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US FDA slams two Chinese API makers for quality systems and data issues

Quality system and data integrity issues have landed two Chinese API makers with US FDA warning letters.

“There are units that are doing first-in-human studies that frankly have no business doing them”

DIA: Calls for set standards in Phase I studies following Bial trial tragedy

Set standards for Phase I trials could stop serious adverse events and patient deaths, says a DIA panellist discussing the recent Bial trial tragedy.

Yellow fever outbreak: Sanofi looks to double vaccine production

A recently opened facility will double production of Sanofi Pasteur’s vaccine Stamaril which could alleviate shortages in the wake of recent yellow fever outbreaks in parts of Africa.

Brexit: Indian firms worried but Big Pharma and EMA remain positive for now

Worried and bewildered: Brexit sparks uncertainty for Indian pharma in Europe

Indian companies in the UK are among many in the pharma industry facing an uncertain future after Britain voted to exit the single-market last week.

Swissmedic ramps up ad hoc inspections in 2015

The Swiss drugs regulator saw a near-doubling in the number of inspections prompted by complaints or suspected infringements in 2015, according to its latest annual report.

Also: Qiagen completes tender offer for Exiqon

Agilent Technologies to acquire assets of iLab Solutions

Agilent Technologies has acquired the assets of a cloud-based laboratory management software firm.

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