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Tandem Diabetes Care Expands Recall

February 13, 2014

Tandem Diabetes Care expands its voluntary recall of select lots of insulin cartridges used with t:slim insulin pump.

EMA Clarifies New Variation Classification Categories

February 11, 2014

EMA and the European Commission revise Q&A document on implementation of marketing authorization guidelines.

European Medicines Agency Updates Seasonal Flu Vaccine Guidance

February 11, 2014

EMA releases an update on its flu vaccine guidance.

Mylan Launches First Trastuzumab Biosimilar in India

February 7, 2014

Mylan Pharmaceuticals launches Hertraz, the world's first trastuzumab biosimilar in India.

FDA Outlines Agenda for New Guidances in 2014

February 5, 2014

FDA plans to issue a number of new guidances in 2014 that will address drug development and manufacturing practices.

NIH, Biopharmaceutical Companies, Non-profits Work to Speed Validation of Disease Targets

February 4, 2014

NIH, 10 biopharmaceutical companies, and several nonprofit organizations form a partnership to develop new treatments earlier for Alzheimer's, type 2 diabetes, and autoimmune disorders.

Thermo Fisher Scientific Completes Acquisition of Life Technologies

February 4, 2014

Thermo Fisher Scientific outlines new business segments with acquisition of Life Technologies.

Edison Pharmaceuticals Enters Alliance with Dainippon Sumitomo Pharma

February 3, 2014

Edison and DSP partner to develop drugs targeting cellular energy metabolism.

ISPE CEO to Step Down at End of 2014

January 31, 2014

International Society for Pharmaceutical Engineering will continue strategic plan initiated by Nancy Berg; search begins for replacement.

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