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FDA Approvals - Kennedy urges tough tests for generic biologic drugs (Boston Globe)


Kennedy urges tough tests for generic biologic drugs (Boston Globe)
WASHINGTON -- Federal regulators charged with approving generic versions of the world's most expensive drugs should follow the lead of their cautious European counterparts, according to Senator Edward M. Kennedy . In Europe, requirements for approval are tailored to the complexity of an experimental drug and can include clinical trials that cost millions for generic manufacturers to conduct.

US approves Novartis drug for treating hypertension (Boston Globe)
Swiss pharmaceutical maker Novartis AG said yesterday it has received US approval for the hypertension drug Tekturna -- a potential blockbuster that has shown the ability to lower blood pressure more effectively than common treatments.

Aethlon Medical Announces FDA Submission (Business Wire via Yahoo! Finance)
SAN DIEGO----Aethlon Medical, Inc. , a pioneer in developing therapeutic devices for infectious disease, announced today it has submitted an Investigational Device Exemption to the U.S.
 

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