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Glenmark Pharmaceuticals Opens Monoclonal Antibody Manufacturing Facility

June 12, 2014

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

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FDA Releases Draft Guidance on ANDA Submissions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Draft guidance from FDA includes information essential for the completion of ANDA applications.

EMA Changes Guideline on Drug Name Acceptability

June 4, 2014

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

Sartorius Stedim Biotech Launches New Generation of Single-Use Bags, Flexsafe

June 4, 2014

Innovative polyethylene film sets new benchmark

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.

Roche Acquires Genia Technologies

June 4, 2014

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

Repligen Acquires Bioprocessing Business of Refine Technology

June 3, 2014

Repligen acquired Refine Technology and its Alternating Tangential Flow system for continuous bioprocessing.

FDA Creates Easy Access to FDA Public Data

June 3, 2014

FDA launches openFDA to provide easy access to FDA public data.

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