Archives for September 15, 2009

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Quintiles: “something needs to change in the industry”

By Nick Taylor

Quintiles believes there is a “dire need” for trial sites that can raise standards and reduce inefficiencies in the clinical research process and is expanding its Prime Site programme to meet this demand.

Vaccine growth and single-use systems boost Pall in ‘09

By Nick Taylor

Revenues from Pall’s biopharmaceuticals division grew in fiscal 2009, excluding foreign currency changes, with the company benefiting from the “thriving market” for vaccines and expanding adoption of single-use systems.

FDA approves four H1N1 swine flu vaccines

By Nick Taylor

The FDA has approved four H1N1 vaccines, made by CSL, AstraZeneca, Novartis and Sanofi-Aventis, that will be distributed in the next four weeks as part of the US’ swine flu preparation.

Virtify launches on-line data disclosure solution

By Gareth Macdonald

Virtify says the new online version of its Virtx CTRR system can help drugmakers comply with the increasingly complex disclosure rules that regulators worldwide apply to clinical trials, in an automated approach that saves time and money.

Welcome, here’s a warning letter; Dekkers named as Bayer CEO

By Gareth Macdonald

News of Bayer’s selection of ex-Thermo Fisher Scientific boss Marijn Dekkers as its CEO was somewhat overshadowed by a new FDA warning letter about quality testing at its manufacturing facility in Bergkamen, Germany.

PPD adds new lab in Singapore

By Gareth Macdonald

US contract research organisation (CRO) PPD has set its sights on the Asian biopharma sector with new a lab at the heart of Singapore’s rapidly expanding drug development and trial industry.