The QMN Weekly Bulletin

FDA officials are offering mixed views on overseas inspection strategies, particularly for biologics and biosimilars, with some calling for enhanced inspections of all foreign facilities and others saying risk-based reviews work well abroad.

Impact Instrumentation didn’t identify or repair flaws, leaving nonconformities in finished or in-process devices, according to a recent Form 483.

Generic competition and ongoing enhancements to quality and manufacturing systems contributed to a slump in domestic sales and an overall revenue decline of 6 percent for Johnson & Johnson (J&J) in the third quarter, but the company’s manufacturing problems are taking a turn for the better.

News that Novartis will shutter two manufacturing sites in Switzerland has highlighted the pressures on the Swiss pharmaceutical industry.

French pharmaceutical manufacturer Sanofi recently notified doctors that they will soon face a shortage of an insulin pen product.

Drug manufacturer Corden Pharma Colorado said it would lay off 60 of its 260 workers as the company focuses on its new roles in contract manufacturing and development.

In order to satisfy increasing demands, Almac is expanding its manufacturing capacity to more than 30m(3) at its European Headquarters in Craigavon, UK.

Pfizer continues to expand its manufacturing operations in Lincoln.

CMC Biologics announced the execution of an agreement with Daiichi Sankyo to provide process development support and manufacture of several clinical-stage antibodies over a three-year period.