BioPharm International Editors

FDA inspection found cGMP violations in the Bangalore, India API manufacturing facility.

The National Institutes of Health and the National Science Foundation set up biomedical innovation and business program.

FDA issues guidance on the use of social media in regards to prescription drugs.

Hospira announces a voluntary nationwide recall due to particulates from a glass defect.

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

FDA provides advice to supply-chain stakeholders on how to identify suspect drug products and how to notify the agency of those products.

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

Catalent and AAPS announce the five winners of its annual academic competition.

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

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Draft guidance from FDA includes information essential for the completion of ANDA applications.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

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

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.