Archives for January 5, 2009

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CMOs fall foul of FDA regulations

By Phil Taylor

Two contract manufacturing organisations PrimaPharm have been cited by the US Food and Drug Administration for not adhering to Good Manufacturing Practice standards.

Synthesis of aromatic polyketides in E. coli solved

By Phil Taylor

US researchers have for the first time synthesised an important class of drug compounds - the aromatic polyketides - in Escherichia coli, a bacteria widely used in microbial production.

$10bn savings from follow-on biologics; CBO report

By Nick Taylor

Implementation of an abbreviated approval pathway for follow-on biologics could result in savings of almost $10bn over a decade, according to a report from the Congressional Budget Office (CBO).

Recipharm firms up French position

By Gareth Macdonald

Recipharm hopes that its new tablet and capsule manufacturing facility in Fontaine-Les-Dijon, France, which significantly expands its dry powder production capacity, will help it broaden its European client base.

Consortium formed to improve QbD software

By Nick Taylor

Blue Reference has formed a Quality by Design Product Development Consortium (QbD PDC) to provide a forum for the improvement of its process analytics software.

Perceptive licenses EQ-5D for use in ePRO

By Nick Taylor

Perceptive Informatics has gained the right to use EQ-5D, which will allow the company to offer clinical study sponsors the option to collect health-related quality of life outcomes using a telephone.