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FDA approves Jazz Pharmaceuticals’ Defitelio

BY David Salazar
SILVER SPRING, Md. — The Food and Drug Administration has approved Jazz Pharmaceuticals’ Defitelio (defibrotide sodium), a first-in-class treatment for a rare, life-threatening liver condition in patients who’ve received a stem cell transplant from blood or bone marrow.  
 
Defitelio is indicated to treat hepatic veno-occlusive disease (VOD in patients with additional kidney or lung abnormalities that develops after a hematopoietic stem cell transplant (HCST). The condition causes some veins in the liver to be blocked, reducing blood flow in the liver. The most severe form of hepatic VOD can cause kidney and lung failure. Though only about 2% of HCST patients develop VOD, the mortality rate among those who do is 80%. 
 
“The approval of Defitelio fills a significant need in the transplantation community to treat this rare but frequently fatal complication in patients who receive chemotherapy and HSCT,” said Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.  
 
The FDA granted priority review status to Defitelio and it received an orphan drug designation. The injectable drug’s distribution is expected to being within a week. 
 
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Omron names new president, CEO

BY Michael Johnsen

LAKE FOREST, Ill. – Omron Healthcare on Thursday announced that Ranndy Kellogg has been named president and CEO. Kellogg assumes his new leadership position from his previous role of COO at Omron Healthcare. The executive transition, as approved by Omron Healthcare's board of directors and effective today, gives Kellogg responsibility for all operations in the U.S. and Canada, as well as administrative and operational support for Latin America. 
 
Kellogg succeeds former managing executive officer, president and CEO Seiji Takeda, who will transition to the role of executive officer, global business strategy planning, sales and marketing, Europe and the Americas.  
 
"In his 12 years at Omron Healthcare, Ranndy Kellogg has been a respected leader for our company and in the field of blood pressure monitors," Takeda said. "Mr. Kellogg's new position will provide him with greater latitude to spearhead Omron's continued growth and influence in the market. On behalf of the board of directors, I would like to thank Ranndy for his stewardship and contributions to Omron Healthcare's vision and growth for the past 11 years."
 
Prior to his work at Omron Healthcare, Kellogg served as VP and director of marketing for Baxter Healthcare. Before joining Baxter Healthcare, Kellogg held the position of group marketing manager at CR Bard. Kellogg holds a master's in business administration from Northwestern University's Kellogg School of Management.
 
"I am honored to have the opportunity to serve as CEO and president of Omron Healthcare and to lead our work forward to empower millions of people to take charge of their heart health through our most advanced, precise technology and tools on the market," Kellogg said.
 
"This year we are ramping up our mission to confront the ongoing epidemic of heart attacks and strokes – we will do that by building upon Omron's heritage of accuracy with new products that provide deeper insights, encourage behavioral change and promote healthier lifestyle habits."
 
Omron Healthcare's team of executives, led by Kellogg, hosted a first look at its "Project Zero" Wrist and Upper Arm Blood Pressure Monitors and the new OMRON Connect App at the Consumer Electronic Show in Las Vegas in January. These clinically-tested, highly accurate heart health tools – set to improve heart health for millions of hypertensive individuals – will be available this year and are part of a major heart health initiative that the company is rolling out in 2016.
 

 
 
 
 
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C&D introduces Amazon Dash Button for Trojan

BY Michael Johnsen
EWING, N.J. – Church & Dwight on Thursday announced the launch of the Amazon Dash Button for Trojan. The Amazon Dash Button, a Wi-Fi connected device, is an Amazon product that helps to ensure Amazon Prime members never run out of their favorite products, allowing members to order items with a simple press of a button. 
 
"Throughout the brand's 100 year history, Trojan™ has always been a leader and innovator in sexual health," stated Bruce Weiss, VP marketing for Trojan. "We're excited to work with Amazon to deliver Trojan condoms right to our consumer's door with the push of a button. The Amazon Dash Button for Trojan further ensures our consumers are always prepared."
 
Amazon Prime members with the Amazon Dash Button for Trojan will be able to order their favorite Trojan condoms in seconds with the press of a button. The launch of the Trojan-branded Dash Button is just in time for April's National STI Awareness Month, C&D noted. 
 
 
 
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