Merck & Co. and Schering-Plough Corp. are running newspaper ads to protect the reputation of the cholesterol-lowering Vytorin drug, after having announced disappointing results last week. The latest ENHANCE study, which aimed at measuring Vytorin’s ability to reduce clogged arteries, showed the drug to be only minimally more effective than a generic statin. Cardiologists are now questioning the use of Vytorin, which combines Zetia and Zocor (or simvastatin) into one pill.

The ENHANCE study was only an initial study and was not as thorough as clinical trials.

Novartis AG has received FDA approval for its Tekturna HCT drug for treating high blood pressure. The drug, which is a combination of the hypertension drug Tekturna (aliskiren) and diuretic (water pill) hydrochlorothiazide (HCT), was found to “offer greater blood pressure reductions that either component alone,” the company said. Possible side-effects include dizziness, diarrhea, cough and allergy. Novartis expects Tektruna HCT to hit the market in early February.

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The U.S. Food and Drug Administration (FDA) has expanded the indication for a liquid fibrin sealant to help control bleeding during general surgery. Fibrin is a protein that helps blood clot.

The sealant, called Evicel, which is manufactured by OMRIX Biopharmaceuticals, is sprayed or dripped on small, oozing blood vessels. Once applied, it forms a covering that helps stop bleeding. Evicel was previously approved for use during liver and vascular surgery. This approval expands Evicel’s indication to include general surgery applications.

A study of 135 patients undergoing abdominal surgery showed Evicel to be safe and effective in controlling bleeding. Adverse events reported during the clinical trial included anemia, abdominal abscess, blockage of the small intestine, and loss of urinary bladder tone, when the urinary bladder does not empty effectively, which can cause discomfort and infection.

FDA approved Evicel’s predecessor (Crosseal) in 2003 for use during liver surgery. It became Evicel in May 2007 when FDA expanded the indication to include use during vascular surgery.

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According to a report by the International Trade Adminstration, the medical device manufacturing market in Europe is expected to grow 9% in 2008. Europe has the second-largest market for medical devices globally. The report was released in October 2007, and credits an aging population and increased health care spending as the reasons for the continued growth.

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Varian Medical Systems has received an FDA 510(k) approval for its RapidArc radiotherapy technology, which makes it possible to deliver image-guided, intensity-modulated radiation therapy (IMRT) two to eight times faster and more precisely than is possible with conventional IMRT or helical tomotherapy.

RapidArc delivers a complete IMRT treatment in a single rotation of the treatment machine around the patient. The two FDA clearances for RapidArc cover the treatment hardware and the RapidArc treatment planning software module in Varian’s Eclipse treatment planning system. Varian will begin taking orders for RapidArc immediately, and will begin delivering it to customers in the spring of 2008.

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