Lilly withdraws sepsis drug Xigris after 10 years

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Lilly withdraws Xigris from market. Eli Lilly (NYSE:LLY) is pulling its sepsis drug Xigris, which accounted for $104 million in sales in 2010, after a new study showed that the drug didn’t improve survival in patients with septic shock. The move will cost Lilly as much as to $95 million in charges next quarter, plus an additional $100 million in sales, the company said. Shares fell 1.2 percent.

Rapid growth for remote monitoring devices. Remote patient monitoring is the fastest growing segment of the medical device market, according to a new report from Kalorama Information. The growth rate was 23 percent from 2008 to 2010.

How effective is the flu shot really? The medical community urges everyone to get a flu shot, but the vaccine may not be as effective as people think. A report published in The Lancet concluded that it is moderately effective in keeping healthy adults healthy, but there is not sufficient evidence of its effect in some people who need it most, including those age 65 and over.

Two afib devices get questionable reviews. Alongside an FDA panel’s review of AtriCure’s afib device comes another concerning review of a trial for a Medtronic’s Cardiac Ablation system. According to an FDA panel, the device was successful in treating arrythmia but increased a patient’s risk for stroke, an alarming finding as the device is pending approval.

The highs and lows of medical device approval reform. Lobbying to “fix” the medical device FDA approval process has surged this year: 10 bills related to the process were introduced by Republicans in the House in October alone. The FDA has responded with initiatives to reduce regulatory burdens and encourage innovation. The Times has put together a deeper look at the dialogue around the medical device approval process that’s happened this year.