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ISPE Announces Quality Metrics Pilot Launch

June 17, 2014

ISPE Metrics Pilot Program is designed to demonstrate the feasibility and value of standard quality metrics.

FDA Licenses First US Facility for Cell-Culture Influenza Vaccines

June 16, 2014

Novartis facility becomes the first US site licensed by the FDA to produce cell-culture influenza vaccines.

Research Firm Predicts Negative Impact of Biosimilars

June 12, 2014

A new report from GlobalData states that biosimilars will overtake the market share after 2019.

FDA Releases Draft Guidance on ANDA Submissions

June 12, 2014

Draft guidance from FDA includes information essential for the completion of ANDA applications.

Total Facility Solutions Opens Hygienic Fabrication Center

June 12, 2014

The fabrication facility will supply modular construction to the US life-science market.

Glenmark Pharmaceuticals Opens Monoclonal Antibody Manufacturing Facility

June 12, 2014

The new mAb manufacturing facility in Switzerland will supply material for clinical development.

Wockhardt Cited by FDA for Quality Control Failures

June 4, 2014

FDA issues a Form 483 to Wockhardt for quality issues at Morton Grove, IL facility.

EMA Changes Guideline on Drug Name Acceptability

June 4, 2014

EMA publishes revised guideline on the acceptability of names for drugs.

Roche Acquires Genia Technologies

June 4, 2014

Genia's DNA-sequencing platform will strengthen Roche's pipeline.

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