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European regulators have given medical devicemaker Medtronic CE mark approval to sell its Endeavor drug-eluting stent (DES) system in EU member countries. The device is designed to open patients’ clogged arteries during angioplasty procedures.
The EU is implementing a series of broad new drug safety requirements this fall that will compel pharmaceutical companies to submit mandatory adverse-event reports as well as risk management plans for their drug products.
Novartis is proposing to divest a small group of pharmaceutical products as a means to gain European Union (EU) approval for its acquisition of German generics company Hexal AG.
Medtronic has introduced its Attain Select 6238 TEL Guide Catheter Set, which aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure.
The pharmaceutical markets of the 10 European Union (EU) member countries added to the EU in 2004 have been rapidly expanding in recent years, despite more subdued growth in the rest of the region, according to a new research report.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a pair of action alerts last week — one for nasogastric enteral feeding tubes and another for peak expiratory flow meters (PFMs).
The European Commission (E.C.) wants to reclassify hip, shoulder and knee implants from class IIb to class III, and health officials in Australia announced last week that they intend to follow the commission’s direction.
The supervisory board of French pharma giant Aventis, which has been trying to fend off a hostile takeover bid by the smaller French drugmaker Sanofi-Synthelabo, is ready to explore the possibility of taking refuge in the arms of Novartis.
A flurry of subsidiary reshuffling occurred within Merck’s global corporate domain this week, including the completion of the sale of its half-interest in Johnson & Johnson MSD.
Early sales figures for Boston Scientific’s drug-coated Taxus stent indicate the device is well on its way to meeting the company’s goal of capturing 70 percent of the U.S. coronary stent market within 70 days of launch.