The QMN Weekly Bulletin

Recent positive regulatory inspections of Genzyme’s new Framingham, Mass., facility are lifting hopes that the agency will approve the plant in the first quarter of 2012, and in the meantime allow for additional sales of the company’s Fabry disease drug Fabrazyme, the drugmaker says.

Device-related adverse events rose 13 percent to 10,280 in the UK during 2010, according to the Medicines and Healthcare products Regulatory Agency (MHRA).

Drug industry intransigence is one barrier the U.S. Food and Drug Administration (FDA) faces in its effort to tighten the world’s pharmaceutical supply chain, according to a new report.

Federal health officials have given a green light for a first step toward reopening for a Wisconsin business shut down after making and distributing contaminated medical wipes blamed for illnesses and deaths nationwide.

Global drugmakers may have turned risk-averse toward buying or forming partnerships with Indian makers of generic medicines after being hit by revenue losses stemming from quality and compliance issues over previous acquisitions and tie-ups.

Pfizer’s biotechnology manufacturing facility at Grange Castle in Dublin is to supply almost 500 million vaccines to developing countries under an initiative part-funded by the Bill and Melanie Gates Foundation.

A company that works with many of the world’s top drugmakers is getting ready to expand its North Charleston, S.C., laboratory and manufacturing operation.

Shasun Pharmaceuticals is planning to expand its contract manufacturing business by partnering with multinational companies to manufacture their patented products for Indian and Asian drug markets.

U.S.-based IGI Laboratories has entered into a long-term strategic partnership with Medimetriks Pharmaceuticals. Under the terms of the alliance, IGI Laboratories will develop and manufacture prescription topical drug products owned by Medimetriks.