Pharmaceutical Technology Editors

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

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

Alexion initiates a voluntary nationwide recall of certain lots of soliris (eculizumab) concentrated solution for intravenous infusion because of visible particulate matter in a single lot.

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

Aastrom acquires Sanofi's CTRM business unit for $6.5 million.

PharmaCell has finalized its purchase of the cell therapy production facility from TiGenix.

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

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

Provence Technologies? strengthens its expertise in therapeutic chemistry with acquisition of Synprosis.

Bend Research installs its first commercial-scale spray dryer at its Oregon facility.

DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.

John Hopkins and UCSF-Stanford join FDA?s Centers of Excellence in Regulatory Science and Innovation.

FDA finalizes guidance on expedited programs for new drug approvals for treatment of serious and life-threatening conditions.

Bristol-Myers Squibb announced collaborations with CytomX on probodies and with Incyte in an immunotherapy clinical trial.

The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.

Actavis develops a solid dosage manufacturing and packing facility at its Manati site in Puerto Rico.

EquipNet announced its 15th year of supplying asset management services.

DPx Holdings B.V. donated $110,000 to more than 20 different hospitals and organizations across the globe.

The EDQM grants Gnosis a CEP for teicoplanin, a true fermentation glycopeptide antibiotic produced by actinoplanes teichomyceticus strains.

Avantor Performance Materials appoints Michael Stubblefield as CEO.

GE Healthcare launches the Xuri IL-2 for the activation and expansion of T-lymphocytes.

Merck KGaA fill-finish expansion in Italy will be completed in 2017.

Cytovance Biologics and Selexys Pharmaceuticals enter an agreement for development of clinical trial materials.

Brookfield continues to supply viscometers and rheometers for laboratory and on-line process control applications.

Pfizer will submit a NDA with FDA for palbociclib, a treatment for locally advanced or metastatic breast cancer.

SAFC offers commercial and pilot-scale continuous-flow capacity.

BMS and AbbVie receive FDA breakthrough therapy designation for elotuzumab, an investigational humanized monoclonal antibody for multiple myeloma.

Novartis settles its litigation with the US subsidiary of Sun Pharma regarding Gleevec.

Meissner moves into its new headquarters in Camarillo, California.

FDA issues complete response letter for Novartis' RLX030 for acute heart failure.