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Lilly and Boehringer Ingelheim’s Basaglar granted tentative approval

BY Ryan Chavis

INDIANAPOLIS and RIDGEFIELD, Conn. — The Food and Drug Administration has granted tentative approval for Basaglar (insulin glargine injection), which is used to improve glycemic control in adults with Type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with Type 1 diabetes.

Basaglar is Eli Lilly and Co. and Boehringer Ingelheim's basal insulin, which provides bloog sugar control in between meals and at night. The drug is not recommended for the treatment of diabetic ketoacidosis, the companies said.

"The tentative approval for Basaglar is another step toward providing an important option for people with diabetes in the United States who need basal insulin treatment," said Enrique Conterno, president of Lilly Diabetes. "We believe insulin glargine will continue to be used widely for many years, and Lilly and Boehringer Ingelheim are committed to addressing the needs of people living with diabetes and providing support beyond the medicine."

While the FDA has determined that Basaglar meets the regulatory requirments for approval, it is subject to an automatic stay of up to 30 months due to litigation filed by Sanofi, which claimed patent infringement. Due to the Drug Price Competition and Patent Term Restoration Act, the agency cannot grant final approval until the end of the 30-month period in mid-2016, unless the court finds in favor of Lilly before such time.

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Nielsen announces new global president and president North America

BY Michael Johnsen

SCHAUMBURG, Ill. — Nielsen on Monday announced the appointments of two executive leaders: John Lewis as global president and Karen Fichuk as president North America. The appointments are effective immediately.
 
“The past seven years have been full of growth, innovation and positive change for Nielsen and I’m pleased to take on a new and expanded role, leading all commercial teams worldwide,” Lewis stated. “Karen Fichuk has been with Nielsen for over 20 years, gaining broad experience across Nielsen’s extensive retailing and manufacturing client base. I have tremendous confidence in her ability to move the business forward with her commitment to analytics and big data outcomes.”  
 
Previously, Lewis was president, Americas with responsibility for leading Nielsen’s Watch and Buy growth strategy in Latin America as well as managing the business performance and strategic direction of Nielsen Buy in the United States and Canada. From 2006 to 2013, John led Nielsen’s North America Buy business, where he oversaw a number of strategic acquisitions to build Nielsen’s analytic and insights capabilities, integrated Watch and Buy offerings across the client base, and championed the global growth of Nielsen’s major CPG clients in North America. From 1994 to 1999, John also served as EVP marketing, ACNielsen USA. During this tenure, he improved the marketing function, accelerated product development, helped restore ACNielsen's competitive leadership position and successfully launched new products. 
 
Fichuk was most recently the North American commercial go-to-market leader. In that role, she introduced new service models to address client needs in a dynamic and competitive CPG marketplace. She has also led the North American Nielsen retail business and served as global client leader for Kraft and Mondelēz. 
 
 

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NBTY names new CEO

BY Michael Johnsen

RONKONKOMA, N.Y. — NBTY on Tuesday named Steven Cahillane CEO. A 25-year consumer goods industry veteran, Cahillane comes to NBTY from Coca-Cola, where he led the successful integration of Coca‐Cola Enterprises' North American bottling operation and drove significant market share gains as president of Coca-Cola Americas. 
 
"Steve has an exceptional track record of building brands and delivering shareholder value in consumer goods industries," stated Sandra Horbach, chairman of the Board of NBTY and head of the Carlyle Group's consumer-retail team. "Steve is an experienced and thoughtful executive who will lead NBTY to the next level of market penetration and financial success."
 
Cahillane, who succeeds Jeff Nagel, begins his new role on Sept. 8. "We appreciate the job that CEO Jeff Nagel has accomplished in positioning NBTY well for the future, and we wish him the best as he transitions to a new career opportunity," Horbach said. 
 
Prior to becoming president of Coca-Cola Americas in 2013, Cahillane was president and CEO of Coca-Cola Refreshments and president of Coca‐Cola Enterprises for North America and Europe. Before joining Coca-Cola in 2007, Cahillane held several senior roles at InBev (now AB Inbev), including chief commercial officer, CEO of Interbrew U.K. and CEO of Labatt USA. Cahillane previously held positions with Coors Distributing Company, State Street Brewing Company and E&J Gallo Winery.
 
Cahillane, 49, earned his BA from Northwestern University and his MBA from Harvard University. He serves on several corporate and philanthropic boards and is an avid marathon runner.

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