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Court denies Elizabeth Holmes' request to remain free while appealing conviction

Theranos founder Elizabeth Holmes and former CEO Ramesh "Sunny" Balwani were on Tuesday ordered to pay $452 million to victims of the blood-testing startup's fraud, and an appeals court also denied Holmes' request to remain out of prison while challenging her conviction. ....

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US FDA staff flag 'serious' safety risks for Intercept's NASH treatment

The U.S. health regulator's staff reviewers on Wednesday raised a string of concerns with Intercept Pharmaceuticals' treatment for a type of fatty liver disease, sending the drugmaker's shares plunging 22%. ....

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Japan's Otsuka Pharma gets FDA approval for Alzheimer's agitation drug

The U.S. Food and Drug Administration approved Otsuka Pharmaceutical's brexpiprazole to treat agitation in patients with Alzheimer's on Thursday, making it the first approved drug for the indication, the company said in a statement. ....

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Eisai, Biogen Alzheimer's drug Leqembi would cost US Medicare up to $5 bln a year, study finds

Wide coverage of Alzheimer's drug Leqembi would raise future costs for the U.S. Medicare health plan by $2 billion to $5 billion a year, according to a study led by researchers at the University of California, Los Angeles (UCLA). ....

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FDA reviewers flag concerns over Sarepta's gene therapy for muscle-wasting disorder

The U.S. Food and Drug Administration's staff reviewers raised concerns over limited data on Sarepta Therapeutics Inc's gene therapy for a muscle-wasting disorder, ahead of a meeting of the agency's advisers on Friday. ....

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