playing field for generics makers, says SOCMA
The new Generic Drugs User Fee Act (GDUFA) means a “level playing field” for drugmakers, according to SOCMA members.
Aptar to enter injectable device components with €165m buy
AptarGroup is buying Stelmi for €165m ($205m) to expand into primary packaging components for injectable delivery devices.