News

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

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

Draft guidance from FDA includes information essential for the completion of ANDA applications.

Cellectis enters an agreement with CELLforCURE for cGMP clinical manufacturing of allogeneic T-cells.

Merck acquires Idenix Pharmaceuticals for $3.85 billion.

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.

Innovative polyethylene film sets new benchmark

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

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

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

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

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

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

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.

Researchers from Harvard have reproduced the structure, functions, and cellular make-up of bone marrow, to create a device known as bone marrow-on- a-chip.

Johns Hopkins researchers use stem cells derived from human body fat to deliver treatment for brain tumors.

NIH study reveals a new cancer immunotherapy method could be effective against a range of cancers.

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

PacificGMP doubles its GMP production capacity with the addition of a second System 1000 Bioreactor platform.

GE Healthcare introduces the Cytiva Plus Cardiomyocytes, a high fidelity human heart cell model.

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

GSK selects Genedata Biologics as an R&D data management and workflow-support platform.

The companies aim to discover and develop kinase inhibitors for treating autoimmune disorders.

Rockland Immunochemicals develops new laboratories in Limerick, PA.

The 11th Annual Global Biomanufacturing Study includes a global analysis of 238 biomanufacturers and 178 suppliers in 31 countries.

FDA targets illegal online pharmacies that sell unapproved prescription drugs to US consumers.

EMD Millipore expands its Provantage upstream bioproduction services into North America.