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The implementation of mandatory electronic filing has resulted in a dramatic increase in the number of drug safety reports filed with the European Medicines Agency (EMEA), according to the EMEA’s annual report.
Boston Scientific stock rose April 6 after the devicemaker won antitrust clearance from the Federal Trade Commission (FTC) for its $27 billion acquisition of former rival Guidant, whose shares also rose, according to published reports.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, Page 1).
Guidant has decided not to release current Xience V inventory and has voluntarily stopped enrolling new patients in one of its stent trials, because some of the products did not meet its manufacturing standards, Guidant announced March 29.
The European Union recently implemented the EU Clinical Trials Directive (CTD) to better protect clinical trial participants while streamlining the bureaucracy to make the EU more attractive for clinical research (CTA, Nov. 17, Page 1).
Canadian device manufacturer Nucryst announced Feb. 6 that its foam dressing with antimicrobial activity was approved for use in the European Union (EU).
A Dutch court has denied Angiotech Pharmaceuticals’ request for a preliminary injunction against coronary stent manufacturer Biosensors International in an ongoing patent infringement case, according to statements released by both companies.
Growing support for minimally invasive surgery combined with a growing elderly population will likely cause an increase in the use of heart stents in Europe, according to a recent study by consulting group Frost & Sullivan.
The European Commission approved Johnson & Johnson’s (J&J’s) planned $25.4 billion takeover of medical devicemaker Guidant Aug. 25, subject to a number of conditions regarding fair competition practices.