Mounting cost pressures, a vast pool of talented scientists in other nations around the world and increasingly abundant opportunities for collaboration with other companies in emerging markets have spurred Western pharmaceutical companies to shift much of the manufacturing operations and clinical-trial work to India and China.

A recent article in the New England Journal of Medicine by researchers from Duke University raises concerns over the increased globalization of clinical trials and the need to strengthen regulation to address this phenomenon. As pharmaceutical companies conduct more trials abroad as part of overall cost-saving measures, such a finding has implications for all stakeholders—patients, suppliers, and the drug companies themselves.

Indian Council of Medical Research (ICMR) and International AIDS Vaccine Initiative are now gearing up to carry out the phase-I study of a combination vaccine for Human Immunodeficiency Virus (HIV) in the country. The combination vaccine is ADAX and TBC-M4. The trials will be undertaken at the National AIDS Research Institute, Pune and at TB Research Centre, Chennai.

Biogen Idec and Elan Corporation, plc announced five-times as many multiple sclerosis (MS) patients taking Tysabri (natalizumab) were free from disease activity versus placebo in the overall patient population. Results from this retrospective analysis showed that two years after beginning treatment with Tysabri, 37 per cent of patients remained free of disease activity, compared to seven per cent of placebo-treated patients. Sixty-four per cent of patients showed no sign of relapse or sustained disability progression and 58 per cent were free of radiological disease activity. Both of these measures were used to define freedom from disease activity in this analysis of the AFFIRM clinical trial. These data were published online today and in the March 2009 issue of The Lancet Neurology.