Pharmaceutical Technology Editors

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

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

EDQM details the agency?s accomplishments in 2013.

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

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

Funding boosts life-sciences manufacturing in West Michigan.

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.

EMA has published a new guidance template for the qualified person’s declaration concerning GMP compliance of API manufacture. The QP declaration template provides the basis for demonstrating compliance of the API manufacture with GMP requirements and ensures that the manufacturer has sufficient knowledge on the supply chain.

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Draft guidance from FDA includes information essential for the completion of ANDA applications.

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

USP and USAID give prequalification status to Capreomycin, an anti-tuberculosis injectable.

Xcelience opens a clinical packaging and distribution facility in Birmingham, UK.

APIC provides guidance on cleaning validation in API plants and how to implement GDP for APIs.

Despite GMP deficiencies, EMA reinstates GMP certificate for Ranbaxy's Toansa facility, citing no threat to public health.

Malvern Instruments will acquire the MicroCal business from GE Healthcare Life Sciences.

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

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.