Archives for November 24, 2008

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ProImmune service spikes immunogenic biologics

By Phil Taylor

UK company ProImmune has launched a suite of services to help drugmakers determine at an early stage whether a biologic drug will elicit an immune response in humans.

Encorium delays financial results

By Phil Taylor

Clinical research organisation Encorium has postponed the release of its third quarter results but said it still expects the figures to be in line with its most up-to-date guidance.

FDA publishes guidance on process validation

By Nick Taylor

The US Food and Drug Administration (FDA) has issued draft guidance on process validation, updating its 1987 document to incorporate advances in manufacturing technology and thinking.

Jubilant buys into EDC sector

By Phil Taylor

India’s Jubilant Organosys has bolstered its mid-range contract research portfolio by buying Canadian electronic data capture (EDC) specialist TrialStat ClinicalAnalytics.

Orbus ducks out of contract manufacturing

By Phil Taylor

Canada’s Orbus Pharma has decided to exit the contract manufacturing business, saying that the division “posed a distraction to the core business and generated low or negative margins.”

DPT highlights R&D prowess at AAPS 2008

By Gareth Macdonald

DPT Laboratories chose this year’s AAPS in Atlanta to showcase its research and development capability with a unique poster presentation examining the role of various excipients in nasal drug delivery applications.

Raw material contamination a hot topic at AAPS

By Nick Taylor

The pharmaceutical industry’s vigilance in ensuring the safety of raw materials was criticised at this year’s AAPS, with significant, challenging alterations needed to improve the system.