The QMN Weekly Bulletin

The European Medicines Agency (EMEA) suspended the marketing authorization for Roche’s HIV treatment Viracept after a manufacturing error resulted in a recall of all batches of the product.

The European Medicines Agency’s (EMEA) new draft guideline on the production and quality control of monoclonal antibodies (MAb) says it is acceptable for firms to employ a “platform manufacturing” approach for production process development.

Following its response to an FDA warning letter regarding its manufacturing facility in Cork, Ireland, Stryker considers its operations in full compliance with agency regulations, saying it has already employed the necessary corrective actions, the company told MQN.

The National Standards Authority of Ireland (NSAI) is redefining the medical device certification industry by offering North America's only time-to-market certification service for medical devices.

MonoGen announced that the FDA has determined the relocation of its manufacturing facility will require a 180-day PMA supplement.

The FDA issued MedWatch alerts for two injectable antibiotics, one to notify physicians of a recall of Merck’s Invanz and one highlighting a new warning for Roche’s Rocephin, the agency said.

Boston Scientific announced plans to explore the sale of its fluid management business, which would include its catheter manufacturing plant in Glens Falls.

Thermo Fisher Scientific, the world leader in serving science, today announced it has entered into an agreement to acquire Qualigens Fine Chemicals, a division of GlaxoSmithKline Pharmaceuticals (GSK India) based in Mumbai.

Singapore's manufacturing output was 7.4 percent lower in June than a year before because the output of the biomedical industry slumped and production of electronics remained weak, the Economic Development Board said.