The QMN Weekly Bulletin

An FDA review of counterfeit drug and diversion cases has identified three common schemes and found pharmaceutical wholesalers make up the largest percentage of suspects.

OraWell USA, a short-lived devicemaker specializing in in vitro diagnostic test kits for HIV detection, has shut down after an FDA warning that its test kits were not cleared and its manufacturing processes violated GMPs.

Efforts to resolve lingering manufacturing problems at Hospira’s Rocky Mount, N.C., facility led to a 17 percent earnings loss for the Illinois-based drugmaker in the third quarter.

“Right now, manufacturing experts from the 1950s would easily recognize the drug manufacturing processes of today,” said Janet Woodcock, director of the FDA’s Center for Evaluation and Drug Researc., during her AAPS 2011 keynote address.

Alnylam Pharmaceuticals has entered into a collaboration deal with GlaxoSmithKline (GSK) in which the UK pharmaceutical giant will use Alnylam’s new VaxiRNA enhanced virus production platform in the development of certain GSK vaccine products, such as a vaccine for influenza.

New research shows how metal surfaces that lack mirror symmetry could provide a novel approach towards manufacturing pharmaceuticals.

The $313 million investment and 707 jobs that Nephron Pharmaceuticals is bringing to the Midlands is one of the biggest economic development coups for Gov. Nikki Haley since taking office this year.

Drugmakers GlaxoSmithKline and Pfizer cemented their local Russian foothold on Wednesday as their HIV joint venture ViiV agreed to launch manufacturing in partnership with Russian drugmaker Binnopharm.

Accellent announced the opening of a 65,000-square foot manufacturing plant in Penang, Malaysia.