FDA to Consider Drug Importation in Battle Against High Drug Prices

FDA Commissioner Scott Gottlieb, once a critic of drug importation, is now tasked with the challenge of figuring out whether bringing certain low-cost drugs in from overseas will provide price relief for consumers.


FDA Approves Medtronic’s Endurant II Stent Graft System for Abdominal Aortic Aneurysm (AAA) | | Katalyst HLS

The Endurant stent graft system was created with the collaboration of over 250 physicians worldwide to treat infrarenal abdominal aortic aneurysms. The Endurant II/IIs Stent Graft System is used in patients who have an abdominal aortic aneurysm (AAA). The Heli-FX EndoAnchor System is used with the Endurant II/IIs Stent Graft System when it is needed to help keep the stent graft in place. http://www.KatalystHLS.com

FDA Priority Review Voucher Program – Katalyst HLS

Fuqua Research into Action: The Priority Review Voucher

In 2006, Fuqua Professors David Ridley, Henry Grabowski, and Jeff Moe published a paper proposing a priority review voucher. The voucher became law the following year. The voucher rewards developers of drugs for neglected diseases.
@Katalyst HealthCares & Life Sciences Inc.,

FDA approved L-glutamine powder for the treatment of sickle cell disease – Katalyst HLS

On July 7, 2017, the U.S. Food and Drug Administration approved L-glutamine oral powder (Endari, Emmaus Medical, Inc.) for oral administration to reduce the acute complications of sickle cell disease in adult and pediatric patients 5 years and older.
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Drug Clinical Trials Snapshots – US FDA

Did you know that some drugs affect men and women differently? For instance, women are often prescribed only half the dose that men take of the sleep medication Ambien. Race and ethnicity also make a difference. One type of drug commonly used to treat high blood pressure, ACE inhibitors, has been shown to be less effective in African American patients than in white patients. FDA’s Drug Trials Snapshots Summary Report provides a yearly average of the diversity of participants in the clinical trials for novel drugs approved in 2015 and 2016.