Archives for April 7, 2009

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USP effort to raise global standards reaches Russia

By Nick Taylor

The USP and Roszdravnadzor, a Russian public health body, are collaborating in an attempt to improve the standards of ingredients and finished products and reduce the availability of counterfeits.

FDA issues final guidance on ICH Q10

By Nick Taylor

The FDA has provided a model for implementing the ICH Q10 quality control system in its final guidance, which is intended help manufacturers adapt processes throughout a product’s lifecycle.

BioDuro to work with Roche on discovery chemistry

By Gareth Macdonald

Just weeks after expanding its relationship with AstraZeneca, Chinese CRO BioDuro has been asked by Swiss drug major Roche to help with its discovery phase R&D programme.

Shire to close Owings Mills Adderall XR plant

By Gareth Macdonald

Biopharmaceuticals firm Shire will cease manufacture at its plant in Owings Mills, Maryland, US with the loss of 260 jobs in the latest stage of its plan to wind up the in-house production of small molecule drugs.

CardioNet breaks into CRO sector with Biotel buy

By Phil Taylor

US company CardioNet, which specialises in mobile cardiac monitoring devices, has made a foray into the contract research sector with a $14m offer to acquire cardiovascular research firm Biotel.