ALSO NOTED: FDA approves MedPointe's SOMA; EntreMed secures $20M loan; and much more...

> The FDA has approved MedPointe's SOMA (carisoprodol) 250 mg as a new recommended dose for the relief of discomfort associated with acute, painful musculoskeletal conditions, such as backache. Release

> EntreMed has completed a $20 million secured loan agreement with a syndicate of lenders led by GE Healthcare Financial Services. Release

> AstraZeneca is planning to outsource its manufacturing--all of it--starting with the basic, active ingredients in its products and then fanning out from there. Contract manufacturers in China and India are most likely to get the business. Report

> For years there's been talk of a centralized repository for all drug-testing data, one that's easily searchable and open to all comers. Now, as a September 30 deadline looms for the PDUFA, House and Senate negotiators are duking it out over the database. Report

> Speaking of the PDUFA, Andrew von Eschenbach (photo) sent out a memo saying that 2,000 workers could get pink slips this week if Congress doesn't renew user fees for drugs and medical devices. Report

And Finally... Researchers believe Chronic Fatigue Syndrome may be linked to a common stomach virus. Report

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