The QMN Weekly Bulletin

Noven Pharmaceutical’s failure to address underlying system problems related to the collection and evaluation of manufacturing information from its Daytrana transdermal patches was cited in a recent FDA warning letter.

St. Jude Medical benefited from Medtronic’s recall of its Sprint Fidelis leads, receiving an estimated $20 million in additional revenue during the fourth quarter of 2007 for its implantable cardioverter defibrillator (ICD) business.

The FDA has updated its recommendations for makers of medical gloves in a guidance covering testing, importation and 510(k) submissions.

Questions are hanging over the role of a Chinese manufacturing facility in the Baxter heparin scare after it has emerged that the U.S. Food and Drug Administration (FDA) has never inspected the facility.

Watson Pharmaceuticals Inc. shares rose Thursday, as analysts said the Food and Drug Administration’s inspection of a troubled Florida plant moves the drugmaker closer to resolving manufacturing issues and restarting operations.

Johnson & Johnson is voluntarily recalling a version of its blockbuster pain patch Duragesic because of manufacturing issues that could lead to accidental overdoses.

Saltigo GmbH, a wholly owned subsidiary of the Lanxess specialty chemicals group, has now officially inaugurated a state-of-the-art multipurpose unit for the production of active pharmaceutical ingredients and intermediates.

Shire Human Genetic Therapies is expanding its footprint in Massachusetts, according to the gene therapy company.

Akorn, Inc., an Illinois maker of sterile specialty pharmaceuticals with facilities in Somerset, said it has won a deal to manufacture an ophthalmic drug at its Garden State plant.