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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.

FDA Releases Draft Guidance on ANDA Submissions

June 12, 2014

Draft guidance from FDA includes information essential for the completion of ANDA applications.

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.

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

FDA Creates Easy Access to FDA Public Data

June 3, 2014

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

AMRI to Acquire Oso Biopharmaceuticals Manufacturing

June 3, 2014

AMRI adds commercial-scale sterile injectable manufacturing capabilities with acquisition of Oso Biopharmaceuticals.

Repligen Acquires Bioprocessing Business of Refine Technology

June 3, 2014

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

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