FDA warns Stryker on quality issues, marketing practices

(Reuters) – Orthopedic implant maker Stryker Corp said it received a warning letter from the U.S. Food and Drug Administration related to quality concerns at its Portage, Michigan facility. The letter, which followed an inspection of the facility in November, also noted that Stryker failed to notify the regulator of a product recall and had been marketing devices without required approvals. The FDA acknowledged that Stryker has submitted corrective action plans for the quality and recall issues, Stryker said. …

Vytorin study to continue after review; Merck shares jump

A view of the Merck & Co. campus in Linden, New JerseyBy Ransdell Pierson and Caroline Humer (Reuters) – An independent monitoring board said a large trial of Merck & Co's Vytorin cholesterol drug can continue, suggesting no major safety issues have yet been seen with the pill. The news eased investor concerns that a safety issue could arise and further hurt sales of already struggling Vytorin. Merck shares were up 3.7 percent in Tuesday morning trading. "We believe it is increasingly difficult to suggest any safety issues with (Vytorin)," JPMorgan analyst Chris Schott said, in view of the panel's green light to continue with the study. …

FDA says Zithromax can cause fatal irregular heart rhythm

A woman walks past the Pfizer Inc. headquarters in New York(Reuters) – The Food and Drug Administration warned on Tuesday that the antibiotic azithromycin, sold as Zithromax, can cause a potentially fatal irregular heart rhythm in some patients. A study in the New England Journal of Medicine last May compared the risk of cardiovascular death from different antibacterial drugs and found that the drug, which is made by Pfizer Inc and is also sold by generic drugmakers, had a higher rate of death. …

Shire boosts rare diseases business by buying Premacure

LONDON (Reuters) – Shire increased its investment in rare diseases on Tuesday by acquiring privately held Swedish biotech firm Premacure, which is developing a drug for a potentially blinding eye disorder in premature babies. Britain’s third biggest drugmaker did not reveal how much it was paying for the Uppsala-based business but said it would pay a sum upfront followed by contingent payments based on clinical development and commercial success. …

U.S. soldier charged in 2009 Iraq shootings to appear in court

By Eric M. Johnson SEATTLE (Reuters) – A U.S. soldier accused of killing five fellow servicemen at a military combat stress center in Baghdad is set to appear at a pre-trial hearing on Tuesday as Army prosecutors and defense attorneys present motions concerning his mental health. Sergeant John Russell, who could face the death penalty if convicted, is accused of going on a shooting spree at Camp Liberty, near the Baghdad airport, in a 2009 assault the military said at the time could have been triggered by combat stress. …

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