FDA panel votes to require new drug label wordings

Food and Drug Administration advisers voted Friday to require makers of widely used osteoporosis drugs to clarify how long patients should take them for the greatest benefit and least risk.

The FDA itself will later decide what the new label wording should say for each of the drugs: Fosamax, Boniva, Actonel, Atelvia and Reclast. The agency could require wording that recommends limiting how long each drug is taken, but it’s unclear how long that would be for each drug.

A few patients have suffered serious complications, including jawbone destruction, unusual thighbone fractures and cancer of the esophagus, generally after several years of taking the medicines.

AT&T counters U.S. attempt to block T-Mobile takeover

AT&T is countering the U.S. government’s attempt to block its $39 billion acquisition of T-Mobile by depicting the deal as a way to provide consumers with better cell phone service at lower prices.

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The argument, submitted in a Friday court filing, is AT&T Inc.’s first legal response to a lawsuit that the Department of Justice filed last week in an effort to ensure T-Mobile remains independent.

AT&T’s 27-page document echoed the company’s previous contention that buying rival T-Mobile will enable it to expand its mobile communications network so there are fewer dropped connections in a world where constant online access is becoming the norm.

The Justice Department believes there wouldn’t be enough competition if AT&T devours T-Mobile. The first hearing in the case is set for Sept. 21 in Washington.

McDonald’s shares tumble on overseas market reports

Shares of McDonald’s Corp. fell more than 4 percent Friday after the fast-food giant reported a slowdown in some overseas markets and missed analysts’ expectations on a key revenue measure.

The company said revenue at stores open at least 13 months declined 0.3 percent in August in the region of Asia/Pacific, the Middle East and Africa. That marked the first monthly decline in that area since November 2009. Companywide, revenue at stores open at least 13 months rose 3.5 percent, the company’s 100th consecutive month of growth by that metric. However, that missed analysts’ expectations for a 4.9 percent rise.

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The figure climbed 3.9 percent in the United States and 2.7 percent in Europe, McDonald’s largest market.

Shares fell $3.58, or 4.04 percent, to close at $85.03 Friday.

Federal regulators close a small Florida bank

Regulators on Friday closed a small bank in Florida, raising to 71 the number of U.S. bank failures this year.

The pace of closures has eased in 2011 as the economy has slowly improved and banks work their way through the bad debt accumulated in the recession. By this time last year, regulators had shuttered 119 banks.

The Federal Deposit Insurance Corp. seized First National Bank of Florida, based in Milton, Fla. The bank had $296.8 million in assets and $280.1 million in deposits.

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German software maker charged in Oracle case

A week after a big win against Oracle, German software maker SAP AG has been dealt a new blow in a theft case involving a now-defunct subsidiary.

The Justice Department has criminally charged the SAP subsidiary, TomorrowNow, with 12 counts related to the theft of software and documents from Oracle Corp. websites in a 4-year-old case. The theft, which SAP has acknowledged, led to a $1.3 billion jury verdict against SAP last year.

Last week, a federal judge threw out the award, calling it “grossly excessive.”

Unless Oracle accepts a lower, $272 million award, a new trial will be ordered in the civil case.

 


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