In the Region FDA requests more data about MedImmune...


July 12, 2002

In the Region

FDA requests more data about MedImmune vaccine

MedImmune Inc. said yesterday that the U.S. Food and Drug Administration requested more information about its inhalable influenza vaccine, FluMist.

The Gaithersburg biotechnology company, which is seeking FDA approval for FluMist, received from the FDA a complete response letter. The FDA has requested clarification and more information about data the company had sent it about the vaccine.

The FDA did not ask for any more clinical trials, the company said.


Xerox reports misallocating 2001 interest expense

Xerox Corp. said yesterday that it misallocated last year's interest expense in its annual report, but the mistake will have no impact on the company's reported net loss for the year.

In an amended regulatory filing released yesterday by the Securities and Exchange Commission, the copier company said it shifted $16 million among the four quarters of last year. The filing marks the second time in two weeks that the company has amended its annual report. On July 1, Xerox amended the document to include the financial statements of its venture with Fuji Photo Film Co. for 1999 and 2000.

On June 28, Stamford, Conn.-based Xerox restated its results for 1997 to last year as part of a settlement with the SEC, which found that the company had improperly accelerated its revenue recognition. The company also settled the SEC charges in April, paying a $10 million civil penalty.

23 more steel products exempted from tariffs

The Bush administration said yesterday that it was excluding 23 more products from the tariffs that the president imposed on imported steel to give the beleaguered U.S. industry time to become more competitive.

The latest exemptions bring to 247 the total number of products that have been excluded from the tariffs, which range from 8 percent to 30 percent.

Officials said the new exemptions cover 40,000 metric tons of imported steel, bringing the total of exempted products to almost 6 percent of the 13.1 million metric tons covered by the president's March tariff order.

SEC seeks more time to file against Kmart

The Securities and Exchange Commission has asked for an extension to file a claim against bankrupt retailer Kmart Corp., which is under investigation after a series of anonymous letters.

Kmart filed for Chapter 11 bankruptcy protection Jan. 22. The deadline for governmental units to file proofs of claim in the bankruptcy case is July 31. In a court filing this week, the SEC asked the court to give it until Oct. 29 to file a claim if it has one.

The SEC said it is investigating potential claims that it might make against the discount retailer. It said an extension would prevent it from filing a claim simply to protect its rights in the case.

Tokyo wary of weakness from the global economy

The Japanese government warned yesterday that though the nation's economy is recovering because of rebounding exports, uncertainties are growing about the global economy.

The Cabinet Office warned in its monthly report that a faltering U.S. rebound, big losses in worldwide stock markets and the plunging U.S. dollar were casting doubt over Japan's fragile recovery.

Japan has been struggling to pull itself out of economic doldrums for more than 10 years. In recent months, the government has noted signs of better times ahead, mostly because of growing exports. But a robust U.S. economy remains crucial if Japan hopes to keep its turnaround going. And a strong dollar is equally important in raising the value of the overseas earnings of Japan's big exporting corporations.

This column was compiled from reports by Sun staff writers, the Associated Press and Bloomberg News.

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