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June 2012 Drug Information Update - Pharmacy Benefits ...

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Heart Associations's Emerging Science Series webinar.<br />

Article link: http://www.medpagetoday.com/Cardiology/Strokes/32373<br />

Source website: http://www.medpagetoday.com/<br />

FDA extends review for Salix diarrhea drug<br />

April 30, <strong>2012</strong><br />

Salix Pharmaceuticals Ltd said U.S. health regulators have extended the review date by three<br />

months for its experimental pill for HIV therapy-related diarrhea. The U.S. Food and <strong>Drug</strong><br />

Administration was to review the drug, crofelemer, on <strong>June</strong> 5. The FDA has notified Salix that it<br />

requires additional time for a full review but did not seek any additional studies, the company<br />

said in a statement.<br />

Article link: http://www.reuters.com/article/<strong>2012</strong>/04/30/ussalixpharmaceuticalsidUSBRE83T135<strong>2012</strong>0430<br />

Source website: http://www.reuters.com/<br />

Obesity-Linked Diabetes Tougher to Treat in Children<br />

April 30, <strong>2012</strong><br />

Type 2 diabetes is harder to treat in children ages 10 to 17 than it is in adults, according to one of<br />

the first large studies of the disease in younger people. The research also found that diabetes<br />

develops more rapidly in this age group. About 700 overweight and obese U.S. children and<br />

teens were given three therapies in the study: The oral drug metformin alone; that medicine<br />

combined with GlaxoSmithKline Plc (GSK)’s Avandia; and metformin used alone with diet and<br />

exercise.<br />

Article link: http://www.bloomberg.com/news/<strong>2012</strong>-04-30/obesity-linked-diabetes-tougher-totreatin-chindren.html<br />

Source website: http://www.bloomberg.com/<br />

U.S. needs better way to track drug safety – study<br />

May 1, <strong>2012</strong><br />

The U.S. Food and <strong>Drug</strong> Administration should review drugs on a regular basis for as long as<br />

they are on the market in order to catch any new safety issues, according to a report from an<br />

independent research body. The Institute of Medicine, which often advises the government on<br />

scientific matters, said the FDA should then create a comprehensive, publicly available<br />

document that reflects risks that crop up throughout the "lifecycle" of the drug.<br />

Article link: http://www.reuters.com/article/<strong>2012</strong>/05/01/us-fda-iom-safetyidUSBRE840154<strong>2012</strong>0501<br />

Source website: http://www.reuters.com/<br />

Protalix Wins FDA Approval for Its First <strong>Drug</strong> on the Market<br />

May 1, <strong>2012</strong><br />

The Food and <strong>Drug</strong> Administration cleared the product called Elelyso to treat a condition caused<br />

by lack of an enzyme that can lead to spleen and liver enlargement known as Gaucher disease.<br />

The drug, chemically known as taliglucerase, is approved for Type 1 Gaucher disease affecting<br />

about 6,000 people in the U.S., the agency said in a statement today.<br />

Article link: http://www.bloomberg.com/news/<strong>2012</strong>-05-01/protalix-wins-fda-approval-for-itsfirstdrug-on-the-market.htmll<br />

Source website: http://www.bloomberg.com/<br />

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