Laura Bush

Following a five-week inspection of Genzyme's plant in Allston Landing, MA, the US Food and Drug Administration is still not satisfied with the company?s large-scale manufacturing of Lumizyme.

The Korean CMO Celltrion and Hospira, a small-molecule injectable generics and drug delivery company based in Lake Forest, IL, agree to co-market biosimilars developed by Celltrion.

Diminutive bacteria with the right geometry (i.e. very thin) may be useful for research and development work on sterilizing-grade and other 0.2 uM filters, said Kurt Brorson, PhD, a staff scientist for the FDA/CDER's Division of Monoclonal Antibodies.

It seems clear that insuring the roughly 46 million Americans who are now uninsured will increase drug sales.

The US Food and Drug Administration announced yesterday that it has approved four vaccines against the 2009(A)H1N1 (?swine?) influenza virus.

Lonza (Basel, Switzerland), broke ground earlier this week on a new cell therapy manufacturing facility in Tuas Biomedical Park, Singapore, adjacent to Lonza?s large-scale mammalian manufacturing facility.

Novavax (Rockville, MD) recently achieved positive Phase 2a results for its trivalent virus-like particle (VLP) vaccine against seasonal influenza, and positive preclinical results for a VLP vaccine against H1NI (swine) flu.

If risk assessments only identify "the usual suspects," the process will not add much value.

ICH Q9 encourages companies to apply the concept of quality risk management. Easier said than done.